NTA Level 6 • Semester 2 • PST06211

Monitoring and Evaluation of Medicine Use – Complete Full Notes

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UNITED REPUBLIC OF TANZANIA

Ministry of Health, Community

Development, Gender, Elderly and

Children

PST 06211

MONITORING AND EVALUATION

OF MEDICINE USE

NTA Level 6 Semester 2

Facilitator Guide

March 2019

NTA Level 6 Semester 2 Facilitator Guide i

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Table of Contents

Background …………………………………………………………………………………………………………………… iii

Acknowledgment ……………………………………………………………………………………………………………. v

Introduction ………………………………………………………………………………………………………………….. vii

Abbreviations ………………………………………………………………………………………………………………… ix

Session 1: Introduction to Monitoring and Evaluation …………………………………………………………. 1

Session 3: Assessing Monitoring and Evaluation of PharmaceuticalsServices ……………………… 19

Session 4: Performance Indicators for Monitoring and Evaluation ……………………………………… 31

Session 5: Factors Hindering Monitoring and Evaluation of Medicines Use …………………………. 42

Session 6: Indicators in Monitoring and Evaluation Medicines Use ……………………………………. 47

Session 7: Tools for Monitoring and Evaluation of Medicine Use ………………………………………. 54

Session 8: The Concept of Pharmacovigillance: ……………………………………………………………….. 62

Session 9: Pharmacovigillance Methods ………………………………………………………………………….. 69

Session 10: Documentation of Pharmacovigillance Data ……………………………………………………. 78

Session 11: Reporting Pharmacovigillance Data ………………………………………………………………. 84

Session 12: Introduction to Adverse Drug Reactions (ADRs) …………………………………………….. 91

Session 13: Documentation of ADRs ………………………………………………………………………………. 97

Session 14: Reporting of ADRs …………………………………………………………………………………….. 103

Session 15: Substandard and Counterfeit Medicines ………………………………………………………… 112

Session 16: Detection of Substandard and Counterfeit Medicines ……………………………………… 121

Session 17: Controlling Substandard and Counterfeit Medicines ………………………………………. 131

Session 18: Distribution of Substandard and Counterfeit Medicines ………………………………….. 139

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Background

There is currently an ever-increasing demand for pharmaceutical personnel in Tanzania. This is

due to expanding investment in public and private pharmaceutical sector. Shortage of trained

pharmaceutical human resource contributes to poor quality of pharmaceutical services and low

access to medicines in the country (GIZ, 2012).

Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with

Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs)

worked together to address the shortage of human resource for pharmacy by designing a project

named ―Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania‖ in

order to improve quality and capacity of PTIs in training.

CSSC prepared a Multi-actor Partnership (MAP) project proposal on how to sustain and

strengthen health care in Tanzania through improvement of pharmaceutical training and an inter-

institutional coordination of actors. This will harmonize and improve access to quality

pharmaceutical service in Tanzania.

The project has a various key stakeholders like; CSSC, NACTE, PC, TCU, CEDHA and

Pharmaceutical Training Institutions (PTIs). Through this project, few PTIs will receive

infrastructural improvements to increase the quantitative and qualitative capacities (CUHAS,

RUCU and KSP). Furthermore this project will train Pharmaceutical tutors from different PTIs

on teaching and assessment methods in Tanzania and thus improved health delivery through

increased qualified human resource.

It was also observed that in the previous stakeholder‘s meetings there was a need for the

development of training manuals and assessment plans for NTA Level 5 & 6, in order to support

the establishment and implementation of the curriculum in PTIs. During MAP kick-off workshop

done in February 2018, Stakeholders agreed that there was a need for development of the said

manuals and it was among the highest priority in Pharmacy education in Tanzania. Therefore this

project aims at developing facilitator‘s guide and assessment plans for NTA Level 5 & 6.

Pharmacy Council, CSSC and action medeor developed the Terms of Reference and selected a

qualified service provider with experience in material development to develop the mentioned

training manuals and assessment plan. Centre for Educational Development in Health Arusha

(CEDHA) was selected and offered a contract to develop Facilitators guide for NTA level 5 & 6

and assessment plan.

Centre for Educational Development in Health Arusha (CEDHA) was offered a leading role with

the instructions to include experts who have developed teaching materials for NTA Level 4.

These experts are primarily experienced pharmaceutical and non-pharmaceutical tutors.

The mode of operation used by CEDHA to develop facilitator‘s guide and assessment plan was

participatory approach which included a number of activities through various workshops such as

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

iii

planning, and orientation of material development. After these preliminary workshops, experts

developed materials individually and in-groups. Thereafter, developed draft materials were

reviewed, edited and formatted and draft one was finalized and shared to stakeholders for inputs.

Finally, CEDHA submitted the finalized Facilitator‘s guides and assessment plans for NTA level

5 and 6 to CSSC for endorsement, printing, dissemination and sharing with relevant authorities.

There are 12 modules for NTA level 6 making 12 Facilitator guides and one Practicum guide.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Acknowledgment

The development of standardized training materials of a competence-based curriculum for

pharmaceutical sciences has been accomplished through involvement of different stakeholders.

Special thanks go to the Pharmacy Council for spearheading the harmonization of training

materials in the pharmacy after noticing that training institutions in Tanzania were using

different curricula and train their students differently.

I would also like to extend my gratitude to Christian Social Service Commission (CSSC) for their

tireless efforts to mobilize funds from development partners (German Ministry of Industry and

action medeor). It is through the implementation of the Multi-Actors Partnership (MAP) project,

CSSC has been able to provide the financial and technical support needed during the development

of this training material.

Many thanks go to the Centre for Educational Development in Health Arusha (CEDHA) experts

on health material development and training who coordinated the development of these module

sessions particularly Ms. Diana H. Gamuyafor her commitment in coordinating and facilitating

the planning and development to its completion.

Particular acknowledgements are sent to Mr. Dickson Mtalitinya and Members from the

secretariat of National Council for Technical Education (NACTE) for facilitating and providing

their expertise to the success of this work.

It will be unfair if I will not recognize the efforts and contributions of all CEDHA supportive

staff that made this process a success; accountant, secretary, drivers and printers

Finally, I very much appreciate the contributions of the tutors and content experts representing

PTIs, hospitals, and other health training institutions. Their participation in meetings and

workshops, and their input in the development of this training manual/facilitators guide have

been invaluable.

These participants are listed with our gratitude below:

Ms. Elizabeth Shekalaghe Registrar, Pharmacy Council of Tanzania

Dr.FadhiliLyimo Assistant Director Allied Health,MoHCDGEC

Dr. Jacqueline Uriyo Acting Principal, CEDHA

Dr.Sungwa N. Kabissi Project Manager – MAP, CSSC

Ms. Diana H. Gamuya CEDHA

Ms. Grace Mallange PC

Mr.WensaaMuro KSP

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Ms. Emily Mwakibolwa Pharmacy Council

Mr.Samwel M. Zakayo Pharmacy Council

Mr.SamweliMdallingwa NACTE

Dr.ByeraShwekerela CEDHA

Dr.MwanduJiyenze CEDHA

Mr.StephanoKiberiti CEDHA

Mr.Amani Phillip HKMU

Mr.OmaryMejjah CUHAS

Mr.Rajabu I. Amiri MUHAS

Ms.Tumaini H. Lyombe MUHAS

Ms.Dilisi J. Makawia KSP

Mr.NemesUisso RAS-KLM

Mr.GoodluckMdugi RuCU

Mr.EvalistShileki DECOHAS

Mr.EliabuMshashi KIUT

Dr.Loishooki S. Laizer

Director of Human Resources Development

Ministry of Health, Community Development, Gender, Elderly and Children

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Introduction

Module Overview

This module content is a guide for tutors of Pharmaceutical schools for training of students. The

session contents are based on sub-enabling outcomes and their related tasks of the curriculum for

Ordinary Diploma Course in Pharmaceutical Sciences. The module sub-enabling outcomes and

their related tasks are as shown in the curriculum for Ordinary Diploma Course in

Pharmaceutical Sciences (NTA Level 6).

Target Audience

This module is intended for use primarily by tutors of pharmaceutical schools. The module‘s

sessions give guidance on the time, activities and provide information on how to teach the

session. The sessions include different activities which focus on increasing students‘ knowledge,

skills and attitudes.

Organization of the Module

The module consists of 18 sessions; each session is divided into several parts as indicated below:

• Session Title:The name of the session

• Total Session Time: The estimated time for teaching the session, indicated in minutes

• Pre-requisites:A module or session which needs to be covered before teaching the session.

• Learning Tasks: Statements which indicate what the student is expected to learn by the end

of the session

• Resources Needed: All resources needed for the session are listed including handouts and

worksheets

• Session Overview: The session overview box lists the steps, time for each step, the activity

or method used in each step and the step title

• Session Content: All the session contents are divided into steps. Each step has a heading

and an estimated time to teach that step as shown in the overview box. Also, this section

includes instructions for the tutor and activities with their instructions to be done during

teaching of the contents

• Key Points: Key messages for concluding the session contents at the end of a session This

step summarizes the main points and ideas from the session, based on the learning tasks of

the session

• Evaluation: The last section of the session consists of short questions based on the learning

tasks to check the understanding of students.

• Handouts: Additional information which can be used in the classroom while teaching or

later for students‘ further learning. Handouts are used to provide extra information related to

the session topic that cannot fit into the session time. Handouts can be used by the students to

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

vii

study material on their own and to refer to them after the session. Sometimes, a handout will

have questions or an exercise for the participants including the answers to the questions.

Instructions for Use and Facilitators Preparation

• Tutors are expected to use the module as a guide to train students in the classroom, field

work and study tourThe contents of the modules are the basis for teaching and learning

monitoring and evaluation of medicine use.

• Use the session contents as a guide

• The tutors are therefore advised to read each session and the relevant handouts and

worksheets as preparation before facilitating the session

• Tutors need to prepare all the resources, as indicated in the resource section or any other

item, for an effective teaching and learning process

• Plan a schedule (timetable) of the training activities

• Facilitators are expected to be innovative to make the teaching and learning process effective

• Read the sessions before facilitation; make sure you understand the contents in order to

clarify points during facilitation

• Time allocated is estimated, but you are advised to follow the time as much as possible, and

adjust as needed

• Use session activities and exercises suggested in the sessions as a guide

• Always involve students in their own learning. When students are involved, they learn more

effectively

• Facilitators are encouraged to use real life examples to make learning more realistic

• Make use of appropriate reference materials and teaching resources available locally

Preparation with Handouts and Worksheets

• Go through the session and identify handouts and worksheets needed for the session

• Reproduce pages of these handouts and worksheets for student use while teaching the

session. This will enable students to refer to handouts and worksheets during the session in

the class. You can reproduce enough copies for students or for sharing

• Give clear instructions to students on the student activity in order for the students to follow

the instructions of the activity

• Refer students to the specific page in the student manual as instructed in the facilitator guide

Using Students Manual When Teaching

• The student manual is a document which has the same content as the facilitator guide, which

excludes facilitator instructions and answers for exercises.

• The student manual is for assisting students to learn effectively and acts as a reference

document during and after teaching the session.

• Some of the activities included in facilitator guide are in the student manual

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

viii

Abbreviations

ACEI Angiotensin converting enzyme inhibitor

ADRs Adverse Drug Reactions

AE Adverse Event

API Active pharmaceutical ingredient

CEM Cohort Event Monitoring

CUHAS Catholic university of health and allied sciences

EML Essential medicine list

FTIR Fourier transfer infrared spectroscopy

GAP Global AIDS program

GPHF Global pharma health fund

HIS Health information system

HKMU Herbert Kairuki Memorial University

HPLC High performance liquid chromatograph

ICSR Individual case safety report

INN International non-proprietary name

KSP Kilimanjaro School of Pharmacy

MAS Mobile Authentication service

MAHs Marketing Authorization Holder

MUHAS Muhimbili University of Health and Allied Sciences

NDP National drug policy

NGOs Nongovernmental organizations

NMP National medicine policy

NMRA National medicine regulatory authority

NSAIDS Non steroidal anti-inflammatory drugs

PMR Personal medication record

PSURs Periodic safety updates reports

QA Quality assurance

QC Quality control

RDU Rational drug use

RuCU Ruaha Catholic University

SAE Serious Adverse Event

SFFC Spurious/falsely-labelled/falsified/counterfeit

SPC Summary of product characteristics

STG Standard Treatment Guideline

TFDA Tanzania Food and Drugs Authority

TLC Thin Layer Chromatograph

TOR Terms of Reference

TRIPS Trade Related aspects of Intellectual Property Right

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 1: Introduction to Monitoring and Evaluation

Total Session Time: 120 minutes + 2 hours of Assignment

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define terms in monitoring and evaluation

• Differentiate between monitoring and evaluation

• Explain importance of monitoring and evaluation in pharmacy practice

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD projector

• Handout 1.1: Glossary of Monitoring and Evaluation Terms

• Handout 1.2:Difference between monitoring and evaluation

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction ToLearning Tasks

2 40 minutes Presentation Terms used in Monitoring and Evaluation

25 minutes Presentation and Differences Between Monitoring and

Buzzing Evaluation

30 minutes Presentation and Importance of Monitoring and Evaluation in

Group Discussion Pharmacy Practice

5 10 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

7 05 minutes Assignment Take home assignment

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning task and clarify

ASK students if they have any questions before continuing.

STEP 2: Termsused in Monitoring and Evaluation (40 minutes)

• Monitoring refers to reviewing on a continuous basis, the degree to which program activities

are completed and performance targets or milestones are being met.

o Typically monitoring focuses on trucking program inputs such as funding, staff

facilities, supplies and training

o As such monitoring is part of the operational management of a program

o Monitoring also track output such availability of medicines and supplies

o It help in identifying potential problems and corrective action to be taken during

program implementation

• Evaluation refers to analysing progress towards meeting established objectives goals or

results.

o It provides feedback on the outcomes of activities such as changes in prescribing

behaviour and health care seeking behaviour, whether plans have been met and reason

for success or failure.

o Monitoring can be done through various informal and informal methods: supervisory

visits, routine reporting, sentinel reporting system, and special studies.

• Monitoring and evaluation plan—a multi-year implementation strategy for the collection,

analysis and use of data needed for project management and accountability purposes.

• Surveillance—the ongoing, systematic collection, analysis, interpretation, and dissemination

of data regarding a health-related event for use in public health action to reduce morbidity

and mortality and to improve health.

• Target—the objective a program is working towards, expressed as a measurable value or the

desired value for an indicator at a particular point in time.

• Validity—the extent to which a measurement or test accurately measures what is intended to

be measured.

• Summative evaluation—a type of evaluation conducted at the end of an intervention to

determine the extent to which anticipated outcomes were produced. It is designed to provide

information about the merit or worth of the intervention.

• Results—the outputs, outcomes, or impacts of an intervention

• Quantitative data—data collected using quantitative methods, such as surveys. Qualitative

data—data collected using qualitative methods, such as interviews, focus groups,

observation, and key informant interviews.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Project—an intervention designed to achieve specific objectives within specified resources

and implementation schedules, often within the framework of a broader program.

• Prevalence—the total number of persons living with a specific disease or condition at a

given time.

• Performance—the degree to which an intervention or organization operates according to

specific criteria or achieves results in accordance with stated goals or plans.

• Objective—a statement of a desired program result that meets the criteria of being Specific,

Measurable, Achievable, Realistic, and Time-phased (SMART).

• Intervention—a specific activity or set of activities intended to bring about change in some

aspect(s) of the status of the target population.

• Health information system (HIS)—a data system, usually computerized, that routinely

collects and reports information about the delivery and cost of health services, and patient

demographics and health status.

• Goal—a broad statement of a desired, usually longer-term, outcome of a program.

• Indicator—a quantitative or qualitative variable that provides a valid and reliable way to

measure achievement, assess performance, or reflect changes connected to an intervention

• Inputs—the financial, human, and material resources used in a program.

• Outputs—the results of program activities; the direct products or deliverables of

intervention activities.

Refer students to Handout1.1: Glossary of Monitoring and Evaluation Terms

STEP 3:Differences between Monitoring and Evaluation (25 minutes)

Activity: buzzing (5 minutes)

ASK students to pair up and buzz the following question

• What is the difference between monitoring and evaluation?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

The difference between monitoring and evaluation is summarized in the table 1.1 below;

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Table 1.1; Differences between monitoring and evaluation

MONITORING EVALUATION

clarify program objectives Analyzes why intended results were or were

not achieved

Link activities and their resources to Assesses specific causal contribution of

objectives activities to results

Translate objectives into performance Examine implementation process

indicators and set target

Routinely collects data on these indicators Explore unintended results

compares actual results with target

Ensures project accountability Judge the overall merit of the project

It is an essential part of good day to day It is an essential activity in a longer term

management process

Takes place during the implementation phase Mid-term or final evaluation is important for

making decision on overall project direction

Focus on tracking performance Focus on judgement learning and merit

Internal management responsibility Usually incorporate external agencies

Refer students to Handout1.2: Difference between monitoring and evaluation

STEP 4: Importance of Monitoring and Evaluation in Pharmacy Practice

(30 minutes)

Activity: group discussion (10 minutes)

ASK students to pair up and discuss the following questions

• What is the importance of monitoring and evaluation in pharmacy practice?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The following are importance of monitoring and evaluation in pharmacy practice

o It help to obtain Information from patients, healthcare providers as well as other

sources such plays a critical role in providing the data necessary for

pharmacovigillance to take place.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o It help to improve the process of pharmaceutical care such us data collection, identifying

drug related problem and develop therapeutic plan

o It help in obtaining drug safety information to health care professionals and other

stakeholders including WHO adverse drug reactions (ADRs) Monitoring Centres, It

help to make informed decisions regarding program operations and service delivery

based on objective evidence which will help to link the objectives together with

resources available ;

o It help to ensure the most effective and efficient use of resources.

o It help to assess the extent to which the program is having or has had the desired

impact, in what areas it is effective, and where corrections need to be considered;

STEP 5: Key Points (10 minutes)

• Evaluationrefers to analyzing progress towards meeting established objectives goals or

results.

• Monitoring refers to reviewing on a continuousbasis, the degree to which program activities

are completed and performance targets or milestones are being met.

• Surveillance—the ongoing, systematic collection, analysis, interpretation, and dissemination

of data regarding a health-related event for use in public health action to reduce morbidity

and mortality and to improve health

• Monitoring link activities and their resources while evaluation assesses specific causal

contribution of activities to results

• Monitoring is essential part of good day to day management while evaluation is essential in

longer term process

STEP 6: Evaluation (5 minutes)

• What is monitoring?

• What is evaluation?

• What is the difference between monitoring and evaluation?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Handout 1.1: Glossary of Monitoring and Evaluation Terms

• Monitoring and Evaluation Terms

This glossary includes terms typically used in the area of monitoring and evaluation (M&E)

and provides the

basis for facilitating a common understanding of M&E. Although most terms in the glossary

can be used generically, they are defined in the context of public health and AIDS programs.

Note: This is not intended to be an exhaustive list of M&E-related terms, but includes the

most commonly used terms.

• Accountability—responsibility for the use of resources and the decisions made, as well as

the obligation

to demonstrate that work has been done in compliance with agreed-upon rules and standards

and to report fairly and accurately on performance results vis-a-vis mandated roles and/or

plans.

• Activity—actions taken or work performed through which inputs such as funds, technical

assistance, and other types of resources are mobilized to produce specific outputs.

• Assumptions-hypotheses about factors or risks which could affect the progress or success

of an intervention. Intervention results depend on whether or not the assumptions made,

prove to be correct.

• Attribution—the ascription of a causal link between observed changes and a specific

intervention.

• Audit—an independent, objective quality assurance activity designed to add value and

improve an organization‘s operations. It helps an organization accomplish its objectives by

bringing a systematic, disciplined approach to assess and improve the effectiveness of risk

management, control and governance processes.

