Benefit-Risk Balance for Marketed Drugs: Evaluating Safety Signals,
Report of CIOMS Working Group IV
CIOMS 1998, 160 pages (English), ISBN 92 9036 068 2, CHF 15.-/USD
13.50; In developing countries: CHF. 10.50, Order no. 1840020. WHO
distribution and sales, CH-1211 Geneva 27, Switzerland.
This report presents and explains a standardized methodology for
reassessing the established benefit-risk relationship of a marketed
drug when a new safety problem arises. Addressed to drug manufacturers
and regulatory authorities, the book responds to the absence of any
standard, systematic procedure for assessing newly detected hazards,
balancing risks against benefits, and reporting the results. The recommended
approach, which reflects the consensus reached by 24 representatives
of industry and government regulatory authorities, includes detailed
advice on concepts and procedures for determining the magnitude of
the safety problem and deciding on the appropriate action, whether
involving a routine change in product information or immediate withdrawal
of the drug from the market. The use of a standard reporting form,
presented here for the first time, forms a central part of the recommended
procedure.
The report adopts a public health approach aimed at encouraging consistent
practices, on the part of both regulators and companies, when a major
safety problem is signaled. Throughout, examples from case studies
are used to illustrate pragmatic responses to the many difficult problems
involved. Information ranges from a checklist of questions to consider
when evaluating benefits, through an agreed-upon method for scoring
the relative seriousness of different adverse reactions, to recommendations
for the standard visual presentation of data. Particular attention
is given to procedures that can help minimize bias when risk profiles
are prepared for competing products from the same therapeutic class.
The report has five chapters. The first provides an overview of recommended
principles, the factors influencing benefit-risk assessments, and
the types of data and analytical approaches that should be used. Chapter
2, which forms the core of the report, presents a standard five-part
reporting form and provides detailed guidelines for its completion.
Examples from case histories are used to illustrate basic principles
and methodologies for collecting and analyzing the data needed for
benefit estimation, risk estimation, benefit-risk evaluation, and
the analysis of options for action. The chapter also suggests standardized
ways of displaying data when profiling and quantifying risks or comparing
the risk profiles of competing drugs.
Chapter 3 covers the decision-making process, including advice on
how to select the best options for action and how to determine the
responsibilities of regulators and companies. The remaining chapters
discuss issues unaddressed or unresolved by the working group, and
summarize key recommendations and proposals.
The report concludes with a series of appendices, which include in-depth
case histories for seven drugs, a model for the quantification of
risks (accompanied by a detailed example of how the model works in
practice), and a summary of results from a survey of actions taken
by manufacturers and regulatory authorities when postmarketing safety
issues arise.
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