Risk Management

Gerald J Dal Pan, Stella Blackburn, Claudia Karwoski

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

All medicines have risks. Risk management is used to ensure that the potential benefits of a medicine exceed its potential risks, and to minimize those risks. The traditional tools used to manage the risks of prescription medicines have been the prescription status itself, labeling for health-care professionals, and the requirement that manufacturers monitor and report to regulatory authorities adverse events that occur with use of the medicine. In the past two decades, additional steps have been taken to manage more actively the risks of certain marketed medications. These measures have included increased communication to patients and health-care professionals, and measures to restrict the usage, in various ways, of certain medicines. Risk management systems are ideally scientifically driven, functional throughout a product's lifecycle, proactive in nature, and inclusive of all stakeholders. The principal current challenges center on advancing the science of assessing the benefits and burdens of risk management efforts.

Original languageEnglish (US)
Title of host publicationPharmacoepidemiology, Fifth Edition
PublisherWiley-Blackwell
Pages505-533
Number of pages29
ISBN (Print)0470654759, 9780470654750
DOIs
StatePublished - Jan 3 2012
Externally publishedYes

Keywords

  • Drug regulation
  • EU risk management plan
  • Pharmacoepidemiology
  • Risk assessment
  • Risk communication
  • Risk evaluation and mitigation strategy (REMS)
  • Risk management

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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