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Islamic Republic of Afghanistan
Ministry of Public Health General Directorate of Pharmaceutical Affairs
June 2016
i
TABLE OF CONTENTS
Acronyms .................................................................................................................................................... iii
Acknowledgements .................................................................................................................................... iv
Executive Summary .................................................................................................................................... 1
Introduction ................................................................................................................................................. 3
Background ................................................................................................................................................. 4
Goal and Specific Objectives ...................................................................................................................... 7 Specific Objectives ................................................................................................................................... 7
Rationale ...................................................................................................................................................... 7
Methods ........................................................................................................................................................ 8 1. Selection of Hospitals for Pilot Phase .................................................................................................. 8 2. Focal Point ............................................................................................................................................ 9 3. Trainings and Pharmacovigilance Orientation Workshop .................................................................... 9 4. Tools ..................................................................................................................................................... 9 5. ADR Data Collection ............................................................................................................................ 9 6. ADR Data Analysis .............................................................................................................................. 9
Results ........................................................................................................................................................ 10 Pharmacovigilance Trainings and Orientation Workshops .................................................................... 10 ADR Data Collection and Analysis ........................................................................................................ 11 Patient Details ......................................................................................................................................... 12 Types of ADR ......................................................................................................................................... 13 Medicines Causing Reported Suspected ADRs ...................................................................................... 15 ADR Reporting Form ............................................................................................................................. 17 SWOT Analysis ...................................................................................................................................... 18
Discussion and Conclusion ....................................................................................................................... 20
Recommendations ..................................................................................................................................... 21
References .................................................................................................................................................. 23
Annex 1: OLD Adverse Drug Reaction Form ........................................................................................ 24
Annex 2: Adverse Drug Reaction (ADR) Reporting Form ................................................................... 25
Annex 3: Associate Membership Confirmation Letter from UMC ...................................................... 26
Annex 4: Istiqlal Hospital ......................................................................................................................... 27
Annex 5: Antani Hospital ......................................................................................................................... 28
Annex 6: Mehtarlam Provincial Hospital (MPH) .................................................................................. 29
Annex 7: French Medical Institute for Children (FMIC) ..................................................................... 30
Annex 8: Schedule: Four-Day Pharmacovigilance Training Course (Sept. 21 to 24, 2014) ............... 32
Annex 9: Pre-test and Post-test for Participants of Five-Day Training Course on Pharmacovigilance
(Sept. 21 to 24, 2014) ................................................................................................................................. 35
Annex 10: Schedule: One-Day Orientation Workshop on Pharmacovigilance (Oct. 29, 2014) ......... 36
ii
Annex 11: Schedule: Pharmacovigilance Orientation Workshop (Four Selected HOSPITALS:
ISTIQLAL, Antani, MPH, and FMIC) ................................................................................................... 37
Annex 12: List of Medicine Safety Committee Members ...................................................................... 38
iii
ACRONYMS ADE Adverse drug events
ADR Adverse drug reaction
AKDN Aga Khan Development Network
API Avicenna Pharmaceutical Institute
DTC Drug and therapeutic committee
EML Essential Medicine List
ENT Ears, nose, and throat
FMIC French Medical Institute for Children
GDCM General Directorate of Curative Medicine
GDPA General Directorate of Pharmaceutical Affairs
GIRoA Government of the Islamic Republic of Afghanistan
GMP Good Manufacturing Practice
ICSR Individual Case Safety Report
ICU Intensive care unit
IDMP International Drug Monitoring Program
IGICH Indira Gandhi Institute of Children’s Health
IPD Inpatient department
LML Licensed Medicine List
MCH Maternal and child health
MoPH Ministry of Public Health
MSC Medicine Safety Committee
MSH Management Sciences for Health
NGO Nongovernmental organization
NTP National Tuberculosis Control Program
OPD Outpatient department
PRIS Pharmaceutical Registration Information System
RMU Rational medicine use
SCA Swedish Committee for Afghanistan
SPS Strengthening Pharmaceutical Systems
SWOT Strengths, weaknesses, opportunities, threats
ToR Terms of reference
UAE United Arab Emirates
UMC Uppsala Monitoring Center
USAID US Agency for International Development
WHO World Health Organization
iv
ACKNOWLEDGEMENTS
The General Directorate of Pharmaceutical Affairs (GDPA) thanks and appreciates the members
of the Medicine Safety Committee (MSC) for the time and energy they have expended to
actively participate in the regular meetings of the MSC and also for their inputs and facilitation
in the medicine safety and pharmacovigilance activities.
The GDPA appreciates the management team of the four hospitals that participated in the pilot
phase (Istiqlal Hospital, Antani Hospital, Mehtarlam Provincial Hospital, and French Medical
Institute for Children) and the focal persons from each pilot hospital (Sayed Hamid Akbari, Shah
Agha Hakimi, Mohammad Saber Hotak, Mohammad Daim Quraishi and Fakhria Younas) for
their collaboration and support in implementing the medicine safety and pharmacovigilance
interventions in their areas.
The consistent efforts of the following members resulted in the development and finalization of
this report-
Authors:
Abdul Khalil Khakzad, GDPA-API Director
Mahmood Samim, SPS/Afghanistan Pharmacovigilance Technical Officer
Mohammad Zafar Omari, SPS/Afghanistan Chief of Party
Faiz Mohammad Delawer, SPS/Afghanistan Tertiary Hospitals Pharmaceutical Services
Technical Adviser
Collaborators:
Ahmad Jawid Ehsan, Afghanistan Tertiary Hospitals Pharmaceutical Services Senior
Technical Adviser
Fauzia Maihanyar, GDPA-API/ADR Unit In-charge
Mohammadullah Alishungi, SPS/Afghanistan Pharmacovigilance Technical Adviser
Andy Stergachis, University of Washington/ Professor of Pharmacy & Global Health
Other colleagues and partners who cooperated in development of this report are-
Mohammad Nasim Sediqqui, FoPh-Pharmacognosist
Khwaja Mir Islam Saeed, MoPH-GCMU Director
Qand Agha Nazari, , FoPh-Pharmacologist
Mohammad Ibrahim Kamal, KMU-Pathologist
Hafiza Hamid, FoPh-Toxicologist
Safiullah Nadeeb, WHO-Representative
Mohammad Azim Samim, Ibn-e-Sina emergency Hospital-General Medicine Trainer
Specialist
Mohammad Nazir Heiderzad, GDPA Technical Coordinator
Noor Ahmad Zulal, GDPA-Quality Assurance Consultant
Aziza Habibi, GDPA-API/Drug Information Manager
Roqia Naser, Representative from Expanded Program on Immunization
Nematullah Nawrozian, NMFB Consultant
v
The GDPA is also thankful to representatives from General Directorate of Curative Medicine
(GDCM) and the Faculty of Pharmacy for providing close coordination and collaboration during
the trainings and orientation workshops.
The Ministry of Public Health (MoPH)/GDPA thanks the USAID-funded Strengthening
Pharmaceutical Systems (SPS) project for technical and financial support running the
pharmacovigilance and medicine safety interventions in piloted areas.
