medicines in emro countries - who · 2 aga khan university karachi ... area of access to and use of...

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Identification of Priority Policy Research

Questions in the area of Access to and Use of

Medicines in EMRO Countries:

Focusing on Iran, Pakistan and Lebanon

Project team for the Eastern Mediterranean Region:

Arash Rashidian1, Shehla Zaidi

2, Samer Jabbour

3, Fatemeh

Soleymani1, Nader Jahanmehr

1

1 Tehran University of Medical Sciences

2 Aga Khan University Karachi

3 American University of Beirut

Funded by:

The Alliance for Health Policy and Systems Research

Access to Medicines Policy Research

July 2011

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Identification of Priority Policy Research Questions in the

area of Access to and Use of Medicines in EMRO Countries:

Focusing on Iran, Pakistan and Lebanon

Country specific teams:

Iran: Arash Rashidian, Nader Jahanmehr, Fatemeh

Soleymani, Rasoul Dinarvand

Pakistan: Shehla Zaidi, Noureen Nishtar

Lebanon: Samer Jabbour, Rouham Yamout and colleagues

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Contents 1

Abstract ..............................................................................................................................10

Executive summary..........................................................................................................12

Background and objectives .............................................................................................16

Goal, purpose and objectives .....................................................................................18

General Objective: ........................................................................................................18

Objectives: .....................................................................................................................18

Methods ..............................................................................................................................20

Literature reviews .........................................................................................................20

Search strategy – regional literature .....................................................................20

Search for Iranian literature in Farsi (Persian) .....................................................23

Previous research priority setting in Iran ..............................................................24

Search Strategy and literature review - Pakistan ................................................24

Search strategy and literature review - Lebanon ................................................28

Inclusion process and criteria and data extraction .................................................31

Data extraction tool ..................................................................................................32

Qualitative interviews ..................................................................................................34

Key informant interviews – Iran and the region ..................................................34

Key informant Interviews - Pakistan......................................................................37

Key informant interviews - Lebanon ......................................................................38

Consensus development ..............................................................................................42

Consensus development - Iran ...............................................................................42

Consensus development - Pakistan .......................................................................45

Consensus development and priority research questions - Lebanon ...............46

Results – literature review – country cases studies ...................................................50

Literature review - Iran ...............................................................................................52

Literature review, papers locally published in Iran and grey literature ...........52

Literature review, papers published from Iran in international journals .........58

Literature review - Pakistan ........................................................................................64

RATIONAL USE OF MEDICINES IN PAKISTAN ......................................................64

AFFORDABILITY & FINANCING ...............................................................................69

RELIABLE HEALTH SYSTEMS ...................................................................................71

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Regulation: Licensing, Registration, Pricing, and Quality Control ....................80

Literature review - Lebanon ........................................................................................85

Journal articles ...........................................................................................................85

Published and unpublished documents and gray literature ...............................88

Research questions emanating from the literature review ................................91

Results - Literature on access to medicines issues in the EMR area .......................93

Producing the evidence: number and geographical distribution of countries of

origins of the identified publications ..........................................................................93

Countries of focus and ATM issues of focus .............................................................96

Limitations of the regional literature review .......................................................... 104

Access to medicine as a research priority: still a Cinderella topic? ....................... 106

Policy maker attention to ATM research ................................................................. 106

Researcher and research funder attention to ATM research ............................... 108

Results – qualitative interviews ................................................................................... 114

Key informant interviews, Iran and the region ..................................................... 114

Key informant interviews, Pakistan ......................................................................... 130

Key informant interviews, Lebanon ......................................................................... 135

Policy concerns ........................................................................................................ 135

General points .......................................................................................................... 135

Thematic analysis .................................................................................................... 137

Research questions emanating from key informant interviews ...................... 140

Results – qualitative interviews, EMRO region ...................................................... 141

Priority research areas for ATM – findings and consensus ...................................... 142

Consensus development on research priorities - Iran.......................................... 142

Consensus development on research priorities - Pakistan .................................. 147

Consensus development on research priorities - Lebanon .................................. 159

Conclusions ...................................................................................................................... 160

Acknowledgements ........................................................................................................ 163

References – regional study ......................................................................................... 164

Reference list. List of EMR region literature on ATM issues ................................ 170

References: list of Journal articles – Lebanon ....................................................... 188

Pakistan references .................................................................................................... 191

Appendices ...................................................................................................................... 196

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Pharmaceutical system in Iran ................................................................................. 196

Pakistan country profile ............................................................................................. 207

Key informant interview rsources ............................................................................ 209

Interview guide for regional experts .................................................................... 209

Interview guide in Farsi .......................................................................................... 213

Interviewee invitation letter for regional experts .............................................. 217

Thematic framework – in Farsi ............................................................................. 218

Appendix : Search strategies for Lebanon .......................................................... 222

Interview guide (modified after the guide provided by Dr. Arash Rashidian et

al) ............................................................................................................................... 225

Access to Medicines list of research priority topics by the level of barriers to

ATM ............................................................................................................................... 228

Research questions emanating from literature review - Lebanon...................... 239

Research questions emanating From key informant interviews - Lebanon ...... 242

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Table of figures

Figure 1. Improving Access to Essential Medicines: A Framework for Collective

Action in Line with Millennium Development Goals* ...................................... 20

Figure 3. Research Study Selection Diagram - Pakistan .................................... 26

Figure 2. Mapping of key stakeholders in Pakistan .......................................... 37

Figure 4: Flow chart of search strategies in electronic databases for ATM ....... 51

Figure 5. ATM issue categorization for papers published in Iran's journals. ..... 54

Figure 6. Growth in ADR reporting in Iran. Figure reproduced using Cheraghali

et al 2003 data. ................................................................................................ 57

Figure 7. An increasing trend: ATM papers on Iran published in local Farsi

(Persian) journals and international English language journals. ....................... 59

Figure 8. Percentage of patients receiving antibiotics. ..................................... 65

Figure 9. Number of medicines per prescription .............................................. 67

Figure 10. Percentage of patients receiving injections ..................................... 68

Figure 11. Share of Total Pharmaceutical Expenditure in Total Health

Expenditure ..................................................................................................... 69

Figure 12. Share of Public and Private Sectors in Total Pharmaceutical

Expenditure ..................................................................................................... 70

Figure 13. Distribution of the country of origin of publications for access to

medicines issues in the EMR ............................................................................ 94

Figure 14. The number of ATM publications per year. Note that 2011 covers

only the first half of this year. .......................................................................... 95

Figure 15. The number of publications discussing AT issues in EMR's low and

middle countries .............................................................................................. 97

Figure 16. Proportion of publications discussing each ATM issue in EMR

countries .......................................................................................................... 97

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Figure 17. Distribution of ATM issues discussed, and the level of barriers

considered in publications: Iran, Jordan, Lebanon, Pakistan and Sudan. ....... 100

Figure 18. Medicines affordability in Iran, in comparison with other countries

(source: WHO, the World Medicines Situation Report – 2011). ..................... 108

Figure 19. The percentage of prescriptions containing antimicrobials or

injectable medicines. Source: The National Committee of Rational Drug Use in

Iran 2010........................................................................................................ 198

Figure 20. Items per prescription in 2006 – a provincial comparison. ............ 199

Figure 21. National trend in mean items per prescription. 1998-2010 ........... 199

Figure 22. The first pharmacy established in Birjand in 1933, eastern Iran. The

pharmacy is still active. Photo © Arash Rashidian, 2010. ............................... 206

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Table of tables

Table 1. Search strategy for regional literature ................................................ 22

Table 2. Data extraction tool ............................................................................ 33

Table 3. Key informants' matrix: The interviewees are selected from the

following categories in Iran and in the region. ................................................. 35

Table 4. The main categories for the identification of research priorities ........ 44

Table 5. An example of the consensus development tool ................................ 44

Table 6. Distribution of papers published annually in Iran's Farsi (Persian)

language scientific journals and the categorization of ATM issues and levels of

barriers discussed. ........................................................................................... 55

Table 7. Provincial or national distribution of issues covered in papers

published in Iran's Farsi (Persian) language scientific journals and the

categorization of ATM issues and levels of barriers discussed. ........................ 56

Table 8. Annual a growth in the number of ATM papers from Iran in

international literature, and the distribution of issues covered and the levels of

barriers discussed ............................................................................................ 60

Table 9. A more detailed analysis of research papers published on ATM in Iran

in local and international literature ................................................................. 61

Table 10. Level of Dissatisfaction with Public Sector and Underlying Reasons . 71

Table 11. Medicine Availability at Public Facilities and Private Pharmacies ..... 72

Table 12. 171717

Availability of Medicines in Percentage of BHUs and RHCs ....... 72

Table 13. Availability of Different Medicines in THQHs and DHQHs ................. 74

Table 14. Median MPRs for innovator brands and lowest priced generics in the

public (procurement only) and private sector (patient price only) ................... 75

Table 15. Availability of Essential Drugs and Vaccines: Comparison between

Contracted and Non-Contracted BHUs ............................................................ 77

Table 16. Areas Covered by National Medicines Policy .................................... 80

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Table 17. ATM issues discussed each year in EMR publications ....................... 98

Table 18. The level of barriers studied in EMR publications each year ............. 99

Table 19. Ten agreed criteria for research priority setting (Pharmaceutical

Sector Research Network). ............................................................................ 110

Table 20. Twenty high priority research topics for pharmaceutical sector,

developed by the Pharmaceutical Sector Research Network. ........................ 112

Table 21. Conceptual thematic framework from Iran and regional data –

qualitative analyses and policy concerns ....................................................... 115

Table 22. Iran ATM research priorities. The results of the consensus

development meeting .................................................................................... 143

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Abstract

Background

The provision of reliable access to affordable, appropriate and high-quality

medicines is a key component of a functioning health system. Access to

medicines needs to be fully integrated with health financing, human resource

planning, service delivery, information and governance systems. We aimed to

identify the policy concerns and related policy research questions in the field

of access to and use of medicines in low and middles income countries (LMICs)

within the Eastern Mediterranean Region (EMR) of the WHO, while focusing on

such issues in Iran, Lebanon and Pakistan.

Methods

Three closely linked teams conducted the studies. The teams conducted

systematic search strategies of international databases, country specific

databases and also search the grey literature to identify country specific and

regional literature on ATM.

A total of seventy key informant interviews were conducted. The interviews

were recorded and transcribed and were subsequently analyzed using

conceptual frameworks developed based on the ATM concepts and regional

and country level concerns.

Consensus development approaches used formal consensus development

methods (in two countries) and focus group discussions (in one country) for

the identification of the research priorities. Then the final outcomes of

different studies (three country case studies and regional study) were collated

with each other.

Main findings

Almost 80% of AT research in the region is originating from the region. While

there is a wide variation in the number of publications originating from

different countries. Conceptual frameworks of policy concerns and research

priority lists for use in the region were developed. The main concerns of the

key informants were around the affordability and financing aspects of access

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to medicines, followed by issues of availability and rational use of medicines.

The key informants paid attention to all levels of barriers to access: the

household level, providers (public or private sector), health system, other

sectors and cross border issues. The identified previous research on the issue,

however, did not reflect that. ATM research in the region is heavily biased

towards RUD.

Conclusions

The picture of research on the ATM in the region is better than what had been

reported in recent publications. There is a growing trend, over the years, of

more and better quality studies from the region appearing in international

journals.

The majority of policy concerns were not addressed by published research. The

study clearly indicates that there is dire need for further research on financing

and affordability aspects of ATM in the region. Also cross-border issues and

other sectors roles on access to medicines in the region has not explored

widely. It seems that many household (demand side) studies in the region

remain of poor quality and limited methods. Together, these main areas

should provide the main aspects of access to medicines research in the region.

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Executive summary


medicines is a key component of a functioning health system. Access to


planning, service delivery, information and governance systems. As part of the

Access to Medicines Policy Research project, funded by the WHO's Alliance for

Health Policy and Systems Research, studies are conducted in order to increase

access to and improve the use of medicines in low and middle income

countries, particularly for the poor (MDG 8). In this study we aimed to identify

the policy concerns and related policy research questions in the field of access

to and use of medicines in low and middles income countries (LMICs) within

the Eastern Mediterranean Region (EMR) of the WHO, while focusing on such

issues in Iran, Lebanon and Pakistan.

This is the first study conducted in this region that has collated published

literature and summarized the main policy concerns to identify ATM research

priorities. In this study we used an extensive search of local and regional

literature, interviews with key informants, analysis of previous priority setting

exercises and consensus development approaches to identify the main

research priorities for ATM research. We developed detailed maps of research

on the issue, conceptual frameworks of policy concerns and issues, and

identified lists of ATM research priorities for the countries of focus and the

region as a whole.

Three closely linked teams based at the Tehran University of Medical sciences

(Iran), the American University of Beirut (Lebanon) and the Aga Khan

University Karachi (Pakistan) conducted the studies. The teams conducted

systematic search strategies of international databases, country specific

databases and also search the grey literature to identify country specific and

regional literature on ATM. Then they collated essential data from the studies

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using purposefully defined data extraction forms. The teams used the

conceptual framework developed by the WHO and the AHPSR for ATM for data

extraction and analysis. Additional to this an analysis of previous research

priority setting exercises was conducted in one country to see how much

attention has been devoted in the past to research priorities relevant to ATM

issues.

The teams conducted a total of seventy key informant interviews across the

region. The interviews were conducted following a pre-defined semi-

structured interview guide. The interviews were recorded and transcribed and

were subsequently analyzed using conceptual frameworks developed based on

the ATM concepts and regional and country level concerns.

Consensus development approaches followed different approaches. In two

countries formal consensus development methods (albeit with variation in

tools deployed) were used. In one country a focus group discussion approach

was followed for identification of the research priorities. Then the final

outcomes of different studies (three country case studies and regional study)

were collated with each other in one report.

The main concerns of the key informants were around the affordability and

financing aspects of access to medicines, followed by issues of availability and

rational use of medicines. The key informants paid attention to all levels of

barriers to access: the household level, providers (public or private sector),

health system, other sectors and cross border issues. The identified previous

research on the issue, however, did not reflect that.

The results of the study indicate that ATM research in the region is heavily

biased towards RUD. RUD research has been mainly in the shape of

prescription audits, the majority of it showing there are important problems in

prescriptions. In recent years there is shift towards interventional studies

assessing the impact of interventions on improving prescribing outcomes.

There are two important patterns to note in here. First, the RUD research,

although forming the majority of ATM research is yet to show a substantial

effect in improving drug utilization patterns. The prescribing problems of focus

in ten years ago remain unresolved today, if not joined by new challenges (e.g.

non-generic prescribing). Second, it seems a change in research strategies is

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required and future studies should focus on interventional issues. Fortunately

there is a move in that direction. Also further demand side (why public still

sees fascinated with antibiotics) and health systems angle (what are the

financial and organizational barriers to improving prescribing patterns)

research will be required.

This study clearly indicates that there is dire need for further research on

financing and affordability aspects of ATM in the region. This should be given

paramount attention in future research funding and calls for proposals. Also

cross-border issues and other sectors roles on access to medicines in the

region has not explored widely. It seems that many household (demand side)

studies in the region remain of poor quality and limited methods. Together,

these main areas should provide the main aspects of access to medicines

research in the region.

This is in no way indicating that further RUD or studies of health systems and

availability access are not needed. Or that the barriers at the levels of

providers and health systems are exhaustively identified. Rather it seems that

individual researchers and available funding route are giving attention to these

issues at the moment, which should continue while further resources should

be mobilized for studies related to the relatively ignored aspects of ATM

research in the region.

Almost 80% of AT research in the region is originating from the region.

However, there is a wide variation in the number of publications originating

from different countries. Certain countries (e.g. Somalia), or certain areas of

other countries, do not appear in the literature.


reported in recent publications that had not followed extensive

methodologies. There is a growing trend, over the years, of more and better

quality studies from the region appearing in international journals. Still, a

concurrent trend will be required to ensure the local audience of such research

(i.e. practitioners, policy makers and media) remains informed of the new

development as a result of ATM research in countries in the region. An active

knowledge translation approach will be essential.

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Finally, the key informant interviews clearly demonstrate that the majority of

policy concerns were not addressed by published research. There was a

mismatch between the concerns and research, and hence the outcomes of this

study can contribute to developing a research agenda for improving access to

and appropriate use of medicines in the region and the three countries of

focus.

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Background and objectives


medicines is a key component of a functioning health system1. Access to


planning, service delivery, information and governance systems.

Prescribing costs have been growing 6-8% per year in the global context (Le

Grand et al, 1999). In Australia in one year prescribing costs rose more than

23% (Beilby and Silagy, 1997), and in the USA the prescribing expenditure

increased thirteen-fold in only thirty years from 1960-1990 (Pippalla et al,

1995). GP prescribing amounts to over 10% of total Britain's NHS spending and

it is estimated that about 75% of visits to office-based doctors end up in

prescribing. Therefore, focusing on quality and cost of prescribing is important

and vital.

The WHO refers to the ideal state of prescribing, distribution and use of drugs

as ‘rational drug use’ and has provided this definition:

The rational use of drugs requires that patients receive medications

appropriate to their clinical needs, in doses that meet their own

individual requirements for an adequate period of time, and at the

lowest cost to them and their community; WHO conference of experts

Nairobi 1985.

Irrational use of drugs (including not using medicines when needed) occurs for

a variety of reasons. Appropriately prescribed medicines may be used

inappropriately. Patients may not use the specified doses of medicines in

appropriate intervals or for prescribed durations. In many LMICs countries

pharmacies dispense a range of drugs without physician (or other clinician)

prescription. It is also part of another problem which is self-medication. In

1 WHO 2007 Framework for Action for Strengthening Health Systems: Everybody's Business -

http://www.who.int/healthsystems/topics/en/index.htm

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countries where the medicines market is not adequately regulated, patients

may decide on what they need and obtain it freely from dispensers. The

problem of irrational use of drugs may be the result of system failure.

Inadequate financial support for patients with chronic or serious infectious

diseases and substantial co-payments put disadvantaged groups in

unfavourable situation in terms of access to drugs. Also lack of availability of

medicines and the problem of counterfeit drugs complicate the picture in

LMIC. We may also add the issues of low uptake of clinical practice guidelines,

limited use of local formularies, weak implementation of essential drug

programmes and a variety of other issues to the picture.

Access to and appropriate use of medicines is often poor in low and middle

income countries (LMICs). WHO estimates that the average availability of

essential drugs in LMICs is 35% in public sector facilities and 66% in the private

sector.2 Medicines account for a high proportion of health spending in LMICs,

between 20% – 60% (developed country spending is around 18%).3 Moreover,

between 50% - 90% of expenditure on medicines in LMICs is out-of-pocket.4

This inequitable mode of financing creates significant access barriers for the

poor and/or may lead to catastrophic household expenditures. The poor as

well as other population groups often rely on the private informal sector for

medicines, particularly in rural areas. Over and inappropriate prescription and

dispensing of medicines are prevalent5.

Despite some progress in some areas - such as price and availability -6 , data on

access to and use of medicines is often weak. Even where data are available,

there is limited contextual evidence and analysis to assist in interpretation or

in the development of policy options to improve access to medicines in

different health systems and country settings, especially for LMICs. Health

2 MDG Gap Taskforce Report (2008): Delivering on the Global Partnership for Achieving he Millennium Development Goals.

3 Cameron et al (2009): Medicines prices, availability and affordability in 36 developing and middle income countries: a

secondary analysis.. Lancet 2009; 373: 240–49 4 WHO (2004)::WHO Medicines Strategy: 2004 – 2007. Countries at the Core’

5 WHO (2008): Medicines use in primary care in developing and transitional countries: fact book summarising results from

studies reported between 1990 and 2006. 6 Data on medicines prices, availability and affordability from WHO-HAI medicines price and availability surveys is now

available for more than 36 countries. See: Cameron, A et al (200): Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet 2009; 373: 240–49

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Systems Research (HSR) is essential to understanding, planning, monitoring

and evaluating the interaction of health system components in delivering

health outcomes efficiently. The importance of health systems research was

confirmed by the High Level Forum task team report at the Global Ministerial

Forum on Research for Health in Bamako in 2008.7 The application of HSR tools

and methods in the field of Access to Medicines will help understand the

weaknesses of this building block and generate and use adequate evidence to

formulate policies.

Goal, purpose and objectives

The goal of the Access to Medicines Policy Research project is to increase

access to and improve the use of medicines in low and middle income

countries, particularly for the poor (MDG 8).

The purpose of this project is to increase the use of evidence in policies to

improve access to and use of medicines in LMICs, focusing on EMRO region as

well as country specific issues in Iran, Pakistan and Lebanon.

General Objective:

Identification of policy concerns and related policy research questions in the

field of access to and use of medicines.

Objectives:

• Identify to the extent possible, regional level policy concerns related

to access to and use of medicines, as perceived by policy makers, civil

society organizations and patients and communities

• Identify and rank, to the extent possible, related policy research

questions in the field of access to and use of medicines in EMRO

region as a whole and in Iran, Pakistan and Lebanon specifically.

7 WHO (2009): Scaling up Research and Learning for Health Systems: Now is the Time.

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Methods

The WHO Framework for Access to Medicine (WHO 2002) was used as the basis for data collection and synthesis. Under this framework accessibility has been defined as having four parameters: that the available medicines are effective and of consistently good quality, that there is no financial obstacle to a patient receiving it, and that required knowledge and guidance are available for proper use of these medicines Any isolated effort to improve one

part may be effective for that part but it would not improve the overall situation.

Figure 1. Improving Access to Essential Medicines: A Framework for Collective Action in Line with Millennium Development Goals*

*Source: Richard Laing, Improving Access to Child Health Medicines, Review and

Discussion Paper, WHO Regional and Country Child Health Advisers, Geneva, 2002

Literature reviews

Search strategy – regional literature

For the extraction of research priorities of barriers to drug access in the EMRO

region, we employed two sets of search strategies: general search for regional

literature, and specific searches for the three countries (Iran, Pakistan and

Lebanon).

1. Rational

Drug Use

4. Reliable

Health Systems

2. Affordable

Prices

3. Sustainable

Financing

ACCES

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General regional search

In Latin sector two major electronic databases- PubMed and SSCI and SCI (ISI

Thompson) - were systematically searched, using a search strategy that we

carefully designed and tested (Table 1).

The PubMed electronic search identified the sixteen low and middle income

countries (according to the World Bank categories) of the WHO's Eastern

Mediterranean Region. The country specific searches were conduced both in

affiliations as well as the titles and abstracts of the papers.

The specific ATM terms were developed in two brainstorming meetings and

then were used for devising the search strategy. The search strategy was applied

and tested in a number of limited searches. Then a full search was conducted

and compared against a country specific list of entries. The results of the

assessment was used to revised and conduct the final search (Table 1).

The main terms selected for this study were drug, medicine, medication and

pharmaceutical and their variations are suitably linked with the terms: use,

access, availability, affordability, utilization, pricing, licensing etc and their

variations. Also certain specific terms were included in the search on their own

(e.g. pharmacy, prescribing). Early searches were conducted in January 2011

and were updated in June 2011.

Moreover, we hand-searched the Journal of Southern Medicine, yielding three

relevant articles. We also looked for relevant WHO reports (regional and

global), and especially the WHO reports of the World Medicine Situation in

2011 were used in this study.

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Table 1. Search strategy for regional literature Pubmed example:

#1- ((((((((((((((((iran[Affiliation]) OR pakistan[Affiliation]) OR lebanon[Affiliation]) OR

Egypt[Affiliation]) OR Afghanistan[Affiliation]) OR Sudan[Affiliation]) OR Yemen[Affiliation])

OR Jordan[Affiliation]) OR Tunisia[Affiliation]) OR Morocco[Affiliation]) OR Syria[Affiliation])

OR Palestine[Affiliation]) OR Iraq [Affiliation]) OR Djibouti[Affiliation]) OR Libya$[Affiliation])

OR Somalia[Affiliation])

#2- ((((((((((((((((((((middle east[Title/Abstract]) OR Iran[Title/Abstract]) OR

Tehran[Title/Abstract]) OR low income countries[Title/Abstract]) OR middle income

countries[Title/Abstract]) OR Pakistan[Title/Abstract]) OR Lebanon[Title/Abstract]) OR

Egypt[Title/Abstract]) OR Afghanistan[Title/Abstract]) OR Sudan[Title/Abstract]) OR

Yemen[Title/Abstract]) OR Jordan[Title/Abstract]) OR Tunisia[Title/Abstract]) OR

Morocco[Title/Abstract]) OR EMRO[Title/Abstract]) OR Syria[Title/Abstract]) OR

Palestine[Title/Abstract]) OR eastern Mediterranean[Title/Abstract]) OR Iraq

[Title/Abstract]) OR Djibouti[Title/Abstract]) OR Libya$[Title/Abstract]) OR

Somalia[Title/Abstract])

#3- (#1) OR (#2)

#4- ((((drug$[Title/Abstract]) OR medicines[Title/Abstract]) OR medication$[Title/Abstract])

OR pharmac$[Title/Abstract])

#5- ((((((((((((((((((use[Title/Abstract]) OR access[Title/Abstract]) OR available[Title/Abstract])

OR availability[Title/Abstract]) OR affordable[Title/Abstract]) OR

affordability[Title/Abstract]) OR utilisation[Title/Abstract]) OR utilization[Title/Abstract]) OR

essential [Title/Abstract]) OR counterfeit$[Title/Abstract]) OR price[Title/Abstract]) OR

pricing[Title/Abstract]) OR licensing[Title/Abstract]) OR licencing[Title/Abstract]) OR

labeling[Title/Abstract]) OR labelling[Title/Abstract]) OR formularies[Title/Abstract]) OR

generic[Title/Abstract])

#6- ((((((((prescription$ [Title/Abstract]) OR prescrib$ [Title/Abstract]) OR "drug

policy"[Title/Abstract]) OR "pharmaceutical policy"[Title/Abstract]) OR

formulary[Title/Abstract]) OR pharmacy[Title/Abstract]) OR pharmacies[Title/Abstract]) OR

pharmacist$[Title/Abstract])

#7- (#3) AND (#6)

#8- (#3) AND (#4) AND (#5)

#9- (#7) OR (#8)

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Search for Iranian literature in Farsi (Persian)

We used the general regional search strategy for retrieving Iran's literature in

English. This is restrictive, as there are Iranian publications in English indexed

in other databases. However it provided a comparative coverage of Iran's

literature, in the context of regional publications.

We searched for scientific publications in Farsi languages using the following

approaches:

1. Systematic searches in specifically designed electronic databases, including

IranMedex and the SID.

2. Searching the grey literature, including student dissertations (at two major

academic libraries) and review of the documents and records of Iran's Ministry

of Health and Medical Education.

The Persian resources – IranMedex and SID – are not yet suitable for systematic

searches as the one described in Table 1. Hence we conducted a very simple and

sensitive search (that is we searched for the word 'medicine' دارو in the title).

Over 700 papers were identified. After reviewing the titles and abstracts, 34

related publications considered relevant and of them were retrieved for full text

assessment and data extraction.

We also searched Farsi theses and dissertations in the libraries of two major

schools: the School of Pharmacy and the School of Public Health of the Tehran

University of Medical Sciences, which yielded eight relevant theses. By hand-

searching in documents and records in the Iranian Ministry of Health we found

150 records and five articles entered final analysis.

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Previous research priority setting in Iran

We also searched for, and conceptually analyzed some previous research

priority activities in the country. We used this to see how much attention has

been devoted in the past to ATM, and to identify potential topics for research

priority.

Search Strategy and literature review - Pakistan

Desk Review: This involved published studies, unpublished studies and grey

literature such as commissioned reports and surveys. A total of 11706 titles

were yielded using the electronic search and reference from bibliographies.

These were sifted by 2 researchers for identification of relevant studies. A total

of 184 studies were shortlisted. Abstracts and report summaries of 184 studies

were reviewed and a total of 96 studies were further short-listed. The full text

of all these 96 studies, including articles, reports, presentations and books was

then reviewed and 92 studies were selected and uploaded into EndNote

In addition 19 policy documents were also included through a system involving

online search as well as opinion taken from experts. Identification and access

to other policy documents that are not in public domain were sought during

stakeholder interviews. Data from each reviewed study and policy documents

was systematically extracted and analyzed using grids based on the WHO

Access to Medicines Framework under the four domains of rational use,

affordability, financing, and reliable health systems. Details of search strategy

and analysis of desk review is presented in Annex.

The scope of the search includes identification of relevant research, policy and

programmatic documents. A systematic wide scoped search was conducted

looking into published and unpublished documents. This primarily involved a

desk review but was assisted by key informant interviews.

Sources included a range of both peer reviewed electronic databases such as

Pubmed, Cochrane, Cinahl as well other unpublished databases such as

WHOLIS, ELDIS and Google Scholar. We also reviewed bibliographies of all

selected articles. A combination of search terms was applied to yield a

sufficiently large number of studies for detailed analysis. Search terms were

carefully selected, keeping in mind the objective of the study. Five sets of

25

search terms were used Drugs Pakistan; Drugs Pakistan Affordability; Drugs

Pakistan Rational Use; Drugs Pakistan Financing; and Drugs Pakistan Health

System.

The following inclusion criteria were applied:

1. Studies reporting on Pakistan, whether Pakistan only studies or multiple

country studies inclusive of Pakistan.

2. Studies published 1990 onwards.

3. Studies on bio-efficacy of drugs were excluded.

4. Commentary articles were excluded with inclusion restricted to primary

research, systemic reviews and reviews supported by research data.

A total of 11706 titles were yielded using the electronic search and reference

from bibliographies. These were sifted by 2 researchers for identification of

relevant studies. A total of 184 studies were shortlisted. Abstracts and report

summaries of 184 studies were reviewed and a total of 96 studies were further

short-listed. The full text of all these 96 studies, including articles, reports and

books was then reviewed, of which 4 were found to be irrelevant and a total of

92 studies were selected and uploaded into EndNote (List attached). Diagram 1

shows the study identification process and yielded results.

26

Figure 2. Research Study Selection Diagram - Pakistan

Policy and Programmatic Documents: For policy and programmatic documents

an online search was conducted as well as opinion taken from experts. Online

search was conducted of websites of the Ministry of health, provincial

Departments of Health, WHO Pakistan, WHO-EMRO and Pakistan Consumer

Protection Network on Rational Use of Drugs and Google Scholar. These

yielded a total of 15 documents. Identification and access to other policy

documents that are not in public domain were sought during stakeholder

interviews and yielded another 4 policy documents. Presently we have a total

of 19 policy documents (List attached).

Data Extraction Strategy: Data from each reviewed study and policy

documents was systematically extracted and analyzed. The WHO access to

medicines framework identifying type and level of barrier to access to

medicines (WHO 2004)i was used as a guideline for extraction of data. Findings

from were categorized under four grids as under:

11706 titles yielded in

the initial search

Stage 1

184 abstracts were

shortlisted and reviewed n=

184

120 were excluded:

duplicates,

commentaries, drug

efficacy studies

Stage 2

96 abstracts were

shortlisted, reviewed and

screened

Stage 3

n=

96

4 were excluded:

because those were

irrelevant

Full texts of 92

publications were

reviewed &

Stage 4

n=

92

27

1. Rationale Use of Drugs in Pakistan

2. Reliable Health System in Pakistan

3. Sustainable Financing of Drugs in Pakistan

4. Affordability of Drugs in Pakistan

Each grid in turn slotted information on:

• study title,

• author,

• study year,

• source,

• type of publication,

• level of barrier,

• methodology,

• key findings,

• identified issues & challenges (See attached).

During review of study, notable findings were highlighted. Findings from each

study were categorized into the relevant grid/s and within each grid into the

relevant sections. A narrative synthesis is also provided on barriers to access

based on the systematic organization of retrieved information.

All the above mentioned documents were analyzed systematically using

different grids employing World Health Organization Access to Medicines

Framework for Essential Medicines for this purpose8.

8 WHO Policy Perspectives on Medicines, March 2004. Equitable access to essential medicines: a framework for

collective action

28

Search strategy and literature review - Lebanon

The research team has developed a multi-pronged and comprehensive search

strategy to identify published journal articles and documents as well as

unpublished (gray) documents. The strategy focuses on identifying publications

and documents in several categories (listed below). Documents within each of

the following categories were sought. Documents were considered of interest

to this research if they focused on issues of ATM, discussed ATM in one or

more part of the document, or discussed issues of direct relevance to ATM.

− Peer-reviewed journal articles identified through a search of multiple

databases.

− Documents of the Lebanese parliament, the Government of Lebanon, the

MoPH, of ministries and of governmental agencies other than MoPH

− Publications and documents of the WHO, WHO/EMRO in Cairo or WHO

country office in Lebanon

− Publications and documents of other international agencies (e.g. UNDP,

UNICEF, World Bank)

− Books on devoted to one or more aspects of ATM in the Arab world, MENA,

EMR or Lebanon

− Books on health systems or public health in the Arab world, EMR, MENA, or

Lebanon where ATM is discussed

− Reports and studies about the pharmaceutical industry or market in

Lebanon

− Other publications, for example as identified by key informants.

In addition to improving our understanding the issues of and surrounding ATM

in Lebanon, the purpose of the search strategy was to create a mini-library of

documents of interest to ATM which can aid future research on ATM in

Lebanon.

Journal articles

The TUMS-based research team was responsible for identifying ATM-specific

journal articles from EMR countries and has followed a consistent search

29

strategy in PubMed to identify journal articles published in English for each

country (see the PubMed search strategy for Lebanon in Appendix 1-A).9 As

this did not seem to represent the body of potentially-relevant literature on

ATM in Lebanon, the Lebanon team felt the need to expand the search

strategy and use multiple databases to retrieve a larger number of articles.

Although it was obvious that this approach might reduce the specificity of the

search strategy, the rationale was that the conceptual framework of ATM, for

example according to WHO 2004, is quite broad and encompassing and many

articles, even if not specific to ATM, can enlighten a better understanding of

the health system issues of direct relevance to ATM. The research team

developed an expanded MeSH terms/keyword list to capture more domains of

the ATM framework (according to WHO 2004) and conducted a systematic

review using the following electronic databases: PUBMED/MEDLINE, EMBASE,

SCIRUS, IMEMR (WHO EMRO’s Index Medicus for the Eastern Mediterranean

Region), and Google Scholar. We reviewed abstracts and excluded irrelevant

articles. For Google Scholar, we searched the first 13 pages of around 36,000

articles obtained. For each step of literature search we retained articles that

have not been found during a previous search to avoid redundancy in the list.

In addition to the aforementioned search strategy, we attempted to identify

additional journal articles by searching the following national resources: The

National Health Information Library, supported by the WHO country office in

Lebanon, and the online database of the Lebanese Corner at the Saab Medical

Library of the American University of Beirut, a resource on all health-related

publications concerning Lebanon.

Document review

To identify documents, whether published or unpublished, of interest to ATM

we carried out a multi-pronged strategy. We searched websites (e.g. MOPH,

WHO-EMRO), databases (WHO Medicines Bookshelf version 6 [2010],

Lebanese Corner at the Saab Medical Library of the American University of

Beirut), and other national resources (e.g. the National Health Information

9 The regional search strategy was later revised. The final regional search strategy can be identified in Table 1.

30

Library of the WHO country office in Lebanon). This led us to identify only a

limited number of documents. In addition, we asked key informants to supply

us with any documents of potential interest to ATM. Key informants supplied

the research team with a large number of documents covering a broad range

of topics.

