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See Inside February 2009

Hurdles Facing Unused Prescription Drug Repositories

State-legislated programs for the donation of unused drugs have seen limited success

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Americans spend some $200 billion annually on prescription drugs. Since 1997, in an effort to keep a lid on costs, 37 states have enacted legislation allowing patients, their families and health care facilities to recycle good, unused pills through local pharmacies for donation to patients lacking sufficient insurance. Thousands of patients could in principle benefit from these “drug repository” laws. But as well intentioned as these efforts are, practical problems have prevented widespread implementation of such programs.

The guidelines for these laws, which began thanks to the lobbying efforts of families of cancer patients, are fairly consistent throughout the country. Donated medications must be in sealed, tamper-evident packaging and usually must be within no more than six months of their expiration date. Pharmacies are not held liable should the drug’s next owner come to unexpected harm from the medication. Some repositories accept cancer drugs only; others take all prescriptions (minus narcotics and sleep aids). Some states accept unused pills from home medicine cabinets, whereas others, as a safety measure, permit donations only from professional facilities such as nursing homes.

Under the rules, Iowa collected more than 300,000 pills with a retail value of approximately $290,000 in 2007 and distributed them to some 780 patients. Recycling medicines from Tulsa-area nursing homes saves Oklahoma about $120,000 a year. These successes, though, are small when compared with the potential of the practice. According to the American Cancer Society, as of June 2008 only about one third of the states with repository laws had up-and-running programs.

Part of the problem is money: pharmacies accepting donations do not want to incur the cost of hazardous waste disposal if the drugs go unused. With no reimbursement code for handling and processing donated meds, pharmacies have to be willing to operate as a repository on a completely charitable basis. And despite the letter of the law, many pharmacists fear lawsuits if the drugs prove faulty. Storing the drugs, especially when refrigeration is required, also poses its own issues and costs.

Physicians themselves have felt reluctant to steer patients toward the repositories. Many consider donated drugs too risky because their pedigree cannot be established. “We don’t give any drug to anybody without knowing exactly where it’s been at all times,” says Roger Lyons, a private hematologist and oncologist in San Antonio, who regards the process as akin to filling prescriptions through the Internet or foreign pharmacies. “I am ultimately responsible for making sure a patient under my care gets the right medicine, so I’m not taking the risk.” Lyons also sees little need for repositories: “There are very few patients for whom we can’t get free drugs if they can’t otherwise afford it.”

The inability to ensure a ready supply is also problematic. Doug Englebert, who oversees Wisconsin’s drug repository program, notes that patients could suffer a potentially harmful gap in treatment if a pharmacy has a donated drug one month but not the next. Physicians, he says, “might have concerns with a repository because it’s not a guaranteed supply.”

Englebert cites some of the legal demands as hampering the usefulness of these programs. For example, the exclusion of drugs due to expire in less than six months, which dramatically reduces the supply of eligible donations, may be overly cautious because many of the medicines would be claimed and used well within that time frame. Because the tamper-evident seal cannot be broken, even a nearly full bottle cannot be given. The requirement essentially limits donations to pills sealed in blister packs—otherwise known in the industry as unit-dose packaging.

“There are very few medications that are in unit-dose packaging,” Englebert remarks, “and so therefore very few that are eligible for donation.” In addition, the lack of funding renders many programs cumbersome. Without databases of participating pharmacies and their current inventory, for instance, would-be recipients need to call every registered outlet to inquire whether their prescription is available.

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