Postmarketing Spontaneous Pharmacovigilance Reporting Systems

Gerald J. Dal Pan, Marie Lindquist, Kate Gelperin

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Only 50 years ago the thalidomide tragedy served as a wake-up call to clinicians and health authorities worldwide and showed the need for effective systems to detect and seek to prevent such unforeseen consequences of therapeutic drug use. Today, increasingly sophisticated methods are employed in this effort, often referred to as pharmacovigilance. Much more needs to be done. Individuals are encouraged to report suspected adverse drug reactions or adverse events to health authorities or drug manufacturers for compilation, analysis, and effective action. This chapter describes some basic features of pharmacovigilance systems around the world.

Original languageEnglish (US)
Title of host publicationPharmacoepidemiology, Fifth Edition
PublisherWiley-Blackwell
Pages135-157
Number of pages23
ISBN (Print)0470654759, 9780470654750
DOIs
StatePublished - Jan 3 2012
Externally publishedYes

Keywords

  • Case report
  • Case series
  • Data mining
  • Database
  • Pharmacovigilance
  • Postmarketing drug safety
  • Reporting ratio
  • Signal detection
  • Spontaneous report
  • Surveillance

ASJC Scopus subject areas

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

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  • Cite this

    Dal Pan, G. J., Lindquist, M., & Gelperin, K. (2012). Postmarketing Spontaneous Pharmacovigilance Reporting Systems. In Pharmacoepidemiology, Fifth Edition (pp. 135-157). Wiley-Blackwell. https://doi.org/10.1002/9781119959946.ch10