An historical overview over Pharmacovigilance

Int J Clin Pharm. 2018 Aug;40(4):744-747. doi: 10.1007/s11096-018-0657-1. Epub 2018 Jun 15.

Abstract

Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefit ratio of drugs, improving patient's safety and the quality of life. In this commentary we report the milestones of pharmacovigilance up to the present day, in order to understand all the steps that have characterized the historical evolution; from the first reports, which were essentially letters or warnings sent by clinicians to publishers of important and famous scientific journals, up to today's modern and ultra-structured electronic registries. The historical phases also help us to understand why pharmacovigilance helped us to achieve such important results for man's health and for pharmacology itself, and to identify the challenges that await Pharmacovigilance in future years.

Keywords: Adverse drug reactions; History; Legislation; Pharmacovigilances; Signal detection; Thalidomide.

Publication types

  • Historical Article

MeSH terms

  • Adverse Drug Reaction Reporting Systems / history*
  • Drug-Related Side Effects and Adverse Reactions / epidemiology
  • Drug-Related Side Effects and Adverse Reactions / history*
  • Drug-Related Side Effects and Adverse Reactions / prevention & control
  • History, 19th Century
  • History, 20th Century
  • History, 21st Century
  • Humans
  • Patient Safety / history
  • Pharmacovigilance*
  • Risk Assessment
  • Risk Factors