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

An historical overview over Pharmacovigilance.

Author information

1
Pharmacy Unit, Centro di Riferimento Oncologico CRO Aviano, National Cancer Institute - IRCCS, Aviano, Italy.
2
Pharmacology Unit, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
3
Pharmacy Unit, Centro di Riferimento Oncologico CRO Aviano, National Cancer Institute - IRCCS, Aviano, Italy. pbaldo@cro.it.

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

PMID:
29948743
PMCID:
PMC6132952
DOI:
10.1007/s11096-018-0657-1
[Indexed for MEDLINE]
Free PMC Article

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