31

Inclusion process and criteria and data extraction

Papers published from 2000 onward were considered for further analysis. All

the titles and the abstracts of the identified papers via the search were

reviewed by one investigator. To insure accuracy, two separated samples of

the papers were reviewed by two authors and disagreements were discussed

and clarified.

Inclusion and exclusion of the papers followed the following criteria:

• Studies that were directly relevant to access to medicine concepts were

included. For example, for RUD studies, we focused on studies that

assessed the RUD in a certain setting, or the studies that have sought to

improve use of medicines specifically. However, studies of improving

clinical care (which might have involved prescribing issues) were not

included; a clinical practice guideline development project may not be

included. Although prescribing is part of the majority of the guidelines,

the purpose of a CPG is not prescribing per se, rather it is improving

quality of care. This criterion was required to ensure we remained

focused on ATM issues. The same logic was applied to the search results.

• Studies of drug resistance that did not elaborate on health system or

access to medicines implications of it were not included.

• Studies of herbal medicines alone were not included.

• Studies of drug abuse were not included.

• Contraceptive medicines use studies that were focused on family

planning issues were excluded.

• Letters to editors and abstract only publications were not included

• Studies focusing only on education methods and curriculum

development for pharmacy issues were not included.

32

After agreeing on inclusion of a study, the full texts of the studies were

retrieved as far as possible. All the identified studies were assessed to extract

the data required by the data extraction tool (Table 2). We extracted data on

title, authors, the year of publication, country of origin, countries of focus,

research design and sample, a summary of main findings, ATM issues

considered in the study, levels of barrier studies, and the research topics

recommended by the authors.

Data extraction tool

Then we collated the extracted data to develop a map of the literature as

pertaining to the study questions. We also used the research topics

recommended by the studies to identify the research priorities, and the maps

for focusing on what topics have been regularly researched in the region and

what topics remain in the Cinderella.

33

Table 2. Data extraction tool

number First

author title year

country (ies) in origin

Country (ies) in focus

Barriers to ATM

discussed? Y/N

Research design

and sample

Main findings

Issues considered (Y/N)

Level of barrier studied (Y/N)

Research topics recommended

affo

rda

bility

Su

sta

ina

ble

finan

cin

g

RU

D

Hea

lth s

yste

m a

nd

ava

ilab

ility

Ho

use

hold

& c

om

mu

nity

He

alth

serv

ice p

ub

lic o

r priv

ate

Natio

na

l He

alth

se

cto

r

Natio

na

l beyond

he

alth

se

cto

r

Cro

ss b

ord

er is

sue

s

34

Qualitative interviews

Key informant interviews – Iran and the region

Participants: We interviewed a purposeful sample of twenty participants. We

selected the sample purposefully. A list of stakeholders was developed in a two

step consultative process. A matrix was developed to categorize the

organizational background and settings from which the stakeholders would be

selected. These included WHO regional office, the ministries of health and their

entities, civil society organizations (as patient representatives), medical

associations (as clinician representatives), pharmacists associations (as

pharmacist representatives), research institutions, development partners etc (see

Table 3. Key informants' matrix: The interviewees are selected from the

following categories in Iran and in the region.). The participants were invited

by telephone calls or emails, explaining the objectives of the study and

introducing the investigators. The time, location and mode of the interviews

(telephone or face-to-face) were mutually agreed. The interviewees were paid

no honorarium.

35

Table 3. Key informants' matrix: The interviewees are selected from the following categories in Iran and in the region.

WHO and

other

sectors

Pharmaceutical

companies

Insurance

organizations

PHC

networks/

public

provision

of health

services

Ministry

of Health

Academics

in relevant

disciplines

Clinicians

/medical

institutions

Pharmacies

And

distribution

Patient

representatives

Interviewees

codes

* * KI10 * * KI15

* * * KI9

* * KI17 * * KI13 * KI3

* KI11

* KI1

* * KI2

* * KI4

* KI5

* KI6

* KI7

* KI8

* KI12

* KI14

* KI16

* K18

* K19

* K20

36

A semi structured questionnaire was developed using the general ATM structure

developed by the WHO and the Alliance. We updated this structure to form

broad questions. Then the structure was discussed in a meeting of investigators.

We then presented the interview structure to a meeting with regional

investigators and study advisers. In the end a three part interview guide was

developed (see Appendices). We shared the tool with colleagues in Pakistan and

Lebanon.

The first part was the introductory and intended to capture the general aspects of

the interviewees' background as educational level, affiliations and experiences.

The second was an open question about issues regarding access to medicines.

This part was meant to investigate the interviewees' personal opinions about the

access and use of medicines concepts. In the third part of the guide – which was

the main part – the interviewees were asked about different level of access

according to each component of the WHO/ATM framework (individual,

household and community level, health service delivery level- both public and

private services delivery channels, health sector policy, beyond the health

sector).

Interview analysis was done manually and the WHO 2002 Access to Medicine

Framework was taken as the conceptual framework for analysis.

Interviews:

Thirty individuals were invited to interviews and twenty three agreed to

participate. In the end twenty face-to-face and telephone interviews were

conducted in late 2010 and early 2011 (three other interviews did not in the end

result in mutually convenient time set ups for the interviews). Interviews, except

one, were tape recorded and transcribed, each interview lasting 30–45 min. Six

participants were female and 14 were male. We used thematic content analysis

approaches to analyze the data.

37

Key informant Interviews - Pakistan

21 in-depth interviews were conducted involving a diverse range of

stakeholders. Purposive sampling was done and the list of stakeholders was

developed in a 2 step consultative process. In a meeting of regional partners

at Tehran University a matrix was developed mapping major organizational

backgrounds for stakeholder selection across all the three participating EMRO

countries. These included MO and its entities, CSOs (as patients’

representatives), medical associations (as clinician representatives),

pharmacists associations (as pharmacists representatives), industry, research

institutions, development partners etc (see attached stakeholder matrix).

These would be consistent for all 3 countries but identification of specific

names and exact numbers would be done by country team. Subsequently a

meeting was held of Pakistan team with WHO Pakistan for identification of

specific interviewees under each organizational category.

Ethical approval was obtained prior to interviews. Written informed consent

was obtained from each interviewee and written project information and

contact details of investigators were provided. Written assurance was also

given of confidentiality of interviewee identity in making reference to

interview results. Interviews were conducted in Islamabad, Karachi and Lahore.

Interviews notes were taken by a two member team and transcribed and

compared between note takers on same day. Interview analysis was done

manually and the WHO 2002 Access to Medicine Framework was taken as the

conceptual framework for analysis.

Figure 3. Mapping of key stakeholders in Pakistan

38

Key informant interviews - Lebanon

The research team conducted in-depth interviews with 29 key informants

whose work directly concern ATM to solicit their views on the most important

policy and research issues concerning ATM.

Inclusion criteria

We initially identified 15 key informants as the target for interviews but ended

up conducting interviews with 29 informants, following the advice provided by

other informants. Although saturation in responses was reached after the first

15 interviews, the later set of interviews were useful in addressing specific

issues and in clarifying particular questions in ATM. We identified informants

whose work encompasses the various domains of ATM. In many cases,

informants served in multiple roles. For example, some informants served in

professional associations or NGOs but were also practitioners of medicine,

pharmacy or nursing. Some practitioners were also educators in their fields. A

key strategy in identification of key informants was to ensure diversity of

n= 184

39

professional backgrounds, fields of work, and perspectives. Informants came

from the public sector, the private sector, professional associations, civil

society groups/NGOs and consumer groups, and from among practitioners.

Appendix 2 presents the complete list of informants

Conduct of key informant interviews

Key informants identified based on the aforementioned criteria were called by

telephone or contacted by email to explore their interest in participating in the

study. If they expressed interest, we sent the consent form (Appendix 3) by

email, fax or delivered it in person and the WHO-2004 paper explaining the

ATM framework. On the interview day, informants were asked to go over the

consent document and encouraged to seek any clarification from the

investigator. Informants were then asked to complete the informed consent

document if they voluntarily agree to participate. Interviews were recorded on

a digital recorder and later transcribed. One to three members of the research

team conducted the interviews which lasted from 30 minutes to 90 minutes,

depending on informant’s time availability.

Informants were told that the interviewers would be exploring ATM in

Lebanon according to the WHO-2004 framework and that there will be an

attempt to cover the four domains of the ATM framework but that the

interview can expand well beyond that. For informants who seemed unfamiliar

with the terminology of ATM and the various domains of ATM framework, the

researcher briefly reviewed the WHO-2004 framework prior to the start of the

interview. It was felt that this allowed interviews to be more focused and allow

more productive use of time. The informants did not seem biased in particular

directions by this approach.

The interviews used loosely the ‘Semi-structured interview guide’ developed

by the research team at TUMS (Appendix 4). The researchers felt that the

interview guide, although comprehensive and useful, did not allow for the

flexibility and fluidity that informants demanded. Consequently, the interviews

40

were largely based on asking the informants about their views of which are the

most important policy concerns, and corresponding research questions, in

ATM and then moved to explore the ATM issues more in-depth using the leads

provided by the informants, the WHO 2004 framework and the semi-

structured interview guide. This method gave the informants the needed space

to move about the ATM sphere freely and gave the researchers the needed

structure to explore ATM issues from various angles.

The initial objective was to elicit from each informant a list of policy research

questions and priorities in the area of ATM. However, this proved difficult as

informants commonly focused on the policy aspect of ATM issues rather than

on identification of related research questions. In some cases, prodding by the

interviewing researcher proved useful in identifying specific research

questions. In other cases, this proved difficult and it became clear to the

researchers that they would need to identify research questions based on the

policy concerns expressed by informants.

Privacy and confidentiality

Several measures were taken to ensure the privacy and confidentiality of

informants. Consent forms lacked any personal identifiers. During the recoded

interviews, informants were asked not to provide any identifiers, such as

names or names of the institution or their positions. If such information was

provided, it was not transcribed or deleted from transcription. The recordings

were downloaded to a password-protected computer immediately after the

interviews and deleted from the digital voice recorder. Only one person of the

research team had access to the recording. Once successfully transcribed and

checked by the PI, the digital recordings were permanently removed from

computers. The consent documents are locked in a safe place with access

restricted only to the PI. All those documents will be permanently destroyed

once the study report is submitted and the articles and papers published.

42

Consensus development

Consensus development - Iran

The results of the qualitative study and literature search were used to

identify a set of potential research priority topics.

All the interviewees were invited to attend the consensus development

meeting. The meeting was conducted following a nominal group

technique approach. First a brief overview of the study and the step that

had been followed was presented in the meeting. Then the participants

were invited to offer their views on the main ATM concerns and issues.

The potential priority topics for research had been categorised under the

main themes developed from the qualitative phase of the study based on

the general categorization of the ATM by the WHO (

43

Table 4). Under each main theme a set of topics were offered to the

participants. After a brief discussion of the topics, they were invited to

vote on the importance of the topic as an ATM research topic relevant to

that category. The voting was in private and on previously prepared

table that allowed the participants to select from 1 (no priority) to 9

(maximum priority) for each potential research topic (Table 5). Voting for

each category was conducted separate from the other categories.

44

Table 4. The main categories for the identification of research priorities

1- National pharmaceutical policies (stewardship and governance)

2- Financing, insurance and financial coverage

3- Pharmaceuticals' production (or import) and distribution

4- Other sectors' policies and players at national and international level

5- Household access to medicine and utilization

6- Health care provider behaviour (including physicians, pharmacists …)

Table 5. An example of the consensus development tool

Please express your opinion about the priority of each issue as a research topic by

ticking a number from 1 (no priority) to 9 (maximum priority)

Code Topic Priority of research on the topic

No priority Maximum priority

1 1 2 3 4 5 6 7 8 9

2 1 2 3 4 5 6 7 8 9

3 1 2 3 4 5 6 7 8 9

For the analysis of the findings, we calculated the mean (standard error)

of the scores for each topic to observe the distribution of the responses.

We then grouped the score into three groups: 1-3 (“low importance”), 4-6

(“medium importance”) and 7-9 (“high importance”). For each category

of issues (

45

Table 4), we identified the topics as “high importance” if 70 per cent of

the respondents scored the topic as high importance.

Consensus development - Pakistan

A consultative process was taken for identification of policy and research

concerns. A Roundtable with stakeholders was held on 12th May at AKU

Karachi involving 25 stakeholders from different entities attended the meeting

including country Investigators from Iran and Lebanon as well as focal person

for ATM project from Alliance HSPR, WHO Geneva. The Roundtable was

chaired by Secretary Health, Sindh, Pakistan. The roundtable took a

consultative process to identify emerging policy concerns and research

questions. It involved presentation of scope and objectives of ATM

prioritization project being carries out globally, brief overviews of findings from

Iran and Lebanon and detailed presentation on Pakistan findings. Following the

presentation, policy concerns were collectively identified and a list of research

questions generated for further action. Written comments were further invited

post Roundtable through an email listing for improvement of data and

incorporation of needed research areas.

46

Consensus development and priority research questions - Lebanon

Two researchers (SJ and RY) reviewed the literature, both journal articles and

documents, to identify ATM areas that have been covered in prior research

and to retrieve new policy-relevant research questions. When a research

question was explicitly expressed, it was added unmodified to the list of

research questions. When a research question was not explicitly expressed but

could be inferred from policy concerns about ATM appearing in the literature,

the two researchers developed the corresponding research questions(s) and

modified the question(s) until a consensus is reached about the wording of

research questions. Identified research questions were categorized in one of

the four domains as per the WHO 2004 framework. An additional category

comprised research questions encompassing cross-cutting and general issues.

The research questions emanating from the literature review are listed in

Appendix 6-A.

Similarly, the transcribed interviews were analyzed to identify policy concerns

and research questions. Just as the case for literature review, when a research

question was explicitly expressed, it was added unmodified to the list of

research questions. When a research question was not explicitly expressed but

could be inferred from policy concerns about ATM stated by the informants,

the researchers developed the corresponding research questions(s). The first

step was to list all possible questions emerging from the analysis of all

transcripts. This exercise was performed by two research assistants. In the

second step, a third researcher reviewed the list of questions, merged similar

questions, and excluded the research questions that seemed incoherent.

During these two steps, identified research questions were categorized in one

of five categories corresponding to the four domains of ATM as presented in

the WHO-2004 framework, and one general cross cutting category

encompassing such research questions that pertain to all the four aspects such

as corruption, governance, or free market. We included a research question,

where expressed explicitly or inferred implicitly from a policy concern, even if

such a question was cited only once by one informant during the two steps of

identification. This process was meant to allow the inclusion of as many

47

research questions as possible. The research questions emanating from the

analysis of KII are listed in Appendix 6-B.

The principal investigator then reviewed all research questions that have

emerged from literature review and key informant interviews, and

consolidated and shortened the research questions, excluding those deemed

redundant, inadequate, or not corresponding to the domain of ATM. In the

final step, two researchers reviewed all research questions and reached

consensus about the research questions in their final reworded and merged

form. This resulted in a list of 57 questions (Appendix 6-C) which were to be

submitted to the validation-prioritization meeting.

All key informants were invited to participate in the validation-prioritization

meeting. Key informants unable to participate were asked to recommend

representatives of their institutions/organizations if possible. The final list of

participants is presented in Appendix 2. Both the participants and the

researchers felt that the number of participants was adequate and allowed for

engagement in discussions and for completing the prioritization tasks within

the allotted time of three hours.

The objectives of the validation-prioritization meeting were to review the

research questions that have emerged from literature review and key

informant interviews, remove the questions that were not thought to be

priorities, modify questions as needed and rank questions according to pre-

specified evaluative criteria.

Although the research questions from literature review and key informant

interviews had been categorized thematically in the previous step (see 3.3.

above), the 57 questions were presented to the participants in one list. The

rationale behind this was to avoid force-fitting the questions into pre-defined

categories, i.e. according to the WHO 2004 framework, and allow the

48

participants to discuss and propose alternative frameworks for approaching

ATM and thus priority research.

The meeting comprised two main steps:

a. Step 1: Validation exercise: Each participant was given a print-out of the 57

research questions and asked to grade the 57 research questions according

to importance (0 if they deem the question unimportant, and 1 if deem it

important or possibly important) and to identify the questions that required

modification. The participants were also encouraged to propose new

questions that deemed important to include in the list of priorities and

those they considered inadequate or illegitimate. After having reworded a

number of questions, the grades were added up. All the questions that

obtained a score of more than 8, signifying that at least 2/3 of participants,

or 8 participants, considered them important, passed to the second round

of prioritization ranking.

b. Step 2: Prioritization exercise: Among the original 57 questions that

emerged from the validation exercise, 22 questions achieved the cut-off

score and were submitted to the participants for prioritization. Each

participant was given a print-out of the list of 22 questions and asked to

give a score each question on five evaluative/ranking criteria for

prioritization. A statement of explanation was provided for each criterion.

The participants provided a critique of criteria and requested modification.

The final list of criteria was:

- Relevance: Would the research study address one or more of the

important issues in ATM?

- Urgency: How soon should the research study be done?

- Feasibility: Can the research study be done using available resources?

- Applicability: What are the practical implications of the research study

on changing policy? Would the political climate allow it to be done?

- Ethical acceptability: Would the research study violate ethical

principles?

For each criterion, the participant were asked to give the research question

a score from 1-10 (10 representing a high priority for the research question

49

on the concerned ranking criterion). The final list of 22 questions ranked

according to these criteria is presented in Appendix 6-D.

50

Results – literature review – country cases studies

Figure 4 provides the details of the search strategy and the number of

papers retrieved at each stage of the search. Search in the Social

Sciences Citation Index and Science Citation Index electronic databases

was very similar to the Pubmed search, the only difference was that

countries in this database searched in the address rather than the

affiliation, and the other terms was limited to the topic. This search

yielded 3393 publications and records.

All the records from the searches were included in the Endnote software,

then merged together. After review all titles of publications, 597 records

were selected then by review the abstract of remaining records ,110

relevant studied were selected. Finally we omitted articles that was

published before 2000. Finally 91 articles were selected to review their

full text.

51

Figure 4: Flow chart of search strategies in electronic databases for ATM

Article titles considered (n=4086) (a) ISI search result (total n=3393)

(b) PubMed search result (total n=693) Search date: 2 nov 2010

Abstracts considered (n=874) (a) ISI abstracts (n=433)

(b) PubMed abstracts (n=198)

Not likely to be relevant by title and therefore excluded (n=3455)

(a) n=2960 (b) n=495

Select of related Articles for read in full text (n=88) (a) ISI or (b) PubMed

Articles read in full text (n=75) Articles read in abstract (n=13 , because of

don’t access to full text)

(a) ISI or (b) PubMed

Not likely to be relevant after examination of the abstract and therefore excluded (n=786)

(a) ISI or (b) PubMed

Article titles considered (n=1311) New result (n=1311-693=669)

- PubMed search result Search update: 21 june 2011

Abstracts considered (n=224) - PubMed abstracts

Select of related Articles for read in full text (n=123) - PubMed

Articles read in full text (n=37) Articles read in abstract (n=86, because of

don’t access to full text)

- PubMed

Not likely to be relevant by title and

therefore excluded (n=445)

Not likely to be relevant after examination of the abstract

and therefore excluded (n=786)

Articles identified (n=211)

Primary search (n=88)

Update search (n=123)

Articles included after final

assessment of inclusion and

exclusion criteria (n=151)

Primary search (n=88)

52

Literature review - Iran

Literature review, papers locally published in Iran and grey literature

Sensitive searches of the databases and websites, revealed 1755 potentially

relevant titles. we then screened the titles and abstracts to identify potentially

relevant articles. Also a Ministry of Health and Medical Education collection of

150 grey literature and published magazine articles were reviewed. We

included articles published from 2001 (1380- Iran's calendar) onward.

As a result the full texts of 46 papers were fully assessed, and 39 papers were

included in the study. As demonstrated in the

53

Figure 5, the majority of these papers (i.e. 79%) discussed the rational use of

medicines, inclusively or in conjunction with other issues. Also most papers

were focused on health service provider level.

54

Figure 5. ATM issue categorization for papers published in Iran's journals.

The included studies came from 18 different provinces (out of 30), and the

majority were from Tehran province (eight studies). Seven studies were

national studies, and two papers reviewed previous research (Table 6 ). We

observed no particular trend in the number of publications each year, or the

focus of the publications in Farsi papers. As we'll demonstrate later on, it

seems that the growth in the number of research outputs from Iran on ATM

has consolidated in English language publications in international journals.

Table 7 demonstrates that not all provinces have been covered by such

studies. Still the focus of attention of ATM issues shows no pattern or

significant geographical variation in the country.

0

5

10

15

20

25

30

35

Papers published in Persian (Farsi) language

research journals

55

Table 6. Distribution of papers published annually in Iran's Farsi (Persian) language scientific journals and the categorization of ATM issues

and levels of barriers discussed.

Year

Total published in that year

ATM issues considered Level of barriers studied

Affordability Sustainable financing RUD

Health system and availability

Household & community

Health service public or private

National health sector

National beyond health sector

Cross border issues

2001 1 1 1

2002 3 2 1 2 1 2 2

2003 6 6 3 3 2

2004 3 1 2 2 2

2005 4 3 1 1 3 1

2006 4 1 4 1 2 2 2

2007 8 8 4 5 2

2008 1 1 1

2009 7 1 1 5 2 1 4 3 1 2

2010 1 1 1

Unknown 1 1 1 1 1 1 1 1 1

Total 39 2 (5%) 5 (13%) 31

(79%) 10 (26%)

13 (33%) 23 (59%) 16 (41%) 2 3

56

Table 7. Provincial or national distribution of issues covered in papers published in Iran's Farsi (Persian) language scientific journals and the

categorization of ATM issues and levels of barriers discussed.

Province

Total published from that province








Cross border issues

East Azarbaijan 1 1 1

Fars 1 1 1

Ghazvin 3 3 2 1

Gilan 2 1 2 1 1 1 1

Gorgan 2 2 2

Isfahan 1 1 1

Kerman 2 2 1 1

Kermanshah 1 1 1 1 Kohkiloyeh & Booyerahmad 1 1

1

Kordistan 1 1 1

Lorestan 1 1 1

Mazandaran 2 1 1 2 1 Sistan & Baloochestan 2 2

2

Tehran 8 1 6 2 3 5 3

Yazd 1 1 1

Zanjan 1 1 1 1

National studies 7 2 3 3 5 5 7 2 2

Review articles 2 1 1 1 2 1

Total 39 2 5 31 10 13 23 16 2 3

57

Although it seems that studies are more concerned with rational use of drugs

at the level of provider (usually measuring mean number of items per

prescription, or proportion prescriptions containing antibiotics), there are signs

that health system level issues are gaining further attention in the country. A

good example of such focus on Adverse Drug Reaction (ADR) reporting system

has been presented in Cheraghali et al 2003.1 We produced using their data to

demonstrate that a move in the right direction is happening (Figure 6).

Figure 6. Growth in ADR reporting in Iran. Figure reproduced using Cheraghali

et al 2003 data.

570620

11631210

1675

0

200

400

600

800

1000

1200

1400

1600

1800

ADRs reported in Iran to the Ministry of

Health and Medical Education 1998-2002

58

Literature review, papers published from Iran in international journals

We also used our international literature search of regional reports, to retrieve

studies published from Iran (see search strategy - Table 1). The analysis of the

data suggests an increasing trend in the number of research output relevant to

ATM issues from Iran (Figure 7). In the period of coverage of our study (i.e. 2001

onward), the first identified paper has been published in 2004, and since then

the number of studies has been growing. Still the absolute majority of the

studies focus on RUD alone or in combination with other ATM issues (Table 8).

In that sense, there is no observable difference between papers published

within or outside Iran. However, there are considerably more papers focusing

on affordability issues (Table 8). This is in line with the increasing cost of

medicines in the country, and national policies that involves gradual move

away from the generic prescribing policy.

59

Figure 7. An increasing trend: ATM papers on Iran published in local Farsi (Persian) journals and international English language journals.

20012002200320042005200620072008200920102011 -

first halfunkown

grand

total

Total 13658710718105180

English papers 000243261195042

Farsi papers 13634481710139

0

10

20

30

40

50

60

70

80

90

An increasing trend: ATM papers on Iran published in

local Farsi (Persian) journals and International English

language journals

Total

English papers

Farsi papers

60

Table 8. Annual a growth in the number of ATM papers from Iran in international literature, and the distribution of issues covered and the

levels of barriers discussed

Year








Cross border issues

2004 1 1 1 1 1 1

2005 1 3 1 3 1 1

2006 3 2 2 3 1

2007 1 1 2 2 2 3 1

2008 1 7 2 7 4

2009 2 1 9 3 3 7 5 1

2010 1 1 8 4 1 7 4 1 1

2011 1 1 4 3 4 3 2 2

Total 8 (19%) 4 (10%) 37

(88%) 16 (38%)

9 (21%) 34 (81%) 22 (52%) 6 (14%) 3 (7%)

61

A joint and more detailed analysis of all identified papers is provided in Table 9.

Table 9. A more detailed analysis of research papers published on ATM in Iran in local and

international literature

No Main issue Topic Number of

papers per

topic

Number

of

papers

per

issue

1 Drug utilization

Processes and patterns of drug use,

self-medication, and household storage

of medicines

12

23

Knowledge and attitudes of public,

patients and health care providers

towards drug use (with or without

prescriptions) and patient sources of

data on medicines

7

Access, availability and medicine

prescribing

3

Assessing level of access to medicines

1

2

Prescribing and

medication

errors

Assessing prescribing patterns, quality

of prescribing, improving prescribing

quality, and prescribing indicators

12

38 Assessing preferences on labeling

options 1

Errors and medicinal interactions in

case notes, prescriptions, and studies of

ADR reporting

12

62


papers per

topic

Number

of

papers

per

issue

Assessing rational use of drugs activities

and their outcomes and successes 3

The role of computer systems in order

registrations, pharmaceutical

information systems and reducing

prescribing and medication errors

3

Drug-related hospital admissions

1

Knowledge and attitudes of

pharmacists … towards drug

interactions

4

The impact of continuous medical

education program on physician

prescribing

1

Patient doctor relationship and

prescribing issues

2

3

Management

and process of

pharmaceutical

procurement,

distribution,

storage and

usage control

Assessing pharmacy system for

procurement, distribution, storage and

supervision on utilization

3

4

New approaches in drug distribution 1

4

Macro policies

And sector

economy

Targeting pharmaceutical subsidies

1

10

Expanding pharmaceutical market and

public access to medicines, and national

pharmaceutical policy

2

63


papers per

topic

Number

of

papers

per

issue

Marketing and promotion

2

History of reforms, and issues and

challenges in Iran's pharmaceutical

industry, policies and market

2

Pharmacies economy in Iran

1

Improving medicines availability and

affordability

2

5

Pharmaceutical

system

performance

Inter provincial pharmaceutical

indicators

1

4

Assessing pharmacy information

systems

1

Challenges in management and

administration of pharmacies,

regulatory visits outcomes

2

6 Other sectors

Impacts of joining to the WTO on

pharmaceutical industry

1 1

Total 80

64

Literature review - Pakistan

RATIONAL USE OF MEDICINES IN PAKISTAN

Irrational drug prescribing, dispensing and self-medication continue to be a major problem in Pakistan. Although a national essential drug list exists it is poorly enforced across the health sector. Irrational prescription is due to high level of prescription by non-qualified practitioners and self medication, frequently inappropriate prescription particularly by qualified providers, particularly high use of injectables, and resulting issues of polypharmacy, unnecessary expenditure, drug resistance, and contributing to high prevalence of Hepatitis B and C in the country.

National Essential Drug List: Essential medicines as defined by WHO are those that satisfy the health care needs of majority of the population. Through 1970s and 1980s the Essential Medicines Program of WHO Pakistan promoted this concept to redress imbalance in selection of drugs. The National Essential Drug List (EDL) of Pakistan was first prepared in 1994 in consultation with relevant experts and using WHO’s model list of Essential Medicines as a template. The list was subsequently reviewed in 1995, 2000 and 2003 and the present list is the fourth revision containing 335 medicines (MOH 2007). Development of EDL is a function of the Federal Ministry of Health (MOH) while compliance and adherence rests with the provincial Departments of Health (DOH). Procurement of drugs in DOHs is based on EDL although non-EDL purchasing has been reported (details in supply side issues). Compliance and adherence to EDL varies from poor to good in different parts of Pakistan 2-4. In a baseline survey in three provinces of Pakistan, it was found out that EDL is only available in one out of five public sector facilities 2. Compliance with EDL in terms of prescriptions was found to be 50% at public sector facilities in one survey 4 and 80% in a survey of three public sector teaching hospitals 3.

Frequent prescription by non-qualified prescribers: Prescription by non-qualified practitioners as well as self medication is common in Pakistan, however there are few studies that capture the magnitude of self medication and hardly any literature on quacks. In a survey of 500 households examining health seeking behavior for childhood illnesses, self-medication was given to 51.3% children (Haider &Thaver, 1995). These mostly comprised of analgesics/antipyretics (25%), anti-diarrheals/ anti-emetics (11%) and antibiotics (11%) while 34% were unidentified drugs (34%). Infants were self medicated particularly during diarrheal episodes, which is a dangerous trend as improper management has resulted in childhood diarrhea being the number two cause of death in children under five 5. A study on youth reported frequent prescription and consumption by college students on medical student’s advice or self prescription 6. 55.3% of medical students prescribe medicines independently and most are likely to belong to 1st and 3rd year of medical college while a third of non-medical students report self prescription 6. Another study pointed out that most potent drugs like antibiotics, psychotropic, narcotics, anti-cancers and hormones are being misused by un-trained doctors or by quacks or through self medication due to lack of co-ordination among the relevant professionals 4. High level of inappropriate prescription by qualified providers: Drug prescription even amongst qualified providers is also frequently irrational. Both general practitioners & public sector physicians have been found to excessively prescribe anti-bacterials, anti-amoebics and anti-diarrhoeals in the case of ARI, diarrhea and fever in children while ORS has been inadequately prescribed (Siddiqi 2002). 30% of prescriptions sent to pharmacies lack a

65

diagnosis or chief complaint making it difficult to counter check and validate drug requirement 2. In addition, GPs in 76.5% of patient encounters also dispense drug formulations of unknown composition, commonly known as 'mixtures', made in their own drug dispensing corner, a practice which is not open to monitoring and needs to be actively discouraged.

Figure 8. Percentage of patients receiving antibiotics.

.

Source: The World Medicines Situation, WHO 2004 Prescriptions amongst general practitioners (GPs) for chronic diseases also need significant rationalization. Although tuberculosis is an endemic disease and Pakistan has a national TB control program there is frequent variation from the recommended treatment. A survey of 88 GPs in KyberPukhtoonkhwa and Northern Areas of Pakistan showed that only 3.4% GPs knew all the components of DOTS, only 35% were able to write a prescription with correct drugs, dose and duration for initial phase and 30% for continuation phase of the therapy 7. In major urban centers, of the 120 private general practitioners surveyed, only half of respondents could prescribe ethambutol or pyrazinamide in the correct doses or for the correct duration 8. Similarly, a survey of 1000 GPs in Karachi reports that appropriate therapy for hypertension in elderly was initiated by only 35% of GPs while thiazide diuretics, internationally recommended as first line regimen, were rarely prescribed (4.2%) 9. Alarmingly, sedatives were commonly used either as first-line medication for lowering BP (23.8%) or in combination with antihypertensive agents (45%). In another study on mental health, the treatment for psychiatric and paediatric illnesses did not correlate to diagnosis in 25% of cases and doses of drugs were inappropriate in 31% prescriptions 3.

Little difference between GP and specialists in inappropriate treatment: While GP prescriptions are frequently inappropriate those of specialists have also been reported to be questionable. Little difference was seen in practices of GPs and specialists in treatment of

66

childhood diarrhea. It was observed that only 17.7% of GPs and 14.3% of pediatricians prescribed ORS in all of their encounters while instructions for preparing ORS were given in only 6% of encounters by GPs and 8.4% of encounters by pediatricians (Nizami et al 1996). A significant difference was observed only in higher prescription of anti-diarrhoeals by GPs over pediatricians (P < 0.01) while there was no significant difference in antibacterial amongst GPs and pediatricians (P <0.16).

High number of drugs per prescription: The average number of drugs prescribed per patient is 3 or more in Pakistan as compared to an average of 2-3 in LMICs, and over 70% of patients are prescribed antibiotics 10. A survey of 10 health care facilities from each province were selected keeping appropriate representation from first level health facilities, district health facilities and tertiary care hospitals, found out that average prescribed number of drugs per patient was 2.77 (Range: 0-7) and would be higher if drugs per prescription rather than drugs per patient were to be computed (Hafeez et al 2004). Drugs prescribed at BHus and RHCs is high at 2.75 medicines per prescription and close to the average of 2.79 prescribed at Teaching Hospitals 2. In a randomized survey of prescriptions of 354 (specialists), practicing in private facilities, there was an average of 4.51 medicines prescribed per prescription with over prescriptions of antimicrobials, vitamins/minerals and injections were overprescribed 4.

67

Figure 9. Number of medicines per prescription

Source: The World Medicines Situation, WHO 2004.

High use of injections: Overuse of drugs also translates into a high rate of injection usage. Pakistan is globally one of countries with the highest rate of injection usage with over 60% of patient encounter involving an injection (WHO 2004). This translates into 13 injections per person per year (DAWN 2009). Studies in Pakistan show that up to 90% of injections are estimated to be unnecessary 10. A cross-sectional survey of general practitioners in urban and rural areas of Murree showed that 80% of the general practitioners give injections to every patient (Janjua 2003). 53% of GPs in rural areas and 28% in urban areas preferred injection as an essential component of treatment 11. When comparing public and private healthcare providers, in Attock district, over 48% of GP prescriptions had at least one injectable drug compared with 22.0% by public providers ( p < 0.0001) 12. Asides from polypharmacy issues, high injection use raises grave risks of spread of blood borne diseases such as Heptatis B, C and HIV. GPs largely make use of unsafe practices with most surveyed GPs using multi dose vials for medications and none of the practitioners used separate syringes for drawing and injecting. There was also seen to be insufficient numbers of sharp material disposal boxes, which were not available in 86% of the facilities. Moreover, 79% of the injection providers were never vaccinated for Hepatitis B 13.

68

Figure 10. Percentage of patients receiving injections

Higher rate of irrational use amongst GPs over public sector: In a survey in 114 health facilities, including 62 public sector and 52 private sector facilities, it was found that the mean number of drugs per prescription was 4.1 (SE: +/- 0.06) for general practitioners and 2.7 (SE:+/- 0.04) for public providers (p < 0.0001) 14. Prescription rate was particularly higher for antibiotics (62%) and injections (48%) amongst GPs as compared to public sector with rates of 54% and 22% respectively (p < 0.0001). Similarly more than 11% of GP prescriptions had an intravenous infusion compared with 1% for public providers (p < 0.001). General practitioners were also found to prescribe anti-diarrheals more frequently than doctors working in the public sector (p < 0.01) (Siddiqi et al 2002). However, many public sector physicians also practice as general practitioners during evening hours and it is uncertain whether the relative edge of prescriptions within public sector facilities is maintained during switch to general practice. Drug resistance: Antimicrobial resistance and containment often results from irrational drug use 15. High level of resistance has been found to ampicillin, cotrimoxazole, chloramphenicol and erythromycin in a large study of 9209 individuals in Karachi 16. The results are alarming as these are the frontline antibiotics for control of infections. The study also found that these drugs had been frequently used by the individuals in the four weeks preceding the resistance survey. It is expected that resistance to front line anti-malarials, anti-tuberculous therapy and HIV retroviral therapy is also present in Pakistan however surveillance of resistance is a major challenge and there is need for robust information in this area.

