Adverse drug reactions: To report, or not to report?

Keywords: adverse drug reactions, pharmacovigilance, spontaneous reporting, post marketing surveillancepost marketing surveillance, Med Safety App

Abstract

Spontaneous reporting of suspected adverse drug reactions (ADRs) is a passive surveillance method that forms the cornerstone of the collection of medicine safety data post-marketing for all medicines and devices. Pharmacovigilance is a science that involves detection, assessment, understanding and prevention of ADRs, and it is a shared responsibility of pharmaceutical applicants, regulatory authorities, clinical institutions, public health programmes, academic researchers, healthcare workers, the media and the public. Clinicians can significantly contribute to medicine and device safety monitoring. They, however, need to be adequately informed, educated and trained on the principles of pharmacovigilance and how to report suspected ADRs.  Clinicians should be active reporters of suspected ADRs and spontaneous reporting must be part of daily clinical practice to provide high-quality medical care to their patients at all levels.

Author Biographies

M Viljoen, University of the Western Cape

School of Pharmacy, Pharmacology and Pharmacy Practice, Faculty of Natural Sciences, University of the Western Cape, South Africa

G L Muntingh, University of the Western Cape

School of Pharmacy, Pharmacology and Pharmacy Practice, Faculty of Natural Sciences, University of the Western Cape and Tygerberg Hospital Pharmacy, Tygerberg Academic Hospital, South Africa

Published
2022-05-11
Section
Review