Table Of ContentManagi ng Pharmaceuti cal s
in International Health
Stuart Anderson
with Reinhard Huss, Rob Summers
and Karin Wiedenmayer
Foreword by Richard Laing
Springer Sasel AG
Authors
Dr. Stuart C. Anderson Dr. Reinhard Huss
Department of Public Health and Policy Department of Tropical Hygiene and Public Health
London School of Hygiene and Tropical Medicine Ruprecht-Karls-University of Heidelberg
Keppel Street Im Neuenheimer Feld 324
WC1 E 7HT London 69120 Heidelberg
United Kingdom Germany
Dr. Karin A. Wiedenmayer Prof. Robert S. Summers
Swiss Centre for International Health School of Pharmacy
Swiss Tropical Institute Medical University of Southern Africa (MEDUNSA)
Socinstrasse 57 P. O. Box 218
4002 Basel MEDUNSA 0204
Switzerland Republic of South Africa
Library of Congress Cataloging-in-Publication Data
Managing pharmaceuticals in international health / Stuart Anderson, with Reinhard Huss
... [et al.) ; foreword by Richard Laing
p. cm.
Includes bibliographical references and index.
ISBN 978-3-7643-6601-8 ISBN 978-3-0348-7913-2 (eBook)
DOI 10.1007/978-3-0348-7913-2
1. Pharmaceutical policy. 2. World health. 1. Anderson, Stuart (1946-
RA401.A1M364 2004
362.17'82--dc22 2004046884
Bibliographic information published by Die Deutsche Bibliothek
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ISBN 978-3-7643-6601-8
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© 2004 Springer Basel AG
Originally published by Birkhiiuser Verlag, Basel, Swilzerland in 2004
Printed on acid-free paper produced from chlorine-free pulp. TCF
00
Cover design: Micha Lotrovsky, CH-4106 Therwil, Switzerland
Cover iIIustration: The Life Cycle of Medicines (see page 7)
ISBN 978-3-7643-6601-8
987654321 www.birkhauser-science.com
Contents
Foreword ........................................................................ ix
Preface.......................................................................... xi
About the Authors .............................................................. xiii
Acknowledgements ............................................................. xv
Glossary of Terms ............................................................... xvii
1 Issues in the Management of Pharmaceuticals in International Health 1
Stuart Anderson and Reinhard Huss
1.1 Introduction .......................................................... . 1
1.2 Pharmaceuticals, medicines and drugs ............................... . 2
1.3 International health .................................................. . 3
1.4 The emergence of medicines ......................................... 4
1.5 Global inequity and the medicines life cycle .......................... 6
1.6 The study of pharmaceuticals in international health . 12
1.7 Approaches to managing pharmaceuticals. . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.8 Layout of the book ................................................... 14
1.9 Conclusion ............................................................ 16
2 Access and Availability of Pharmaceuticals in International Health. 19
Karin Wiedenmayer
2.1 Introduction. . . . . .. .. . . .. .. . . .. . . . . .. . . . . .. . . . . .. . . . . . . . . . . . . . . . . . .. . . . 19
2.2 Access to essential medicines ........................................ . 20
2.3 Neglected diseases ...................................... . 26
2.4 Strategies for developing medicines and ensuring access. . . . . . . . . . . . . 28
2.5 Conclusion ............................................ ............... 29
3 Assessing the Pharmaceutical Needs of Patients and Populations 33
Reinhard Huss
3.1 Introduction........................................................... 33
3.2 Public health pharmacology ....................................... 34
3.3 Incidence of disease...................................... ............ 34
3.4 Needs and priorities for medicines ................... . . ......... 37
vi Table of contents
3.5 Culture and the use of medicines ................................ . 42
3.6 Patients as consumers .......................................... . 45
3.7 Compliance, adherence and concordance 47
3.8 Empowerment ................. . 49
3.9 Conclusion 50
4 The Role of Health Professionals 53
Karin Wiedenmayer
4.1 Introduction ......................... . 53
4.2 Classifying health professionals ........ . 54
4.3 Health professionals and medicine responsibilities 54
4.4 The role of the doctor ........ . 57
4.5 The role of the pharmacist .. .. ........ 59
4.6 Traditional healers .. 63
4.7 Integrating traditional medicine and Western medicine 66
4.8 Conclusion ... . . . . . . . . . . . . . . . . . . . . . . .......... . 68
5 The Role of the Pharmaceutical Industry 71
Stuart Anderson
5.1 Introduction. . . ................... . 71
5.2 The origins and development of the pharmaceutical industry .. 72
5.3 Structure ofthe industry today ... . . . . .. . . . . .... ......... 74
5.4 Pharmaceutical company partners 77
5.5 The activities of the industry .. . . . . . . . . . . .. . . . . .. .. . .. .. .. . 79
5.6 Pharmaceutical markets . . . . . . . . . . . 82
5.7 The pharmaceutical industry and international health . 82
5.8 Conclusion... .......... ..... . ........... . ..... .. ........... 84
6 The Role of Governments 87
Rob Summers
6.1 Introduction. . . . . . . . . . . . . . . . . . ............... . 87
