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Executive Summary

UNIT-OF-USE PACKAGED PRODUCTS ARE 10% OF PMA MEMBER LINES of oral solid dosage form products, Schering Labs Manager-Inventory Policy and Analysis Vincent Core said Dec. 14 at a USP/University of Maryland unit-of-use conference in Baltimore. Core presented the results of a Pharmaceutical Manufacturers Association survey on unit-of-use packaging. The survey responses of 20 PMA firms showed that "there is no discernable trend...that suggests that we are moving in any clear strong way towards unit-of-use," Core said. While the trend in the name brand drug sector is not clear, Core said that for multi-source products there "is a trend towards large volume packages" such as bottles of 500, 1,000, or 5,000 tablets or capsules. The survey also showed that only 50% of responding firms "have taken a position for or against unit-of-use packaging," but did not say what those positions were. "Nobody sees a clear mandate coming from the marketplace for manufacturers to move to unit-of-use," he concluded. University of Minnesota pharmacoeconomics professor Stephen Schondelmeyer, PhD, said that his research showed that 102 of the 200 top-selling prescription drugs come in "original dispensing packs that can be used in the outpatient environment." Schondelmeyer's figures apparently include oral liquids, ophthalmics, otics, metered-dose inhalers and topicals, which are usually marketed in unit-of-use packages. From his figures, Schondelmeyer concluded: "pharmacies and wholesalers already have these packs in their inventory...for at least half of their products." Schondelmeyer disputed assertions made by several meeting participants that unit-of-use packaging is more expensive for producers and wholesalers. By looking at "the first eight or 10 outpatient dispensing packs I found," Schondelmeyer concluded that they cost "no more" than larger packs. He said that unit-of-use packs that were withdrawn from the market "may have been a pricing issue, not a packaging issue per se." In some cases, the manufacturer "may have tried to charge substantially more" for the unit-of-use pack. The Minnesota professor predicted that unit-of-use packaging will be accepted by third-party payers. "Retail pharmacy is coming under prospective payment limits just like we saw in hospital pharmacy" in the 1980s, Schondelmeyer said, adding that 89% of U.S. hospitals have unit dose systems for greater than 90% of their beds. He said this level of use in hospitals was "enabled by the reimbursement of pharmaceuticals in hospital use by Medicaid and Medicare" beginning in the mid 1960s. He emphasized that hospitals converted to unit-of-use "without mandates" from government. As an example of how unit-of-use packaging can enhance patient compliance, Kaiser Permanente Chief Pharmacist-Orange County Service Area Carey Cotterell said that Kaiser's unit-of-use packaging for niacin doubled the compliance rate of patients receiving the vitamin for hyperlipidemia. Aside from "improving the therapeutic outcome," Cotterell said the enhanced niacin therapy compliance has allowed Kaiser to avoid conversion to "lovastatin [Merck's Mevacor] or other drug therapies that are phenomenally more expensive and are no more or even less effective." Cotterell said the "extensive" utilization of unit-of-use packaging has led to Kaiser "saving lots of time and providing better [physician consulting and patient counseling] service because [a] pharmacist wasn't burdened with the tedium of counting and repackaging." Cotterell said he believed Kaiser is able to "improve patient care, quality of service, reduce medication errors and...effectively manage costs" through the use of unit-of-use. Other meeting participants were more skeptical of the patient compliance benefits of unit-of-use packaging. Revco Manager- Professional Services Joseph Sabino said that he believes "counseling is ultimately the key" to compliance, not packaging. Sabino said that in addition to startup costs for manufacturers switching to unit of use packaging, "there have been estimates of a 12% to 15% increase in continuing production cost" for packaging in unit-of-use bottles and "13% to 40% for some sort of compliance-enhancing blister packs." Summaries of the two days of discussions on unit-of-use packaging stated that most participants felt adoption of unit-of- use should be market driven, not mandated; adoption would raise production and/or storage costs for manufacturers, wholesalers and pharmacists; that the value of unit of use to patient treatment and cost of treatment must be documented; that flexibility in prescribing should be allowed for; and that unit-of-use should be considered first for large volume, important products for diseases amenable to standardized dosing. USP plans to publish a complete transcript of the meeting and a summary of the conclusions.

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