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EU readability testing

EU readability testingOver the past couple of years, readability testing has become a hot topic in the EU.

The safe and correct use of medicines has always depended (amongst other things) on consumers reading the labeling and packaging accurately, and being able to understand and act on the information presented. Almost 20 years ago, the European Commission published A Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use.

But it is only since the recent introduction of the Centralised Procedure that companies selling medicines in Europe had to account for this and conduct readability testing of patient leaflets ("PL"). If user testing is required (there are some exceptions, such as for products intended for hospital use or type II variations), it needs to be conducted in any one of the official EU languages.

The aim of readability testing is to demonstrate that patients can locate information in the PL, understand this information, and know how to act on it. Unfortunately, there are no absolute guidelines on how readability tests should be performed. Tests are generally conducted in two rounds with 10 subjects each. To pass, 16 out of 20 people (i.e., 80%) need to be able to answer each question correctly.

Not surprisingly, drug companies have encountered some challenges in getting used to these new requirements. In addition to having to schedule (and pay for) an additional step, many of the early readability tests have shown the PL to be lacking in clarity. Companies often had to rethink how information is compiled, written, and presented.

The good news is that companies have seen that readability testing greatly improves the quality of written and translated information. Each round of readability tests provides input for and improves future PLs. By developing style guides and terminology glossaries, companies can further improve readability scores, making medicines easier and safer to use.

Currently, as many as 1 in 9 patients avoid using medicines because the leaflet scares them off. Improved compliance rates will result in more patients actually receiving the treatment that was prescribed for them and adds millions of Euros to companies' income.

1 Comment:

  1. dvdsmpsn said...
    There are some great copywriters and also readability testing tools around. So there's no reason for drugs companies to produce complicated instructions.

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