With Regards
Pharmacist Abdul Hafiz Quraishi
General Director of Pharmaceutical Affairs
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
1
EXECUTIVE SUMMARY
Introduction: The World Health Organization (WHO) defines pharmacovigilance as “science
and activities relating to the detection, assessment, understanding, and prevention of adverse
effects or any other possible drug-related problems.” [1]
Drug safety and pharmacovigilance
remains a dynamic clinical and scientific discipline. It plays a vital role in ensuring that the
doctors, together with the patient, have enough information to make a decision when it comes to
choosing a drug for treatment. [2]
In Afghanistan, the General Directorate of Pharmaceutical
Affairs (GDPA), with support from the Strengthening Pharmaceutical Systems (SPS) project,
implemented an assessment in six national hospitals located in Kabul for adverse drug reaction
(ADR) reporting and management from March to August 2013. The results showed that there is
no national system for ADR detection, reporting, and management in Afghanistan. Physicians
recognized that a multidisciplinary approach is needed, and confirmed the important role of
nurses and pharmacists in ADR detecting, reporting, and management system.” [7]
Background: The Quality Assurance Assessment conducted in 2011 showed that Afghanistan
has weak capacity for existing medicines regulation and control in both public and private
sectors. There are newly developed structures, procedures, and policies to properly regulate the
pharmaceutical sector for quality assurance; and efforts are underway to implement the national
Good Manufacturing Practice (GMP) guidelines. [5]
In support of rational medicine use (RMU),
Afghanistan’s Ministry of Public Health (MoPH) took the initiative of establishing drug and
therapeutic committees (DTCs) at hospitals and at the national level in 2010. According to 2014
DTC quarterly assessments from12 national and provincial hospitals, 55 percent of patients
received antibiotics. [6]
However, according to another study in three provincial hospitals, about
40 percent of the patients received antibiotics which are not clinically required according to the
standard references. [9]
The percentage of patients who received injections in 12 national and
provincial hospitals during 2014 showed acceptable results of about 1.6 percent on average.
Similarly, the percentage of generic medicines prescribed to patients was 87 percent, which is
satisfactory in the context of the country but not sufficient according to WHO standards. [6]
Methodology: The data for this pilot phase were gathered from Medicine Safety Committee
(MSC) meeting minutes, four selected hospitals, and Individual Case Safety Reports (ICSRs)
collected from February 2015 to August 2015 from pilot hospitals. The MSC reviewed and
analyzed suspected ADR cases through a systematic approach. Moreover, a SWOT (strengths,
weaknesses, opportunities, threats) analysis was performed over the observed time period to
gather information in order to analyze the existing strengths in pharmacovigilance
implementation in the selected hospitals, to improve the weaknesses of the pharmacovigilance
system by making effective use of available opportunities, and to avoid threats to the extent
possible.
Key findings: A total of 23 suspected ADR cases were reported spontaneously to MSC. It was
found that 22 suspected ADR cases were expected mild and moderate reactions (e.g., skin
irritations, skin flushing, urticaria, fever convulsion). However, one case experienced a severe
(life-threatening) reaction: ceftriaxone caused anaphylactic shock. Most of the cases had more
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
2
than one type of symptom, such as skin irritation (72 percent) and fever (12 percent). Nurses
reported the majority of suspected ADR cases (52 percent). The largest percentage of reported
ADR cases were due to ceftriaxone (35 percent), followed by ciprofloxacin (9 percent),
ampicillin (9 percent), and streptomycin (9 percent). Of the 13 medicines that were reported as
causing the suspected ADRs, 10 medicines (77 percent) were injectables while the remaining
were oral tablets. Moreover, the majority of medicines that caused those reactions were imported
from Pakistan.
Conclusion: Adverse drug reactions, adverse events, and medications errors are common in
Afghanistan’s health institutions, particularly at the hospital level. These events harm people’s
health and result in hospital admissions if patients seek or require further treatment. In spite of
the observed low rates of ADR reporting by health care providers during the pilot phase, there is
an opportunity to expand patient safety activities by strengthening the ADR reporting system at
the hospital level. A technical assistance program is needed to sensitize and train the health
providers on patient safety issues and to encourage them to report ADRs and other adverse
events. Most of the adverse events that occurred are preventable at the hospital level and their
prevention could save patients from harm.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
3
INTRODUCTION
The World Health Organization (WHO) defines pharmacovigilance as the “science and activities
relating to the detection, assessment, understanding and prevention of adverse effects or any
other possible drug-related problems.” [1]
A pharmacovigilance system should include all entities
and resources that protect the public from medicine-related harm, whether in private health care
settings or public health services. It should also include the timely identification, collection, and
assessment of adverse drug events (ADEs), by communicating risks and benefits to support
decision-making about medicines at various levels of the health care system.
“Drug safety and pharmacovigilance remains a dynamic clinical and scientific discipline. It plays
a vital role in ensuring that doctors and the rest of the health care team, together with the patient,
have sufficient benefit-risk information to make decisions when choosing drugs for treatment
and prevention. However, despite all their benefits, all medicines have the potential for adverse
reactions. While often preventable, adverse drug reactions (ADRs) can cause of illness,
disability, and even death. In some countries, ADRs rank among the top 10 leading causes of
mortality. In order to prevent or to reduce harm to patients, and thus improve public health,
mechanisms are vital for evaluating and monitoring the safety of medicines in clinical use.” [2]
The specific aims of pharmacovigilance systems are to improve patient care and safety in
relation to the use of medicines and all health care interventions; to improve public health and
safety in relation to the use of medicines; to detect problems related to the use of medicines and
communicate the findings in a timely manner; to contribute to the assessment of benefit, harm,
effectiveness, and risk of medicines, leading to the prevention of harm and maximization of
benefit; to encourage the safe, rational, and more-effective (including cost-effective) use of
medicines; and to promote understanding, education, and clinical training in pharmacovigilance
and its effective communication to the public.[1]
The ultimate goals of pharmacovigilance are the
rational and safe use of medicines; the assessment and communication of the risks and benefits
of drugs on the market, and educating and informing of patients.[3]
Pharmacovigilance in drug regulation: Pharmacovigilance programs are strengthened by
having links with regulators. Regulators understand that pharmacovigilance plays a specialized
and pivotal role in ensuring ongoing safety of medicinal products. [2]
Post marketing safety drug monitoring: These include detection of drug interactions,
measuring the environmental burden of medicines used in large populations, assessing the
contribution of “inactive” ingredients to the safety profile, systems for comparing safety profiles
of similar medicines, surveillance of the adverse effects on human health of drug residues in
animals, e.g. antibiotics and hormones. [2]
Pharmacovigilance in national drug policy: The provision of good quality, safe, and effective
medicines and their appropriate use is the responsibility of national governments.
Multidisciplinary collaboration is of great importance. In particular, links need to be forged
between various departments of the ministry of health and also with other stakeholders, such as
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
4
the pharmaceutical industry, universities, nongovernmental organizations (NGOs), and those
professional associations having responsibility for education on rational use of medicines and
pharmacotherapy monitoring. [2]
BACKGROUND
Medicine safety is a global challenge. Research on medicine-related hospitalizations carried out
over the past 35 years suggests that approximately 50 percent of medicine-related patient harms
leading to hospitalization are preventable. That is, are not associated with the intrinsic properties
of the medical products themselves, but rather with the manner in which they are prescribed,
dispensed, administered, and/or used.[4]
Afghanistan’s porous and non-secure border connects it to several countries and allows multiple
points of entry for medicines. Recent data indicate that more than 95 percent of the medicines in
Afghanistan are manufactured outside Afghanistan, primarily in Pakistan, Iran, India, and the Middle
East. Medicines transported across these borders include both branded and generic products, as well
as counterfeits and sub-standard pharmaceuticals. [5]
The Quality Assurance Assessment conducted in 2011 showed that Afghanistan has weak
capacity for existing medicines regulation and control in both public and private sectors. There
are newly developed structures, procedures, and policies to properly regulate the pharmaceutical
sector for quality assurance; and efforts are underway to implement the national Good
Manufacturing Practice (GMP) guidelines. [5]
In support of rational medicine use (RMU) in Afghanistan, the Ministry of Public Health
(MoPH) established drug and therapeutic committees (DTCs) at hospital and national level in
2010. According to an assessment of12 national and provincial hospitals in 2014, 55 percent of
the patients received antibiotics. [6]
However, according to another study in three provincial
hospitals, about 40 percent of the patients received antibiotics which are not clinically required
according to the standard references. [9]
The percentage of patients who received injections in 12
national and provincial hospitals during 2014 showed acceptable results of about 1.6 percent on
average. Similarly, the percentage of generic medicines prescribed to patients is 87 percent,
which is believed to be satisfactory in the context of the country. [6]
In Afghanistan, the General Directorate of Pharmaceutical Affairs (GDPA) established the ADR
section on in November 27, 2006, with two staff members. The ADR section developed an ADR
form (annex 1) and planned to implement ADR reporting in 10 tertiary Kabul-based national
hospitals: Malalai, Istiqlal, Indira Gandhi Institute of Children’s Health (IGICH), Wazir
Mohammad Akbar Khan, Rabia Bulkhi, Ibn-e-Sina Emergency, Ibn-e-Sina Chest, Maiwand, Ali
Abad, and Khair Khana 120-Bed. However, due to lack of technical, financial, and political
support, this program collapsed and the ADR section did not have any other activities until
October 2012.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
5
In 2010, six individuals with the MoPH and the Strengthening Pharmaceutical Systems (SPS)
project participated in an international conference entitled “National Pharmacovigilance
Systems: Ensuring the Safe Use of Medicines” held in Nairobi, Kenya, and visited relevant sites
(Kenya hospitals and ministry of health departments). These individuals acquired knowledge and
analyzed the current status of pharmacovigilance in Afghanistan and pharmacovigilance work of
ministries of public health in other countries. Assisted with this input, the entire team discussed
the way forward with relevant bodies in MoPH/GDPA and proceeded to develop a
pharmacovigilance implementation plan as part of the next five-year strategic plan of GDPA;
this plan included a request for technical support from SPS. [6]
The SPS project, which provides technical and financial support to the GDPA, started to assist
them in medicine safety and pharmacovigilance activities in October 2012. An assessment was
needed to determine the real situation of recording and reporting ADRs, drug errors, and other
drug-related problems; assessment findings would then inform evidence-based decisions. The
GDPA and SPS implemented an assessment in the six national hospitals located in Kabul for
ADR reporting and management from March through August 2013.