69

AFFORDABILITY & FINANCING

Total financing to health sector is inadequate: In Pakistan 2.4% of GDP is spent on health with total health expenditure being extremely low at $15/capita/ year. National Health Accounts analyzing 2005-06 data shows that of the total health expenditure, that only 32% is spent by public sector including the Ministry of Health, para-statal organizations and facilities of Armed Forces Federal Bureau of Statistics 17. Private health expenditure is responsible for the major share 64% of total health expenditure of which 97.5% comes from out of pocket spending by households with very few covered by pre-payment schemes 17. International development partners have a marginal contribution of 1.9% of total health expenditures. Medicine expenditure is low and responsible for shortages: Overall, an estimated 47% of the total health expenditure in Pakistan is spent on medicines (WHO 2004). The public sector is responsible for only 27% of medicine expenditure while private health expenditure on medicine comprises nearly three-fourth with the burden borne by households through out of pocket payments (WHO 2004). 43% of private sector users pay for medicines within the facility while 60% pay for medicines at outside pharmacies/ drug stores. Spending in the public sector on medicines is clearly inadequate and a major contributor to drug shortages as shown in later sections. WHO predicts that governments spending less than US$2 per person per year on essential drugs are likely to face shortages in the public sector forcing patients and their families to purchase from the private sector 18. The MOH in Pakistan spends $3 per capita on health (NHA 2009) and available evidence shows that the Ministry of Health’s operational budget is mainly taken up by salaries with a 30-20% spent on non-salary expenditures including medicines 19-21.

Figure 11. Share of Total Pharmaceutical Expenditure in Total Health Expenditure

70

Figure 12. Share of Public and Private Sectors in Total Pharmaceutical Expenditure

Out of pocket medicine expenditure at public and private sector facilities: A synthesis of national evidence shows that out of pocket expenditure at public sector facilities consists largely of payments for medicines bought outside the facility by nearly two-thirds of users. Mean cost of medicines outside is Rs. 252 in private and Rs. 198 in public facilities 22. With lack of specific financing schemes such as prepayment schemes for risk-pooling or commodity vouchers, the poor and sick are vulnerable to prescription practices of health staff and the pharmaceutical market 23. A study reported that low income users of obstetric care at a government hospital in Karachi spent 44% of the direct medical expenses on drugs

24. Expenditure estimation for out-patient diabetes care at three facilities including a NGO, private sector and government health facility in Karachi found that 46% of the total out of pocket expenditure is on drugs 25. A population based study on 2675 households in Karachi reported that 54% of patient expenditure on hypertension control at outpatient cares across is spent on purchase of medicines (Zaidi et al 2008). The high share of expenditure consumed by medicines is one of the major reasons underlying patient non-compliance with chronic care therapy. Available studies examining non-compliance report that in at least 33.5% of psychiatric patients and 41% of tuberculosis patients unaffordability of drugs was the primary reason for non-compliance (Rizwan 2005; Ahmed 2009). The above findings highlight that sufficient financial access to even generic equivalents needs to be guaranteed for the poor while use of originator brands needs to be substantially rationalized. Medicine prices of public sector procurement: The Median Price Ratio (MPR) gives an indication of country price to international reference price with a ratio of 1 or below considered to be efficient. The public sector procurement of generics medicines is at an acceptable Median Price Ratio of 0.6 however that for originator brands is substantially high with a MPR of 7.0 as compared to international average of 3.0. This shows that generics in the public sector are purchased at acceptable prices however it does not give an indication of quality of medicines. At the same time the gap between generics and originator brands is extremely high and needs to be reduced through both price regulation and rational selection.

71

Medicine prices in private sector: In the private retail sector, Median Price Ratios of drugs are substantially higher in private retail outlets than those observed in public sector procurement both in Pakistan and most LMICs with the exception being countries such as Kuwait where because of pricing regulations there is little price differential between originator brands and generics. In Pakistan basic generic medicines in private retail outlets have a MPR range of 1.2-7.3 and originator brands for basic therapy have a range between 0.8-15.8. Specific medicines suffer from excessive prices and need to be targeted for regulatory action and cautious prescription Affordability Indexes and Studies: A price and availability survey by the World Health Organization and Health Action International studied the affordability of 29 important medicines in 36 countries including Pakistan 26. The affordability of treatment was estimated as the number of days’ wages the lowest paid government worker would be required to pay to purchase a standard one-month medicine therapy for a chronic illness or for one episode of acute illness. A treatment requiring more than one day’s wage is considered unaffordable. In the public sector in Pakistan, like most of other countries, medicines are generally provided free of charge however given frequent non-availability of medicines, patients were commonly forced to seek supply from private retail pharmacies. Medicine therapy for acute respiratory infection was affordable given a range of 0.3-1 days wage, therapy for chronic illness such as hypertension, depression, diabetes, epilepsy, arthritis and peptic ulcer was unaffordable even with use of low priced generics (WHO-EMRO 2008). Affordability of chronic conditions with low priced generics was 1.7-7.7 while with originator brand was the range was much higher from 1.9-36.4 (WHO-EMRO 2008).

RELIABLE HEALTH SYSTEMS

1.Public Health Care System

Public sector facilities provide medicines free of charge. There are more than 10000 health public sector facilities ranging from 5798 Basic Health Units (BHUs), 581 Rural Health Centres (RHCs), 947 Tehsil HeadQuarter and District HeadQuarter Hospitals (THQH/ DHQH), and 29 Teaching Hospitals 27. Supply of medicines to primary and secondary facilities is based on essential drug list for each tier of health facility and inlcude approximately 70-80 drugs for BHUs, 100-120 for RHCs and 300 for District Hospitals. Tertiary facilities, including Teaching Hospitals, procure medicines independently based both on the National EDL as well as recommendations of the hospital drug procurement committee. Low utilization of public sector facilities: Overall utilization of public sector is low with 21% of the population utilizing public sector while the rest utilize a primarily fee based private 28. Low utilization is consistent across both rural and urban areas with respectively 36% and 22% of households utilizing the public sector 27. There is particularly low utilization of primary care tiers of the health systems, with 1 visit/capita/ year to a PHC facility, while there is heavy utilization of tertiary hopsitals. Amongst users of public sector facilities, 40% are dissatisfied with services provided with lack of medicine availability being the most frequent reason for dissatisfaction 29.

Table 10. Level of Dissatisfaction with Public Sector and Underlying Reasons

Percentage dissatisfied with service 40

72

Reason for dissatisfaction

No doctor 12

No trained staff 20

No medicine available 23

Long waiting 13

Staff not helpful 14

Treatment unsuccessful 11

Source: PSLM 2004/05.

Availability of medicines in public sector facilities: Availability of even essential recommended generics is extremely low in public sector facilities with a 3.3.% median availability and is much lower than the range of 29-54% found in LMICs while originator brand medicines are generally not available in public sector facilities in Pakistan as well as other LMICs 26. Availability in public sector is lower than that in private sector as discussed in a following section. Availability of medicines for acute care range between 30-67% while availability of essential chronic care drugs for management of cardiovascular disease, diabetes, chronic respiratory disease, glaucoma and palliative cancer therapy ranges between 3-57% 30.

Table 11. Medicine Availability at Public Facilities and Private Pharmacies

0% beclomethasone inhaler, Carbamazepine, Hydrochlorothiazide, Indinavir,

Losartan, Lovastatin, nevirapine, Nifedipine retard, phenytoin, zidovudine

1-10% Acyclovir, fluconazole, fluoxetine, fluphenazineinj, ranitidine, salbutamol inhaler, Sulfadoxine/Pyrimethamine

11-40% Amitriptyline , ceftriaxone inj , Co-trimoxazole, susp, Diclofenac ,

Glibenclamide, Omeprazole

41-50% Ciprofloxacin

51-60% Captopril, diazepam

61-80% Amoxicillin, atenolol, metformin

>80% None

Source: Pakistan: Medicine Prices, Availability, affordability & price components, WHO/HAI Report 2008 There is lack of comprehensive assessments of drug availability across the country giving details by drug type and by primary and secondary tiers. Available information from one province, the province of Sindh, shows that there was not a single BHUS or RHC maintaining a full stock of mandated drugs 31. Stock outs were comparatively higher in BHUs as compared to RHCs. BHUs had 10-25% availability of antibiotics in BHUs, followed by 25-50% availability of iron tablets, anti-malarials and anti-tuberculosis drugs and 50-80% availability of anti-pyretics while in RHCs there was

Table 12. 171717Availability of Medicines in Percentage of BHUs and RHCs

Medicines Availability of Medicines in

%age BHUs

Availability of Medicines in

%age RHCs

Antibiotics <25% <25%

73

Analgesics

Paracetamol 70%

Antituberculosis

Streptomicin, Isoniazid

Pyrazinamide, Ethambutol

<50% >80%

Rifampicin <50% 50-80%

Antimalarials

Fansidar <50%

Chloroquin <50% 50-80%

Obsterics

Oxytocin <25%

Source: NPPI Baseline Survey, Sindh 2009, One UN Program in Pakistan, NMNCH

Program, & Department of Health Government. Medicine availability in THQs and DHQs, particularly of emergency medicines, is also sub-optimal. Asides from dexamethasone, the availability of emergency medicines ranges between 30-50%, and is even lower for certain basic drugs such as Calcium Gluconate and Magnesium Sulphate 32. Availability of basic obstetric care medicines was also very poor with 45-60% availability of ergometrine and oxytocin and 0% of mesoprostol. Availability of antibiotics was comparatively better however only 1 antibiotic had 100% availability with availability of others ranging between 25-80%.

74

Table 13. Availability of Different Medicines in THQHs and DHQHs

Availability in % THQs Availability in % DHQs

Emergency Medicines

Diazepam and Frusemide 50% 50%

Dexamethasone 80% 86%

Cagluconate and

Magnesium Sulphare

20% 3%

Insulin and Adrenaline 30-40% 30-40%

Antibiotics

Cloxacillin 80% 25%

Amoxacillin 56% 100%

Metronidazole 100% 73.3%

Ciprofloxacillin 40% 60%

Obstetric Medicines

Ergometrine 60% 46%

Oxytocin 60% 56%

Misoprostol 0% 0%

Source: NPPI Baseline Survey, Sindh 2009, One UN Program in Pakistan, NMNCH

Program, & Department of Health Government. . Shortage of medicines for, at least for obstetric care, has also been reported by other studies. Essential low cost drugs such as iron tablets, folate tablets, broad spectrum antibiotics and oxytocin were largely unavailable at primary and secondary health facilities 33. while Magnesium Sulfate needed for basic emergency obstetric care services was only sporadically available or completely unavailable 34

Procurement and Supply of Drugs: Procurement of drugs is based on an essential list of medicines specific for each facility tier, however procurement in practice has also frequently involved purchasing of other drugs not on the list. Although a computerized Health Management Information System (HMIS) exists there is little link between case volume and morbidity generated by HMIS reports and the process of forecasting and budgeting. Purchasing is done on the basis of cheapest tender submitted by any licensed drug production company. This has often been criticized as resulting in a low quality threshold as company registration is used as the only quality criteria and with presence of 500-650 licensed production companies in Pakistan, it does not serve to discriminate on quality aspects. The onwards supply chain essentially relies on manual record keeping and although a computerized drug logistics management systems is in place for the GFATM it is yet to be applied to the public sector.

Existing public sector procurement practice has resulted in curtailing drug expenditure. A median price ratio (MPR) compares local price to international price and a MPR of greater than 2.5 indicates excessive medicine prices. Generics purchased by public sector are either below or equal to the international price index however branded drugs have been bought up to 3.5 times the international reference prices 26. The price index of public sector, for both generics and branded drugs, is more efficient than that of the private sector in Pakistan. Whether efficiency has been achieved as a result of quality compromise, needs serious exploration. Anecdotal evidence highlights institutionalized malpractices in procurements

75

where standard mark-ups are charged as a result of collusion between public entities and production companies (N2 35.

Table 14. Median MPRs for innovator brands and lowest priced generics in the public (procurement only) and private sector (patient price only)

Median Price Ration (MPR) to Reference

Price (MSH, 2003)

Reference

Price

Sector Type and No.

of Medicines

Median MPR

(25% - 75%

IQR)

Minimum

MPR

Maximum

MPR

MSH, 2003

Public Brand (n=2) 2.24 (1.60-2.87) 0.96 3.51

Lowest Priced Generic (n=14)

0.57 (0.38-0.74) 0.24 1.04

Private Brand (n=23) 3.36 (2.20-5.88) 0.72 26.20

Lowest Priced Generic (n=21)

2.26 (1.15-3.60) 0.20 7.02

Source: Synthesis report of medicine price surveys undertaken in selected countries ,WHO-EMRO 2008. Procurement has traditionally been done at the provincial level with supply onwards to different districts however as a result of devolution to district level under the Local Governance Ordinance of 2001 drug budgeting, procurement and management took place at the district level for a stretch of nearly ten years. With lapse of the ordinance in 2010, it is uncertain whether there will be a shift back to centralized procurement and supply. As yet there has been no study to assess the relative performance of district versus provincial based drug management.

Issues related to drug storage & dispensation: A survey of first level care facilities, district hospitals and tertiary hospitals conducted as part of Emergency Drug Supply Project in NWFP, Punjab and Balochistan, highlighted issues related to drug storage and dispensation2; 36. Dispensing time on average is merely half a minute which is inadequate for good dispensing while communication with patients was poor and is a cause for concern given low awareness level of patients. Preparation of prescriptions by dispensers is often unhygienic, prone to mistakes and every one in five prescription is dispensed without validation. Preparation of drugs, labeling of drugs and record keeping were also inadequate. Storage issues were also examined at public sector facilities. It was found that while stock auditing was satisfactory at majority of sites, presence of essential drug list was seen in only 1 facility, storage conditions including temperature maintenance, hygiene and pest control was unsatisfactory at majority of places, and actual store capacity was not known by 97% of storekeepers. Store keepers lacked both pre-service and in-service training on proper stock handling. Another study reports labeling and storage of anesthetic medications across 58 operation rooms. Only 15% of operating rooms were compliant with proper drug labeling 36.

2. New Modalities of Health Care Provision – Contracting out of Health Facilities

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The Government of Pakistan launched a country wide program known as the People’s Primary Healthcare Initiative (PPHI) involving contracting the management of BHUs for improved service delivery. Out-sourcing of BHUs has been done to the National Rural Support Program (NRSP) and the initiative is administratively housed under and financially assisted by the Federal Ministry of Industries. It is an example of contracting-in through management contracts and involves outsourcing the operation budget of BHUs by the department of health to the contractor accompanied with financial and administrative powers for flexible usage of budget and staffing to improve BHU utilization. Overall, 2391 BHUs and 701 other health facilities including dispensaries and MCH centers have been contracted out over 127 districts including 36 in Punjab, 23 Sindh, 30 in Balochistan, 31 in NWFP and 7 in Gilgit-Baltistan. Further experiments with alternative financing models are underway with performance based contacting out, contacting in and competitive voucher schemes being rolled out in the province of Sindh with Norwegian government and One UN Program assistance. Availability of medicines at contracted BHUs:A study to evaluate the pilot of BHU contracting in Rahim Yar district of Pakistan was conducted using intervention and control districts. Although it found mixed result with improvements in curative care and under performance in preventive and promotive care, drug availability was improved in contracted BHUs. Users reported 30% availability of medicines in contracted BHUs as compared to only 7% in non-contracted37. A national third party evaluation has been recently conducted which confirms that there have been improvements in essential drugs availability. Overall 22.5% of contracted BHUs were in the highly satisfactory category for drug availability as compared to only 8.3% of non contracted BHUs, while close to 87% of non-contracted BHUs fell in the unsatisfactory or highly unsatisfactory category compared to 57% of contracted BHUs. Greatest improvement with contracting was seen in Sindh and least in Khyber Pukhtunkhwa. A breakdown of results by essential drugs shows that highest improvement was in availability of amoxicillin, oral pills and chloroquin, with little change seen in availability of iron/ folic acid and IV infusions.

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Table 15. Availability of Essential Drugs and Vaccines: Comparison between Contracted and Non-Contracted BHUs

Source: Third-Party Evaluation of the PPHI in Pakistan Volume 1 – Draft One for comments - 14 December 2010

Source: Third-Party Evaluation of the PPHI in Pakistan

Procurement and Supply in Contracted BHUs: The contracted BHUs have a more expanded list of approved drugs - 117 drugs as compared to 70-80 drugs at non-contracted BHUs – with some drugs falling outside the national EDL. Procurement and supply of drugs in the

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case of contracted BHUs is centralized at the provincial level. Some adaptation of public sector purchasing rules has been done for procurement and purchase not necessarily bound by cheapest tender in an attempt to improve drug quality. Although availability has been proven to be higher, there are concerns over presence of inappropriate drugs at BHUs not required for first level primary care. Standardized and clear selection and procurement systems are needed across all provinces. 3. Essential Medicine Management during Emergencies In Pakistan, areas affected by the earthquake in 2005 and floods in 2010 are being supported for drug supply through the WHO and international NGOs. Assessment of essential medicines management in disaster hit areas in Pakistan showed that a steady supply of medicines without stock-outs was seen in 56 first-level care government facilities of calamity hit area 38. WHO has been assisting in the procurement and supply of drugs to in disaster areas and has outlined modalities for acceptance of donated medicines, assisted in speedy procurement, developed tools for forecasting, designed customized kits and implemented a computerized logistic support system for assisting in sustained supply and inventory control. Due to lack of WHO certified production units in Pakistan, drugs are procured internationally. A computerized Disease Early Warning System provides alert on diseases meeting in disaster areas for timely provision of essential and life saving drugs. Large international NGOs have also been directly procuring and dispensing drugs through their health delivery network. The most notable amongst the INGOs is Merlin which is providing services to a population of 2 million though 100 government health facilities.

4. Private Sector Market

Composition of private sector: In Pakistan, 79% of the population utilizes the private health sector 22. Private providers largely rely on private pharmacies and medical stores for provision and dispensing of medicines to patients with few large hospitals maintaining own chain of selection and supply of medicines. Of the total expenditure on medicines, private health expenditure on medicine comprises nearly three-fourth with the burden borne by households through out of pocket payments (Lancet 2009). The private sector comprises a wide mix of providers including at least 20,000 registered general practice clinics, 340 dispensaries, 300 MCH centers and 450 laboratories/ diagnostic centres, however actual numbers are probably much higher as all cadres of government health staff also maintain private practice 27. There are also 500 small to medium sized hospitals and although large regular hospitals are much fewer in number (WHO-EMRO 2011) they include some of the longest established philanthropic hospitals that continue to be heavily utilized (Rahman 2008). In addition there are 1800 local NGOs providing health care services including few large national NGOs and several small-medium scaled NGOs. Beside the allopathic sector, there are at least 52,600 registered unani medical practitioners providing non-allopathic remedies. Private pharmacies/ medical stores: Pharmacies and medical stores are an important source of care as there is little restriction on drug sales and patients frequently resort to self medication. Although there are no national figures for self medication, available studies indicate 6-51% depending on the contextual setting (Thaver & Haider 1995; Sturn 1997), and figures are nearly two decades old and require updating. There are 45000-50000 pharmacies and medical stores in Pakistan (Butt et al 2005), one of the highest numbers in LMICs.

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Many drug sellers have minimal formal education and little or no professional training; of those with training, most were absent from pharmacies (Rabbani et al 2001) a practice also observed in other developing countries. While there are regulatory checks on drug quality at retail outlets there is little regulation of quality of retail outlet. A cross-sectional survey of 311 pharmacies /medical stores in Rawalpindi showed that the proportion of pharmacies meeting licensing requirements was only 19.3% [95% C.I: 15.1, 24.2] 39. Qualified staff was present in only 22% of pharmacies. Only 10% had a temperature monitoring device and only 4% had an alternative power supply for refrigerators as a back-up for frequent power outages.

Availability of medicines in private sector: In private retail pharmacies medicine availability is higher than public sector both for generics and originator brands. Availability of originator brands exceeds that of low cost generics with respective figures of 59% for originator brands and under 30% for low priced generics. There is excess availability of originator brands in the private sector, exceeding the 23-47% range found in LMICs while low priced generics needs to be increased as it falls much below the 50-75% availability figures for LMICs. The originator brand versus generic imbalance is influenced by local regulations on production of medicines as well as demand, marketing by industry and demand of health care providers and patients. Marketing of Drugs to Health Providers: Malpractices in the distribution chain are evident in the area of marketing, where members of the industry collude with health providers in order to promote the use of medicines, products, and technologies without regard for cost, quality or appropriateness of use (Nishtar 2010). Health care facilities whether in the public and private sector, with extremely few exceptions, do not place any restriction on industry representatives to health providers. Pakistan Medical and Dental Council’s ordinance on relationship between the industry and registered doctors and dentists is vague at best. It does not prohibit the receiving of gifts, inducements, or promotional aids by registered practitioners from pharmaceutical industry provided it does not compromise professional integrity 40 Visit by industry representative for many general practitioners is alarmingly often the only source of treatment information, underscoring the lack of in-service training, however information provided is questionable. A study found that 18% of sales advertisements had unjustified or misleading claims 41. Another study involved promotional brochures claiming that full prescribing information was available on request. When doctors requested information from a mix of 45 multinational and local companies 26% letters received a response and only 15% of responses met the WHO criteria for optimal drug information 42. 5. Trained Human Resource: Inadequate supply and use of pharmacists: Pharmacists in developing countries are still underutilized and their role as health care professionals is not deemed important by either the community or other health care providers (Azhar et al 2009). There is inadequate supply of pharmacists with a total of 28 pharmacy institutions but only 8102 pharmacists in the country as compared to 110,000 doctors. This provides a ratio of 0.9 pharmacists: 10000 population as opposed to a recommended ratio of 1 pharmacist: 2000 population (WHO-EMRO 2009). Among the total number of pharmacists in Pakistan, approximately 55% are engaged in the production of pharmaceuticals – 15% of them working at the federal and provincial drug control authority and hospital pharmacy level – with another 15% in sales and marketing of pharmaceuticals, 10% in community pharmacy, and the rest 5% in teaching and research

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(Azhar et al 2009). Particularly acute shortage of pharmacists is seen in the areas of drug procurement, management and dispensing across both the public and private sectors. Within the public sector, the post of pharmacist is only seen in district and teaching hospitals, however numbers are meager with for example only 1 pharmacist posted in Civil Hospital Karachi a large teaching hospital with an OPD of 800 patients/ day and 1500 beds. Although elsewhere in the world the role of pharmacists is recognized in community pharmacies, hospital and drug regulatory authorities, the health care system of Pakistan has yet to recognize this role. Regulation of pharmacy practice: There are legal provision requiring pharmacists to be registered and requiring private pharmacies to be licensed however National Good Pharmacy Practice Guidelines have not been made public by the government 43. A Pharmacy Council has been recently formed under the Pharmacy Council Act 2009 to regulate the practice of pharmacy. Specific functions include developing and overseeing standards for conduct of pharmacists and allied staff, standard of teaching and accreditation of pharmacy degrees, maintaining registers of qualified pharmacists and pharmacy technicians, and training programs, and organization of continuing training courses. The Pharmacy Council is currently functional however its functions are limited to the relatively low numbers of pharmacists in the country and has no control over the vast number of medical stores in the country manned by those holding no training or qualification in pharmacy.

Regulation: Licensing, Registration, Pricing, and Quality Control

Drug Policy & Acts: Access to essential medicines/technologies as part of the fulfillment of the right to health, is recognized in the national constitution. Regulation of the pharmaceutical sector had traditionally been by the Drug Act 1940 and the Pharmacy Act 1967. In 1972 the Generic Drug Act was introduced but had to be revoked in the wake of strong opposition by the commercial sector and the medical community 35. The Drug Act 1976 currently regulates the pharmaceutical sector and is a comprehensive document setting out extensive stipulations for industry licensing, drug registration, quality control etc. However implementation of the act is loosely monitored and creates space for abuse. Furthermore, it has not been updated since the declaration of the World Trade Organization’s (WTO) statutes and Pakistan’s Patent Ordinance 2000. A National Medicines Policy was also formed in 1993, updated in 1997 and is currently again in the process of update. At present there is no strategic plan for implementation of National Medicine Policy. Issuance of Statutory Regulatory Orders further creates confusion and unevenness in the application of policies. In response to quality concerns over drugs in the market, the Federal Cabinet has approved the establishment of an independent Drug Regulatory Authority (DRA), however its constitution has not taken place so far.

Table 16. Areas Covered by National Medicines Policy

Selection of essential medicines Yes

Medicines financing NO

Medicines Pricing Yes

Procurement Yes

Distribution Yes

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Regulation Yes

Pharmacovigilance Yes

Rational use of medicines Yes

Human resource development Yes

Research Yes

Monitoring and evaluation Yes

Traditional Medicine Yes

Source: Pharmaceutical Country Profile. Pakistan. Ministry of Health. 2010

Regulatory Functions & Organizational Structure: The federally based Ministry of Health (MOH) is responsible for licensing of drug production companies, registration of drugs and pricing while the function of quality control lies with the provincial Departments of Health (DOH). Each function has detailed and well developed guidelines given by the Drug Act 1976.

Source: Ministry of Health Pakistan

Drug Production: Pakistan meets 70% of its domestic demand of medicines from local production and 30% through imports (MOH 2011). Although at the time of independence in

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1947, there was hardly any pharmaceutical industry in the country there are currently 30 multinational and 411 local units involved in pharmaceutical manufacturing 44. However, share of market both in terms of number of medicines manufactured and revenues, is almost evenly divided between the few multinationals and large number of local companies. The local market for pharmaceuticals in Pakistan has been expanding at a rate of around 10-15% over the last few years. The value of pharmaceuticals sold in Pakistan exceeded US$1.4 billion, which equates to per capita consumption of less than US$ 10 per year while it is expected to exceed US$2.3 billion by 2012 45. The Pakistan pharmaceutical industry has a small share of the international market with an export turnover of US$ 400 Million and accounts for 1% of the exports 45. However there is wide variation in quality of drugs manufactured with existence of both sophisticated manufacturing units having well developed quality monitoring mechanisms as well as low cost units having non-existent quality assurance systems 35. There is lack of local production of WHO certified drugs which are mandated for usage in donor funded programs such as GFATM and also required for use by international NGOs serving mainstream and refugee populations. So far industry has not shown interest in investing in quality assurance for WHO or FDA certification, and quality measures are up to interest and motivation of individual production units. Drug Licensing: In Pakistan, there are legal provisions requiring manufacturers to be licensed and requiring manufacturers to comply with Good Manufacturing Practices 43. Drug Act 1976 provides a system for licensing of each manufacturing unit. The Licensing Board at the MOH examines and approveslayout plans of new manufacturing units, inspects units through panel of experts and processes applications for renewal of licenses. However there is wide variation in terms of quality of registered production units. At present there is no WHO certified nor FDA approved manufacturing facility in the country. In the process of manufacturing, very few manufacturers in Pakistan comply at best, only with minimal quality standards and the barest minimum current Goods Manufacturing Practices (GMP) stipulated criteria raising quality concerns. These entities find compliance with regulations costly and try to influence regulators to get their products registered, speed up approval processes, get favorable prices or to have their drugs included in the formularies of various hospitals and institutions 35. Drug Registration: The Drug Registration Board processes application for registration of any new pharmaceutical item including new molecules, new dosages of approved molecules as well as different brands of approved molecules under the Drug Act 1976, the de-registration process is also a function of the board. Registration can be made on basis of proven efficacy in any country and does not require bio-equivalency results from Pakistan. Cost effectiveness studies are also not required for registration of products. At present there are 1100-1200 registered molecules and approximately 76000-88000 registered products which is one of the highest across LMICs. This is due to a high number of drug registrations for example there are seven forms of Acetaminophen in the market being sold under different brands, dosages and prices. Another underlying reason is that there is no systematic system of de-registration of old and superfluous products. With record keeping still manual it is difficult to access and review data of the numerous registered products. Pricing & Issue of Orphan Drugs: In Pakistan, there are regulatory provisions affecting pricing of medicines targeted at manufacturers, wholesalers and retailers. Pricing is fixed at the MOH with the standard practice of pricing based on reported price of raw material, other input and overhead costs. This also creates opportunity for collusion to obtain high prices 35. As yet there has been no move towards a clear pricing formula. By law, wholesalers can

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markup goods by maximum 2% of the final price and retail markup for locally produced medicines is 15% of the final price. Regulations exist mandating that retail medicine price information should be publicly accessible and the information is made publically available through the Official Gazette Notification and printed on each medicine box. The capacity of inspectors to comprehensively monitor prices and ensure adherence to officially set prices is limited and there is no official data on levels of adherence 46. The MOH has consistently provided measures for low pricing tax breaks as well as price control. There is tax exemption on import of raw material and equipment for basic manufacturing of drugs and is of considerable importance given that there is little production of raw material with most being imported in large quantities from different countries. In addition, medicines are exempted from the general sales tax on commodities. Moreover, full import tariff exemptions are provided for UN partners and for HIV/AIDS medicines when procured by a donor funded program 46. Asides from tax breaks, there is flat price control is in place since the last 10 years in which prices of all pharmaceutical products have been frozen. The only attempt at partial price de-regulation attempt led to several fold increase in price of drugs and had to be rescinded. The issue of Orphan Drugs: While price control is well intentioned it has also contributed to the issue of ‘Orphan Drugs’ by which essential low cost drugs have disappeared from the market due to lack of profit margins. The list is alarming and includes basic essentials such as phenytoin, thiazide, adrenaline, thyroxine, primaquin, folic acid to name a few. Action by the MOH to enforce production of ‘orphan drugs’ has usually been counter productive leading to sub-standard production. Reliance is often on import of ‘orphan drugs’ to plug in chronic shortages. The MOH has not yet explored the potential of various approaches of differential pricing to control prices of drugs on the National EDL. Differential pricing is expected in the new National Drug Policy currently under development.

Quality Control: The quality of drugs on the market is an important public health concern in many countries. In Pakistan the quality monitoring of products on the market is done by the provincial governments while registration authority, as earlier mentioned, rests with the federal government. Quality control in Pakistan follows the traditional approach of being a government dominated function relying on monitoring and punitive action. There has been little attempt for more participatory regulation of drug quality that could result in more buying in from industry, distributors ns retailers. The basic functions for quality monitoring include sampling and testing of drugs being sold at retail outlets, inspection of drug storage and inspection of drug transportation. Investigation reports for sub-standard drugs, misbranded or adulterated drugs are sent to Federal Licensing and registration Boards and through them to all the provincial governments for ensuring effective recall of drugs. 7 laboratories exist in Pakistan for Quality Control testing, however reportedly only 3 have required capacity. The federal Drugs Testing Laboratory is located at Karachi and an Appellate Laboratory for re-testing is in Islamabad. The Provincial Governments have their own Drug Testing laboratories at Peshawar, Quetta, Lahore and Karachi. In the past 2 years, 60,000 samples were taken for quality control testing of which 1,194 failed to meet the quality standards, however results are not publicly made available 43 Issues of counterfeit medicines: According to WHO, 25% of all medicines in developing countries are counterfeit with prevalence far higher in certain countries. Counterfeit medicines constitute between 40-50% of total supply in Nigeria and Pakistan 47.Counterfeit

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medicines result in either under-dosage or even active harm causing injury or death. It also undermines the incentives of registered pharmaceutical producers to invest in quality control. Report from pharmaceutical manufacturers of the European Union and another from US Trade Office have alleged that the Pakistani market has almost 50% spurious drugs 48. Counterfeit medicines can get access into the medicines chain either through regulated or unregulated channels. The latter include manufacturing of spurious drugs by unlicensed manufacturers and smuggling. Both spurious as well as sub-standard medicines can also get access into the market through regulated channels. For example, when licensed manufacturers use substandard raw material and/or fail to comply with stipulated manufacturing practices, quality may be detrimentally affected. Similarly, official channels of trade can involve trade of counterfeit medicine inadvertently or intentionally and it is reported that 6-10% of cross border trade in medicines in developing countries comprises of counterfeit medicines (Nishtar 2010).

Research fund tax: A Central Research Fund is maintained by the MOH for investigation, evaluation or development of a drugs and its use is governed by detailed guidelines given by the Drug Research rules 1978. Every pharmaceutical manufacturer is supposed to contribute 1% of gross profit, before deduction of income tax, towards the Central Research Fund 46 An Expert Committee is responsible for fund allocation to individuals and/ or Institutions, which are engaged in research in the field of pharmacy and medicine however to date there has been little utilization of research funds.

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Literature review - Lebanon

Here a review of what has been written (both journal articles and documents).

You can build on the paragraphs you had previously. It just needs to be a more

formal review.

Journal articles

Using the expanded search strategy, a total of 44 journal articles were identified

as relevant to ATM (Appendix 5-A). No articles specifically discussed the issue

of access and no articles examined ATM in a comprehensive manner that

includes the four domains of the WHO 2004 framework.

As common in ATM research globally, the area of rational selection and use has

received attention from researchers in Lebanon. Saab et al (2001) described that

“In 1966, Lebanon had around 19,000 drug formulations registered in the

Ministry of Public Health. The government decreased that number to 5400 in

1992 through numerous interventions.” They described the process of

development of a list of essential drugs for primary care by an ad hoc committee

set up by the Lebanese government.

Several studies have looked at prescribing behaviors, in general or for specific

conditions. In a university health center, Hamadeh et al (2001) studied

prescribing practices and found low rate of generic and essential drug

prescribing and frequent prescribing in respiratory or ear infections (about 50%

of encounters). Bizri et al (2002) reviewed available data at the time on patterns

of antibiotic prescribing in ambulatory care. In a four-country (Lebanon,

Morocco, Spain and USA) study of medical management of menopause, Sievert

et al (2008) reported that physicians were generally well informed and that

prescription patterns and perceived benefits of hormone therapy appeared to

reflect local medical culture rather than simply physician characteristics. El

Sayed et al (2009) described that pediatricians prescribed antibiotics to infants

at least once in 21.4% of cases diagnosed as the common cold and 45.5% of

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cases of acute bronchiolitis. Antibiotics misuse was more common among

infants born to mothers with lower educational levels. Pediatricians tend to

prescribe antibiotics in dispensaries more often than in private clinics. Abi Risk

et al (2010) reported that primary care physicians prescribed antibiotics for

pharyngitis at high rates (42% with 68% in winter and 38% in summer) and “No

physician used all the criteria in the score adopted by the CDC to decide on the

prescription of antibiotic or throat culture.”

Prescribing practices in hospital settings appear largely adequate. Azzam et al

(2002) reported that antimicrobial prophylaxis for surgical procedures was

appropriate. Kanafani et al (2005) found that antibiotic prescribing for acute

cholecystitis was erratic and costly in the absence of international guidelines on

appropriate use. Nassar et al (2008) found high rates of appropriate prescribing

among obstetricians for a specific indication. The area of management of post-

operative pain was, however, sub-optimal as reported by Madi-Jebara et al

(2008).

Several studies described development of practice guidelines and other

interventions to improve prescribing practices for managing specific conditions.

Azar (2000) proposed practice guidelines for managing hypertension in

diabetics. El-Hajj Fuleihan et al (2002) proposed guidelines for managing

osteoporosis. These guidelines were updated in 2008 (El-Hajj Fuleihan et 2008).

