023-rational use of drugs

8/8/2019 023-Rational Use of Drugs

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Rational use of drugs:an overview

Kathleen HollowayTechnical Briefing Seminar 2004Essential Drugs and Medicines Policy

WHO Geneva


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WHO, Dept. Essential Drugs and Medicines Policy 2

Objectives

Define rational use of medicines and identify the magnitude ofthe problem

Understand the reasons underlying irrational use

Discuss strategies and interventions to promote rational use ofmedicines

Discuss the role of government, NGOs, donors and WHO insolving drug use problems


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The rational use of drugs requires that patients receive

medications appropriate to their clinical needs, in doses

that meet their own individual requirements for anadequate period of time, and at the lowest cost to them

and their community.WHO conference of experts Nairobi 1985

correct drug appropriate indication

appropriate drug considering efficacy, safety, suitability for the

patient, and cost

appropriate dosage, administration, duration

no contraindications

correct dispensing, including appropriate information for patients

patient adherence to treatment


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4

% PHC patients treated according to guidelines

0

10

20

30

40

50

60

70

1990/1 1992/3 1994/5 1996/7 1998/9 2000/1

Africa Asia

Africa/Asia 1990/1 1992/3 1994/5 1996/7 1998/9 2000/1no.countries 5/5 3/3 10/3 12/5 12/5 3/2

no.surveys 9/7 4/6 16/6 15/6 14/7 3/4

Source: WHO database on drug use 2003


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% drugs that are prescribed unnecessarilyestimated by a comparison of expected versus actual prescription

Chalker HPP 1996, Hogerzeil et al Lancet 1989, Isah et al 2000

0

10

20

3040

50

60

70

80

Nepal Yemen Nigeria

% antibiotics % injections % drugs % cost


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Adequacy of diagnostic processThaver et al SSM 1998, Guyon et al WHO Bull 1994, Krause et al TMIH 1998, Bitran HPP

1995, Bjork et al HPP 1992, Kanji et al HPP 1995.

0 10 20 30 40 50 60

Tanzania

Angola

Senegal

Burkino Faso

Bangladesh

Pakistan

% observed consultations where the diagnostic process was adequate


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7

5-55% of PHC patients receive injections -

90% may be medically unnecessary

0% 10% 20% 30% 40% 50% 60%

Eastern Caribean

J amaica

El S alvador

Guatemala

Ecuador

L.AME R. & CA R.

Nepal

Indonesia

Yemen

ASIA

Zimbabwe

Tanzania

Sudan

Nigeria

Cameroon

Ghana

AFRICA

% of primary care patients receiving injections

Source: Quick et al, 1997, Managing Drug Supply

15 billion injections per year globally

half are with unsterilized needle/syringe

2.3-4.7 million infections of hepatitis B/C

and up to 160,000 infections of HIV peryear associated with injections


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8

30 to 60 % of PHC patients receive antibiotics -

perhaps twice what is clinically needed

0% 10% 20% 30% 40% 50% 60% 70%

Guatemala

Jamaica

El Salvador

Eastern Caribean

L.AMER. & CAR.

Bangladesh

Nepal

Indonesia

ASIA

Zimbabwe

Tanzania

Ghana

Cameroon

Swaziland

Sudan

AFRICA

% of PHC patients receiving antibiotics

Source: Quick et al, 1997, Managing Drug Supply


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Overuse and misuse of antimicrobials contributes

to antimicrobial resistance

Malaria

choroquine resistance in 81/92 countries

Tuberculosis

2 - 40 % primary multi-drug resistance Gonorrhoea

5 - 98 % penicillin resistance inN. gonorrhoeae

Pneumonia and bacterial meningitis

12 - 55 % penicillin resistance in S. pneumoniae Diarrhoea: shigellosis

10-90+ % amp, 5-95% TMP/SMZ resistance

Source: DAP, EMC, GTB, CHD (1997)


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Adverse drug eventsReview by White et al, Pharmacoeconomics, 1999, 15(5):445-458

4-6th leading cause of death in the USA

Estimated costs from drug-related morbidity &

mortality 30 million-130 billion US$ in the USA

4-6% of hospitalisations in the USA & Australia

commonest, costliest events include bleeding,

cardiac arrhythmia, confusion, diarrhoea, fever,hypotension, itching, vomiting, rash, renal failure


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Drug Purchases through the Private Sector

50-90% of all drug purchases are private

25% to 75% illness episodes self-medicated

1/2 consumers buy 1-day supply at a time

50% of people worldwide fail to take drugs correctly

Results not always therapeutic

over-treatment of mild illness

inadequate treatment of serious illness mis-use of anti-infective drugs

over-use of injections


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Prescribing by dispensing and non-dispensing doctors in ZimbabweTrap et al 2000

2 .3

2 8 .

