Drug Topics - November 5, 2007 - (Page 28)

28 DRUG TOPICS NOVEMBER 5, 2007 www.drugtopics.com Government and Law Standard prescription labels gain interest Kathryn Foxhall articipants at a recent roundtable meeting agreed to move forward to create a forum on standardizing prescription medication labels. The approximately two dozen roundtable members included representatives from health plans; government agencies, including the Centers for Medicare & Medicaid Services; drug manufacturers; employers; physician groups; and other interests. The meeting, held last month by the Institute of Medicine (IOM) Roundtable on Health Literacy in Washington, D.C., also heard the announcement that California—just the day before—had become the first state to commit to standardizing medication labels. Although the roundtable’s mandate was to discuss issues rather than make recommendations, there was an apparent consensus among the group that standardization could create better drug labels and that representatives at the meeting could help create a convening entity to make recommendations. 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. P 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 Best practices the primary method of communiIt was widely agreed that more evidence is needed on cation with a patient and as the how to make labels more comprehensible. United best, most easy thing to legislate States Pharmacopeia (USP) CEO Roger Williams, and to really get the biggest bang M.D., told participants they might want to use one for our buck to help a lot of peoof USP’s expert committees, along with an advisory ple.” Some pharmacies and phargroup such as the roundtable participants, and start macy associations were initially by just setting a standard format for the label. Sever- Alastair J.J. Wood, concerned about it, said Cajina. M.D., advocates stanal speakers urged creation of a “best practices” stan- dard time slots during “It’s going to be a major change in dard for the drug label. the way they do business.” But the day for prescripTwo proposals presented to the roundtable focused tion drug labels. most pharmacy interests, she indion how to improve drug labeling and other consumer in- cated, eventually became supporters. formation. A white paper commissioned by the American The legislation mandates the state board of pharmacy to College of Physicians Foundation found that the lack of set regulations before Jan. 1, 2011, that require “a standarduniversal standards and medication labeling is a root cause ized, patient-centered” label on all Rx medications. The of medication error and that an evidence-based set of prac- board must hold public meetings statewide to seek infortices should guide all label content and format. mation from groups representing consumers, seniors, pharAlastair J. J. Wood, M.D., managing director of Sym- macists, and other healthcare professionals. The board is to phony Capital LLC, proposed that all medications be slot- consider medical literacy, understandability of labels, and ted into a “Universal Medication Schedule” consisting of the needs of people with limited English proficiency. breakfast time, lunchtime, supper time, and bedtime. He THE AUTHOR is a writer based in the Washington, D.C., area. Photo: Kathryn Foxhall http://www.drugtopics.com

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Drug Topics - November 5, 2007 Contents Latebreakers Latebreakers in Depth Letters Rx Care Community Practice 150 Years of American Pharmacy Hospital Practice Pharmacists at Risk Government and Law High-Density Lipoprotein New Products Advertisers Index Classified Viewpoint

Drug Topics - November 5, 2007

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