FDA Patient Information Needs Work

Prescription medication guides required by FDA are too complex to be useful to the patients they are intended to help, according to a study of suitability, readability, and comprehension published int the December issue of the Journal of General Internal Medicine.  Medication guides for patients are increasingly important, serving as a key tool to diminish potential medication risks. As of September 2011, 305 drugs were required to have medication guides, up from 40 in 2006.

Medication guides are required documents given to patients receiving some prescription medications in to convey risks and cautions associated with certain prescribed medicines. Although used for many years, little has been known about the effectiveness of this information for informing patients on safe use of prescription drugs.

The JGIM study examined 185 medication guides and found that virtually all of them fell below the threshold of acceptable standards for patient education materials set by both professional societies and the federal government. In two general internal medicine clinics in Chicago, 449 adults seeking primary care services were asked to read three medication guides. The guides were for Ritalin, Aranesp, and Morphine Sulfate, and the participants read and answered questions about the drugs. The participants were allowed to refer back to the guides and allowed as much time as needed.

Comprehension of medication guides by study participants was poor, and in multivariable analyses, low and marginal literacy was independently associated with poorer understanding. The researchers concluded that current medication guides are of little value to patients because they are too complex and difficult to understand, especially for individuals with limited literacy. This  concern is important because medication guides are frequently the only means patients have for receiving crucial information on how to safely use high risk drugs.

The paper also provides clear and unambiguous guidance for improving these print materials. And in a companion editorial in JGIM, experts offer evidence-based suggestions for improving comprehension. They include reorganizing the content in the guides, making greater use of tables, and quantifying by benefits rather than side effects.

Click here to read about the study at Pharmalot.com, here to read the study itself, and here for the editorial on suggestions for improving comprehension.