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The supermarkets do it - so why can't we raise the "bar" in health care?

From the July 25, 2001 issue

For many years, bar code technology has demonstrated its power to improve productivity and accuracy in a variety of diverse industries. As such, one would expect this technology to spread quickly to health care to enhance patient safety. Not so! A 1987 survey by the American Hospital Association showed that bar codes were used most often in materials management, not in clinical applications (Longe K. The status of bar codes in hospitals: a survey report. Hospital Technology Series. Chicago: AHA; 1989:8). Little has changed since then according to 1435 hospitals that completed the 2000 ISMP Medication Safety Self Assessment. While 43% of hospitals had discussed the possibility of bar coded drug administration, only 2.5% used this technology in some areas of the hospital, and less than 1% had fully implemented it throughout the organization. Likewise, just 2% of hospitals used bar coding technology to dispense most medications throughout the organization.

What's the problem with applying bar code technology in medicine, and specifically to the medication use process? The catch lies largely with the pharmaceutical industry's apparent unwillingness to adopt a universal bar code standard and apply a bar code consistently to the immediate container of all medications, including unit dose packages. Further complicating the issue, there is an extended lag time between the launch of new medications and their availability (if ever) in unit dose packaging. And sadly, unit dose packaging for some established products has been discontinued and this trend appears to be increasing. At this point, hospitals that employ bar code technology must repackage many medications and relabel each with a bar code. This can only be done at considerable cost in manpower and/or automated repackaging equipment. Further, error risk is increased because doses must be taken from their original container for repackaging/relabeling.

As yet, the FDA has failed to issue a regulatory mandate to print bar codes on all medication packages. But just this month, the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) and the American Society of Health-System Pharmacists (ASHP) publicly called for a renewed effort in this regard. On the heels of an August 2000 conference with a wide variety of stakeholders, the NCCMERP proposed the expeditious implementation of bar codes down to the immediate unit-of-use package, and laid out guidelines to standardize the data elements, format, location, and scope of bar codes on packages (see for details). Likewise, ASHP sent a letter to Tommy Thompson, Secretary of the Department of Health and Human Services, to press for collaborative efforts to establish bar code regulations within 6 months, stressing that the FDA has both a mandate to protect the public and the authority to require manufacturers to print bar codes on their products (see for details). According to Henry Manasse, ASHP Executive Vice President and CEO, ASHP has concluded that 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. Manasse wrote, "The time for discussion is over, and the time for substantive action has arrived."

We couldn't agree more. We estimate that there are about one million hospitalized patients in the US who receive about 16 doses of medications daily (over 16,000,000 doses per day). Assuming a very conservative 2% medication error rate, about 320,000 medication errors occur daily. Using data from Leape et al (Systems analysis of adverse drug events. JAMA 1995;274:35-43), over 100,000 errors occur during drug administration(38%) and 35,000 during drug dispensing (11%). Using machine-readable code may prevent most of these errors, including some that cause death or permanent injury!

What will a fully realized bar code system in health care bring us? For now, such knowledge is confined to the few who are just beginning to demonstrate the enormous value of this technology in clinical settings. But its slow adoption in health care is clear evidence that it will not catch fire until manufacturers are required to place uniform bar codes on their products. Nevertheless, while we all join in support of ASHP and NCCMERP in their push for bar code regulations, hospitals must begin now to prepare for bar coding by gaining familiarity with available technology and establishing comprehensive unit-dose dispensing systems. Unless medications are dispensed in patient-specific doses and in the most ready-to-use form, bar code technology can offer only a partial solution - which may well be no solution at all if, in the end, medications frequently bypass the very system designed to ensure their accurate use.

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