6.2 The development of national drug policies ........ . 88
6.3 The drug supply process .............................. . 91
6.4 Health systems that support drug supply ............. . 95
6.5 Pharmaceutical legislation and regulation 98
6.6 Research, monitoring and evaluation . 101
6.7 Conclusion ... . ............. . 103
7 The Role of the European Union, National Assistance Agencies
and NGOs ............ . .......... . 105
Reinhard Huss and Stuart Anderson
7.1 Introduction ...................... . 105
7.2 The European Union ............................ . 106
7.3 The national aid agencies .. . 109
7.4 International and national NGOs 113
Table of contents vii
7.5 Some non-governmental organizations .......................... . 115
7.6 Equitable pharmaceutical supply and distribution 120
7.7 Conclusion ... 123
8 The Role of International Organizations 125
Rob Summers
8.1 Introduction.. . ...................... . 125
8.2 WHO and other UN organizations 126
8.3 Industry organizations . . . . . . . . . . . . . . ....... . 128
8.4 Other organizations. . . . . . . . . . . . ................... . 129
8.5 Essential drugs .. ' ........... . 130
8.6 Pharmaceutical procurement. . ................. . 132
8.7 International agreements and intellectual property rights 135
8.8 Case study-HIV / AIDS and anti retrovi ral treatment in South Africa. 137
8.9 Conclusion ......... . . . . . . . . . . . . . . ....... . 140
9 Rational Use of Medicines 141
Karin Wiedenmayer
9.1 Introduction 141
9.2 Consequences of non-rational medicine use 142
9.3 Medicine use behaviour 143
9.4 Investigating medicine use problems ............... . 145
9.5 Medicine use interventions ........... . 146
9.6 Effectiveness of interventions . 149
9.7 Conclusion 150
10 Medicine Quality, Adverse Reactions and Antimicrobial Resistance 153
Karin Wiedenmayer
10.1 I ntrod uction 153
10.2 Quality of medicines .. 154
10.3 Counterfeit medicines. 160
10.4 Adverse drug reactions 163
10.5 Antimicrobial resistance 167
10.6 Conclusion 172
11 Managing Medicines Information ..................... . 175
Reinhard Huss
11.1 Introduction .' 175
11.2 The users of medicine information 176
11.3 Sources of information .' .......... . 177
11.4 The quality of medicines information ................. . 181
11.5 The assessment of information 183
11.6 Classification systems 185
11.7 Conclusion 188
viii Table of contents
12 Investigating the Use of Medicines . 191
Reinhard Huss
12.1 Introduction ... 191
12.2 Drug utilization studies ........... . 192
12.3 Pharmacoeconomics 194
12.4 Pharmacovigilance .. 198
12.5 Pharmacoepidemiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 201
12.6 Health systems and policy studies ...... . ....... . 203
12.7 Conclusion . . . . . . . . . . ....................... . 204
13 Trends and Developments ...... 207
Stuart Anderson and Karin Wiedenmayer
13.1 In trod uction ............. 207
13.2 Trends in the use of herbal remedies 208
13.3 The contribution of pharmacogenetics and pharmacogenomics . . . . .. 209
13.4 The changing role of the internet . . . . . . . . .. 211
13.5 Changes in the health care workforce.. ........... . .... 214
13.6 Conclusion . .. . .. . . .. . . . . .. .. .. . . . .. . . 220
14 Policy Initiatives and their Implications .............................. 223
Stuart Anderson and Rob Summers
14.1 Introduction ......... . '" 223
14.2 The role of public-private partnerships ......... 224
14.3 The Global Fund and other initiatives ..................... 229
14.4 Global procurement of medicines ..... 231
14.5 AIDS drugs post Doha. . ......... 233
14.6 Conclusion .... 235
Selected Websites and Webportals . . ............... 237
Index ..................... 249
Foreword
"One third of the world's population lack effective access to quality assured
essential medicines used rationally".
When WHO first made this statement fifteen years ago, there was general concern
that medical miracles such as antibiotics, antiparasitic medicines, vaccines and anal
gesics would not be available to many people. Today, the proportion of those lack
ing access is lower in Asia and Latin America and higher in Africa but there are
probably about two billion people in this situation. This book describes the many
problems involved, and then puts together possible solutions based on country expe
riences in a comprehensive and coherent manner.
Many people lack access to essential medicines because they and their countries
are poor, and because of inefficiencies in their health systems. We know that in low
and middle income countries between 25 and 40 per cent of health expenditure is
on medicines, and that most of that expenditure is out of pocket. Often this
amounts to less than US $ 2 per head per year! In contrast, high income countries
spend only 8 to 15 per cent of health expenditure on medicines, and this is mostly
paid for by health insurance or social security funds. High income country expen
diture may be over US $ 400 per person per year! So managing the scanty resources
available in low income countries becomes all the more important. Inefficiencies are
becoming an increasing financial burden for many people even in high income coun
tries; but the poor in low income countries may pay for any waste or managerial
failures with their health or life.