Riachy et al (2010) reported that an intervention using clinical guidelines aimed

at improving the use of nebulizers in a university hospital did not succeed in

lowering inappropriate prescriptions. Zgheib et al (2011) describe the

introduction of “rational prescribing” sessions, using team-based learning

format, to medical students at AUB.

Several studies have looked into medication use patterns. Naja et al (2000)

carried out a first pharmaco-epidemiological study on benzodiazepine

consumption, as such medicines were often available without a prescription at

the time. Benzodiazepine use during the past month was found in 9.6% of

subjects and described as “particularly high”. Benzodiazepine dependence was

found in 50.2% of users. Makhlouf Obermeyer et al (2002) analyzed medication

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use in the 1999 National Household Health Expenditures and Utilization Survey

and found that education and employment were associated with lower rates of

medication use while higher socioeconomic status was associated with higher

use rates. The researchers highlighted three areas for further research and

interventions: the higher use of antibiotics in rural areas, the greater use of

psychotropics by women, and the possible obstacles to obtaining needed

medications for those with lower incomes. Among elderly Lebanese, Saab et al

(2006) documented that about 60% were taking at least one inappropriate

medication and identified correlates of inappropriate use. Soldberg (2008)

reported increasing use of medication to treat mental health challenges which

may be related to Lebanon’s recent history of conflict. In a multi-country study

involving Lebanon, Scicluna et al (2009) documented the highest rates of self-

medication in Lebanon (37%). Lebanon had the highest percentage (60%) of

people keeping antibiotics at home. There was a significant association between

antibiotic hoarders and intended users of antibiotics for self-medication.

Because irrational use of medicines is common, several studies have reported on

consequences. As antibiotics are accessible without a prescription, several

studies have documented the consequences in terms of microbial resistance

(Araj 1994; Araj 1999; Araj & Kanj 2000), including in specific conditions such

as tuberculosis (Hamze et al 1997; Araj et al 2006), haemophilus influenzae

(Santanam et al 1990) and streptococcus pneumonia (Araj 1999; Harakeh 2006;

Uwaydah et al 2006).

Major et al (1998) studied the incidence of drug-related hospitalization in a

tertiary medical center and its association with self-medicating behavior. They

found that among adults and children admitted, 10.2% and 7.9% had drug-

related illnesses, respectively. Adverse drug reactions accounted for 7.0% and

5.7% and therapeutic failures for 3.2% and 2.2% of adult and pediatric

admissions, respectively. Self-medication was commonly practiced (52.6% of

adults and 41.6% of children). Interestingly, female sex increased the risk of

adverse drug reaction in adults, whereas self-medication decreased the risk. In

children, the risk of adverse drug reaction was increased in lower

socioeconomic groups. Kassab et al (2005) reported the first-year results of a

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national system of adverse drug reactions. They found that antimicrobial agents

were the most common drugs involved in such reactions (43%).

Articles concerning the health and supply systems highlighted a few interesting

aspects. Kyriacos et al (2008) studied the quality of amoxicillin formulations in

Lebanon, Jordan, Egypt and Saudi Arabia and found that 56% of amoxicillin

capsules did not meet the United States Pharmacopeia (USP) requirements.

They identified several factors that might jeopardize the quality status of

medicines: lack of effective quality assurance system during manufacture in

both Arab and export countries, and uncontrolled storage conditions, especially

unsuitable pharmacy premises. Use of substandard antibiotic preparations

increases the risk of therapeutic failure and the emergence of drug-resistant

microorganisms.

The practice of pharmacy received important attention. Dib et al (1998)

described pharmacy practice and outlined the challenges. Bou Antoun and

Salameh (2006) carried out a survey among community and pharmaceutical

company pharmacists in Lebanon to evaluate their satisfaction with professional

status and willingness to work as clinical pharmacists. The first group was more

satisfied and more willing to engage in clinical pharmacy. Salameh et al (2007)

carried out a survey of a pharmacist and a nurse in each of 59 hospitals in two

regions of Lebanon on the drug circuit starting from prescription to

administration. There were gaps in all hospitals that could lead to drug errors.

Salameh et al (2008) noted that clinical pharmacy is not professionally applied

in Lebanese hospitals despite the accreditation requirements and showed that

the majority of physicians and nurses thought that interventions by clinical

pharmacists would be beneficial. Khachan et al (2010) described pharmacy

education in Lebanon but did not describe aspects relevant to ATM.

Published and unpublished documents and gray literature

Using the previously discussed search strategy and supplemented with

documents provided by key informants, the research team has assembled a

library of documents of direct relevance to ATM (Appendix 5-B). It is beyond

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the scope of this report to review all such documents. Therefore we focus in this

section on observations about key aspects of the ATM situation in Lebanon.

These observations supplement the evidence-based review of research published

in peer reviewed journal articles (see section 5.1.1. above) and can inform the

agenda for essential research on ATM.

Expenditures on medicines (ATM) are an important concern in Lebanon.

Different resources estimate that medicines account for 25% of total health

expenditures (Hamra et al 2009; Chebaro 2010). Reported market sales in 2007

exceeded USD900 million (Ammar 2009, p. 102). The Lebanese

pharmaceutical market is expected to reach USD1.1 billion in 2015 (Chebaro

2010). This means that Lebanon, with a population of a little more than four

million, comes third in the region after such populous countries as Egypt and

Saudi Arabia in terms of the bill for medicines. About 80% of medicines are

sold in pharmacies, 14% consumed in hospitals and 6% purchased directly by

the MOPH (Ammar 2009, p. 103).

An important proportion of spending on medicines is out-of-pocket (OOP),

accounting for 67.8% of total spending on medicines (rate calculated from

Table IV-2, Ammar 2009, p. 104) and for 31.01% of total household spending

on health in 2005 (which increased from 25.35% in 1998) (Ammar 2009, p.

104). Between 1998 and 2005, while spending on medicines by

“intermediaries” increased by 34.2%, household spending on medicines

increased only by 0.7% indicating that “cheaper sources of supply have become

available for at least a part of the population” (Ammar 2009, p. 104). In 2005,

household annual spending on medicines was estimated between USD100 and

USD 125 per capita (Ammar 2009, p. 102; Hamra et al 2009). However, there

are indications that this figure is underestimated (Hamra et al 2009).

Lebanon is the leading importer of pharmaceuticals in the region. There are

between 85 and 142 agents (importers) (Chebaro 2010; Hamra et al 2009) who

import some 5,995 drugs from more than 558 factories in 32 countries

constituting between 92% and 94% of the products available in the market

(Hamra et al 2009; Chebaro 2010). Among all registered medicines in 2008,

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79.42% came from European countries, 9.59% from Arab countries, 5.75%

from USA and 5.24% from other countries (Ammar 2009, p. 102). The local

pharmaceutical manufacturing industry is still small but is expanding. In 2010,

medicines manufactured by seven local factories made up from 6 to 9% of all

medicines consumed (Hamra et al 2009; Chebaro 2010).

Prices of medicines are a major concern. In a study of prices of 32 medicines

based on an international standardized methodology, Karam (2004) found that

the public sector purchases medicines at reasonable prices for poor patients and

provides medicines for free in public health facilities but availability in the

public sector is “very low” and “poor patients are forced to buy expensive

medicines from private pharmacies.” In the private sector, availability is very

good but that “almost all the surveyed medicines are over-priced if compared

with the international reference price and the prices of innovator brands are up

to 5 times more expensive than the prices of their generic equivalents.” Chebaro

(2010) notes that the Lebanese spend three to six times more on the prices of the

essential medicines they need than they should. Karam (2004) also notes that a

“big part of price problem is the current price structure including profit margins,

expenses and fees as well as the incremental calculation method.” Hamra et al

(2009) note that the profit component of prices designated for pharmacies is

considerable, reaching 22.5% of the original price, which encourage

pharmacists to promote for more expensive products. High rates of importation

from European countries and USA (over 85% according to Ammar 2009, p.

102) contribute to the high prices of medicines.

A major contribution to the medicines situation is low rates of generic

prescribing. Karam (2004) notes that Lebanon is a “brand name” country. She

notes that “innovator brands drugs are possibly used more extensively as there

are “no incentives to prescribe and sell generic equivalents.” Ammar (2009, p.

104) attributes this to “absence of any framework for medical prescription

accountability”. The well-known oversupply of physicians, especially

specialists, and pharmacists in Lebanon contributes to high rates of prescribing

and dispending of branded medicines. Hamra et al (2009) note that pharmacists

are not allowed to substitute a prescribed product with a cheaper or generic one.

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Almost all publications acknowledge the role of aggressive promotion by

pharmaceutical firms and the incentives for physicians to prescribe branded

medicines. For example, physicians commonly reply on pharmaceutical

companies to finance their continuous education by sponsoring their trips to

international conferences (Chebaro 2010). The heavy promotion of brands

creates trade name affinity, discouraging doctors from prescribing generics

(Hamra et al 2009). The MOPH has proposed a code of ethics for promotion of

pharmaceutical products and has recently revised it and re-circulated it to

stakeholders but this document has not been formally adopted by any

stakeholder yet.

At the policy level, Hamra et al (2009) note that Lebanon lacks a “modern

medicine regulatory authority structure in place or a national medicine policy or

policy document that lays out a vision for the future of the sector and that

defines political, technical, economic and health related parameters that form

the framework for pharmaceutical legislation”. While there is large political

interest in the pharmaceutical sector, there is “insufficient will and

commitment” to carry out reform.

There are common media reports of corruption in the medicines sector but there

are no studies that document or measure the level of such corruption. In their

study of governance in the public pharmaceutical sector, Hamra et al (2009)

evaluated vulnerability to corruption of the policy, structures, and procedures in

place at the time of the survey. They found that “the area of medicine

distribution received the highest score and is minimally vulnerable to

corruption; medicines registration, inspection, and procurement are marginally

vulnerable to corruption; and the promotion and selection functions had the

lowest scores and are moderately vulnerable to corruption.”

Research questions emanating from the literature review

It is apparent from the aforementioned literature review that there is important

evidence for policy action to improve ATM. Nevertheless, the review indicates

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that evidence is lacking in many key areas. The research questions that emanate

from the literature review are provided in Appendix 6-A.

93

Results - Literature on access to medicines issues in the EMR area

We found several comparative studies that used data from EMR or

discussed issues relevant to EMR countries. These are included in the

analyses and data provided in different tables and figures. We also

identified a further twelve international studies that although had no

specific mention of the EMR countries, had important implications

about access to medicines in low and middle income countries of the

region.49-51

{Vreeman 2006}52-59

Among these twelve studies, eight

had been published in 2011 alone. We used these studies to discuss

and highlight some of the identified issues.

Six papers identified via international databases were in languages

other than English. Five papers published in French (2 each from

Tunisia and Morocco and one from Lebanon) and one in Czech

(about Yemen).60-65

We used the abstracts of these studies to include

and categorize them according to the issues and levels of barriers

discussed in the studies.

Producing the evidence: number and geographical distribution of countries

of origins of the identified publications

In total, 151 articles were identified that focused entirely, or in some parts of

the reports on ATM issues in one or more of EMR countries. Most of these

articles (125, 83%) were originated (as the corresponding author's address)

from EMR countries in that sense the majority of evidence on ATM in the EMR

region is homegrown. There is a wide variety in the number of publications per

94

country. As Figure 13 demonstrates, the countries that produce most

publications on ATM issues in the region that have published more than 10

articles in the last decade in international journals (journals indexed in PubMed

and Web of Science databases) are in turn Iran, Pakistan, Jordan and Lebanon.

Iran has produced 41 out of the total of 151 identified literature (i.e. over a

quarter) in the region.

Figure 13. Distribution of the country of origin of publications for access to

medicines issues in the EMR

95

The number of publications for some countries is proportionately very low. For

example, if we had excluded the studies from Egypt that were published

because of the presence of WHO regional office in Cairo, then very few studies

from Egypt would have remained in our sample. This is indeed very surprising

given that Egypt is one of the most populous countries in the region, and it

enjoys an expanded academic sector.

EMR The last decade demonstrates a relatively steady growth in the number of

publications per year on ATM in the EMR. This is a good sign that with further

development of health systems in the issue, the number of publications are

growing (see Figure 14). While in the first three years of this period we

observed only about ten publications from the region, the last three years

demonstrates there over 80 studies published. Most of this increase in the

number of publications per year

Figure 14. The number of ATM publications per year. Note that 2011 covers

only the first half of this year.

96

Countries of focus and ATM issues of focus

In total, 14 low and middle income countries have been the focus of at least

one ATM research in the past decade. Out of these countries, two countries

(Iraq, Libya) have been discussed in only two papers each (Figure 15). More

importantly we found no studies on Somalia and Djibouti. There were also no

studies of South Sudan, i.e. none of the publications discussing Sudan issues,

had specific attention or data from South Sudan, which is now an independent

country.

It should be noted that in these publications, the total number of publications

will add up to more than 151, because some publications discuss more than

one country each.

97

Figure 15. The number of publications discussing AT issues in EMR's low and

middle countries

It is important also to see what are the ATM issues of focus in the published

literature. We noted the issues of focus for each identified publication, using

the WHO categorization of issues into: affordability (25 publications), financing

(18 publications), rational use of drugs (106 publications), and health system

and availability (63 publications) (Figure 16; Table 17). If a publication was

discussing more than one issue, we noted as many issues as applied to that

publication.

Figure 16. Proportion of publications discussing each ATM issue in EMR

countries

98

Table 17. ATM issues discussed each year in EMR publications



2000 2 1

2001 1 1 2

2002 1 1 5

2003 1 2

2004 2 1 2 2

2005 10 1

2006 2 8 5

2007 1 1 8 6

2008 4 5 16 9

2009 7 7 20 15

2010 4 20 10

2011 3 3 13 10

Total 25 18 106 63

Also it is visible that despite the importance of cross border issues and the role

of sectors beyond the health sector in facilitating or impeding access to

medicines, scarce attention is devoted to those issues (Table 18). The majority

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of the studies are limiting themselves to health services level (i.e. mainly

assessing RUD issues at the level of providers).

Table 18. The level of barriers studied in EMR publications each year



National Health sector


Cross border issues

2000 2

2001 1 2 1

2002 3 3 2

2003 2 2

2004 1 2 2 1 1

2005 4 8 8

2006 3 10 5 2 1

2007 3 6 8 1

2008 9 18 13 1

2009 9 22 16 1 1

2010 6 20 14 1 1

2011 5 13 8 2 3

Total 44 108 79 7 9

As a further analysis, it is also interesting to see that in countries for which

there are more 10 publications focusing on their issues, what proportion of

these publications are on each of the ATM's four categories (Figure 17). This

information provides a clear picture of limited attention to affordability and

financing issues in these countries, and cross border and other sectors studies.

These areas and issues should be considered of paramount research priorities

for all the countries in the EMR.

100

Figure 17. Distribution of ATM issues discussed, and the level of barriers considered in publications: Iran, Jordan,

Lebanon, Pakistan and Sudan.

101

Lack of attention to financing and affordability aspects of ATM in EMR studies

is despite the fact that several studies have demonstrated the importance of

these aspects. In an international study using household survey data from

World Health Surveys, it was clear that affordability is a major barrier to access

at the level of household. The study concluded that between 41% and 56% of

households in LMICs spent almost all of health care expenditures on

medicines.66 The study called for expanded benefit packages and further

coverage of medicines in insurance plans in low and lower middle income

countries. Whether or not this will be taken up in the region is another matter.

As reported by Zafar Mirza, among low and middle income countries in the

region, Jordan, Iran, Egypt, Morocco and Tunisia have health care insurance

systems developed and established by the government 67. These schemes have

various successes and limitations which may impede access to medicines. For

other LMICs in the region, without such nationally funded programs, adopting

Wagner et al's advice may be more difficult.

Another study that used a small dataset from Pakistan observed that 45% of

households' out of pocket health care expenditure was for obtaining

medicines.68

Also others assessed the effects of expenditure on medicines on

impoverishing household in developing world.69

They used data from three

countries in the region (among other countries). As an example the study

noted the strong impoverishing effects of using originator brand glybenclamide

instead of generic products in Yemen. Another study focused on the impact of

GIPAP program (that provides free of charge drugs for CML patients) on access

to iminitab for these patients in poor countries. 70

Data from Pakistan and

Sudan was included in the study (among other countries), which in general

suggested that GIPAP had been helpful in improving patient access and health

outcomes.

Another issue for both affordability as well as financing of medicines in LMICs,

is the pricing aspects of medicine. Wagner et al noted that there an array of

reasons and manifestations of price differences for medicines in different

countries. Despite the importance of the issue they noted that literature from

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developing countries has showed very little attention to pricing issues.49 on the

positive side, Thatte et al provide a useful coverage of procedures for

medicines approval, entry to market decisions and pricing in Pakistan and

three other countries from South East Asia and Western Pacific regions of the

WHO 71

. Obviously this is not the only study from the region on the issue (there

are country specific publications), but very few have looked at the issue

critically in the region.

Other sectors (other than health care sector) effects on access to medicines

are barely considered in publications from the region. A secondary analysis

tried to link data on duration of untreated psychosis with GDP per capita (as an

indicator of country's macroeconomic situation).72 Although it did not include

any ATM study from EMR, it used data from three studies of duration of

untreated psychosis from Egypt, Iran and Pakistan. The general finding of the

study was that lower GDP per capita was correlated with longer duration of

untreated psychosis in low and middle income countries.

Despite the fact many studies assessed health systems and availability aspects

of ATM, there are very few studies that discuss important policy directions on

ATM. For example we did not find any study that had assessed the impact of

essential drug lists initiatives on access to medicines in a country. This is

despite the fact that according to Mirza (2008), by that time all the low and

middle income countries in the EMR region, except Libya and Lebanon, had a

policy of essential drug lists in place.67 Other reports published in 2010 suggest

that now also Libya has a national essential medicines list.73

A study not

specific to EMR countries provides a summary of available evidence on

different interventions for improving access to essential medicines in primary

care settings.74

Fortunately, further attention has been devoted to studies on availability of

medicines than to affordability and financing. An international comparative

study provides a good summary of the picture.75

It identified while in the public

103

sectors of South-East Asia, the Americas and the Eastern Mediterranean

regions, medicines for acute conditions were more available compared with

medicines for chronic diseases, in the European and the Western Pacific

regions medicines for chronic conditions were more available.

We found many studies of RUD issues (Table 17), including several studies that

focused on adverse drug reaction reporting in several countries (see also the

sections relevant to the three country case studies). Still, an eye-opening

international study suggests still along way is ahead of the countries until such

programs are implemented effectively. The study assessed the ADR repots for

artimisin based anti-malaria treatments at global level.76 It concluded that the

ADR systems in countries prone to malaria were extremely weak. In the EMR

region the situation was similar: only three countries in the region (Iran,

Morocco, Tunisia) had ever reported an ADR for such medicines, and the

number of ADRs reported was very small compared to what should be

expected. This is despite the fact the three countries mentioned in the study

are not those with high burden of malaria in the region, while for countries

with hyper- and meso- endemic malaria problems they did not find a single

report of ADR for artimisin based medicines. The same goes with other aspects

of quality of prescribing care in the region. A systematic review of studies of

pharmacy service quality included two papers from Alexandria in Egypt.77

The

studies demonstrated low quality of service and room for improvement in

provision of care at the pharmacies. Similar problems were reported in several

other studies. It is also important to consider the strong and weak aspects of

presence of private sector in health care systems in the region, as there is

evidence from low and middle income countries that private sector performs

as good as the public sector in terms of availability of medicines and quality of

services and responsiveness.54

In a way, maybe it is safe to conclude that even RUD studies have not been

that effective in improving access, or tackling the main issues. Still, the region

should move towards more interventional studies linked with RUD issues in

which the effects if different interventions in improving rational use of

104

medicines are assessed. There are signs, at least in some countries, that a

move in that direction is shaping.78-82

Limitations of the regional literature review

The bibliographic research in which we have used the affiliations of

the corresponding author as the identifying reason for the authors

country of origin has indeed several limitations. For example, it may

be a team work, in which authors from different countries

contribute. Also several identified studies were from research

students attending high-income countries institutions and then

running research on their own countries. Many such students are

also funded by their own countries. On the other hand, there are

studies conducted by foreign missions based in a country, and

although the address of the foreign mission is from that country, the

study cannot be strictly considered as home grown. Despite such

limitations, for the purposes we followed in this study, the

bibliographic search can be useful and informative.

We conducted systematic searches of the main international

databases for identifying ATM papers published on or from low and

middle income countries in the EMR. Although we conducted the

search meticulously and tried to ensure that we did not miss relevant

papers, the search should not be considered exhaustive. There may

be further papers published from these countries and not indexed in

the databases we systematically searched. It is highly possible that if

e.g. Scopus or Embase databases had been published, or databases

more attentive to French language publications, there should have

been further papers identified from the region. Despite these

105

limitations, we believe our main and general findings from the

literature search remain valid, as it provides an explicit and

comparable platform to assess between country and regional

variations in ATM research and to identify the research gaps in the

region.

106

Access to medicine as a research priority: still a Cinderella topic?

It is safe to assume that certain aspects of aspect to medicine are still an

'orphan' research topic in the region. We use part of our case study in Iran to

demonstrate it further. Before doing so, it is important to highlight that our

findings demonstrated that the status of ATM studies in the EMR is not as bas

it had been presented in a previous study.83

Ritz et al 2010 provide a

bibliographic analysis of access to medicine literature and tries to provide a

picture of the number and distribution of publications from different regions

and countries. Our findings demonstrate that Ritz et al work has important

factual errors in its analysis and results. It underestimates the number of

papers produced from the EMR region by a wide margin, and certain countries

are altogether excluded from their findings.

Policy maker attention to ATM research

Another reason for limited attention to ATM research, may be due to the

perceived level of availability of medicines. For example in Iran it is generally

considered that medicines availability is high, and with a well spread health

systems in the country, they are also widely distributed to the remote areas of

the country. The exception to this may be highly specialized or expensive

cancer treatments which are offered via limited outlets in the country, and the

most of these outlets are located in Tehran or other metropolitan areas. Hence

the issues of ATM may not be considered as major research issues. There are

valid reasons for this: the success of the generic production of medicines in

Iran, relative low price of medicines in the country, and the wide spread

coverage of health care insurance in the country. See also

107

Figure 18.

108

Figure 18. Medicines affordability in Iran, in comparison with other countries

(source: WHO, the World Medicines Situation Report – 2011).

Researcher and research funder attention to ATM research

The regional review demonstrates that in the EMR region the comparative

level of attention to ATM issues by Iranian scholars is relatively higher. Our

search indicates that a large proportion of ATM research in the region has

been conducted by Iranians. This is interesting and encouraging. However if we

put in the context, then the ATM issues are not given a priority attention in

Iran. The fact is that the research output of Iran is the highest in the region in

general. The high proportion of papers from the country may just be the by-

product of the level of research activity, and not because a serious attention is

109

paid to the issue by researchers or research funding bodies. We will discuss

this further later on.

A demonstration of this is the way the formal research priority outputs are

presented. Assessing to relatively recent research priority setting exercises,

one for the pharmaceutical sector research (Pharmaceutical Sector Research

Network) (

110

Table 20), and the other for the School of Pharmacy of the Tehran University of

Medical Sciences are demonstration of lack of research institutions attention

to ATM.

The Pharmaceutical Sector Research Network conducted a consensus

development exercise in which they first agreed on the criteria for priority

setting (Table 19), and then voted on the different pharmaceutical main

categories. As it can be observed in Table 1, apart from the first issue (burden

of the disease) the remaining criteria are tuned towards innovation or market

aspects of pharmaceutical research. This is a clear attention to only limited

aspects of ATM.

Table 19. Ten agreed criteria for research priority setting (Pharmaceutical

Sector Research Network).

Ten agreed criteria for research priority setting (Pharmaceutical Sector Research Network)

Rank Criterion Score

1 Disease burden 7.86

2 Innovation 7.41

3 Network members capacity 7.05

4 Applicability of the output 6.64

5 Increase in monetary value of local market sale 6.59

6 Total monetary value of local market sale 6.59

7 Existing technological capacity 6.50

8 Existing internal resources 5.95

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9 Expanding the status of pharmaceutical research 5.23

10 Increase in total volume of sale 5.09

The Pharmaceutical Sector Research Network final research priority list was

clearly targeted at innovative research that could result in production (re-

production) of innovative or expensive medicinal products, for use in the

country as well as future export and market expansion. This direction of

attention is in-line with the interests of the majority of high rank research

institutions in the country.

112

Table 20. Twenty high priority research topics for pharmaceutical sector, developed by the

Pharmaceutical Sector Research Network.

Twenty high priority research topics for pharmaceutical sector, developed by the Pharmaceutical

Sector Research Network*

Lipid modifying agents

Agents acting on the renin-angiotensin system

Antineoplastic agents

Beta blocking agents

Analgesics

Drugs used in diabetes

Antihistamines for systemic use

Anti-inflammatory and antirheumatic products

Antibacterials for systemic use

Antihypertensives

Drugs for functional gastrointestinal disorders

Antiepileptics

Cardiac therapy

Calcium channel blockers

Psychoanaleptics

Anti-parkinson drugs

Anti-acne preparations 17

Drugs for acid related disorders

Diuretics

Vaccines

* unpublished data. Provided to us courtesy of Prof Kebriaeezadeh.

The research priority list of the School of Pharmacy provided a similar picture.

Only two or 3 topics for a list of over 80 research priority areas are directly

relevant to ATM issues: i.e. 'Drug Utilization Review and Drug Utilization

Evaluation'; 'phamacovigilance for adverse reactions to medicines' and a third

broad areas titled as 'social pharmacy, pharmacoeconomics and rational use of

drugs'.

This is, however, about to change in major schools of pharmacy in Iran.

Departments of Phamacoeconomics and Pharmaceutical Managements are

being established. A couple of universities now offer (from three years ago)

PhDs in Phamacoeconomics and Pharmaceutical Managements, and a few

researchers have started establishing their careers around ATM research areas.

The reality is that the capacity for health policy and systems research in the

country is expanding and not just pharmacy related disciplines, but also health

economics, health policy, epidemiology and other disciplines are giving more

and more attention to these issues.

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Results – qualitative interviews

Key informant interviews, Iran and the region

We invited thirty to interviews and conducted twenty interviews. Fourteen

respondents were male and six female. The distribution of their backgrounds is

presented in Table 3. The interviewees represented all the main stakeholders

relevant to ATM issues, including pharmaceutical and physician providers,

policy makers, industry, patient representatives, distribution chains, insurance

organizations, and sectors beyond health care.

As a result of analyzing the interviews, we identified 90 sub-themes or

important ATM policy and practice issues. Examples of concerns relevant to

each main category of the themes are provided in Table 21. The quotes have

been translated from Farsi to English. The quotes are not meant to be

representative, rather they provide a glimpse of rich discussions and issues

raised by the participants.

In practice it was very difficult to keep the focus of interviewees on research

priorities. They discussed policy concerns and barriers to ATM. In terms of the

main concerns, as we can now clearly see, the AT concerns are largely different

from the majority of issues covered by research projects so far. While RUD

remains a big policy concern, it is not the biggest issue to deal with. There are

many more concerns that needs to be tackled, for the perspective of the key

informants, to reduce barriers to access and appropriate use of medicines.

115

Table 21. Conceptual thematic framework from Iran and regional data – qualitative analyses and policy concerns

Examples of verbatim quotes and policy concerns Sub-themes Main theme

and issue

"We cannot ignore educational problems. Our education

system is not perfect."(KI3)

"I believe we do not have a serious and strong policy to

support research and development in drug production and

the margin of benefit for importing drug is higher, and this is

why we she drug imports are increasing."(KI4)

"The biggest problem is questioning the generic strategy in

the country."(KI4)

"Ministry of Health and health system decision makers should

consult the experts before making decisions … [such as]

Thalassemia Society, physician societies, Cancer Society,

scientific societies or senior and established physicians …

many decisions are without using expert opinions."(KI5)

"The main responsible organization has to be the Ministry of

Health and the Food and Drug Organization, and all other

1. Public-private health system mix

2. decentralization

3. Pharmaceutical policy

formulation/evaluation &

promotion

4. Pharmaceutical regulatory function

and enforcement

5. Human resources for the

pharmaceutical sector

6. Human resources for policy

planning

7. Health facilities (hospitals, clinics)

8. Family physicians/referral system

1. Health sector

organization

116


and issue

inter-sectoral organizations should act on that basis. I

personally think that inert-sectoral organizations should not

act like an ectopic [unit] in vital issues such as

medicines…"(KI8)

"Some people say we need to give monetary issues to the

Ministry of Commerce, and the Ministry of Health focuses on

quality control. Even before the revolution that we think the

structure was different, at that time for medicines pricing,

the ministries of commerce and health representatives were

present."(KI15)

"Access to medicines should be approached from a health

system perspective." (KI18)

"Each company that intends to import a medicine, they need

to get the Article 20 Commission's approval. … this takes

time, they need to have full documentation … then there are

monetary issues, nowadays opening an LC with a bank is

difficult."(KI2)

"National formulary is the first hurdle. If the medicine is not

listed, it cannot be imported."(KI2)

1. National drug policy

2. National drug formulary

3. Pricing

4. Labelling

5. Licensing/regulations on import

medicines

6. Generic versus brands

7. Quality assurance( GMP)

8. Quality control/ Drug quality

2. Health

sector

pharmaceutical

policies

117


and issue

" 'Single item importers' are an issue in Iran. They bring

medicines that are listed on Iran's national formulary.

Physicians decide they need a drug for their patients and

'single item importers' deliver." (KI2)

"At the moment we at the Ministry of Health set the

[medicines'] price, while insurance organizations are best

suited to do that. I mean it is the insurance organization that

can bargain with the producer, importer to reduce the prices

…"(KI3)

"Sometimes in meetings they [industry] mention it, in the end

the difference in cost of substance of 96% purity and 99%

purity, for the one with 99%, the price may triple, and that 2-

3 per cent impurity may cause the majority of adverse

reactions, most problems that people suffer from it."(KI17)

"… because of weakness in our insurance system, they keep

down the medicines' prices at the company, and [the

company] in turn will buy cheap ingredients. Medicines price

in Iran, part of it is from outside via 'single item' importing

which are very expensive, the ones that have to be of good

quality are very very cheap and lacks quality …"(KI11)

9. Post marketing surveillance

10. Adverse drug reactions

11. Audit –Drug utilization review

12. Medication errors

13. Essential drug list

14. Vertical programmes(malaria, HIV,

tuberculosis)

15. Conflict of interests providers and

pharmaceutical company

16. Regulations on drug promotion

and advertisement in the society

17. Drug share in health expenditures

18. Public and private health system

interactions

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and issue

"We have the problem of medicines, as they are cheap, being

smuggled to the neighboring countries… "(KI12)

"Our first statement is this: if the quality of a medicine is bad,

and the price is low, that's no use to us because we need to

pay the price later."(KI16)

" … the issues is that do countries have essential package of

services at the primary care level … is there a clear essential

medicines list … if that essential package is there … how are

those being financed … in Pakistan .. there is a clear lack of

access to medicines …[due to] insurance issues, lack of

government funding …"(KI18)

"… in Afghanistan the medicines are available, but the

medicines that are of good quality , that are effective … that

is the problem. ."(KI19)

KI1. "Financial [limitations] has resulted in insurance

organizations, including both basic and complementary

insurance, do not make contracts with all existing

pharmacies. This has important access implications."(KI1)

"Pharmacies have contracts with insurance organizations and

1- Health system financing, national

health budgets, social health

protection

2- Universal coverage

3- Social welfare and social protection

policies

3. Health

system

financing /

insurance

system

119


and issue

should be reimbursed by them. Sometimes the insurance

companies do not pay pharmacies for 6-9 months. A

pharmacy has 20 million Tomans [~20 thousand US$] with

the insurance organization and may not dispense a patient's

prescription …"(KI2)

"Our insurance system is unhealthy …"(KI3)

"Should we include expensive and unaffordable-for-all

medicines in the national formulary or no? If we say it should

be included, then many people cannot afford it, and naturally

some people will be deprived of it. If we say it they should

not be included, then some people say that we could afford

it, why shouldn't we get it?"(KI4)

"60% of our patients [thalassemia] are covered by the

Medical Services Insurance Organization, they have lots of

problem. Their coverage is less than Social Security Insurance

Organization."(KI5)

"Most of our patients [thalassemia] are from low

socioeconomic groups. They problems in paying for their

medical costs."(KI5)

4- List of medicines under coverage

5- Cost coverage – financial protection

6- High expenditure disease groups

cost coverage

7- Cost coverage for other target

groups

8- National subsidy and benefit

distribution

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and issue

"Certain private insurances, or insurances provided by the

banks offer full coverage for the insured … even plastic

surgery … others don’t. Even the coinsurance level differs,

some at 10%, others 20% or 30%. Hence we do not see the

equity we expect to see between insurance packages. While

most probably the premium they [users] pay is not that

different."(KI6)

"At least we need to have a database of all diabetic patients.

… If the insurance organization and the Ministry of Health

who is responsible for it have the data, a lot or repetitions

will disappear and many costs will reduce and can be used to

cover other expenditures …" (KI7)

"All medicines are now [covered by insurance] … some are

covered 90% of cost, other insurance [organizations] may pay

all of it, or are covered via separate subsidies. 300 million US$

is just the subsidy paid for special diseases of hemophilia,

thalassemia, MS."(KI9)

"We need to look at the large picture, and see if there is a

disease that each year 50 people suffer from it and die, is it

ok to spend 10, 20 million dollars on it, or should we keep

that to vaccinate 1-2 million children. Which one is our

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and issue

priority?"(KI17)

"As for insurance coverage, I think we need to compare

ourselves with other countries. Our insurance coverage is not

bad."(KI14)

"evidence from both low income countries and middle

income countries in the region, particularly middle income

countries suggest people pay substantial costs for medicines

out of their own pockets for life saving drugs … these are the

gaps that exist between policy and practice"(KI18)

"… in Afghanistan the policy is to keep primary health care

drugs free of charge … in secondary care NGOs charge people

… the Ministry of Public Health policy is that secondary care

treatment in public hospitals is free of charge but the

majority of doctors do not admit patients until they get paid

by the patient."(KI19)

" We need to pay attention to health insurance and coverage

as it could lead to over prescribing and polypharmacy. This is

a very clear case in Palestine. More research is needed in the

area of insurance coverage in relation to rational use."(KI20)

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and issue

"Right now not all medicines can be distributed everywhere.

