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Recent concerns about the unexpected adverse effects of marketed
drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific
statins, raise concerns not only about reporting these events
during premarket studies, but also about the responsibility for
ongoing surveillance of drugs once they are on the market.
Sometimes serious adverse drug reactions are fully appreciated only
after a drug has been on the market for years. Therefore, when a
drug is approved and released to the market, large numbers of
patients will be exposed before all the potential adverse effects
have been identified and thoroughly studied. Currently, there is no
clearly defined process for addressing safety questions about drugs
after premarketing research has occurred. In November 2005, the
Institute of Medicine's Forum on Drug Discovery, Development, and
Translation convened a workshop to explore issues associated with
the reporting of ADEs. The workshop addressed the following
questions: How can ADEs be effectively identified, particularly
when the adverse effects are rare? How can the direct, causal
effects of drugs be distinguished from simple associations? How can
health-care professionals and their patients' aid in the
identification of drug-related adverse events? How can knowledge of
ADEs be more effectively used in clinical practice? Adverse Drug
Event Reporting reviews current sources of information on adverse
drug events, including the FDA's MedWatch program and the AERS,
institutional review boards, and the CMS. This report considers the
ways that consumers and advocacy groups can be involved in
reporting adverse events, and discusses drug interactions, problems
with current databases for capturing and evaluating interactions,
and difficulties in communicating information about adverse drug
interactions. This report also describes new requirements for
information contained on drug labels and how labels can be used to
communicate information about risks and drug interactions to
consumers and practitioners. Table of Contents Front Matter Summary
1 Introduction 2 Current Adverse Event Reporting Systems 3 Active
Surveillance Systems 4 Consumer Involvement in Reporting Adverse
Events 5 Drug-Drug Interactions 6 Drug Labels References A Workshop
Agenda B Speaker Biographies
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