The Perception and Management of Drug Safety Risks PDF
Preview The Perception and Management of Drug Safety Risks
HEALTH SYSTEMS RESEARCH Edited by K. Davis and W. van Eimeren B. Horisberger R. Dinkel (Eds.) The Perception and Management of Drug Safety Risks With 29 Figures and 13 Tables Springer-Verlag Berlin Heidelberg New York London Paris Tokyo Dr. Bruno Horisberger Interdisciplinary Research Centre for Public Health Rorschacher StraBe 103c CH- 9007 St. Gallen Dr. Rolf Dinkel HealthEcon Ltd. SteinentorstraBe 19 CH-40S1 Basel ISBN-13:978-3-642-74274-3 e-ISBN-13:978-3-642-74272-9 DOl: 10.1007/978-3-642-74272-9 This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in other ways, and storage in data banks. Duplication of this publication or parts thereof is only permitted under the provisions of the German Copyright Law of September 9, 1965, in its version of June 24, 1985, and a copyright fee must always be paid. Violations fall under the prosecution act of the German Copyright Law. © Springer-Verlag Berlin Heidelberg 1989 Softcover reprint of the hardcover 1st edition 1989 The use of general descriptive names, trade names, trade marks, etc. in this publication, even if the former are not especially identified, is not to be taken as a sign that such names, as understood by the Trade Marks and Merchandise Marks Act, may accordingly be used freely by anyone. Product Liability: The publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check its accuracy by consulting other pharmaceutical litera ture. 2119/31401543210 - Printed on acid-free paper Preface In the past two decades public debate about the risks, benefits, and safety associated with drugs has intensified. Public disputes over risks are brought to court when individuals seek compensation for health problems attributed to a pharmaceutical product. The issue reaches legislatures and regulatory agencies when consumer advocates seek to influence the standards of drug usage. Front-page news tends to focus on accidents or other risk events with drugs. Drug risk and drug safety have become an important political issue. Drug regulat ory agencies have been instituted, and their responsibility has increased. The approval to market a drug is dependent on a set of sophisticated studies executed according to strict protocols and scientifically defined criteria. Drug surveillance activities have gained recognition, and reporting systems to identify drug safety problems have been strengthened. The understanding and management of drug safety is, nonetheless, beset by doubts, disagreements, and disputes. Conflict occurs over the significance of risk, the adequacy of evidence, the methodologies used to evaluate and measure risk, the standards that guide regulation, and the optimal means of communicating risk information to the public. An international and interdisciplinary conference, convened by Ciba-Geigy in the spring of 1988, was designed to explore these areas of conflict from every angle and to initiate a collaborative effort to address existing shortcomings. The meeting at Wolfs berg, a historic estate overlooking Lake Constance, was a continuation of previous Wolfsberg Conferences dealing with issues of health care such as cost sharing, technology assessment, and socioeconomic evaluation of drug therapy. The 1988 conference assembled academic experts in pharmacology, epidemiology, risk perception research, risk communication, and regulatory affairs, together with representatives of 30 leading pharmaceutical companies from 10 countries. The Council for International Organizations of Medical Sciences (ClaMS) was represented as well as an industry association, the International Federation of Phar maceutical Manufacturers Associations (IFPMA). Leaders of the consumer move ment and representatives of the media participated actively in the debate. This heterogeneous audience reflected the conference rationale: that the manage ment of drug safety and risk is no longer a concern specific to the pharmaceutical industry, but has gained a social dimension. Speakers and discussants emphasized common concerns and showed a strong interest in a collaborative approach to addressing them. Multidisciplinary collabora tion was recognized as the sine qua non of successful management of drug risks. VI Preface In Part I of this book the drug safety issue is put in the larger perspective of the worldwide public debate on technological risks in an increasingly industrialized world. Many people have become sceptical and frightened of advanced technologies. Risk acceptance, however, constitutes an inherent part of human life and is a prere quisite for the development of human civilization and culture. To balance risks against benefits, to define acceptable risk, and to exclude what no longer falls within this category remain perpetual challenges. Benefitlrisk assessment often leads to controversy because it involves both factual analysis and value judgements. Within a given country, different groups have differ ent stakes in defining the risks and benefits of drugs and evaluating the acceptability