Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology

Research output: Contribution to journalComment/debate

1 Citation (Scopus)

Abstract

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
Volume40
Issue number4
DOIs
Publication statusPublished - Aug 1 2018

Fingerprint

Pharmacovigilance
Workflow
Terminology
Italy
Drug-Related Side Effects and Adverse Reactions
Pharmaceutical Preparations
European Union

Keywords

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

ASJC Scopus subject areas

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

Cite this

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abstract = "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.",
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AB - 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.

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