Difficult to Reconcile
Ziegler et al. (2013) take from their survey the result that the frequencies of side effects reported in package inserts—which are reported as very common, common, and rare—are not always consistent with the interpretations of probabilities among pharmacists, doctors, and lawyers, and they conclude that that definitions of probabilities of side effects given in the package inserts probably do not correspond to the use of the terms in ordinary language. This raises the question of how—in view of the fact that the information on the package inserts and its interpretation by experts threw up substantial differences—these results would have looked if patients had also be included in the survey.
The subsequent discussion will have to be around whether—since the side effects and their frequencies as mentioned on package inserts are difficult to understand—such package inserts in general are too difficult for patients to understand. This applies for formal criteria as well as criteria relating to the actual content, although we need to remind readers that the obligation to provide comprehensible information to patients is still the responsibility of doctors. Supplementing this with written information on the package insert makes sense only if this information has been worked up in such a way that patients can understand it.
In this context I wish to point out an article by Beate Beime and Klaus Menges (2012), which focuses on the legibility and comprehensibility of package inserts in general and which, in particular, analyses package inserts on the basis of formal criteria, such as font size etc.
They draw the conclusion that it is very difficult to reconcile the legal regulations on providing information with comprehensibility, and they make concrete suggestions as to how at the very least their formal legibility and comprehensibility might be improved.
Finally, the article concludes that package inserts often do not only not make it easier for doctors to provide pertinent information to their patients, but actually make it more difficult. This is the case for the aspect of form as well as for the content. It should be made a requirement for intensive efforts to finally reconcile the demand for precision and for comprehensibility.
Dipl.-Psych. Dr. phil. Dr. med. Helmut Niederhofer
Klinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
Sächsisches Krankenhaus für Psychiatrie und Neurologie, Rodewisch
|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|
|2.||Beime, B, Menges K: Does the requirement of readibility testing improve package leaflets? Evaluation of the 100 most frequently prescribed drugs in Germany marketed before 2005 and first time in 2007 or after. Pharmaceutical Regulatory Affairs 2012; 1: 2 CrossRef|