title: Comprehension of the description of side effects in drug information leaflets: a survey of doctors, pharmacists and lawyers.
abstract: BACKGROUND
  The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) states that it uses standardized terms to describe the probabilities of side effects in drug information leaflets. It is unclear, however, whether these terms are actually understood correctly by doctors, pharmacists, and lawyers.
  
  
  METHODS
  A total of 1000 doctors, pharmacists, and lawyers were questioned by mail, and 60.4% of the questionnaires were filled out and returned. In the absence of any particular, potentially suggestive context, the respondents were asked to give a numerical interpretation of each of 20 verbal expressions of probability. Side effects were the subject of a hypothetical physician-patient case scenario. The respondents were also asked to give percentages that they felt corresponded to the terms "common," "uncommon," and "rare." The values obtained were compared with the intended values of the BfArM.
  
  
  RESULTS
  The results obtained from the three professional groups resembled each other but stood in marked contrast to the BfArM definitions. With respect to side effects, the pharmacists matched the BfArM definitions most closely (5.8% "common," 1.9% "uncommon" and "rare"), followed by the physicians (3.5%, 0.3%, 0.9%) and the lawyers (0.7%, 0%, 0.7%). When the context of the side effects was not mentioned, the degree of agreement was much lower.
  
  
  CONCLUSIONS
  Statements about the frequency of side effects are found in all drug information leaflets. Only a small minority of the respondents correctly stated the meaning of terms that are used to describe the frequency of occurrence of side effects, even though they routinely have to convey probabilities of side effects in the course of their professional duties. It can be concluded that the BfArM definitions of these terms do not, in general, correspond to their meanings in ordinary language.
authors.affiliation: Institute of Medical Biometry and Statistics, University of Lübeck ; Centre for Clinical Trials, University of Lübeck.
authors.forename: Andreas
authors.initials: A
authors.lastname: Ziegler
authors.forename: Anka
authors.initials: A
authors.lastname: Hadlak
authors.forename: Steffi
authors.initials: S
authors.lastname: Mehlbeer
authors.forename: Inke R
authors.initials: IR
authors.lastname: König
mesh_terms: D032882:Comprehension; D004282:Documentation / Q000592:standards / Q000706:statistics & numerical data; D004348:Drug Labeling / Q000379:methods / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D006801:Humans; D033241:Lawyers / Q000706:statistics & numerical data*; D010174:Pamphlets; D010595:Pharmacists / Q000706:statistics & numerical data*; D010820:Physicians / Q000706:statistics & numerical data*; D017410:Practice Guidelines as Topic; D009626:Terminology as Topic