“The key findings of the assessment were that the physicians detect, report, and
manage ADRs as part of their professional duty, and are in favor of setting up
hospital-based and national systems for ADR detection, reporting, and
management. Physicians recognize that a multidisciplinary approach is needed,
and confirm the important role nurses and pharmacists would play in an ADR
detecting, reporting, and management system. [7]
Some of the main recommendations of the assessment include—
The MoPH should establish a Medicines Safety Advisory Committee, consisting of
different stakeholders.
Through hospital DTCs, the MoPH should define and implement medicines safety
activities.
SPS should assist the MoPH to set up linkages with international and regional institutions
that can serve as resources to promote capacity building in medicines safety. [7]
Consistent with the assessment recommendations, a Medicine Safety Committee (MSC) was
formed with members representing the following disciplines, based on WHO Standards
(Guidelines for Setting up and Running a Pharmacovigilance Center)—
General medicine
Pharmaceutics
Clinical pharmacology
Toxicology
Epidemiology
Pathology
Drug regulation and quality assurance
Phytotherapy
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
6
Experts selected for the MSC were as follow—
MoPH (epidemiologist and general practitioner)
GDPA (chairman, secretary, and two other members from Medicine Information Center
and Planning Department)
Kabul Medical University (pharmacologist and pathologist)
Kabul University Faculty of Pharmacy (toxicologist and pharmacognosist)
Clinical pharmacologist
Drug regulation and quality assurance representatives
The MSC conducted regular monthly meetings in which the terms of reference (ToR), annual
action plan, and selection of hospitals for the pilot phase were finalized. Istiqlal, Antani, and
Mehtarlam Provincial Hospital in Laghman Province were selected; later, the French Medical
Institute for Children (FMIC) in Kabul city asked to participate in the pilot.
MSC adopted the ADR reporting form that was implemented in the piloted hospitals. The ADR
reporting form (annex 2) was adapted from the previous ADR reporting form and those of other
countries, such as England, India, United Arab Emirates (UAE), and the WHO. A glossary of
pharmacovigilance terms from the Uppsala Monitoring Center (UMC) and other well-known
sources were requested by pilot hospitals for their staff. It was translated into the local language,
printed, and then distributed to each pilot hospital.
SPS assisted GDPA to apply as an associate member to the WHO’s International Drug
Monitoring Program (IDMP). The status of associate membership was confirmed by WHO on
February 12, 2015 (annex 3).
MSC later developed formats and documents to support the pilot period in the mentioned
hospitals. The main tools were—
Template for reviewing ADR cases
Feedback form for reporters
Form for obtaining information regarding registration of suspected medicines in GDPA
ADR Case Management Flow Chart
Allergy Card for pilot hospitals
VigiAccess chart for pilot hospitals
The National Tuberculosis Control Program (NTP) agreed to initiate pharmacovigilance
activities under the MSC and to send their reports to the MSC. Additionally, SPS developed a
pharmacovigilance database for recording the suspected ADR cases received from the pilot
hospitals.
Building capacity of MSC: SPS translated and edited 18 articles on ADR and drug safety into
the local language in preparation for developing a pharmacovigilance training package. Next,
two other pharmacovigilance resources were translated and edited for MSC members: SPS’s
Supporting Pharmacovigilance in Developing Countries, and WHO’s Guidelines for Setting up
and Running a Pharmacovigilance Center.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
7
Eight MSC members participated in two training courses in Jaipur, India, from January 26to
February 6, 2014: “Quality Management and Patient Safety in Hospital and Health Care” and
“Pharmacovigilance and Patient Safety.”
Following the pharmacovigilance trainings held in India, MSC members developed
pharmacovigilance training materials for the pharmacovigilance training and orientation
workshops for the pilot hospitals.
GOAL AND SPECIFIC OBJECTIVES
The main goal of this pilot phase was to assess the need for medicine safety and a
pharmacovigilance program in Afghanistan by implementing a pharmacovigilance program in
least three public hospitals.
Specific Objectives
To assess the extent of ADR reporting in pilot hospitals during the period of February
through August 2015.
To implement medicine safety and pharmacovigilance interventions in the selected
hospitals.
To assess the pharmacovigilance system, identify gaps, and define elements of a strategy
that could lead to successful establishment of a functional pharmacovigilance system.
RATIONALE
Pharmaceutical products are frequently very expensive and therefore prone to counterfeiting and
substandard production in Afghanistan. The capacity is still emerging for medicines regulation,
control, and enforcement in both the public and private sectors in Afghanistan. The
establishment of viable and sustainable market protection through regulatory processes is
essential. These processes must be capable of detecting unacceptable medical products to help
provide a deterrent to unscrupulous manufacturers and suppliers. Therefore, establishment of a
pharmacovigilance center is vital for patient safety in Afghanistan. Based on the consideration of
poor rational medicine use, a weak regulatory system, and inadequate quality control of
medicines in the country, there is high risk to patients’ safety. Therefore, post-market
surveillance or pharmacovigilance is essential.
Pharmacovigilance needs to be strengthened among the Afghanistan’s hospital DTCs. This is
based on the recommendations of the Adverse Drug Reaction Reporting and Management
Assessment in Six Hospital of Kabul, which was conducted from March to August 2013. Main
findings from this assessment included the absence of a system for recording of ADRs, a lack of
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
8
follow-up of ADRs and risk management, and poor communication of medicine risks. The
assessment concluded that patient safety programs are necessary to prevent ADEs and promote
and focus on patient safety.
METHODS
The data for this pilot phase were gathered from MSC meeting minutes, four selected hospitals
and Individual Case Safety Reports (ICSRs) collected from February to August 2015 from pilot
hospitals. After ICSRs were collected, MSC members reviewed the suspected ADR cases,
finalized decisions, and submitted feedback to the reporter; then information was entered in the
VigiFlow database. A number of steps were taken in order to pilot the medicine safety and
pharmacovigilance interventions in the selected hospitals. The steps are described below.
1. Selection of Hospitals for Pilot Phase
For implementing the medicine safety interventions, initially, three hospitals were selected for
the pilot: Istiqlal, Antani, and Mehtarlam-PH in Laghman Province. The selection criteria follow
for Kabul and provincial hospitals.
