Prof Ilse Truter, Dr Johan c lamprecht, Prof Jan hp serfontein, Dr V stuvig, Mr t serfontein, Prof Martie s lubbe

НазваниеProf Ilse Truter, Dr Johan c lamprecht, Prof Jan hp serfontein, Dr V stuvig, Mr t serfontein, Prof Martie s lubbe
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Study guide compiled by:
Prof Ilse Truter, Dr Johan C Lamprecht,
Prof Jan HP Serfontein, Dr V Stuvig, Mr T Serfontein, Prof Martie S Lubbe

=Page layout by Elsabé Botha, graphikos.

Printing arrangements and distribution by Department Logistics (Distribution Centre).

Printed by The Platinum Press (018) 299 4226.

Copyright  2012 edition. Date of revision 2012.

North-West University, Potchefstroom Campus.

No part of this book may be reproduced in any form or by any means without written permission from the publisher.


A word of welcome vi

Pre-requisite vi

Rationale vi

Module outcomes vii

Study materials vii

Support references viii

How to use this study guide viii

Study process icons viii

Action verbs xi

Evaluation xiii

Time schedule xiii

Assignments xiv

Warning against plagiarism xv

1 An introduction to pharmacoepidemiology 1

1.1 Introduction 2

1.2 Historical development of pharmacoepidemiology 3

1.3 Scope of pharmacoepidemiology 6

1.4 Introduction to epidemiology and public health 8

1.5 In summary 11

2 Epidemiological concepts 13

3 Observational study designs 19

3.1 Observational study designs 22

4 Experimental study designs 29

5 Data identification and analysis 35

6 Concept of risk and risk assessment in pharmacoepidemiology 39

7 Screening and diagnostic testing 47

8 Post-marketing surveillance 55

9 An overview of drug utilisation studies 59

9.1 Definition and overview 60

9.2 Classification of drug utilisation review (DUR) 62

9.2.1 Quantitative DUR 62

9.2.2 Qualitative DUR 62

9.3 Drug utilisation review studies 63

9.4 The purpose of DUR 64

9.5 The need for DUR 65

9.5.1 Prescribing and utilisation of drugs 65

9.5.2 Increasing cost of medicine. 65

9.6 Importance of DUR 66

9.6.1 Clinical research 66

9.6.2 The identification of adverse drug reactions 66

9.6.3 Importance to the manufacturer 66

9.6.4 Economic importance 67

9.6.5 Quality importance 67

9.6.6 Forces behind the outcome-based approach 67

9.7 Applying quality control to health care 68

9.8 Aspects of implementing a DUR programme 68

9.8.1 The characteristics of a detailed DUR programme 68

9.8.2 Local implementation 68

9.8.3 The use of voluntary techniques to attain more rational use of drugs 69

9.8.4 Automated systems 69

9.9 Managed health care and DUR 69

9.9.1 Hospital preadmission certification programmes 69

9.9.2 Second surgical opinions 69

9.9.3 Medical case management 70

9.10 Different types of DUR studies 70

9.10.1 DUR methods that aim to evaluate the quality of prescribed drugs 70

9.10.2 Consumption studies 70

9.10.3 Studies on prescribing habits 70

9.10.4 Studies on prescription prevalence 71

9.10.5 Studies on therapeutic profiles 71

9.10.6 Medical report review 71

9.10.7 Studies on prescription compliance 71

9.10.8 Studies on drug effects 71

9.10.9 Studies on patient's information about drugs 71

9.11 Limitations of a DUR programmee 72

9.11.1 Considerations when implementing a DUR programme for medical funds 72

9.11.2 Utilisation review is not just a technique to reduce the number of drugs used 72

9.11.3 Utilisation review should not be used exclusively as a cost containment measure. 72

9.11.4 Utilisation review should not be confused with the examination of the demographic information of the patient 73

9.11.5 Utilisation review should not replace a student’s training in pharmacology 73

9.12 Problem areas concerning DUR 73

9.13 The Drug use process 73

9.13.1 Determining the need for a drug 73

9.13.2 The selection of the specific drug product 73

9.13.3 Selection of a treatment regime 74

9.13.4 Obtaining the drug product 74

9.13.5 Administration / consumption of the drug product 74

9.13.6 Effects of drug therapy 74

9.13.7 Drug utilisation studies in the ambulatory setting 74

9.13.8 Conclusion 74

9.14 The DUR process 75

9.14.1 Data sources and DUR studies 75

9.14.2 Disadvantages of data bases 76

9.14.3 The use of data bases 77

9.14.4 Conclusion 78

9.15 Drug classification system used 79

9.16 DUR criteria 84

9.16.1 Terminology 84

9.16.2 Defining criteria 84

9.16.3 Objective of criteria application in DUR 85

9.16.4 Requirements for developing and implementing criteria 85

9.17 Conclusion 86

9.18 Requirements for DUR criteria 87

9.18.2 Different types of criteria 89

9.18.3 The Defined Daily Dose 90

9.19 DUR interventions 95

9.19.2 Characteristics of behavioural change intervention 95

9.19.3 Types of interventions 95

