11 / 2023
Joint press release from PEI and BfArM
#MedSafetyWeek is a joint campaign involving medicines authorities from more than 80 countries around the world that are seeking to raise awareness about the importance of reporting suspected adverse drug reactions. The campaign will take place this year from 6 to 12 November 2023. The focus of this year's campaign is "Who can report?", highlighting the important role of healthcare professionals and patients in contributing to the safety of medicines by reporting suspected side effects. 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.
Reports of suspected side effects play an important role in identifying potential safety signals from medicinal products and allow authorities to take any necessary measures to protect patients or vaccinees. Such measures are included in the tasks of the BfArM and the Paul-Ehrlich-Institut.
Anyone can report suspected side effects directly to the BfArM and the Paul-Ehrlich-Institut via the online reporting portal www.nebenwirkungen.bund.de.
According to their professional code, healthcare professionals are obliged to submit any reports of suspected side effects to the relevant drug commission. The commissions in turn forward the reports to the responsible higher federal authority. In the case of vaccinations, doctors and heads of pharmacies that carry out vaccinations are also obliged under the Infection Protection Act to report the suspicion of a vaccination complication, i.e., symptoms that go beyond a typical vaccination reaction, to the health authorities, which forward the report to the Paul-Ehrlich-Institut.
Patients can report a suspected side effect directly to the competent higher federal authority, to the pharmaceutical company that holds the marketing authorisation for the medicine used or taken, to their doctor, or to their pharmacy. A doctor should be consulted for a diagnosis and for the treatment of symptoms or complaints.
Every suspected side effect report submitted to the BfArM or Paul-Ehrlich-Institut is recorded in accordance with international standards and forwarded electronically to the common European database EudraVigilance. The pharmaceutical company that holds the marketing authorisation is also legally obliged to report suspected cases of side effects directly to the European EudraVigilance database. This EU-wide data pool enables medicinal product risks to be collected throughout Europe, monitored, and countered with risk-minimising measures if necessary.
The aim of the #MedSafetyWeek campaign is to raise awareness of adverse drug reactions in the population through widespread dissemination and to encourage people to report suspected side effects. It also serves as a reminder to healthcare professionals of the possible occurrence of adverse drug reactions and as motivation to report suspected side effects.
"It only takes a few minutes to report medicinal product side effects online. Everyone can thus contribute to the safety of medicines,"
emphasised Professor Karl Broich, President of the BfArM. Broich continued, "Some medicinal product risks only become apparent when a medicine has been put into frequent use. That is why every report is important so that we can identify safety signals early from the widespread use of a medicinal product and take effective measures for patient protection if necessary."
"Everyone can contribute to medicines safety through spontaneous reporting and help to increase knowledge about possible side effects to medicines, therapies, and vaccines. This enables measures to be taken to reduce or prevent any resulting damages to health. The recording of spontaneous reports is an important pillar of medicines safety,"
summarises Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut.
Updated: 06.11.2023