Some medicines are just for certain pharmacies. E.g. some

people may have to travel to Tehran for certain medicines, as

they are not available in provincial cities."(KI2)

"Drug distribution in slow. Pharmacies have to stock a lot of

medicines. … and in the end they stock high usage medicines,

and not necessarily essential medicines."(KI3)

"Subsidized medicines are the same story, because we have

not used proper technology … patient has to go to a certain

pharmacy once or twice a month, because we say that

medicine is in short supply, is expensive, is subsidized [by the

government] …using IT and modern distribution systems we

could have get it to the patient where she lives …"(KI3)

"The laws are [part of the problem]. E.g. for opioids … and

end stage cancer patient has to travel to the center [to get it]

…"(KI3)

"In distribution system, sometimes no medicine reaches an

area. Recently following a lot of lobbying I though medicine

problems are resolved. But yesterday I saw a letter that

claimed in their city there no Desferal and no Desfonac."(KI5)

1- Private –sector drug distribution

systems

2- Governmental /public distribution

systems

3- Drug availability in the

market(pharmacies)

4- Informal distribution network

5- Geographical distribution

(pharmacy, health facility, hospital

drugs,…)

6- Drug distribution in the hospital

7- Prescriptions' drug distribution

without prescription

8- Drug distribution in the health

facility

9- Drug's import

10- Counterfeits

11- Corruption

12- Drug's export

13- Trained human resources delivery

14- Technical capacity of distribution

staff/well trained manager

15- Monitoring and evaluation

16- Marketing

4. Drug

Distribution

system

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and issue

"[From the pharmacy point of view] we have problem at the

distribution system. The pharmacy cannot be sure whether a

medicine gets more expensive or cheaper. It does not how

much they can stock and for how long the drug is easily

available. … sometimes you have to stock medicine instead of

the distributors."(KI6)

"There was a time that we had a critical situation, if you

remember we were suffering, and our people were suffering

because of medicines scarcity, I mean there always was a

long list of medicines in short supply."(KI9)

"We have good competition in distribution [system]. In fact

there is no monopoly. There are almost tens of distribution

companies, provincial companies, national companies who

distribute medicines [registered] with the Ministry of

Health…".(KI9)

"Another problem of distribution companies is that we have

lots of distribution companies and some of the do not have

the minimum standards for keeping medicines."(KI10)

"we, in the pharmaceutical sector, gave permission of

17- Competition

18- Distribution generic drugs

124


and issue

accessing medicines via emergency center [single item

importers] , it affected quality, and the medicines were

bought from distributer before the quality was assessed in a

laboratory."(KI13)

"… [in Afghanistan] some medicines samples are assessed

and then it becomes possible they have not be assessed by

specialized laboratories … around the country in different

areas there are low quality medicines, expired medicines

around"(KI19)

"… unfortunately in Afghanistan, access to medicines, but low

quality medicines, is very easy. People when they go to

pharmacies even outside the pharmacies … in groceries …

they can get it [without prescriptions]. ."(KI19)

"In our country inappropriate use of medicines, is more deep-

rooted than many other countries. If you ask doctors why

they prescribe such medicines, they respond that because of

patients' request."(KI3)

"Whoever prescribes the medicines, also sets public

preferences [that is] … the medical society influences

[people], people alone are not that influential."(KI4)

1- Demand for medicines and health

care services

2- Public knowledge and awareness

3- Self medication

4- Affordability ,Out-of-pocket ,price

of medicines

5- Drug promotion in the community

6- Specific groups( geriatrics,

5. Individual,

household

and

community

level

125


and issue

"For certain internally produced drugs, the users do not have

enough trust in local products, sometimes because they

cannot see the quality."(KI6)

"Sometimes [people] believe foreign products are better than

domestic products."(KI6)

"Physician has to send him [patients] to other physicians to

give him consultation. The patient might say I would not get

insulin, and the physician will back down and we will be away

from our aim of treating the patient."(KI7)

"Access can be viewed from different angles. In terms of

availability, we have no access problem … but whether

people can afford it is another matter."(KI10)

"There are other diseases not considered by the Ministry of

Health as 'special disease',10

while the disease are really

special and their medicines are expensive."(KI14)

"I think [household] out-of-pocket [expenditure] is important,

pediatrics,)

7- Chronic disease

8- Socio-cultural constrains

9- Stigmas and cultural barriers to seek

treatment

10

'Special disease' is a certain category in Iran health system, based on a parliamentary law, that includes thalassemia, hemophilia, and kidney replacement therapies. These diseases receive a substantial amount of subsidies to cover the costs of the required expensive treatments.

126


and issue

but the cultural issues are more important. If the demand

reduces and becomes more rational, access will

improve."(KI14)

"… our problem is that [in Afghanistan] people who have low

education level, when they get the medicine do not know

how to use it, and those that give them the medicines, do not

teach them how to use it."(KI19)

"We do not have standards for the required number of

[pharmacist] providers, have copied other countries, or have

lowered standards based on the number of pharmacists. We

need to define evidence base geographical access standards

…."(KI1)

"If a pharmacist just thinks of money, she would not care

what the patients get, will give them whatever they want,

even without prescription, if they pay."(KI2)

"Pharmaceutical companies should not be allowed to serve

doctors … to keep medical society away from the low of

financial links with pharmaceutical producers and

importers."(KI4)

1- Induced Demand for medicines and

health care services

2- Rational drug use/ Evidence based

medicine

3- Payment methods

4- Pharmacy

5- Role of medicines' Income in

hospital/clinics' income

6- Drug safety and medication errors

7- Fee splitting

8- OTC drugs

9- Traditional and herbal drugs

10- Consultant pharmacist, clinical

pharmacy

11- Chronic disease

6. Health care

providers

127


and issue

"The set so many laws for OTCs but the pharmacies dispense

whatever they want to people."(KI11)

"A very important role that pharmacies can play is to correct

costumer drug utilization culture. Many people when they

visit a pharmacy may be looking for more expensive and

trendier medicines. … the pharmacists … can guide people

…"(KI12).

"For example, does the Ministry of Commerce has enough

expertise for market control? … or does is look at it

[pharmacy] like a general shop or outlet? This is a specialized

issues and should be outside the Ministry of Commerce."(KI1)

"Each company that intends to import a medicine … there are

monetary issues, nowadays opening an LC with a bank is

difficult."(KI2)

"Scientific societies are influential in adding a medicine to the

national list, and with the relations they have with companies

and can heavily promote a drug. For example if a company

collaborates with the neurology society and introduce its

drug, and the medicine becomes the best seller in Iran, you

know how much it will sell. The can increase or decrease drug

1- Ministry of finance

2- Standard organization

3- The medical council – medical

societies

4- Pharmacists association

5- Ministry of commerce

6- Ministry of industries

7- charities

8- WHO guidelines

9- WTO agreements

10- Gavi

11- World Bank - UNICEF

12- Global Fund – other UN agencies

13- International NGOs

14- SWAp

7. Policies

beyond the

health

sector

128


and issue

sale, bankrupt a company …"(KI2)

"If a drug needs to be imported in an emergency, its import

should register with us, and another time with [Ministry of]

Commerce, and once with the Customs."(KI3)

"If the Ministry of Commerce comes and opens an office in

Foods and Drugs [Organization] and do the works from there

… is better than we send people in the [Ministry of]

Commerce's loop … when we move around people between

different ministries, different organizations … this puts an

expense on the person or company … the company will not

pay out of pocket … public have to pay more in the end from

their pocket as insurance budget is limited."(KI17)

"… we have problems in making regulations within the sector,

not much problem with the Ministry of Commerce but within

the Ministry of Health …"(KI10)

"… I want to see to what level exists a governmental

commitment to access to essential medicines … most

countries in the region that have committed themselves to

strategic plans [they do better]… "(KI18)

15- Philanthropic organizations – Bill &

Melinda Gates

16- Roll Back Malaria

17- PEPFAR / USAID

18- EU / JICA / DfID / …

129


and issue

"… there are signs that some importers of medicines [to

Afghanistan] change of the label of the expired drugs they

import from Pakistan, India or China."(KI19)

"Cross-border smuggling of medicines is a major issue in

Afghanistan."(KI19)

"In Palestine, the stewardship and governance are well

organized with coordination between the Ministry of Health

and the union of Pharmacists. However, other challenges

related to Israeli Occupation manifested in controlling the

boarders, affecting supply chain, delays, controlling which

types to import and all quality control tests. The same could

be extrapolated to other countries in the region with war like

conditions."(KI20)

Key informant interviews, Pakistan

Access and Magnitude of the issue: All stakeholders were unanimously of the

opinion that access to medicines was a major issue in Pakistan. There was divided

opinion on extent of work done in this area with close to half of the opinion that

some work had been done on this area but major work needed to be done while

others opinion that substantially little work had been done so far.

Only 3 respondents identified access as involving elements of quality, affordable

prices and availability at nearest access while others mainly tended to identify

with one aspect either physical availability, quality or affordability.

Main Barrier to Access: Weak regulation, supply side issues and irrational

prescription of drugs were identified as the main barriers to access. Although

open end in-depth interviews precludes computing of quantitative frequency,

broadly most stakeholders identified weak regulation is the main barrier, followed

closely by irrational prescription while a variety of supply side issues was the third

common response. Weak regulation covered a range of issues including low

quality threshold for registration, weak enforcement of existing regulations, flat

price control leading to drug disappearances from the market, and corruption

nexus at the level of licensing, registration and quality control. Supply side issues

cited included inappropriate procurement of drugs, lack of pharmacists rile in

supply management, and poor management of drug availability at public sector

facilities. Irrational use responses involved inappropriate prescription by

providers, undue influence of medical specialists in procurement and nexus

between providers and industry.

Rational Use: “Essential generics don’t have star status like new brand drugs..”

(Intw: 21)

131

There was unanimous opinion that prescribing practices need improvement from

specialists down to dispenser level. With more than 70% of health care provide by

private providers there was felt to be a huge role o f the private retail market and

dominance of well promoted products. Essential drugs have been around for a

long time and don’t have the same prestige as new brand products. A number of

factors were cited for market dominance over drug usage. A foremost one was

the open access of doctors to industry representatives and entrenched practices

of receiving incentives at all levels of the medial profession. Others included lack

of institutionalization of pharmacists role in selection of drugs at health care

facilities with much left in the hand of doctors or civil servants. Yet another factor

cited was weak pre-service training and almost a complete lack of in-service

training on standard therapy. Formularies are absence at all levels of the health

system and there is as a result little concept of referral to formularies for

appropriate drug use.

Wide Variation in Registered Products: “There is an open access policy in Pakistan

for drug registration..” (Intw: 4)

All stakeholders expressed grave concerns over registration of too many products

and wide variation in quality of registered drugs, however there were slightly

differing perceptions over underlying reasons. Acknowledgement of wide quality

variation in products was also acknowledged by industry which felt that presently

the onus was on individual companies who felt that the low threshold was a

disincentive advantage to those manufacturers who invested in quality.

Some stakeholders cited weak technical management and planning by Ministry of

Health and others were wont to blame this on a nexus between industry and

technical registration staff. Respondents reported that there were close to 88000

products, exact number was not available even with MOH and there is lack of

national formulary. Registration does not look into cost effectiveness,

comparative cost analysis over other products, local bio-equivalency is not

required and scrutiny of submitted bio-equivalence is variable. Registration

system is still manual making it difficult to manage the data and there are few

132

attempts at de-registration. Staff managing registration has not received targeted

training for registration nor been exposed to drug registration best practices in

other countries. Stakeholders also expressed concerns at opportunity for

corruptions in the registration process due to the loosely managed system of

registration. Lack of an independent drug regulatory board was felt to enhance

undue political influence over registration with swings of high and low corruption

taking place according to the leadership in place.

Flat Price Control & Issue of Orphan Drugs: The issue of critical shortages of

essential drugs was felt to be of high concern across all stakeholders. Basic drugs

such as phenytoin, phenobarbitone, thyroxine, thiazide, folic acid have been

missing from the market. On the part of the industry the major underlying factor

was flat price control in place over drugs leading to disincentive to produce low

cost drugs. Political sensitivities of the MOH and fear of public outcry leads to

reluctance to deregulate prices. Forced production by Ministry leads to sub-

standard methods Experts also pointed to cross border traffic of drugs to regional

counties offering better prices. A suggestion was put forward to move to regional

basket of drugs to avoid drug shortages. There was much interest in exploring

different formulas for pricing to encourage rational use and increase access.

There was also demand that pricing deliberation should be made more

participatory with greater inclusion of provincial implementors.

Procurement: Quality of drugs at public sector facilities was generally felt to be

suspect was due to weak discrimination during procurement. The practice of

going for the cheapest tender was felt to allow companies with low quality drugs

to be eligible for tenders. At least one province has shown interest in tightening

the threshold for tenders. From the industry many of the better quality producers

stayed away from public sector tenders due to uncertainty over payments and

preference of favorites and rent seeking in public sector. Moreover although

133

public sector had a generic procurement policy with provincially pre-approved

tenders at an annual rate contract, in practice district health managers were

reported to often purchase drugs not on the national EDL and inclusion of other

suppliers. Forecasting was another area for improvement with current practice

relying on incremental increase in inventory rather than scientifically being

forecasting on scientific forecasting based on morbidity data and patient volume

statistics, while in case of hospitals procurement was also excessively dominated

by specialists. Some stakeholder pointed to marginal involvement of pharmacists

in procurement- some of the larger teaching hospitals having only 1 pharmacist

for 1000 beds - while others felt that drug selection was an area that could be

taken care off by medical doctors. Another area of concern was frequent shortage

of drugs, with stakeholders divided over whether this was an issue of inadequate

funds or lack of aggressive management of stock. In contrast NGOs were felt to be

more scientific in procurement based on morbidity reports, a stronger check on

drug quality with discrimination on quality parameters and avoidance of stock-

outs through bumper stocks.

Supply chain & Stock-outs: “We have always focused on macro-economic policies

but attention to service delivery level; has been lacking …there lies the

gap”(Interview 5)

Respondents felt that drug supply chain was an area that would not get

highlighted due to attention spotlight usually on registration and pricing, however

needs practical attention and may be more amendable to quick wins rather than

larger contentious issues. Vertical program often due to centralized procurement

were wont to end up with stock outs while the mainstream government health

facilities faced stock outs due to lack of scientific forecasting, more a problem of

management of funds rather than non-availability of funds. Logistics management

systems were no in place and where developed were being applied only to donor

funded programs with little roll out to the mainstream public health care sector.

Drug storage and dispensing were also felt to have received little technical input.

Professional staff has not been inducted for handling drug distribution and

134

storage nor is there a practice of staff training and capacity building. Junior staff

does dispensing with only secondary school qualification raising grave issues of

quality.

Post Devolution Prospects: While respondents saw partial devolution as an

opportunity for increased implementer feedback on drug regulation there was

concern by nearly all stakeholders on total devolution of drug regulation to

provinces. The latter was viewed as creating inequities in terms of physical

availability, quality and pricing within country population. Respondents expressed

concern that if medicine is registered in one province but not another then

patients in one province can be deprived of the drug. This can create legal

implications by compromising right of patient access to drugs and furthermore

not all provinces have even capacity to register and test drugs putting in question

their regulatory role. Similarly the same drug will be registered cross-province

movement of drugs with low availability in provinces with higher prices.

Respondents cited example of OECD countries where drug regulation is a

centralized function but autonomous function and current situation in Pakistan

can be improved by an autonomous regulatory body with adequate stakeholder

representation.

Key Researchable Areas: Stakeholders identified the following key areas for

research feeding into practice:

- how to increase compliance with standard therapy amongst providers and

patients;

- how can awareness of patients and end users be increased for rational drug

use;

- what are the underlying factors behind poor availability of medicines at

public sector facilities;

- what measures are needed to improve quality control of drugs;

- what measures are needed to address issue of orphan drugs.

135

Key informant interviews, Lebanon

Policy concerns

The transcriptions of interviews with key informants provide for a rich material

for understanding the various concerns regarding ATM. As expected, concerns

reflect the positions and interests of stakeholders; different stakeholders have

varying and sometimes opposing concerns. It is an important exercise, indeed a

research question, to map out the ATM concerns in relation to stakeholder

positions and interests. However, as this is beyond the scope of this report, we

focus in this section on highlighting a few general points which are of particular

relevance to a future agenda of ATM research in Lebanon and then move to

provide a thematic analysis using the WHO 2004 ATM framework.

General points

The concept of ATM. All informants identified the situation of medicines are a

challenge of profound public health dimensions. However, very few informants

expressed and voiced this challenge in terms of “access”. Access therefore was

not prioritized as a concept in the interviews. While many informants highlighted

important and specific challenges that limit ATM such as high prices of medicines

in the private sector or interrupted supplies in the public sector, very few

informants explicitly expressed such concerns in terms to equity, which lies at the

heart of the concept of access. Equity did not come up as a central theme in the

discussions of ATM.

The approach to ATM. Most informants identified concerns with ATM that impact

people and patients. However, only a few informants stressed the need to make

136

the perspectives of people and patients the central aspect of approaching the

subject of ATM. One informant brought up the concern that the WHO 2004

framework for ATM focuses on the policy level and is directed to policymakers

and suggested alternatively the use of the framework of Frost and Reich (2009)

which approaches ATM from the perspective of users by focusing on attributes

that concern them directly: availability, affordability and acceptability. This

informants wondered how the ATM research agenda would be different if ATM is

approached from the perspective of health as a basic human right to all.

The importance of the political and economic context to understanding and

improving ATM. Irrespective of the sometimes-opposing positions of different

informants, the majority of informants emphasized that ATM must be understood

in relation to the political set-up and the economic free market and the

prominent role of special interests and confessional parties. Medicines in Lebanon

are treated as consumption goods rather than as public goods and are submitted

to free market laws and profit making. Several informants were quick to highlight

that they don’t see improvements in the ATM situation, or the point of carrying

out research on ATM, unless the political governance are first addressed as the

broader governance framework directly impacts and determines governance of

medicines.

The party(ies) which are most responsible for ensuring ATM. Informants

pinpointed to the fragmentation in the governance, financing, and supply of

medicines. Almost all informants stress the need for a stronger role for the state

and especially the MOPH. The MOPH already plays a key role, seen for example in

policy development and regulation or in supply such as through the YMCA-

administered program to ensure availability of medicines for chronic conditions in

PHC centers and in dispensaries or through the free provision of expensive

medicines for conditions such as HIV/AIDS, multiple sclerosis and cancer.

137

However, the role of the MOPH is undermined by powerful interests. How to

strengthen the role of the MOPH in improving ATM within the current political

set-up remains an open question.

The important role of non-state parties in improving the ATM situation.

Informants have acknowledged that the CSOs and NGOs have played an

important role in ensuring access, for example through the dispensaries and

through health NGOs, and this role must continue even as they stress the priority

of strengthening the role of the MOPH in ATM. However, informants also see the

need for more supervision and better coordination of the contributions of CSOs

and NGOs in order to make their contributions more effective.

The role of practitioners and their professional associations. Informants have

acknowledged the important role of practitioners and professional associations.

These can do much more to improve access but must be protected and given the

mandate to play such a role.

Thematic analysis

Here we summarize some of the recurrent concerns expressed by key informants

using the WHO’s 2004 ATM framework.

Financing: Of the four areas, concerns were expressed the least often in this area.

Spending on medicines, as a proportion of total health expenditures, is much

higher than in many other high middle-income countries and is unacceptably

high. Out-of-pocket expenditures for medicines are the primary source of

financing posing a challenge to access. There is significant fragmentation of

138

financing as seen for example in the absence of a common medicines financing

framework for all six social insurance organizations.

Affordable prices: The prices of medicines, and consequently affordability,

indicate that there are major challenges. Prices are much higher than would be

expected, and are much higher than prevailing prices in other countries in the

region. The free market logic cannot alone explain this situation. Presumed open

competition has not led to reducing prices of medicines. The regulations

stipulating that new imported medicines must be cheaper than medicines of the

same compound that exist in the market, has not led to need reductions in the

prices of medicines.

Rational selection and use: This is a key ATM challenge. There are almost 7200

medicine formulations on the market of which almost 5900 are registered by the

MOPH. This well exceeds the needs of the country, leads to wastage and over-

spending on advertisements and creates the opportunities for corruption. An

essential medicines list has not been updated in many years. However, even if

such a list were to be updated and provided, its impact is not clear in the absence

of strong governance, regulatory capacity, and implementing and sanctioning

bodies. For example, even the NSSF does not have an essential medicines list.

Medicines are neither rationally prescribed nor rationally dispensed. Physicians’

prescribing practices are unduly influenced by pharmaceutical promotions and

self-interest. There is no prescribing accountability. Many physicians draw their

knowledge from pharmaceutical companies’ prospectors, and they depend on

them to acquire continuous learning as alternative systems, either supported by

public funds or by professional associations are very weak. Clinical practice

139

guidelines are very few. The over-supply of physicians and pharmacists tends to

increase irrational prescribing and dispensing of medicines.

Rational use of medicines by the public is also a major problem. There is common

misconception about generics and the superiority of medicines from expensive

sources such as manufacturers in Europe. Some informants felt that cultural

particularities in Lebanon encourage use of branded medicines; other informants

disagrees stating that irrational use is more related to the lack of a strong

governance and the nature of the political and health system. Many people

purchase medicines without prescriptions or consume medicines prescribed by

the multiple providers, especially specialists, they might seek for consultation.

Health and supply systems: Supply systems are reasonably well developed in

Lebanon especially that much of such services are in the private sector and are

for-profit. Informants did not think of important concerns about inadequate

storage, or inadequate transportation of medicines. However, they expressed

serious concerns about the quality of medicines on the market and the presence

of counterfeit drugs. The closure of the central laboratory is a major impediment

to improve quality of medicines. Some medicines that have been withdrawn from

the market in North America or Europe may remain on the market in Lebanon for

a while. There are regular interruptions in the supply of medicines supported by

the MOPH, especially expensive medicines for conditions such as HIV/AIDS,

multiple sclerosis and cancer. The problem is less pronounced in the supply of

medicines for chronic conditions through the program administered by YMCA.

Geographical access of the population to health care and medicines is not usually

seen as a major problem. However, much of the dispensing of medicines in

dispensaries and PHC centers is not necessarily well linked to provision of care

and users may get their medicines in these outlets but have their actual care

elsewhere, especially by private providers.

140

Research questions emanating from key informant interviews

Appendix 6-B presents the list of research questions that emerged from the KII.

141

Results – qualitative interviews, EMRO region

142

Priority research areas for ATM – findings and consensus

Consensus development on research priorities - Iran

A total of 125 potential research topics were presented to the consensus

development meeting. The participants further added 15 new potential topics

during the discussions that took place in the meeting.

As explained in the methods, the topics were categorized under the six main

themes. In the end twenty priority topics were selected by the participants. Three

topics appeared twice in the results (i.e. under two different main themes). Hence

seventeen unique research topics were identified in this process (Table 22).

Under one theme (beyond the health sector), no agreement on a topic as a

research priority issue was observed. This is despite the fact that this area was

considered a major policy concern in qualitative interviews. This may reflect the

nature of the health system in Iran, in which the majority of decisions are taken

within the sector, and hence the impact of issues from outside is not seen as

important. It may also be the result of a lack of useful input from the interviews

and literature and hence resulting in a situation in which the proposed topics did

not deemed priorities.

143

Table 22. Iran ATM research priorities. The results of the consensus development meeting

Access to Medicines priority topics by the level of barriers to ATM

No Topic

Frequency of

those agreeing

the topic is a

high priority

research topic

A: Health sector policy

2

Assessing the procedures and regulations for adding

medicines to the national drug list (formulary) and

identifying improvement models

11

3 Evaluation of the impact of laws and regulations on

controlling drug use 9

4

Evaluation of the effect of the 'single item importing'

policy on final cost of medicines, quality and access,

and health system expenditure 9

5

Assessing strategies to eliminate financial links

between providers and patients, and its impact on

provision of pharmaceutical services

9

6 Evaluation of the impact of different payment

methods on quality of health care services 9

7

Evaluation of drug pricing policies and its impact drug

utilization and access to medicines and health

outcomes

9

144


No Topic

Frequency of

those agreeing

the topic is a

high priority

research topic

8

Evaluation of pharmaceutical policies,regulatory

function and enforcement for traditional and herbal

medicines

8

9

Evaluation of pharmaceutical policies and procedures,

and the applications of post marketing surveillance

reports

8

B: Health system financing/insurance system

34

Evaluation of the process of adding medicines to the

insurance organizations' list of medicines covered

11

35 Evaluation of the impact of different payment

methods on quality of health care services 9

36

Evaluation of drug pricing policies and its impact drug

utilization and access to medicines and health

outcomes

9

37

Evaluation of the effect of free medicine provision in

SSIO11 (and charity) owned facilities on drug usage

patterns and access to medicines

9

38

Evaluation the relationship between pharmaceutical

pricing policies and costs and benefits of

pharmaceutical companies

8

11

Social Security Insurance Organization, a major social insurance organization in Iran

145


No Topic

Frequency of

those agreeing

the topic is a

high priority

research topic

39

Assessing strategies to eliminate financial links

between providers and patients, and its impact on

provision of pharmaceutical services

8

C: Drug production and distribution system in the country

44

Evaluation of the extent and effects of drug

promotions activities of the industry and its impact

on prescribing behavior of providers

9

45

Evaluation of the effect of the 'single item importing'

policy on final cost of medicines, quality and access,

and health system expenditure 9

46

Evaluation of the impact of regulatory function providing

financial incentives for pharmacists' that provide

appropriate pharmacy services on increasing quality and

improving rational drug use indicators

8

47 Evaluation the role of pharmaceutical companies on

prescribing and drug use patterns 8

D: Beyond the health sector

No agreement was made for this domain

E: Individual, household and community level

146


No Topic

Frequency of

those agreeing

the topic is a

high priority

research topic

90

Identifying effective methods on improving public

knowledge and awareness about drug use

8

F: Health care providers

108

Identifying effective continuous education methods

for physicians to improve drug use patterns and

access to medicines

8

147

Consensus development on research priorities - Pakistan

Policy Concerns: The following were the policy concerns prioritized through the

Roundtable discussion.

Rational Use

� Unnecessary, and often inappropriate prescriptions, by medical

practitioners

� Large and unregulated private sector with reportedly high utilization levels

of informal providers and quacks

� Underutilized role of pharmacists in health service delivery

� Little presence of therapeutic protocols & formularies

� No restriction of type of prescriptions by level of health care

� Open access of industry to health care providers

Financing & Affordability

� Burden of medicine payment mainly on households

� Chronic care therapy unaffordable with both generics and originator bands

� Inadequate operational budget for medicine in public sector

� Existing budget in public sector need to be more efficiently managed

� Contracting out of BHUs has resulted in better availability of drugs

� Need to explore new financing mechanisms for health service delivery that

can improve access to drugs

Supply Side Issues

� Low availability of medicines in public sector at all tiers of health

system

� Low quality threshold for procurement in public sector

� Information on pricing fixed by MOH is not readily available for

procurement

� Lack of bumper stocks & advance forecasting based on morbidity

pattern

� Outdated logistics management systems

� Drug storage and dispensing poor across public and private sector

� Lack of sufficient number of pharmacists across public and private

sector

148

� Too many drug stores o proper regulation

� Black-marketing practices in private retail market due to collusion

Registration

� Too many registered products

� Low quality threshold for registration

� No WHO or FDA certified production unit in the country

� Need for regular review of EDL

� Little utilization of Central Research Funds despite need for evidence

Pricing

� Clear cut pricing formula needed

� Flat price control is counter productive

� Low priced essential drugs, even life saving ones, are chronically short in

the market

� Wide gap between prices of generics and originator brands

� Uneven regional pricing contributes to cross border supply resulting in

stock-outs

Quality Assurance

• Lack of incentives to produce quality drugs

� Continuous capacity building of for quality surveillance

� Government dominance and punitive measures not enough for quality

improvement

Decentralization

• Need for independent drug regulation authority with greater

representation of provinces

• Total devolution of drug regulation can potentially have negative

consequences on drug availability and cost across provinces

Research Concerns: The following were the research priorities identified

collectively through the Roundtable discussion

• Impact of decentralization on

– Prices

149

– Availability

– Overall access

• Regulations exist in Pakistan but need to be implemented : research into

implementation gap for existing medicines policies (determinants, reasons)

• Investigating the success and failures (and reasons) of the essential

medicines programme in the past 20+ years in Pakistan

• Human resources:

– The role of pharmacists at decision making level on medicines

policies

– Credibility of health professionals and the issue of trust

• Pricing policies

– Deregulation or price regulation? Which regulation mechanism

– How to improve access to orphan medicines

– Monitor price in the actual market to inform pricing regulations

- Lack of medicine unit cost estimation

• Role of private sector

– Informal / shadow pharmacies: prominent role that need to be

investigated

– Regulated private sectors

– Traditional healers

• Documentation of quality – post-marketing surveillance system

• Transparency of information, availability in public domain:

– Research into a health /medicines information system

• Registered medicines (and unregistered)

• Human resources

• Prices

– Routine monitoring of relevant indicators on medicines access

– Integrated HMIS

• Medicines policies part of an overall health policy – Research needs to feed

national health policy

• Harmonization and Alignment –

• Access to research – feedback on research made – Need for a wider

research network, continuous culture of research

• Consumer perspective

150

– Health seeking preferences

– Other

In Pakistan there has been considerable work in terms of Policy Acts, legislations,

and detailed regulatory and operative guidelines for the pharmaceutical sector.

From 1960s onwards to date Pakistan has introduced at least 16 documented

regulations for enhancement of access to medicines, including an abortive

attempt to bring into place the Generic Drug Policy Act, however gaps exist

between policy and practice. This is due to weak implementation, absence of

monitoring framework, as well as a traditional tilt of policies towards punitive

action by government rather than co-option of other stakeholders towards more

participatory regulation.

There is dire need for update of policies in line with on ground evidence and

infusion of new strategies involving an innovative mix of measures.

PRIORITY POLICY CONCERNS FOR INCREASING ACCESS TO MEDICINES:

Using the WHO’s Access to Essential Medicines Framework (Laing 2002) we came

up with the following policy concerns.

Rational Use: Medical practitioners, including both GPs and specialists, often

prescribe unnecessary number of medications with average for Pakistan being

>3 medicines per prescription as compared to 2-3 in LMICs and injection usage

rate one of the highest in the world. Pakistan was one of the first countries in

which the Essential Medicine Program of WHO was started back in the 1970s and

a National EDL comprising of 335 medicines is in place, however rational drug use

continues to be a major issue. There is unnecessary prescription of antibiotics,

vitamins and painkillers, preference for higher line therapy over standard therapy,

sub-optimal knowledge of standard therapy for endemic diseases even amongst

licensed practitioners. Apart from medical practitioners, population in Pakistan

frequently utilizes quacks and informal providers who are not only unqualified to

prescribe but alarmingly also dispense their own medication mixtures. Rate of

injection usage in Pakistan is one the highest in the world at 13 injections/person/

capita and is driven by quacks as well as qualified medical practitioners. With

largely unrestricted access to drugs in pharmacies and medical stores, there is

also considerable self medication and although its prevalence has not been

comprehensively assess, indicative figures are of 30-55%. Drug resistance to first

151

line antibiotics has been established at least in urban Pakistan while there is also

high prevalence of Hepatitis B and C diseases as a result of injection usage across

Pakistan.

There are several contributing reasons for irrational drug use requiring

integrated action at multiple tiers of the health systems. Standard therapies are

poorly enforced in the medical sector with prescribing practices influenced by

peer modeling on specialists, patients demand for quick treatment and

information by industry. Industry representatives have unrestricted access to

medical practitioners and reported nexus of industry and practitioners has been a

long-standing concern in Pakistan. Moreover over 79% of the population utilizes

the private sector which also comprises of both licensed providers as well as

quacks and informal providers, and continues to be loosely regulated. Although

there are successful examples of large CSOs franchising with GPs for appropriate

treatment these have yet to be replicated on a large scale. There is also

unrestricted access to drugs in retail outlets and an unnecessarily high number of

drug stores most of which do not meet appropriate dispensing requirements.

Financing & Affordability: 63% of total drug expenditure is borne by households,

one of the highest in developing countries, as opposed to only 18% in OECD

countries and leads to non-compliance with chronic care treatment and risk of

catastrophic expenditure. The public sector in Pakistan spends merely $5 per

capita when compared with other countries with similar income levels. Spending

by public sector is only 34% of total health expenditure and of that less than 25%

is spent on non-salary items including medicines. Patients incur costs for

medicines at both public and private sector facilities with drug shortages in public

sector forcing patients to private retail pharmacies. Patient spending on

medicines at public sector facilities is considerable at Rs198 on medicines / visit

versus Rs258 per visit at private sector facilities. At present there are no pre paid

schemes and commodity vouchers to ensure patient compliance with therapy and

protect households against catastrophic expenditure

There is wide gap between prices of generics and originator brands in Pakistan.

Certain medicines have very high prices several fold those of international

reference prices. Unaffordability of medicines has been documented as one of the

primary reasons for loose compliance with chronic care therapy. Medicine

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therapy for chronic care is clearly unaffordable even with use of low cost

generics (MPR of 1.7-7.7) while it can be dangerously expensive with originator

brands (MPR of 1.9-36.4).

Reliable Health Systems: Policy concerns within this area are further sub-divided

into:

Supply Side Issues: In Pakistan availability of essential generics is extremely low

in public sector 3.3% in public sector compared to 29-54% in LMICs. only 21% of

the population utilizes the public sector facilities, despite provision of free

services, with medicine non-availability reported by users as one of the primary

reasons for dissatisfaction with public sector services. Amongst medicines, there

is relatively better availability of acute illness drugs 30-60%), much lower for

chronic care (1-57%), while that of emergency life medicines is alarmingly low (30-

50%). Reasons for frequent drug stock-outs have not been properly investigated

but are attributed to a combination of low budget, lack of rational procurement

and delayed release of funds.

There has been limited attention to management of drugs supply in the public

sector with issues of low quality and logistics management. Generic

procurement and cheapest tender practice in the public sector has managed to

secure efficient prices for drugs however lack of a quality threshold raises

widespread concerns over quality of drugs. Companies better known for quality

are hesitant to apply for public sector tenders due to fears of delayed payments,

rent seeking and government preference for favored suppliers. Lack of scientific

forecasting, budgeting and procurement results in areas of inefficiency and

inappropriate drug selection. Over the last decade, drug management has been

devolved to districts however there is little assessment of its impact on drug

quality and availability. Additionally manual logistic management systems and

poor storage facilities are key issues needing attention and while new systems are

in place for GFATM supported TB and malaria programs these need to be rolled

out to the mainstream public sector.

Improvement in drug availability has been seen in contracted Basic Health Units

with need for attention to alternative financing mechanisms for improving drug

availability. Only 8.3% falling in unsatisfactory category as compared to 87% of

153

those directly managed by the Department of Health, however quality,

appropriateness of drugs and storage have not been assessed. New financing

mechanisms can potentially improve drug access for the poor and need to be

aggressively explored.

Private retail outlets are the predominant means to supply to both private and

public sector patients however the existence of close to 80,000 drug stores, one

of the highest in developing countries, defeats attempts at regulation. Most of

these are drug stores rather than pharmacies, are manned by untrained persons

rather than pharmacists, and only a fifth of all retail outlets meet licensing

requirements. Disappearance of certain drugs from the market drugs is common

and is due to withholding by and black-marketing by wholesalers and distributors.

There is shortage of trained human resource across public and private sector for

drug procurement, management and dispensation. As opposed to WHO’s

recommended ratio of 1:2000 pharmacists per population, Pakistan has only 0.9

pharmacists per 100000 population, of which 70% are engaged in industry with a

very small core serving in health service delivery. Role of pharmacists is also not

institutionalized with selection and procurement dominated by medical doctors

while dispensing is done by junior untrained staff.

Regulation & Production: Pakistan produces 70% of consumed medicines

however close to 50% of the market belongs to multinationals and is far from

achieving self-sufficiency in production. Local production units number up to 414

but vary widely from well equipped units to those with questionable quality of

drugs putting into question licensing and quality assurance practices. Self-

sufficiency in tem of raw material production is yet to be achieved with

dependence essentially on imports. Although TRIPS has afforded certain new

opportunities there has been little use of patents and local companies need

assistance in deciphering legalities of patents on offer.

