What is it about?

A significant increase in the amount of text in package inserts of medicines has been observed over the last years. This study investigated the consequences of this increase.

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Why is it important?

The results of this readability test study with 1105 participants show: The more extensive the package inserts, the worse patients feel informed. Increasing the amount of text significantly decreases the ability to locate information, thus putting people off from reading the contents (P ≤ 0.021).


The results of this readability test study suggest that decreasing the amount of text is a key factor, whereby a maximum of 1,500 words per package insert should be the aim. Conclusion: The way forward in package insert user testing is to concentrate on patient requirements and package insert improvements. Appropriate solutions are required for the further development of guidelines, templates, and directives, such as a shorter QRD template used in the European Union.

Dr Jörg Fuchs

Read the Original

This page is a summary of: The Way Forward in Package Insert User Tests from a CRO's Perspective, Drug Information Journal, March 2010, SAGE Publications,
DOI: 10.1177/009286151004400203.
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