NTA Level 6 • Semester 2 • PST06211

Distribution of Substandard and Counterfeit Medicines ………………………………….. 139

Monitoring and Evaluation of Medicine Use • Source Session/Topic 18

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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

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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

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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

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