For more than a decade the U.S. Food and Drug Administration (FDA) has required that special medication guide handouts, or “med guides,” be given to consumers for prescription drugs viewed as having “serious and significant public health concerns.” Yet, according to recent analyses, the current state of this prescription drug information for helping patients to correctly and safely take their medications is deficient in many respects.
Writing in the Journal of General Internal Medicine, Michael S. Wolf, PhD, MPH — from the Feinberg School of Medicine at Northwestern University, Chicago — and colleagues report a two-part study that examined the readability, suitability, and comprehensibility of med guides, particularly among persons with limited literacy [Wolf et al. 2012]. A special objective was to document what the researchers called “a prevalence of misunderstanding” that med guides engender and to provide a systematic evaluation of their current contents and formats.
- In the first part of their analysis, they examined 185 med guides, which were found to contain an average of 1,923 words each and had a mean reading level of 10th-to-11th grade. Only one was deemed suitable according to the researchers’ assessment guidelines, and none of them provided summaries or overviews, or framed the context before giving instructions. Only 8% attempted to make the purpose of the guide evident to readers and only about 1 in 5 (22%) limited the scope of content to the most essential information.
- In a second part of the analysis, 449 adult primary care patients at two Chicago clinics were asked to read 3 med guides — for methylphenidate (Ritalin®), darbepoetin alfa (Aranesp®), and morphine sulfate — and then answer basic questions about the drugs, including decision-making prior to use, proper storage, and possible side effects. The participants were permitted to refer back to the guides (“open book”) and allowed an unlimited amount of time for answering.
On average, participants were able to correctly answer only about half of the questions correctly. As might be expected, low and marginal literacy were associated with poorer understanding. About a third of all participants had less than a high school education and 37% had limited literacy skills; those with the lowest literacy answered only about a quarter of the questions correctly, while those with the highest level of literacy answered about 65% correctly.
Based on their findings, Wolf et al. concluded, “Current medication guides are of little value to patients, as they are too complex and difficult to understand, especially for individuals with limited literacy.” The researchers call for substantial revisions to these guides for patients, applying evidence-based readability standards, and emphasizing “need to know” content targeted to patients at all literacy levels.
In an accompanying editorial, a pair of researchers — from the VA Outcomes Group at the Department of Veterans Affairs Medical Center in White River Junction, Vermont, and the Dartmouth Institute for Health Policy and Clinical Practice — concur that, “The current state of prescription drug information is pretty grim” [Woloshin and Schwartz 2012]. However, they also note that, “there are evidence-based solutions to improve patient understanding of how well medications work and how to take them as prescribed. Fortunately, we do not need an alchemist to work miracles. We just need policy makers to implement sensible strategies that work.”
COMMENTARY: Overall, it appears that current med guides fall below acceptable standards for patient educational materials set forth by both professional organizations and government agencies. Wolf et al. comment that, “Despite a nearly eight-fold increase in the past five years in the number of drugs required by the FDA to have a med guide — from 40 in 2006 to 305 as of September 2011 — little to no improvement has been made in their readability and accessibility.”
In fact, in 2006, Wolf and colleagues had analyzed the literacy qualities of all 40 med guides existing at that time and found gross deficiencies. For example, the average reading level was 11th-to-12th grade rather than the federal recommendation of 6th-to-8th grade [discussed in UPDATE July 2009 here]. Most guides were deemed unsuitable and, consequently, less than a quarter (23%) of patients in their study reported having used the med guides as a source of information (less than 1 of 6 patients with low literacy levels).
As we also reported in the 2009 UPDATE, the FDA had scheduled a workshop to discuss “Providing Effective Information to Consumers About Prescription Drug Risks and Benefits.” Apparently, however, nothing came out of that meeting resulting in improvements of subsequent med guides, as evidenced in the current study by Wolf et al .
Med guides are developed by drug manufacturers but require FDA approval prior to distribution, so both channels may be accountable for the dismal state of these important documents. And, as Wolf and colleagues note, “Prior investigations have repeatedly found that physicians and pharmacists miss opportunities to counsel patients on appropriate use of prescribed medicines, so med guides remain a frontline and often sole channel for conveying risk information to patients.”
The FDA has increasingly relied on med guides to provide crucial safety information about prescription drugs, and these handouts have become key components Risk Evaluation and Mitigation Strategies (REMS) that manufacturers have been required to develop to help stem adverse events. This has been a special concern with many opioid analgesics.
As Wolf et al. found, “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.” This explains at least in part why patients may not commonly review medication information provided to them and, in fact, the researchers observed in the present study that the majority of patients had never even heard of med guides.
Clearly, med guides are not serving their intended purpose and little has been accomplished in recent year to improve them. A concern might be that required REMS for opioid analgesics, such as those recently mandated for extended-release and long-acting opioid formulations, may fail to achieve their targeted objectives unless more adequate patient education materials are developed.
> Wolf MS, King J, Wilson EAH, et al. Usability of FDA-Approved Medication Guides. J Gen Intern Med. 2012;27(12):1714-1720 [article here].
> Woloshin S, Schwartz LM. Getting to Better Prescription Drug Information. J Gen Intern Med. 2012;27(12):1582-1584 [article here].
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