Spontaneous reporting is a cornerstone of pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It involves the voluntary reporting of suspected adverse drug reactions (ADRs) by healthcare professionals, patients, and consumers to regulatory authorities or pharmaceutical companies. Spontaneous reporting plays a vital role in identifying and monitoring medication safety signals, contributing to patient safety and the overall assessment of drug benefits and risks. In this article, we will delve into the significance of spontaneous reporting, its process, strengths, limitations, and its crucial role in ensuring medication safety.
PATH: PHARMD/ PHARMD NOTES/ PHARMD FIFTH YEAR NOTES/ PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS/ SPONTANEOUS REPORTING.