Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology

Paolo Baldo, Sara Francescon, Giulia Fornasier

Research output: Contribution to journalComment/debatepeer-review


The terminology used in pharmacovigilance can cause confusion, because there are similar terms that describe different phenomena (e.g. adverse reactions, adverse drug reactions, and side effects). Incorrect use of terminology can have negative effects on the reporting of adverse drug reactions and on the interpretation of these reports. To explain the most common terms used in pharmacovigilance, this article first describes the pharmacovigilance workflow process in the European Union and, as an example, in Italy. Then, the article reviews common pharmacovigilance terms.

Original languageEnglish
Pages (from-to)748-753
Number of pages6
JournalInternational Journal of Clinical Pharmacy
Issue number4
Publication statusPublished - Aug 1 2018


  • Adverse drug reaction
  • Alerts
  • Definitions
  • Pharmacovigilance system
  • Signal
  • Terminology

ASJC Scopus subject areas

  • Pharmacy
  • Toxicology
  • Pharmacology
  • Pharmaceutical Science
  • Pharmacology (medical)


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