Pakistan has 76000-88000 registered drugs, one of the highest numbers in

LMICs, with many being unnecessary drugs having marginal therapeutic effect

over each other or multiple variations of the same drug available at different

prices and quality. Although Pakistan has detailed guidelines on licensing of drug

production units and registration of drugs however implementation has been

154

questionable with existing practice encouraging a market monopoly with loose

control. This results in irrational prescription, unnecessary drug expenditure and

weakens monitoring of quality assurance. Reliance on a traditional manual

registrations system makes it difficult to strategically plan and review drug

registrations while there has also been little utilization of the Central Research

Fund in bioequivalence and comparative cost analysis. There are wide

discrepancies in terms of quality of registered products with little incentive for

more sophisticated production units to invest in quality control. The Supreme

Court and Cabinet have recommended Creation of an autonomous Drug

Registration Authority to counter poor drug quality but still needs to be put into

practice.

Counterfeit medicines are common in Pakistan and need new modalities of

control. Traditional market monitoring systems is government dominated,

punitive and there are widespread concerns of nexus between laboratories,

inspectors, suppliers and industry. More participatory and incentive based

policies need to be implemented.

Price of standard chronic care therapy is unaffordable across generics and

originator brands and excessive prices are in place for certain medicines in

general. Pricing is based on input costs but lack of a clear pricing formula creates

opportunity for collusion and inefficient market spending on products. A flat price

control is in practice and although well intentioned has resulted in disappearance

of low cost essential medicines, even life saving drugs, from the market, little

impact on high priced items, and a general disincentive to producers.

Greater participation of implementers is needed in regulation however move to

totally devolve drug registration to provinces as part of ongoing devolution of

Ministry of Health may have serious repercussions. Regulatory capacity of

provinces is very uneven at present. Moreover total devolvement can result in

creation of potential inequities across the country with differential drug

availability and prices across provinces as well as cross provincial trafficking in

drugs. Institutional realignments need to be directed towards creation of an

autonomous drug regulation authority but built along more participatory lines.

155

RESEARCH NEEDS FOR ADDRESSING POLICY CONCERNS:

There is high need for evidence generation to assist action on prioritized policy

concerns. So far research in the pharmaceutical area in Pakistan has not been

from a comprehensive health systems perspective with the result that existing

research is small scale, mostly confined to rational prescription while areas such

as policy, supply side and financing have largely been overlooked. There is need

for collation of best practice from other countries, routine monitoring surveys to

assess policy impact, operational pilots for testing out new financing and supply

side strategies, formative research on health seeking and affordability, and

increased pharmaco-vigilance studies. For achieving this, an expanded range of

researchers needs to be involved including policy analysts, financing specialists,

health systems specialists in addition to pharma experts.

Key research priorities were identified through the consensus building exercise

and salient features are given as follows:

Continuous surveillance is needed into effect of national policies on medicine

availability, prices and affordability covering both the market and the public

sector. It is internationally recommended that such surveys should be repeated

periodically every two years however there has been no updating of information

since the last WHO global survey in 2004. District level information is also need to

assess impact of Local government Ordinance as well as Devolution of federal

Ministry of Health on access to medicines. Accompanying this there is also high

need for policy analysis research as to explore reasons underlying gap between

policy regulations and actual practice.

Pricing policies require examination to improve access to essential generics

particularly for standard chronic care therapy and contain prices of excessively

priced originator brands. There is need to move away from flat price control to

exploring optimal mix of pricing regulations based on lessons learnt from other

countries. There is also need to monitor price in the actual market to inform

pricing regulations and production of disaggregated information by prices fixed by

MOH, prices at retail pharmacies, and prices for public sector procurement.

156

Bottlenecks faced by the Essential Medicines Programme in Pakistan need to be

examined to reduce the gap between policy and practise. This would required

identification of constraints and opportunities at different health systems level.

Compilation of lessons learnt from other LMICs is needed for promotion of

generics at policy level, supply side level, individual provider levels and consumer

level.

Examination of alternative financing mechanisms is required to reduce medicine

expenditure borne by households particularly on chronic care therapy, and

supplement public sector provision. Possible mechanisms include franchising

with GPs, contracting with NGOs, commodity vouchers, health equity funds and

pre-payment schemes, to supplement public sector provision. As a first step

operational research pilots and compilation of best practise lessons are needed to

inform decision-making on best-suited financing mechanisms for Pakistan’s

context. Unit cost estimation of standard therapies will also be needed to roll out

financing support platforms for drugs.

Standardised mapping and assessment surveys of private sector are required

including of qualified providers, informal providers, shadow pharmacies, and

traditional healers. Information is needed on adequate licensing, prescription

practises, dispensation practises, medicine charges, and patient satisfaction.

Qualitative information is also needed on sources of information, openness to

regulation, and expressed information needs of private sector.

Formative research is needed into consumer demand, health-seeking

preferences, willingness to pay, and enhancing patient role in accountability.

Credibility of health professionals and the issue of trust is also an area that needs

to be explored.

Finally operation research is also needed into improving logistics and human

resource management in the public sector for improving drug access. Areas t be

looked into include scientific budgeting, forecasting and procurement, integrated

HMIS for drugs, institutionalization of pharmacists and increasing supply,

monitoring of quality storage, and routine monitoring of access to health

facilities.

157

CONCLUSION

Pakistan has relatively well documented policy and operative guidelines however

there is gap between policy and actual practice. There is tremendous need for

both standard assessment surveys to assess policy impacts as well exploratory

research to identify major constraints.

Priority areas as identified through this exploratory study and consensus building

exercise include

• Continuous surveillance of impact of policies on availability, price and

affordability

• Identification, regulation and monitoring of standard chronic care therapies

that would particularly benefit from reduced pricing and wider availability.

• Optimal mix of pricing regulations to reduce expenditure burden on

households.

• Tighter regulatory control to cut down on unnecessary medicines having

marginal therapeutic effect over each other.

• Market vigilance for spurious drugs and participatory strategies to counter

spurious drugs

• Multi-tiered health system measures for promotion of generics

• Operation pilots on alternative financing mechanisms to supplement public

sector through a range of commodity voucher, GP contracting, pre-payment

schemes, equity funds for increasing drug availability and affordability

• Mapping of private sector and exploring support needs for rational use

• Consumer health seeking preferences and participation in accountability

mechanisms

• Improvement of logistics and human resource management in public sector

for drug access

Pharmaceutical policy and research need to be centrally placed within larger

health systems related initiatives, reviews and policy updates. This needs to be

accompanied by sustained dialogue and interaction between entities including

public health sector, pharmacists association, medical doctors association, local

governments, industry, researchers and development partners. Adequate steps

also need to be taken to ensure access to research, feedback on research and a

continuous culture of research feeding into evidence based policies.

159

Consensus development on research priorities - Lebanon

As discussed under “Methods”, the researchers combined the research questions

emanating from the literature review and from the KII into one list. The

researchers aimed to reduce the large volume of questions and produce a list of

around 50-60 questions. As a result, a list of 57 questions was generated and

submitted to the validation and prioritization meeting (Appendix 6-C). While

questions were initially categorized according to four domains of the WHO 2004

ATM framework, it was decided to remove the categories and just provide a

single list. The rationale for this approach was to avoid imposing categories on

participants as they prioritized questions in the validation-prioritization meeting.

Furthermore, the researchers hoped that this would allow discussions among

participants to suggest whether the WHO 2004 framework was appropriate or

whether there are alternative frameworks that need to be considered.

After the first round we retained the 22 questions deemed important by at least

two thirds of the participants. Those questions were submitted to the ranking

exercise. The participants were asked to rate each question for a scale from 1 to

10 by each of five criteria. We then added up the scores of all 12 participants.

Appendix 6-D shows the rank of the 22 questions. The five questions that receive

the highest scores are (in descending order):

1. Assessment of quality of medicines on the market and role of counterfeit

medicines and black market.

2. A study of attitudes of physicians and of the public towards generic substitution

and the opportunities for implementing relevant policies

3. Is access to medicines a priority for policymakers, for professional associations,

and for consumer advocates?

4. Evaluation of the role of civil society organizations and non-governmental

organizations in improving access to medicines especially for the poor, vulnerable

groups and hard-to-reach populations.

5. What happens at the dispensary? Dispensing medicines or delivering primary

health care? Adherence to generics in PHC and dispensaries.

160

Conclusions


medicines is a key component of a functioning health system. Access to medicines

needs to be fully integrated with health financing, human resource planning,

service delivery, information and governance systems. This is the first study

conducted in this region that has collated published literature and summarized

the main policy concerns to identify ATM research priorities. In this study we used

an extensive search of local and regional literature, interviews with key

informants, analysis of previous priority setting exercises and consensus

development approaches to identify the main research priorities for ATM

research. We developed detailed maps of research on the issue, conceptual

frameworks of policy concerns and issues, and identified lists of ATM research

priorities for the countries of focus and the region as a whole.

The main concerns of the key informants were around the affordability and

financing aspects of access to medicines, followed by issues of availability and

rational use of medicines. The key informants paid attention to all levels of

barriers to access: the household level, providers (public or private sector), health

system, other sectors and cross border issues. The identified previous research on

the issue, however, did not reflect that.

The results of the study indicate that ATM research in the region is heavily biased

towards RUD. RUD research has been mainly in the shape of prescription audits,

the majority of it showing there are important problems in prescriptions. In

recent years there is shift towards interventional studies assessing the impact of

interventions on improving prescribing outcomes. There are two important

patterns to note in here. First, the RUD research, although forming the majority of

ATM research is yet to show a substantial effect in improving drug utilization

patterns. The prescribing problems of focus in ten years ago remain unresolved

today, if not joined by new challenges (e.g. non-generic prescribing). Second, it

seems a change in research strategies is required and future studies should focus

161

on interventional issues. Fortunately there is a move in that direction. Also further

demand side (why public still sees fascinated with antibiotics) and health systems

angle (what are the financial and organizational barriers to improving prescribing

patterns) research will be required.

This study clearly indicates that there is dire need for further research on

financing and affordability aspects of ATM in the region. This should be given

paramount attention in future research funding and calls for proposals. Also

cross-border issues and other sectors roles on access to medicines in the region

has not explored widely. It seems that many household (demand side) studies in

the region remain of poor quality and limited methods. Together, these main

areas should provide the main aspects of access to medicines research in the

region.

This is in no way indicating that further RUD or studies of health systems and

availability access are not needed. Or that the barriers at the levels of providers

and health systems are exhaustively identified. Rather it seems that individual

researchers and available funding route are giving attention to these issues at the

moment, which should continue while further resources should be mobilized for

studies related to the relatively ignored aspects of ATM research in the region.

Almost 80% of AT research in the region is originating from the region. However,

there is a wide variation in the number of publications originating from different

countries. Certain countries (e.g. Somalia), or certain areas of other countries, do

not appear in the literature.


reported in recent publications that had not followed extensive methodologies.

There is a growing trend, over the years, of more and better quality studies from

the region appearing in international journals. Still, a concurrent trend will be

required to ensure the local audience of such research (i.e. practitioners, policy

makers and media) remains informed of the new development as a result of ATM

162

research in countries in the region. An active knowledge translation approach will

be essential.

Finally, the key informant interviews clearly demonstrate that the majority of

policy concerns were not addressed by published research. There was a mismatch

between the concerns and research, and hence the outcomes of this study can

contribute to developing a research agenda for improving access to and

appropriate use of medicines in the region and the three countries of focus.

163

Acknowledgements

The study is funded by the Alliance for Health Policy and Systems Research

(AHPSR). AHPSR works within the Health Systems Strengthening cluster of WHO

HQ. It aims at promoting the generation and use of health policy and systems

research as a means to improve the health systems of developing countries. The

Access to Medicines (ATM) Policy research is a new program of work,

implemented by the AHPSR and funded by the UK Department for International

Development (DfID). The program aims at improving the availability and use of

evidence on access to medicines in Low and Middle Income countries.

The investigators thank the AHPSR for its support and guidance, especially Dr

Abdul Ghaffar, Dr Maryam Bigdeli and Maryse Coutty and their colleagues for thei

excellent support. Especially we would like to thank Maryam Bigdeli for he hands-

on support and for attending our workshop and focus group discussion in Karachi.

The authors also thank the research ethics committees in the three universities

and the research governance bodies. The authors are indebted to the

interviewees and the consensus development participants for their valuable input

and time. The teams received advice and support from different individuals in the

three countries. They would also thank Prof Soonman Kwon who attended the

workshop in Tehran as a resource person.

The views expressed in the document are those of the individual authors and do

not necessarily reflect the views of their respective organizations or the funding

body.

164

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Reference list. List of EMR region literature on ATM issues

First author Title Year Country of

origin

Country (ies) in

focus

Abdo-Rabbo, A Prescribing rationality and availability of antimalarial drugs

in Hajjah, Yemen 2003 Yemen Yemen

Abi Rizk, G

Determinants of antibiotic use and throat culture in

managing pharyngitis among primary health care physicians

in Beirut

2010 Lebanon Lebanon

Abu Rumman, K Training on the Practical Approach to Lung Health: effect on

drug prescribing in PHC settings in Jordan 2009 Jordan Jordan

Aburuz, S. M. Comprehensive assessment of treatment related problems

in hospitalized medicine patients in Jordan 2011 Jordan Jordan

Ahmed, A. M Drug use practices at pediatric hospitals of Khartoum State,

Sudan 2010 Sudan Sudan

Al Seyed prospective study on antibiotic misuse among infants with

upper respiratory infections 2009 Lebanon Lebanon

Al-Abbadi, I One-Year Assessment of Joint Procurement of

Pharmaceuticals in the Public Health Sector in Jordan. 2009 Jordan Jordan

Al-Azzam, S. I. Self-medication with antibiotics in Jordanian population 2007 Jordan Jordan

171


origin

Country (ies) in

focus

Al-Bakri, A. G

Community consumption of antibacterial drugs within the

Jordanian population: sources, patterns and

appropriateness

2005 Jordan Jordan

Albsoul-Younes,

A

Abuse and misuse of prescription and nonprescription drugs

sold in community pharmacies in Jordan 2010 Jordan Jordan

Al-Faham, Z The sale of antibiotics without prescription in pharmacies in

Damascus, Syria 2011 Syria Syria

Ali, G. K How to establish a successful revolving drug fund: the

experience of Khartoum state in the Sudan 2009 Sudan Sudan

Ali, G. K. A prescription for improvement: A short survey to identify

reasons behind public sector pharmacists' migration 2006 Sudan Sudan

Ali, G. K. M. Accessibility of medicines and primary health care: The

impact of the revolving drug fund in Khartoum State 2009 Sudan Sudan

Ali, O QUALITY OF CEFTRIAXONE IN PAKISTAN: REALITY AND

RESONANCE 2009 Pakistan Pakistan

Al-Niemat, S. I

Drug use evaluation of antibiotics prescribed in a Jordanian

hospital outpatient and emergency clinics using WHO

prescribing indicators

2008 Jordan Jordan

172


origin

Country (ies) in

focus

Altaf, A The cost of unsafe injections in pakistan and challenges for

prevention program 2006 Pakistan Pakistan

Al-Taiar, A

Who develops severe malaria? Impact of access to

healthcare, socio-economic and environmental factors on

children in Yemen: a case-control study

2008 Yemen Yemen

Alwarafi, A The Yemen health service and possibilities of cooperation

with the Czech Republic in the area of pharmacy 2001 Czech Yemen

Ameli, O.

Contracting for health services: effects of utilization and

quality on the costs of the Basic Package of Health Services

in Afghanistan

2008 Afghanistan Afghanistan

Amin, M. E Sources of drug information for patients with chronic

conditions in Alexandria, Egypt. 2011 Egypt Egypt

Awad Drug-use practices in teaching hospitals of Khartoum State,

Sudan

2006 Sudan Sudan

Awad, A Self-medication practices with antibiotics and antimalarials

among Sudanese undergraduate university students 2007 Kuwait Sudan

Awad, A Medical doctors' perceptions and expectations of the role

of hospital pharmacists in Sudan 2007 Kuwait Sudan

173


origin

Country (ies) in

focus

Awad, A Self-medication with Antibiotics and Antimalarials in the

community of Khartoum State, Sudan 2005 Kuwait Sudan

Awad, A. A. I Drug use practices in teaching hospitals of Khartoum State,

Sudan 2009 Kuwait Sudan

Azhar The role of pharmacists in developing countries: the current

scenario in Pakistan

2009 Malaysia Pakistan

Azhar, S.

A survey evaluating nurses' perception and expectations

towards the role of pharmacist in Pakistan's healthcare

system

2011 Malaysia Pakistan

Azoulay, L Inappropriate medication prescribing in community-

dwelling elderly people living in Iran 2005 Canada Iran

Babar Social pharmacy strengthening clinical pharmacy: why

pharmaceutical policy research is needed in Pakistan? 2008 NewZealand Pakistan

Baniasadi Developing an Adverse Drug Reaction Reporting System at a

Teaching Hospital 2008 Iran Iran

Bashrahil, K. A Antimalarial drugs: availability and mode of prescribing in

Mukalla, Yemen 2010 Yemen Yemen

Basmenji PHARMACEUTICALS IN Iran: AN OVERVIEW 2004 Iran Iran

Belkacem, A. Profile of prescription of psychotropic drugs in a National

Fund of Social Foresight Organisation in Morocco 2006 Morocco Morocco

174


origin

Country (ies) in

focus

Ben Abdelaziz,

A.

[Circulation of pharmaceutical information among general

practitioners in the region of Sousse (Tunisia)] 2002 Tunisia Tunisia

Ben Salem, K Essential drugs: availability and prescription in Monastir

(Tunisia) health district 2000 Tunisia Tunisia

Bodenschatz, C Injection prescribing patterns in public health care facilities

in Egypt. 2009 Egypt Egypt

Bukhari Essential medicines management during emergencies in

Pakistan 2010 Pakistan Pakistan

Butt, Z. A Quality of pharmacies in Pakistan: a cross-sectional survey 2005 Pakistan Pakistan

Cameron

Differences in the availability of medicines for chronic and

acute conditions in the public and private sectors of

developing countries

2011 Switzerland

mentions Iran,

Jordan, Lebanon,

Morocco,

Pakistan, Sudan,

Syria, Tunisia,

Yemen

Cameron, A., M

Medicine prices, availability, and affordability in 36

developing and middle-income countries: a secondary

analysis

2009

World Health

Organization,

Geneva,

Switzerland

mentions Jordan,

Lebanon,

Pakistan, Sudan,

Syria, Tunisia,

Yemen, UAE,

Kuwait

Cheraghali, A. M Improving availability and affordability of plasma-derived

medicines 2010 Iran Iran

175


origin

Country (ies) in

focus

Cheraghali, A. M Economical impact of plasma fractionation project in Iran

on affordability of plasma-derived medicines 2009 Iran Iran

Cheraghali, A. M Availability of blood components and plasma derived

medicines in Iran 2007 Iran Iran

Cheraghali, A. M Evaluation of availability, accessibility and prescribing

pattern of medicines in the Islamic Republic of Iran 2004 Iran Iran

Cheraghali, A. M Availability, affordability, and prescribing pattern of

medicines in Sudan 2009 Iran sudan

Das, N. Prescribing practices of consultants at Karachi, Pakistan 2001 Pakistan Pakistan

Dashti-

Khavidaki, S

Clinical pharmacy services in an Iranian teaching hospital: a

descriptive study 2009 Iran Iran

Davari Pharmaceutical policy and market in Iran: past experiences

and future challenges 2011 Iran Iran

Dinarvand, R

New National Drug Policy in Iran leading to Expanded

Pharmaceutical Market and Extended Access of Public to

Medicines

2009 Iran Iran

Ebrahimzadeh,

M. A

Utilization pattern of antibiotics in different wards of

specialized Sari Emam University Hospital in Iran 2008 Iran Iran

176


origin

Country (ies) in

focus

Elnour, A. A Awareness and reporting of adverse drug reactions among

health care professionals in Sudan 2009

United Arab

Emirates Sudan

Elrayah-

Eliadarous, H

Direct Costs for Care and Glycaemic Control in Patients with

Type 2 Diabetes in Sudan. 2010 Sweden Sudan

Esmaily, H. M Can rational prescribing be improved by an outcome-based

educational approach? A randomized trial completed in Iran 2010 Sweden Iran

Esmaily, H. M.

Identifying outcome-based indicators and developing a

curriculum for a continuing medical education programme

on rational prescribing using a modified Delphi process

2008 Iran Iran

Fahimi, F Evaluation of Stat Orders in a Teaching Hospital: A Chart

Review 2011 Iran Iran

Fahimi, F Transcription errors observed in a teaching hospital 2009 Iran Iran

Fattouh, R Impact of using essential drug list: analysis of drug use

indicators in Gaza Strip 2010 Palestine Palestine

Garjani, A Relationship of pharmacist interaction with patient

knowledge of dispensed drugs and patient satisfaction 2009 Iran Iran

Garjani, A Effect of interactive group discussion among physicians to

promote rational prescribing 2009 Iran Iran

177


origin

Country (ies) in

focus

Gelders Price, availability and affordability An international

comparison of chronic disease medicines 2006 Egypt

mentions Jordan,

Lebanon,

Morocco,

Ghadimi, H General practitioners' prescribing patterns for the elderly in

a province of Iran 2011 Sweden Iran

Hachfi, W Prescribing practices of fluoroquinolones in Tunisia 2011 Tunisia Tunisia

Hafeez, A Prescription and dispensing practices in public sector health

facilities in Pakistan: survey report 2004 Pakistan Pakistan

Hajebi, G

A Survey of Knowledge, Attitude and Practice of Nurses

towards

Pharamacovigilance in Taleqani Hospital

2010 Iran Iran

Hamidi, S Implementing an essential medicines list: effects on pricing

and utilization in West Bank, Palestine 2008 Palestine Palestine

Harper

Afghanistan pharmaceutical

sector development: problems and

prospects

2011 Hungary Afghanistan

Hassan, N. A

The impact of problem-based pharmacotherapy training on

the competence of rational prescribing of Yemen

undergraduate students

2000 Yemen Yemen

178


origin

Country (ies) in

focus

Hosseini SAR Counterfeit medicines: Report of a cross-sectional

retrospective study in Iran 2010 Iran Iran

Imran, M. Standards for labelling and storage of anaesthetic

medications--an audit. 2009 Pakistan Pakistan

JANJUA Injection use in two districts of Pakistan: implications for

disease prevention 2005 pakistan Pakistan

Kanavos, P

Benefits of global partnerships to facilitate access to

medicines in developing countries: a multi-country analysis

of patients and patient outcomes in GIPAP

2009 UK mentions

Pakistan, Sudan

Kassab, I Setup of a national system of adverse drug reaction

reporting in Lebanon: results of the first year of activity 2005 Lebanon Lebanon

Khalili, H Anticoagulant utilization evaluation in a teaching hospital: a

prospective study. 2010 Iran Iran

Khalili, H Is deep vein thrombosis prophylaxis appropriate in the

medical wards? A clinical pharmacists' intervention study 2010 Iran Iran

Khalili, H

Descriptive analysis of a clinical pharmacy intervention to

improve the appropriate use of stress ulcer prophylaxis in a

hospital infectious disease ward

2010 Iran Iran

Khan, M. S Common trend of antibiotics usage in a tertiary care

hospital of Peshawar, Pakistan 2010 Pakistan Pakistan

179


origin

Country (ies) in

focus

Khawaja, M. R Prescription pattern of benzodiazepines for inpatients at a

tertiary care university hospital in Pakistan 2005 Pakistan Pakistan

Khdour, M. R Extent and nature of unlicensed and off-label medicine use

in hospitalised children in Palestine 2011 Palestine Palestine

Kheir Pharmacy Education and Practice in 13 Middle Eastern

Countries 2008 Qatar

focuses on Arab

speaking

countries

Khowaja, K., R A systematic approach of tracking and reporting medication

errors at a tertiary care university hospital, Karachi, Pakistan 2008 Pakistan Pakistan

Kuemmerle

Assessment of global reporting of adverse drug reactions

for anti-malarials, including artemisininbased combination

therapy, to the WHO Programme for International Drug

monitoring

2011 USA mentions Iran,

Morocco, Tunisia

Large, M., S Relationship between gross domestic product and duration

of untreated psychosis in low- and middle-income countries 2008 Australia

mentions Egypt,

Iran, Pakistan

Lowe Legislation, regulation, and consolidation in the retail

pharmacy sector in low-income countries 2009 USA

mentions

Pakistan,

Lebanon

180


origin

Country (ies) in

focus

Makhlouf

Obermeyer, C

Medication use, gender, and socio-economic status in

Lebanon: analysis of a national survey 2002 Switerland Lebanon

Mannan, A. A Antimalarial prescribing and dispensing practices in health

centres of Khartoum state, 2003-04 2009 Sudan Sudan

Mashayekhi, S.

O

Study of awareness among pregnant women of the effects

of drugs on the fetus and mother in Iran 2009 Iran Iran

Mendis, S., K

The availability and affordability of selected essential

medicines for chronic diseases in six low- and middle-

income countries

2007 Switzerland mentions

Pakistan

Mirza, Z. Thirty years of essential medicines in primary health care 2008 Egypt mentions EMR

Mohagheghi, M.

A

Community-based outpatient practice of antibiotics use in

Tehran 2005 Iran Iran

Mustafa, A. A

A comparative analysis of the Libyan national essential

medicines list and the WHO model list of essential

medicines

2010 libya libya

Mustafa, A. A A need for the standardization of the pharmaceutical sector

in Libya 2010 libya libya

Nader, F Patient sources for drug information in Iran: A

questionnaire-based survey 2008 Iran Iran

Namazi, S A Drug Utilization Research on Aminophylline/Theophylline

in Ali-Asghar Hospital, Shiraz, Southern Iran 2010 Iran Iran

181


origin

Country (ies) in

focus

Nasser, S. C Cost reduction associated with restriction policy on

dispensing intravenous esomeprazole in Lebanon 2010 Lebanon Lebanon

Niens, L. M

Quantifying the impoverishing effects of purchasing

medicines: a cross-country comparison of the affordability

of medicines in the developing world

2010 The

Netherlands lebanon

Nikfar, S., A

Monitoring of National Drug Policy (NDP) and its

standardized indicators; conformity to decisions of the

national drug selecting committee in Iran

2005 Iran Iran

Nishtar, S Pharmaceuticals--strategic considerations in health reforms

in Pakistan 2006 Pakistan Pakistan

Otoom, S Evaluation of drug use in Jordan using WHO prescribing

indicators 2002 Jordan Jordan

Otoom, S. A

Health care providers' perceptions of the problems and

causes of irrational use of drugs in two Middle East

countries

2006 Bahrain Jordan, Syria

Pourseyed, S Adverse drug reactions in patients in an Iranian department

of internal medicine 2009 Iran Iran

Rao, K. D An experiment with community health funds(CHF) in

Afghanistan 2009 India Afghanistan

182


origin

Country (ies) in

focus

Raoof

Awareness and Use of Benzodiazepines in Healthy

Volunteers and Ambulatory Patients Visiting a Tertiary Care

Hospital: A Cross Sectional Survey

2008 Pakistan Pakistan

Rickrode, G. A Internal reporting system to improve a pharmacy's

medication distribution process 2007 Lebanon Lebanon

Ritz A bibliometric study of publication patterns in access to

medicines research in developing countries 2010 USA mentions EMR

Saab, B. R List of essential drugs for primary care in Lebanon 2001 Lebanon Lebanon

Saab, Y. B Inappropriate medication use in elderly lebanese

outpatients: prevalence and risk factors 2006 Lebanon Lebanon

Sabawoon, W Delay in the treatment of pulmonary tuberculosis: a report

from Afghanistan 2011 Japan Afghanistan

Sabzghabaee, A.

M

The design and equipments of hospital pharmacies in

Isfahan, Iran 2010 Iran Iran

Sahebi, L Self-medication and storage of drugs at home among the

clients of drugstores in Tabriz 2009 Iran Iran

Salameh, P Drug circuit in Lebanese hospitals 2007 Lebanon Lebanon

Salameh, P Pharmacy manpower in Lebanon: An exploratory look at

work-related satisfaction 2007 Lebanon Lebanon

183


origin

Country (ies) in

focus

Salameh, P. R Clinical pharmacy in Lebanon: a pilot study regarding health

care professionals' opinion 2006 Lebanon Lebanon

Sallam, S. A Pharmacoepidemiological study of self-medication in adults

attending pharmacies in Alexandria, Egypt. 2009 Egypt Egypt

Sarahroodi, S Antibiotics Self-Medication among Southern Iranian

University Students. 2010 Iran Iran

Sawair, F. A Assessment of Self-Medication of Antibiotics in a Jordanian

Population 2009 Jordan Jordan

Sawalha, A. F Analysis of prescriptions dispensed at community

pharmacies in Nablus, Palestine 2010 Palestine Palestine

Sawalha, A. F Self-therapy practices among university students in

Palestine: focus on herbal remedies 2008 Palestine Palestine

Sedighi, B. Evaluation of self-medication prevalence, diagnosis and

prescription in migraine in Kerman, Iran 2006 Iran Iran

Sepehri, G The quality of prescribing in general practice in Kerman,

Iran 2005 Iran Iran

Sepehri, G The patterns of antihypertensive drug prescription by

cardiologists in Kerman province of Iran 2008 Iran Iran

184


origin

Country (ies) in

focus

Sepehri, G.

Pattern of drug prescription and utilization among Bam

residents during the first six months after the 2003 Bam

earthquake

2006 Iran Iran

Shabila

Iraqi health system in kurdistan region: medical

professionals’ perspectives on challenges and priorities for

improvement

2010 Iraq Iraq

Sharrad, A. K Consumer perception on generic medicines in Basrah, Iraq:

preliminary findings from a qualitative study 2011 malaysia Iraq

Siddiqi, S Prescription practices of public and private health care

providers in Attock District of Pakistan 2002 Pakistan Pakistan

Smith, F The quality of private pharmacy services in low and middle-

income countries: a systematic review 2009 UK mentions Egypt

Soleymani, F Challenges and Achievements of Promoting Rational Use of

Drugs in Iran 2009 Iran Iran

Soussi-Tanani, D Consumption analyze of the antihypertensive drugs in

Morocco: period 1991-2005 2008 Morocco Morocco

Sweileh, W. M Storage, utilization and cost of drug products in Palestinian

households 2010 Palestine Palestine

Sweileh, W. M Extent of potential drug interactions among patients

receiving anti-hypertensive medications 2005 Palestine Palestine

185


origin

Country (ies) in

focus

Tabarsi, P

Representative drug susceptibility patterns for guiding

design of re-treatment regimens for multidrug-resistant

tuberculosis in Iran

2008 Iran Iran

Tahaineh, L. M

Perceptions, experiences, and expectations of physicians in

hospital settings in Jordan regarding the role of the

pharmacist

2009 Jordan Jordan

Thatte, U

Evidence-Based Decision on Medical Technologies in Asia

Pacific: Experiences from India, Malaysia, Philippines, and

Pakistan

2009 India

India, Malaysia,

Philippines, and

Pakistan

Vessal Detection of prescription errors by a unit-based clinical

pharmacist in a nephrology ward 2010 Iran Iran

Vessal, G Knowledge, attitudes, and perceptions of pharmacists to

adverse drug reaction reporting in Iran 2009 Iran Iran

Vialle-Valentin,

C. E

Medicines coverage and community-based health insurance

in low-income countries 2008 USA

mentions

Pakistan, no

specific attention

to EMR

Wazaify, M Drug information resources at community pharmacies in

Amman, Jordan 2009 Jordan Jordan

Wazaify, M Societal perspectives on the role of community pharmacists

and over-the-counter drugs in Jordan 2008 Jordan Jordan

186


origin

Country (ies) in

focus

Wells, W. A Size and Usage Patterns of Private TB Drug Markets in the

High Burden Countries 2011 USA

mentions

Pakistan

WHO/HAI Medicine prices, availability, affordability and price

components 2008 Egypt

mentions Jordan,

Lebanon,

Morocco, Egypt,

Pakistan, Sudan,

Syria, Tunisia,

Yemen

Wright, K

Afghanistan: an assessment of the status of health care and

pharmacy mentoring efforts in an Afghan National Army

hospital

2003 Afghanistan Afghanistan

Yousef, A. M Self-medication patterns in Amman, Jordan 2008 Jordan Jordan

Yousif, E Deficiencies in medical prescriptions in a Sudanese hospital 2006 Sudan Sudan

Yousif, M. A In-home drug storage and utilization habits: a Sudanese

study 2002 Sudan Sudan

Yousif, M. A Investigation of medication prescribing errors in Wad

Medani, Gezira, Sudan 2011 Sudan Sudan

Zafar S. N. Prescription of medicines by medical students of Karachi,

Pakistan: a cross-sectional study

2008 Pakistan Pakistan

187


origin

Country (ies) in

focus

Zaid, A. N Appropriate use of oral drops: perception of health

professionals and assessment of package insert information 2010 Palestine Palestine

Zargarzadeh H Prescription and nonprescription drug use in Isfahan, Iran:

An observational, cross-sectional study 2008 Iran Iran

Zargarzadeh H Drug-related hospital admissions in a generic

pharmaceutical system

2007 Iran Iran

Zargarzadeh, A.

H

Design and test of preference for a new prescription

medication label 2011 Iran Iran

188

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Maturitas. 2008 Jan 20;59(1):7-21. Epub 2008 Jan 4.

Salameh P, [Drug circuit in Lebanese hospitals]. Rev Epidemiol Sante Publique. 2007 Aug;55(4):308-13.

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Bizri AR

The current status of antibiotic prescribing in ambulatory care the Lebanese experience.


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Acta Psychiatr Scand. 2000 Dec;102(6):429-31.

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Azar S. A practical guideline for management of hypertension in patients with diabetes.

J Med Liban. 2000 Nov-Dec;48(6):392-5.

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Dib JG, Saade S, Merhi F.

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Scicluna E.A., Self-medication with antibiotics in the ambulatory care setting within the Euro-Mediterranean region;

results from the ARMed project

Journal of Infection and Public Health 2009 2:4 (189-197)

Araj G.F., Kanj S.S.

Current status and changing trends of antimicrobial resistance in Lebanon

Journal Medical Libanais 2000 48:4 (221-226)

Araj G.F. Antimicrobial resistance in Lebanon Enfermedades Infecciosas y Microbiologia 1999 19:4 (197-198)

Araj G.F., Antimicrobial susceptibility patterns of bacterial isolates at the American University Medical Center

in Lebanon

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Khachan V Pharmacy education in Lebanon Currents in Pharmacy Teaching and Learning Volume 2, Issue 3, July 2010, Pages 186-191

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International Journal of Antimicrobial Agents, Volume 27, Issue 3, March 2006, Pages 242-246

Steve Harakeh Antimicrobial-resistance of Streptococcus pneumoniae isolated from the Lebanese

environment

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Appendices

Pharmaceutical system in Iran

A couple of valuable resources have summarized succinctly the progress in Iran's

pharmaceutical industry and sector over the last half a century, by Basmenji

(2004) and Davari et al (2011) 84-85

. Here we provide a summary of those two

papers, updated with other resources and info relevant to the issue.

