Not too Much to Ask
After conducting a postal survey among doctors, pharmacists, and lawyers, the authors concluded that definitions of the frequency of side effects that Germany’s Federal Institute for Drugs and Medical Devices (BfArM) adopted in consensus with the standardized set of terms established by the European Commission (EC) Pharmaceutical Committee do not, in general, correspond to how the respective terms are defined in ordinary language.
The authors therefore suggest redefining the terms (“very common >10% … very rare <0.01%) and adapting these to ordinary everyday language. One could obviously do so and thereby completely descend into chaos.
The BfArM terms have for years been common parlance in all product information for users (package inserts), technical information for doctors and pharmacists, and patient information for participants in clinical trials.
Rather than redefining them, should it not become a requirement that pharmacists and doctors, who are tasked with advising and informing their patients and/or study participants, familiarize themselves with the national (and international) terminology? As there are only five stages of probability, this is surely not asking too much. Otherwise someone might come up with the idea that regional differences should be considered, because something that is “very common” in Bavaria may well be “uncommon” in Mecklenburg-West Pomerania, or vice versa.
Prof. Dr. med. Frank P. Meyer
|1.||Ziegler A, Hadlak A, Mehlbeer S, König IR: Comprehension of the description of side effects in drug information leaflets—a survey of doctors, pharmacists and lawyers: Dtsch Arztebl Int 2013; 110(40): 669–73 VOLLTEXT|