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Latest studies urge policy makers to implement evidence-based strategies to improve patient understanding of how their medications work and how to take them as prescribed.

By Louise Kelly on Jan 2, 2013

For the past several years, the Food and Drug Administration (FDA) has progressively relied on patient medication guides to provide crucial information about prescription drugs – 305 drugs were required to have med guides as of September 2011, up from 40 in 2006. Now, a new analysis – the brainchild of a number of researchers across a number of medical institutes – reveals that the guides are of practically useless as they are often too difficult to understand.

The FDA recently published supporting guidance on med guides, entitled Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).   As a result of gripes from the pharma market that these guides are both a burden for physicians with demanding schedules and of no significance to bewildered patients, the FDA has been reviewing med guides as part of a larger rethinking of REMS programs. The study, which was published in the Journal of General Internal Medicine, has therefore been made public at a most opportune time, adding weight and justification to these criticisms.

Drug information on labels and inserts is oft the main source of knowledge for patients as they attempt to balance the risks and benefits of drugs. While the workload strain of the general physician is easy to sympathise with – a reason for this dependence on the literature – these leaflets and guides have been proven to be inconsistent, incomplete, and difficult for the general layman to read and understand. As the FDA reviews its existing processes, the academics involved in the latest investigation wanted to provide a systematic evaluation of the existing material to explain why many patients find med guides hard to digest.

In their analysis of 285 guides, the researchers found that only one was deemed suitable according to guidelines while a mere 8 percent attempted to make the purpose of the guide evident. In a separate part of the study, a sample of 449 adults – of a wide range of literacy skills – were asked to read three guides and answer questions about the related drugs. Despite being allowed to refer back to the guides and under no time constraints, the participants were able to correctly answer only half of the questions. The extent to which patients across all literacy levels did not understand any aspect of the med guides demonstrates that they are too complex to be useful, according to the report.

This study only serves to consolidate the opinion that patients must be supplied with coherent, well-structured information about their prescription drugs rather than the redundant material that they have access to now. In an accompanying editorial to the published analysis, two of the researchers offer some suggestions for improving comprehension among patients: a reorganization of the content in the guides; greater use to be made of visuals ie tables; restructure the guides by indication rather than by questions, and quantification by benefits rather than side effects. Further research may be needed to evaluate the optimal ways to communicate written information to patients, but it is blatantly obvious that the existing policies and format must be changed.