Note: Internal auditing is conducted by a unit reporting to management, while external

auditing is conducted by an independent organization.

• Baseline—the status of services and outcome-related measures such as knowledge,

attitudes, norms, behaviors, and conditions before an intervention, against which progress

can be assessed or comparisons made.

• Benchmark—a reference point or standard against which performance or achievements can

be assessed.

Note: A benchmark refers to the performance that has been achieved in the recent past by

other comparable organizations, or what can be reasonably inferred to have been achieved in

similar circumstances.

• Beneficiaries—the individuals, groups, or organizations, whether targeted or not, that

benefit directly or indirectly, from the intervention.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Case study—a methodological approach that describes a situation, individual, or the

like and that typically incorporates data-gathering activities (e.g., interviews,

observations, questionnaires) at selected

sites or programs/projects. Case studies are characterized by purposive selection of sites

or small

samples; the expectation of generalizability is less than that in many other forms of

research. The findings are used to report to stakeholders, make recommendations for

program/project improvement, and share lessons learned.

• Conclusions—point out the factors of success and failure of the evaluated intervention,

with special attention paid to the intended and unintended results, and more generally to

any other strength or weakness. A conclusion draws on data collection and analysis

undertaken through a transparent chain of arguments.

• Coverage—the extent to which a program/intervention is being implemented in the

right places (geographic coverage) and is reaching its intended target population

(individual coverage).

• Data—specific quantitative and qualitative information or facts that are collected and

analyzed.

• Economic evaluation—use applied analytical techniques to identify, measure, value

and compare the costs and outcomes of alternative interventions. Types of economic

evaluations include cost-benefit, cost-effectiveness, cost-efficiency evaluations.

• Effectiveness—the extent to which a program/intervention has achieved its objectives

under normal conditions in a real-life setting.

• Efficacy— the extent to which an intervention produces the expected results under ideal

conditions in a controlled environment.

• Efficiency—a measure of how economically inputs (resources such as funds, expertise,

time) are converted into results.

• Epidemiology—the study of the magnitude, distribution and determinants of health-

related conditions in specific populations, and the application of the results to control

health problems.

• Evaluability—extent to which an intervention or program/intervention can be evaluated

in a reliable and credible fashion.

• Evaluation—the rigorous, scientifically-based collection of information about

program/intervention activities, characteristics, and outcomes that determine the merit or

worth of the program/intervention. Evaluation studies provide credible information for

use in improving programs/interventions, identifying

lessons learned, and informing decisions about future resource allocation.

• Facility survey—a survey of a representative sample of facilities that generally aims to

assess the readiness of all elements required to provide services and other aspects of

quality of care (e.g., basic infrastructure, drugs, equipment, test kits, client registers,

trained staff). The units of observation are facilities of various types and levels in the

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

same health system. The content of the survey may vary but typically includes a facility

inventory and, sometimes, health worker interviews, client exit interviews, and client-

provider observations.

• Findings—Factual statements based on evidence from one or more evaluations.

• Formative evaluation—a type of evaluation intended to improve the performance of a

program

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Handout 1.2: Difference between monitoring and evaluation

Differences between monitoring and evaluation

Monitoring Evaluation

It determines Programme efficiency It determines Programme effectiveness

It establishes standard of performance at the It identifies inconsistencies between the

activity level programme objectives and activities

It forms a basis for Programme accountability It alerts the management of discrepancies

between actual and anticipated levels of

programme impact

It alerts the management of discrepancy It suggests changes in programme

procedures, operation and objectives

It identifies strong &weak points of programme It identifies the possible side effects of the

operations programme

• Monitoring and evaluation are essential management tools which help to ensure that health

activities are implemented as planned and to assess whether desired results are being

achieved.

• A process of measuring, recording, collecting and analyzing data on actual implementation

of the programme and communicating it to the programme managers so that any deviation

from the planned operations are detected, diagnosis for causes of deviation is carried out and

suitable corrective actions are taken.

• Monitoring:

o To provide concurrent feedback on the progress of activities

o To identify the problems in their implementation

o To take corrective action

o It helps in setting norms of performance

o It helps in measuring level of performance

o It helps in comparing performance level with standards or norms

o It helps in identifying deviations and explain the reasons for the deviation for taking

necessary corrective action

• Evaluation: To assess whether the desired results of a programme have been achieved if not how it

should be redesigned

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 2: Introduction to Pharmaceutical Assessment and

Monitoring

Total Session Time: 60 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List the aims of pharmaceutical assessment and monitoring

• Give reasons for monitoring and assessment of pharmaceutical services

• Explain the use of assessment and monitoring results

• List importance of using indicators in monitoring and evaluation of pharmaceuticals

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

• Handout 2.1:Pharmaceutical assessment and monitoring

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

10 minutes Presentation Aims of Pharmaceutical Assessment and

Buzzing Monitoring

10 minutes Presentation Reasons for Monitoring and Assessment of

Brainstorming PharmaceuticalServices

15 minutes Presentation

4 Usage of Assessment and Monitoring Results

Buzzing

10 minutes Presentation Importance of Indicators in Monitoring and

Evaluation of Pharmaceuticals services

6 05 minutes Presentation Key Points

7 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Aims of Pharmaceutical assessment and Monitoring

(10 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are aims of pharmaceutical assessment and monitoring?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The following are aims of pharmaceutical assessment and monitoring;

o Monitoring and assessing the pharmaceutical sector are vital to determine if the key

pharmaceutical objectives are met.

o Evaluate accessibility of essential medicines to people.

o Help to assess the safety, efficacy and quality of medicines

o Monitoring of rational use of medicines.

STEP 3: Reasons for Monitoring and Assessment of Pharmaceuticals

Services (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What Reasons for Monitoring and Assessment of Pharmaceuticals Services?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• There are various reasons why we monitor and assess pharmaceutical situations these

includes;

o To assess country capacity in infrastructures, resources and human

resources to support the pharmaceutical sector and implement NMPs;

o To review implementation strategies so adjustments can be made. Such as

implementation of national medicine policy

o To measure outcome of pharmaceutical objectives in terms of access and rational use of

quality medicines.

o To evaluate progress towards identified objectives

STEP 4: Usage of Assessment and Monitoring Results (15 minutes)

Activity: Buzzing (5minutes)

ASK students to pair up and buzz on the following question for 5 minutes

• What are usage of assessment and monitoring pharmaceuticals results?

ALLOW few pairs to respond and let other pairs add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Various results from monitoring and assessment of pharmaceuticals situations can be used

by different stakeholders ;

• Countries

o To focus action, prioritize, measure achievement

• National policy-makers

o To synchronize health and economic policies

o To get a clear picture of national problems and identify and prioritize strategies

o To present the performance of the pharmaceutical sector to donors and other

governmental agencies

• Health facilities

to be aware of the institutional problems and identify strategies to improve the situation

• International agencies

o To assess the structure and capability of countries when developing new projects

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o To assess the progress and accomplishment of current projects

o To assess the impact of aid

• Professional groups, NGOs and academia

o To focus their activities on advocacy activities and information campaigns

Refer students to Handout 2.1: Usage of Assessment and Monitoring Results

STEP 5:Importance of Indicators in Monitoring and Evaluation of

Pharmaceuticals Services (10 minutes)

• The following are importance‘s of using indicators in monitoring and evaluation of

pharmaceutical services

o It helps in comparing the performance of facilities, districts, regions and the overall

situation in the country. By using indicators we can compare situations such the

availability and accessibility of essential medicines between one country and another,

one region and another and districts as well.

o It helps in seeing trends over time. Helps to identify the rise and fall in availability of

essential medicine in particular time and specifically the demands of the health facilities

o It helps in setting targets. It helps set goals and guiding policy-makers in developing and

planning national strategy, including budget planning, reallocation of funding and

human resource management. Which are key cross-cutting factors that can influence

access to medicines

STEP 6: Key Points (5 minutes)

• Various results from monitoring and assessment of pharmaceuticals situations can be use

by; countries, international agencies,national policy makers, health facilities, Professional

groups, NGOs and academia

• Monitoring and evaluation of pharmaceuticals by using indicators facilitates; seeing trends

overtime, setting targets and comparing performance of facilities.

• Key objectives in monitoring and assessment of pharmaceuticals are to ensure people have

access to essential medicines, quality medicines, and use of medicines rationally.

STEP 7: Evaluation (5 minutes)

• Who can use the results from assessment and monitoring of pharmaceuticals?

• What are the aims of monitoring and assessment of pharmaceuticals?

• What are the importance of using indicators in monitoring and assessment of

pharmaceuticals?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Handout 2.1:Usage of Assessment and Monitoring Results

• Monitoring and assessing the pharmaceutical sector are vital to determine if the key

pharmaceutical objectives are met: people have access to essential medicines, these

medicines are safe, effective and of good quality, and they are used correctly.

A systematic method to assess and monitor the impact of strategies and activities will

provide information on issues and gaps, all-important input in the development of

health policies.

The WHO process for pharmaceutical monitoring and assessment uses a hierarchical

approach with three groups of indicators: Level I, Level II and Level III. This provides a

standard methodology to follow progress over time and to compare situations in

different facilities, districts and countries.

• Given the complexity of the pharmaceutical sector, a systematic method of gathering

data is very important for assessing access, quality and rational use of medicines. There

are multiple, cross-cutting factors that can influence access and rational use of quality

medicines, and a variety of strategies that countries can adopt and implement to

improve their pharmaceutical situations.

Indicators have been developed for monitoring national medicines policies (NMPs)

that enable systematic assessment, evaluation and monitoring of the formulation and

implementation of pharmaceutical policies and programmes.

• These can be used to:

o Assess country capacity, such as available infrastructure, logistics and human

resources to support the pharmaceutical sector and implement NMPs;

o monitor the implementation of NMPs;

o measure the impact of implementation strategies; and

o Evaluate progress towards identified objectives.

• Who can use the results?

All stakeholders in the pharmaceutical sector can use indicator-based assessment of the

pharmaceutical situation to inform priorities and set targets.

• They can also use regular monitoring of the sector through indicator-based studies to assess

strengths and weaknesses of strategies to improve the provision of pharmaceuticals.

o Indicators provide policy-makers and managers with a clear picture of national and

institutional problems.

• Policy-makers and managers can refer to study results when developing strategies to

strengthen the pharmaceutical sector.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Results can also be used to synchronize policies. For instance:

o Low access, as measured by availability and affordability of essential medicines, could

indicate that policies on health and medicines financingshould be reviewed.

o Economic policies may be focused on joining the global economy without adequate

consideration of the implications on pricing, affordability and availability of important

medicines.

• The presence on the market of a large number of substandard medicine

products could indicate the need to assess various policies and systems,

including licensing and inspection of manufacturers, quality assurance or

product registration.

International agencies and donors can use the results of indicator-based studies to

identify where their activities will achieve the greatest impact. Professional groups and

nongovernmental organizations (NGOs) can use the results to focus their advocacy and

information campaigns.

Standard indicators allow informative comparisons among countries. For example an

indicator-based assessment in 12 countries revealed:

• Most of the countries surveyed have relevant structures in place, however, ―it is

easier to create a structure than to make it work‖.

• Most of the countries have medicines regulatory authority with a mandate to

enforcement of regulations is often weak.

• In most of the countries, public financing for medicines is limited.

Countries may use the information as follows:

• Advocacy to disseminate and to share the results with national stakeholders,

politicians, civil society, academia and key partners (awareness issue).

Comparison with other countries at a similar level of economic development,

within the region or globally can also be made.

• Sharing the information through national workshops, by posting the

information on website links and through national brochures. These are also

good ways to elicit feedback from stakeholders.

• Analysing the country situation allows gaps, probable causes of problems and

unmet objectives to be identified. This in turn facilitates the identification of

appropriate strategies.

• Reporting by topic (access, quality, safety and rational use of medicines), and

doing the analysis by type of indicator (structure, process and output) will also

guide countries to share sub-regional experiences, through informative

comparisons.

• Guiding policy-makers in developing and planning national strategy, including

budget planning, reallocation of funding and human resource management.

Which are key cross-cutting factors that can influence access to medicines.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Providing the national medicines regulatory authorities with adequate

information for the enforcement of regulations and to assess the level of

regulatory authority capability.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 3: Assessing Monitoring and Evaluation of

PharmaceuticalsServices

Total Session Time: 120 minutes + 2 hours of Assignment

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List components of WHO operational package for assessing monitoring and evaluation of

country pharmaceutical situations

• Explain each component of WHO operational package for assessing monitoring and

evaluation of country pharmaceutical situations

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD projector

• Handout 3.1 :Components of the WHO Operational Package for Assessing, Monitoring and

Evaluation CountryPharmaceutical Situation

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

20 minutes List of Components of WHO Operational

Presentation

2 Package for Assessing Monitoring and

Buzzing

Evaluation of Pharmaceutical

85 minutes Presentation Explanation of Component of WHO

3 Small Group Operational Package for Assessing Monitoring

Discussion and Evaluation of Pharmaceutical

4 05 minutes Presentation Key Points

5 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Components of WHO Operational Package for Assessing

Monitoring and Evaluation of Pharmaceutical (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are the components of WHO operational package for assessing monitoring and

evaluation of pharmaceutical situations?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The WHO Operational Package for Assessing, Monitoring and Evaluating Country

Pharmaceutical Situations is intended as a useful tool for researchers, policy-makers,

planners and others who need to use standardized measurement tools to gather data and

other information.

• The WHO process for pharmaceutical monitoring and assessment uses a hierarchical

approach with three groups of indicators.

• The components of the WHO Operational Package for Assessing, Monitoring and

Evaluationof CountryPharmaceutical Situations include the following;

o Pharmaceutical indicators for monitoring and assessment

 Level I core indicators.

 Level II facility-based core indicators

 Level III indicators

o Preparing the survey (Level II – facility survey)

o Training data collectors

o The survey

o Data processing, analysis and reporting

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

STEP 3: Explanation on Each Component of WHO Package for Assessing

Monitoring and Evaluation of Pharmaceutical(85minutes)

Activity: Small group discussion (30 minutes)

ASK students to form small manageable group and discuss the following questions

• What are pharmaceutical indicator for monitoring and assessment?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Pharmaceutical indicators for monitoring and assessment

o Given the complexity of the pharmaceutical sector, a systematic method of gathering

data is very important for assessing access, quality and rational use of medicines.

o There are multiple, cross-cutting factors that can influence access and rational use of

quality medicines, and a variety of strategies that countries can adopt and implement to

improve their pharmaceutical situations.

o Indicators have been developed for monitoring national medicines policies (NMPs)

that enable systematic assessment, evaluation and monitoring of the formulation and

implementation of pharmaceutical policies and programmes.

o These can be used to:

 Assess country capacity, such as available infrastructure, logistics and human

resources to support the pharmaceutical sector and implement NMPs;

 monitor the implementation of NMPs;

 measure the impact of implementation strategies; and

 Evaluate progress towards identified objectives.

o All stakeholders in the pharmaceutical sector can use indicator-based assessment of

the pharmaceutical situation to inform priorities and set targets.

o Indicators provide policy-makers and managers with a clear picture of national and

institutional problems. Policy-makers and managers can refer to study results when

developing strategies to strengthen the pharmaceutical sector

o Information and data can be used to:

 Formulate or revise the NMP.

 Assess the quality of governance, such as systems and mechanisms that

would safeguard against vulnerability to corruption.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

 Encourage and facilitate cooperation between the different main players in a

o Level I indicators provide a rapid means of obtaining information on the existing

infrastructure and key processes of each component of the pharmaceutical sector.

 These indicators are assessed using a short questionnaire completed at the national

level.

o Level IIindicators

 Provide systematic data on access and rational use of quality

medicines through facility-based surveys.

 Systematic survey processes to collect data on these indicators are contained in WHO

package.

 A population-based survey has been developed as part of the current process and is

discussed in a separate document, Manual for the Household Survey to Measure

Access and Use of Medicines.

o Preparing the survey (Level II – facility survey)

 The survey of Level II indicators is a very important part of monitoring the

pharmaceutical sector because these indicators measure the outcome and impact of

pharmaceutical programmes in a country.

 Adequate preparation is needed and data collectors must be trained.

o Coordination and survey coordinator

 A national coordinator should be selected to take charge of the overall coordination of

the Level II survey, to oversee the survey process, data analysis, reporting and

presentation of results.

 The coordinator has to go through the manual carefully, covering concepts of

assessment, monitoring, indicators and how to carry out a systematic survey.

• Training data collectors

o Selecting data collectors- Based on experience, the most effective data collectors are

those with clinicalexperience such as physicians, nurses, pharmacists or paramedical

staff

o Health ministry/department staff and temporary employees with some health-related

background and experience are possible candidates.

o It can also be useful to select data collectors from different parts of the country to reflect

language differences and enable a more diverse sampling of geographical areas–this

could also resolve any concerns data collectors may have about travelling to unfamiliar

areas.

o Data collection is the most crucial part of the monitoring process. For accuracy and

reliability of information and indicator measurement, the data collectors must be well

trained.

o Training should focus on ensuring data collectors have a common understanding of the

required information and know how to gather the data and complete the survey forms in

a standardized fashion.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• The survey

o Notifying facilities to be visited- Obtain permission from officials

responsible for public health facilities.

o In some cases verbal permission may be sufficient; in others it may be necessary to send

a formal letter.

o Data collectors must be properly introduced to the facility (both for the field test and

actual survey) through an endorsement letter from the health ministry or department or

the WHO country office.

• Data processing, analysis and reporting:

o What to do with the results.The coordinator should oversee the analysis of the data and

the writing of the report.

o Guidance and a suggested report outline are provided below.

o Data processing should be carefully planned.

o Even before data collection begins, the necessary resources and a person to tabulate the

data and do the computations must be identified.

o Computation of Level II facility indicators

 During the survey, the coordinator must check the accuracy of data and

information reported as far as possible in the field

 The data entered on the Survey Forms should be calculated following the

instructions and formulas on each of the Survey Forms.

 These should be checked for completeness and consistency before making the

final calculations and analysis. Data coding and entry must be double-checked.

o Analysis and interpretation of Level I and Level II facility indicators

 Using the information from the Level I questionnaire and data from Level II

facility Summary Forms, the country pharmaceutical situation can be analysed and

discussed.

 The information in the Level I questionnaire can be used to discuss the existing

pharmaceutical sector structures, and what activities and strategies have been and

are being implemented in the country.

o Written report

 A report should be prepared in order to disseminate the information obtained.

 This report is an important source of information and a basis for decisions on

medicine policy and strategies.

 It should be persuasive and well prepared.

 The results must be discussed in a comprehensive and systematic manner, taking

into account the objectives and strategies of the medicine policy.

 Clear recommendations should be included, based on the study findings.

Refer students to Handout3.1: Components of the WHO Operational Package for

Assessing, Monitoring and Evaluation CountryPharmaceutical Situation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

STEP 4: Key Points (5 minutes)

• The components of the WHO operational package for assessing and monitoring includes;

o Pharmaceutical indicators for monitoring and assessment

o Preparing the survey (Level II – facility survey)

o Training data collectors

o The survey

o Data processing, analysis and reporting

• Level II indicators provide systematic data on access and rational use of quality

medicines through facility-based surveys

• Level I indicators provide a rapid means of obtaining information on the existing

infrastructure and key processes of each component of the pharmaceutical sector.

STEP 5: Evaluation (5 minutes)

• What are the components of WHO operational package for assessing and monitoring

country pharmaceutical situation?

• What are pharmaceutical indicators for monitoring and assessment?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Handout 3.1: Components of the WHO Operational Package for

Assessing, Monitoring and Evaluation CountryPharmaceutical

Situation

Pharmaceutical indicators for monitoring and assessment

• Monitoring NMPs is a complex task. While important, it is difficult to establish a

sustainable system of regular monitoring. Resources are not consistently allocated to

this task and there is limited advocacy for a culture of monitoring. Further, many

efforts to develop monitoring tools have been exhaustive, but impractical.

