Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology
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Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology Paolo Baldo1 · Sara Francescon1 · Giulia Fornasier1 Received: 24 January 2018 / Accepted: 1 August 2018 © The Author(s) 2018
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. Keywords Adverse drug reaction · Definitions · Pharmacovigilance system · Signal · Alerts · Terminology
Introduction As Socrates is thought to have said, “The beginning of wisdom is the definition of terms”. Definitions are essential for understanding the meaning of words and how to use them correctly, and this is ever more true for scientific terminology. In pharmacovigilance, there are many similar-sounding terms with unique yet complex definitions (e.g. adverse reaction, adverse drug reaction, side effect, serious adverse event, and unexpected adverse event). To complicate matters further, this field involves the efforts of, and interactions among, operators from different professions: doctors, pharmacists, nurses, and more [1, 2]. Misuse of this terminology can lead to misunderstanding, with potentially serious consequences on pharmacovigilance activities. Accurate use of this terminology is important so that regulatory agencies can take measures to ensure the safety of medicines [3]. Moreover, a basic knowledge of pharmacovigilance systems and terms will be useful for healthcare professionals and may help reduce the phenomenon of under-reporting of adverse drug reactions (ADRs) [2].
* Paolo Baldo [email protected] 1
Pharmacy Unit, CRO Aviano IRCCS, National Cancer Institute, Aviano, Italy
Under-reporting of ADRs by health care professionals can be the consequence of poor knowledge of pharmacovigilance terms and processes [2, 4]. If all health care operators know which ADRs to report and how to report them, the problem of under-reporting may improve. A first step in this direction is understanding pharmacovigilance terminology and processes. Therefore, in this article of this special issue on pharmacovigilance, we describe the pharmacovigilance processes in Italy and the European Union (EU), and define the most common terms used to describe ADRs. We take as example the Italian context to highlight the close relationships between the EU and national systems.
Pharmacovigilance workflow: Italy and the EU When a drug is suspected of having caused an adverse reaction, the pharmacovigilance system is activated by a spontaneous report (Fig. 1). As defined by the European Medicines Agency (EMA), a spontaneous report is a v
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