At a recent hearing, medical professionals advocated the use of unit-dose packaging to prevent medication dispensing errors in hospitals.

According to FDA, 1.3 million people are unintentionally harmed every year in hospitals and other in-patient healthcare facilities because of improper medication use and medical device failures. What's more, says FDA, many of these problems are caused by prescription drug packages and labels that are misunderstood by the caregiver.

While the frequency of these problems is probably not surprising to hospital administrators, liability lawyers, insurance companies, and some pharmaceutical industry executives, medication errors during hospital treatment have now captured FDA's attention. During a January 8 public hearing it convened on the subject, the agency sought expert testimony "for the first time" on the issues of medication error and the proper roles for government and industry to play in solving the problem.

Several of the experts testified that the number of adverse drug events and medication errors that occur in hospitals is actually much larger than reported. Lucian Leape, MD, adjunct professor of health policy at the Harvard School of Public Health (Boston), cited recent research indicating that as many as 10% of all patients experience an adverse drug event during hospital treatment, even though only 0.2% of these events are reported.

Leape's statement is based on quantification efforts undertaken by Harvard to objectively measure the number of adverse drug events that have occurred in the university's hospital system.

How can the problem be solved? According to Leape, the key is better in-patient pharmaceutical distribution systems. "Adverse drug events are caused by bad systems," he told FDA, "not by bad people." Pharmaceutical manufacturers can assist in this effort, Leape continued, by dispensing all drugs intended for in-patient use in unit-dose formats and by adding bar codes to these products. Citing a "long history of altruism" by the pharmaceutical manufacturing industry, Leape said that distribution of products in unit-dose packaging is the "right thing" for drug makers to do even if there are no financial incentives.

Leape's call for greater use of unit-dose packaging and bar coding in hospitals was echoed by several other speakers during the hearing. Bruce McWhinney of Cardinal Health Inc., pointed out that research clearly demonstrates that use of unit-dose blister packaging "can dramatically improve compliance while cutting pharmacy costs," and affirmed the need for "new ways of packaging drug products." And William M. Ellis, MS, RPh, noted that the National Coordinating Council for Medication Error Reporting and Prevention has recently recommended that pharmaceutical manufacturers employ bar coding during the labeling of their products.

The Healthcare Compliance Packaging Council (HCPC; Washington, DC) strongly agrees that unit-dose packaging and bar coding of drug products can help reduce drug distribution errors—especially when used together in a comprehensive hospital drug distribution system. HCPC believes that packaging can play a major role in ensuring that patients get the right drugs at the right times and in the right dosages.

HCPC also agrees with all of those who spoke in favor of better packaging during the FDA hearing, and it strongly supports those who advocated the view that packaging should be the centerpiece of reengineered pharmaceutical distribution systems. When 1 in 10 patients is found to be experiencing adverse drug events, and solutions have been identified by credible experts, immediate action should be taken.

Peter Mayberry is the staff director for HCPC, a not-for-profit trade association that promotes the benefits of using unit-dose blister and strip packaging. For more information, call HCPC at 202/828-2328.

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