What is it about?

Regardless of all efforts by the authorities and manufacturers to ensure that package leaflets of medicines are patient-oriented, they are still under discussion. The survey Package Insert Test1 (PAINT1) aimed to examine the availability and comprehensibility of the information contained on five package leaflets available on the market and five model versions for the same medicines.

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Why is it important?

In a cross-over readability test design, each of the 1105 participants received an original package leaflet and a newly developed model version. The participants located and understood significantly more information (92.6–94.4%) requested to all 15 content questions in the model package leaflets, in comparison to the originals (74.7–85.8%). Most of the problems regarding the original versions were associated with the fact that the dosage instructions were given in active substance quantities rather than ‘‘tablet’’ or ‘‘volume’’, non-quantifiable phrases in the dosage instructions (e.g. take 1–3 times 2–4 tablets) and in the frequency of side effects (e.g. rare). Information regarding suitable counter measures to possible side effects, was also difficult to understand.


Optimising package leaflets, particularly dosage instructions and information regarding possible side effects, is essential and achievable. Our recommendations based on the study results are as follows: (1) every dose should be quantified in number of tablets or in volume (2) use a dosage instruction table (3) provide short and precise information only (4) do not use non-quantifiable statements

Dr Jörg Fuchs

Read the Original

This page is a summary of: Inappropriate dosage instructions in package inserts, Patient Education and Counseling, July 2007, Elsevier, DOI: 10.1016/j.pec.2007.03.009.
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