When we look at what poor people spend their precious resources on, we dis
cover many related problems needing solutions. The quality of commonly used anti
malarial and TB drugs have recently been shown to be substandard in some African
and Asian countries. Prices of widely used brand and less commonly used generic
products may vary one hundredfold. Taxes, duties and excessive markups may more
than double the prices paid by consumers. We see irrational use of injections, with
more than 15 billion injections given per year, and antibiotics being frequently pre
scribed unnecessarily. Finally, we have very little research for new medicines for
neglected diseases such as malaria, TB, trypanosomiasis and leishmaniasis.
But for all of these problems we see solutions existing in different environments.
WHO has led the way with selection by providing a Model Essential Medicines List.
In addition, the WHO Medicines Library provides all the needed information to
select national Essential Medicines Lists. Pool procurement efforts in regions as dif
ferent as those of the Eastern Caribbean or the Persian Gulf have enabled countries
x Foreword
that have combined together to obtain quality assured essential medicines at very
competitive prices. WHO in conjunction with other UN organizations now provides
a prequalification service to identify the AIDS, TB and malaria products of assured
quality. Price information is more widely available than ever before through the
efforts of consulting companies, Medecins sans Frontieres (MSF) and the WHO
regional office in Africa.
The rational use of medicines has improved in some countries for several rea
sons. A dramatic drop in the use of injections in Indonesia, the effective treatment
of pneumonia in children, and of sexually transmitted infections (STIs) in adults
according to guidelines, are all signs of improvement. AIDS is being treated accord
ing to modern treatment guidelines in Brazil and other low and middle income
countries. Public Private Partnerships such as the Medicines for Malaria Venture
(MMV) or Drugs for Neglected Diseases (DNDI) have been established to ensure
that research is undertaken to discover the new medicines for neglected diseases.
The European Union is providing support for a clinical trials network to test these
new medicines in the environments where the diseases occur. Finally, there has been
unprecedented international support for the Global Fund to fight AIDS, tuberculo
sis and malaria. A major portion of these resources will go towards the purchase,
distribution and measures to ensure the rational use of these medicines.
This book has been written by experienced teachers and practitioners to bring
together personal and global experiences in an accessible fashion. It will be useful
for international public health practitioners who need to know about pharmaceuti
cals, and pharmacists who need to know about international public health. Addi
tionally, activists, NGO members, donors and UN officials may find the informa
tion useful for their work.
When poor people have limited resources and great needs, their lives depend on
these scanty resources being spent as efficiently as possible. Managing pharmaceu
ticals in international health in a way which provides the greatest possible benefit
for those in greatest need should be the goal of any public health practitioner or
pharmacist working in the field. This book provides the information needed to
understand the real causes of many access problems, and suggests possible solutions
to them. The challenge now is to take these lessons and implement them, to ensure
universal access to essential medicines.
Richard Laing
Geneva, March 2004
Preface
The ready availability of essential medicines to entire populations is a key determi
nant of public health in all countries. Even in the remotest parts of the world peo
ple consume modern medicines. Yet the 75 per cent of the world's population living
in low and middle income countries consume barely 20 per cent of the world's med
icines. And just eight low and middle income countries consume over 60 per cent of
all the medicines available in the developing world.
Addressing these great inequalities is one of the major challenges in internation
al health. But the issues surrounding medicine use are complex. Many of the prob
lems can only be tackled at a global level by many agencies, governments and phar
maceutical companies working together. An enormous literature now exists that
addresses the economic, social and political factors involved.
Despite this, pharmaceutical policy issues receive only scant attention in text
books of international health. For the student of international health the task of get
ting to grips with the subject is a daunting one. Even the literature on essential med
icines lists and developing medicines policies produced by the WHO is now vast,
and requires careful scrutiny and interpretation.
This book aims to provide the student of international health with little previous
knowledge of managing pharmaceuticals with an introduction to the international
pharmaceutical scene. Who are the key players and what are their roles? What has
been achieved so far, and what strategies have been adopted to achieve it? What
remains to be done? And what are the prospects for the future?
The book has been written by a group of academics and practitioners from insti
tutions in different countries who collectively have enormous experience of the
issues involved. Although each chapter has one or two lead authors in practice all
the authors have contributed to all chapters. We think the book has been greatly
strengthened as a result. We particularly acknowledge Reinhard Huss's work in
developing the medicines cycle, the representation of which appears on the book's
cover.
The book will be of interest to all those who wish to learn more about this
important area of international health. They will include students and educators
from the fields of public health and pharmacy, health professionals, policy makers
and programme managers, and indeed all those involved with the day to day prob
lems of improving the state of the world's health by pharmaceutical means.
Stuart Anderson
London, March 2004