• In the past,most monitoring tools included indicators that were difficult to collect, especially

if this was done regularly.

• A number of indicator-based monitoring tools now exist. Indicators for Monitoring

National Drug Policies, a WHO manual, includes approximately 120 indicators covering

structure, process and outcomes of various NMP components. Several countries have

used it to monitor and evaluate their pharmaceutical situations. Another set of

indicators, developed by Management Sciences for Health,8 focuses on rapid

assessment of strengths and weaknesses in the pharmaceutical sector. The WHO

manual ―How to Investigate Drug Use in Health Facilities‖ has been used extensively in

many countries.

• This document, WHO Operational Package for Assessing, Monitoring and Evaluating

Country Pharmaceutical Situations. Guide for Coordinators and Data Collectors, was

developed to provide a practical indicator-based tool that can be implemented

regularly without investing large amounts of human or financial resources. This

package relies on a hierarchical approach to monitoring built around three groups of

core indicators.

• The core indicators are easy to collect using standardized methodologies, small samples of

data and simple survey techniques. These core

indicators systematically measure the most important information needed to gain a

comprehensive picture of the pharmaceutical situation in a country.

• Grouping monitoring indicators by level (Level I and Level II) has the following

advantages:

• It offers flexibility to those interested in information on the country

pharmaceutical situation:

• Rapid assessment of key pharmaceutical components;

• Monitoring outcome and achievement of key objectives of the

pharmaceutical policy; and in-depth assessment of specific system components.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• It provides practical methods for regularly monitoring NMPs and their

components.

• It encourages regular reporting and exchange of pharmaceutical information

among facilities, districts, regions, government and nongovernmental agencies

as well as international organizations.

• Level I indicators provide a rapid means of obtaining information on the existing

infrastructure and key processes of each component of the pharmaceutical sector.

These indicators are assessed using a short questionnaire completed at the national

level.

• Level II indicators provide systematic data on access and rational use of quality

medicines through facility-based surveys. Systematic survey processes to collect data

on these indicators are contained in this package. A population-based survey has been

developed as part of the current process and is discussed in a separate document,

Manual for the Household Survey to Measure Access and Use of Medicines.

• Level I core indicators

The Level I core indicators are used to assess existing structures and processes in a

national pharmaceutical system. They provide a method to rapidly assess the

implementation of NMPs and their components.

• For Level I indicators, a knowledgeable informant can coordinate the gathering of

information. Most data will be available within the Ministry of Health, although data

on intellectual property rights protection may require consultation with the responsible

ministry.

• Data collection does not require field surveys and information can easily be

updated periodically, for example every two years.

Data from Level I indicators can be used to array the achievements and weaknesses of

individual pharmaceutical systems and to illustrate common sectoral strategies and

approaches. Many WHO Member States have submitted data from the Level I

questionnaire to EDM. The WHO MedNet can be consulted to compare results over

time and among countries. Comparisons among countries can be particularly

interesting and convincing for policy-makers. The questionnaire on Level I indicators is

included as Annex 1. The indicators in this questionnaire are summarized below.

• Level II facility-based core indicators

o The Level II facility core outcome indicators support the Level I structure and process

indicators by providing specific data about important pharmaceutical outcomes. This

set of indicators requires field surveys. For data to be collected accurately and reliably,

attention must be paid to appropriate survey design, sampling and data gathering

techniques. In selecting the core outcome indicators, consideration was given to the

need to obtain the most relevant information from as limited a data collection process

as possible

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o These indicators measure the degree of attainment of strategic pharmaceutical

objectives: improved access, quality and rational use. Access is measured in terms of

the availability and affordability of essential medicines, especially to the poor and in

the public sector. Measuring the actual quality of medicines by testing samples can be

expensive. Instead, the presence of expired medicines on pharmacy shelves and the

adequacy of handling and conservation conditions of medicines are used as indicators

of quality. Finally, rational use is measured by examining prescribing and dispensing

habits and the implementation of key strategies such as standard treatment guidelines

(STGs) and essential medicines lists (EMLs).

o Level II indicators are measured in public health facilities, private drug outlets, and in

warehouses supplying the public sector.

o The survey of Level II indicators is a very important part of monitoring the

pharmaceutical sector because these indicators measure the outcome and impact of

pharmaceutical programmes in a country

• Preparing the survey (Level II – facility survey)

the survey of Level II indicators is a very important part of monitoring the

pharmaceutical sector because these indicators measure the outcome and impact of

pharmaceutical programmes in a country. Adequate preparation is needed and data

collectors must be trained.

• Coordination and survey coordinator

A national coordinator should be selected to take charge of the overall coordination of

the Level II survey, to oversee the survey process, data analysis, reporting and

presentation of results. The coordinator should be someone who is knowledgeable

about the pharmaceutical sector and experienced in conducting surveys. A thorough

working knowledge of the pharmaceutical sector will help to ensure that important

aspects of the sector are not overlooked in planning for the Level II survey. The results

of the Level I questionnaire will also inform the planning process.

o The roles and functions of the coordinator include:Communicating with government

officials and other local agencies to gain approval for the survey and to request

personnel who will do the survey; Communicating with officials and health facilities to

be visited for the field test and for the actual survey; Selecting geographical areas and

identifying facilities to be surveyed; Allocating budget and, if necessary, requesting

financial (Annex 4,) and technical support. Be sure that main components, such as data

collector training, the survey itself, including transport and per diem details, analysis and

dissemination of results, are covered; Coordinating and identifying sources of

information for the Level I questionnaireon structures and processes of the country

pharmaceutical situation;

• Identifying country-specific items on the survey forms, for example, the key

basket of medicines, treatment guidelines; Preparing all the necessary materials for training,

the field test, and survey of Level II indicators;

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Providing training and arranging the field test exercise for Level II data collectors;

Supervising the actual survey of Level II indicators; Checking that survey forms are

completed correctly and in full;

• Checking the computations on the survey forms;

• Coordinating completion of the summary forms, analysing results, writing of

the report, and presenting/giving feedback of the results to appropriate groups

• Training data collectors

• Selecting data collectors

• Based on experience, the most effective data collectors are those with clinical

experience such as physicians, nurses, pharmacists or paramedical staff. Health

ministry/department staff and temporary employees with some health-related

background and experience are possible candidates. It can also be useful to select data

collectors from different parts of the country to reflect language differences and enable

a more diverse sampling of geographical areas–this could also resolve any concerns

data collectors may have about travelling to unfamiliar areas. In all, 10 data collectors

will be needed–one team of two data collectors for each geographical area.

• The survey

o Notifying facilities to be visited

 Obtain permission from officials responsible for public health

facilities. In some cases verbal permission may be sufficient; in

others it may be necessary to send formal letter.

 Data collectors must be properly introduced to the facility (both for the

field test and actual survey) through an endorsement letter from the health

ministry/department or the

• Data processing, analysis and reporting:

o The coordinator should oversee the analysis of the data and the writing of the report.

Guidance and a suggested report outline are provided below.

Data processing should be carefully planned. Even before data collection begins, the

necessary resources and a person to encode/tabulate the data and do the computations

must be identified.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 4: Performance Indicators for Monitoring and

Evaluation

Total Session Time: 120 minutes + 2 hours Assignment

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List performance indicators in monitoring and evaluation of different pharmaceutical

situations

• Explain each performance indicators in monitoring and evaluation of different

pharmaceutical situations

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Pointer

• Computer and LCD projector

• Handout 4.1:Summary list of performance indicators

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

20 minutes Performance Indicators in Monitoring and

Presentation

2 Evaluation of Pharmaceutical Situations

Buzzing

80 minutes Explanation on Performance Indicators in

Presentation Small

3 Monitoring and Evaluation of Pharmaceutical

group discussion

Situations

4 10 minutes Presentation Key Points

5 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Performance Indicators in Monitoring and Evaluation of

PharmaceuticalSituations (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are performance indicators in monitoring and evaluation of different pharmaceutical

situations?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The WHO process for pharmaceutical monitoring and assessment uses a hierarchical

approach with three groups of indicators: Level I, Level II and Level III. This provides a

standard methodology to follow progress over time and to compare situations in

different facilities, districts and countries

• Level of core indicators are shown on diagram below

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Level II

indicators

(outcome)

Level III

• WHO NDP indicators

• Indicators for specific pharm

• How to investigate drug

• Assessing regulatory ca

Level I • TRIPS, Drug pricing, Tra

indicators

(structure& process)

• Level I indicators provide a rapid means of obtaining information on the existing

infrastructure and key processes of each component of the pharmaceutical sector.

• Level II health facility indicators provide systematic data to measure outcomes on

access (affordability and availability of key medicines and geographical accessibility of

dispensing facilities) and rational use of quality medicines, including some indication

of the quality of medicines at health facilities and pharmacies.

• Level III indicators are a more detailed and expanded list of indicators covering key

components and areas such as those elaborated in several indicator documents in

medicine pricing, medicine supply management, HIV/AIDS, TRIPS, rational drug use

(RDU) and regulatory capacity assessment.

STEP 3: Performance Indicators in Monitoring and Evaluation of

Pharmaceutical Situations (80 minutes)

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Activity: Small Group Discussion ( 30 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

• What components are in level I indicators?

ALLOW students to discuss for 15 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

• Level I core indicators

o The Level I core indicators are used to assess existing structures and processes of

national pharmaceutical system. They provide a method to rapidly assess the

implementation of NMPs and their components.

o Indicators, a knowledgeable informant can coordinate the gathering of information.

Most data will be available within the Ministry of Health, although data on intellectual

property rights protection may require consultation with the responsible

ministry. Data collection does not require field surveys and information can easily be

updated periodically, for example every two years.

o The questionnaire on Level I indicators is included as Annex of the WHO operational

package for assessing and monitoring pharmaceutical situations. The indicators in this

questionnaire are summarized below.

• Pharmaceutical components in Level I indicators

o National Medicines Policy (NMP)- An NMP document that covers the public and

private sectors, a written implementation plan and the integration of medicine and

health policies provide a basic framework to organize and improve the pharmaceutical

system.

 They also assist in coordinating the functions and strategies of each component as

they are being implemented. Regular monitoring helps to inform the NMP and its

implementation.

o Regulatory system-Regulations on medicine manufacturing, promotion and advertising,

sales, distribution, dispensing and prescribing must be in place. Legislation directed at

generic prescribing, dispensing and substitution can help increase access to essential

medicines in both the private and public sectors

o Medicines supply system- Access and availability of essential medicines, especially at

public sector facilities, are affected by how medicines are purchased and distributed

and how medicines are managed in the health system.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o Medicines financing- Access and availability are also affected by how much money

the government can allocate to medicines, pricing policies, financing schemes (such as

insurance programmes and user fees) and medicine donations.

o Production and trade – Activities ranging from repackaging to formulation of products

to developing new medicines are important in assessing the pharmaceutical sector.

Implementing TRIPS flexibilities in public health can increase access to medicines.

o Rational use of medicines – Medicines policies can often have greater impact with

effective use of strategies to improve the prescribing and dispensing practices of health

workers. Key strategies include standard treatment guidelines, curricula and

continuing education programmes on essential medicines concepts, medicines

information centres and public education campaigns.

• Level II facility-based core indicators

o The Level II facility core outcome indicators support the Level I structure and process

indicators by providing specific data about important pharmaceutical outcomes.

o This set of indicators requires field surveys

o These indicators measure the degree of attainment of strategic pharmaceutical

objectives: improved access, quality and rational use.

o Access is measured in terms of the availability and affordability of essential medicines,

especially to the poor and in the public sector.

o Measuring the actual quality of medicines by testing samples can be expensive.

o Instead, the presence of expired medicines on pharmacy shelves and the adequacy of

handling and conservation conditions of medicines are used as indicators of quality.

o Finally, rational use is measured by examining prescribing and dispensing habits and the

implementation of key strategies such as standard treatment guidelines (STGs) and

essential medicines lists (EMLs).

o Level II indicators are measured in public health facilities, private drug outlets, and in

warehouses supplying the public sector.

• Level III indicators are a more detailed and expanded list of indicators covering key

components and areas such as those elaborated in several indicator documents in

o Medicine pricing,

Medicine supply management

o TRIPS- Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

o Rational drug use (RDU)

o Regulatory capacity assessment.

o Countries can use any of these set of indicators as baseline assessment and follow-up

studies depending on needs and capabilities.

Refer students to Handout4.1: Summary list of performance indicators

STEP 4: Key Points (10 minutes)

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• The performance indicators in assessing and monitoring are grouped into three categories by

WHO level I, level II and level III indicators.

• Level II health facility indicators provide systematic data to measure outcomes

• Level III indicators are a more detailed and expanded list of indicators covering key

components and areas such as those elaborated in several indicator documents in

• Medicine pricing, and medicine supply management

• The Level I core indicators are used to assess existing structures and processes

• Level I indicators Covers key components of pharmaceutical system which include the

followings;National medicines policy,Access,Legislation and Regulation, ,Medicines supply

system and Rational use of drugs

STEP 5: Evaluation (5 minutes)

• What are the components of level II indicators?

• What are the level II indicators?

• What are level III indicators?

References

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Handout 4.1: Summary list of performance indicators

Survey Forms 1—17 have been developed to obtain data from survey sites.

The table belowsummarizes the Level II indicators and lists the corresponding survey forms.

Information on data collection and calculation can also be found on the respective survey forms.

Will be given later

Summary list of indicators and corresponding survey form used to collect the data

Indicator Survey

Form

Access

Availability of key medicines in public health facility dispensaries, 1, 10, 15

private drug

1 outlets and warehouses supplying the public sector

% of prescribed medicines dispensed or administered to patients at 6

public health

2 facility dispensaries

Average stock out duration in public health facility dispensaries 4, 16

and warehouses

3 supplying the public sector

Adequate record keeping in public health facility dispensaries and 4, 16

warehouses

4 supplying the public sector

Affordability of treatment for adults and children under 5 years of 3, 12

age at public

5 health facility dispensaries and private drug outlets

Price of key medicines in public health facility dispensaries and 2, 11

6 private drug outlets

Price of paediatrics medicines in public health facility dispensaries 2, 11

and private drug

7 outlets

Average cost of medicines at public health facilities and private 6, 14

8 drug outlets

Geographical accessibility of public health facility dispensaries 6, 14

and private drug

9 outlets

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Quality

% medicines expired in public health facility dispensaries, private 1, 10, 15

drug outlets and

1 warehouses supplying the public sector

Adequacy of conservation conditions and handling of medicines in 5, 13, 17

public health

2 facility dispensaries and warehouses supplying the public sector

Rational use of medicines

% medicines adequately labelled at public health facility 6, 14

dispensaries and privatedrug outlets

% patients knowing how to take medicines at public health facility 6, 14

dispensaries and

2 private drug outlets

Average number of medicines per prescription at public health 6, 7

facility dispensaries

3 and public health facilities

% patients prescribed antibiotics in public health facilities 7

5 % patients prescribed injections in public health facilities 7

% prescribed medicines on the essential medicines list at public 7

6 health facilities

% medicines prescribed by generic name (INN) at public health 7

7 facilities

Availability of standard treatment guidelines at public health 8

8 facilities

9 Availability of essential medicines list at public health facilities 8

% tracer cases treated according to recommended treatment 9

protocol/guide at public

10 health facilities

11 % prescription medicines bought with no prescription 14

Other information

1 % of facilities that comply with the law (presence of a pharmacist) Sections

A,C

% facilities with pharmacist, nurse, pharmacy aide/health assistant Sections

or untrained staff A,C

2 dispensing

% facilities with doctor, nurse, trained health worker/health aide Section B

3 prescribing

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

4 % facilities with prescriber trained in RDU Section B

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 5: Factors Hindering Monitoring and Evaluation of

Medicines Use

Total Session Time: 60 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List factors hindering monitoring and evaluation of medicines use

• Explain factors hindering monitoring and evaluation of medicines use

• Identify measures to improve monitoring and evaluation of medicines uses

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

15 minutes Factors Hindering Monitoring and Evaluation

Presentation

2 of Medicines Use

Buzzing

15 minutes Explanation on Factors Hindering Monitoring

3 Presentation and Evaluation of Medicines Use

15 minutes Presentation Measures to Improve Monitoring and

Brainstorming Evaluation of Medicines Uses

5 05 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Factors Hindering Monitoring and Evaluation of Medicines Use

(15 minutes)

Activity: Buzzing (5minutes)

ASK students to pair up and buzz on the following question for 5 minutes

• What are the factors hinder monitoring and evaluation of medicine uses?

ALLOW few pairs to respond and let other pairs add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Poor record keeping, availability and accessibility of medical records

• Unsustainable system of regular monitoring and evaluation of medicine use

• There is limited advocacy for culture of monitoring and evaluation of medicine use

• Economic factors

• Patient factors such as a delay of patient to be included in the sampling frame

• Inadequate number of human resource

• Lack of expertise

• Most monitoring tools include indicators that are difficult to collect data especially if done

regularly

• Limited resources that are not consistently allocated

STEP 3: Factors hindering Monitoring and Evaluation of Medicines Use

(15 minutes)

• Poor record keeping, availability and accessibility of medical records. Difficulties in

assessing the patient‘s medical files it becomes a challenge in obtaining data during

monitoring and evaluation of medicine use although others might be available but

accessibility becomes also a challenge.

• Unsustainable system of regular monitoring and evaluation of medicine use. Many

established systems for monitoring and evaluation of medicine use they do not sustain for

long time therefore it becomesdifficult to establish it again.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• There is limited advocacy for culture of monitoring and evaluation of medicine use.

Many facilities have no tendency or behaviour of carrying out monitoring and evaluation of

medicine use this lack support from facilities, pharmacies and the government itself have no

tendency of promoting monitoring and evaluation of medicine use

• Economic factor. Economy stability to support the monitoring and evaluation of medicine

use also have become unreliable due to inadequate funds to take people to field for data

collection

• Patient factors. Delay of patient to be included in the sampling frame. Delay of patients to

participate in interview during data collection on the field is ain obtaining information from

some medicine use indicators in monitoring and evaluation of medicine use.

• Inadequate number of human resource. Lack of expertise and adequate number of personnel

to perform monitoring and evaluation of medicine use

• Most monitoring tools include indicators that are difficult to collect data especially if done

regularly.

• Limited resources that are not consistently allocated. The allocation of resource for

conducting monitoring and evaluation of medicine use are not consistently allocated which

becomes difficult in conducting the assessments and monitoring of medicine uses.

STEP 4: Measures to Improve Monitoring and Evaluation of Medicines Uses

(15 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are the measures to improve monitoring and evaluation of medicine uses?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Establishment of sustainable system of monitoring and evaluation

• There should be a clear communication of plans and targets

• To promote advocacy on culture of monitoring and evaluation of medicine use

• Training personnel on importance of monitoring and evaluation of medicine use well as how

to carry it

• To put a clear availability and accessibility of medical record this will enable expertise to

carry the task easily.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• To allocate resources consistently

• To increase more number of human resource to coordinate the activity.

STEP 6: Key Points(5 minutes)

• Factor hindering monitoring and evaluation of medicine uses includes; lackof expertise,

economic factors, patient factors and insufficient human resource.

• Measures to improve monitoring evaluation of medicine uses is by allocation of more

resources consistently, making availability and accessibility of medical records

STEP 7: Evaluation (5 minutes)

• What are factors hindering monitoring and evaluation of medicine uses?

• What are measures to improve monitoring and evaluation of medicine uses?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 6: Indicators in Monitoring and Evaluation

Medicines Use

Total Session Time: 120 minutes + 2 hours of Assignment

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List indicators used in monitoring and evaluation of medicines use

• Explain application of each indicator in monitoring and evaluation of medicines use

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

35 minutes Indicators used in Monitoring and Evaluation

Presentation

2 of Medicines use

Buzzing

65 minutes Presentation

Application of Each Indicator in Monitoring

3 Small Group

and Evaluation of Medicines use

Discussion

4 05 minutes Presentation Key Points

5 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Indicators used in Monitoring and Evaluation of Medicines use

(35 minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question for 5 minutes

• What are indicators used in monitoring and evaluation of medicine use?

