TY - JOUR
AU - Traynor,, Kate
AB - Members of the Institute of Medicine’s (IOM’s) roundtable on health literacy in April convened a diverse group of stakeholders to discuss how they can assist FDA in its efforts to help Americans use medications safely. A major focus of the meeting was to exchange ideas with FDA about the agency’s Safe Use Initiative, which was launched last fall. The initiative’s goal is to reduce unnecessary adverse events resulting from the inappropriate use of medications (see January 1, 2010, AJHP News). “We’re really just getting started with this effort,” said FDA Principal Deputy Commissioner Joshua M. Sharfstein. Safe use projects Goals FDA wants to target under the Safe Use Initiative include improving dosing devices for nonprescription liquid medications and making consumer medication information (CMI) leaflets more relevant for patients, according to the agency’s website. H. Shonna Yin, assistant professor of pediatrics at the New York University School of Medicine, presented information from a study examining the packaging and labeling of 200 nonprescription liquid pediatric cough, cold, allergy, and gastrointestinal-symptom medications. Yin said 25% of the products’ packages did not include a dosing device. Of those products whose package did include a dosing device, essentially all had at least one inconsistency that could make it difficult for purchasers to use the medication properly. Specifically, she said, 81% of the dosing devices—most of which were cups—contained superfluous volume markings unrelated to the dosing instructions. Of those dosing devices, 89% had markings for units of measurement that did not match the dosing instructions, 53% had numeric values, either decimals or fractions, that did not match the instructions, and 22% were missing markings for volumes specified in the instructions. Other problems Yin described included nonstandard abbreviations for milliliter and teaspoon, the use of nonstandard units like dram, “cc,” fluid ounce, and dessertspoonful, and the lack of a leading zero on dosage instructions or devices. “It’s not a new issue,” Yin said of the inconsistencies reported in the study. Gerald McEvoy, ASHP’s assistant vice president for drug information, gave a presentation on CMI leaflets and FDA’s guidance for creating the documents. He said CMI leaflets are “the most widely used supplemental information” patients have about their medications. ASHP is a commercial provider of a database of CMI. But FDA has determined that the documents do not meet the agency’s criteria for containing useful and relevant information for patients. McEvoy said ASHP supports collaborative efforts to improve CMI content, consistency, and simplicity. He also suggested that FDA work with state boards of pharmacy to ensure that CMI products meet FDA’s expectations for content, format, and distribution at the point of dispensing. Where to start Sharfstein said that he thinks the Safe Use Initiative will take a “one-drug-at-a-time” approach to solving problems, but he asked for input about alternative ways to proceed. Daniel Budnitz, director of the Centers for Disease Control and Prevention’s (CDC’s) medication safety program, promoted an “injury-based approach” to improving medication use. For example, he said, a CDC analysis of emergency-room visits for unintentional overdosages in children under five years of age identified acetaminophen, cough and cold products, and nonsteroidal antiinflammatory drugs as the leading underlying reason for the visits. More than 80% of the overdosages were attributed to unsupervised ingestion, he said, making this a possible target for action to improve safe medication use. For prescription drugs, McEvoy proposed that FDA start with a list of products whose labeling contains a boxed safety warning and focus Safe Use Initiative activities on those medications. “The fact that they do have a [boxed] warning indicates that FDA considers them to carry some of the highest risks of any drugs,” McEvoy said. But he noted that the list would be long, because “hundreds of drugs” have labeling that includes a boxed warning. Protecting the public Sharfstein characterized the Safe Use Initiative as part of the agency’s focus on public health under Commissioner Margaret Hamburg. “FDA is a public health agency,” Sharfstein said. He said he hopes FDA, by working with outside partners on public health issues, will “save a lot of lives, and prevent a lot of disease, and save a lot of costs, and prevent a lot of suffering.” Sharfstein said that relying on productive partnerships to improve public health can lessen FDA’s need to implement “blunt” regulatory tools like risk evaluation and mitigation strategies, or REMS. He said such tools affect the work of clinicians and pharmacies and may reduce a drug’s benefits along with its risks. He singled out pharmacies as being accessible to patients and having “a very important role to play” in efforts to improve medication safety. In some cases, he said, pharmacy communications with patients could be more effective than a REMS for encouraging safe medication use. For example, Sharfstein said, pharmacies might be able to use text messaging to help patients properly dispose of expired or unused narcotics, a problem FDA highlighted last October (see December 1, 2009, AJHP News). “Would it be that hard for a pharmacy to send an instant message to somebody’s cell phone saying, ‘If you still have any lying around the house, now is the time to get rid of it?’” he asked. Karen Weiss, a medical officer in FDA’s Office of the Commissioner, said FDA needs to work with other stakeholders because many unsafe medication practices take place “outside of FDA’s purview.” “Everyone has an important role in medication safety,” she said. Copyright © 2010 by the American Society of Health-System Pharmacists, Inc. All rights reserved.
TI - FDA reaches out on safe medication use
JO - American Journal of Health-System Pharmacy
DO - 10.2146/news100045
DA - 2010-06-15
UR - https://www.deepdyve.com/lp/oxford-university-press/fda-reaches-out-on-safe-medication-use-SE4imTd6F9
SP - 962
VL - 67
IS - 12
DP - DeepDyve
ER -