Islamic Republic of Afghanistan Ministry of Public Health ...gdpa.gov.af/Content/Media/Documents/AfgPVpilotphasereportE-final... · Islamic Republic of Afghanistan Ministry of Public

Islamic Republic of Afghanistan

Ministry of Public Health General Directorate of Pharmaceutical Affairs

June 2016

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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

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Annex 11: Schedule: Pharmacovigilance Orientation Workshop (Four Selected HOSPITALS:

ISTIQLAL, Antani, MPH, and FMIC) ................................................................................................... 37

Annex 12: List of Medicine Safety Committee Members ...................................................................... 38

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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

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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

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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)

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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



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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.



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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



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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.



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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



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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.



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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



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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.



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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,



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.



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Figure 1: ADR Case Management Flow Chart



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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.



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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



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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



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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



14

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).



15

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



16

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



17

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



18

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.



19

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.



20

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



21

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.



22

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.



23

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.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964775/



24

ANNEX 1: OLD ADVERSE DRUG REACTION FORM



25

ANNEX 2: ADVERSE DRUG REACTION (ADR) REPORTING FORM



26

ANNEX 3: ASSOCIATE MEMBERSHIP CONFIRMATION LETTER FROM UMC



27

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



28

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


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



29

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


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



30

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



31

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



32

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


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




33


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. 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


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


10:30 am - 11:00 am

Good Pharmacovigilance practice

Dr. Nematullah Nawrozian

Dr. Nazir Heidarzad

11:00 am - 11:30 am

Tea/Coffee Break



34


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


12:00 pm - 1:00 pm

Drug Efficacy Dr. Mohammad Zafar Omari


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


Day 4, 24 Sep 2014 (Wednesday)

8:30 am - 9:30 am

ADR reporting form



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


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


12:00 pm - 1:00 pm

Closing of the course and certificate distribution

1:00 pm - 2:00 pm

Lunch/Pray time



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



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


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



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



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: [email protected]

Web: www.msh.org/sps