ALLOW few pairs to respond and let other pairs add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Medicine use indicators were developed to be used as measures of performances in three

general areas related to the rational use of medicine in primary care

o Pharmaceutical prescribing practices by health providers

o Key elements of patient care covering both clinical consultation and pharmaceutical

dispensing

o Availability of facility specific factors which support rational use such as key essential

drugs and minimum pharmaceutical information

• The medicine use indicators would typically be measured within a defined geographic or

administrative area either to describe medicine use at a given point in time or to monitor

changes over time

• Usually they tend to measure the rational use of medicine measured by facilities

• The level II indicators are used to monitor and evaluate medicine uses and they can be group

into the following aspects as from the WHO operational package ;

o Prescribing Indicators

 Average number of medicines per encounter

 Percentage of medicines prescribed by generic name

 Percentage of encounters with an antibiotic prescribed

 Percentage of encounters with an injection prescribed

 Percentage of medicines prescribed which are from the essential medicines list or

formulary list

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o Patient Care Indicators

 Average consultation time

 Average dispensing times

 Percentage of medicines actually dispensed

 Percentage of medicines that are adequately labeled

 Percentage of patients who know how to take their medicines

o Health Facility Indicators

 Availability of essential medicine list or formulary

 Availability of key set of indicator medicines

 Availability of standard treatment guideline (STG)

 The above indicators are the minimum set of measures to be calculated during a

single medicine use indicators survey

o Complementary Indicators (this have less standardization and less experience in

actual use

 Percentage of patients treated without medicines

 Average medicine costs per encounter

 Percentage of medicine cost spent on antibiotics

 Percentage of medicine cost spent on injections

 Percentage of prescriptions in accordance with STG

 Percentage of patients satisfied with care provided

 Percentage of facilities with access to impartial information

STEP 3: Application of Each Indicator in Monitoring and Evaluation of

Medicines Use (65 minutes)

Activity: Small Group Discussion ( 30 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

• What are applications of medicine use indicators?

ALLOW students to discuss for 15 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Below is the description of application of each indicator for motoring and evaluation of

medicine use;

• Prescribing Indicators

o The indicators of prescribing practices measure the performance of healthcare providers

in several key dimensions related to appropriate use of medicines

 Average number of medicines per encounter

 Purpose-To determine the prevalence of polypharmacy, which is one measure of

unnecessary prescribing.

o Percentage of medicines prescribed by generic name

 Purpose -To measure the degree to which prescribing practice conforms to the

principles of generic prescribing.

o Percentage of encounters with an antibiotic prescribed

 Purpose -To determine the prevalence of antibiotic prescribing, since over-

prescribing of antibiotics is one common type of inappropriate medicine use.

o Percentage of encounters with an injection prescribed

 Purpose -To determine the prevalence of injection use, since over-prescribing of

injections is one common type of inappropriate medicine use.

o Percentage of medicines prescribed which are from the essential medicines list or

formulary list

 Purpose -To measure the degree to which prescribing practice conforms to the

national essential medicines list (EML). The essential medicines concept is one of

the main strategies being promoted in medicines policy. More and more countries

are formulating national EMLs. For most countries, this should be the basis for all

public medicines procurement and prescribing.

• Patient Care Indicators

o Patient care indicators address key aspects of what patients experience at health facilities

and how well they have been prepared to deal with the pharmaceuticals that have been

prescribed and dispensed.

o The time that prescribers and dispensers spend with limits on the potential quality of

diagnosis and treatment

o Average consultation time

 Purpose- to measure the time that medical personnel spend with patient in the

process of consultation and prescribing

o Average dispensing times

 Purpose- To measure the average time that personnel dispensing medicine spend

with patients

o Percentage of medicines actually dispensed

 Purpose -To measure the degree to which healthy facilities are able to provide the

medicine which were prescribed

o Percentage of medicines that are adequately labeled

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

 Purpose -To assess quality of dispensing practice. If medicines are to be used

properly, they should be labelled appropriately by the person dispensing them.

o Percentage of patients who know how to take their medicines

 Purpose -To assess if patients have adequate knowledge about how to take their

medicines.

• Health Facility Indicators

o The ability to prescribe medicines rationally is influenced by many features of the

working environment. Two particularly important components are an adequate supply of

essential medicine and access to unbiased information about these medicines. Without

these it‘s difficult for health personnel to function effectively

o Availability of essential medicine list or formulary

 Purpose -To determine if prescribers and/or dispensers have access to themas key

source of pharmaceutical information that should be the basis for all

medicineprescribing and dispensing.

o Availability of key set of indicator medicines

 Purpose-to measure the availability of health facilities of key medicine

recommended for treatment of some common health problem

o Availability of standard treatment guideline (STG)

 Purpose-To determine if prescribers have available to them the key source of

therapeutic information they need in daily practice.

STEP 4: Key Points (5 minutes)

• Medicine use indicators in rational use of medicine can be group into three main categories

of indicators; prescriber indicators, patient care indicators and healthy facility indicators

• Complementary Indicators are other types of medicine use indicators with less

standardization and less experience in actual use

• Percentage of encounters with an injection prescribed is applied to determine the prevalence

of injection use, since over-prescribing of inappropriate medicine use.

• Availability of standard treatment guideline (STG) is applied to determine if prescribers

have available to them the key source of therapeutic information they need in daily practice.

• Medicine use indicators collectively measure rational use of medicine

STEP 5: Evaluation (5 minutes)

• What are the common medicine use indicators?

• What is the application of the medicine use indicators?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 7: Tools for Monitoring and Evaluation of Medicine

Use

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List tools used in monitoring and evaluation of medicine use

• Describe tools used in monitoring and evaluation of medicines use

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD projector

• Handout 7.1. Description of tools used in monitoring and evaluation of medicines use

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

25 minutes Presentation Tools used in Monitoring and Evaluation of

Buzzing Medicine use

80 minutes Presentation Description of Tools used in Monitoring and

3 Small Group Evaluation of Medicines use

Discussion

4 05 minutes Presentation Key Points

5 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning task and clarify

ASK students if they have any questions before continuing.

STEP 2: Tools used in Monitoring and Evaluation of Medicine use

(25 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are tools used in monitoring and evaluation of medicine use?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The WHO Operational Package for Assessing, Monitoring and Evaluating Country

Pharmaceutical Situations is intended as a useful tool for researchers, policy-makers,

planners and others who need to use standardized measurement tools to gather data

and other information.

• The tools presented here have already been used for several years at global and country

levels.

• The listed below are tools used in monitoring and evaluation of medicine use as per WHO

operational package for assessing and monitoring;

o Level I questionnaire.The Level I questionnaire, which is sent to countries once every

four years to update global pharmaceutical data, is included in the annexes. It can also

serve as a rapid assessment and checklist for countries to check current the

pharmaceutical structure and processes of their national pharmaceutical systems.

o Level II survey forms. The annexes contain the technical descriptions of Level II facility

indicators and the sampling process. Survey forms are included, and graphs and tables

can be from the analysis template.

o Medicine use indicators-prescribing indicator form

o A Guide for Coordinators and Data Collectors of the Level II Facility Survey Checklist

for data collectors

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o Coordinator checklist

o Copies of the National Medicines List.

o Patient records and stock cards.

• The above are necessary tools use to gather information that are brought together with WHO

operational package.

• A diskette that contains Level II facility survey forms, summary forms and

training slides.

STEP 3: Description of Tools used in Monitoring and Evaluation of

Medicines use (80 minutes)

Activity: Small Group Discussion ( 30 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

• What are the Tools used in Monitoring and Evaluation of Medicines use?

ALLOW students to discuss for 20 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

• Level I questionnaire

o The Level I questionnaire, which is sent to countries once every four years to update

global pharmaceutical data, is included in the annexes. It can also serve as a rapid

assessment and checklist for countries to check current the pharmaceutical structure and

processes of their national pharmaceutical systems

o Level I questionnaire is a questionnaire on theexisting infrastructures and key

processes of each component of the pharmaceutical sector. The completion of the

questionnaire can be accomplished in a relatively short time after identifying sourcesof

accurate information.

o The survey of Level II indicators is a very important part of monitoring the

pharmaceutical sector because these indicators measure the outcome and impact of

pharmaceutical programmes in a country.

• Level II Survey Forms numbered 1—17; these are various forms used for gathering

data in monitoring and evaluation of medicine use.

o Adequate preparation is needed and data collectors must be trained.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o The forms are given below together with their indicators use to monitor and assess

medicine use

• Survey Forms 1-6

o in Public health facility pharmacies/dispensaries

• Survey form 1

o percentage key medicines available

o percentage medicines expired

• Survey form 2

o Price of key medicine

o Price of paediatric medicines

• Survey form 3

o Affordability of treatment for adults and children under 5 years of age

• Survey form 4

o Average stock out duration

o Adequate record keeping

• Survey form 5

o Adequate conservation conditions and handling of medicines in the storeroom and

dispensing area

• Survey form 6

o Average number of medicines per prescription

o percentage medicines dispensed or administered

o percentage medicines adequately labelled

o percentage patients knowing how to take medicines

o Average cost of medicines

o Geographical accessibility of dispensing facilities

• Survey Forms 7–9Gather information regardingRational medicine use – Prescribing

indicator form

• Indicators:

o prescribed medicines on EML

o percentage patients prescribed antibiotics/injections

o percentage medicines prescribed by generic name

o public health facilities

o survey form 7

 Average number of medicines per prescription

 Percentage of patients prescribed antibiotics/injection

 Percentage ofprescribed medicines on essential medicines list

 Percentage of medicines prescribed by generic name (INN)

o Survey form 8

 Availability of Standard Treatment Guidelines

 Availability of Essential Medicines List

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o Survey form 9.percentage tracer cases treated according to recommended treatment

protocol/guide

• A Guide for Coordinators and Data Collectors of the Level II Facility Survey detailing

operational procedures to carry out the indicator survey, with step-by-step

procedures on administrative preparation (budget, training plan and schedule)

and technical requirements (training and field-testing, surveying, analysis and

reporting). Training slides are also provided.

Refer students toHandout7.1:Description of tools used in monitoring and evaluation of

medicines use

STEP 4: Key Points(5 minutes)

• Tools used in monitoring and evaluation of medicine use include; survey forms, level I

questionnaire ,checklist for data collectors, coordinator checklist

• Level one questionnaire focuses on major components such as rational use of medicine,

regulatory systems, medicine financing and national medicine policy.

• Level II Survey Forms numbered 1—17; these are various forms used for gathering data in

monitoring and evaluation of medicine use.

• A Guide for Coordinators and Data Collectors of the Level II Facility Survey detailing

operational procedures to carry out the indicator survey, with step-by-stepprocedures on

administrative preparation.

• Level I questionnaire is a questionnaire on theexisting infrastructures

STEP 5: Evaluation (5 minutes)

• What are tools used in monitoring and evaluation of medicine use?

• What are components of level one questionnaire?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Handout 7.1: Description of tools used in monitoring and

evaluation of medicines use

The level one questionnaire have the following components used to monitor and assess

medicine use together with some questions use to gather information

• National medicines (drug) policy (NMP)

o Is there a National Medicines Policy (NMP) document?

o Has a national assessment/indicator study been conducted?

• Regulatory system

o Are there legal provisions establishing the powers and

responsibilities of the medicines regulatory authority?

o Is there an existing formal medicines regulatory authority?

• Marketing authorization

o Are there legal provisions for marketing authorization

o Is a list of all registered products publicly accessible?

• Pharmacovigillance

o Are adverse drug reactions (ADRs) monitored?

• Dispensing and prescribing

o Are there legal provisions for the following Licensing and practice of pharmacy,

Licensing and practice of prescribers

• Medicines supply system

o Who is responsible for public sector medicines procurement and distribution

o Is public sector procurement pooled at the national level (i.e. there is centralized

procurement for the regions/provinces)

• Medicines financing

o What is the total public or government expenditure for

medicines in US$ for the most recent year for which data are available?

• Rational use of medicines

o Is there a national Essential Medicines List (EML)?

o If yes, how many unique medicine formulations does the national

EML contain?

• Survey Forms 10–14 collect information‘s in Private pharmacies/drug outlets

• survey form 10

o percentage of key medicines available

o percentage medicines expired

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• survey form 11

o Price of key medicines

o Price of paediatric medicines

• Survey form 12 Affordability of treatment for adults and children under 5 years of age

(moderate pneumonia with no

hospitalization)

• Survey form 13 Adequate conservation conditions and handling of medicines conditions in

storeroom and dispensing area

• Survey form 14 Average number of medicines purchased

o percentage prescription medicine bought without prescription

o percentage medicines adequately labelled

o percentage patients know how to take medicines

o Average cost of medicines

o Geographical accessibility of dispensing facilities

• Survey Forms 15–17 are used to collect information in Central/regional/district warehouses

supplying the public sector

• Survey form 15

o percentage medicines expired

o Availability of key medicines

• Survey form 16

o Average stock out duration

o Adequate record keeping

• Survey form 17

o Adequate conservation conditions and handling of medicines

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 8: The Concept of Pharmacovigillance:

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Explain pharmacovigillance

• Define terminologies used in pharmacovigillance

• List the aims of pharmacovigillance

• List key partners in pharmacovigillance

• Explain the importance of pharmacovigillance

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

2 05 minutes Presentation Explanation of Pharmacovigillance

3 15 minutes Presentation Definition of Terms in Pharmacovigillance

15 minutes Presentation and

4 Aims of Pharmacovigillance

Buzzing

5 10 minutes Presentation Key Partners in Pharmacovigillance

50 minutes Presentation and

6 Importance of Pharmacovigillance

Group discussion

7 10 minutes Presentation Key Points

8 10 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Pharmacovigillance(5 minutes)

• The etymological roots for the word "pharmacovigillance" are: pharmakon (Greek for drug)

and vigilare(Latin for to keep watch). As such, pharmacovigillance heavily focuses on

adverse drug reactions.

• Pharmacovigillance (PV) is defined as the science and activities relating to the detection,

assessment, understanding and prevention of adverse effects or any other drug-related

problem(According to WHO definition)

• Why Pharmacovigillance is needed?

The processes involved in the clinical development of medicines once put onto the market; a

medicine leaves the secure and protected scientific environment of clinical trials and is

legally set free for consumption by the general population. At this point, most medicines

will only have been tested for short-term safety and efficacy on a limited number of

carefully selected individuals.

STEP 3: Definition of Terms in Pharmacovigillance (15 minutes)

The following are some of pharmacovigillance terminologies as adopted in TFDA guideline:

• Adverse Drug Reactions (ADRs) a response to a medicinal product that is noxious or

potentially harmful and unintended and which occurs at doses normally used in human for

prophylaxis, diagnosis or therapy of a disease or for the modification of physiological

function in which individual factors may play an important role.

• Adverse eventAny unfavourable medical occurrence that in coincidence may present during

treatment with a pharmaceutical product, but which does not necessarily have a causal

relationship with the treatment.

• Benefit/risk analysis Examination of the favourable and unfavourable results of

undertaking a specific course of action.

• Life-threatening reaction isa reaction in which the patient was at risk of death at the time

of the event and does not refer to an event, which hypothetically might have caused death if

it was more severe.

• Serious adverse drug reaction A noxious and unintended response to a drug that at any

dose, may result in death, is life threatening (such as Stevens-Johnson Syndrome), requires

patient hospitalization or prolongation of existing hospitalization, causes a congenital

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

anomaly or birth defect, results in persistent or significantly is ability or incapacity, or

require intervention to prevent permanent impairment or damage.

• Side effect any unintended effect of a pharmaceutical product occurring at doses used in

man for medical treatment which is related to the pharmacological properties of the product

and in which there is no deliberate overdose.

• Unexpected adverse drug reaction An adverse reaction, the nature or severity of which is

not mentioned in the summary of product characteristic or market authorization, or expected

from characteristics

• Biological products Medical products prepared from biological material of human, animal

or microbiologic origin (such as blood products, vaccines, insulin).

• Clinical trial A systematic study on pharmaceutical products in human subjects (including

patients and other volunteers) in order to discover or verify the effects of and/or identify any

adverse reaction to investigational products, and/or to study the absorption, distribution,

metabolism and excretion of the products with the objective of ascertaining their efficacy

and safety.

• Efficacy The ability of a drug to produce the intended effect as determined by scientific

methods, for example in pre-clinical research conditions (opposite of hazard).

• Potency is a measure of drug activity expressed in terms of the amount required to produce

an effect of given intensity.

• Individual case safety reports (ICSR)A report that contains ‗information describing a

suspected adverse drug reaction related to the administration of one or more medicinal

products to an individual patient.

• Post-marketing The stage when a drug is generally available on the market.

• Pre-marketing The stage before a drug is available for prescription or sale to the public.

• Poly-pharmacy The concomitant use of more than one drug, sometimes prescribed by

different practitioners.

• Placebo An inactive substance (often called a sugar pill) given to a group being studied to

compare results with the effects of the active drug.

• Cohort study – A study that identifies defined populations and follows them forward in

time, examining their rates of disease.

• National pharmacovigillance centre – A single, governmentally recognized centre within

a country with the clinical and scientific expertise to collect,

collate, analyse and give advice on all information related to drug safety.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

STEP 4: Aims of Pharmacovigillance (15 minutes)

Activity: Buzzing (5minutes)

ASK students to pair up and buzz on the following questions for 5 minutes

• What are the aims of pharmacovigillance?

ALLOW few pairs to respond and let other pairs add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The following are aims of pharmacovigillance:

o To improve patient care and safety in relation to the use of medicines, and all medical

and paramedical interventions;

o To improve public health and safety in relation to the use of medicines;

o To contribute to the assessment of benefit, harm, effectiveness and risk of medicines,

encouraging their safe, rational and more effective (including cost-effective) use;

o To promote understanding, education and clinical training in pharmacovigillance and its

effective communication to health professionals and the public

o To identify and quantifynew adverse drug reactions (ADRs)

o To identify risk factors and populations at risk

o To detect increase in frequency of known ADRs

o To detect drug interactions

o To monitorbenefit-risk profile of a medicines and ensure that they remain within

acceptable bounds

o ADR profile of medicines within therapeutic class

o To contribute to good clinical practice in pharmacotherapy

o To prevent patients from unnecessary harm

STEP 5: Key Partners in Pharmacovigillance (10 minutes)

• The management of the risks associated with the use of medicines demands close and

effective collaboration between the key players in the field of pharmacovigillance.

• Key partners are listed below

o Government

o Industry

o Hospitals and academia

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o Medical and pharmaceutical associations

o Poisons and medicines centres information

o Health professionals

o Patients

o The media

o World Health Organization

STEP 6: Importance of Pharmacovigillance (50 minutes)

Activity: Small group discussion (15minutes)

ASK student to form small groups and answer the following question for 15 minutes

• What is the importance of pharmacovigillance?

ALLOW students to discuss for 15 minutes

WRITE their responses to the flip chart/ board

CLARIFY and SUMMARIZE by using the content below

• The following are Importance of pharmacovigillance as a field of study (Safety monitoring

of medicinal products)

o Pharmacovigillance is important study to all partners of pharmacovigillance, since it

help to ensure; Equity of access to essential drugs Drug quality and safety

and rational use of drugs.

o Pharmacovigillance is important study to country‘s drug authority

a new medicine must pass three hurdles before its approval by the national drug

regulatory authority.

o It help to provide Sufficient evidence required to show the new drug to be of good

quality, effective, and safe for the purpose or purposes for which it is proposed.

o Pharmacovigillance is important study post marketing researchers

o It help to detect drug interactions measuring the environmental burden of

medicines used in large populations

o It help assess the contribution of ‗inactive‘ ingredients (excipients) to the safety

profile

o It help to compare safety profiles of similar medicines

o Pharmacovigillance is important study of train in health professionals

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

STEP 7: Key Points (10 minutes)

• Pharmacovigillance is the science and activities relating to the detection, assessment,

understanding and prevention of adverse effects or any other drug-related problem.

