Print

Council Calls on FDA, USP to Establish Bar Code Standards for Medicines Recommendations Aimed at Reducing Medication Errors and Improving Care July 11, 2001 Rockville, MD — The National Coordinating Council for Medication Error Reporting and Prevention (Council) has issued a set of recommendations that calls upon the U.S. Food and Drug Administration (FDA) and the U.S. 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 Recommendations 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 guarantee that the right drug and the right dose are being administered to the right patient. Technology developments allow for increased information to be imbedded within a bar code and make the coding of smaller packages possible. The Council recommends 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 recommends that the data elements be uniformly ordered, and that the bar code print density should be consistent to enable an accurate scan each time. The Council’s recommendations also call for professional associations to develop relevant standards of practice, including but not limited to: Repackaging and labeling of extemporaneous or compounded preparations Educating practitioners on the proper and optimal use of bar codes Avoiding "work-around" processes that allow health care professionals to bypass standard operating procedures that give the perception of improving efficiency. "The Council recognizes that integrated computer systems will need to be developed to incorporate standardized bar code technology into the medication use process and that this will be a costly, complex, and difficult undertaking that will require the commitment of all stakeholders," said Council Chairperson Jerry Phillips, associate director for medication error prevention, Office of Post-Marketing Drug Risk Assessment, FDA. "Once implemented, however, we believe that this standardized approach to bar coding technology is a primary and important mechanism to improve patient safety in hospitals and other health care institutions." The Council has forwarded the Recommendations to FDA and USP for their consideration. The private, not-for-profit USP, through the Federal Food, Drug, and Cosmetic Act, is responsible for establishing strength, quality, purity, packaging, and labeling standards for medicines. Potential regulatory requirements for bar coding would fall under the FDA’s labeling standards for pharmaceuticals. The FDA is being urged to collaborate with USP and other stakeholders in establishing the bar coding standards, and will oversee implementation of the final standards. "The NCC MERP is an important conduit for identifying issues that may require establishing or revising USP standards," said Roger L. Williams, M.D., USP executive vice president and CEO. "We will work closely with appropriate stakeholders to address the bar code recommendations issued by the Council." The bar coding recommendations originate from an August 2000 conference organized by the Council. Four expert panels explored specific areas relative to bar code technology, including needs assessment, current standards, equipment manufacturers, and cost implications. Alan Goldhammer, Ph.D., associate vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA) and NCC MERP delegate from PhRMA, said, "Pharmaceutical manufacturers are eager to test and implement a standard format for pharmaceutical label bar codes. We see the NCC MERP Bar Code Recommendations as a way of moving forward our mutual goals of improving patient safety." Sal Peritore, R.Ph., associate director, regulatory affairs, ESI Lederle and Generic Pharmaceutical Association (GPhA) delegate to NCC MERP added, "We are committed to the safe use of pharmaceutical products and we—and our customers—see standardized bar codes as one way to achieve this. The recommendations promote a standard mechanism for manufacturers to implement bar coding into pharmaceutical labels, which is more efficient than if we did it individually. The sooner we get this accomplished, the sooner patient safety will be improved." This is the ninth set of Council Recommendations. For additional information about the Council, its activities or membership, contact Council chairperson Jerry Phillips (301/827-3246), or Council secretary Diane D. Cousins (301/816-8215). Visit the Council’s Internet site at www.nccmerp.org. * unit-of-use packaging is defined in the USP 24-NF 19 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. 2001-03 NCC MERP Attachment: Promoting and Standardizing Bar Coding on Medication Packaging: Reducing Errors and Improving Care © 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.