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Council Supports FDA Proposed Rules For Bar Coding Rules to Reduce Medication Errors and Improve Patient Care April 1, 2003 Rockville, Maryland—The National Coordinating Council for Medication Error Reporting and Prevention (Council) supports the U.S. Food and Drug Administration's (FDA) proposed rules to require bar coding on medicines. In July 2001, the Council called for the FDA and the United States Pharmacopeia (USP) to collaborate with pharmaceutical manufacturers and other appropriate stakeholders to establish and implement uniform bar code standards, including standards for unit-of-use packages.* The proposed FDA rules support recommendations released by the Council in July 2001 which state that patient safety can be improved by information technology through the use of machine-readable codes such as bar codes in a standardized format. A scannable bar code can help ensure that the right drug and the right dose are being administered to the right patient. Technology developments allow increased information to be imbedded within a bar code and make the coding of smaller packages possible. The Council recommended that the data elements of the bar code include, at a minimum, the National Drug Code (NDC), the lot/control/batch numbers, and the expiration date. The Council also recommended that the data elements be uniformly ordered, and that the bar code print density should be consistent to enable an accurate scan each time. Although the proposed rules do not address all of the Council's recommendations, the rule is a big step forward. The proposed rule requires that the barcode include product identification but does not require inclusion of lot number and expiration date. Lot numbers are important data for identifying recalled drug products. Expiration dates that are embedded in the bar code will enable tracking of outdated products in the hospital and point-of-care validation of the expiration date. The Council's recommendations also called for professional associations to develop relevant standards of practice, including but not limited to: Repackaging and relabeling of extemporaneous or compounded preparations; Educating practitioners on the proper and optimal use of bar codes; and Avoiding "work-around" processes that allow health care professionals to bypass standard operating procedures that give the perception of improving efficiency. "These recommendations are a great first step in making the administration and dispensing of medications safer. The Council applauds the FDA for promulgating these regulations and pledges to work with them for the smooth implementation of the rule. The Council will also work with the provider community to take advantage of the bar coded labels to make a safer healthcare system," said John R. Combes, M.D., Chair of the Council. The Council forwarded the recommendations to FDA and USP for their consideration. The private, nonprofit USP, through the Federal Food, Drug, and Cosmetic Act, is responsible for establishing strength, quality, purity, packaging, and labeling standards for medicines. Regulatory requirements for bar coding fall under the FDA's labeling standards for pharmaceuticals. For additional information about the Council, its activities, or membership, contact Council chairperson John R. Combes (717-561-5235), or Council secretary Diane D. Cousins (301/816-8215). * Unit-of-use packaging is defined in the USP 26-NF 21 as "one that contains a specific quantity of a drug product that is intended to be dispensed as such without further modification except for the addition of appropriate labeling." # # # # The National Coordinating Council for Medication Error Reporting and Prevention (Council) was founded in 1995 to promote the reporting, understanding and prevention of medication errors. The Council comprises health-related organizations, societies and agencies, including medicine, pharmacy and nursing groups, consumer groups, standards-setting and federal regulatory bodies, and manufacturers. The Council's goals are to examine and evaluate the causes of medication errors; increase awareness of medication errors and methods of prevention throughout the health care system; recommend strategies relative to system modifications, practice standards and guidelines; stimulate development and use of medication error reporting and evaluation systems; and stimulate reporting to a national system for review, analysis and development of recommendations to reduce and prevent medication errors. NCC MERP FY0303N © 1998–2008 National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved. *Permission is hereby granted to reproduce information contained herein provided that such reproduction shall not modify the text and shall include the copyright notice appearing on the pages from which it was copied.