9.19.4 Restricted lists or drug formularies 97

9.19.5 Conclusion 99

9.20 Outcome measurement 99

9.20.1 Conclusion 99

10 Evidence-based medicine 101

10.1 Introduction to evidence-based medicine 101

10.2 What is evidence-based medicine 101

10.3 Disease management, evidence-based medicine and chronic disease states 102

10.4 Steps in developing an evidence-based disease management programme 103

11 Pharmacoepidemiology in pharmacy practice 109

Bibliography 111

Appendix A:
Glossary 125

Appendix B: Reading Compendium 127

Bibliography 165

A word of welcome

Welcome to this module in Applied Pharmacoepidemiology. We trust that you will enjoy and complete the course successfully. This course will demand perseverance and discipline from you. It is very satisfactory, however, to realise how your perspective widens while working through each study unit.

Pharmacoepidemiology is a relatively new field of study, with concepts, methods and applications that have made increasing contributions to health care as the field has evolved over the past few decades. This module gives you an overview of the scope of pharmacoepidemiology and also describes the potential of this field, in terms of what it can achieve, the strengths, weaknesses and limitations of the different pharmacoepidemiological methods. It will also try to give you an idea of possible future developments in this area of science.


The pre-requisite in order to enter this course is a B.Pharm. degree or similar qualification approved or endorsed by the Senate.


Your aim in studying this module is to obtain knowledge of the disciplines pertaining to pharmacoepidemiology and also to partially fulfil the requirements to obtain the M.Pharm degree. This module may be regarded as complementary to FPHA811 the other module in the M.Pharm programme in being a discipline required to understand the basic concepts of pharmacoepidemiology applicable in a pharmaceutical practice environment or a similar health care environment.

The text format in this study guide explains the method of self-study; it helps you work through the study units and illustrates how to answer questions. An answer key will be given at the end of each study unit. (Some answers will be given and others will not – the “insight” type of questions.)

In Study Unit 1 the learner will be exposed to some introductory material on the underlying aspects and definitions of pharmacoepidemiology.

In Study Unit 2 the learner will be exposed to the learning of Medical Surveillance and Outbreaks of Disease.

In Study Unit 3 the learner will be exposed to the learning of Observational Study Designs in Epidemiology.

In Study Unit 4 the learner will be studying Experimental Study Designs.

In Study Unit 5 the learner will be exposed to the learning of Data Identification and Analysis.

In Study Unit 6 the learner will be studying Risk Assessment.

In Study Unit 7 the learner will be exposed to the learning of the principles of Screening and Diagnostic Testing.

In Study Unit 8 the learner will be studying aspects of Post-Marketing Surveillance.

In Study Unit 9 the learner will be studying an overview of Drug Utilisation Studies.

In Study Unit 10 the learner will be studying the principles of Evidence-based medicine.

In Study Unit 11 the learner will be studying Pharmacoepidemiology in Pharmacy Practice.

Module outcomes

After completion of the module the student should

  • have advanced and comprehensive specialist knowledge of certain epidemiological and pharmacoepidemiological principles, concepts and techniques, as well as of evidence-based medicine;

  • demonstrate the ability to plan and apply/propose appropriate epidemiological research designs in the field of medicine consumption;

  • demonstrate skills to identify, collect and analyse appropriate data needed for pharmacoepidemiological studies by making use of correct data analysis techniques, while at the same time applying the principles of risk and risk-determining techniques to pharmacoepidemiological data; and

  • demonstrate skills for reviewing published reports critically with the aid of meta-analyses and then compiling own results in a pharmacoepidemiological report of a prescribed format.

Study materials

One specific textbook and a separate READING COMPENDIUM are prescribed. The module consists of a folder with text in order to serve as a study guide allowing you to accomplish this course.

The one book and the reading compendium are therefore prescribed but it is, however, in your own interest to read as widely as possible (see bibliography listing at the end of the module) to improve your knowledge and skills in the field of Pharmacoepidemiology.