For Kabul hospitals—
DTC should be available
Expression of commitment to the pilot activity was required
The hospital needed to be multidisciplinary (several clinical wards)
Use of different medicine, especially antibiotics
All age groups are diagnosed and treated
For provincial hospitals—
DTC should be available
Expression of commitment to the pilot activity was required
The hospital needed to be multidisciplinary (several clinical wards)
Use of different medicine, especially antibiotics
All age groups are diagnosed and treated
Adequate security is in place
Easy access for the pilot activity
Ability for regular monitoring by SPS field coordinators
Later, the MSC decided to run the pharmacovigilance interventions in one of the private
hospitals (FMIC), based on their request and interest.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
9
2. Focal Point
It was agreed in MSC meetings that the head nurse in selected hospitals should serve as the
pharmacovigilance focal point because of their extensive involvement in the medicines process
and access to patients.
3. Trainings and Pharmacovigilance Orientation Workshop
SPS and GDPA planned to conduct a four-day pharmacovigilance training course for three
selected hospitals (Istiqlal, Antani, and Mehtarlam-PH), MoPH-GDPA, and SPS. Following this,
a one-day orientation workshop on pharmacovigilance was planned for Kabul hospitals, MoPH-
GDPA, and other stakeholders. Then, a one-day orientation workshop on pharmacovigilance and
ADR reporting was planned for each of the four selected hospitals (Istiqlal, Antani, FMIC, and
Mehtarlam-PH).
4. Tools
To better manage and analyze ICSRs, the MSC/GDPA applied for access to VigiFlow and
VigiLyze tools from UMC. Access was granted to the pharmacovigilance team (which is
comprised of GDPA and SPS representatives). UMC and the GDPA signed a VigiLyze service-
level agreement for maintenance and support of the database. Nine team members now have
access to the VigiLyze tool, and two have access to VigiFlow. The associate membership to the
IDMP makes tools such as VigiFlow and VigiLyze available to the pharmacovigilance team in
Afghanistan.
5. ADR Data Collection
Orientation workshops on pharmacovigilance and the ADR reporting form were held for clinical
staff of each of the selected hospitals. Then the ADR reporting form was distributed to them for
reporting of any suspected ADR cases to MSC. The reporting of ADRs is one important aspect
of pharmacovigilance. Physicians, pharmacists, nurses, midwives, and other health care
professionals were requested to spontaneously report suspected ADRs to the MSC through
designated focal points at each pilot hospital.
6. ADR Data Analysis
Two types of analysis were performed over the time period with data gathered from the pilot
hospitals—
MSC reviewed and analyzed the suspected ADR cases through a systematic approach
involving several steps (detailed in figure 1). The ADR data received from the pilot
hospitals were collected and, for the purpose of analysis, were reviewed and finalized,
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
10
feedback was sent to the reporter, and then the data were entered into the VigiFlow
database. Later, the data were analyzed based on pharmacovigilance and medicine safety
indicators.
A SWOT (strengths, weaknesses, opportunities, threats) analysis was performed over the
observed time period to gather information, to analyze the strengths that exist in
pharmacovigilance implementation in the selected hospital, and to identify and improve
on the weaknesses of the pharmacovigilance system by making effective use of available
opportunities.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
9
Figure 1: ADR Case Management Flow Chart
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
10
RESULTS
Pharmacovigilance Trainings and Orientation Workshops
As planned, SPS and GDPA conducted a four-day pharmacovigilance training course for 34 (28
male, 6 female) participants from the three selected pilot hospitals (Istiqlal, Antani, and
Mehtarlam-PH), and staff from MoPH-GDPA and SPS. There were considerable improvements
between pre-test and post-test assessment results among those attending this four-day
pharmacovigilance training course (annex 9, figure 2).
Figure 2: Pre- and post-test results from four-day pharmacovigilance training course
(September 21–24, 2015)
A one-day orientation workshop on pharmacovigilance was conducted for 58 (48 male, 10
female) participants from Kabul hospitals, Mehtarlam-PH, MoPH-GDPA, and other
stakeholders. Additionally, orientation workshops on pharmacovigilance and ADR reporting
were conducted for each of the four selected hospitals (Istiqlal, Antani, FMIC, and Mehtarlam-
PH) from December 2014 to March 2015. A total of 299 (226 male, 73 female) clinical staff
participated in these orientation workshops.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
11
ADR Data Collection and Analysis
A total of 23 suspected ADR cases were reported by the clinical staff of pilot hospitals through
the spontaneous ADR reporting system to MSC during the pilot period of February 2015 to
August 2015. After reviewing and analyzing the received suspected ADR cases, the MSC found
the following results. All but one of the 23 suspected ADR cases were expected, mild adverse
reactions. One of the 23 cases was serious (life-threatening) reaction. Antani Hospital submitted
the most reports (39 percent, n=9), followed by Istiqlal Hospital (35 percent, n=8), and
Mehtarlam-PH and FMIC (each 13 percent, n=3) (figure 3).
Figure 3: Percentage of suspected ADR cases reported by pilot hospitals
Since the pharmacovigilance focal points in the piloted hospitals were head nurses, the majority
of the ICSRs were reported by nurses during the study period, contributing to 52 percent of all
reported cases. Physicians reported about 26 percent of the ADR cases, while midwives reported
18 percent of the cases. Patients reported only 4 percent (n=1) of the suspected ADR cases
(figure 4).
Istiqlal 35%
IDH 39%
MPH 13%
FMIC 13%
% of suspected ADR cases reported by pilot hospitals
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
12
Figure 4: Percentage of suspected ADR cases, by reporters (n=23)
Patient Details
Thirty-nine percent of reported ADR cases were male patients and 61 percent were female
patients. Note that the number of female patients presenting at the hospitals was much higher
than male patients at these four hospitals (figure 5).
Figure 5: Percentage of suspected ADR cases, by patient sex
Patient’s age for reported ADRs ranged from two to 64 years; adults comprised the greatest
percentage of reported ADRs (figure 6).
39%
61%
% of suspected ADR cases, by patient sex
Male
Female
Physician 26%
Midwife 18%
Nurse 52%
Relative of Patient 4%
% of suspected ADR cases, by reporters
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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Figure 6: Percent of suspected ADR cases, by patient age
The 23 reported ADR cases were mainly from inpatient departments (IPDs) (83 percent), while
17 percent of the reported cases were from outpatient departments (OPD) (figure 7).
Figure 7: Percent of suspected ADR cases, by setting
Types of ADR
Most of the 23 reported ADR cases described more than one type of symptom, such as skin
irritation and breathing difficulties (table1).
IPD 83%
OPD 17%
% of suspected ADR cases, by setting
17%
22%
30%
30%
0%
0%
0% 5% 10% 15% 20% 25% 30% 35%
2-11 years
12-17 years
18-44 years
45-64 years
65-74 years
> 74 years
% of suspected ADR cases, by patient age
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A Pilot Phase Report (September 2014 to August 2015)
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Table 1: Types of symptoms and signs among suspected ADRs reported by pilot hospitals
Suspected ADRs experienced by clinical staff
Name of pilot hospital
Symptom & sign
Symptom & sign Symptom & sign Symptom & sign
Symptom & sign
Istiqlal Skin irritation Itching Skin flushed Breathing difficult
Istiqlal Skin irritation Urticaria Pruritus Dyspnea
Istiqlal Nausea Pruritus
Istiqlal Skin irritation Urticaria Injection site swelling
Mehtarlam-PH Convulsions Urticaria Allergy
Mehtarlam-PH Itching Urticaria Allergy
Istiqlal Tremor Hyperthermia
Istiqlal Vomiting Dyspnea
Antani Itching
Antani Itching
Istiqlal Skin irritation Pruritus Sensation of warmth
Antani Injection site irritation
Skin flushed
Antani Skin discoloration
Pruritus aggravated
Antani Itching Skin flushed
FMIC Injection site pain
Skin irritation Injection site swelling
Fever
FMIC Injection site erythema
Itching Injection site pain Bullous eruption Agitation
Antani Pruritus Urticaria Skin flushed Temperature elevation
Antani Pruritus Urticaria
Mehtarlam-PH Urticaria Allergy
FMIC Skin dry Fever Tremor Skin peeling
Istiqlal Anaphylactic shock
Fever
Antani Temperature elevation
Rash
Antani Rash
The most commonly reported symptom was skin irrational, which contributed to 72 percent of
all reported symptoms. Fever was present in 12 percent of reported cases; respiratory problems
and convulsion and tremor were each reported in 5 percent of cases (figure 8).
