Standard prescription labels gain interest

November 5, 2007

Participants at a recent roundtable meeting, including government and industry representatives, agreed to move forward with creating a forum on standardizing prescription medication labels.

George Isham, M.D., M.S., medical director of HealthPartners plan in Minnesota and roundtable chair, asked various speakers the question, Who should convene a group for writing such recommendations? Speakers pointed to the Institute of Medicine, the National Council for Prescription Drug Programs, and others.

Best practices

Two proposals presented to the roundtable focused on how to improve drug labeling and other consumer information. A white paper commissioned by the American College of Physicians Foundation found that the lack of universal standards and medication labeling is a root cause of medication error and that an evidence-based set of practices should guide all label content and format.

Alastair J. J. Wood, M.D., managing director of Symphony Capital LLC, proposed that all medications be slotted into a "Universal Medication Schedule" consisting of breakfast time, lunchtime, supper time, and bedtime. He further proposed putting a table-like illustration on labels, with a column for each of those time slots and the number of doses prescribed for each time slot.

Nancy Ostrove, Ph.D., senior advisor for risk communication, Food & Drug Administration Office of Planning, said the agency's sense is that evidence-based standardization is conceptually the way to go. "I think the FDA has demonstrated our belief in this through the regulations that require nutrition-facts panels on foods-and the drug-facts panels for OTC products-to convey basic facts in a standard format." However, she said, "the risk is that this desire to achieve standards rapidly can undermine the determination to base what we do on appropriate research."

California is first

In other news on Rx labels, California governor Arnold Schwarzenegger signed legislation on Oct. 11 making his state the first to commit to adopting standardized prescription drug labeling. Vanessa Cajina of the Latino Coalition for a Healthy California told the roundtable that her group worked with senior advocacy organizations to secure the legislation "because we saw the label as the primary method of communication with a patient and as the best, most easy thing to legislate and to really get the biggest bang for our buck to help a lot of people." Some pharmacies and pharmacy associations were initially concerned about it, said Cajina. "It's going to be a major change in the way they do business." But most pharmacy interests, she indicated, eventually became supporters.

The legislation mandates the state board of pharmacy to set regulations before Jan. 1, 2011, that require "a standardized, patient-centered" label on all Rx medications. The board must hold public meetings statewide to seek information from groups representing consumers, seniors, pharmacists, and other healthcare professionals. The board is to consider medical literacy, understandability of labels, and the needs of people with limited English proficiency.

THE AUTHOR is a writer based in the Washington, D.C., area.