Improving Drug Safety — A Joint Responsibility

336 Pages·1991·6.187 MB·English

by  Dr. Rolf Dinkel, Dr. Bruno Horisberger, Prof. Kenneth W. Tolo (auth.), Dr. Rolf Dinkel, Dr. Bruno Horisberger, Prof. Kenneth W. Tolo (eds.)

HEALTH SYSTEMS RESEARCH
Edited by W. van Eimeren

R. Dinkel B. Horisberger K.Tolo (Eds.)
Improving Drug Safety
A Joint Responsibility
With 35 Figures and 21 Tables
Springer-Verlag
Berlin Heidelberg New York London
Paris Tokyo HongKong Barcelona
Dr. Rolf Dinkel
HealthEcon Ltd.
Steinentorstr. 19
CH-4051 Basel
Dr. Bruno Horisberger
Interdisciplinary Research Centre
for Public Health
Rorschacher Strasse 103c
CH-9007 St. Gallen
Prof. Kenneth W. Tolo
The University ofTexas at Austin
Main Building 201
USA-Austin, Texas 78702
ISBN-13: 978-3-642-64762-8 e-ISBN-13: 978-3-642-61250-3
001: 10.1007/978-3-642-61250-3
This work is subject to copyright. All rights are reserved, whether the whole or partofthe
material isconcerned, specifically the rights oftranslation, reprinting, reuse ofillustration,
recitation, broadcasting, reproduction on microfilms orin otherways, andstorage in data
banks. Duplication ofthis publication or parts thereofisonly permitted under the
provisions ofthe German Copyright LawofSeptember9, 1965, in itscurrent version, and
acopyright fee must always be paid. Violationsfall under the prosecution act ofthe Ger
man CopyrightLaw.
©Springer-VerlagBerlin Heidelberg 1991
Softcoverreprintofthehardcover1stedition1991
The use ofgeneral descriptive names, trademarks, etc. in this publication, even ifthe
former are not especiallyidentified, is not to be taken as asign thatsuch names, as under
stood bythe Trademarks and Merchandise Marks Act, may accordingly be used by
anyone.
Product Liability: The publishercan give no guarantee for information about drug dosage
and application thereofcontained in this book. In everyindividualcase the respective user
mustcheck its accuracy byconsultingother pharmaceutical literature.
2119/3140/543210- Printed on acid-free paper
Preface
Asthefocus on pharmaceuticalshasbroadenedfrom concernfortheircostand
effectivenesstotheirrealandpotentialrisksandbenefits, acriticalquestionhas
beenraised: whoseresponsibilityisittoimprovedrugsafety?InApril1990,this
questionbecamethethemeforaconferenceatWolfsberg,Switzerland,nearthe
shoresofLakeConstance. Called an "internationaldialogueconference" byits
organizers, the meeting brought together leaders from the pharmaceutical
industry, regulatory authorities, academia, medicine, consumer organizations
andthe media. OpeningaddressesweregivenbyrepresentativesoftheCouncil
forInternationalOrganizationsofMedicalSciences(CIOMS),theInternational
Federation ofPharmaceutical ManufacturersAssociations (IFPMA), the Swiss
International Pharmaceutical Agency, and the RAD-AR Consortium.
This book documents the papers presented and discussions held at this
conference, which took the topicofrisks and benefits ofdrug therapyone step
further to responsibility. It includes a rich menu of issues for those who care
abouttheevaluationofdrugtherapy,theethicsbehindit,theexpectationsofthe
patient, and the role oftraditional and nontraditional drug safety communica
tions. Theideasexpressedherecomefromdifferentpartsoftheworldbutrelate
tocommondrugsafetyproblems,observations, andscientificassessments; they
provide insights into innovative approaches, cautious changes, and desired
actions.
The papers in this volume are broadly divided into conceptual perspectives
(ethics, how the knowledge about drug risks and benefits is generated and
appraised, the expectations in drug safety) and operational perspectives
(communication, discussion, and action).
TheethicalperspectivesinPartsIIIandXIIcomenotonlyfrom academiaand
theWorldHealthOrganizationbutalsofromthepharmaceuticalindustry.Parts
IVandVlookatthegenerationofknowledgeondrugrisksandbenefitsfromthe
view of national regulators, medical researchers, and an epidemiologist.
Thecomplexitiesofassessmentoftherisklbenefitrelationshiparediscussedin
PartVIandthechallengesarepointedouttimeandagain.Therearedistortions,
differing scientific evaluations, and personal judgments to be taken into
consideration, as well as cultural influences.
Expectations in drug safety communication, of the media, the patient, the
pharmacologist and the regulator, are all mentioned in Part VII. Some
traditional channels ofdrug safety communications are discussed in Part VIII,
whilemoreinnovativechannelsaredescribedinPartIX. Aspecialsection(Part
X) is devoted to the program for Risk/Benefit Assessment ofDrugs- Analysis
and Response (RAD-AR) in the USA, Europe, and Japan.
VI Preface
It became clear through the conference and the papers presented that an
agenda for action is needed. One set of future directions is described in Part
XIII. It is followed by the Wolfsberg Think Pieces, which were set out at the
conclusionofthe 1990conferenceandwhichshowhowtheleadersfrom various
countries and fields of work viewed specific drug safety issues and how they
thought responsibility for improving the situation could be shared.
The editors drew from about 50 manuscripts and countless pages of
transcripted discussions from plenary sessions and workshops to compile a
representativepictureoftheconferenceproceedings.Theyattemptedtoconvey
specific problems in an interdisciplinary dialogue without becoming mired in