• Key partners in PV include, Government, Industry, Hospitals and academia,

Poisons and medicines centres information, Health professionals, Patients and the media

• The aims of pharmacovigillance are to improve patient care and safety , to improve public

health and to promote understanding and education

• Adverse Drug Reactions (ADRs) a response to a medicinal product that is noxious or

potentially harmful and unintended and which occurs at doses normally used in human for

prophylaxis, diagnosis or therapy of a disease or for the modification of physiological

function in which individual factors may play an important role.

• Pharmacovigillance is important in post marketing researchers and country‘s drug authority.

• Pharmacovigillance is important source of drug information‘

STEP 8: Evaluation (10 minutes)

• What is pharmacovigillance?

• What is adverse drug reaction?

• What are the aims of pharmacovigillance?

• What are the key partners in pharmacovigillance?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 9: Pharmacovigillance Methods

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define pharmacovigillance methods

• List pharmacovigillance methods

• Explain each pharmacovigillance methods

• Compare reporting methods in pharmacovigillance

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD projector

• Handout 9.1 pharmacovigillance methods

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

2 05 minutes Presentation Definition of PharmacovigilanceMethods

45 minutes Presentation

3 Small group Pharmacovigillance Methods

discussion

4 20 minutes Presentation Explanations on Pharmacovigillance Methods

25 minutes Presentation Comparing the Reporting Methods of

Buzzing Pharmacovigillance

6 10 minutes Presentation Key Points

7 10 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Pharmacovigillance Methods (5 minutes)

• Pharmacovigillance methods are those methods used in pharmacovigillance in conducting

surveillance of adverse events or any other drug related problem. It can be either active

surveillance or passive surveillance

• It‘s a way to monitor drug safety.

• Are methods for gathering information

STEP 3: Pharmacovigillance Methods (45 minutes)

Activity: Small Group Discussion (20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following questions

• What are the pharmacovigillance methods?

ALLOW students to discuss for 15 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

• The following are pharmacovigillance methods used in monitoring drug safety;

o Spontaneous reporting

o Intensified ADR reporting

o Targeted reporting

o Cohort Event Monitoring

o Electronic health record(EHR) mining

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Also pharmacovigillance methods can be categorized into;

o Passive surveillance methods include; Spontaneous reports, Case series, Stimulated

reporting

o Active surveillance methods include; Sentinel sites, Medicine event monitoring, Cross-

sectional study (survey) ,Case-control study

Refer students to Handout9.1: pharmacovigillance methods

STEP 4:Explanations on PharmacovigillanceMethods(20 minutes)

• Spontaneous reporting

o A system to monitor the safety of all medicines on the market

o Voluntary submission of ICSRs by health professionals, pharmaceutical

manufacturers and patients to the nationalpharmacovigillance centre

o Requires two initial steps:

 A reporter

 Suspects that an undesirable medical event may have been caused by exposure to a

medicine

o Reports the suspicion to the national pharmacovigillance centre

o Reports may include;

 Serious ADRs

 Severe ADRs

 New drug

 Unknown (unlabelled reactions)

 ADRs in vulnerable groups (children, pregnant women, elderly

o Advantages of this method

 Most commonly used method

 Easiest method to establish

 least labour intensive

 relatively inexpensive

o Disadvantages of this method

 Inherent under‐reporting

 Captures only suspected ADRs

 Possibility ofReporting bias

• Intensified ADRs reporting

o To enhance ADR reporting of specific medicines in early post‐marketing phase

o Extension of Spontaneous Reporting Programme

o Medicines under additional monitoring include, medicines contain new active substance,

biologicalmedicines that require additional studies e.g. more data on long term use or on

rare side effects in clinical trials

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Targeted reporting

o intensified ADR Reporting within a defined cohort

o it target specific medicines, population, ADR, and clinics

• Cohort event monitoring

o To gather more information on the safety profile of a new chemical entity in early post‐

marketing phase

o Observational cohort study design

o Patients enrolled into cohort and actively followed‐up during treatment to record all

adverse events (not just suspected ADRs)Characterise known reactions

o Detect signals of unrecognised reactions

o Identify interactions with other medicines

o Detect inefficacy of medicine

o Assess safety in pregnancy and lactation

• Electronic health record(EHR) mining

o Make use of existing health records to supplement pharmacovigillance activities

o Potentially rich source of ADR data

o Mining of the THIN data base is currently being evaluated

• Which method and when?Routine pharmacovigillance (spontaneous reporting) is

recommended for all products focused pharmacovigillance is better out under specified

conditions when safety issues or potential safety issues need to be addressed .Active studies

are undertaken when data is needed quickly

STEP 5: Comparing the Reporting Methods (25 minutes)

Activity: Buzzing (10minutes)

ASK students to pair up and buzz on the following question

• Which methods report all types of ARDs?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

METHOD MEDICINES POPULATION REPORTS

Spontaneous Reporting All medicines life, All exposure All ADRs

cycle of products individuals but

denominator

unknown

Intensified ADR Reporting Specific medicines All exposure All ADRs

individuals but

denominator

unknown

Targeted Reporting Specific medicines Defined cohort Specific ADRS

All ADRs

Cohort Event Monitoring Specific medicines Defined cohort All events

Electronic health record All medicines Defined cohort All events

mining

STEP 6: Key Points (10 minutes)

• Pharmacovigillance methods are ways to monitor drug safety.

• Pharmacovigillance method spectrum include;Spontaneous Reporting, Intensified ADR

Reporting, Targeted Reporting and Cohort Event Monitoring

• Pharmacovigillance methods can be categorized into passive and active surveillance

• Spontaneous reporting involves a system to monitor all medicines

• Intensified ADR reporting involves reporting of specific medicines at early post-marketing

surveillance

• Spontaneous reporting is recommended for all products

• Active studies are undertaken when data is needed quickly

STEP 7: Evaluation (10 minutes)

• What is a pharmacovigillance method?

• What is spontaneous reporting?

• What is targeted reporting?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Handout 9.1: : Pharmacovigillance methods

• Spontaneous reporting is the mainstay of pharmacovigillance

• Definition: Spontaneous report, synonym: Spontaneous notification; An unsolicited

communication by a healthcare professional or consumer to a company, regulatory authority

or other organization (e.g. the World Health Organization, a regional centre, a poison

control centre) that describes one or more adverse reactions in a patient who was given one

or more medicinal products and that does not derive from a

study or any organized data collection scheme

• Spontaneous vs. StimulatedReporting

o Stimulated reporting can occur in certain situations, such as after a direct healthcare

professional communication, a publication in the press or questioning of healthcare

professionals by company representatives, and adverse reaction reports arising from

these situations are considered spontaneous reports

o Reporting can also be stimulated by invitation from patients‘ or consumers‘

organizations to their members

o Reporting made in the context of early post-marketing phase vigilance (EPPV), e.g. in

Japan, is also considered stimulated reporting.

• Pharmacovigillance Methods

o Passive Surveillance

o Stimulated Reporting

o Active Surveillance

o Comparative Observational Studies

o Targeted Clinical Investigations

o Descriptive Studies

• Stimulated Reporting

o Mostly for new products for early post authorization (e.g., black triangle schemes)

EPPV in Japan

o Stimulation after notification of certain risks, not managed by the MAH

o MAH planned stimulation also possible to gather more information on certain safety

issues Handled as spontaneous reports

• Active Surveillance

o Seeks to ascertain completely the number of adverse events via a continuous reorganized

process.

o Examples described include:

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o Sentinel Sites

o Drug Event Monitoring

o Registries

• Comparative Observational Studies

o Cross-Sectional Study (Survey)

o Case-Control Study

o Cohort Study

o Use of databases

• Targeted Clinical Investigations

o pharmacokinetic and pharmacodinamicstudies

o Genetic testing

o Interaction studies (drug-drug, drug-food)

o In special populations

o Large simplified trial

• Descriptive studies

o Natural History of Disease

o Drug Utilization Study

• Active Surveillance

o Seeks to ascertain more completely the number of adverse events in a given

population via a continuous organized process E.g. follow-up of patients treated with

a particular medicinal product through a risk management system. Patients who fill a

prescription for this product may be asked to complete a brief survey form and give

permission for later contact

o Active surveillance gives more comprehensive data on individual adverse event

reports than passive reporting system

o Automatic detection of abnormal laboratory values from computerized laboratory

reports in certain clinical settings may also provide an efficient active surveillance

system

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 10: Documentation of Pharmacovigillance Data

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Explain pharmacovigillance tools

• Explain handling pharmacovigillance data

• List characteristic of good documentation practices in pharmacovigillance

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

Presentation

2 10 minutes Pharmacovigillance Tools

Brainstorming

50 minutes Handling Pharmacovigillance Data

3 Presentation

45 minutes Presentation Characteristic of Good Documentation

Buzzing practices in Pharmacovigillance

5 05 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Pharmacovigillance Tools (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are the Guidelines for Monitoring of Medicines safety?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Guidelines for Monitoring of Medicines safety

o These are guidelines provided regulatory authority (TFDA) that facilitate the collection

of pharmacovigillance information

• Tanzania Pharmacovigillance Training Manual- manual for training stakeholders who are

involve in documenting and reporting of pharmacovigillance information

• Other tools include;

o Yellow forms (ADR forms)

 The Yellow card system for collecting information on suspected adverse drug

reactions (ADRs) to medicines.

 The system allows the safety of the medicines and vaccines that are on the market to

be monitored.The system was founded in 1964 after the thalidomide disaster.

 Yellow Cards are available from TFDA and a few are presented near the back of the

BNF as tear-off pages.

o Patient reporting forms –are used by patients to report any ADRs during the cause of

treatment

o Poor Quality Products reporting forms-they are used to report medicines that show poor

efficacy or poor quality products

o Patient alert cards-are carried by patient to identify them as patient with hypersensitive or

allergic to particular kind of drug

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

STEP 3: Handling Pharmacovigillance Data (50 minutes)

• Companies are required to take appropriate measures against unauthorised or unlawful

processing of personal data and against accidental loss, destruction or damage.

• Documentation containing Pharmacovigillancedata should not be left unattended and

companies should adopt a clear desk policy for Pharmacovigillance documents.

• Hard copies of documents, including those in workflow progress should be stored in a

secure and robust area such as fire- retardant cupboards/archives.

• Any database containing personal data used in PV should be fully validated or tested, as

appropriate, to ensure changes to data can be identified and access to these systems should

be restricted to named individuals. Companies may also consider configuring

Pharmacovigillance databases to restrict access to sensitive personal data so only the

country of collection has access, although this is not a requirement of the law.

• Sensitive data should be encrypted to ensure the integrity of data transmissions.

• Data and record management

o All data, documents and records related to pharmacovigillance system are physically and

electronically stored in designated folders and databases, and retained in accordance

with the relevant legislation and requirements of the regulatory integrated quality

management system on data and record management.

o Acknowledgement on receipt of the Pharmacovigillance information

o Entering the data into Vigi Flow

 Done by trained officer

 Manager review and audit the data before commitment

 A web based data management tool used to manage ADR database.

 All data are stored on a database server in Uppsala, Sweden.

o Receipt of pharmacovigillance data and follow up

 Companies collect data using a variety of tools and sources.

 When an Adverse Effect is reported to a company it is important that some personal

data is collected to meet the Pharmacovigillance requirements of having an

identifiable patient and reporter.

 Good Vigilance Practices requires that companies ensure individual case safety

reports (ICSRs) contain a minimum set of information.

 It also specifies that information relating to the patient is as complete as possible, in

accordance with local privacy laws.

 However, data subjects (persons who have experienced an Adverse Effect and if

different, the persons making the Adverse Effect reports) must understand what

personal data relating to them is being collected, by whom and for what purposes.

 Data subjects should be allowed to give their consent.

 Company follow-up request forms or Adverse Effect forms sent to a reporter for

completion.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

 Data entered into safety databases must only be processed for Pharmacovigillance

purposes and should not be processed for purposes not disclosed to the data subject.

STEP 4: Characteristics of Good Documentation practices in

Pharmacovigillance (55 minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question

• Which are characteristics of good pharmacovigillance practices in documentation?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• To ensure good pharmacovigillance practices, it is essential to have documentation with the

following characteristics :

• They must be designed, prepared, reviewed, and distributed on the basis of their usefulness;

• They must be approved, signed, and dated by the authorized personnel.

• They must be written unambiguously; their title, nature, and objective must be clear and

they must be distributed in an orderly and easily verifiable fashion;

• Reproductions of documents must be clear and legible, and the introduction of errors and

distortions in materials taken from original sources must be avoided;

• All documentary entries must be periodically reviewed and duly updated. When a document

is modified, care should be taken to prevent reappearance of previously deleted information.

• Documents should not be handwritten; however, if data need to be introduced, they can be

entered by hand clearly and legibly in indelible ink. Enough space should be left for

additional data;

• Any changes in writing the data must be signed and dated; changes should not prevent the

original data from being read. If necessary, the reason for the change will be indicated;

• Documents connected with the same report of a suspected adverse reaction should be kept in

the same file or, in its absence, clear reference should be made to their location, so that

important activities related to the report and its documentation or assessment can be

monitored;

• There should be a record book containing the number assigned to the report, dates of

reporting and entry, data on the origin of the report, and a brief description of the adverse

reaction and the medicines. It will also contain other data, such as an importability

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

algorithm, communications with the author of the report, and other comments. This book

can be generated from a computer database;

• The data can be entered through electronic data processing systems, photographic systems,

or other reliable methods.

o However, detailed information on procedures for the system used should be kept, and

the accuracy of the entries should be verified. If the documentation is processed

electronically, only authorized personnel may enter or change the data on the computer,

and a record should be kept of any alterations or deletions.

o Access should be restricted with passwords or other security measures, and it

should be possible to verify independently the results of introducing basic data.

• The confidentiality of data on the patient and the author of the report should be preserved

with codes.

o Electronically stored report files should be protected through back-up copies, so that

data can be easily accessed as long as they are kept.

STEP 5: Key Points (5 minutes)

• When an Adverse Effect is reported to a company it is important that some personal data is

collected to meet the Pharmacovigillance requirements of having an identifiable patient and

reporter.

• The confidentiality of data on the patient and the author of the report should be preserved

with codes.

• The data can be entered through electronic data processing systems, photographic systems,

or other reliable methods

STEP 6: Evaluation (5 minutes)

• What are the tools used for Monitoring of Medicines safety?

• What are characteristics of good documentation practices in pharmacovigillance?

• How are pharmacovigillance Data and records managed?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 11: Reporting Pharmacovigillance Data

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Explain ways of reporting pharmacovigillance data

• List expedited reporting requirements

• List necessary information in pharmacovigillance Reports

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

35 minutes Presentation

2 Ways of Reporting pharmacovigillance Data

Buzzing

3 25 minutes Presentation Expedited Reporting Requirements

45 minutes Presentation Necessary Information in pharmacovigillance

Brainstorming Reports

5 05 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Ways of Reporting Pharmacovigilance Data (35 minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question

• What are ways of reporting pharmacovillance data?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

The following are ways of reporting pharmacovigillance data

• Spontaneous reporting

o Spontaneous reports are termed spontaneous as they take place during the clinician's

normal diagnostic appraisal of a patient, when the clinician is drawing the conclusion

that the drug may be implicated in the causality of the event.

o Spontaneous reporting system relies on vigilant physicians and other healthcare

professionals who not only generate a suspicion of an ADR, but also report it.

o It is an important source of regulatory actions such as taking a drug off the market or a

label change due to safety problems.

o Spontaneous reporting is the core data-generating system of international

pharmacovigillance, relying on healthcare professionals to identify and report any

adverse events

o One of the major weaknesses of spontaneous reporting is that of under-reporting.

o Spontaneous reports are a crucial element in the worldwide enterprise of

pharmacovigillance and form the core of the World Health Organization Database

• Clinical trial reporting

o Also known as SAE (serious adverse event) reporting from clinical trials, safety

information from clinical studies is used to establish a drug's safety profile in humans

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

and is a key component that drug regulatory authorities consider in the decision-making

as to whether to grant or deny market authorization (market approval) for a drug.

o SAE reporting occurs as a result of study patients (subjects) who experience serious

adverse events during the conducting of clinical trials. (Non-serious adverse events are

also captured separately.)

o SAE information, which may also include relevant information from the patient's

medical background, are reviewed and assessed for causality by the study investigator.

This information is forwarded to a sponsoring entity (typically a pharmaceutical

company) that is responsible for the reporting of this information, as appropriate, to drug

regulatory authorities.

• Expedited reporting

o This refers to ICSRs (individual case safety reports) that involve a serious and unlisted

event (an event not described in the drug's labelling) that is considered related to the use

of the drug.

o Spontaneous reports are typically considered to have a positive causality, whereas a

clinical trial case will typically be assessed for causality by the clinical trial investigator

and or the license holder.

• Periodic Safety Update Reporting

o Periodic Safety Update Reports (PSURs) are important pharmacovigillance documents.

o They provide an opportunity for Marketing Authorization Holders (MAHs) to review

the safety profile of their products and ensure that the Summary of Product

Characteristics (SPC) and Package Leaflets are up to date.

o They also provide a valuable source of pharmacovigillance data.

o MAHs should submit PSURs to regulatory outhority example TFDA.

• PSURs should as a minimum contain the following information:

o Information on the product (i.e. brand name, dosage form, strength,

manufacturer and country of origin),

o The scope of drug safety data and the surveillance period,

o Collection of adverse drug reaction (ADR) information (i.e. local serious ADRs,

local non-serious ADRs, foreign serious ADRs, foreign non-serious ADRs, case

reports published on international or local literatures including academic

conferences).

• Patient reporting

o A simplified reporting form (Annex 5 of TFDA) should be used by patients to report

information on suspected adverse drug reactions.

o Patients should be encouraged to report adverse events and seek medical attention

through their health care providers.

o Further information on the report can be sought from the health care provider for

serious

and/or unknown reaction reported directly from patients.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

STEP 3: Expedited reporting requirements(25 minutes)

• All serious reactions must be reported on an expedited basis using the same ADR

reporting form (Annex 1of TFDA).

• Expedited reports should be submitted to TFDA immediately and not later than 15 calendar

days from receipt of the minimum information required for an adverse reaction report by a

health care provider or personnel of the manufacturer.

• Serious suspected adverse reactions occurring in all post-marketing studies of which

the manufacturer is aware should be reported to the TFDA on an expedited basis.

• When additional medically relevant information is received for a previously reported

case, the reporting time is considered to begin again for submission of the follow-up

report.

• In addition, a case initially classified as a non-expedited report, would qualify

for expedited reporting upon receipt of follow-up information that indicates the case

should be re-classified (e.g., from non serious to serious).

STEP 4: Necessary information in Pharmacovigillance Reports (45 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What basic information should Pharmacovigillance reporting forms contain?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• The content of the cards may differ from country to country, but all have four sections that

should be completed: patient information, description of the event, medicine information,

and notified information.

• This is the basic information that reporting forms should contain:

o Information on the suspect medicine: generic or patent name, dosage, route of

administration, treatment start and end dates, indications for use, expiration date, lot

number, and manufacturer;

o Data from the patient on his/her disease: health status before starting the medication,

co-morbidities, relevant family history of disease;

o Concomitant medicines. All other medicines taken by the patient (including self-

medication): names, dosage, route of administration, start and end dates;

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o Information on the notifying professional. The name and address of the notifier should

be considered confidential and used only to verify or complete the data or follow-up on

the case.

o Risk factors (for example, altered kidney function, exposure prior to taking the suspect

medicine, known allergies, use of recreational medicines);

o Documentation on the diagnosis of the event, including the procedures used to obtain the

diagnosis;

o The clinical course of the patient and outcome (hospitalization or death). Patient

outcome might not be available when the report is sent. In such cases there will be a

follow-up.

o Laboratory findings (including blood levels) corresponding to the start of treatment, the

medication period, and subsequent therapies.

o Information on the response after the medication is suspended, and re-exposure.

o Any other relevant information (e.g., additional details related to the event or

information on benefits received by the patient, if important for assessing the event).

