19 / 2022
"MedSafetyWeek" is a joint campaign involving medicines authorities around the world. Regulators are seeking to raise awareness about the importance of reporting suspected adverse drug reactions. This year's campaign focuses on the important role of the healthcare professionals and patients who contribute to the safety of medicines by reporting suspected adverse reactions. The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (BfArM) receive all reports of suspected adverse reactions submitted in Germany and evaluate them. The "MedSafetyWeek" campaign will take place this year from 7 to 13 November 2022 for the seventh year in a row. A total of 82 countries worldwide are participating.
Besides providing a therapeutic effect, medicines can also cause adverse reactions in patients. Knowledge of the medicinal product may not be complete at the time of authorisation, as these products are tested in clinical trials on a limited number of persons. Rare and especially very rare adverse reactions associated with the use of the medicinal product can only be detected when a very large number of people have used it. This is usually the case only after authorisation.
Measures are in place to continuously monitor the safety of medicinal products, even after they have been placed on the market. The aim is to obtain more information about known side effects and to discover new side effects, especially if they are rare. The German Medicinal Products Act (AMG) stipulates that after the authorisation of a medicinal product, all experiences that relate to the safety of the medicinal product are to be continuously and systematically collected and evaluated. This is one of the tasks of the Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (BfArM). Reporting suspected adverse reactions is an important component in the work of drug safety. Individuals, reporting suspected adverse drug reactions, contribute to making medicines even safer and thus help other patients.
The Paul-Ehrlich-Institut and the BfArM depend on real-world data that is as comprehensive as possible in order to identify possible safety signals for a medicinal product, such as previously unknown adverse reactions. Healthcare professionals, patients and their relatives can report a suspected case via the reporting portal www.nebenwirkungen.bund.de. The suspected cases reported through this channel reach drug safety experts quickly, directly and safely. The reports will also be placed in the central European database of suspected adverse drug reactions, the EudraVigilance database. This database provides an extensive data pool to monitor drug risks across the EU.
Help make medicines even safer by taking advantage of the opportunity to report suspected drug adverse reactions – this is the global appeal from health authorities for "MedSafetyWeek" 2022.
Updated: 07.11.2022