jargon and technicalities of the experts' knowledge. There was no space for a
full-scale report on all the discussions that followed the presentation of the
individual keynote addresses, the papers, and the working group reports.
Nevertheless, we hope those who were presentwillfind we have preservedthe
essence of the 1990 Wolfsberg meeting in this publication. What participants
carried home with them in the way of contacts and insights has perhaps
preserved and conveyed this even better.
Drugsafetyhasbecomeanareawhichdecisionmakersrealizemustbeopento
completeandknowledgeableevaluation. Morethanthat,someindustryleaders
atWolfsbergmaintainedthatgooddrugsmeangoodbusiness.Thatcomesclose
to what consumers are hoping for. Physicians and other health practitioners
should be able to offer nothing less than good drugs, knowledge of their full
capacity, and instruction on how to use them wisely.
Contents
Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . V
Participants , XIII
Affiliations ofParticipants XIX
Part I: The Wolfsberg Dialogue
1. From Questions to Missions and Actions 3
2. The RAD-AR Agenda
W. P. VON WARTBURG 5
Part II: Welcoming Addresses
3. Council for International Organizations of Medical Sciences
Z. BANKOWSKI . . . . . . . . . . . . . . . . . • . . . . . . . . . . . . . . . . . . 13
4. International Federation of Pharmaceutical Manufacturers Asso
ciations
R. B. ARNOLD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5. Intercantonal Office for the Control of Medicines
J. PFANNER .•. . . . . . . . . . . . . . • . . . . . . . . . . . . . . . . . . . . . 17
6. RAD-AR Consortium
P. SIMON. . . . . . . . . . . . . . . • . . . • . . . . . • . . . . . . . . . . . . . • 19
VIII Contents
Part III: Ethical Perspectives
7. The Discipline of Ethics
S. GOROVITZ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
8. Ethics and Health
Z. BANKOWSKI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
9. A Biomedical Ethical Perspective
E. W. D. YOUNG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
10. Corporate Ethics
K. M. LEISINGER .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
11. Discussion...................................... 58
Part IV: Generating Knowledge AboutDrug Risks
12. Categories of Risk and Worldwide Resources
J. K. JONES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
13. International Risk Assessment
K. STRANDBERG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
14. Resources Needed for Risk Assessment
G. A. FAICH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Part V: Generating Knowledge AboutDrug Benefits
15. Quality ofLife and Health Status: Innovative Outcome Variables
for Research in Population Health
W. O. SPITZER 89
16. The Socioeconomic Evaluation of Medicines:
A New Dimension
S. R. WALKER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
17. Expanding Measures of Benefit in Socioeconomic Studies
B. R. LUCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Contents IX
Part VI: Assessing the Risk/Benefit Relationship
18. Challenges in Benefit/Risk Appraisal
W. W. LOWRANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
19. Analysis and Synthesis of Adverse Drug Reaction Evidence
R. BRUPPACHER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
20. The Complexities of Assessment
A. J. GORDON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
21. A Review of the Regulatory Process in Japan
H. NAKAGAWA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 125
22. Postmarketing Surveillance in Japan: An Industry View
Y. TAKEUCHI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
23. Distortions in Risk Assessment
J. HAAS 128
24. Weighing Risk/Benefit Assessment:
Views of a Swedish"Regulator"
B.-E. WlHOLM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
25. Scientific Evaluations and Personal Judgments
G. KREUTZ 135
26. Discussion 137
Part VII: Expections in Drug Safety Communication
27. The Challenge of Communicating Drug Safety Information
P. CARPENTER .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 143
28. The Media Perspective
H. H. BRAUTIGAM ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
29. The Culture of Weighing
G. M. FOLGRAFF .... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
X Contents
30. Patient Package Inserts: Carriers of Consensus Information
R. VANDER STICHELE . . . . . . . . . . . 151
31. The Patients' View
K. WHITEHORN 156
32. Patient Motivation
L. A. MORRIS, E. TABAK, and N. OUNS 160
33. Japans's Other Drug Market: Exports via Tourists
G. KOIDE 164
34. Controlling Drug Safety: Making Cautious Changes
R. D. MANN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
35. Discussion...................................... 174
Part VIII: Experiences in Drug Safety Communication Through
Traditional Channels
36. Principles, Experiences, and Desired Actions
G. LEWANDOWSKI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
37. Physician-Patient Communication and Decision Making
P. ARNTSON. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
38. Problem-Oriented Drug Information Services
F. FOLLATH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Part IX: Responses Beyond Traditional Communication
Channels
39. Manufacturer Standards for Communicating Risks and Benefits
L. A. MORRIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
40. Health Behavior Change via Community Education
N. MACCOBY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207