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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Figure 8: Type of suspected ADR cases reported by clinical staff (n=23)
Medicines Causing Reported Suspected ADRs
Thirteen medicines and 10 groups of medicines were determined to cause the suspected ADRs
(figure 9). The majority of the reported ADR cases were due to ceftriaxone sodium (35 percent),
followed by ciprofloxacin, ampicillin sodium, and streptomycin sulphate (9 percent each). It
should be noted that most of the reported ADR cases were allergic reactions to antibiotics.
5%
72%
12%
5% 4%
2%
Type of suspected ADRs (n=23)
Respiratory problem
Skin reactions
Fever
Convulsion & Tremor
Nausea & Vomiting
Shock
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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Figure 9: Percentage of suspected ADR cases, by medicine
Twenty-one of the medicines (91 percent) involved in the reported ADRs were included in the
Licensed Medicine List (LML). Of those medicines that were included in LML (n=21), 86
percent were also included in Essential Medicine List (EML). Moreover, only 18 of the 23
medicines (78 percent) were registered in the Pharmaceutical Registration Information
System(PRIS) database. Of the 23 medicines reported to have caused the suspected ADR cases,
20 medicines (87 percent) were injectable while the remaining ones were tablets (table 2).
The majority (57 percent) of medicines that caused the reported ADRs were imported from
Pakistan (figure 10); other countries of origin included China, India, Iran, and UAE.
5% 9%
5%
4%
35% 9%
4%
4%
4%
4%
9%
4% 4%
Percentage of suspected ADR cases, by medicine
Amikacin Sulphate
Ampicillin sodium
Benzathine benzylpenicillin
Benzyl Penicillin Sodium
Ceftriaxone Sodium
Ciprofloxacin
Diclofenac potassium
Drotaverine HCl
Metronidazole
Pantoprazole
Streptomycin Sulphate
Tramadol HCl
Vancomycin hydrochloride
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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Figure 10: Percentage of suspected medicines, by country of origin
ADR Reporting Form
During the implementation of the ADR reporting form at the pilot hospitals and data entry into
VigiFlow, it was observed that there were some missing data fields in the ADR reporting form.
These missing data fields or indicators include—
Name of health facility/or company reporting the ADR case
Patient body height (in centimeters)
Patient hospitalization date and discharge date
More spaces needed for reaction details in section B.7, and for tests and procedures in
section B.12 in the current ADR reporting form.
Outcome of reaction is not according to ICH-E2B guidelines,* which classify outcomes
as Recovered/resolved, Recovering/resolving, Not recovered/not resolved,
Recovered/resolved with sequelae, Fatal, and Unknown.
In the section pertaining to seriousness of the reaction (B.10) other medically important
condition(s) need to be added, and also Requires hospitalization or Prolongation
hospitalization should be there instead of Prolonged hospitalization.
* International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use: Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for
Transmission of Individual Case Safety Reports E2B(R2)
2, 9%
5, 22%
1, 4% 13, 57%
1, 4% 1, 4%
Number/percent of suspected medicines, by country of origin
China
India
Iran
Pakistan
U.A.E
Unknown
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The order of the fields should be reconsidered. As of now Discontinuation and Outcome
are mentioned before the reporter has stated the reaction. Order of suspected and
concomitant medicines also needs to be reconsidered.
Dose and strength of medicines should be added in separate columns.
Time interval between administration of suspected medicine and event needs to be added.
On reverse side of ADR form, information of the ADR reporting needs to be added (e.g.,
what to report, where to report, who can report, and what happens after reporting).
SWOT Analysis
In order to understand the feasibility of pharmacovigilance interventions at the pilot hospitals,
the pharmacovigilance and medicine safety pilot team performed a SWOT analysis using the
gathered information, information shared in the MSC, and information otherwise observed.
Figure 11 shows several strong points in the existing system as reflected in the pilot phase (e.g.,
cooperation of hospitals and regular MSC meetings). The next phase of medicine safety and
pharmacovigilance activities should focus on building on the strengths of this phase and should
focus on improving weaknesses (e.g., incomplete ADR forms) by using different capacity
building methods and try to use the opportunities that are available to them. The GDPA/MoPH
and SPS are supporting these hospitals in improving the pharmacovigilance and medicine safety
measures by providing technical support and building the capacity of these hospitals. Now, it is
important for these hospitals’ management teams to ensure effective use of these opportunities
available to them, in order to improve their services further.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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Figure 11: SWOT analysis of medicine safety and pharmacovigilance interventions
implementation in the selected hospitals.
SWOT
Weakness
Underreporting of suspected ADR cases
by pilot hospitals.
Limited follow up of ADR cases.
Incomplete ADR forms by reporter of
suspected ADR cases.
Incorrect filling out of the ADR reporting
form.
Limited knowledge of PV by health care
services providers.
Limited ADR knowledge by the patients.
Lack of PV focal points motivation and
proper feedback.
Low commitment of medical doctors
than rest healthcare services providers
Threats
Lack of cooperation by some of
medical personnel in filling of the
ADR forms.
Patient’s interest in reporting of
ADR.
Poor contact of health professionals
with patients in case of reporting.
Limited patient doctor or nurse’s
time, which makes the reporting
difficult.
Low capacity of PV focal persons in
the pilot hospitals.
Turnover of the clinical staff in the
hospitals.
Strengths
Regular meetings of MSC and active
participation by the members
Full support of pilot hospitals while
implementing medicine safety and PV
interventions.
Hospital’s focal persons had good
collaboration with MSC/ GDPA staff.
Support of clinical staff of pilot
hospitals.
Existence of PV support in related
MoPH strategies and policies.
Commitment of MoPH authorities
Opportunities
Political support from MoPH and
stakeholders in implementing
medicine safety and PV
interventions.
Technical and financial support
from donors and international
agencies in implementing the
medicine safety and PV
interventions.
Availability of media to inform the
public and raise their knowledge in
medicine safety, PV and ADRs.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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DISCUSSION AND CONCLUSION
As planned by the MSC, the pilot pharmacovigilance activities were implemented successfully
with four pilot hospitals. During the six months of the pilot period (February to August, 2015), a
total of 23 ICSRs or suspected ADR cases were reported spontaneously to the MSC by pilot
hospitals. MSC members reviewed the cases and found that 22 were expected, mild reactions and
one out of 23 cases was a serious (life-threatening) reaction. Skin reactions were the most
common symptom reported through the ICSRs by nurses, physicians, midwives, and relative of
patient. In the pilot phase nurses reported more suspected ADR cases than physicians and other
healthcare professionals. It was also noted that the current ADR reporting form has some missing
points and needs to be revised.
As a result of a 2014 RMU assessment in 12 national and provincial hospitals, 55 percent of
patients were found to have received antibiotics. [6]
However, according to another study in three
provincial hospitals about 40 percent of the patients received antibiotics which are not required
clinically according to the standard references. [9]
Based on the findings of the pilot phase, most
suspected ADR cases were commonly due to antibiotics (62 percent). Therefore, promotion of
RMU can potentially reduce ADR considerably.
It is clear from the SWOT analysis of the pilot phase (figure12), that there are several existing
strengths (including the cooperation of hospitals and health professionals, and regular MSC
meetings). The next phase of pharmacovigilance should focus on building upon the strengths of
this pilot phase, and should focus on improving the weaknesses (e.g., incomplete ADR forms) by
using different capacity building methods, and attempt to increase the number of ADR reports
from hospitals to the MSC. The MoPH-GDPA and SPS are supporting these hospitals in
improving medicine safety measures and pharmacovigilance by providing technical support and
building the capacity of these hospitals. Now, it is important for these hospitals’ management
teams to ensure effective use of these opportunities available to them, in order to improve their
services further.