5 8

8 .6

1 .6

9 .5

4 8

1 3

0 1 0 2 0 3 0 4 0 5 0 6 0 7 0

n o . d ru g it e m s / P x

% P x w i t h in j e c t i o n s

% P x w i t h a n t i b io t i c s

c o n s u l t a t io n t i m e ( m in s )

d i s p e n s i n g d o c t o r sn o n - d i s p e n s in g d


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Changing a Drug Use Problem:

An Overview of the Process

1. EXAMINEMeasure Existing

Practices(Descriptive

Quantitative Studies)

2. DIAGNOSEIdentify Specific

Problems and Causes(In-depth Quantitativeand Qualitative Studies)

3. TREATDesign and Implement

Interventions(Collect Data to

Measure Outcomes)

4. FOLLOW UPMeasure Changes

in Outcomes(Quantitative and Qualitative

Evaluation)

improveintervention

improve

diagnosis


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Treatment

Choices

Prior

KnowledgeHabits

Scientific

Information

Relationships

With Peers

Influence

of DrugIndustry

Workload &

Staffing

Infra-

structureAuthority &

Supervision

Societal

Information

Intrinsic

Workplace

Workgroup

Social &

CulturalFactors

Economic &

Legal Factors

Many Factors Influence Use of Medicines


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Economic:

Offer incentives Institutions Providers and patients

Managerial:Guide clinical practice Information systems/STGs Drug supply / lab capacity

Regulatory:

Restrict choices Market or practice controls Enforcement

Educational:Inform or persuade

Health providers Consumers

Use ofMedicines

Strategies to Improve Use of Drugs


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Educational StrategiesGoal: to inform or persuade

Training for Providers Undergraduate education

Continuing in-service medical education e.g. seminars, workshops

Face-to-face persuasive outreach e.g. academic detailing

Clinical supervision or consultation

Printed Materials Clinical literature and newsletters

Formularies or therapeutics manuals

Persuasive print materials

Media-Based Approaches Posters

Audio tapes, plays

Radio, television


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Training for prescribersThe Guide to Good Prescribing

WHO has produced a Guide for Good

Prescribing - a problem-based method

Developed by Groningen University in

collaboration with 15 WHO offices and

professionals from 30 countries,

Field tested in 7 sites

Suitable for medical students, post grads,

and nurses

widely translated and available on the

WHO medicines website


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18

Impact of Patient-Provider Discussion Groups on

Injection Use in Indonesian PHC Facilities

Hadiyono et al, SSM, 1996, 42:1185

Intervention Control

0

20

40

60

80

% Prescribing Injections

PrePre

PostPost


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Effects of Opinion Leader on Choice Antibiotic

for Prophylaxis in a Teaching Hospital

Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct84 85 86

0

0.1.1

0.2

0.3

0.4

0.5

0.6

0.7

% of all C-sections Discuss-ion with

Obstetric

Chief

Cefazolin

recommend-

ed

Cefoxitin

not

recommended


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Managerial strategiesGoal:to structure or guide decisions

Changes in selection, procurement, distribution to ensure

availability of essential drugs

Essential Drug Lists, morbidity-based quantification, kit systems

Strategies aimed at prescribers

targeted face-to-face supervision with audit, peer group monitoring,

structured order forms, evidence-based standard treatment guidelines

Dispensing strategies

course of treatment packaging, labelling, generic substitution

Avoidance of perverse financial incentives prescribers salaries from drug sales, flat prescription fees,

insurance policies that reimburse non-essential drugs or incorrect doses


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Review of 59 evaluations of clinical guidelinesGrimshaw & Russell, Lancet, Nov.27 1993, 342:1317-1322

Significant improvement found in:

55/59 studies concerning the process of care

9/11 studies concerning patient outcome

Size of the improvement varied 5-60% and washigher if there was:

involvement of users in guideline development

a specific educational intervention

a patient-specific reminder at consultation e.g. a

decision by a funding body not to reimburse

prescriptions not meeting guidelines


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RCT in Uganda of the effects of STGs, training &

supervision on the % of Px conforming to guidelines

Kafuko et al, UNICEF, 1996.

