Require Bar Codes On All Drug Product Containers, ASHP Tells HHS' Thompson
ASHP today sent Tommy G. Thompson, secretary of Health and Human Services, a letter urging him to direct the Food and Drug Administration to require manufacturers to provide machine-readable coding for all pharmaceutical product packages. This action, says ASHP, would help to protect the safety of patients in health care facilities.
July 10, 2001
The Honorable Tommy G. Thompson
Dear Mr. Secretary:
The American Society of Health-System Pharmacists (ASHP) urges the Department of Health and Human Services, through the regulatory authority of the Food and Drug Administration (FDA) to develop regulations that mandate that drug manufacturers provide a standardized machine-readable code (bar coding) on all drug product containers, including single unit containers, which are essential for hospital unit dose drug distribution systems. ASHP believes that drug manufacturers have an obligation, in the interest of patient safety, to provide bar coding for drug products. However, the pharmaceutical industry is unlikely to apply bar codes to all sizes of containers of drug products in a timely manner without a regulatory mandate from the FDA. Regulatory action by the FDA would be consistent with the strong commitment you have demonstrated, Mr. Secretary, in protecting the safety of patients treated in the health care facilities of this nation.
While ASHP realizes that the FDA has long been considering a requirement for bar-coding on prescription drug product labeling, we believe that because of the irrefutable patient safety benefits of such coding, the time for discussion is over, and that the time for substantive action has arrived.
Bar-coding on containers provides an obvious means for product verification, and it can be used in medication-use systems in pharmacies and hospitals to ensure patient safety. Bar-coding should appear on the labels of drug products at all levels of use, from the largest bulk to the smallest single-unit containers.
Recently, on June 26, the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) took the significant step of recommending the implementation of uniform bar code standards into the medication use process. This echoes a policy statement adopted by ASHP's House of Delegates in June 2001:
To declare that the identity of all medications should be verifiable through machine-readable coding technology and to support the goal that all medications be verified before they are administered to patients in the inpatient setting; further,
To urge the Food and Drug Administration to mandate that standardized machine-readable coding be placed on all manufacturers' single-unit drug product packaging to (1) ensure the accuracy of medication administration, (2) improve efficiencies within the medication-use process, and (3) improve overall public health and patient safety.
ASHP developed this new policy statement because its members recognize that the inclusion of machine-readable coding on all drug product packages is the key step in applying technology to the prevention of medication errors. As the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care agencies, and other components of health systems, ASHP believes that there are three primary goals of using bar-coding systems in the inpatient setting:
The benefits of bar-coding technology in preventing medication errors are certainly well known. The 1999 Institute of Medicine (IOM) report, "To Err is Human: Building a Safer Health Care System," notes that bar coding "is an effective remedy" for medication errors, "a simple way to ensure that the identity and dose of the drug are as prescribed, that it is being given to the right patient, and that all of the steps in the dispensing and administration processes are checked for timeliness and accuracy."1
Similarly, the February 2000 report prepared by the Quality Interagency Coordination (QuIC) Task Force in response to the IOM report noted the advances made in medication safety by the Department of Veterans Affairs. That report described the use of bar coding technology and concluded: "bar-coding of medications and use of robotics in dispensing medications can ensure that the appropriate medication is provided to the appropriate patient at the appropriate time."2
NCCMERP's recent action called upon the U.S. Pharmacopeia (USP) and the Food and Drug Administration (FDA) to collaborate with drug manufacturers in establishing and implementing uniform bar code standards. NCCMERP's rationale for issuing these recommendations was that the implementation of such technology is "the most immediate and far-reaching" solution to the unacceptable numbers of medication errors in hospitals.3 This is particularly important in light of the well-documented pharmacist shortage, the greater complexity of drug products that are being developed by pharmaceutical manufacturers, and the increased acuity of illness of patients in hospitals and other components of health systems.
The FDA has discussed the issue of bar-coding for a number of years. In January 1998, the agency held a workshop at the National Institutes of Health entitled "Minimizing Medical Product Errors: A Systems Approach." At that meeting, Dr. Lucian Leape of the Harvard School of Public Health stated that drug manufacturers should make high leverage changes prior to marketing a product, including providing medications in unit dose packages and bar-coding their products. In an article in Packaging World following that workshop, an FDA spokesperson was quoted as saying that "an FDA requirement that drug companies package in unit-dose form 'is on the table.' Requiring bar codes could be an obvious parallel move."4
That was more than two years ago. The latest that we have heard is that the issue of bar-coding is still in the "working" stage at the agency. This situation is untenable. The issuance of the recent NCCMERP white paper indicates that all the stakeholders realize the urgency of applying this technology to drug product packaging. The most recent (May 14, 2001) Unified Regulatory Agenda, however, does not assign this issue to either the pre-rule stage of the agency's thinking, or to contemplated long-term actions. ASHP believes that because of the FDA's mandate to protect the public health, the agency has the authority, under its packaging and labeling regulations, to require manufacturers to provide machine-readable coding for all pharmaceutical product packages. Patient safety requires that action be taken now.
ASHP realizes that there are a number of issues that need to be addressed regarding industry standards for bar-coding technology. We also realize that not all health care facilities and providers are currently equipped to implement this technology. However, we believe that a requirement for standardized bar-coding will motivate many providers to make use of it in their dispensing and dosage form administration systems.
We suggest that FDA staff who are working on this issue meet with ASHP staff and other stakeholders to discuss how substantive action can be taken. ASHP believes that, working together, the stakeholders can assist the FDA in developing regulations within six months. If you need further clarification of the issues ASHP has raised, please contact Gary C. Stein, Ph.D., Director of Federal Regulatory Affairs in ASHP's Government Affairs Division. Dr. Stein can be reached by telephone at 301-657-3000, ext. 1316, or by e-mail at email@example.com.
1Institute of Medicine, Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health Care System. Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, Editors. National Academy Press, p. 195.
2Quality Interagency Coordination Task Force. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact (February 2000), p. 74.
3Promoting and Standardizing Bar Coding on Medication packaging: Reducing Errors and Improving Care. NCCMERP, 2001-03.
4Federal "Medicine" for Drug Errors May be Hard to Swallow. Packaging World, May 1998, p. 74.