Afghanistan’s porous and non-secure border connects it to several countries and allows multiple
points of entry for medicines. Recent data indicate that more than 95 percent of the medicines are
imported to Afghanistan. Pakistan may have producers specifically targeting the Afghan market
with their pharmaceutical supply. There is weak existing capacity for medicines regulation and
control for both the public and private sectors, and no functional medicine regulatory authority in
Afghanistan. Structures, procedures, and policies are lacking to properly regulate the pharmaceutical
sector for quality assurance. There is no GMP inspectorate or national GMP guidelines. Although
policies, legislation, and regulations do exist, implementation is weak due to insufficient budgets,
poor infrastructure, and limited technical human resources. Afghanistan does not have an adequate
mechanism or system for monitoring the quality of medicines and there was not a system for
pharmacovigilance over the country. It is clear from this pilot phase that medicine safety and
pharmacovigilance interventions are necessary to be implemented in the healthcare system in
Afghanistan. There is support for their implementation both from the side of government
(MoPH-GDPA) and from the side of implementing bodies (hospitals). Moreover, as an added
advantage, the USAID-funded SPS project is also willing to provide technical support to
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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facilitate the pharmacovigilance intervention implementation. Other strengths and limitations
noted in the pilot phase area and recommendations should be considered for the next phase of
medicine safety and pharmacovigilance interventions.
Adverse drug reactions, adverse events, and medication errors are believed to be common in
Afghanistan health institutions, particularly at the hospital level. These adverse events harm
peoples’ health and can result in hospital admissions for further treatment. In spite of the
observed low reporting of ADRs during the pilot phase by health providers, there is an
opportunity to expand patient safety by promoting a good ADR reporting system at the hospital
level. A technical assistance program is required to train and sensitize health providers on patient
safety issues and encourage them to report ADRs. Most of the reported adverse events that
occurred are preventable and their prevention could save patients from harm.
RECOMMENDATIONS
At the policy level—
GDPA should develop national pharmacovigilance policy, guidelines, and standards.
GDPA should develop a plan to apply for full membership in the WHO IDMP.
GDPA should plan for capacity building of health staff regarding pharmacovigilance and
medicine safety interventions for promoting pharmacovigilance.
GDPA should develop mechanisms to encourage spontaneous reporting of medical
product quality issues and medication errors.
MSC should revise the current ADR reporting form, based on findings of pilot phase.
MSC should assign responsive physicians or pharmacists as the hospital focal persons
rather than nurses. (Physicians and pharmacists are better positioned than nurses to
advocate for pharmacovigilance throughout the hospital.)
GDPA should develop and distribute pharmacovigilance and medicine safety information
charts, posters, and job aids to health care facilities in order to increase knowledge of
clinical staff on pharmacovigilance and ADR reporting.
GDPA should improve the provision of information on medicines to health care workers
and to the public in order to improve safe and rational use of medicines.
Based on the pilot reports, the medicine safety and pharmacovigilance activities should
be expanded to more national and provincial hospitals.
Regular monitoring and supervision of the pharmacovigilance interventions should be
performed by the GDPA.
Budget allocation for national PV Activities.
At the hospital level—
Encourage and motivate the health care professionals to report any suspect drug events or
ADRs using the ADR reporting form.
The health care staff of hospitals should actively explain the adverse effects of drugs to
patients, and discuss with patients if any of adverse reactions occur.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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The MSC should actively monitor and supervise the health professionals in their
respective hospitals.
MSC should involve hospital DTCs in their activities.
MSC should periodically perform a gap analysis to improve ADR reporting in their
hospitals.
Each hospital’s DTC and MSC should coordinate their activities and plan capacity
building activities and trainings.
The use of allergy cards should be monitored and encouraged by hospital administrations.
Hospital DTCs should coordinate immediate decision-making at the hospital level if
several ADRs occur, and then immediately send them to MSC for further investigation,
causality assessment, and decision regarding patient safety.
ADR reporting should be added in the job descriptions of medical doctors, nurses and
pharmacists.
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A Pilot Phase Report (September 2014 to August 2015)
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REFERENCES
1. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products.
Geneva, World Health Organization, 2002. P (7, 8).
2. Pharmacovigilance: A Worldwide Master Key for Drug Safety Monitoring. G Jeetu and
G Anusha (editors), J Young Pharm. 2010 Jul-Sep; 2 (3): 315–320. doi:10.4103/0975-
1483.66802. (Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964775/ )
3. Safety Monitoring of Medicinal Products: Guidelines for Setting up and Running a
pharmacovigilance Centre. Uppsala Monitoring Centre, 2000. P (5).
4. Olsson, Sten, Shanthi N Pal, and Alex Dodoo. Pharmacovigilance in Resource-Limited
Countries. Pages 449-460, DOI: 10.1586/17512433.2015.1053391.
5. Inua Yusuf, D. Lee, Zakeria Fatehzada, Wahidullah Karwar, M. Morris, M. Zafar Omari,
Aisha Noorzaee, and T. Layloff. April 2011. Afghanistan Medicines Quality Assurance
Assessment – A Qualitative Survey. Submitted to USAID by the SPS Program. Arlington,
VA: Management Sciences for Health.
6. Hospital DTCs quarterly assessment reports, 2014.
7. National Pharmacovigilance Systems: Ensuring the Safe Use of Medicines. August 16–
18, 2010. Nairobi, Kenya. Submitted to USAID by the SPS Program. Arlington, VA:
Management Sciences for Health.
8. Adverse Drug Reaction Reporting and Management Assessment in Six Hospitals of
Kabul, Afghanistan. March–August 2013.Submitted to USAID by the SPS Program.
Arlington, VA: Management Sciences for Health.
9. Prescription analyses report of provincial hospitals, quarter 2, 2015.
10. Medicine Safety Committee meeting minutes.
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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ANNEX 1: OLD ADVERSE DRUG REACTION FORM
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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ANNEX 2: ADVERSE DRUG REACTION (ADR) REPORTING FORM
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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ANNEX 3: ASSOCIATE MEMBERSHIP CONFIRMATION LETTER FROM UMC
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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ANNEX 4: ISTIQLAL HOSPITAL
Istiqlal Hospital is a national hospital located in Kabul city, Afghanistan, which has 14
departments and 290 active beds.
The hospital is not part of EPHS and Reform, and has been autonomized since November 7,
2012 (17/8/1393).
Istiqlal Hospital is funded by the Government of the Islamic Republic of Afghanistan (GIRoA)
and the World Bank.
Istiqlal Hospital department names and staffing
SN Name of the department Number of staff in each department
Remarks
1 Internal ward 39 Doctor
2 Surgery ward 40 Doctor
3 OBGYN ward 51 Doctor
4 Burn and plastic Surgery ward 16 Doctor
5 Anesthesia ward 4 Doctor
6 Neonatal Dept. 3 Doctor
7 Diagnostic Dept. 4 Doctor
8 X-ray Dept. 6 Technician
9 Physiotherapy Dept. 5 Physiotherapist
10 Laboratory Dept. 10 Technician
11 Pharmacy Dept. 8 Pharmacist
12 Anesthesia Technician 11 Technician
13 Nursing Dept. 109 Nurse
14 Med wives Dept. 43 Med wife
15 Vaccinator 2 Vaccinator
16 Admin and Supportive Staff 162 Admin & workers
Total staff: 513
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
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ANNEX 5: ANTANI HOSPITAL
Antani is a national hospital located in Kabul city, Afghanistan. It has five departments and 100
active beds.
The hospital is funded by GIRoA and the World Bank. It is not part of EPHS and Reform.
Antani Hospital has been autotomized since November 7, 2012 (27/8/1391).
