Reporting suspected adverse medicine reactions is an important component of pharmacovigilance. Reports of suspected cases help to identify any previously unknown potential medicinal product safety signals. The identification of rare and very rare side effects in particular is facilitated by reporting.
Spontaneous reports are especially important because they allow for side effects to be detected in the course of widespread, everyday medicine use. This makes it possible to gain insights into possible side effects of medicinal products in contexts that are not investigated in clinical trials. Physicians, pharmacists, and pharmaceutical companies or marketing authorisation holders are obliged to report suspected side effects. Patients and their relatives can also submit reports themselves. #MedSafetyWeek is an annual international social media campaign that draws attention to the importance of spontaneous reporting as an essential component in monitoring the safety of medicines.
The article that appeared in Bulletin on Drug Safety 03/2023 introduces the campaign and reports on the activities of the Federal Institute for Drugs and Medicinal Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and Paul-Ehrlich-Institut. BfArM and Paul-Ehrlich-Institut will also participate in this year's campaign, which runs from 06 to 12 November 2023.
Updated: 31.10.2023
