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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
Module outcomes vii
Study materials vii
Support references viii
How to use this study guide viii
Study process icons viii
Action verbs xi
Time schedule xiii
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
Appendix B: Reading Compendium 127
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.
After completion of the module the student should
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
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
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
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.
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.
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.
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.
Give the precise meaning of something, very often definitions have to be learnt word for word.
EXAMPLE: Define the concept curriculum.
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.
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.
Comment on something in your own words. Often requires debating two viewpoints or two different possibilities.
EXAMPLE: Discuss the differences between objectives and goals.
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.
An extensive description of a topic is required.
EXAMPLE: Write an essay about the value of Psychological Education for the teacher.
A practical illustration of a concept is required.
EXAMPLE: See our examples after every definition of a task word.
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
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.
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.
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.
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
Briefly describe without giving details.
EXAMPLE: Name three research methods in Nursing
Name the two major schools of thought (paradigms) on education.
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.
Supply the required information without discussing it.
EXAMPLE: State three functions of a computer.
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%
To pass this module you need to achieve a minimum of 40% in the examination paper and a total mark of 50%.
Two compulsory assignments are required for admission to the examination. The course mark will be calculated using the average of the two marks.
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
YOUR ASSIGNMENTS WILL CONSIST OUT OF 2 ASSIGNMENTS THAT MUST BE POSTED TO PROF MARTIE S LUBBE ON GIVEN DATES DURING THE COURSE.
(A LETTER CONTAINING RELEVANT INFORMATION WILL BE MAILED TO YOU SOON AFTER THE DATE OF YOUR ENROLLMENT).
Two compulsory assignments are required for admission to the examination. The course mark will be calculated using the average of the two highest marks.
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
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
ASSIGNMENTS ARE INDIVIDUAL TASKS AND NOT GROUP ACTIVITIES. (UNLESS EXPLICITLY INDICATED AS GROUP ACTIVITIES)
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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