Medication Leaflets: Useful or a Nuisance?

The quality of consumer medication information leaflets is inconsistent at best, a new study finds. Through counseling and awareness, pharmacists can prevent confusion and minimize risk.

Dispensing medications requires pharmacists to negotiate a delicate balance between face-to-face interaction and detailed written communication. Consumer medication information (CMI) leaflets distributed at many retail pharmacies have the potential to derail that balance, according to a new study.

Although the FDA provides recommendations to private publishers that produce the leaflets, they remain one of the least regulated elements of the medication dispensing process. The result is dramatic inconsistency in the quality, accuracy, and readability of the leaflets, according to Carole Kimberlin, PhD, a professor at the University of Florida’s College of Pharmacy.

Despite their intent to inform and clarify, the leaflets in their current state could create an opposite effect—confusion that compromises the safe use of medications. “Although distribution through pharmacies seems effective, the content, format, reading level, and excessive length of CMI are disconcerting. Private sector initiatives to provide useful CMI have failed,” Kimberlin wrote.

Redefining “Useful”

Using prescriptions written by FDA-recruited physicians, Kimberlin and her colleagues gathered leaflets distributed with 2 widely used drugs—metformin and lisinopril—in 365 retail pharmacies across the country. To evaluate the quality of information provided in the leaflets, the researchers used 8 standards specified in the FDA’s guidelines for designing “useful CMI.” Results were published in the American Medical Association's Archives of Internal Medicine.

Although 94% of participating pharmacies distributed CMI leaflets, they varied widely in length—from as short as 30 words to as long as 2482 words. Only 11 prescriptions for lisinopril and 1 for metformin came with CMI that met 80% or more of the FDA’s usefulness criteria. Leaflets were largely accurate, but often lacked specific directions for use and monitoring. For example, some leaflets for metformin did not provide any information about the risk of lactic acidosis associated with the drug. In other cases, different leaflets for the same drug contained contradictory information.

Legibility and readability were also persistent problems. Less than 1/3 used a font size of 10 points or larger; only 15% used enough white space between lines of text; and only 7% used bulleted lists. Most leaflets were written at about a 9th grade reading level, with only 16% meeting the standard for health information of 8th grade or lower. Although the longest CMI leaflets scored higher on content, excessive text led to significant formatting issues, according to the report.

Kimberlin and her colleagues believe explicit regulatory oversight by the FDA, as well as more in-depth research, is needed to improve and standardize the way CMI leaflets are designed, produced, and distributed. The researchers proposed a solution similar to the system that governs package inserts, “but with distinct differences in content, reading level, and formatting.”

Professional Patient Education

FDA regulations in this area have been a challenge in the past, the researchers noted. If approved, a regulatory system would likely take years to implement. Until then, pharmacists can reduce the potential for confusion by being aware of the issue and addressing it with patients, according to Jeff Prescott, PharmD, RPh, Director of Scientific Content for Pharmacy Times.

Many inconsistencies can be traced back to a pharmacy’s computer system, Dr. Prescott said. Factors as simple as what size paper a pharmacy uses to print CMI or how often software is updated can play a role. “Different prescription systems present the same information in a variety of formats, which is not something the pharmacist has 100% control over,” he added.

Dr. Prescott advised pharmacists to help patients by sifting through longer leaflets to extract key points. “Clinical trials may reveal a certain side effect in 1 in 1 million patients, yet it is still presented with equal weight because it has to be there,” he said. “But without information to contextualize the warning, it can be confusing for readers.” Individualized counseling can help counteract the “one-size-fits-all” nature of the pamphlets.

Above all, he urged pharmacists to read the pamphlets before distributing them to patients. It’s a challenge, Dr. Prescott conceded, particularly in pharmacies that fill 200 prescriptions a day or more, but it must be done. “I think that’s the absolute number one thing. If you do nothing else—and you might not have the ability to do anything else—you should review the handout.”

Finally, he said, pharmacists should advise patients to do their own thorough research on the drug and, as always, come back to the pharmacy if they have any questions about the material provided.

Guidelines published by state pharmacy boards; professional pharmacy associations, such as the American Pharmacists Association; and trade magazines, such as Pharmacy Times’ patient education columns, are other sources of up-to-date patient education information for pharmacists.

In the end, staying fully informed is the best way a pharmacist can manage the risks of inconsistent or confusing CMI. “There’s professional education and there’s patient education,” Dr. Prescott said, “but there’s also professional education for the patient.”

For other articles in this issue, see:

• Should Pharmacists Prescribe Social Media?
• Anti-Cancer Vaccine May Fight Tumor Growth
• Study Ties Acetaminophen to Asthma Risk in Teens