FDA works toward product naming, packaging guidance

Abstract

Pharmacists and other health care professionals in June urged FDA to standardize how medications are named and simplify labeling and packaging to help reduce medication errors. The two-day public workshop, held in College Park, Maryland, was convened by FDA to gather input from stakeholders as the agency prepares a guidance document for industry on medication labeling, packaging, and naming practices. “This is the first step in future development in regulation,” said Carol Holquist, director of FDA’s Division of Medication Error Prevention and Analysis (DMEPA). “What we are trying to do is consider the body of knowledge that’s out there and come to a consensus.” She said that although preparing regulations can take “10 to 15 years,” FDA hopes to produce a draft guidance document by the end of this fiscal year. Look-alike and sound-alike drug names are a well-recognized source of medication errors, said Michael Cohen, president of the Institute for Safe Medication Practices (ISMP) and a member of the expert panel FDA convened for the June workshop. ISMP’s website lists pairs of drug names that have been linked to medication errors, including problematic names for which the Joint Commission requires accredited health care organizations to take action to improve patient safety.