Randomisedgroup

No. healthfacilities

Pre-intervention

Post-intervention

Change

Control group 42 24.8% 29.9% +5.1%

Dissemination ofguidelines

42 24.8% 32.3% +7.5%

Guidelines + on-site training 29 24.0% 52.0% +28.0%

Guidelines + on-site training + 4supervisory visits

14 21.4% 55.2% +33.8%


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Pre-post with control study of an economic

intervention (user fees) on prescribing in NepalHolloway, Gautam & Reeves, HPP, 2001

Fees (completedrug courses)

control fee / Pxn=12

1-band item feen=10

2-band item feen=11

Av. no. itemsper prescription

2.9 2.9(+/- 0)

2.9 2.0(-0.9)

2.8 2.2(-0.6)

% prescriptionsconforming to

STGs

23.5 26.3(+2.7%)

31.5 45.0(+13.5%)

31.2 47.7(+16.5%)

Av.cost ( NRs)per prescription

24.3 33.0(+8.7)

27.7 28.0(+0.3)

25.6 24.0(-1.6)


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PHC prescribing with & without Bamako

initiative in NigeriaScuzochukwu et al, HPP, 2002

5 .3

7 2 .

6 4 .

9 3

3 5 .

2 .1

3 8

2 5 .

2 1

1 5 .

0 20 40 60 8 0 1 0 0

n o . d ru g i te m s /P x

% P x w i th i n j e ct io n s

% P x w i th a n t i b i o t ic s

% p r es E D L d ru g s

n o . E D L d r u g s a v a il

2 1 B a m a k o P H C s1 2 n o n - B a m a k o P


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25

0

1

2

3

4

5

1994

1995

1996

1997

1998

1999

0

10

20

30

40

Sources: Danish Medicines Agency & H. Westh, Hvidovre Hosp, 2000.

Monnet DL., 40th ICAAC, Toronto, Canada, 527 [abstr. 628].

Change in subsidization: from 50 to 0% (01/1996)

Tetra

cycline-R

E.coliHospital

Isolates

(%,

5-monthm

ovingaverage)

Tetracycline prescription rate & tetracycline-resistant

E.Coliin hospital isolates, 2 municipalities in Denmark,

01/1994-12/1999

Tetracycline

Use

(#

presc

riptions

per1,

00

0

inhabitants

)


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Regulatory strategies

Goal: to restrict or limit decisions Drug registration

Banning unsafe drugs - but beware unexpected results

substitution of a second inappropriate drug after banning a

first inappropriate or unsafe drug Regulating the use of different drugs to different levels of

the health sector e.g.

licensing prescribers and drug outlets

scheduling drugs into prescription-only & over-the-counter Regulating pharmaceutical promotional activities

Only work if the regulations are enforced


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Choosing an Intervention

A single educational strategy is often not effective anddoes not have a sustainable impact

Printed materials alone are not effective

Combination of strategies, particularly of different types

(e.g. educational + managerial) always produces betterresults than a single strategy

Focused small groups and face to face interactive

workshops have been shown to the effective

Audit and feedback, peer review, are very effective

Economic strategies are very powerful strategies to change

drug use but may be difficult to introduce


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Review of 30 studies in developing countriessize of drug use improvements with various interventions

0

Improvement in outcome measure (%)

10 20 30 40 50 60

Large group training

Small group training

Diarr. community case mgt

ARI community case mgt

Info/guidelines

Group process

Supervision/audit

EDP/Drug supply

Economic strategies

Minor Moderate Large

Source: Ross-Degnan et al, Plenary presentation, Conference onImproving the Use of Medicines, 1997, Chiang Mai, Thailand.


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Combined Intervention StrategyPrescribing for Acute Diarrhea in Mexico City

0

20

40

60

80

100

% cases treated in line with algorithm

Study Physicians

Control Physicians37/52

79/115

20/84

BaselineStage

(n = 20)

After

Workshop

AfterPeer

Review

(n = 20)

18-months

Follow-up

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31/110

16/7025/102

42/82


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Impact of Training on Use of Diarrhea Treatment

Algorithm in Three Mexico Settings

Source: Munoz, et al, unpub. (1993); Guiscafre, et al, Arch. Med. Res. (1995)

Interventiongiven by:

"Experts" in 2 clinics(San Jeronimo)

"Leaders" in 18 clinics(Coyoacan)

"Coordinators" in 124

Prescribers

31

65

157

Baseline%

24.5

17.7

24.7

Post%

71.2

43.4

31.2

Change%

+46.7

+ 25.6

+ 6.5clinics (Tlaxcala)


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Drug & Therapeutic Committee Activitiesvery little data on drug use impact

0

20

40

60

80

100

Australia 1996 USA 2001 Netherlands

1999

Germany 1995

% hospitals w ith a D TC Drug use monitor ing / D UEStrategies to improve drug use


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10 national strategies to promote RUDneeds sufficient govt. investment for medicines & staff !