Antani Hospital department names and staffing
SN Name of the department Number of staff in each department
By type (staff)
1 Antani Ward 49 Doctor
2 Pharmacy 6 Pharmacist
3 Nursing 44 Nurse
4 Diagnostic Department 13 Technician
5 Admin &supportive staff 111
Total staff: 223
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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ANNEX 6: MEHTARLAM PROVINCIAL HOSPITAL (MPH)
MPH is located in Laghman Province and was established in 1975 as an OPD. In 1984, it
became an IPD with 30 beds, then 50 beds, and improved 70 beds. At the end of 1363, MPH
worked as a district hospital.
Recently MPH was changed to a provincial hospital with 100 beds. Hospital wards include, as
OPD: male and female, surgery, pediatric, gynecology, ENT (ears, nose, and throat),
ophthalmology, dermatology, mental health, dental, MCH (maternal and child health) service,
immunization, and pediatric nutrition assessment, and as IPD: an internal medicine section,
pediatric, general surgery/orthopedic and gynecology/obstetric.
The hospital is presently a public hospital under MoPH regulation, supported by Swedish
Committee for Afghanistan (SCA).
Mehtarlam-PH department names and staffing
SN Name of the department Number of staff in each department
By type (staff)
1 Internal ward 7 Specialist 2, Nurse 3
Physician 2
2 Surgery ward 11
Specialist 3
Anesthetist specialist 1 Anesthesia technician 3 Physician 1
Nurse 3
3 OBGYN ward 12
Specialist 3
Midwife 8
Nurse 1
4 Pediatric ward
Internal
18
Specialist 2
Physician 3
Nurse 13 Nutrition
Neonatal
5 Emergency ward 6 Physician 3
Nurse 3
6 OPD 4
Dermatologist 1,
Ophthalmologist 1,
Psychologist 1
Nurse 1
7 Pharmacy department 3 Pharmacist 1,
Dentists 2
8 Admin & supportive staff 58
Total staff: 119
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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ANNEX 7: FRENCH MEDICAL INSTITUTE FOR CHILDREN (FMIC)
FMIC is a tertiary hospital in based in Kabul which was established April 01, 2006.
The FMIC is run through an innovative four-way partnership between GIRoA, the Government
of France, the Aga Khan Development Network (AKDN), and French NGO La Chaîne de
l’Espoir. The Aga Khan University manages FMIC on behalf of AKDN.
FMIC has 672 staff, 89 beds, and the beds per nurse is 6-7/nurse for wards and 1/1 for intensive
care unit (ICU).
FMIC department names and staffing
SN Name of the department # of staff in each department
Qualification
1 Medical Coordinator Office (doctors + admin staff) 4 BBA, MD & MBA
2 Cardiac Diagnostic & Surgery (doctors + nurses + receptionists porter)
32 12 Grade , BScN/ diploma & MD
3 Dental Clinic (doctors) 4 MD
4 ENT (doctors) 1 MD
5 Eye Care (technicians and doctors) 8 14 grade – MD
6 Medicine (doctors) 41 MD
7 PGME-Manager Office (receptionist, technician, doctor)
8 12 grade – MD
8 Surgery (doctors) 24 MD
9 Anesthesia (nurses + doctors) 13 Diploma – MD
10 Endoscopy (doctors) 2 MD
11 Administrator Nursing Services (admin + nurses) 5 BA and Diploma
12 Consulting Clinic (admin, receptionist, porter, nurses)
44 12 grade, BScN, Diploma & BBA.
13 CSSD (nurse + technician) 6 Diploma
14 Infection Control (nurse) 1 Diploma
15 ICU (receptionist, porter, nurses) 40 12 grade, BScN, Diploma
16 Medicine Ward (IPD-2) (receptionist, porter, nurses)
27 12 grade, Diploma & BScN
17 Nursing Education Services (nurse) 1 BScN
18 Operating Room (receptionist, porter, nurses) 17 12 grade, Diploma, BScN
19 Physiotherapy (physiotherapy) 3 Diploma
20 Quality Assurance (nurse + doctor) 3 BScN – MD
21 Recovery Room(nurses) 5 Diploma -BScN
22 Surgical Ward (IPD-1) (receptionist, porter, nurses 24 12 grade – Diploma
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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FMIC department names and staffing
SN Name of the department # of staff in each department
Qualification
23 Laboratory (receptionists, porter, technicians, technologist, doctors)
49 12 grade, Diploma Pharm D &MD
24 MRI + Radiology (receptionist, porter, technician, doctors)
45 12 grade, Diploma & MD
25 Pharmacy (pharmacists and technicians) 14 Diploma- BSc, Pharm D
26 Admin and support staff 249 6 grade up to MBA
27 Vaccinator 2 12 grade
Total staff: 672
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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ANNEX 8: SCHEDULE: FOUR-DAY PHARMACOVIGILANCE TRAINING COURSE (SEPT. 21 TO 24, 2014)
Time Topic Facilitator Co-Facilitator
Day 1, 21 Sep 2014 (Sunday)
8:00 am - 8:30 am
Registration and distribution of stationery
All
8:30 am - 8:35 am
Recitation of Holy Quran Qari Sahib
8:35 am - 8:40 am
Speech of Directorate GDPA Dr. Abdul Hafiz Quraishi
8:40 am - 8:45 am
Speech of SPS CoP Dr. Mohammad Zafar Omari
8:45 am - 9:00 am
Pretest all facilitators
9:00 am - 9:45 am
Overview of Medicine Safety in Afghanistan
Dr. Abdul Khalil Khakzad
Dr. Faiz Mohammad Delawer
9:45 am - 10:45 am
Group work and presentation: Group one: Withdrawal of drug from Market Group two: How to prevent the ADR Group three: Sharing the ADR experiences
Dr. Abdul Khalil Khakzad Dr. Mir. Islam Saeed Dr. Faiz Mohammad Delawer Dr. Mohammad Zafar Omari
Dr. Fauzia Maihanyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
10:45 am - 11:00 am
Tea/Coffee Break
11:00 am - 12:00 pm
Introduction of Pharmacovigilance
Dr. Faiz Mohammad Delawer
12:00 pm - 1:00 pm
Group work (Reviewing Articles): Group Two: Background and Objective Group One: Methodology Group Three: Result and Conclusion
Dr. Nazir Heiderzad Dr. Faiz Mohammad Delawer Dr. Mohammad Zafar Omari
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
1:00 pm - 2:00 pm
Lunch/Pray time
Day 2, 22 Sep 2014 (Monday)
8:30 am - 9:30 am
Benefit-Risk Assessment Dr. Mohammad Shafiq Mashal
Prof. M. Nasim Sediqi
9:30 am - 10:30 am
Group work: Adverse drug reactions in hospital in-patients: a pilot study Group One: Background and Objective Group Three: Methodology
Dr. Mohammad Shafiq Mashal Dr. Mohammad Zafar Omari Dr. Faiz Mohammad Delawer
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
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Time Topic Facilitator Co-Facilitator
Group Two: Result and Conclusion
10:30 am - 11:00 am
Tea/Coffee Break
11:00 am - 1:00 pm
Biostatistics concept and terms
Dr. Ataullah Saeedzai Dr. Faiz Mohammad Delawer
1:00 pm - 2:00 pm
Lunch/Pray time
2:00 pm - 2:30 pm
Medication Error and patient safety
Dr. Faiz Mohammad Delawer
Dr. Mohammad Zafar Omari
2:30 pm - 3:30 pm
Group work: Adverse Drug Events Caused By Serious Medication Administration Errors Group Three: Background and Objective Group One: Methodology Group Two: Result and Conclusion
Dr. Mohammad Zafar Omari Dr. Faiz Mohammad Delawer Dr. Nazir Heidarzad
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
Day 3, 23 Sep 2014 (Tuesday)
8:30 am - 9:30 am
Spontaneous reporting and signal detection
Dr. Nazir Heidarzad Dr. Mohammad Shafiq Mashal
9:30 am - 10:30 am
Group work: Spontaneous Adverse Drug Reaction Reporting in Rural Districts of Mozambique Group One: Background and Objective Group Two: Methodology Group Three: Result and Conclusion
