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

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.