Medication guides developed under the FDA REMS program are of little value, say researchers

Study of technical readability, and a trial of potential patients, show little progress in improving patient understanding

The FDA Risk Evaluation and Mitigation Strategies (REMS) program, initiated under the FDA Amendments Act of 2007, was intended to upgrade various types of “post approval communications” with which drugs were allowed to be marketed. Since then, hundreds of products—and most newly launched drugs—have a REMS requirement, which obliges the drug sponsor to be engaged with patients and prescribers, and report back to FDA how successful the program has been in, for example, avoiding known adverse events for the drugs’ use.

Now, a newly published study in the J. of General Internal Medicine [27(12):1714-20; an online version was published earlier this year] indicates that the language of medication guides—a key component of nearly all REMS requirements—is still too technical for patients, and that, after a cross-section of potential patients read the instructions, only just over half of them were able to comprehend the full details of what the guides were saying. The language evaluation was performed according to a pair of protocols known as the Lexile readability score and the Suitability Assessment of Materials (SAM) measurement by trained evaluators. These protocols shows that the readability of current REMS documents averages around a 10.5 grade level; five years earlier, when a similar study was performed, the average was around 11th grade. (There is no specific grade-level-equivalent for meeting REMS requirements, but the authors do tie low readability to low comprehension.)

The comprehension testing, performed on 449 consumers seeking medical attention at primary care facilities, showed that patients averaged 52.7 (on a 0-99 scale), with specific categories like “comprehension of side effects” scoring only 25.1. (The data were also sorted by level of education; the overall score for those with “adequate” education was 64.3).

Medication guides, per se, were separated from the overall REMS programs over a year ago, although they can still be imposed by FDA as a requirement for approval (more complex REMS programs still have a medication-guide component). These results are “a serious concern, as med guides are frequently the only means that patients have for receiving critical information on how to safely use higher risk drugs. 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,” conclude the authors, led by Dr. Michael Wolf of the Feinberg Medical School at Northwestern University. An editorial accompanying the Journal issue, by Lisa Swartz of the Dept. of Veterans Affairs, concludes that “The current state of prescription drug information is pretty grim” and worries that FDA is going to take years to complete a re-evaluation of the program.