The following textbook is prescribed for this module:

Title: Pharmacoepidemiology: Principles and Practice (The specific handbook is out of print and we will provide you with a copy)

Authors: Waning B & Montagne M

Year of publication: 2001

Publisher: McGraw-Hill

Place of publication: New York

In addition, the reading compendium is prescribed for Study Unit 9:

Title: An Overview of Drug Utilisation Studies

and Rational Drug Therapy

Author: I Truter

Year of publication: 2001

Publisher: Potchefstroom University for CHE

Place of publication: Potchefstroom

Support references

Other handbooks that you may consult are (not compulsory):

Pharmacoepidemiology in general:

HATZEMA, A.G., TILSON, H.H., CHAN, K.A. 2008. Pharmacoepidemiology and Therapeutic Risk Management. Cincinnati: Harvey Whitney Books Company. (Handbook is available at Prof Lubbe and relevant sections will be made available to you.)

STROM, B.L. (Editor) 1994. Pharmacoepidemiology. 2nd Ed. Chichester: John Wiley & Sons.

HARTZEMA, A.G., PORTA, M. & TILSON, H.H. (Editors) 1998. Pharmacoepidemiology: an introduction. 3rd Ed. Cincinnati: Harvey Whitney Books Company.

EINARSON, T.R., BERGMAN, U. & WIHOLM, B.-E. 1997. Principles and practice of Pharmacoepidemiology. (In Spite, T.M. & Holford, N.H.G., Eds. Avery’s drug treatment. 4th Ed. Auckland, New Zealand: Adis International. pp. 371-392).

Drug utilisation studies specifically:

DUKES, M.N.G. (Editor) 1992. Drug utilisation studies: methods and uses. Copenhagen: WHO Regional Publications, European Series, No 45.

How to use this study guide

Read the outcomes formulated for the Study Units, and then work through each section systematically.

Icons are used to convey certain messages to you. Follow these messages carefully in order to stay on schedule with your study process.

Complete all the activities to the best of your ability. The activities provide you with the opportunity to apply and review what you have learnt.

Submit your assignments on the specific dates.

Report any difficulties encountered to the learning facilitator.

Study process icons

The following study process icons will be used

Test your current knowledge and insight. Make sure that you are able to answer the questions on this study material before continuing

Read/study/get an overview/scan the prescribed material.

Individual exercise.


Important information

Assignment. You should complete this assignment as a computer printout and submit it on the date indicated

Prepare yourself (by making notes) for answering questions on this issue in a group discussion or exam.

Preparation for contact session.

Group work/exercise/syndicate

Answers/solutions. This is used after a self-evaluation exercise, where you receive information about possible answers to the activity that you just completed.

List of concepts.

Summary of main learning points.

Additional literature. Although not compulsory, it will enrich your knowledge and insight to read this.

Attend the contact session.

Practical example

Study hints.

Introductory statements

Underline the main concepts.

General overview.

Make a summary.

Study the following section carefully


Rewrite this statement in your own words and explain its meaning. If you are not able to do this, or if you are not sure that you understand it correctly, make a note and come back to it once you've worked through this study section. If it is still unclear, you should ask for an explanation.




Physical experiment


Physical experiment

Case study

Class test

Listen to the audio cassette and complete the accompanying exercise

You need approximately X hours to complete this study unit successfully

Mail to specified address

Send in by e-mail

Do the following practical assignment in your electrical, electronic or computer engineering subject

Consult the ‘HELP’ file of the relevant computer programme

Insert in stiffy drive and follow the instructions


Using Computer-Aided Design software.

Using the Help file on the computer software

Complete the drawing assignment according to the instructions.

General overview

Action verbs

Some action verbs are included, in order to provide clarity of what is expected of you as a student. Please study them and make sure that you understand the meaning of each.

  • Analyse

Identify parts or elements of a concept and describe them one by one.

EXAMPLE: Analyse a typical lesson structure and describe each aspect in detail.

  • Compare

Point out the similarities (things that are the same) and the differen­ces between objects, ideas or points of view. The word “contrast” can also be used. When you compare two or more objects, you should do so systematically - completing one aspect at a time. It is always better to do this in your own words.

EXAMPLE: Compare philosophical and empirical knowledge. Compare the views of Piaget and Ausubel about the nature of learning.

  • Criticise

This means that you should indicate whether you agree or disa­gree about a certain statement or view. You should then describe what you agree/disagree about and give reasons for your view.

EXAMPLE: Write critical comments about the progressive liberal view of education.

  • Define

Give the precise meaning of something, very often definitions have to be learnt word for word.

EXAMPLE: Define the concept curriculum.

  • Demonstrate

Include and discuss examples. You have to prove that you understand how a process works or how a concept is applied in real-life situations.

EXAMPLE: Give a written demonstration of the application of the procedural moments of a lesson.

  • Describe

Say exactly what something is like; give an account of the charac­teristics or nature of something; explain how something works. No opinion or argument is needed.

EXAMPLE: Describe the characteristics of philosophical thought.