Dr. Nazir Heidarzad Dr. Faiz Mohammad Delawer Dr. Mohammad Zafar Omari
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
10:30 am - 11:00 am
Good Pharmacovigilance practice
Dr. Nematullah Nawrozian
Dr. Nazir Heidarzad
11:00 am - 11:30 am
Tea/Coffee Break
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
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Time Topic Facilitator Co-Facilitator
11:30 am - 12:00 pm
Group work: Pattern of ADR related queries received by DIC Group Three: Background and Objective Group One: Methodology Group Two: Result and Conclusion
Dr. Nematullah Nawrozian Dr. Nazir Heidarzad Dr. Faiz Mohammad Delawer Dr. Mohammad Zafar Omari
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
12:00 pm - 1:00 pm
Drug Efficacy Dr. Mohammad Zafar Omari
Dr. Faiz Mohammad Delawer
1:00 pm - 2:00 pm
Lunch/Pray time
2:00 pm - 3:00 pm
Group work: Group Three: Group One: Group Two:
Dr. Nematullah Nawrozian Dr. Nazir Heidarzad Dr. Faiz Mohammad Delawer Dr. Mohammad Zafar Omari
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
Day 4, 24 Sep 2014 (Wednesday)
8:30 am - 9:30 am
ADR reporting form
Dr. Faiz Mohammad Delawer
Dr. Abdul Khalil Khakzad
9:30 am - 10:30 am
Group work: Group one: Practice of form and review of action plan Group two: Practice of form and review of action plan Group three: Practice of form and review of action plan
Dr. Nazir Heidarzad Dr. Faiz Mohammad Delawer Dr. Mohammad Zafar Omari
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
10:30 am - 11:00 am
Tea/Coffee Break
11:00 am - 12:00 pm
Post-test and Evaluation of course
Dr. Mir. Islam Saeed Dr. Faiz Mohammad Delawer Dr. Mohammad Zafar Omari
Dr. Fauzia Maihnyar Dr. Nematullah Nawrozian Dr. Mohammad Shafiq Mashal
12:00 pm - 1:00 pm
Closing of the course and certificate distribution
1:00 pm - 2:00 pm
Lunch/Pray time
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
35
ANNEX 9: PRE-TEST AND POST-TEST FOR PARTICIPANTS OF FIVE-DAY TRAINING COURSE ON PHARMACOVIGILANCE (SEPT. 21 TO 24, 2014)
Name: _______________________ Designation: _________________ Date: 20/Sep/2014
Please describe the following question and write down the appropriate definition:
Question1: What is Pharmacovigilance?
Question2: What is the difference between Adverse Drug Reactions and Drugs Side Effect?
For the questions below please mark one of the best answers:
Question3: What are the resources for a safety signal?
Spontaneous Reporting System
Anecdotal literature Reporting
Intensive hospital monitoring
Prescription event monitoring
None of above
All of above
Question4: Please name at least three areas where the drugs errors are mostly occur?
Drug Prescription
Drug dispensing
Drug Administration
a and b are correct
none of above
All of above
Question5: If an ADR case is found in any clinical setting, how it should be reported?
By phone to director of the hospital
By ADR form to DTC of the hospital
By ADR form to pharmacovigilance center
b and c are correct
all of them are correct
none of them are correct
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
36
ANNEX 10: SCHEDULE: ONE-DAY ORIENTATION WORKSHOP ON PHARMACOVIGILANCE (OCT. 29, 2014)
Time Topic Facilitator
8:00 am - 8:30 am Registration and distribution of stationery All
8:30 am - 8:40 am Recitation of Holy Quran Qari Sahib
8:40 am - 8:50 am Speech of API Directorate Dr. Abdul Khalil Khakzad
8:50 am - 9:00 am History of Medicine Safety Dr. Mohammad Zafar Omari
9:00 am - 9:30 am Overview of Medicine Safety in Afghanistan
Dr. Abdul Khalil Khakzad
9:30 am - 10:00 am Introduction to Pharmacovigilance Dr. M. Shafiq Mashal and Dr. Faiz Mohammad Delawer
10:00 am - 10:15 am Tea/Coffee Break
10:15 am - 10:45 am Medication Error and Patients Safety Dr. Khwaja Mir Islam Saeed
10:45 am - 11:30 am Presenting the Medicine Safety Action Plan of Antani, Istiqlal, and Mehtarlam
Dr. M. Saber Hotak, Dr. Hamid Akbari, and Dr. Daim Quraishi
11:30 am - 11:45 am Conclusion Dr. Mahmood Gul Kohdamani
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
37
ANNEX 11: SCHEDULE: PHARMACOVIGILANCE ORIENTATION WORKSHOP (FOUR SELECTED HOSPITALS: ISTIQLAL, ANTANI, MPH, AND FMIC)
Time Duration Topic Facilitator
9:00 - 9:15 am 15 min Registration All
9:15 - 9:25 am 10 min Recitation of Holy Quran Qari Sahib
9:25 - 9:35 am 10 min Opening speech Dr. Abdul Khalil Khakzad/Hospital director
9:35 - 9:45 am 10 min Overview of medicine safety in Afghanistan Dr. Abdul Khalil Khakzad/Dr. Azim Samim
9:45 - 10:15 am 30 min Introduction to pharmacovigilance Prof. Mohammad Shafiq Mashal
10:15 -10:40 am 25 min Presenting the medicine safety action plan of Istiqlal Hospital and ADR form
PV focal person of hospital
10:40 -10:50 am 10 min Tea/Coffee Break
10:50 -11:00 am 10 min Conclusion Medical director of hospital
Running the Pharmacovigilance and Medicine Safety Program in Afghanistan
A Pilot Phase Report (September 2014 to August 2015)
38
ANNEX 12: LIST OF MEDICINE SAFETY COMMITTEE MEMBERS
S/N Name Designation
1. Ph. Abdul Khalil Khakzad Chairperson
2. Ph. Fawzia Maihanyar Secretary
3. Prof. Mohammad Nasim Sediqqui Pharmacognosist
4. Prof. Qand Agha Nazari Pharmacologist
5. Prof. Hafiza Hamid Toxicologist
6. Dr. Khwaja Mir Islam Saeed Epidemiologist
7. Dr. Mohammad Azim Samim General medicine doctor
8. Dr. Mohammad Ibrahim Kamal Pathologist
9. Ph. Mohammad Saber Hotak Clinical pharmacist
10. Ph. Mohammad Nazir Heiderzad Representative from drug regulatory authorities
11. Ph. Noor Ahmad Zulal Representative from quality assurance department
12. Ph. Aziza Habibi Representative from Drug Information department
13. Ph. Roqia Naser Representative from Expanded Program on Immunization
14. Dr. Safiullah Nadeeb Representative from WHO
15. Ph. Nematullah Nawrozian Member
16. Dr. Faiz Mohammad Delawer Member
17. Ph. Mahmood Samim Member & Technical assistant
This report is made possible by the generous support of the American people through the U.S.
Agency for International Development (USAID), under the terms of leader with associate
cooperative agreement number 306-A-00-11-00532-00 under leader award number GHN-A-00-
07-00002-00. The contents are the responsibility of Management Sciences for Health and do not
necessarily reflect the views of USAID or the United States Government.
About SPS
The Strengthening Pharmaceutical Systems (SPS) Program strives to build capacity within
developing countries to manage all aspects of pharmaceutical systems and services effectively.
SPS focuses on improving governance in the pharmaceutical sector, strengthening
pharmaceutical management systems and financing mechanisms, containing antimicrobial
resistance and enhancing access and appropriate use of medicines.
Strengthening Pharmaceutical Systems
Center for Pharmaceutical Management
Management Sciences for Health
4301 North Fairfax Drive, Suite 400
Arlington, VA 22203 USA
Telephone: 703.524.6575
Fax: 703.524.7898
E-mail: sps@msh.org
Web: www.msh.org/sps
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