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Federal 'medicine' for drug errors may be hard to swallow

Agencies are now considering requirements for unit-dose packaging and bar coding of containers to reduce the potential for medication errors.

Federal regulators may prescribe a bitter packaging bill for the pharmaceutical industry. Two separate agencies within the Department of Health and Human Services are in the midst of deciding on techniques that will decrease medication errors whether they happen in hospitals nursing homes or at retail pharmacies. The kinds of "errors" the Health Care Financing Administration (HCFA) and the Food and Drug Administration are addressing: when a pharmacist misreads a physician's "scrip" and gives the patient the wrong medication or when the pharmacist pulls the wrong jar of pills off his shelf because it looks exactly like another jar. For hospitals HCFA is likely to adopt a ceiling on medication errors; the current proposal says 2%. Health care providers would have to decide themselves how to stay beneath that ceiling. Many drug companies already sell to hospitals in unit-dose packaging and some hospitals even have their own unit-dose packaging operations. The next step would be for hospitals to pressure drug manufacturers to bar code single-dose packs. The FDA may be more prescriptive in sparking packaging reform perhaps by revising packaging sections within good manufacturing practices (GMPs) for drugs. Or the FDA could require pharmaceutical companies to jump through hoops during the new drug application process-hoops designed to prove that a new drug would be labeled and packaged in such a way so as not to be mistaken for another drug. In January the FDA held a workshop in Washington called "Minimizing Medical Product Errors." One of the speakers was Lucian Leape M.D. an adjunct professor of health policy at the Harvard School of Public Health and a member of the Health Sciences Division at Rand a West Coast policy research consultancy. A major part of his presentation was an exhortation to pharmaceutical companies to package their products in unit-dose form and to bar code their packages for verification by scanners. Action plan coming Jerry Phillips director of the division of labeling and program support in the FDA's office of generic drugs is in charge of the FDA's "error" project. The public workshop was the culmination of a one-year internal review of the problem. The next step is for the FDA to publish an executive summary of the January proceedings. That was scheduled to be out last month. An FDA action plan is planned to follow soon. Phillips says an FDA requirement that drug companies package in unit-dose form "is on the table." Requiring bar codes could be an obvious parallel move. Peter Mayberry staff director for the Healthcare Compliance Packaging Council says he is glad the FDA has recognized the dimensions of the problem of medical products errors which he believes is much bigger than has been reported or previously believed. In terms of the known dimensions of the problem the FDA receives 150 reports per month on its MedWatch system according to the FDA's Phillips. Pharmacists nurses and others call MedWatch-a voluntary confidential system-when the wrong medication is dispensed. Phillips says those errors typically occur when a pharmacist is handed a prescription for one drug but another similar-sounding one is dispensed. Sound-alikes look-alikes For example Norvasc a calcium channel blocker could be confused with Navane which is a sleeping pill. He says there are 600 drugs with names similar to at least one other drug. Prozac for depression and Prilosec used to treat "acid stomach" are another pair that get confused. Phillips has some personal experience in this matter. He took a prescription for his wife to his local drug store. She needed Toradol an analgesic. When the pharmacist went to his shelf to get the bottle he mistakenly reached for Ticlid used for blood platelet problems. The two drugs were packaged in similar bottles with labels of similar color and sat side-by-side on the shelf. Fortunately the pharmacist realized the mistake and called Phillips when he returned home. Of course a similar kind of switcheroo can and does happen in hospital pharmacies. Eliminating these kinds of mistakes is the objective of the proposed rule HCFA published in December 1997. It revises the "conditions of participation" (COPs) hospitals must adhere to if they want to receive payments from Medicare and Medicaid. One of the COPs focuses on pharmaceutical services. HCFA cited a study that showed medication errors in hospitals between 1962 and 1987 ranging from 1.6% to 20.6%. HCFA's current COPs for drugs dispensed in hospitals have no ceiling on error rates; there is a 5% ceiling imposed on long-term care facilities such as nursing homes however. But in the December 1997 proposal HCFA identified a 2% ceiling on significant and non-significant errors (e.g. correct medication given at the wrong time) for hospitals. In its proposal HCFA cited Lucian Leape's 1995 paper in the Journal of the American Medical Assn. (JAMA) entitled "Systems analysis of adverse drug events." One of the points the paper made is that 42% of serious and life-threatening adverse drug reactions are preventable. Two percent too tough? The "2% pill" has been hard for many industry groups to swallow. Grumblings forced the HCFA to extend the comment period for two additional months until April 20 1998. Gary Stein senior government affairs associate for the American Society of Health System Pharmacists (ASHSP) says about 80% of the drugs dispensed by hospital pharmacies are already in unit-dose form. Though the ASHSP has not written its comments yet Stein says that setting a medication error rate makes no sense. The problem is that pharmacists may then underreport errors out of fear of tripping the 2% wire. Packaging Coordinators Inc. (Philadelphia PA) a division of Cardinal Health does a big business turning bulk quantities of pharmaceuticals into unit-dose packages. Dan Gerner president of PCI says the cost of unit-dose packaging depends on a couple of factors. For instance the size of the bulk quantity being packed into unit-doses must be considered and so does the material used for the blister packaging. The larger the quantity the smaller the unit price he says. Using polyvinyl chloride for the blister he says is more economical than using a material with a better MVTR barrier. Gerner says PCI is capable of putting bar codes on the back of blister packs. But most drug companies do not ask his company to do so. He surmises that the absence of demand from his customers is the result of low demand or the cost consciousness of their customers the hospitals and retail pharmacies. Pharmaceutical manufacturers generally wince at the thought of an FDA edict on unit-dose packaging and bar coding whether direct or indirect. Margo Herron associate director of regulatory agency relations for Merck Research Laboratory notes that her company and others met last year with Sharon Smith Holston the FDA deputy commissioner for external affairs. Herron said she would try to get someone to call back and explain Merck's position on this issue. But she cautioned that the company might want to clam up. No one called. At least Herron made an effort. Two different officials at Pfizer did not return phone calls. John Kropas a senior packaging development engineer at Wyeth Lederle Vaccines and Pediatrics attended the FDA meeting in January. When asked about the implications on packaging of potential FDA action he said "no comment." Paul Minicozzi director of scientific affairs at Wyeth Ayerst Laboratories also attended the FDA meeting. When reached by phone he promised to get clearance from corporate public relations and either call back himself or have someone else respond. No call ever came. Obviously this is a sensitive issue to these companies.

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