U.S. Senate: Initiative to introduce readability testing for PMI

For several years, the usability and safety of package inserts for drug products, or Patient Medicine Information (PMI), has been a source of growing concern for regulators, politicians, and patient organisations alike. At the centre of this concern is mostly the question whether patients, particularly those with lesser degrees of literacy and language competence or poor eyesight, are able to find and understand all necessary information to use the medicine safely and effectively.

The latest move to ensure the quality of leaflets handed to patients together with their (prescription) drug products now comes from the United States: in a bill introduced in the U.S. Senate under the name of Cody Miller Initiative for Safer Prescriptions Act on May 22, Sen. Kirsten Gillibrand proposes amendments to the existing legislation.

Not surprisingly, standardization of both content and design play a key role in the proposal; it is a path that also the European Medicines Agency (EMA) has followed in recent years. And quite like the EMA readability guideline for package leaflets, the Senate bill requires the information in a package insert to be in “nontechnical, understandable, plain language”.

The bill also proposes “developing a process, including consumer testing, to assess the quality and effectiveness of PMI in ensuring that PMI promotes patient understanding and safe and effective medication use”. This could mean that in the future, studies similar to the readability tests that became mandatory in the European Union in November 2005 have to be conducted in the U.S. too. While it is yet unclear if the bill will pass, it is expected to receive some backing from the FDA. Should this initiative become legislation, however, it will be interesting to see whether particularly the regulations for the consumer testing will indeed have the nature of “standards”, as the bill demands, and how strict they are – or if, like in the EU, a rather “soft” approach is taken in regards to how a readability test must be performed.

Please get in touch with us if you want to know more about readability testing at ADAPT.