Side effects risks in the leaflet

Side effects risks in the leaflet - difficult to interpret

23/10/2013

Side effects of medication must be included in the instruction leaflet. Many patients can not classify these risks. But can medical professionals do it better? Researchers from Lübeck wanted to know. The result: No, they too often misjudge the risks.

The scientists found that even physicians and pharmacists have a hard time properly assessing the frequency of side effects. In the opinion of the Lübeck researchers, they significantly overestimate the risk of side effects.
The Federal Institute for Drugs and Medical Devices (BfArM) provides a coding for the frequency of side effects. It defines five terms: „very often“, „frequently“, „occasionally“, „Rare“ and „very rare“. These were associated with side effects probability numbers and odds. Thus, side effects are e.g. "common" if they occur in less than 1 in 10 but more than 1 in 100 people.

Now it turned out that the verbal descriptions of physicians, pharmacists and lawyers are not rated correctly. The risk of side effects is especially in the description „Frequently“ significantly overestimated (60% instead of 10% correctly).

Source: Ziegler A, Hadlak A, Mehlbeer S, King 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.

Picture: Peter Franz