STEP 5: Key Points (5 minutes)

• Ways of reporting Pharmacovigillancedata include periodic reporting, patient reporting,

expedited reporting,periodic safety reporting and clinical trial reporting.

• Basic information of Pharmacovigillance report include patient information , information of

the medicine suspected and description of the nature of adverse event

STEP 6: Evaluation (5 minutes)

• What are the ways of reporting Pharmacovigillance data?

• What are general information should Pharmacovigillance reporting forms contain?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 12: Introduction to Adverse Drug Reactions (ADRs)

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define ADRs

• Explain the predisposing factors for ADRs

• Classify ADRs

• Explain each class of ADRs

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction to Learning Tasks

10 minutes Presentation

2 Definition of ADRS

Buzzing

3 20 minutes Presentation Predisposing Factors for ADRs

20 minutes Presentation

4 Classification of ADRS

Brainstorming

5 55minutes Presentation Explanations on each Class of ADRs

6 05 minutes Presentation Key Points

7 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of ADRS (10 minutes)

Activity: Buzzing (10 minutes)

ASK students to pair up and buzz on the following question

• What is Adverse drug reaction?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Adverse drug reaction is a noxious and unintended reaction that occurs at a dose used for

the treatment, diagnosis and prevention of disease, disorder or syndrome.

• Side effects and ADRs are associated with drug use posing serious health consequences.

Sometimes the word side effect and ADR are used alternatively but there is a clear

difference between them. Side effect is often termed as type A ADR.

• Sid effect is also an undesirable effect of drug and comes under ADR.

STEP 3: Predisposing Factors for ADRs (20 minutes)

• Age:The incidence of adverse drug reaction appears to be highest in the very young and

very old people. In these two extreme periods of life, there is poorly developed and altered

physiological function respectively. Therefore, metabolism and elimination of some drugs

may be delayed.

• Pathophysiological conditions:Diseases may alter the pharmacokinetic handling of a drug,

its tissue sensitivity or the response to a drug. That is, diseases can alter drug absorption,

metabolism, elimination and the body‘s response to drugs.

• Amount of drug administered:An excessive response to drug or prolonged therapy may be

a predisposing factor for ADRs. Over dosage is often relative rather than absolute because

the individual response to a drug varies.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

• Sex:several studies have shown that for some drugs women are more likely to suffer from

ADRs than men. This is due to pharmacokinetic and or pharmacodynamic sex-related

factors.

• Previous history of allergy:Patients who have previously suffered an allergic drug reaction

appear to be more susceptible than others to allergic ADRs in general. Heredity may make

some people more susceptible to the toxic effects of certain drugs

• Racial or Genetic Factors: There may be racial differences in the incidence of some type

of ADRs or some individuals have a genetically determined response to development of

ADRs. e. g. Ethno-pharmacological difference such as glucose 6-phosphate dehydrogenise

deficiency, which predisposes to some drug induced haemolytic anaemia, is commoner

amongst Africans.

• Multiple Drug Therapy (Polypharmacy)

The incidence of ADRs increases with the number of drugs given due to risk of

interactions. Interaction between prescribed drugs is therefore an area, which is of concern

to every health care professional.

STEP 4: Classification of ADRS (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are classes of adverse drug reactions?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• There are four basic systems used to classify ADRs

o Alphabetical or ABCDE system – by Rawlins and Thompson

o According to intensity

o Underlying mechanism mode

o ADR according to frequency

STEP 5: Explanations on each class of ADRs (55 minutes)

• ABCDE SYSTEM – classify ADRs into five types

o Type A („augmented―)

 These ADR are expected

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

 They can be predicted on the base of pharmacodynamic properties of drug

 They depend on drug dose, they appear at higher doses

 Frequency is high > than 1%

 Mortality is low

 Therapy consists in dose adjustment

 e.g.: cough after ACEI, bleeding from GIT after

NSAIDs, aspirin, corticoids

o Type B (bizard―)

 Idiosyncratic reactions

 These ADR are not expected

 They can be hardly predicted

 Doesn´t depend on dose

 Occur in predisposed, intolerant patients – can be explained by rare genetic

polymorphism, allergic reactions

 Frequency is low < than 0,1%

 Mortality is high

o Type C continuous)

 This type of ADR increases number of ―spontaneous― diseases

 They occur usually after long-lasting administration

 They are often serious and persistent

 Mechanism of genesis is unclear

 They are unexpected, not predictable

 They can´t be verified experimentally

 e.g.: oral contraceptives and increased occurrence of thromboembolia.

o Type D (delayed)

 Adverse effect may be presented years after a drug was used (years resp.

generations)

 Teratogenity

 Carcinogenetic

 Mutagenity

 e.g.: cancer of vagina at daughters of mothers treated with diethylstilbestrol

o Type E (End of use)

 After therapy ending (syndrome from omitting i.e. Withdraw syndrome)

 Rebound phenomenon e.g.: beta blockers, opioids, corticosteroids, nitrates

Note: WHO in this system adds their sixth type which they referred to as type F

o Type F— (no response)

 Due to Failure of efficacy

 Caused by Resistance to antimicrobials

o ADR ACCORDING TO INTENSITY

 Mild – don´t require to stop or to change treatment

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

 Moderate – require to change therapy, but don´t threat life of the patient

 Serious – death, hospitalization, teratogenity

o ACCORDING TO FREQUENCY

 Very common – when it is greater or equal to 1/10

 Common – when it is greater or equal to 1/100

 Uncommon – when it is greater or equal to 1/1,000

 Rare – when it is greater or equal to 1/10,000

 Very rare – when it is below 1/10000

o ACCORDING TO UNDERLYING MECHANISM MODE

 Intolerance – lower than usual dose produce anticipated response

 Idiosyncratic (―unusual‖) response – determined by genetic alteration, producing

response that is not anticipated

 Allergy – response modulated by immune system

 Pseudo allergy – reaction similar to allergy but not mediated by immune system

STEP 6: Key Points(5 minutes)

• Adverse drug reaction is a noxious and unintended reaction that occurs at a dose used for the

treatment, diagnosis and prevention of disease, disorder or syndrome.

• There are four basic systems used to classify ADRs, Alphabetical or ABCDE system ,

According to intensity, Underlying mechanism mode and ADR according to frequency

• predisposing factors for ADRs include age, Racial or Genetic Factors, Previous history of

allergy, Sex, Amount of drug administered and Pathophysiological conditions

STEP 7: Evaluation (5 minutes)

• What is ADRs?

• Classify ADRs?

• What are predisposing factors for ADRs?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

Session 13: Documentation of ADRs

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List necessary information for documentation in ADRs

• Explain types of ADR reporting forms

• Explain handling of ADR data

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

30 minutes Presentation Necessary Information for Documentation of

Brainstorming ADRs

30 minutes Presentation

3 Types of ADR Reporting Forms

Buzzing

5 40 minutes Presentation Handling of ADR Data

6 10 minutes Presentation Key Points

7 05 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Necessary Information for Documentation of ADRs (30 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are the necessary information for documentation of ADRs?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Properly charting a patient‘s ADR can protect him/her from further harm and shield you and

your facility from legal problems.

• Because a significant part of the evaluation for any drug's long-term safety occurs after it's

on the market, serious ADRs should be reported to TFDA.

• Document the patient's clinical condition, your interventions, and the patient's response.

• Fill out an incident report and internal ADR report, which should contain all the information

that will be needed.

• To properly document an ADR, first document the clinical facts in the patient's medical

record. Then complete an incident report.

• Your documentation in the patient's chart and incident report should include:

o Patient information, such as date of birth, sex, race, and weight; pre-existing or

coexisting medical conditions; other medications taken, allergies; and relevant

diagnostic and lab results

o The date of the event

o Specific patient outcomes attributed to the ADR, such as prolonged hospitalization

o A clear, factual, objective and chronologic description of the problem or event.

o Document your assessment findings and interventions, all persons notified and their

responses, the dates and times of these notifications, and the actions taken by those

you've informed and the patient's response to interventions.

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o The name of the drug, the manufacturer, the lot number and expiration date on the

packaging (if available), dosage, frequency, duration, route, and times of administration.

Returning any packaging or containers to the pharmacy or retaining them as evidence.

o Your name, title, and credentials as a reporter.

STEP 3: Types of ADR Reporting Forms (30 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question

What are types of documents used to report ADRs?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The following forms/tool are used to document and report ADRs;

o Yellow form -for reporting ADRs to medicines or vaccines

 The Yellow card system for collecting information on suspected adverse drug

reactions (ADRs) to medicines.

 The system allows the safety of the medicines and vaccines that are on the market to

be monitored.The system was founded in 1964 after the thalidomide disaster.

 Yellow Cards are available from TFDA and a few are presented near the back of the

BNF as tear-off pages.

 Blue form -for reporting poor quality products. This can be used to report

substandard and counterfeit drugs

o Pharmacovigillance Register – For recording details on filled forms

o Green form -for reporting ADRs by patients themselves

o Pink card -Patient ADR alert card. The criteria for issue of alert card to patient include

 Patients who are hypersensitive/allergic/intolerance to particular drug

 Patient who develop near fatal reaction to any particular drug

 Patient who had a drug induce morbidity to any drug

 Patient who had hospital admission due to an ADR to any drug

• Apart from ADR reporting tools other documents may help obtaining information for

patients such as

• Personal Medication Record

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

o The personal medication record (PMR) is a comprehensive record of the patient‘s

medications (prescription and non-prescription medications, herbal products, and other

dietary supplements).

o Pharmaceutical personnel in their carrier may use personal medication record to include

category which will need the patient to report other medication-related problems (e.g.,

what medication caused the problem? What was the problem?)

o This will help to trace signal

STEP 5: Handling of ADR Data(40 minutes)

• An acknowledgement letter or note will be sent to the reporter for every ADR report

received with an additional reporting form.

• The ADR reports shall be stored in a confidential database at TFDA and analysed report

sent to the WHO database of International Programme on safety monitoring of drugs to

which all case reports received by the National centres are sent.

• The names of reporter and the patient will be removed before any details about a specific

adverse drug reaction are used or communicated to others.

• Publications will not disclose trade name of products unless regulatory actions have been

taken.

• In this regard information obtained from spontaneous ADR monitoring system will not be

used for commercial purposes.

• The information is only meant to improve our understanding on use of medicinal products

by reducing the risks associated with drug prescribing and administration and to ultimately

improve patient care, safety and treatment outcome.

• In the same way suspected ADR reports cannot be used in a court of law under any

circumstances.

• TFDA is responsible for providing reporting forms, collecting, analysing and

communicating the findings and evaluation reports.

• Data collected will be used for provision of timely advice to health-care professionals and

consumers on drug safety issues at facility level, national and international level.

• Who helps in gathering data relating to ADR occurrence?

o Researchers in clinical trials, patients using medicines, Pharmaceutical companies,

database, pharmacovigillance personnel, Regulatory managers, health practitioners in

general e.g. pharmacists, physicians.

• Utilisation of ADRs Data

o Data collected will be used for provision of timely advice to health-care professionals

and consumers on drug safety issues at facility level, national and international level. A

well-documented adverse drug reaction case could result in one or more of the

following;

o Further investigation of signals. For example, identifying `at risk‘ group, a dose range

which might be more suspected, suggesting a pharmaceutical group effect,

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

100

pharmacological mechanisms, lack of effect by a particular drug or investigation into the

use of a drug in the country

o Drug regulation and dissemination of information of current importance

o Education and training initiatives to improve the safe use of the medication and other

health promotion interventions as the situation may warrant including change in supply

status or withdrawal

STEP 6: Key Points(10 minutes)

• Yellow form is used for reporting ADRs to medicines or vaccines

• Documentation in the patient's chart and incident report should include,patient information,

date of the event and name of the drug

• The ADR reports shall be stored in a confidential database at TFDA and analysed report

sent to the WHO database.

• In handling of ADR datathe names of reporter and the patient will be removed before any

details about a specific adverse drug reaction are used or communicated to others.

• Researchers in clinical trials, patients using medicines, Pharmaceutical companies, database,

pharmacovigillance personnel, Regulatory managers, health practitioners in general e.g.

pharmacists, physicians helps in gathering data relating to ADRs occurrences

STEP 7: Evaluation (5 minutes)

• What is the necessary information required in documentation of ADRs?

• Mention types of ADRs reporting forms?

• Who help in gathering data in ADRs occurrences?

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

101

References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

102

Session 14: Reporting of ADRs

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List objective of ADRs monitoring

• Explain procedures for reporting ADRs

• List centres for monitoring ADRs

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard marker

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

15 minutes Presentation Objective of ADRs Monitoring

Buzzing

70 minutes presentation and Procedures for Reporting ADRs

group discussion

4 10 minutes presentation Centres for Monitoring ADRs

5 10 minutes Presentation Key Points

6 10 minutes Presentation Evaluation

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

103

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Objectives of ADRs Monitoring (15 minutes)

• The System of ADRs notification in Tanzania is a centralized reporting, whereby suspected

case reports of ADR are reported by health care professionals and pharmaceutical

manufacturers to TFDA.

• ADR reporting covers all pharmaceutical products, biologicals, herbal drugs, cosmetics and

medical devices circulating in the Tanzanian market

• In addition, drug monitoring is important in detection of lack of efficacy, detection and

prevention of counterfeit and substandard products in clinical practice.

• It is essential that the ADR monitoring program for safety of medicinal product be

supported by health care professionals

• Objectives Of ADRs Monitoring

o To detect the nature and frequency of ADRs including periodic re-evaluation of the

benefit-risk ratio of medicinal products in order to assist the drug regulatory authority,

public health programs, scientists and consumer society take appropriate action to

minimize risks of ADRs to consumers.

o To identify risk factors that may predispose, induce or influence the development,

severity and incidence of adverse reactions in the population of Tanzania, examples;

 Patient factors: genetics, racial differences, diets, diseases, prescribing practices,

culture of drug use and traditions of the people e.g. high carbohydrate, fat diet etc

 Drug interactions, drug distribution, storage and use including indications, dose,

availability and other underlying condition

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

104

STEP 3: Procedures for Reporting ADRs (70 minutes)

Activity: Small group discussion (30 minutes)

ASK students to form small manageable groups and discuss following questions

• What are procedures for reporting ADRS?

ALLOW few groups to respond and let other groups to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

The following are procedures for reporting ADRs as per TFDA guidelines

• What to report

o Any undesirable adverse event suspected to be associated with use of drug; biological

(including blood products), herbal drugs, cosmetics or medical devices should be

reported. They should include;

 All ADRs as a result of prescription and non-prescription medicine

 All suspected adverse drug reactions regardless of whether or not the product was

used in accordance with the product information provided by the company

marketing the product

 Unexpected reaction, regardless of their nature or severity, whether not consistent

with product information or labelling

 An observed increase in frequency of a given reaction

 A serious reaction, whether expected or not

 All suspected ADRs associated with drug-drug, drug-food or drug-food supplements

interactions

 ADRs in special field of interest such as drug abuse and drug use in pregnancy and

during lactation

 ADRs occurring from overdose or medication error

 Unusual lack of efficacy or when suspected pharmaceutical defects are observed

o What information is required for ADRs case report?

 The minimal standard information to be provided for proper assessment of the ADR

case report are;

 Patient information

 Adverse reactions description (include laboratory results if available)

 Information related to the suspected drug(s)

 Information on management of the adverse reactions

PST 06211 Monitoring and Evaluation of Medicines Use NTA Level 6 Semester 2 Facilitator Guide

105

 Information about the reporter

o Patient information

 Patient identity: indicate initials or record number of the patient in hospital, medical

institution, dispensary, clinic or pharmacy.

 Birth dates or age: indicate date, month and year

 Sex: Male or Female

 Weight: should be in Kilograms

• Adverse reaction(s)

o Brief description of the ADR(s): indicate the adverse(s) reaction by marking X in the

appropriate box. Preferably describe briefly the nature of the adverse reaction being

reported but as clearly as possible, including the body site and severity.

o Time/date of onset of the adverse reactions: State the time of onset or the occurrence of

the adverse reaction in relation to the administration of the drug. Indicate the date of

onset in the following order; day, month and year. For example, did the drug reaction

appear immediately following drug administration or there was temporal or spatial

correlation with administration.

o Other relevant information:

Patient medical history or laboratory data including dates if available, considered

relevant to the case or the adverse reaction being reported should be entered.

 Mention appropriate laboratory tests done to the patient and results to confirm the

adverse reaction.

 State this concisely but clearly

• Suspected drug(s)

o Name of the suspected drug (s): trade name should preferably be used, if trade name not

available, generic name may be used. Strength of the drug (s) should be stated

 Dosage, frequency and route of administration should be clearly notified.

For example;

 Dosage (specify dosage form; tablet, capsules, syrup, injection, cream, eye drops,

etc. including total amount of drugs).

 Frequency: specify unit first i.e. mg, ml, mg/kg and number of time given e.g. 4

times daily.

 Route of administration by which the drug was administered.

 Therapy date: the dates of beginning and termination of the administration of each

drug should be stated, and preferably recorded as follows:- date, month and year. If

dates are not available, record duration of treatment. If drug administration has not

been terminated at the time of reporting, state ‗Continuing‘

 Batch number and expiry date: provide these information if are available

 Reason for use: state indication or condition for which the drug(s) was given for.

 Particular of concurrently drugs(or other treatment): state particulars of other drug

administered by the patient concurrently with the suspected drug, including drug

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administration for at least 1 month back with dosage, route of administration,

duration of administration and indications.

 Provide relevant information on medical devices

• Reporter information

o Details on reporter of an ADR: mention the particulars:-name, address of the health

facility (hospital, institution, dispensary, clinic, company, pharmacy or maternity home).

E-mail address (optional), signature, telephone number and date of reporting the reaction

(indicate date, month and year)

• Who should report

o Pharmaceutical personnel, traditional medicine practitioners and others health care

providers

o Manufacturers or Product registrants

they should develop system for ADR follow-up within their company and assessment of

impact of notification of significant safety data on their products.

o All government hospitals, private hospitals, health centres, dispensaries private clinics,

private pharmacies and private nursing homes have obligation to report all ADR cases

encountered or reported to them by the patients.

In charge of the following facilities; government and private hospitals, health centres

and dispensaries they are required to nominate a focal person who will coordinate the

ADRs collection and reporting within the facility. This person will be a link between the

institution and TFDA

• When to report

o Any suspected ADR should be reported as soon as possible. Delay in reporting will

make reporting inaccurate and unreliable. If possible, report while the patient is still in

the health facility this gives a chance to reporter to clear any ambiguity by re-

questioning or examining the patient

• How to report

o Reporters should send accurate information to achieve a better and efficient program on

ADRs monitoring in Tanzania.

o Report should be sent in a standardized form for reporting ADRs. The reporting form is

self adhesive postage paid ―yellow form‖

o Dully fill in the ADRs reporting form (annexed) when encountering an ADR to the

patient.

o Use a separate form for each patient (refer to filling guides)

o A completed ADRs case report form should immediately be sealed and mailed

preferably directly to TFDA within three days or through other reporting centres for

onward transmission to the TFDA

o Reports can also be submitted online by going to the TFDA website

http://www.tfda.or.tz and clicking on ―adverse drug reaction reporting‖ on the bottom-

right

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o Reports may be sent by e-mail through the following e-mail address; adr@tfda.or.tz

o ADR reports may be faxed in cases of perceived urgency

o Any follow-up information for an ADR case that has already been reported can be sent

on another ADR form, or communicated by telephone, fax or e-mail. To enable this

information be matchedwith the original report it is very important that follow-up

reports are identified and the following should be indicated in the report;.

