Protect Patients Now with Bar Coded Drugs
Pharmacists group urges FDA and industry to code all container sizes.
In the interest of patient safety, pharmaceutical manufacturers have an obligation to bar code their products. Bar coded containers allow for immediate product verification, and they can be used in pharmacies and hospitals to ensure patient safety. To be truly effective, bar codes should appear on the labels of drug products at all levels of use, from the largest bulk to the smallest single-unit containers.
However, without a regulatory mandate from FDA, industry is unlikely to apply bar codes to all sizes of containers of drug products in a timely manner. The American Society of Health-System Pharmacists (ASHP) urges the Department of Health and Human Services, through the regulatory authority of FDA, to develop regulations that mandate that drug manufacturers apply a standardized machine-readable code, such as a bar code, to all drug product containers, including single-unit containers, which are essential for hospital unit-dose drug distribution systems.
Recently, on June 26, the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) 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.
- To urge FDA to mandate that standardized machine-readable coding be placed on all manufacturers' single-unit drug product packaging in order to ensure the accuracy of medication administration, improve efficiencies within the medication-use process, and 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 key to preventing 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 to accomplish by using bar coding systems in the inpatient setting:
- Coding would help eliminate medication errors and other preventable adverse drug events by ensuring accurate drug product and patient identification at the point of administration.
- Coding would improve monitoring of drug-use trends within a population of patients so that staff resources can be allocated for optimal patient care.
- Coding would improve overall efficiencies in the medication-use process, including the purchasing, storage, and distribution of drug products.
The benefits of bar coding technology in preventing medication errors are 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; it is "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."
Similarly, a 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."
NCCMERP's recent action called upon the U.S. Pharmacopeia (USP) and 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. 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.
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, 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. Following that workshop, an FDA spokesperson was quoted in Packaging World 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."
That was more than two years ago. The latest 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 prerule stage of the agency's thinking, or to contemplated long-term actions. ASHP believes that because of 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 a number of issues need to be addressed regarding industry standards for bar-coding technology. We also realize that not all healthcare 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.
For more information, contact Gary C. Stein, Ph.D., Director of Federal Regulatory Affairs, in ASHP's Government Affairs Division, at 301/657-3000, ext. 1316, or by e-mail at firstname.lastname@example.org.