Literacy advocates call for drug label uniformity

The central questions include what such a label should look like and whether it will lead to better health outcomes.

By Victoria Stagg Elliott — Posted Nov. 19, 2007

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Patients frequently confront difficulties finding the information they need on prescription drug labels. The resulting misunderstandings can make it more likely a drug will be taken incorrectly. For these reasons, physicians and other advocates for improved health literacy are contemplating the standardization of medication labels.

This concept was among the suggestions included in a white paper on the subject published last month by the American College of Physicians Foundation. An Institute of Medicine Health Literacy Roundtable also met to discuss the idea.

"There is just so much variation, and there's general agreement that it is to the detriment of patients," said Cindy Brach, senior health policy researcher at the Agency for Healthcare Research and Quality. She represented the agency at the IOM meeting.

But while growing agreement exists regarding the need for a uniform prescription drug label format, it's unclear what information should be included and how it would be presented. Related research is ongoing, and physicians said it would be necessary to demonstrate how changes would facilitate improved comprehension and outcomes.

"We generally agree with the direction, but this is going to take further work," said William A. Dolan, MD, an American Medical Association trustee, who represented the organization at the IOM meeting. The AMA recognizes poor health literacy as a barrier to good medical care, although it does not have a position on standardizing drug labels. The AMA Foundation also has several health literacy programs.

Those working on this issue also want the label to become part of a cohesive chain of communication, starting with the written prescription handed to the patient and continuing to the package insert as well as other information provided by the pharmacy.

"None of it looks like it goes together, and it's not very patient centered," said Terry Davis, PhD, professor of medicine and pediatrics at the Louisiana State University Health Sciences Center in Shreveport.

Some experts would like to see Latin fall out of favor for prescription writing to better incorporate prescriptions into the patient education process.

"There are very few things in life that have changed so little as communication between a physician and pharmacist. Nothing else is written in Latin," said Alastair J.J. Wood, MD, professor of medicine and pharmacy at the Weill Cornell Medical College in New York. He also is managing director of Symphony Capital LLC, a private equity firm that invests in novel biopharmaceuticals.

The most controversial item suggested at the meeting, although not resulting from the ACP Foundation paper, was a proposal to develop a uniform schedule to further simplify the process of taking multiple medications. This would allow many patients to ingest various medications at set times, such as breakfast, lunch, dinner and before bed. It would replace current practices in which patients try to take each individual drug at specific times or time intervals.

Those advocating this approach say it would most likely be effective for 90% of medications taken by patients. It also would improve regimen adherence.

"Patients take multiple different medications at different times, and it's needlessly complicated," said Dr. Wood, former chair of the Food and Drug Administration's Nonprescription Drugs Advisory Committee. "Only the most attentive are taking them the way they are prescribed, and they are probably ruining their lives doing it. Most are just not taking them."

Those who challenge this idea say that drugs have not been studied in this way and suspect it may not work for as many as suggested by those behind this idea.

A summary of this meeting will be published within the next few months. The ACP Foundation and the IOM will also host the sixth National Health Communications Conference, "Advances in Health Literacy," at the end of November in Washington, D.C.

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