Iran with a population of almost 75 million is one of the most populous counties in

the region. The share of health system from GDP is estimated at about 6 percent

(the estimates range from 5.6% to 7.4%), and Ministry of Health and Medical

Education is responsible for providing healthcare services all over the country, and

197

one of the most duties of it, is to ensure the efficacy and cost effectiveness of

health care services.

Medicines as an essential part of health care services are important and having

access to them is one of the most important duties of policy makers. Access to

medicines reflects the strengths and weaknesses of health system governance,

prioritization of equity in policymaking, and the role of primary health care in the

health system and it is closely linked with professional practice too. Regarding to

have an efficient system in ATM, some plans like implementing of rational drug

use committees, adverse drug monitoring and pharmacovigilance center, national

drug formulary committee were implemented and promoted specially in last two

decades.

Irrational drug use and self-medication continue to be a major problem in Iran.

Although national committee of rational drug use in the ministry of health and it's

branches in the 44 universities all over the country have developed some strategies

adopted from WHO for improving and promoting RUD, still there is inappropriate

drug use particularly high use of injectables, antimicrobials, and resulting issues of

polypharmacy, unnecessary expenditure, drug resistance.

The average number of drugs prescribed per patient is 3 or more in Iran and over

50% of patients are prescribed antibiotics.(FSoleymani, M Valadkhani, R Dinarvand.Challenges

and Achivements of Promoting Rational Use of Drugs in Iran.Iranian J of Public Health, Vol 38, Sppl.1, 2009,pp

166-168

198

Figure 19. The percentage of prescriptions containing antimicrobials or injectable

medicines. Source: The National Committee of Rational Drug Use in Iran 2010

.

0

10

20

30

40

50

60

70

19

98

19

99

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

% P

resc

rip

tio

n

Percentage of prescriptions containing antimicrobials , injectable drugs

Antimicrobials

Injectable drugs

Items per prescription 1385-2 to -1 SD-1 to 0 SD0 to1 SD1 to 2 SDNot available data

Items per prescription 1385Mean= 3.43 , SD= 0.23

199

Figure 20. Items per prescription in 2006 – a provincial comparison.

Figure 21. National trend in mean items per prescription. 1998-2010

The history of medicines goes back a hundred years to the establishment of the first modern drugstores in Tehran by foreign missionaries.84 Alongside that development,

European academicians started teaching sessions on pharmacology in the Polytechnic School in Tehran

(Dar-ol-Fonoun).84 However, the real start for modern medicines in Iran goes back to the establishment of the first modern School of Pharmacy in Tehran in 193612 85. By 1946, some simple dosage forms were produced, but the first modern pharmaceutical factory was established in 1953. The first supervising law on the regulation of pharmaceuticals, foods and drinks and cosmetics was passed in 1955.(Lotfi K.Iran's drug industry in the past 80 years(part 1). Chemistry and development.2000;4:6-11) From 1964, the government encouraged foreign investment in Iran, so that many European and American pharmaceutical companies established local subsidiaries which imported the ingredients and completed final production in Iran. Forty-one pharmaceutical factories were operating in Iran by 1979, most of which were branches of the foreign companies and there were around 4000 different

12

Others have noted the date as 1934 84. Basmenji K. Pharmaceuticals in Iran: an overview. Archives of Iranian Medicine 2004;7(2):158-64.

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Mean item per prescription

Mean item per prescription

200

pharmaceutical products available on the Iranian market – 70% of which were exclusively license from foreign companies.85

) jphs_42 47

After the Islamic revolution in 1979, all the foreign owned factories were

nationalised produced medicines under generic names. (Siyamak-Nejad F. Generic scheme: a

revolution in the Iranian pharmaceutical sector. Razi. 1989; 1(2): 1–3) .The war with Iraq from 1980

onwards caused scarcity of medicines, particularly in the early years of the war.

This disruption to the supply of medicines was difficult for both patients and the

government. This was because the domestic factories were unable to meet the war

need for pharmaceuticals and the government had financial difficulties limiting

importation of foreign products. Patients were faced therefore with a limited range

and unreliable supply of pharmaceuticals. In response, the idea of a ' Generic

Scheme' came about in late 1980. The elements of this scheme were government

support for domestic manufacture, a national list of essential drugs, a commitment

to promote equity of access to good quality essential drugs at a reasonable and

regulated price, and the manufacture and prescribing of all drugs by international

non-proprietary names (INN).85s_42

Since the end of the war with Iraq in 1988, the pharmaceutical industries were able

to meet 86% of demand and eight new pharmaceutical companies had been

established.(Montaseri A, Bahaane-ye B. Gozareshe Saazmaan-e Behdaasht-eJahaani [In the reason of the

Report of theWorld Health Organization].Daaroo wa Darman [Drugs and Therapeutics] 1986; 3:

3–4.) , and the share was increased to 95% of the pharmaceutical market in the 2008

year. (Food and Drug Department. Iranian Drugs Statistics Letter [CD].2009.Tehran: Chemi Darou Co.)

The state was the main owner of the pharmaceutical factories and its first priorities

in the early years of the Generic Scheme were to simply ensure availability of

commonly used drugs. Government management of the industry was heavy

handed; every single activity in pharmaceutical factories needed to get the

agreement from the government: purchasing raw materials, pricing, marketing, etc.

On the positive side, factories had access to subsidized foreign currency to allow

them to import raw materials, machinery parts and other relevant materials based

on their capability and share of the production. This helped keep the price of the

medicines low and stable.852

201

Another important reform was establishing a centralized national distribution

system, in which six state-owned firms wholly administrated the country's

centralized medicines distribution. This and the low prices enhanced access to

essential medicines across the country significantly. (Montaseri A, Bahaane-ye B. Gozareshe

Saazmaan-e Behdaasht-eJahaani [In the reason of the Report of theWorld Health Organization].Daaroo wa Darman

[Drugs and Therapeutics] 1986; 3:3–4.)

In the beginning of 1990s, the pharmaceutical system faced new challenges to

those of the 1980s. From the consumers' perspective, there was poor availability of

some newer imported drugs, rarely access to more than a limited range of drugs,

and even poor packaging of the domestic product which undermined patients trust

in its quality. From the industry perspective, the lack of market competition and

guaranteed price regardless of quality led to unfair profit, and the bureaucratic

barriers were major disincentives to innovation and change hindering development

and growth.

From 1989, as a part of broader economic and social development programme in

Iran, some market-oriented reforms were started in the pharmaceutical industries.

The first was to transfer the state owned pharmaceutical industries to the private

and semi-private sectors, which started from 1989 and was completed by 1994.

The government started to reduce the supply of subsidized currency to the factories

from 1989 and introduced a new pricing system, allowing gradual increases in

prices to reflect true production costs. Importation regulations were eased, and it

fell to factories rather than the government to ensure quality and price of raw

materials. Factories were allowed to use brand names for their products, and

previous central controls on production were removed; industry was encouraged to

export surpluses.

In this period, the government faced greater demand for foreign and new medicines

from both the population and physicians. As a response to this pressure, import and

export regulations became much freer than before, with import licences easily

obtained even for drugs already manufactured in Iran. This led to a wider

availability of drugs and a competitive market, such that formal rationing of drugs

was no longer considered necessary and therefore ceased.85

202

Mainly from Davari et al:85

The first modem School of Pharmacy in Iran was established in Tehran in 1936,

and then later also in Tabriz in 1949 and Esfahan in 1956. Production of some

simple dosage forms was under way by 1946, but the first modern pharmaceutical

factory was not established until 1953.13 The first law regulating pharmaceuticals,

foods and drinks was passed in 1955. From 1964, the government encouraged

foreign investment in Iran, so that many European and American pharmaceutical

companies established local subsidiaries which imported the ingredients and

completed final production in Iran. Cheap labour and the large and expanding

market made such investment attractive, and these foreign companies were also

allowed to import their other non pharmaceutical products for industrial or

domestic use, e.g. washing powder. Forty-one pharmaceutical factories were

operating in Iran by 1979, most of which were branches of the foreign companies

and there were around 4000 different pharmaceutical products available on the

Iranian market – 70% of which were exclusively license from foreign companies.

There was no regulation of the extensive promotional activities of companies or of

prescribing. The lack of an effective national systematic distribution for

pharmaceutical products caused problems with inequality of access across the

country.

After the Islamic revolution in 1979, all the foreign owned factories were

nationalised. They continued production but now produced medicines under

generic rather than branded names. The war with Iraq from 1980 onwards caused

13

Others have argued the fist modern factory was built three years later in 1335 Iranian calendar (i.e. 1956)

203

scarcity of medicines, particularly in the early years of the war. This disruption to

the supply of medicines was difficult for both patients and the government. This

was because the domestic factories were unable to meet the war need for

pharmaceuticals and the government had financial difficulties limiting importation

of foreign products. Patients were faced therefore with a limited range and

unreliable supply of pharmaceuticals. In response, the idea of a ' Generic Scheme'

came about in late 1980. The elements of this scheme were government support for

domestic manufacture, a national list of essential drugs, a commitment to promote

equity of access to good quality essential drugs at a reasonable and regulated price,

and the manufacture and prescribing of all drugs by international non-proprietary

names (INN). Some drugs not manufactured in Iran were designated by the Iranian

Food and Drug Department as essential and could be only imported by two state

owned companies, and prescribed by brand name. These rationalisation measures

reduced the numbers of drug available (only around 1000 of the previously

available drugs were included in the Iranian Drugs List – the other 3000 drugs

were considered ' me-too' drugs, or simple duplication, and unnecessary) while

increasing supply and often dramatically reducing the price; e.g. the price of a

Mebendazole tablet decreased to one-eleventh of its previous level.

The young pharmaceutical industry struggled at first to meet these expectations,

but by 1988 it was able to meet 86% of demand and eight new pharmaceutical

companies had been established. By early 2008, this share increased to 95% of the

pharmaceutical market. However, there was a shortage of newer and more difficult

to manufacture drugs.

204

The state was the main owner of the pharmaceutical factories and its first priorities

in the early years of the Generic Scheme were to simply ensure availability of

commonly used drugs. Government management of the industry was heavy

handed; every single activity in pharmaceutical factories needed to get the

agreement from the government: purchasing raw materials, pricing, marketing, etc.

On the positive side, factories had access to subsidized foreign currency to allow

them to import raw materials, machinery parts and other relevant materials based

on their capability and share of the production. This helped keep the price of the

medicines low and stable.

Another important reform was establishing a centralized national distribution

system, in which six delivery companies delivered the pharmaceutical products to

all pharmacies across the country. This and the low prices enhanced access to

essential medicines across the country significantly.

In the beginning of 1990s, the pharmaceutical system faced new challenges to

those of the 1980s. From the consumers' perspective, there was poor availability of

some newer imported drugs, rarely access to more than a limited range of drugs,

and even poor packaging of the domestic product which undermined patients trust

in its quality. From the industry perspective, the lack of market competition and

guaranteed price regardless of quality led to unfair profit, and the bureaucratic

barriers were major disincentives to innovation and change hindering development

and growth.

205

From 1989, as a part of broader economic and social development programme in

Iran, some market-oriented reforms were started in the pharmaceutical industries.

The first was to transfer the state owned pharmaceutical industries to the private

and semi-private sectors, which started from 1989 and was completed by 1994.

The government started to reduce the supply of subsidized currency to the factories

from 1989 and introduced a new pricing system, allowing gradual increases in

prices to reflect true production costs. Importation regulations were eased, and it

fell to factories rather than the government to ensure quality and price of raw

materials. Factories were allowed to use brand names for their products, and

previous central controls on production were removed; industry was encouraged to

export surpluses.

In this period, the government faced greater demand for foreign and new medicines

from both the population and physicians. As a response to this pressure, import and

export regulations became much freer than before, with import licences easily

obtained even for drugs already manufactured in Iran. This led to a wider

availability of drugs and a competitive market, such that formal rationing of drugs

was no longer considered necessary and therefore ceased.

So, after more than 29 years of implementation of the Generic Drug Scheme in

Iran, and despite its major achievements, drug policy makers in Iran are moving

towards a freer competitive market with brand name prescribing and looser

pricing.

206

Figure 22. The first pharmacy established in Birjand in 1933, eastern Iran. The pharmacy is still

active. Photo © Arash Rashidian, 2010.

207

Pakistan country profile

Pakistan is situated in the North-Western part of South Asia, with about 185 million people and annual population growth rate is 1.9%. It is bordered by China on the northeast side, India on the eastern side, Iran and Afghanistan on the western side and the Arabian Sea on its south. The GNP per capita is $1200 and 1% is spent on health.

Life expectancy in Pakistan is 63 for males and 65 for females. Maternal mortality ratio is 276, infant mortality rate is 74 and under five mortality rate is 98 (PDHS 2006-07). Total fertility rate in Pakistan is 4.1, 3.3 in urban and 4.5% in rural areas and CPR is 30%, whereas unmet need of contraception is 25%. (PDHS 2006-7). At the same time Non Communicable Disease burden in Pakistan is also high and accounts for 59% of the forgone DALYs while the remaining 41% disease burden is due to communicable diseases and maternal, child care and nutritional issues (World Bank 2011). In recent years natural disasters have also had a detrimental effect on health status. 75,000 people died in the 2005 earthquake and 1,810 in the 2010 floods but asides from fatality these disasters resulted in widespread communicable diseases and destroyed the health care infrastructure and peoples’ livelihoods in affected areas. Health care provision in Pakistan comprises private and public services. Although the public sector has a well developed infrastructure of primary, secondary and tertiary facilities as well as an outreach Lady Health Worker Program, public sector is under-utilized and serves 21% of the population (WHO-EMRO 2011). The private sector serving nearly 79% of the population is

208

primarily a fee for service system and covers the range of health care provision from commercial private sector, CSOs, philanthropic institutions and traditional faith healers. Under Pakistan’s constitution, health is primarily the responsibility of the provincial government, except in the federally administrated areas. Ministry of Health (MOH) at the Federal level has played the major role in developing national policies and strategies, hosts 11 vertical programs and also the Drug Control Organization. Under a recent constitutional amendment the Federal MOH along with a number of other ministries is to be devolved to the provinces in 2011 with retaining of a minimalist MOH under the Cabinet Division. Areas and functions to be devolved to provinces are as yet unclear.

209

Key informant interview rsources

Interview guide for regional experts

Identification of Priority Policy Research Questions in the area of Access to and

Use of Medicines in EMRO Countries

Introduce yourself to the interviewee. Give a summarizing statement about the project and the

purpose of the interviews. Clarify that the interview will be tape-recorded. Ask for consent to

record.

• Ask the interviewee to briefly introduce himself/herself.

1-How do you define 'access and use of medicines'? What are the different aspects of it?

2- Thinking of access and use of medicines, in your view what are the roles of issues and

aspects such as affordability to pay, insurance coverage, governmental expenditure on

drugs, drug quality, rational drug use and/or health system financing in 'access and use of

medicines'?

(note to the interviewer: you may need to ask about issues one by one.)

3- How do you think of the health system's performance in this region (i.e. EMRO

countries – especially LMICs) or your country about different aspects of access to

medicine?

4-What are the challenges in access and use of medicine at the level of health sector policy

(stewardship and governance function)?

(examples of governance issues may include: national drug lists, pricing, import or production

regulation, generic or branding policy, subsidizing, quality control, pharmaceuticals share of

total health expenditure …)

210

A. How much do we know about these topics in the region or your country? Is there enough

research evidence in the region in this field? Do you know about any published or

unpublished reports, articles or ongoing research, and which ones do you recommended as

useful research?

B. What is the priority of research for these issues? What questions remain and for what

questions more research is required?

5- Thinking of access and use of medicines, what are the challenges in your country or

other countries in the region in terms of health insurance systems or general revenue

financing in securing access to medicines?

(Including insurance coverage, decision to allocate governmental revenues, the decisions to

cover medicines, depth of coverage, entitlements, medicines' pricing …)

A. How much do we know about these topics in the region or your country? Is there

enough research evidence in the region in this field? Do you know about any published

or unpublished reports, articles or ongoing research, and which ones do you

recommended as useful research?



6- What is your view about the challenges in production, procurement and supply chain for

access to medicine and what factors may improve it?

(Factors influencing public and private sectors, drug pricing, pharmacies' geographical

distribution and geographical access and use of medicines, healthcare networks, hospital

pharmacies, ..)




useful research?



7- Thinking of the role of other sectors in access and use of medicines, what are the

challenges at the national and international level?

211

(e.g. think of the positive or negative roles that they followings may have: ministries of finance,

commerce and industry; authorities that issue standards, medical councils or unions,

pharmaceutical societies, NGOs, patient groups, medical societies, WTO, WHO, donors in this

region or your country …)




useful research?



8- What do you think the factors that affect access to medicine at the individual, household

and community levels?

(e.g. demand for medicines, care-seeking behaviour, knowledge and preferences of users, beliefs,

socio-cultural constraints, financial barriers for individuals, households and communities)




useful research?



9- What are the barrier and challenges in access and use of medicines related to providers

(physicians, pharmacist...) behaviour?

(e.g. induced demand, rational drug use, reimbursement methods, retailing behaviour, generic

substitution policy, pharmacy revenue, OTCs, herbal medicines, drug counterfeits and fraud …)




useful research?



10- Is there anything else to add? Are there other research priorities you may propose?

212

Thank you.

213

Interview guide in Farsi

م ��ا� � �� :��ح�� راه

� او�� داروه� %$وه#� در ز� �&�در (#�ر و � )'� د

� �ور�

*� � �)�+� و �� (,�+�

��ح �2�1 �� 0 ��ا� �� * �)�ر در ا�/�ا ه�ف از ا-�ا�

(�;> �4ف و �;:� 9�2 8 داد* �� د. د��0* (6� ��ح ��5 �� 34م

) �/=� � ن ��د. @? < ا�< �&� زه �� د �� در ا�/�ا �

� (�2* ��ت و � ن :�رت �6� و (#�ر� ا�� و زه در �'�C ز�

1�40/� �� د. / �E ��ح ��ا� �D* ��دار� �2 F ��ت ��G ا

� �� H�9ت ��1�2 �� دارو ه5/ � و � �I;H �) ��K > ''Lص �0وه

��/NOاران MK دارو ��رد ا�/4د* ا � � � *�D F و ��)�C ��دم

.�� اه

(P5 ر9�� ا� 1�9 :�ا

� �� دارو Q �5 و از .1�&�� و ا�+د� ��رد �Q �-�2 د�I�R ��ر

ا��؟

G � ,�ا@� در • �2= �� =/� ��ا� �� 0: %�T �OU=< ا)

�W+� .� �زار، ��2 � دا�R، �2ز��Z- Cا, ��، .. و X �* ا�ر* (

�T �OU=< � 2( � ��2ارد د��O در ��ال % � Q ه� ،�� *� ��%

.(� ا�� @ < - ا�ر* (

�G [ ا�+د� G � �2ان %�دا�� ا� دا .2 �� M��% ، رو و�ا

Gم �;�� در ^ � �� و � 2� < ��'( � F��_ � 4 � دارو و )

� �� دارو" دار�؟�&�� در ��34م "د�- �Q دارو

• ��=/� ��ا� �� T :�0=< ا) *� ��% �bزم ��د ا-Fا� ,�ق -�ا0

��.(

3. 8(��/NOار� در �دارو�� ا� � c/5 (��2 � و �(� �) (;ن

� ه� D �Q& �� دارو �)�ح �(#�ر �Q ��اC و � �5�&�6� -�3 د

� �� N0ار�، �eز واردات (�Rd ورود �� ,�3�� دارو��، I ��؟ �

�c3 دارو از ،�Gرت ( 4 ،�� 2 �، ��ح ژ��f، �2ز�C �را

(... ��;� � ��ت �Fه

ان ا��؟ �� •�� دردر ا�� ز�� دا�� روز ��ط ��ر � ا� از� ��&% $#وه� ! � ا��؟ در �� ار�

��پ ��0/.�ت ��پ ! � ، و �� ت، �*�( ه� �� )ارش

214

و�2د دارد � �5 در ��12ن و �� در �4ل ا12ا�%�� % �� ؟�6�� ن ��!� و � ام را

ز�� ؟� � ا� > ا;�م $#وه� در �4ل 1:�4او/��89 •� ��ا?��% ��<% �� و ا��؟ ه�> $#وه�% ��= ��ز�

��ع $#وه�%��8 ��= �% ��ا�� @� ��!� ؟�

4. R�H f� ان� H �� (#�ر �م � �� اG� �� دارو ، �&�در ز� � د

رو��؟ �6� رو��2N0 � hار در Gم �;�� Q �Q�#3 و �5

(... �/� I M��% انF � ،�ا �� M��% �� c ��2)

ان ا��؟ �� •�� در در ا�� ز�� دا�� روز ��ط ��ر � ا� از� ��&% $#وه� ! � ا��؟ در �� ار�

��پ ��0/.�ت ��پ ! � ، و �� ت، �*�( ه� �� )ارشو�2د دارد � �5 در ��12ن و �� در �4ل ا12ا�%��

�% �� ؟�6�� ن ��!� و � ام را

ز�� ؟� � ا� �ل 1:�4> ا;�م $#وه� در 4او/��89 •� ��ا?��% ��<% �� و ه�> $#وه�% ��= ��ز ا��؟�

��ع $#وه�%��8 ��= �% ��ا�� @� ��!� ؟�

� ,�ا� � ��2 � و �2ز�C دارو در (#�ر در .5�&��اC ��ط �� د

5� �Q �5 و Q� � � �)�ح ��j�, >در ا� ��&�6� ��ا� ��Dد د

� و ��(� �� ؟:�� MK �� ارN0� h2 Rا��H) �� I ،�ه� دو�/

دارو، �2ز��Z- Cا, �� دارو��، ��=� �Dا�� و در�ن، داروه�

�U5 f2 ،�/� ا� ...)� �ر


��پ ��0/.�ت ��پ ! � ، و �� ت�(، �* ه� �� )ارشو�2د دارد � �5 در ��12ن و �� در �4ل ا12ا�%��

�% �� ؟�6�� ن ��!� و � ام را

ز�� ؟� � ا� > ا;�م $#وه� در �4ل 1:�4او/��89 •� ��ا?��% ��<% �� و ه�> $#وه�% ��= ��ز ا��؟�

��!� ؟ ��ع $#وه�%��8 ��= �% ��ا�� @� �

6. MK �Oد� �� *O�;��، ه� ��h �� در (�� دارو در �&��ح د

��6 3#�Q �Q � �66kو و � < ارو��5 �'M رو ا��؟�6)

�ارد، Gم /��، وزارت اI/�د، اوزارت : �C، وزارت �زر0

�، اl�< ه� دارو�ز� و دارو�زان، �ز�ن=�F%دم�� د، هm

215

>�lا>�lران، ا� � �نهز�� ،��n ��6H �ه �66k< ا � �ه

� �WTO وWHO(


��پ ��0/.�ت ��پ ! � ، و �� ت، �*�( ه� �� )ارشو�2د دارد � �5 در ��12ن و �� در �4ل ا12ا�%��

�% �� ؟�6�� ن ��!� و � ام را


��ع $#وه�%��8 ��= �% ��ا�� @� ��!� ؟�

7. Q5� �� &��ار R و �#=;2� در ار�2ط � د� 8(�دارو در

�؟�� (,�ه o 2'9 و ��ف ��ت �;�� و دارو، 0jه� �)�ح �

��، ��د در��H(�2ان %�دا�� ،


��پ��0/.�ت ��پ ! � ، و �� ت، �*�( ه� �� )ارشو�2د دارد � �5 در ��12ن و �� در �4ل ا12ا�%��

�% �� ؟�6�� ن ��!� و � ام را


��ع $#وه�%��8 ��= �% ��ا�� @� ��!� ؟�

� دارو ��ط �� H�6=�د 5� �Q�R و �#=;2� در .8�&�ار�2ط � د

�0ن ��ت (%F�=ن، دارو�زان ...) �)�ح �� ؟ ارا�� (

� دارو، روش'( � F��_ ،�-ه� %�دا�� ارا��(2'9� ا�'�

� و اI/�د دارو��، _��F ژ��f و دارو� ? % �U5 �0ن، )

� و 0 ه�) �ر-�، IQق دارو، دارو� ��ون �U5، داروه�/ �

ان ا��؟ �� در ��ر در ا�� ز�� دا�� روز ��ط �� ا� از� ��&% $#وه� ! � ا��؟ در �� ار�

و ��پ �� 0/.�ت ��پ ! � ، و �� ت، �*�( ه� )ارشو�2د دارد � �5 در ��12ن �ن ��!� �� در �4ل ا12ا�%

�% �� ؟�6�� و � ام را

216

ز�� ؟� � ا� ا;�م $#وه� در �4ل 1:�4> او/��89� ��ا?��% ��<% �� و ه�> $#وه�% ��= ��ز ا��؟�

��ع $#وه�%��8 ��= �% ��ا�� @� ��!� ؟�

� �� دارو .9�&��ال و زه� %$وه#� �j در ار�2ط � ��اC د

د��O� و-�د دارد (� در ا�< �� < �� jن ا�ر* =�دم؟

217

Interviewee invitation letter for regional experts

Subject: interview on research priorities on access to medicines

Dear Dr ,

Hope this email finds you well.

We are conducting a regional EMRO study to identify priority research areas relevant to 'access

and use of medicines' (ATM) in the region. The study team includes Shehla Zaidi (Pakistan) and

Samer Jabbour (Lebanon) as well as other collaborators.

The study is funded by the Alliance for Health Policy and Systems Research, which is a

partnership working within the HSS cluster in WHO and is part of a global research agenda by

the Alliance. The findings of the study will influence research funding decisions for ATM

research at the Alliance as well as other agencies. As such, it is very important to ensure an

accurate picture of research priority areas is identified.

The study involves a systematic search of literature from the region, as well as qualitative

interviews with experts and key individuals.

For the interviews, we would like to invite you to spare a few minutes of your time (about 30-45

minutes). As you are a knowledgeable person on the issues and wider health system aspects of

access to medicines, it will be great if you agree with this. Your contribution will be gratefully

acknowledged in the reports.

I do hope you find this request agreeable. The interview guide is attached to this email.

For conducting the interview there are three options. I'll be happy to go along whichever you

find more convenient.

1. Telephone interview.

2. Recording your responses to the question using an electronic tape recorder and sending

us the files.

3. Written responses to the questions. This is not the ideal choice as we would like to

receive your detailed responses to the questions. Typing down responses may be time

consuming for you

I am happy to provide any further information regarding this research, which we hope will

provide useful information to researchers and policy makers in the region and worldwide, with

a new vision86

of the pharmaceutical sector as a core component of a responsive health system.

With warm regards

218

Thematic framework – in Farsi

� او�� ه� %$وه#� در ز� �&�در (#�ر داروو ا�/4د* از د

� و � )'� �ور�

�� #��% c هر �4/��

ز�� 9ع ��9ع�/NOار� . 1-1 �: (;ن

ز�� ه� ��1�2 در Gم ��;�

�s �� ارز�� H�6=�د > �Iاt 6�2 / �� vارا

�e و �� ز ��2 �ز��

/ �5 �و� ا � ��2 دارو�ز

�� / دو�/:�� MK �2ان

� F)�w زدا� ��;�352 ;ت و ا�=ت Gم

(*O (� �ر�/ن، در��اد* / Gم ار-ع / � �=�F%

�3 �� ر�F� در - �5 �و� ا��;�Gم

�/NOار� . 1-2 �: اH�ل (;ن� �)�

) ��/NOار� (;ن دارو� �NDP( � ورود �� ,�3�� دارو�

�� I�ارN0 P5Q��- labeling دارو

�eز / 2 c G وارداتf�� o ژ�� /

�Gرت ( 4 )GMP( &ل ( 4 � / ( 4 � دارو)

Gرت %x از ورود �� زار (PMS(

F0ار��ه� و �H ��hارض ) �/��اADR(

� �)ه� دارو�) F��_ 6=�د�H �� رتGaudit – drug

utilization review( ��) �� essentialداروه� ا

drugs( ،R�� ه� H��د� ارا�� (��

�bر�، ا��ز ...)ه� دارو�� و ارا�� ار�2ط ��(�

�0ن ) Gرت �� t 6�2 در -�+�

�c3 دارو ��;� � ��ت �Fاز ه

219

�� و دو�/:�� MK ;ت�2+ Gم � �� ا� �� M��% �

��;� (#�ر��ت > �2��;�Gم ��

��;�� ت O@ M��% انF �)universal coverage(

�/�z M��% /�ا �� M��% �� c ��2 M��% م ��رد;Iا

�/� I M��% انF � � �F%�ه �ه �ر� � �و�$* ��ا M��%–

�0و* ه� ه�ف� �2ز�C �را

'M �2ز�C دارو در (#�ر �:�� MK M'�)�� / �� دو�/� ه� دو�/

دارو�� ه – ,�ا@� در �زار�زار � * –�2ز�X C � ر}� (�Zز* ه

(... �2ز��Z- Cا, �� دارو��، ��=� �Dا�� U5 f2 ،�/�- و در�ن، داروه� � �ر

ا� ...)'M –�2ز�C ��ون �U5 دارو� �U5 ا�

| % �U5 ��Q �2ز�C در � �ر�/ن

��ت او� � �2ز�C دارو در ��=�2 c G واردات –واردات �داروو I P6'2Qق �

C�2ز� ��Q د در5,- corruption ��وج دارو –:درات

� ��jزش د��*5 �و� ا C�2ز� C�2ز� ��Q *~� �5 �و� ا–

C�2ز� �� =� ه� –Gرت و ارز� �

�5 �2H;ا� � �زار��

��Iد رEا� f�� 2ز�C ژ

�ار� 8(�,�ه o 2'9 و ��ف ��ت �;�� و و -�+� دارو

��H � 0jه� ��د در�

I �� دارو – �2ان %�دا�� c '/5� t 6�2 در -�+�

�ان –�0و* ه� ه�ف k� –ا�4ل – زن �< �رور�

>�F� �ه �ر� � � در�,� –اo ه O �#=;ت ,�ه

در�ن �0ن ��ت 2'9� ا�'�� H�6=�د ارا�� (

220

� دارو'( � F��_ – �� /�� اه�

�0نه� %�دا�� ارا��روش ) �� و اI/�د دارو�? % �U5

��jاز دارو در در �� jدر M'*O � �ر�/ن / در�

�� و �)ه� دارو� ا�� _��F ژ��f و دارو� �ر-

*� –ار�2ط دارو�� و ارا�� (fee splitting

�U5 دارو� ��ون �� و 0 ه/ � داروه�

�� –�#ور* دارو� دارو�ز� �� O و -�+�

>�F� �ه �ر� � (�� 8�� و 6#K رج� > �

�66kا C� وزارت :

� وزارت �زر0 وزارت اI/�د

�ارد �ز�ن/� ا�ز�ن �=�F% مG

اl�< ه� دارو�ز� و دارو�زان mده� ��دم�ز�ن >�lرانا� � �ه >�lا��n ��6H �ه

International NGOs SWAp WHOراه �ه� �2WTOا,'ت

Gavi Global Fund World Bank Philanthropic organizations – Bill & Melinda Gates Roll Back Malaria PEPFAR / UNAID EU / JICA / DfID / …

222

Appendix : Search strategies for Lebanon

A. PubMed Search Strategy used by the TUMS-based research team (limit 2000 and newer)

- #1- ((((((((((((((((iran[Affiliation]) OR pakistan[Affiliation]) OR lebanon[Affiliation])

OR Egypt[Affiliation]) OR Afghanistan[Affiliation]) OR Sudan[Affiliation]) OR

Yemen[Affiliation]) OR Jordan[Affiliation]) OR Tunisia[Affiliation]) OR

Morocco[Affiliation]) OR Syria[Affiliation]) OR Palestine[Affiliation]) OR Iraq

[Affiliation]) OR Djibouti[Affiliation]) OR Libya[Affiliation]) OR Somalia[Affiliation])

- #2- ((((((((((((((((((((middle east[Title/Abstract]) OR Iran[Title/Abstract]) OR

Tehran[Title/Abstract]) OR low income countries[Title/Abstract]) OR middle income

countries[Title/Abstract]) OR Pakistan[Title/Abstract]) OR Lebanon[Title/Abstract]) OR

Egypt[Title/Abstract]) OR Afghanistan[Title/Abstract]) OR Sudan[Title/Abstract]) OR

Yemen[Title/Abstract]) OR Jordan[Title/Abstract]) OR Tunisia[Title/Abstract]) OR

Morocco[Title/Abstract]) OR EMRO[Title/Abstract]) OR Syria[Title/Abstract]) OR

Palestine[Title/Abstract]) OR eastern Mediterranean[Title/Abstract]) OR Iraq

[Title/Abstract]) OR Djibouti[Title/Abstract]) OR Libya[Title/Abstract]) OR

Somalia[Title/Abstract])

- #3- (#1)OR (#2)

- #4- ((((drug$[Title/Abstract]) OR medicines[Title/Abstract]) OR

medication$[Title/Abstract]) OR pharmaceutical$[Title/Abstract])

- #5- ((((((((((use[Title/Abstract]) OR access[Title/Abstract]) OR available[Title/Abstract])

OR availablity[Title/Abstract]) OR affordable[Title/Abstract]) OR

affordability[Title/Abstract]) OR utilisation[Title/Abstract]) OR

utilization[Title/Abstract] OR prescription$ [Title/Abstract]) OR prescribe$

[Title/Abstract])

- #6- (#3) AND (#4) AND (#5)

Number of retrieved articles: 4

B. Modification of the PubMed search strategy used by the TUMS-based research team for the

Lebanon study (no time limit)

- #1- (((Lebanon[Affiliation]) OR Lebanese[Affiliation]) NOT Dartmouth[Affiliation]

- #2- ((((drug$[Title/Abstract]) OR Medicines[Title/Abstract]) OR

medication$[Title/Abstract]) OR pharmaceutical$[Title/Abstract]) OR

preparation[Title/Abstract]

- #3- ((((((use[Title/Abstract]) OR access[Title/Abstract]) OR rational[Title/Abstract]) OR

affordab$[Title/Abstract]) OR prescription[Title/Abstract]) OR

prescribing[Title/Abstract]

223

- #4- (#1) AND (#2) AND (#3)

C. Search strategy for the systematic literature review followed by the Lebanon team

Code Database Search terms #

1 PubMed ((Lebanon[MeSH Terms]) NOT Dartmouth [Affiliation])

AND pharmaceutical[MeSH Terms] 4

2 PubMed

(("pharmaceutical preparations"[MeSH Terms] OR

("pharmaceutical"[All Fields] AND "preparations"[All

Fields]) OR "pharmaceutical preparations"[All Fields]) OR

("medication systems"[MeSH Terms] OR ("medication"[All

Fields] AND "systems"[All Fields]) OR "medication

systems"[All Fields]) OR ("pharmaceutical

preparations"[MeSH Terms] OR ("pharmaceutical"[All

Fields] AND "preparations"[All Fields]) OR "pharmaceutical

preparations"[All Fields] OR "drugs"[All Fields]) OR

medicines[All Fields] OR ("pharmaceutical

preparations"[MeSH Terms] OR ("pharmaceutical"[All

Fields] AND "preparations"[All Fields]) OR "pharmaceutical

preparations"[All Fields] OR "medication"[All Fields]))

AND "lebanon"[MeSH Terms]

56

3 PubMed

(("prescriptions"[MeSH Terms] OR "prescriptions"[All

Fields] OR "prescription"[All Fields]) OR prescribing[All

Fields]) OR Treated[Title] AND ("lebanon"[MeSH Terms]

OR Beirut[All Fields])

55

4 PubMed

("therapy"[Subheading] OR "therapy"[All Fields] OR

"treatment"[All Fields] OR "therapeutics"[MeSH Terms] OR

"therapeutics"[All Fields]) AND ("guideline"[Publication

Type] OR "guidelines as topic"[MeSH Terms] OR

"guidelines"[All Fields]) AND "lebanon"[MeSH Terms]

29

5 PubMed

("pharmacy"[MeSH Terms] OR "pharmacy"[All Fields] OR

"pharmacies"[MeSH Terms] OR "pharmacies"[All Fields])

AND practice[All Fields] AND "lebanon"[MeSH Terms]

6

6 Embase Drugs/Lebanon 68

7 Scirus

(Drugs OR Medicines OR Medications OR Pharmaceutical)

AND (Use OR utilisation OR utilization OR access OR

financing OR supply OR Storage OR labeling OR

Affordability OR Affordable OR cost effective) AND

54

224

Lebanon (Keyword)

8 SML LEB (drug in Title) Or (medicines in Title) Or (pharmaceutical in

Title) 343

9 IMEMR (Drugs OR Pharmaceuticals OR medicines OR Prescription

OR Prescribing) AND (Lebanon Or Lebanese) 63

10

Google

Scholar

(Drugs OR Medicines OR Medication OR Pharmaceutical)

AND (Use OR utilisation OR utilization OR access OR

financing OR supply OR Storage OR labeling OR

Affordability OR Affordable OR cost effective) AND

(Lebanon OR Lebanese OR Beirut)

36,000

entries

IMEMR: Index Medicus for the Eastern Mediterranean Region (WHO Regional Office for the Eastern

Mediterranean)

LEB SML: Lebanese Corner at Saab Medical Library of the American University of Beirut

225

Interview guide (modified after the guide provided by Dr. Arash Rashidian et al)

Introduce yourself to the informant. Give a summarizing statement about the project and the purpose of

the interviews. Clarify that the interview will be digitally-recorded and transcribed without identifying

information. Review the consent document and ask for consent prior to proceeding. Ask the informant not

to provide any identifying information during the interview.