  • Discuss

Comment on something in your own words. Often requires debating two viewpoints or two different possibilities.

EXAMPLE: Discuss the differences between objectives and goals.

  • Distinguish

Point out the differences between objects, different ideas, or points of view. Usually requires you to use your own words.

EXAMPLE: Distinguish between a positivistic and a hermeneutic view of science.

  • Essay

An extensive description of a topic is required.

EXAMPLE: Write an essay about the value of Psychological Education for the teacher.

  • Example

A practical illustration of a concept is required.

EXAMPLE: See our examples after every definition of a task word.

  • Explain

Clarify or give reasons for something, usually in your own words. You must prove that you understand the content. It may be useful to use examples or illustrations.

EXAMPLE: Briefly explain the following research methods:

(a) The experiment

(b) Correlation studies

  • Identify

Give the essential characteristics or aspects of a phenomenon e.g. a good research design.

EXAMPLE: Identify the characteristics in a text about the research process, which is indicative, a good research design.

  • Illustrate

Draw a diagram or sketch that represents a phenomenon or idea.

EXAMPLE: Explain the life cycle of a butterfly. Write a short essay and illustrate this model.

  • List

Simply provide a list of names, facts or items asked for. A particular category or order may be specified.

EXAMPLE: List ten psychosocial problems associated with alco­hol abuse in high school pupils.

  • Motivate

You should give an explanation of the reasons for your statements or views. You should try to convince the reader of your view.

EXAMPLE: Write an essay about your own philosophical educa­tion. Motivate your views

  • Name or mention

Briefly describe without giving details.

EXAMPLE: Name three research methods in Nursing

Name the two major schools of thought (paradigms) on educa­tion.

  • Outline

Emphasise the major features, structures or general principles of a topic, omitting minor details. Slightly more detail than in the case of naming, listing or stating of information is required.

EXAMPLE: Outline the major features of a lesson structure.

  • State

Supply the required information without discussing it.

EXAMPLE: State three functions of a computer.

  • Summarise

Give a structured overview of the key (most important) aspects of a topic; must always be done in your own words.

EXAMPLE: Give a summary of the core characteristics of the con­ser­vative-normative oriented school of thought on education.


Your final mark will be calculated as follows:

Compulsory work assignments 33%

Examination 67%

To pass this module you need to achieve a minimum of 40% in the examination paper and a total mark of 50%.

Compulsory assignments:

Two compulsory assignments are required for admission to the examination. The course mark will be calculated using the average of the two marks.

Time schedule

This module has been developed in such a way that learners should need approximately 160 hours to complete FPH748.

The following scheduling division of your time is suggested:

Study unit 1 20 hours

Study unit 2 16 hours

Study unit 3 16 hours

Study unit 4 16 hours

Study unit 5 16 hours

Study unit 6 16 hours

Study unit 7 12 hours

Study unit 8 12 hours

Study unit 9 12 hours

Study unit 10 8 hours

Study unit 11 16 hours




Two compulsory assignments are required for admission to the examination. The course mark will be calculated using the average of the two highest marks.

Assignment 1:

Discuss drug utilisation studies as an important application of Pharmacoepidemiology and elaborate on its potential contribution to health care in South Africa.

(Approximately 1 000 words)

Date to be handed in: 31 Maart 2012

Assignment 2:

Discuss critically (in other words discuss and criticise) the potential future contribution of Pharmacoepidemiology to the practice of pharmacy and health care delivery in South Africa.

(Approximately 1 000 words)

Date to be handed in: 30 April 2012

Warning against plagiarism


Copying of text from other learners or from other sources (for instance the study guide, prescribed material or directly from the internet) is not allowed – only brief quotations are allowed and then only if indicated as such.

You should reformulate existing text and use your own words to explain what you have read. It is not acceptable to retype existing text and just acknowledge the source in a footnote – you should be able to relate the idea or concept, without repeating the original author to the letter.

The aim of the assignments is not the reproduction of existing material, but to ascertain whether you have the ability to integrate existing texts, add your own interpretation and/or critique of the texts and offer a creative solution to existing problems.

Be warned: students who submit copied text will obtain a mark of zero for the assignment and disciplinary steps may be taken by the Faculty and/or University. It is also unacceptable to do somebody else’s work, to lend your work to them or to make your work available to them to copy – be careful and do not make your work available to anyone!

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Prof Ilse Truter, Dr Johan c lamprecht, Prof Jan hp serfontein, Dr V stuvig, Mr t serfontein, Prof Martie s lubbe iconAuthors: Mrs a de Wet, Dr/Adv em serfontein, Prof hj steyn, Dr L meyer, Prof pj mentz, Mrs n morake

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