Pharmacy Leaflets Overlooked as Potential Patient Education Tools

Pharmacy leaflets hold much potential for helping patients properly assess the risks and benefits of their medications.

These leaflets, along with medication guides and package inserts, comprise the major sources of written information about individual drugs given to patients in the pharmacy. Of these 3 drug information vehicles, only pharmacy leaflets are ubiquitous.

Despite their wide distribution, pharmacy leaflets are not subject to FDA regulation, so the written information attached to the same medications from different pharmacies can vary greatly in both content and format.

To resolve this discrepancy, an FDA committee recommended in 2009 that the agency replace medication guides, patient package inserts, and pharmacy leaflets with a single, standardized document that would be distributed with all prescriptions.

While a template for such a standardized patient-information document has yet to be determined, a viewpoint recently published online in JAMA Internal Medicine suggested that pharmacy leaflets have the most potential to disseminate this information.

What’s missing from them, the viewpoint authors contend, is a “trustworthy, plainly worded” quantitative summary of a drug’s risk-benefit profile. Such a summary would allow patients to “weigh the potential benefits vs. the potential harms of a specific medication,” they wrote.

Yet, earlier this year, the FDA said it would not require the inclusion of a quantitative summary of a drug’s risks and benefits because standardizing the format of this information across all prescriptions would be difficult.

However, lead viewpoint author Anna Hung, PharmD, of the University of Maryland School of Pharmacy told Pharmacy Times that the qualitative summaries currently provided in pharmacy leaflets aren’t enough to keep patients informed.

“The key benefit of having pharmacy leaflets include quantitative summaries of the risk and benefits of a medication is that numbers can convey the likelihood of patients actually experiencing specific benefits and specific harms—information needed to make an informed health care decision,” she said.

Pharmacists should be concerned about this because patients who experience adverse effects that they may not have anticipated are more likely to be nonadherent to their medications.

“The pharmacist can play a crucial role by providing quantitative information...as well as answering questions from patients and directing [them] to other trustworthy publicly available medication information resources,” Dr. Hung said.

Because quantitative information could be drawn from high-quality systematic review results, as well as data that the FDA uses to initially approve a drug, there is no reason why pharmacy leaflets can’t include quantitative summaries of individual medications, the viewpoint authors concluded.

“To a great extent, the know-how already exists,” Dr. Hung told Pharmacy Times. “It’s the will that we’re lacking.”