1-How do you define 'access to medicines'? What are the different dimensions of such access?

2- In your view what are the key issues relating to access to medicines in Lebanon (if not mentioned

by the informant, the interviewer can explore issues such as affordability to pay, insurance

coverage, drug quality, rational drug use and/or health system financing in 'access to medicines')?

(note to the interviewer: you may need to ask about issues one by one.)

• If the informant seems well knowledgeable about the key issues, explore the policy concerns

and corresponding research questions under each key issue. Then use a snow-bowling

technique to explore other issues that come up in the discussion and identify relevant policy

concerns and research questions.

• If the informants seems uncomfortable with the opening questions or does not appear

knowledgeable about the issues, please to ask specific questions as below.

3-What do you think of the health system performance in Lebanon in relation to access to

medicines?

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

4-What are the challenges in access to medicine at the level of health sector policy (stewardship and

governance function)?

(examples of governance issues may include: national drug list, pricing, import or production regulation,

generic or brand policy, subsidizing, quality control, pharmaceuticals share of total health expenditure

…)

• How much do we know about this area in Lebanon? Is there enough research evidence in Lebanon in this area? Do you know about any published or unpublished reports, articles or ongoing research in

226

this area? What questions remain and for what questions more research is required? In which areas do you think research would be most useful? What are the priorities for research in this area?

5- What are the challenges in Lebanon's health insurance system in securing access to medicines?

(Including insurance coverage, the decisions to cover medicines, depth of coverage…)


6- What are the challenges in production, procurement and supply chain for access to medicine?

What factors may improve this system? (Factors influencing public and private sectors, drug pricing,

pharmacies' geographical distribution and geographical access to medicines, healthcare networks,

hospital pharmacies, ..)


7- Thinking of the role of other sectors in access to medicines, what are the challenges at the

national and international level? (e.g. think of the positive or negative roles that the following may

have: ministries of finance, commerce and industry; authorities that issue standards, medical councils or

unions, pharmaceutical societies, NGOs, patient groups, medical societies, WTO, WHO, donors in your

country …)


8- What do you think are the factors that affect access to medicine at the individual, household and

community levels? (e.g. demand for medicines, care-seeking behaviour, knowledge and preferences of

users, beliefs, socio-cultural constraints, financial barriers for individuals, households and communities)


9- What are the barriers and challenges in access to medicines related to provider (physicians,

pharmacist...) behaviors? (e.g. induced demand, rational drug use, reimbursement methods, retailing

behaviour, generic substitution policy, pharmacy revenue, OTCs, herbal medicines, drug counterfeits and

fraud …)

227


10- Is there anything else you would like to add? Are there other research priorities you would like

to propose?

Thank you very much for your participation in this study.

Access to Medicines list of research priority topics by the level of barriers to

ATM

Access to Medicines list of research priority topics by the level of barriers to ATM – for Iran

Topic

Frequency of

those agreeing

the topic is a

high priority

research topic

A: Health sector policy

Assessing the procedures and regulations for adding medicines to the national

drug list (formulary) and identifying improvement models 11

Evaluation of the impact of laws and regulations on controlling drug use 9

Evaluation of the effect of the 'single item importing' policy on final cost of

medicines, quality and access, and health system expenditure 9

Assessing strategies to eliminate financial links between providers and patients,

and its impact on provision of pharmaceutical services

9

Evaluation of the impact of different payment methods on quality of health care

services 9

Evaluation of drug pricing policies and its impact drug utilization and access to

medicines and health outcomes 9

Evaluation of pharmaceutical policies,regulatory function and enforcement for

traditional and herbal medicines

8

Evaluation of pharmaceutical policies and procedures, and the applications of post

marketing surveillance reports 8

Evaluation of pharmaceutical policies,regulatory function and enforcement for

drug promotion 7

229

Evaluation of the impact of pharmaceutical policies,regulatory function and

enforcement on private sector presence in the market and competitiveness of

different pharmaceutical functions 7

Evaluation of the effects of privatization of distribution system on quality and

quantity of medicines 7

Evaluation of the impact drug registration and regulations for adding medicines

to the national drug list (formulary) on drug use patterns and access to medicines 7

Evaluation of the efficacy of pharmaceutical regulatory function and

enforcement 7

Evaluation of the effect of family physicians and referral system on drug use

patterns and access to medicines 7

Identifying the effectiveness of post marketing surveillance and ADR on drug

quality 7

The impact of governments national policy of re-directing governmental subsidies

on pharmaceutical system and households' access to medicines 7

Assessing the policy of cost-plus and reference based pricing methods in the

country 7

Evaluation of the effect of generic and brand system in the country 7

Assessing the methods of using research result on decision making in

pharmaceutical sector 6

Assessing the methods for improving production and distribution of

pharmaceutical sector in the country 6

Assessing the effect of decentralization and privatization on pharmaceutical

sector on access to medicines 6

Assessing the relationship between different pricing approaches and the

pharmaceutical companies' margins of benefit 5

Identifying the methods for evaluation of the top managers in the pharmaceutical

planning and decision makers 5

230

Assessing the methods for distribution systems of human resources for the

pharmaceutical sector 5

Evaluation the effect of sanction on the quality, distribution and cost of drug

production 5

Assessing the impact of the policy of allowing the retailers and distributers to use

a certain percentage their total sale of medicines as the benefit on

pharmaceutical sector behavior 5

Improvement of pharmaceutical policies on assessing the ADR reports on

decision making in the pharmaceutical sector 5

Assessing the methods of health system financing, national health

budgets, public funding for medicines 4

The impact of mandatory 'in-house pharmacist' policy for food and cosmetic

industry on quality of industry products 3

The effect of using a specialist committee to develop a well-defined

pharmaceutical distribution system adapted to country socioeconomic and

cultural characteristics

2

Evaluation of the role of nanotechnology on pharmaceutical care system 0

B: Health system financing/insurance system

Evaluation of the process of adding medicines to the insurance organizations' list

of medicines covered 11


services 9

Evaluation of drug pricing policies and its impact drug utilization and access to

medicines and health outcomes 9

Evaluation of the effect of free medicine provision in SSIO14

(and charity) owned

facilities on drug usage patterns and access to medicines 9

14


231

Evaluation the relationship between pharmaceutical pricing policies and costs and

benefits of pharmaceutical companies 8



8

Identifying and comparing the different insurance packages for pharmaceutical

care system 7

Assessing the effect of co-payment on pharmaceutical care system and access to

medicines and identifying the best method 5

C: Drug production and distribution system in the country

Evaluation of the extent and effects of drug promotions activities of the industry

and its impact on prescribing behavior of providers

9

Evaluation of the effect of the 'single item importing' policy on final cost of

medicines, quality and access, and health system expenditure 9

Evaluation of the impact of regulatory function providing financial incentives for

pharmacists' that provide appropriate pharmacy services on increasing quality and

improving rational drug use indicators 8

Evaluation the role of pharmaceutical companies on prescribing and drug use

patterns 8

Assessing the impact of electronic point of access cards on controlling drug usage 7

Evaluation the efficacy and safety of current pharmaceutical care system in

hospitals 7

Assessing the effect of implementing drug information and auditing prescriptions

centers in universities of medical sciences on promoting rational drug use 7

232

Evaluation the effect of implementing computerized system for registering the

prescriptions order on decreasing the medication errors 7

Evaluation the role of pharmacist on pharmaceutical care 7

Assessing the improvement methods for drug production and distribution in the

country 7

Evaluation the raw materials and drug registry system on quality and cost of drug

and time of access 7

Assessing and comparing the current drug distribution systems and designing a

national model adjusted to the cultural, political and socio economical

environment

6

Assessing the relation between the number of pharmacists and the quality of

pharmaceutical care in the hospitals 6

Evaluation and improving the methods of data gathering and registering in drug

production and distribution system 6


(and charity) owned


The effectiveness of continuing outreach visits by health network pharmacists on

training of CHWs and their (limited) prescribing behavior 5

Evaluation of the effect of family physicians and referral system on drug use

patterns and access to medicines 5

Evaluation of health care providers ideas and problems about pharmaceutical

care system by pharmacists and pharmacies in hospitals 4

Assessing the effect of access to databases and drug information systems on

accuracy and speed of pharmaceutical care in the pharmacy 4

Identifying the methods for evaluating the managers in the drug production and

distribution system 4

15


233

Assessing the effect of privatization on the quality and quantity of drug


Assessing the methods of health system financing, national health budgets,

public funding for medicines 4

Determining the WHO drug use indicators in pharmacies for implementing

strategies to promote rational drug use 3

Identifying the relationship methods between pharmaceutical industry, pharmacy

faculties and research centers and the methods for improving them 3

Assessing the methods for human resources distribution on pharmaceutical care

system and identifying the best methods 3


production 3

Evaluation of the role of nanotechnology on pharmaceutical care system 0

D: Beyond the health sector

Assessing the role of pharmaceutical companies on drug prescribing patterns 7

Assessing the role of NGO's and scientific associations on access to medicines

and drug use pattern 6

Evaluation the raw materials and drug registry system on quality and cost of drug

and time of access 6


(and charity) owned


Evaluation the impact of drug promotion on drug use patterns 5

16


234


production 5

Assessing the methods and impact of relationship between pharmaceutical

companies and scientific associations 4

Identifying the relationship methods between pharmaceutical industry, pharmacy

faculties and research centers and the methods for improving them 4

Evaluation and improvement the methods of inter sector corporations 4

Assessing the effect of decentralization and privatization on ATM 4

Assessing the methods and impact of relationship between pharmaceutical

companies and patients' associations 3

Assessing the effect of privatization on the quality and quantity of drug


E: Individual, household and community level

Identifying effective methods on improving public knowledge and awareness about drug

use

8

Assessing the role of medical group and patient education on improving self

medication in geriatrics 7

Assessing the observance of patient rights in pharmaceutical care sectors and

the methods for improving it 6



6

Evaluation the effect of pregnant women knowledge on drug use pattern by them

during pregnancy 5

Assessing the effectiveness of educational interventions on drug use patterns by

pregnant women 5

Assessing the impact of patient education about pharmacists' role on rational

drug use 5

235

Assessing the impact of patient education about drug use and adverse effect of

self medication on rational drug use 5

Assessing the effect of co-payment on pharmaceutical care system and access to

medicines and identifying the best method 4


(and charity) owned


Identify the methods for improvement the relationship between health providers

and patients 3

Assessing the effect of counseling interventions in universities and dormitoriesو

on CNS's drug use patterns in university students 2

F: Health care providers

Identifying effective continuous education methods for physicians to improve

drug use patterns and access to medicines 8

Assessing the current system in drug delivery system in hospitals 7




services 7

Assessing the role of pharmacies in drug use patterns 7

17


236

Evaluation of the impact of regulatory function providing financial incentives for

pharmacists' that provide appropriate pharmacy services on increasing quality and

improving rational drug use indicators

6


and its impact on provision of pharmaceutical services 6

Identifying the effectiveness of PMS and ADR on drug Quality 6

Assessing the role of medical group and patient education on improving self

medication in geriatrics 5

Evaluation of the effect of educational strategies on improving NSAIDs prescribing

patterns by general practitioners 5

Revisiting the role of pharmacists in pharmacies 5

Assessing the impact of patient education about pharmacists' role on rational

drug use 5

Identify the methods for improvement the relationship between health providers

and patients 5

Assessing the role of family physicians and referral system on ATM and drug use

patterns 5

Assessing the impact of patient education on pharmacist role in the rational drug

use process 4

Assessing the relation between drug interactions in prescriptions and

demographic factor of physicians such as gender 4

237

Determining the WHO drug use indicators in pharmacies for implementing

strategies to promote rational drug use 4

Assessing the effect of implementing drug information and auditing prescriptions

centers in universities of medical sciences on promoting rational drug use 3



Assessing the observance of patient rights in pharmaceutical care sectors and

the methods for improving it 3

Assessing the quality of pharmaceutical care and the methods for improvement 2ا

Evaluation of health care providers ideas and problems about pharmaceutical

care system by pharmacists and pharmacies in hospitals 1

Other topics proposed by the participants

Assessing the impact and methods of delegating hospital pharmacies to the

private sector and comparing with governmental sector

Evaluation the impact of implementing electronic prescribing system on drug

and patient safety

Assessing the approaches used for provision of expensive medicines for certain

high costs diseases on access to medicines

238

Assessing the policies and regulations for issuing permissions to establish a

pharmacy (certificate of need) on access to medicines

Assessing the current situation on counterfeit drug and fraud

Evaluation of the effect of pharmaceutical regulatory function and enforcement

on controlling counterfeit drug and fraud

Assessing the effect of biosemiolars on ATM

Evaluation the drug prescribing patterns

Evaluation of the effect of the 'single item importing' policy on drug distribution

system

Assessing the impact of relationship between pharmaceutical companies and

providers

Evaluation of the presence and impact of conflict of interest in pharmaceutical

and the other part of health sector

Research questions - Lebanin

Research questions emanating from literature review - Lebanon

Research question

Study of drug resistance, clinical comparison over time of resistance, and assessment of factors influencing it.

Determinants of medication purchasing and use behaviors among the public.

The relationship between emergence of resistant strains and poor prescribing and user behaviors.

Prevalence and incidence of drug-related complications at a national level. Comparison with regional and international numbers, linked with

the characteristics of drug market regulation.

Study of off-label use of medicines.

Study of physician prescribing behaviors and the link with characteristics of clinical practice.

Evaluation of adherence of providers to treatment guidelines in their prescribing practices, the factors reinforcing or hindering adherence.

Evaluation of the drug reporting system, and assessment of obstacles.

Evaluation of the impact of audits on physicians' compliance with prescribing guidelines.

Assessment of the impact of different interventions to regulate the medicines market and promote rational prescribing, dispending and use of

medicines. Comparison of outcomes before and after the intervention.

Assessment of medication use behaviors in major groups of illnesses.

Evaluation of curricula of medical students in relation to access to medicines.

240

What is the link between prescribing legislation and use patterns of psychotropic drugs and narcotics

Determinants of medicines use behaviors. How does family income influence medicines use?

Assessment of quality control of medicines in the market.

Are counterfeit drugs an important issues in the Lebanese market? Tracing the path of entry of counterfeit drugs.

Evaluation of cost effectiveness of generic vs. branded medicines

Study of prescribing behaviors and determinants of non-compliance with evidence-based guidelines

The influence of cultural factors on prescribing and use behaviors

Evaluation of regulatory laws in prescription

Comparative studies between generic and brand drugs in the goal of advertising for the use of generics and optimize cost effectiveness of

medication

Determinants of patterns of self-medication

Evaluation of guidelines in terms of cost effectiveness of different treatment strategies

Assess the perceptions of pharmacists regarding access to medicines

Assessment of population needs for medicines through epidemiologic studies

Evaluation of budget allocation for medicines and assessment of impact on ATM

Comparative studies of prices of medicines and of expenditures on medicines with other countries in the region and with countries of similar

level and level of development

Study of the processes for selection and registration of medicines, and the factors influencing these processes

In relation to the import of medicines, assess the cost-effectiveness of the import of medicines. Are the alternatives valid?

241

Assess whether selection of coverage of medicines by social insurance funds is rational and explore alternatives to improve the rational

selection

Assessment of public and professional perceptions about generics and their cost effectiveness

Comparative studies of clinical and cost-effectiveness between generics, branded generics and originator brands

Among local pharmaceutical manufacturing companies, assess adherence to good manufacturing practices (GMP)

Assess the efficiency of the medicines distribution network (through the PHC centers and dispensaries) and its reach to underserved areas

and how the network impacts ATM

Evaluate the program for distribution of medicines for chronic condition by YMCA in terms of the process, wastes and corruption, overuse

and misuse by beneficiaries, reach to intended users, and user satisfaction.

Explore the sources and outcomes of conflict of interests of different stakeholders in the health workforce

Assess the satisfaction of different health professionals with the way medicines are handled.

Evaluate the influence of over-supply of physicians and pharmacists on ATM. Assess the relationship between over-supply of physicians

and poor prescribing practices and assess the relationship between over-supply of pharmacists and poor dispending practices

Assess the quality of user-pharmacist interactions in pharmacies and in dispensaries

Study the marketing strategies of pharmaceutical companies, and link it with the rational selection and use of medicines.

Compare the marketing strategies of multinational pharmaceutical companies, and those of local companies and link it with the prescribing

behavior of doctors, and with purchasing behavior of patients.

242

Research questions emanating From key informant interviews - Lebanon

Rational Use

Explore perceptions of providers and patients about the use of generic drugs

Explore the drug seeking/purchasing behavior. Compare and contrast between different Lebanese communities, SES categories

Study the existing data to pinpoint trends of drug purchasing behavior

Assessment of Prescribing behavior of providers and its determinants

What are the factors that interplay the physicians’ prescribing behavior?

Drug purchasing behavior and its determinants and factors

Need assessment to guide rational selection

Assessment of central control of prescriptions, dispensing and promotion of medicines

Production of treatment guidelines to guide selection of drugs

Assessment of abidance to guidelines

Explore the factors influencing the misuse of Antibiotics/ antidepressants / sedatives, etc

What should a unified structured prescription form include and how it can be applied and monitored?

Cost analysis of the unified prescribing form

What are the barriers faced by NSSF to reinforce RU and how they can be overcome?

What are the possible mechanisms that can be used to control dispensing of drugs?

How can we control the aggressive marketing of drugs

explore the pharmaceutical companies marketing and its influence over access to medicines

Do doctors and hospitals follow the guidelines? And how this can be ensured?

Explore the appropriate mechanism to implementation generic substitution

Settle the standards of update the essential drug list?

Factors that affect the population’s basic drug knowledge in Lebanon?

Explore the methods of increasing providers and patients' awareness regarding drug rational use

How can international guidelines be adapted for management of diseases and prescriptions?

Explore the abidance to the code of ethics and professionalism among physicians

Why do people take medications without consulting a physician? And how this can be overcome?

Explore self-medication and factors leading to it

To what extent drug representatives stick to codes of ethics?

knowledge of doctors about law related to prescriptions?

explore barriers of doctors' knowledge and abidance by the prescription laws.

Explore the household pattern of drug usage

What are the guidelines for substitution of drugs by generics and how they can be implemented and monitored?

Assess factors influencing follow up on patients taking chronic medications?

Affordability

Study the cost effectiveness of Are generics cost effective?

How can we ensure sustainability of high quality services regarding education and drugs?

Assess processes and explore ways of improvement of medicines price control

Price analysis of imported and locally manufactured drugs, especially chronic medication.

Assess processes of better pricing tenders just like the army to help get discounts for the MOH on big drug quantities

Settle guidelines for fair pricing

Pricing studies: Price structure in origin country.

Assess transparency in pricing mechanisms

Trace the sources of price increase

Study the Lebanese drug market

Anticipate the influence of the generic drugs on the cost of essential medicines

243

Pharmaco-economic study (multidisciplinary): is the pricing good? Should have multiplicity of choice or a standard list?

Anticipate the change in the need for free or subsidized drugs and explore the ways of securing the growing need

Assessment of barriers against increase % of generics in the market?

Assess the relationship b/w the affordability/prices and the rational use of drugs?

Comparing with other countries in the regions, authentification of documents,

Assess the abidance of pharmacies by the law or regulations concerning pricing of drugs including discounts

Explore the patterns of marketing generics as trade?

Assess time trends in drug bills considering that the bill is increasing in spite of the introduction of generic drugs

Assess the relationship b/w the price of drugs and the profit of pharmacists

Anticipate the measures to be taken to increase the competition and decrease monopoly

Explore the possibility to have locally manufactured drugs to eventually decrease the prices?

Assess the benefits of the economic exchange policy with other Arab countries?

Retrieve the standards and qualifications of factories and raw materials and apply to local factories

Explore way of encouraging and improving local/national production?

Compare the compliance of insured versus non insured people to few indicator expensive drugs

What causes prices’ fluctuation? How it can be controlled?

Assess the drug bill of tertiary care and compare with international standards

Comparative prevalence of chronic diseases, recurrent expenses on health, by income

Exploration of speculation b/w Lebanese agents and the manufacturer

Assess critically governmental purchasing chronic drugs policies through YMCA with focus on protectionist policy to emphasize the local industry

Financing

Review eligibility criteria for coverage by MOH and NSSF to ensure that only people in need are covered

Assess patients' satisfaction when using reimbursed drugs from NSSF and other insurance schemes

Census of insurance and NSFF coverage in Lebanon in sight of planning better drug budget

Assess the compliance of insurance companies to cancer drugs coverage during the whole treatment period

Assess the part of donation in the drug market, and plan for measures to face the currently ongoing decreasing

donations for drugs

Compare accessibility between the army, NSSF, and MOH?

What is the most effective national insurance model and what are possible ways to implement among other

national insurance organizations?

Explore way of collaboration b/w the private and public sector, in terms of insurance

Explore possibilities of expanding NSSF to cover child vaccination, dental care and psychotherapy?

Explore the MOH coverage by eligible patients

People perception about cheaper drugs from PHC centers and dispensaries

Compare treatment cost by diseases b/w users of private versus public sectors

244

Explore the justifiability of the high budget of cancer treatment on MOH

Set quality control guidelines on the MOH expenses on cancer drugs

Assess abuse of insurances, and explore ways to avoid it.

Assess the reasons of the high OOP in Lebanon and explore ways of its reduction

Supply

What is named generic, list of generics and their category

Draft national guidelines for management of certain diseases to base the essential drug list on (to ensure cost

effectiveness)

Assess the marketing of generics, the patterns of marketing generics as trade?

What is the list of drugs that a pharmacist can prescribe without a physician’s order

Study the market of antibiotics and sedatives in sight of self-medication and lack of prescription?

Study the drug market in general,

Are pharmacists aware of the law related to prescriptions? If they are, why they do not apply it?

Explore ways of introducing and ensuring sustainability of high quality services in pharmacies regarding

education and drugs

Retrieve the standards of reliable quality-control in the national control lab?

Assessment of the quality of drugs entering Lebanon

Retrieve and adopt standards for classifying products as pharmaceuticals

Study counterfeit and non-regulated drug market

Exploring the legislations specific to registering or allowing drugs in Lebanon on possible pitfalls

Establishment of a pharmaco-vigilance system

Set mechanisms to determine appropriate quota of drugs to be allowed in Lebanon

Assess monitoring and evaluation of drug distribution in dispensaries

Establish a database of the cases covered and people using private insurances

Prioritizing exercise of the recommendations of WHO

Evaluation of the effectiveness of the WHO recommendations

Accreditation of dispensaries, and PHC centers run by NGOs

245

Evaluation of the equipment and presence of specialized doctors in dispensaries far from Beirut

Assess duplication and explore ways to avoid it (in dispensaries)

List of all drugs on the Lebanese market including donations and those distributed by dispensaries

Patients perceptions of access to dispensaries

Set standard for transportation and storage of drugs and ways of control

How can MOH monitor the chain of supply that includes pharmacists, wholesalers and importer

How can we ensure that all products including locally manufactured and imported generics and generics have

bioequivalence?

Assessment of the influence of political power and its influence over the effectiveness of the central lab work

Assessment of the registration process from the perspective of importers and companies?

Assess the effectiveness of health system when based on primary health care and explores ways of application

how can this be applied?

How to control and monitor clinical trials done on patients through agreements between doctors and drug

companies?

Assess emergency preparedness of dispensaries

What are generics supervised by original countries and subject to control lab and how they can be prioritized?

General

The status of corruption and its influence over the drug market

Assess the morbidity trends and health seeking behavior trends in Lebanon in sight of informing policy, selection,

guidelines, and eligibility criteria

What are the criteria for registering a medicine? Are they online with international standards?

The status of conflict of interests and its influence on the drug access

Explore people's voices, and their needs as they state them

Settle indicators to raise accountability in selection and delivery of medicines

Explore the mechanisms of influence of magnetic card to rationalize utilization

What is the part of each element of the framework in shaping drug accessibility?

Assess the causes of drug monopolies

246

How can we draft a national health policy without the influence of politicians

What are the economic, social, political, and sectarian determinants of access to medicine in Lebanon?

Assess the effectiveness of possible collaboration of MOH, pharmacists and NGOs with educational institutions

regarding drugs.

How continuous education of physicians can be ensured without the interference of drug companies?

How can people’s awareness on their health rights be raised?

What are the laws regarding drugs in Lebanon and what are the physicians and pharmacists views on it?

247

Research questions submitted to the validation-prioritization exercise - Lebanon

1. Is access to medicines a priority for policymakers, for professional associations, and for consumer

advocates?

2. Assessment of quality of pharmacy services at the different levels of the health system (public as well as

private pharmacies, different geographical areas).

3. Current and future projection of health needs assessment at the population level to guide rational selection

of medicines.

4. Assessment of adherence of pharmaceutical manufacturing to good manufacturing practices (GMP)

5. Evaluation of the current procedures of inspection and quality control of pharmaceutical products.

6. Assess the impact of the good governance for medicines (GGM) program on access to medicines

7. Assess the perceptions and current practices of different members of the health care team (physicians, nurses

pharmacists, community educators) in facilitating or impeding rational use of medicines at the community level.

8. Evaluate the process of registration and pricing of medicines and compare between Lebanon and other

countries in the region.

9. The equity dimension: Assessment of patterns of use and access to medicines between different

socioeconomic groups including insured vs. un-insured population groups.

10. Public and professional perceptions of ATM as part of the right to health.

11. Exploration of the political economy (e.g. influence of special interests, different power relations and

sectarian politics) of the situation of medicines and the role of corruption

12. Assessment of options for cost-savings such as through introducing a unified list of medicines (formularies)

and improving prescribing behaviors for different social insurance organizations and joint procurement of

medicines by NGOs and assess the impact on affordability.

13. The cost savings of developing a system for coding of pharmaceutical products according to international

guidelines for coding of consumer products.

14. Evaluation of the role of civil society organizations and non-governmental organizations in improving

access to medicines especially for the poor, vulnerable groups and hard-to-reach populations.

15. Evaluation of the impact of electronic health information system and electronic card on improving

efficiency, reducing potential corruption, and improving access to medicines

16. Study of consumer behaviors such as purchasing patterns, intake patterns, selection patterns, and home

storage and use of medicines

248

17. Prescribing behaviors of physicians, and adherence to international prescribing indicators, and explanatory

factors of such behaviors

18. Barriers to development of a national policy for medicines

19. Mapping the capacity of researchers and research institutions to carry out essential research on access to

medicines

20. What happens at the dispensary? Dispensing medicines or delivering primary health care? Adherence to

generics in PHC and dispensaries

21. Consumer satisfaction with medicines services at different points of service in the health system (both

public and private)

22. Price analysis and surveillance and monitoring of prices of medicines in Lebanon compared with prices in

other countries in the region.

23. A study of the lost value of medicines purchases due to various factors in the medicines supply chain (higher

than needed procurement prices, poor distribution, irrational prescribing, irrational use)

24. The patterns of use of supplements for medicinal purposes by the public and corresponding physician

prescribing

25. Sources of information for physicians and their influences on their prescribing behaviors

26. A study of attitudes of physicians and of the public towards generic substitution and the opportunities for

implementing relevant policies

27. Assess the coverage of medicines by private insurers and practices in sustaining medicines coverage in the

event of emergence of a costly disease.

28. Assess the impact of medicines donations on access to medicines and the supply system

29. Feasibility of pharmaco-vigilance studies

30. Exploring conflict of interest in both the public and private sector and its impact on access to medicines

31. Cultural factors influencing consumers’ preferences for originator brands vs. generics

32. Developing and testing a framework for physician prescribing accountability (which has three components:

scientific, ethical, and regulatory)

33. Consumers’ unmet needs due to current restrictions on access to medicines (e.g. narcotics and pain control)

34. Impact of irregularity in medicines supply (e.g. through MOPH central pharmacy, or YMCA) on adherence

to medicines and on proxy health outcomes

35. Rational selection and use of medicines in hospitals and potential for savings for smaller and medium size

hospitals from adherence to formularies

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36. Assessment of quality of medicines on the market and role of counterfeit medicines and black market.

37. The proportion of emergency room visits and hospitalizations that results of irrational prescribing or

irrational use of medicines

38. Impact of delay in reimbursement by NSSF on ATM among NSSF beneficiaries on finances of families and

on increasing rates of hospitalization. What are the equity dimensions for such delays (among low and middle

income households)? How do NSSF beneficiaries solve their medicines needs?

39. The impact of the institutional policy framework (e.g. at the hospital level) in influencing prescribing

behaviors

40. Assessment of barriers to adoption of code of ethics for drug promotion proposed by the Ministry of Public

Health among different stakeholders.

41. The impact of developing disease management protocols (e.g. for management of hypertension) and

prescribing guidelines (which drugs to start with, which ones to add) for improving the rational use of medicines.

42. Impact of audits on physicians’ prescribing behaviors.

43. Developing and testing different incentive structures to improve physician prescribing behaviors

44. The impact of social networks (e.g. access to specialists among family and friends) on irrational use of

medicines

45. Who are the users of dispensaries and PHC network? Are they the poor and low income household? How

important are the medicines to their use of these dispensaries and PHC network?

46. Assessment of the availability and affordability of medicines in dispensaries and PHC network.

47. Challenges facing pharmaceutical manufacturing and options for reform.

48. Assessment of sustainability of access to medicines during emergencies

49. Differentials in access to medicines vs. access to health services.

50. The potential role of professional associations (physicians, pharmacists, nurses) working together to

improve rational prescribing, dispending and use.

51. The role of medical education and residency training on developing irrational prescribing behaviors.

52. Obstacles to and opportunities for empowering consumers to improve their access to medicines.

53. The impact of alternative administrative structures (e.g. a separate drug agency similar to Jordan FDA

within MOPH or independent) on improving registration, pricing and monitoring of medicines.

54. Pharmacoeconomic studies on various pharmaceuticals

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55. Change in availability of medicines due to fluctuating currency exchange rates and the impact on adherence

to medical therapy.

56. Study of access to medicines among special populations such as those supported by the MOPH (for cancer,

HIV…), refugees, and Bedouins.

57. Reasons for professional perception of low quality of generics or low-priced branded generics

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Research questions submitted to the ranking exercise and the results of ranking according to five

evaluative criteria - Lebanon

1= Urgency, 2= Feasibility, 3= Applicability, 4= Ethical acceptability, 5=Relevance, T=Total score

Possible score for each criterion = 0-10 (10 being most important)

Total score = the combined score from all evaluative criteria

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Research question 1 2 3 4 5 T

Assessment of quality of medicines on the market and role of counterfeit medicines and black market. 112 63 62 88 103 340

A study of attitudes of physicians and of the public towards generic substitution and the opportunities for

implementing relevant policies 90 80 74 83 92 336

Is access to medicines a priority for policymakers, for professional associations, and for consumer advocates? 88 75 77 102 81 321

Evaluation of the role of civil society organizations and non-governmental organizations in improving access to

medicines especially for the poor, vulnerable groups and hard-to-reach populations. 92 71 76 106 82 321

What happens at the dispensary? Dispensing medicines or delivering primary health care? Adherence to generics in

PHC and dispensaries 98 70 65 87 87 320

The potential role of professional associations (physicians, pharmacists, nurses) working together to improve rational

prescribing, dispending and use. 85 87 73 97 73 318

The equity dimension: Assessment of patterns of use and access to medicines between different socioeconomic

groups including insured vs. un-insured population groups. 97 77 64 103 79 317

Prescribing behaviors of physicians, and adherence to international prescribing indicators, and explanatory factors of

such behaviors 93 65 64 85 91 313

The role of medical education and residency training on developing irrational prescribing behaviors. 91 68 65 99 84 308

Assessment of sustainability of access to medicines during emergencies 85 70 68 99 85 308

Reasons for professional perception of low quality of generics or low-priced branded generics. 95 70 68 90 74 307

Impact of delay in reimbursement by NSSF on ATM among NSSF beneficiaries on finances of families and on

increasing rates of hospitalization. What are the equity dimensions for such delays (among low and middle income 108 59 50 75 89 306

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households)? How do NSSF beneficiaries solve their medicines needs?

Developing and testing different incentive structures to improve physician prescribing behaviors 95 61 61 76 81 298

Barriers to development of a national policy for medicines 94 63 63 87 77 297

Evaluation of the current procedures of inspection and quality control of pharmaceutical products. 87 65 58 98 84 294

The impact of developing disease management protocols (e.g. for management of hypertension) and prescribing

guidelines (which drugs to start with, which ones to add) for improving the rational use of medicines. 73 72 66 93 83 294

Impact of irregularity in medicines supply (e.g. through MOPH central pharmacy, or YMCA) on adherence to

medicines and on proxy health outcomes 75 73 63 83 72 283

Developing and testing a framework for physician prescribing accountability (which has three components:

scientific, ethical, and regulatory) 77 67 64 82 69 277

Evaluation of the impact of electronic health information system and electronic card on improving efficiency,

reducing potential corruption, and improving access to medicines 81 65 52 88 78 276

Assessment of barriers to adoption of code of ethics for drug promotion proposed by the Ministry of Public Health

among different stakeholders. 77 59 54 88 69 259

Assessment of options for cost-savings such as through introducing a unified list of medicines (formularies) and

improving prescribing behaviors for different social insurance organizations and joint procurement of medicines by

NGOs and assess the impact on affordability.

77 60 61 77 52 250

Current and future projection of health needs assessment at the population level to guide rational selection of

medicines. 67 51 47 73 84 249