• Basic principles of efficient reporting

o All reports must have the following four data elements

 An identifiable patient

 A suspected adverse effect

 A named suspected drug (s)

 An identifiable reporter

 Always write legibly.

• Where to report

o Report any suspected ADRs for pharmaceutical products marketed in Tanzania to the

appropriate channels as follows:-

o Preferably directly to TFDA by post or online

o Via Zonal Drug Information Centres at Muhimbili National Hospital (MNH), Mbeya

Consultant Hospital, Bugando Medical Centre (BMC) and Kilimanjaro Christian

Medical Centre (KCMC), for onward transmission to TFDA

o Via a focal person in the following health facility; government hospitals, private

hospitals, health centres, dispensaries for onward transmission to TFDA

• How to obtain the reporting form?

o The ADR reporting form is obtained free of charge from;

 TFDA offices,the website of TFDA, downloaded at http://www.tfda.or.tz

 Zonal Drug Information Centres.

 Regional hospital,district hospitals and ADRs focal persons in hospitals, health

centres, clinic and dispensaries.

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Figure 14.1:Adverse drug reaction patient reporting form

Source: TFDA (2003).

Figure 14.2: Flow of ADR information

Source:TFDA(2003).

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STEP 4:Centres for Monitoring ADRs (10 minutes)

• Various centres are used to monitor and collect information regarding the occurrences of

adverse drug reactions include

• TFDA headquarter

• Zone TFDA centres; Eastern Zone ,Northern Zone ,Central Zone Dodoma and South

highland Zone

• Pharmacovigillance office Kigoma

• Pharmacovigillance office Mtwara

• Government/Private Health facilities

STEP 5: Key Points(10 minutes)

• The minimal standard information to be provided for proper assessment of the ADR case

report are; Patient information, Adverse reactions description (include laboratory results if

available), Information related to the suspected drug(s)

Information on management of the adverse reactions, Information about the reporter

• All reports must have the following four data elements, An identifiable patient a

suspected adverse effect, a named suspected drug (s) and an identifiable reporter

• Report the adverse reaction immediately after it occurs

STEP 6: Evaluation (10 minutes)

• What to report in ADRs?

• When to report ADRS?

• What information is required in ADRs case report?

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References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

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Session 15: Substandard and Counterfeit Medicines

Total Session Time: 120minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Explain substandard and counterfeit medicines

• Distinguish between counterfeit and substandard medicines

• Explain the effect of substandard and counterfeit medicines to the public health

• List challenges in preventing counterfeit and substandard medicines

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

20 minutes Presentation

2 Substandard and Counterfeit Medicines

Buzzing

30 minutes Presentation Differences between Substandard and

Brainstorming Counterfeit Medicines

35 minutes Presentation

Effect of Substandard and Counterfeit

4 Small Group

Medicines to the Public Health

Discussion

15 minutes Presentation Challenges in Preventing Counterfeit and

Substandard Medicines

6 10 minutes Presentation Key Points

7 05 minutes Presentation Evaluation

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Substandard and CounterfeitMedicines (20 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are the Substandard and Counterfeit Medicines?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Counterfeit medicines are medicines that are deliberately and fraudulently mislabeled with

respect to identity and /or source.(WHO)

o Their quality is unpredictable as they may count the wrong amount of active ingredients.

o In all cases counterfeit medicines are manufactured secretly with no possibility of

control.

o Counterfeiting occurs both with branded and generic products.

o It has been found that counterfeiters copy or imitate existing products but they also

manufacture products that are completely invented

o Counterfeit medicines represent an enormous public health challenge.

o Anyone, anywhere in the world, can come across medicines seemingly packaged in the

right way but which do not contain the correct ingredients and, in the worst – case-

scenario may be filled with highly toxic substances.

o In some countries, this is rare occurrence, but in others, it is an everyday reality.

• Substandard medicine Any branded or generic drug that does not meet national or

international standards for quality, purity, strength, or packaging. ―And the amount of active

substance is lower or higher than as stated in standards for quality.

• Substandard products could result from

o Poor manufacturing practices,In some countries 10–20% of medicines fail laboratory

tests for quality, substandard products could result from poor manufacturing practices,

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unsuitable packaging, storage and distribution or when generic drugs are produced by

unregistered manufacturers. Not only potency but also dissolution rates of tablets and

capsules are a problem ,Unsuitable packaging, Storage and distribution

o When generic drugs are produced by unregistered manufacturers.

o Forms in which substandard and counterfeit occurs

 Correct drug, correct ingredients not registered brand i.e. copies of original products

 Wrong ingredients, but therapeutically active

 No active ingredients

 Toxic ingredients

 Correct drug and quantities but fake packaging

 Products with high level of impurities and contaminants

 Incorrect quantities of Active Pharmaceutical Ingredient

STEP 3: Differences between Substandard and Counterfeit Medicines

(30mins)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What is the difference between substandard and counterfeit medicine?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Both counterfeit drugs and substandard drugs can be harmful, but it is important

to understand that they are different.

• By contrast, counterfeit medicines, defined by the World Health Organization (WHO) as

―spurious/falsely-labelled/falsified/counterfeit‖ medicines, are ―deliberately and

fraudulently mislabelled with respect to identity and/or source‖ (World Health Organization

2010).

• Although substandard and counterfeit medicines are similar in that both have serious public

health implications, counterfeits are not produced by licensed manufacturers.

• Although counterfeits tend to be substandard (in that they do not contain correct amounts of

active ingredient), this is not inherent in the definition of counterfeits.

• The difference in manufacturers means the problems with substandard and counterfeit

medicines are distinct.

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• Substandard medicines, for example, can be controlled through effective regulation and

enforcement, because manufacturers are known and licensed. Counterfeits, however, can be

produced in homes, small industries, and backyards, and are harder to regulate (International

Medical Products Anti-Counterfeiting Taskforce 2008).

• Substandard medicines are made by licensed manufacturers operating within the framework

of national pharmaceutical regulatory standards.

• Also referred to as ―out of specification‖ products, these include medicines sold past their

expiration date, medicines that have been compromised in shipping or storage, and

medicines that are missing active ingredients or contain the wrong ratio of active ingredients

(World Health Organization n.d.c).

• Substandard medicines may arise due to human error, negligence, or resource restrictions

(World Health Organization 2003). They may result from both inadvertent and deliberate

actions by a legitimate manufacturer.

The differences exist between counterfeit and substandard medicine aresummarized in the table

below;

SUBSTANDARD MEDICINES COUNTERFEIT MEDICINES

When substandard medicines are found, the With counterfeit drugs, the company that

company that made them is known. manufactured them is unknown.

Consequently, the authorities can work with the Authorities cannot remove the problem

company to remove the substandard medicine since the manufacturer is unknown

and correct the problem.

Have the key ingredients‘ but do Missing key ingredients

notspecifications

Have the correct active ingredients but may be May have the wrong active ingredients‘

below or above the stated standards

Are registered products Are unregistered products

Usually labelled Mis labelled

Also called out of specification, these are Medical products that are deliberately or

authorized medical product that fails to meet fraudulently misrepresent their identity

either their quality standard or their specification composition or source

or both

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STEP 4: Effect of Substandard and Counterfeit Medicines to the Public

Health (35 minutes)

Activity: Small Group Discussion ( 20 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

• What are effects substandard and counterfeit medicines to the public health?

ALLOW students to discuss for 15 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

• Impacts of counterfeit drugs may be categorized into three categories namely;

o In public health

o In the health care system

o In industrial system

• The effect of substandard and counterfeit drugs in public health include the following;

o Therapeutic failure;the regular use of substandard or counterfeit medicines can lead to

therapeutic failure or drug resistance; in some cases it can lead to death.For example:

During a meningitis epidemic in Niger in 1995, more than 50 000 people were

inoculated with fake vaccines, received as a gift from a country which thought they were

safe. The error resulted in 2500 deaths.

o Increase of mortality and morbidity;It is difficult to quantify the continental

morbidity and mortality toll of counterfeit or falsified medical products. There have

been no comprehensive studies to quantify its damage. Estimates put the total loss of life

to counterfeit pharmaceuticals between 500000 and 1 million people each year

(Kafchinski, 2009).

o In 1999, at least 30 people died in Cambodia after taking counterfeit antimalarials

prepared with sulphadoxine-pyrimethamine (an older, less effective ant malarial) which

were sold as Artusenate.

o Drug resistance (especially against antibiotics);Perhaps one of the most worrying

implications of the global boom in counterfeit medicines is the acceleration of new,

drug-resistant strains of viruses, parasites and bacteria. Counterfeit medicines for

infectious diseases containing too little or sub-therapeutic amounts of active ingredients

destroy the clinical efficacy of the genuine medicine by promoting drug resistant

pathogens.

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o Undermining public confidence in medicines;Patients who take counterfeits fail to get

better and lose faith in the effectiveness of modern medicine. In Asia where

complementary medicine is widespread, patients may turn instead to traditional or herbal

medicine. Counterfeit or falsified medicines may create the wrong impression that the

medicines themselves are ineffective and, thus, lead prescribers to unnecessarily opt for

others as their first line treatment

o Betraying the vulnerability of the pharmaceutical supply system;This is due to

interference of substandard and counterfeit in the supply chain

o Compromise credibility of national authorities;It causes devaluation of drug

authorities such TFDA

o Impact of cost;Counterfeit or falsified medicines may create the wrong impression that

the medicines themselves are ineffective and, thus, lead prescribers to unnecessarily opt

for others as their first line treatment which are of higher costs.

• Effects in health care system

o Loss of facility‘s public trust

o Growth of Irrational prescribing

o Nosocomial infections exist, since drugs are not treating diseases.

o Ethical deviation to health practitioners

o Hospital underserviced concept arise Jeopardizing credibility of national authorities

• Effects in drug industrial system

o Take away incremental revenue from the pharmaceutical companies – the vast majority

of which would have gone straight to their bottom lines.

o Some country‘s regulations, insist companies responsibilities to counterfeit medicines,

including withdrawing product from the supply chain. This could result in loss of lot of

money to the respective company.

o Drug industry profile gone down, this could lead negative market environment

STEP 5: Challenges in Prevention of Counterfeit and Substandard Medicines

(10 minutes)

• Lack of regulation and enforcement; the quality, safety and efficacy of both imported and

locally manufactured medicine in many developing countries cannot be guaranteed but lack

of regulation and enforcement poses challenge

• Unawareness of the consumer; most consumer cannot differentiate between counterfeit or

substandard and standard medicines

• Use of Inadequate equipments with low quality; the availability of the equipment is low so

is the quality e.g.; most parts of developing countries example Tanzania do not have this

equipments which makes it hard in preventing counterfeit/ sub-standards medicines

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• Lack of motivation to specific authority boards like FDAs lack motivation in fighting to

prevent counterfeit and sub-standards medicines

STEP 6: Key Points (10 minutes)

• Counterfeit medicines are medicines that are deliberately and fraudulently mislabeled with

respect to identity and /or source.(WHO)

• Substandard medicine any branded or generic drug manufactured by a registered company

that does not meet national or international standards for quality, purity, strength, or

packaging. ―And the amount of active substance is lower than as stated in standards for

quality.

• When substandard medicines are found the company that made them is known while for

counterfeit manufacturer is unknown

• Effect of substandard and counterfeit medicines to the public health includes therapeutic

failure,drug resistance, costs and compromise of drug authorities.

STEP 7: Evaluation (5 minutes)

• What are counterfeit medicines?

• What are substandard medicines?

• What is the effect of substandard and counterfeit medicines to the public health?

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References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

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Session 16: Detection of Substandard and Counterfeit

Medicines

Total Session Time: 120 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List methods for detecting substandard and counterfeit medicines

• Explain methods for detecting substandard and counterfeit medicines

• Explain how consumers can identify substandard and counterfeit

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

30 minutes Presentation Methods for Detecting Substandard and

Buzzing Counterfeit Medicines

50 minutes Presentation and

Explanation on Methods for Detecting

3 Small Group

Substandard and Counterfeit

Discussion

20 minutes Presentation and Identification of Substandard and Counterfeit

Brainstorming by Consumers

5 10 minutes Presentation Key Points

6 5 minutes Presentation Evaluation

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Methods for Detecting Substandard and Counterfeit Medicines (30

minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question in 2 minutes

• What are the methods used to identify counterfeit and substandard medicines?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The following are ways of identifying counterfeit and substandard drugs

o Chromatographic Techniques, Thin-layer chromatographic (TLC) method

o HPLC, Gas Chromatography, Ion Chromatography, and Capillary Electrophoresis.

o Visual inspection

o Use of Cutting Edge Technologies ( example Truscan)

o Test-tube colour reactions

o Melting-point determination

• A Fake drug is a drug product which is not what it purports to be. It is any drug product

which is formulated or made to appear to be better than it really is.

• The term can also refer to a drug which is deliberately and fraudulently mislabeled with

respect to identity and/or source or with fake packaging

• WHO basic tests represent one of the many screening procedures for verifying the identity

of pharmaceutical dosage forms.

• According to WHO, these tests were designed

o To provide a simple and readily applicable method for verifying the identity of drug

substances, using a limited range of easily available reagents, when the labeling and

physical attributes give rise to doubt;

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o To provide a practicable means of confirming the identity of a drug when a well-

equipped laboratory facility is not available;

o To indicate if gross degradation has occurred in certain substances that are known to

decompose readily under adverse conditions.

• Because these tests only confirm the identity of drug substances, or the presence of

impurities, the tests are not in any way intended to replace the requirements of international

pharmacopoeia or other pharmacopoeia monographs which give assurance of quality.

• How Counterfeit Drug Enter Drug Distribution System

o There can be one or more manufacturer or even repackager who handles the drug before

it reaches the retailer.

o Counterfeit drugs are associated with the practice of diversion.

o Diversion is the sale of drugs outside the distribution channels for which they were

originally intended

o Diverted drugs can originate domestically-redirection of prescription drugs from other

legitimate sources (free samples for doctors or lower priced drugs for non- profit clinics

or Medicaid programs).

o Diverted drugs can originate from the foreign market (prescription drugs are donated or

a lower-priced product is diverted to a country where a higher price product is marketed.

o Counterfeit drugs enter the distribution system, because they are purchased outside the

normal distribution chain and without the usual regulatory safeguards.

STEP 3: Explanation on Methods for Detecting Substandard and Counterfeit

Medicines (50 minutes)

Activity: Small Group Discussion ( 30 minutes)

DIVIDE students into small manageable groups

ASK students to discuss on the following question

• What are Methods for Detecting Substandard and Counterfeit Medicines?

ALLOW students to discuss for 15 minutes

ALLOW few groups to present and the rest to add points not mentioned

CLARIFY and SUMMARIZE by using the contents below

• Thin-layer chromatographic (TLC) method

o This method is used to identify and estimate the amount of the drug substance or the

presence of impurities in a drug sample. TLC method for identifying drug substances is

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based on selective affinity of test samples for the stationary or the mobile phase. TLC

procedures have been found to be suitable for testing drug products with insufficient

active ingredients and are chosen over WHO basic tests due to its specificity and

selectivity. This method is also subject to less interference by excipients.

o TLC is a planar chromatographic technique that is ideal for field drug testing

o In TLC comparisons, authentic samples travel the same distance on a TLC plate and

yield main spots of highly similar shapes, colours, intensities, and sizes as reference

standards.

o TLC is a qualitative and, when used with visual detection, semi-quantitative technique.

o The distance the sample travels is associated with its identity; the intensity of the spot

correlates with the amount of the drug present.

o High concentrations of impurities may be visible on a TLC plate as well.

o Many researchers use TLC to distinguish between authentic and falsified versions of

several medicines.

o TLC is an uncomplicated assay useful in developing countries because it yields

―versatile and robust‖ results at a low cost.

• Visual inspection

o This method involves a thorough examination of both the packaging system and dosage

forms before, during, and after purchase and even before administration. This method

serves as a lead to identifying fake products even in the absence of the knowledge of the

physical characteristics of a drug product

• Test-tube colour reactions

o Test-tube colour reaction is a WHO basic test which provides a simple and readily

available method for verifying the identity of pharmaceutical dosage forms when the

packaging system or physical attributes of the dosage form give rise to doubt. These

tests are carried out by mixing a calculated amount of the drug sample with reagents;

and observing the colour changes that may accompany the reaction. This method can

only identify a drug substance but cannot ascertain if they are in amounts other than

those declared.

• Melting-point determination

o This is another way of verifying if a drug product is genuine or not. It involves

determining the melting range; that is, the span of temperature from the point at which

the drug sample first begin to melt to the temperature at which a given drug samples is

completely melted, as indicated by the disappearance of the solid. The acceptable

melting point is usually in the range ± 4 o C from the stated value, unless otherwise

stated.

• Analytical techniques, for sophisticated counterfeits

o Advancement in technology has made product faking more sophisticated and

organized. This has led to the manufacturing of fake drugs that can hardly be

distinguished from the genuine drugs products by mere visual inspection or simple basic

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test. The use of analytical methods e.g., mass spectroscopy, High Performance Liquid

Chromatography (HPLC), etc., in identifying, separating or quantifying drug products

have greatly reduced the chances of obtaining a ―false positive‖ or a ―false negative‖

result of test drug samples under investigation.

• Use of Cutting Edge Technologies

o This involves the use of high technology devices to identify and semi-quantify active

ingredients present in drug products. These devices are portable, requiring small

amount of sample and gives immediate results on the identity of drug products in a

matter of minutes with the help of computerized control. Examples include Truscan

 TruScan is an invention by the US military. It is a hand-held non-destructive point-

and-shoot sampling device that uses Rahrnan‘s spectroscopy for on-the-spot

detection of counterfeit medicines. This device is used to conduct field based

screening of drug products and can be used to verify broad range of chemical

compounds.

• Mobile authentication service

o The Mobile Authentication Service (MAS) is one of the methods for testing counterfeit

drugs that has given many cell phone users the power to detect fake drugs. It is the

world‘s first anti- counterfeiting device that uses the short message platform. This

method of identify fake drugs is very simple to apply, and generates immediate results

on the identity of drug products.

• The ―Black eye‖

o The ―Black eye‖ is a bench-top device developed in Israel. It is a device which uses the

principle of active thermographs (Infra-Red technology) for the detection of fake drugs.

This device is very advantageous, in that, it is a non-destructive process. The Black Eye

has the capacity to screen multiple drug samples at the same time. In addition to

detecting if a drug product is genuine or not, the Black Eye can further give details of

the constituent ingredients in a pharmaceutical dosage form.

• The Radio Frequency Identification system (RFID)

o This device has the ability to automatically track and trace regulated foods and

medicines from production to the consumer using electromagnetic fields, thus

preventing the forgery of sensitive documents.

o The Global Pharma Health Fund (GPHF) Minilab Test Kit

• The Global Pharma Health Fund Minilab Test Kit is a reliable, simple, inexpensive, self-

contained mobile laboratory that is used for speedy evaluation of drug products.

o GPHF-Minilab contains the essential lab wares, chemicals, and reference materials for

testing drug products in places where formal laboratory facilities are inaccessible.

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STEP 4: Identification of Substandard and Counterfeit by Consumers (20

minutes)

Activity:Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• How can a consumer identify counterfeit drugs?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• As a consumer, you may not have access to most of the test equipment used by regulatory

bodies to verify the identity of drug products. The following tips will serve as a guide to

purchasing genuine drug products.

• Visual inspection

o Visual inspection as stated by World Health Organization (WHO) (1999) still

remains the first step in identifying potential fake drug irrespective of the analytical

methods used. This is because such observation serves as a lead to identifying fake

products even in the absence of the knowledge of the physical characteristics of a

genuine drug product. You are expected to examine carefully both the package and

its content before purchase or use

o Visual inspection of the Package

 Examine the package and check if it appears suspicious or different from what

you previously know.