1. Evidence-based standard treatment guidelines

2. Essential Drug Lists based on treatments of choice

3. Drug & Therapeutic Committees in hospitals

4. Problem-based training in pharmacotherapy in UG training5. Continuing medical education as a licensure requirement

6. Independent drug information e.g bulletins, formularies

7. Supervision, audit and feedback

8. Public education about drugs9. Avoidance of perverse financial incentives

10. Appropriate and enforced drug regulation


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Why does irrational use continue?

Very few countries regularly monitor drug use &implement effective nation-wide interventions -

because

they have insufficient funds or personnel?

they lack of awareness about the funds wasted

through irrational use?

there is insufficient knowledge of concerning thecost-effectiveness of interventions?


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WHO future priorities

Developing a model formulary process, the WHO

Essential Drugs Library

Training programmes

Pilot projects to contain antimicrobial resistance Promoting drug & therapeutic committees

Intervention research to promote RUD

cost-effectiveness of interventions, policies

Advocacy for the rational use of drugs (RUD) Essential Drug Monitor, effective drug information

ICIUM2004


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Creating theWHO Essential Drugs Library

to facilitate the work of national committees

WHO

Model List

Summary of clinical

guideline

Reasons forinclusion

Systematic reviews

Key references

WHO Model

Formulary

Cost:

- per unit- per treatment- per month- per case prevented

Quality information:

- Basic quality tests- Internat.

Pharmacopoea

- Reference standards

Evidence-

based Clinical

guideline


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WHO-sponsored training programmes

INRUD/MSH/WHO: Promoting the rational use ofdrugs

MSH/WHO: Drug and therapeutic committees

Groningen University, The Netherlands/WHO:Problem-based pharmacotherapy

Amsterdam University/WHO: Promoting rational

use of drugs in the community

Newcastle, Australia/WHO : Pharmaco-economics

Boston University, USA/WHO: Drug Policy Issues


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Local pilot projects to contain AMR

Objectives develop, implement & evaluate interventions to contain AMR

using surveillance data in local sites

to develop a new method for the integrated surveillance, at

community level, of antimicrobial use and resistance that can

be used in many different countries

to build local capacity in developing a multi-disciplinary

approach to the containment of AMR

3 phases (1) set up surveillance,

(2) develop, implement & evaluate interventions

(3) expand to other sites


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P r o m o t in g D T C s : im p a c t o f m a g t . ,

p l a n n in g th o u g h h o s p i t a l D T C s i

0 %

2 0 %

4 0 %

6 0 %

8 0 %

1 0 0 %

1 2 3 4 5 6 7 8M o n t

% P x w i

A b s / I n j

0

1

2

3

4

5

A v . n o . d r u g s

Injections

Antibiotics

No.drugs


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Identifying effective strategies to promote

more rational use of drugs Joint research initiative between

WHO/EDM, MSH and ARCH

over 20 intervention research projects indeveloping countries

WHO database on drug use

quantitative data on drug use and interventionsto improve drug use over the last decade


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ICIUM2004

2nd International conference for improving use of medicines Next milestone in assessing progress on global

medicines agenda

Chiang Mai, Thailand, Mar 30-Apr 2, 2004

Objective: Examine state of the art in improving

medicines use in focus areas:

Intl. policy & systems -Natl. policy & systems

Hospitals - Primary care Private pharmacies - Community use


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ICIUM2004: topic tracks

Meetings Within a Meeting Key constituencies and interest groups working on

pharmaceutical issues researchers, policy makers,donors and NGOs

Summarize topical lessons and research needs

Topic tracks include Child health - Adult health

TB - HIV/Aids, STIs

Malaria - Antimicrobial resistance

Impact of access on use


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ActivityDiscuss in groups the following questions

Choose a major drug use problem in your country or project

Identify the causes underlying the problem

What are the main 1-2 strategies being undertaken to addressthis problem?

Are these 1-2 strategies being evaluated? If so, how?

What should be the roles of government, NGOs, donors, and

WHO be in filling the gap in strategies/policies to address thisproblem?

023-rational use of drugs

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