Drop in unit-dose packaging raises concerns over safety

HEALTH-SYSTEM EDITION
PROFESSIONAL PRACTICE

Drop in unit-dose packaging raises concerns over safety

Health-system pharmacists and medication safety advocates are reacting critically to the results of a survey that revealed a decline in the number of drug products available in unit-dose packaging over the past five years. Of the respondents to the survey, conducted by the Institute for Safe Medication Practices (ISMP), 76% reported that they've seen a decline in unit-dose items. In addition, 72% of the respondents reported a problem with medications that were previously packaged by the manufacturer in unit-dose form but are no longer available. And 73% claim that they've been having the same problems with newly marketed medications, especially those that have been available less than 18 months.

If manufacturers continue to reduce the supply of unit-dose medications, more and more hospitals will be forced to repackage products themselves or resort to outsourcing. That could place a heavy financial and manpower burden on hospitals, industry observers contend. "If we have to repackage this stuff, it will be very cost prohibitive," said William Gouveia, director of pharmacy at the New England Medical Center in Boston.

At Hartford Hospital in Connecticut, director of pharmacy Gregory Gousse commented, "We have to package more and more items in unit dose because we can't buy it anymore." In addition, he noted, when hospitals repackage a medication, under USP guidelines, the expiration date that they put on the label can only be six months to a year, because in the process of repackaging, the integrity of the package is destroyed. By contrast, a manufacturer's expiration date can be longer, as much as two to three years.

The apparent reduction in the production of unit-dose packaging by drug companies took some industry insiders by surprise. Recent empirical evidence links a drop in medication errors to an increased use of unit-dose medications in combination with bar-code technology. "At a time when everyone is trying to cut back on errors, we have a situation that could contribute to more errors," commented Michael Cohen, president of ISMP. He said the pharmaceutical industry should step up to the plate and help hospitals find strategies that reduce medication errors. Instead, he lamented, "they're creating some of the worst problems we have."

Jerry Phillips, associate director, Office of Drug Safety for the Food & Drug Administration, noted that there is an absolute correlation between a reduction in errors and the implementation of bar-coded, unit-dose medications on the patient level. Phillips said that in some instances that combination has reduced medication errors by as much as 60% to 70%.

According to the ISMP survey, almost half the respondents indicated that they are actively engaged in bar-code strategies for their hospitals. But industry observers point out that as long as hospitals have to incur additional costs by farming out the repackaging of medications in unit-dose form or do it themselves, they're less likely to move toward bar-coding.

Peter Mayberry, executive director of the Healthcare Compliance Packaging Council (NCPC), based in Falls Church, Va., called ISMP's survey data "distressing.... From the IOM report a few years ago and all of the recommendations made by every learned body on how to reduce medication errors, all of them cite the benefit of unit-dose packaging coupled with bar-coding as a means of reducing medication errors." Mayberry is concerned about the correlation between a decrease in the number of unit-dose medications being shipped and a corresponding increase in the number of medications errors that occur in hospitals.

"The whole point of unit dose is that multiple people can handle a medication and it's identifiable until the moment of administration," said Russ Lazzaro, director of pharmacy at Holy Name Hospital in Teaneck, N.J. For example, he commented, without unit dose, pharmacies are forced to deal with bulk materials involving greater numbers of people handling tablets. "Why would you do this? We're trying to do things better. The trend should be the opposite."

Why are drug companies cutting back on unit-dose packaging? "Cost," said NCPC's Mayberry. One theory is that by eliminating the expensive machines and personnel required to package drugs in unit-dose forms, for example, drug companies free up production facilities and personnel to make more profitable items.

Meanwhile, there may be some relief in sight. In December 2001, the FDA issued notice of a proposed rule mandating the use of bar codes in inpatient facilities. However, Cohen said he doubts that without Congressional action there will be any movement in this area any time soon.

The ISMP survey was sent to approximately 6,000 respondents with 350 responding, resulting in a response rate of 6%.

Anthony Vecchione

Tony Vecchione. Drop in unit-dose packaging raises concerns over safety.

Drug Topics

2002;8:HSE36.