 Check if the security seal has been tampered with by looking for breaks or tears

in the sealing tape and seals.

 Look for unusual fonts, font sizes, print colour, and spelling errors.

 Check the legibility of the information on both the primary and secondary

packages.

 Check if the batch number, expiry date and manufacturer‘s address on the

secondary package are the same with that on the primary package.

 Check if the manufacturer‘s address is traceable, that is, if it contains the exact

location of the company and not just the country address.

 Check if the registration number, TAN reg. number as the case is for products

marketed or sold in Tanzania) is properly printed or if it appears to be tampered

with.

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o Visual inspection of the Dosage form

 At this stage, you are meant to

 Check for differences in the physical appearance (colour uniformity, size, shape,

consistency etc.) of the drug. As stated by WHO, commonly encountered physical

defects that should be looked out for in tablets include:

 Excessive powder and/or pieces of tablets at the bottom of the container (from

abraded, crushed or broken tablets);

 Cracks or chips in the tablets, swelling, mottling, discoloration, fusion of tablets;

 Appearance of crystal on the walls of the container or on the tablet.

 Hardening or softening, cracking, swelling, mottling or discoloration of capsule shell

should also be looked out for.

 Also check the organoleptic properties of the dosage form if you have been using the

medication.

o Source

 The source of the drug also determines if you are buying a fake drug or not. Filling

your prescription in a reputable pharmacy greatly reduces your chances of buying

fake drugs while buying from illiterate and unqualified vendors who hawk drugs in

buses, motor parks and in the streets increases your chances of buying fake drugs.

o Price

 This is another way of identifying fake product. If the price is far cheaper than what is

expected, then you have to think twice. However, this may not always be true

especially for some products (fake innovator/generic brands) which may be sold at

the same price as the genuine one.

o Unexpected side effect

 Counterfeit drugs most of the time contains inert substances other than the

appropriate Active Pharmaceutical Ingredient (API).

 They may also contain incorrect substances, improper dosage or hazardous

substances which do no elicit therapeutic effect.

 Unusual side effects, allergic reactions, or a worsening of medical condition after

taking a medication may be a pointer to identifying a fake drug. The medication

should be stopped once any of the above is noticed.

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STEP 5: Key Points(10 minutes)

• The following are ways of identifying counterfeit and substandard drugs;

o Chromatographic Techniques e.g.Thin-layer chromatographic (TLC) method

o Visual inspection

o Use of Cutting Edge Technologies

o Test-tube colour reactions

o Melting-point determination

• TLC used to identify and estimate the amount of the drug substance or the presence of

impurities in a drug sample

• The Global Pharma Health Fund Minilab Test Kit is a reliable, simple, inexpensive, self-

contained mobile laboratory that is used for speedy evaluation of drug products

• Tips to identify genuine drugs by consumers include through visual inspection of the

package and dosage form, source, price.

STEP 7: Evaluation (5 minutes)

• What are the ways to identify counterfeit and substandard medicines?

• What is mini lab test kit?

• What are the uses of TLC?

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References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

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Session 17: Controlling Substandard and Counterfeit

Medicines

Total Session Time: 60 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List and explain methods for controlling substandard and counterfeit medicines

• Explain mechanisms for curbing spread of substandard and counterfeit medicines in

Tanzania

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD projector

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

25 minutes Presentation and Methods for Controlling Substandard and

Buzzing Counterfeit Medicines

20 minutes Curbing Spread of Substandard and Counterfeit

Presentation and

3 Medicines in Tanzania

Brainstorming

4 05 minutes Presentation Key Points

5 05 minutes Presentation Evaluation

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Methods for Controlling Substandard and Counterfeit Medicines

(25 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What measures can be taken to control substandard and counterfeit medicines?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

Given the diverse and complex nature of the issues and challenges related to substandard and

counterfeit medical products, a wide range of interventions are needed to effectively address

them.

• Member States should reaffirm their commitment to the fight against counterfeit medical

products and engage in updating, developing, implementation and monitoring of national

medicines policies.

• Member States should establish NMRAs that have adequate legal mandate, independence

and institutional capacity to ensure and strictly enforce compliance of medical products with

standards of quality, safety and efficacy; and to effectively

• Control the manufacture, export, import and distribution of substandard/spurious/falsely

labeled/falsified/counterfeit medicines.

• In order to address the problem of sufficient training and availability of qualified staff,

Member States should develop and implement a sustainable human resource strategy for the

pharmaceutical sector that ensures adequate human resource capacity including specialized

training and retention of regulatory personnel

• Continuing education and training programmes should be constituted into training curricula

to enhance the knowledge and skills of health personnel to enable them to prevent,

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recognize and appropriately deal with cases of substandard and counterfeit medical

products.

• Member States should put in place reliable supply systems and the requisite financial

resources to ensure the availability of quality and affordable essential medical products in

public health facilities. Comprehensive quality assurance systems for procurement and

distribution should be strengthened for the public, private and other health care providers.

• Necessary measures to ensure access to affordable medical products that meet quality and

safety standards should be incorporated and given due emphasis in national health policies

and strategic plans. Government authorities should monitor and regulate the prices of

medical products to ensure their availability and affordability

• Member States should establish effective systems to carry out specific studies and routine

market surveillance to quantify the magnitude of the problem and to inform the

development and implementation of appropriate policies and regulations

• The strategy should involve all activities aimed at fighting illegal production, distribution

and use of these medical products.

• Based on the findings of the studies, Member States should develop information, education

and communication strategies to increase awareness of policy makers, health workers and

the general public about the dangers of using substandard/spurious/ falsely labeled/falsified/

counterfeit medical products

• Member States should establish effective national, regional and interregional cooperation

and collaboration mechanisms including reinforcing regulatory networks and exchange of

information among public health, law enforcement, professional associations, NGOs and

other relevant authorities to improve prevention, detection, investigation and prosecution of

cases related to substandard/ spurious/falsely labeled/ falsified/counterfeit medical products.

• WHO should

o further develop tools and guidelines enabling Member States to adapt and implement

policies and strategies;

o Continue to assess and strengthen National Medicine Regulatory Aauthorities in order

to ensure the quality, efficacy and safety of medical products

o (Support Member States to mobilize more resources for developing human resource

capacity for the pharmaceutical sector;

o Continue to facilitate the exchange of objective and independent regulatory information

among Member States

o Intensify the promotion and implementation of good governance, accountability and

transparency in Member States;

o Strengthen the conduct and dissemination of operational research on

substandard/spurious/falsely labeled/falsified/counterfeit medical products and

encourage Member States to use evidence for policy actions; and

o Strengthen monitoring and evaluation of programmes dedicated to combating the

manufacture, distribution and use of substandard and counterfeit medicines.

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STEP 3: Curbing Spread of Substandard and Counterfeit Medicines in

Tanzania (20 minutes)

Activity:Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What measures can be taken to control spread of substandard and counterfeit medicines in

Tanzania?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• The following are measures to be taken to control spread of substandard and

counterfeitmedicines in Tanzania

o At the national levels, the government must:

 Improve the availability and affordability of medicines;

 Enact deterrent legislation prohibiting the manufacture, importation, exportation,

distribution and sale of substandard and counterfeit medicines;

 strengthen TFDA by clearly setting out its power, duties and responsibilities;

 Provide the necessary human, financial and other resources to the TFDA and

regulatory authorities;

 Training the regulatory authorities personnel‘s, including enforcement officers such

the police in the detection and investigation of substandard and counterfeit

medicines;

 Foster cooperation between TFDA and other national law enforcement agencies such

as police, customs, and the judiciary which will reduce corruption among these

agencies in the effort to reduce spread of counterfeit and substandard medicines

 Ensure that personnel working in national medicine regulation and those involved in

the detection and investigation of counterfeit medicines sign conflict of interest

forms;

 Ensure that the medicine legislation is enforced;

 Ensure that courts speedily dispose of cases involving counterfeit and substandard

medicines and that sentences passed by the judiciary reflect the seriousness of the

problem and the offence;

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 Ensure that substandard and counterfeit medicines are confiscated and destroyed

o TFDA (regulatory authorities) must:

 Ensure that all medicine manufacturing, importation, exportation and distribution

activities are carried out in premises approved by the TFDA and pharmacy council,

and that individuals and companies engaged have license to operate such activities;

 Inspect medicine establishments regularly to ensure that they comply with the

specification and standards of that particular drug;

 Ensure that all medicines are assessed and authorized before they are introduced to

the market;

 Define the ports of entry for medicines and starting materials used for the

manufacture of pharmaceutical products and should have adequate number of staffs.

 Control importation of finished pharmaceutical products and starting materials by

issuing import permits and inspecting consignments at points of entry as necessary

 Inspect the informal market to prevent any illegal trade in medicines;

 Monitor the quality of medicines on the market to detect and prevent any

substandard and counterfeit medicines from reaching the public;

 Work closely with national law enforcement agencies such as the police and custom

officers inform the public about the problem of counterfeit medicines and educate

and advise them to buy medicines from TFDA authorized sources rather than from

market places and streets;

 Encourage and advise consumers to report to their prescribers or physicians any lack

of improvement in their health status in spite of the treatment or any adverse

reactions experienced;

 Foster bilateral and multilateral agreements with other countries, in particular with

countries sharing common borders such Kenya, Zambia, Malawi, Mozambique and

Uganda where many counterfeit and substandard drug crosses these boarders;

 Seek international cooperation with organizations such as WHO, Interpol, the World

Customs Organization

o Consumers should:

 Buy medicines only from licensed pharmacies and medicine outlets;

 Be suspicious of heavily discounted medicines;

 Be insisted to get receipts when buying medicines;

 Check packaging carefully if it is properly sealed;

 Check if the packaging indicates the batch number, manufacturing date, expiry date,

and the manufacturer's name and this should be encourage through mass media so as

consumers to get this knowledge.

 Report to health worker or doctors any lack of improvement after taking a medicine

o Raising awareness

 Government must encourage a more widespread recognition of the multidimensional

nature of this growing threat and institute appropriate collaborative mechanisms.

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Legitimate private industry must also recognize their role in prevention and work more

transparently with the government.

o Development of a transparent and verifiable chain of custody from point of production

to point of sale

 Governments should work collaboratively with industry to identify common e-

pedigree standards and, where necessary, incent compliance with those criteria.

 Regular inspection.

 Post marketing inspection.

 Education on counterfeit identification.

 Legal gap analysis:the government should be encouraged to ensure that they have

relevant, up-to-date laws as well as rigorous penalties consistent with the sale and

distribution of counterfeit medicines. Our legislations govern control of drug should

be reviewed to analyze the gap exist.

 Develop a communication strategy to ensure that health professionals , the general

public and the media are aware of the dangers associated with counterfeit

medicines.

 Improve collaboration among government entities like health, police, customs; local

administration and judiciary they work together in order to effectively combat

counterfeiters.

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STEP 4: Key Points(5 minutes)

• In control of substandard and counterfeit medicines WHO should

o Further develop tools and guidelines enabling Member States to adapt and implement

policies and strategies;

o Strengthen monitoring and evaluation of programmes dedicated to combating the

manufacture, distribution and use of substandard and counterfeit medicines.

• Controlling spread of substandard and counterfeit medicines in Tanzania,

TFDA must ensure that all medicine manufacturing, importation, exportation and

distribution activities are carried out in premises approved by the TFDA and pharmacy

council, and that individuals and companies engaged have license to operate such activities;

STEP 5: Evaluation (5 minutes)

• What are the methods to control substandard and counterfeit medicines?

• What measures can be taken to control spread of substandard and counterfeit medicines in

Tanzania?

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References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

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Session 18: Distribution of Substandard and Counterfeit

Medicines

Total Session Time: 60 minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• List factors contributing to existence of substandard and counterfeit medicines

• Identify possible points of entry for substandard and counterfeit medicines into Tanzania

• Identify loopholes contributing to spreading of substandard and counterfeit medicines in

health systems

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• Computer and LCD Projector

• Handout 18.1:Factors Contributing to Existence of Substandard and Counterfeit Medicines

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 minutes Presentation Introduction, Learning Tasks

15 minutes Factors Contributing to Existence of

Presentation and

2 Substandard and Counterfeit medicines

Brainstorming

15 minutes Presentation Points of Entry for Substandard and Counterfeit

Buzzing Medicines into Tanzania

15 minutes Presentation Loopholes Contributing to Spreading of

4 Substandard and Counterfeit medicines in

Health Systems

5 05 minutes Presentation Key Points

6 05 minutes Presentation Evaluation

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Factors Contributing to Existence of Substandard and Counterfeit

Medicines (15 minutes)

Activity:Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are the factors contributing to existences of substandard and counterfeit medicines?

ALLOW few students to respond

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Factors which encourage or contribute to existence of substandard counterfeit medicines

includes;

o Delay of raw materials / Shortage of raw material

o Poor supervision and inspection

o Poor maintenance of equipment

o Lack of quality equipment

o Employment of unskilled personnel

o Poor storage condition

o Absence of or a weak drug regulation body

o Corruption and conflict of interest

o Lack of awareness among health professions and consumers.

o Ineffective cooperation among stakeholders

o Expansion of trade and deregulation.

Refer students to Handout 18.1: Factors Contributing to Existence of Substandard and

Counterfeit Medicines

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STEP 3: Points of Entry for Substandard and Counterfeit Medicines into

Tanzania (15 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are possible points of entry for substandard and counterfeit medicines?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• The following are the approved designated ports of entry for all pharmaceutical products

and raw materials imported into the country

o Dar-es-salaam International Airport

o Dar es salaam sea Port

o Kilimanjaro International Airport,

o Horohoro ,Holili, Namanga, Sirari, Mwanza Port,

o Mwanza airport, Tanga Port and Tunduma.

• There are only eleven official ports approved to import and export pharmaceutical data

shows that there other unofficial/unregulated ports almost 49 which are also used to import

and export drugs of which gives a big chance from counterfeit drugs to be

imported.(according to a research conducted by Phoibe Clifford MagiliMzumbe university

2013)

• TFDA lacks adequate work forces to cover all mini unnoticed ports of entrieswhere drug

dealers can use as avenue to import fake products, because the inspection guards are only in

the official ports while unofficial ports are left freely unregulated.

• Mainly noticed points of entry of substandard and counterfeits in Tanzania are

o Lake Zone-The problem in Tanzania‘s Lake Zone is serious because counterfeit drugs

aresmuggled from neighbouring countries through ‗panya roots‘. Worse still, members

of thepublic are not aware of the problem and its dangers.

o Southern Highlands Zones covers Mbeya, Ruvuma, Rukwa and Iringa with only one

office located in Mbeya with few staffs.

o Also regions such as Tabora and Lindi are not covered hence these places are easily

taken advantage of.

• International trade of pharmaceuticals and sales through the Internet has further facilitated

the entry of counterfeit products into the supply chain.

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• Unregulated borders such as Holili, Tarakea also become points of entry since there are no

regulatory authority personnel

• Unregulated official ports of entry there are more than 49 but only nine are regulated

• The majority of imported counterfeit goods (80 per cent) enter Tanzania through the Port of

Dar es Salaam and to a lesser extent through Tanga and Mbeya, while entry via Zanzibar is

also widespread.(according to confederation of Tanzania industries research of 2017)

STEP 4: Loopholes Contributing to Spreading of Substandard and

Counterfeit Medicines in Health Systems (15 minutes)

• In Tanzania, the problem of counterfeit drug has grown higher especially when laws were

weak and more unserious especially in 1990‟s where there were no at all sufficient laws to

deal with the problem.

• From 2003 after establishment of TFDA laws concernedwhith regulation of drugs were

established. However there has always been a loophole that gives way to the problem to

keep flourish hence counterfeit drugs still flow to some extent in Tanzania.

• The following are weaknesses which contribute to the spread of substandard and counterfeit

medicines in the healthcare systems;

o Corruption and conflict of interest-The efficiency of personnel working in medicine

regulation and those involved in law enforcement activities such as police, customs and

the judiciary, is adversely affected by conflict of interest and corruption resulting in laws

not being enforced and criminals not being arrested, prosecuted and convicted for their

crimes

o Weak medicine legislation-Legislation and regulations form the basis for medicine

regulation. Where legislation and regulations do not exist or are inadequate for proper

control of medicines, criminal are encouraged to produce substandard and counterfeit

medicines.

o The absence of legislation prohibiting the manufacture of and trade in counterfeit

medicines or the absence of deterrent sanctions encourages counterfeiters since there is

no fear of being apprehended and prosecuted

o Unregulated prices of medicines;When prices of medicines are high and price

differentials between identical products exist there is a greater incentive for the

consumer to seek medicines outside the normal supply system.

o Shortage or erratic supply of medicines;when the supply of medicines in a country is

short or erratic, patients and consumers tend to look for alternative sources. Such

situations encourage criminals to smuggle in medicines or manufacture counterfeit

medicines and distribute them as a substitute for genuine medicines

o Uncontrolled uses of medicines;Consumers who use medicines inappropriately generate

demand for such medicines, the sourcesof which may beSpurious/falsely-

labelled/falsified/counterfeit (SFFC) medicines

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 For example, the misuse of creams containing steroids for skin bleaching and body

building medicines has generated a market for SFFC steroid-containing medicines.

 Often, these medicines are distributed through unauthorized channels or illicit

markets

• Legal gap;There is a great deficiency in the laws regulating importation and exportation of

medicines whereby it has no well define what is counterfeit and substandard

• Inefficient cooperation between stakeholders;lnterSectoral cooperation between regulatory

authorities, police, and customs services and the judiciary is essential for effective control of

the national drug market and enforcement of drug legislation.

o When such cooperation is ineffective, counterfeiters can escape detection, arrest, and

penal sanctions.

o Equally, the cooperation of the pharmaceutical industry, wholesalers, and retailers to

report to the national drug regulatory authority cases of counterfeit drugs is necessary in

combating counterfeit drugs.

o Where such cooperation is lacking the national drug authority may not be able to take

measures.

STEP 5: Key Points (5 minutes)

• Several factors which contribute to existence of substandard and counterfeit medicines

includes , Poor storage condition, Absence of or a weak drug regulation body, Corruption

and conflict of interest, Lack of awareness among health professions and consumers.

• Possible points of entry for substandard in Tanzania are lake zone, southernhigherland zone,

Zanzibar routes, unregulated ports of entry and borders.

• Some of the weakness that contribute to spread of substandard and counterfeit medicines in

Tanzania are; legal gap, , corruption and conflict of interest and Inefficient cooperation

among stakeholders

STEP 6: Evaluation (5 minutes)

• What are factors contributing to existences of counterfeit and substandard medicines?

• Mention points of entry of substandard and counterfeit medicines in Tanzania?

• What are the loopholes that contribute to spread of substandard and counterfeit medicines

in health system?

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References

Quick, J. D. (1997). Managing drug supply the selection, procurement, distribution and use of

pharmaceuticals. West Hartford, CT: KumarianPress.Bartsch, S. (2007).

The Global Fund to Fight AIDS, Tuberculosis and Malaria. Global Health Governance and the

Fight Against HIV/AIDS,146-171. doi:10.1057/9780230591349

WHO Operational package for assessing, monitoring and evaluating country pharmaceutical

situations. (2015, November 20). Retrieved from

https://www.who.int/medicines/publications/WHO_TCM_2007.2/en/

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Handout 18.1: Factors Contributing to Existence of Substandard and

Counterfeit Medicines

• Competition in pharmaceutical industries thus make industries to produce medicines

with lower prices

• Easy to manufacture

• Lack of supervision, security and inspection.

• Economic factors i.e. poverty and lower income of a country.

• Lack of trained personnel

• Poor quality of equipment

• Lack of capital

• Poor availability of raw materials

• Poor storage condition of the product

• Poor quality of raw materials

• Poor manufacture

• mishandling of drugs e.g. poor storage leading to sub-standard drugs

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