Bulletin on Drug Safety - Current Issue 4/2023 Published
The Bulletin on Drug Safety is a cooperation between the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI). The quarterly publication provides information from both federal institutes on current aspects of the risk assessment of drugs. It focuses on pharmacovigilance – the continuous monitoring and evaluation of drug safety before and after marketing authorisation. The Bulletin includes articles on individual drugs as well as background information on pharmacovigilance and research in this area.
The publication is available in German only.
Topics in the Current Issue
- Editorial: Current study results on COVID-19 mRNA vaccines and management change for the division responsible for medicinal product safety at the Paul-Ehrlich-Institut
- Prescription of parenteral iron (III) preparations in the outpatient pharmaceutical supply in Germany
- Measures to minimise the risk of ocular adverse events involving miltefosine – ACSoMP (WHO) collaboration with BfArM and UMC
- Follow-up and comparison of children and adolescents with COVID-19 vaccine-associated myocarditis versus non-vaccine-associated myocarditis in the MYKKE registry
- Vaccine safety monitoring using artificial intelligence
- Reports from BfArM and PEI
- PRAC recommendations within EU referral procedures – September to November 2023
- Revised product information wording – Extracts from the PRAC recommendations on signals
- References to ‘Dear Doctor Letters’ (Rote-Hand-Briefe) and safety information
Further Information
Bulletin on Drug Safety, Issue 4/2023 (German only)
www.pei.de/bulletin-safety