of the risks and benefits. At the international level, cultural and political values and expectations influence the way in which potential risks are perceived, evaluated, and controlled. Several authors analyze the factors which influence public perception of risks and benefits and propose means of anticipating, identifying, evaluating, and managing controversy about risks to health. A concluding paper presents a brief analysis of the significance of the major drug issues that have occurred in recent years and demonstrates the extent to which these issues are related to either efficacy, information, quality, cost-effectiveness, or safety. Of these five categories, safety concerns are predominant in the assessment, appraisal, and communication of the benefit/risk relationship of drugs. Part II deals more specifically with benefit/risk analysis and appraisal in connection with drugs. Several authors delineate the current status, limitations, and pitfalls of pharmacoepidemiology resources and biostatistical data interpretation. The data bases available today are not sufficiently comprehensive to show all possible adverse reactions to drugs. Computer-based medical records linkage systems could help solve this problem. A case study about public controversy and government intervention related to adverse reaction reports on a nonsteroidal anti-inflammatory drug demon strates the vital importance of adverse drug reaction reporting and other epidemiolog ical resources in establishing regulatory and public consensus regarding the safety of a drug. Two papers present results of recent surveys of physician and public perception of hazardous activities and pharmaceuticals in Sweden and Japan. One finding is that, by providing information to the public about the adverse reactions possibly associated with a drug's use, the public's acceptance of drug risks may be increased. Another interesting finding is that physicians believe that their patients require relatively little information regarding medication, while patients indicate that they expect fairly comprehensive information. Regulatory decisions are affected by both scientific and social considerations. Analysis and assessment of risk and benefit must be distinguished from the evaluation of the data. Whereas analysis and assessment are processes in which the scientific components prevail (e. g., animal and human data bearing on the safety of medicines), the evaluation of the data obviously goes beyond scientific evidence. Social and political factors (e.g., patient group interests, the media, economic pressures, ethical concerns) playa major role, the relative importance of which varies from country to country and over time. In regulatory decision making, scientific evidence and individual perceptions are closely intertwined. Information is assimi lated and interpreted in different ways by professional groups and the general public. Preface VII Media coverage about risk analysis and appraisal influences policy decisions and stimulates public interests. "Identify with the people who take the risks, then people will identifiy with you." This statement expresses the concern of several authors in Part III. This section deals with the consumer's perspective on pharmaceutical risk. The industry not only needs to develop a much better understanding of consumer perceptions but must also develop more effective ways of communicating with consumers. The industry's over all good track record in providing "hardware" - medicines and other therapeutic aids - has not been matched by its performance in providing "software" - information that the nonspecialist can understand. The challenge for the pharmaceutical industry is, therefore, to ensure that the patient is properly informed about the therapy and the risk associated with its use. A willingness and ability to communicate are key to improving society'S acceptance of risk. Part IV comprises, in a standardized format, a number of specific collaborative drug risk evaluation and management projects to the international pharmaceutical industry. The proposals cover the themes dealt with at the conference: phar macoepidemiology, risk perception analysis, communications regarding the benefit! risk relationship, and risk appraisal on an international scale. In Part V of this book the organizer of the conference expresses the conviction that people have great expectations for action and improvement. He concludes by sum moning the pharmaceutical industry to transcend traditional boundaries and to reach out more imaginatively toward the industry's ultimate reason for being: the preserva tion and improvement of human life. Part VI contains the curricula vitae of the authors, a very extensive bibliography, and index sections on subjects and data sources for those who want either to follow a topic that the book itself does not use as a structural principle or to seek specific information. Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V List of Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. XIII List of Companies and Institutions Represented. . . . . . . . . . . . . . . . . . .. XXI Opening Address: J. ORSINGER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Part 1: Society and the Benent/Risk Relationship 1. Acceptable Risk in Society A. KRAUER ................................. . 5 2. A Broad Framework for Confronting Health Risks W.W. LOWRANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3. Communicating the Risks and Benefits of Technology: The Case of Pharmaceuticals D. NELKIN ........................................ 19 4. Overview of the Drug Safety Issue and Ciba-Geigy's Response: RAD-AR W.P. VON WARTBURG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 37 5. Summary of Part I: Presentations and Discussions. . . . . . . . . . . . . . .. 45 Part II: BenentlRisk Analysis and Appraisal 6. Limitations of Available Sources of Data on Prescription Drug Safety H. A. GUESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 51 7. Strategies, Designs, Criteria, Tactics and Statistics to be Considered when Evaluating Scientific Evidence W.O. SPITZER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 57 X Contents 8. Statistics in Drug Risk Research: The Background of Pharmacoepidemiology H. LETZEL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 70 9. Industry-Sponsored Risk Institutes W. W. LOWRANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 77 10. The Feldene Experience: A Case Study R.M.SACHS,G.S.DIECK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 81 11. Risk Perception of Prescription Drugs: Report on a Survey in Sweden P. SLOVIC, N. N. KRAUS, H. LAPPE, H. LETZEL, and T. MALMFORS ...... , 90 12. Risk Perception of Prescription Drugs: Report on Surveys in Japan S. FUITNO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 112 13. Scientific and Political Components of Regulatory Decision Making: General Considerations G. FULGRAFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 117 14. Scientific and Political Components of Regulatory Decision Making: The United States Experience L. LASAGNA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 121 15. Summary of Part II: Presentations and Discussions . . . . . . . . . . . . . .. 128 Part HI: Current Challenges 16. Professional Drug Information: A Consumer Perspective C.MEDAWAR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 135 17. Going Patient, Going Public P.F. CARPENTER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 141 18. Reporting Adverse Drug Reactions: The Media Approach P.J.BROWN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 149 19. What Can Be Learned from Drug Safety Issues? G. LEWANDOWSKI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 158 20. Summary of Part III: Presentations and Discussions. . . . . . . . . . . . . .. 161 Part IV: Responding to the Issues 21. Editor's Note ...................................... 167 22. Pharmacoepidemiology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 169 Comparative Data Base Analysis NSAIDs Data Base Management Training in Epidemiology 23. Risk Perception Analysis 172 Public Perception Perception Research 24. Communicating the BenefitlRisk Relationship. . . . . . . . . . . . . . . . .. 174 Communication Proposals Participating in the Public Debate: The United Kingdom as an Example Political Intelligence System 25. Risk Appraisal on an International Scale ..................... 177 Council for International Organizations of Medical Sciences Pharmaceutical Risk Management Activities in Japan Establishment of Risk Institutes Part V: Outlook 26. The Wolfsberg Questions W. P. von WARTBURG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 183 Part VI: Annex 27. Curriculum Vitae of Authors. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 189 28. Bibliography...... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 193 29. Subjectlndex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 203 30. A Handbook of International Data Sources for Drug Benefit/Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 207 List of Participants Dr. RICHARD B. ARNOLD Executive Vice-President, International Federation of Pharmaceutical Manufacturers Associations, Geneva, Switzerland Dr. MICHEL AURICHE Head of Drug Safety Department, RhOne-Poulenc Sante, Antony, France Prof. ZBIGNIEW BANKOWSKI Executive Secretary, Council for International Organizations of Medical Sciences (CIOMS), Geneva, Switzerland Dr. EDWARD A. BORTNICHAK Director, Pharmacoepidemiology, Pharmaceutical Division, Ciba-Geigy Corporation, Summit, NJ, USA Dr. ARNo BRANDT Director, Institute for Medical Informatics, Basle, Switzerland PATRICIA BROWN European Editor, SCRIP World Pharmaceutical News, Richmond, Surrey, UK Dr. PHILIP J. BROWN Publisher and Managing Director, SCRIP World Pharmaceutical News, Richmond, Surrey, UK Prof. RUDOLF BRUPPACHER Head of Pharmacoepidemiology and Drug Safety, Ciba-Geigy Ltd., Basle, Switzerland Dr. DENNIS M. BURLEY Director, Centre for Pharmaceutical Medicine, Woking, Surrey, UK LESLEY BYGRAVE-MALIN Chairman and Managing Director, Medical Viewpoint Ltd., London, UK
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