To promote the establishment of universal standards for prescription medication labels -- and to address the widespread problem of patient misinterpretation of medication instructions -- an advisory panel formed by the U.S. Pharmacopeial Convention (USP) recently issued a set of recommendations to bring consistency to labeling on dispensed prescription packaging. The recommendations are patient-centered, and were developed following a call for such standards by the Institute of Medicine (IOM) on the issue of health literacy. The recommendations were presented to the IOM Health Literacy Roundtable.
Limited health literacy has been cited as a major problem by IOM, which states that 90 million adults are affected. Those with limited health literacy cannot fully benefit from much that the health and health care system have to offer, according to IOM. One critical component to health literacy is the ability to properly understand medication instructions and important supplemental information (such as drug interactions). Poor health literacy can lead to non-adherence and medication errors, which may pose significant health risks to patients. Medication misuse results in over 1 million adverse drug events per year.
USP, a nonprofit scientific organization that sets legally enforceable standards for the identity, as well as the strength, quality and purity of medicines in the United States, formed a Health Literacy and Prescription Container Labeling Advisory Panel in 2007 to examine ways to improve prescription drug container labeling. USP recently released the panel's recommendations, which cover format, appearance, content and language of prescription labels -- all of which contribute to optimal patient understanding, which leads to safe and effective use of medications.
"Patients have the right to understand health information that is necessary to safely care for themselves and their families," said Joanne G. Schwartzberg, M.D., co-chair of the USP Health Literacy and Prescription Container Labeling Advisory Panel. "Confusing medication labels is one area that can be improved considerably. As most of us who have ever received a prescription drug know, the content and appearance of medication labels can vary widely. Sometimes, there is so much information included that it can be difficult to find the most essential information -- the directions for use. By standardizing labels of medications so that they provide reliable, simple and concise information, I think we can significantly advance patient health and safety."
The recommendations by the advisory panel include:
The USP panel, which is co-chaired by Dr. Schwartzberg and Gerald McEvoy, Pharm.D., is composed of a group of experts in the fields of health literacy, health policy and medication safety. The panel members are: Cynthia Brach; Sandra Leal, Pharm.D., CDE; Linda Lloyd, M.Ed.; Melissa Madigan, Pharm.D., J.D.; Dan Morrow, Ph.D.; Ruth Parker, M.D.; Cynthia Raehl, Pharm.D., FASHP, FCCP; William Shrank, M.D., MSHS; Patricia Sokol, R.N., J.D.; Darren Townzen, R.Ph., MBA; Jeanne Tuttle, R.Ph.; Joan E. Kapusnik-Uner, Pharm.D., FCSHP; Michelle Weist, Pharm.D., BCPS; and Michael Wolf, Ph.D., MPH.
Their recommendations will form the basis for consideration of a new USP general chapter on prescription container labeling, which is being developed by USP's Safe Medication Use Expert Committee. A proposed General Chapter <17> Prescription Container Labeling is expected to be completed within the next few months. USP then will seek input from the public, including consumer and health care organizations, on its content.
The full recommendations can be found at www.usp.org/USPNF/compendialNotices/recommendContainerLabeling.html.
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