Date:
June 26, 2003

Location:
Renaissance Washington D.C. Hotel, 999 9th Street, N.W., Washington, D.C. 20001

Purpose of the Meeting

The FDA has determined that many of the medication errors reported to the agency result from medical products having brand names that look or sound like the brand names of other medical products. A December 1999 Institute of Medicine report (recommendation 7.3) said that the FDA "require pharmaceutical companies to test (using FDA approved methods) proposed pharmaceutical names to identify and remedy potential sound alike and look alike confusion with existing pharmaceutical names." Subsequently, the Office of the Secretary published Recommendation #238 (from the November 21, 2002 report from the HHS Advisory Committee on Regulatory Reform). This recommendation calls for the FDA to shift from doing drug name safety testing, in most cases, to reviewing data from sponsors who follow protocols designed to evaluate potential for look-alike and sound-alike pharmaceutical naming errors with proprietary names prior to the FDA approval. During this meeting, the FDA will encourage an open public discussion with representatives from industry, health professional and consumer groups, and academia on how best to minimize the potential for medication errors due to similarities in drug names, including discussion on current methods and approaches.

Products Naming

This public meeting is co-sponsored by the FDA, the Institute for Safe Medication Practices, and the Pharmaceutical Research and Manufacturers Association. This meeting discussion will not cover other factors that may also contribute to medication errors, such as poor handwriting, incomplete patient and drug information, the use of dangerous abbreviations and dose expressions, distractions in various health care settings, working conditions, and staffing conditions. The meeting will also not cover the evaluation of brand names for their promotional implications.
Products Naming

Meeting Agenda