Unopened, Unused Prescription Drugs Destroyed at Taxpayer Expense

By Joseph J. Wang
jwang@central.uh.edu
Health Law & Policy Institute

As perfectly good prescription drugs, sealed and unused, are flushed down the commode, state lawmakers are doing little to stop such waste. It is estimated that in Oklahoma, nursing homes destroy between $3 and $10 million worth of unused prescription drugs a year. Forest Manor nursing home in Alabama estimates that prescription drugs in blister packs and sealed bottles retailing for $4000 are flushed or emptied down drains every month. Regulations in many states require that unused drugs be destroyed after a period of time. In Alabama, leftover medications must be destroyed within 30 days. State regulations are also inflexible as to the donation of unused medication. Considering the high cost of medicines and the need for prescription drugs by the poor and elderly, it seems wasteful, imprudent, and unethical to destroy quality drugs that could benefit so many individuals.

To comply with Food and Drug Administration (FDA) policy and state laws, many nursing homes and other long-term care facilities across the country destroy unused prescription drugs after a specific period of time. Destruction of unused drugs is done under the guise of safety. The concern is that after these drugs have left the control of the pharmacist, the pharmacist "would no longer have any assurance of the strength, quality, purity or identity of the articles." (See FDA Compliance Policy Guide, CPG 7132.09 at http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-300.html.)

Although safety is a legitimate concern in certain circumstances, drugs that have not expired, are sealed and unused, and can be returned to the dispensing pharmacy by nursing homes should not raise the safety issues the FDA CPG was intended to address. Safety is not entirely irrelevant in cases where pills from opened unsealed bottles are repackaged in unit-doses. However, in cases where pills originally packaged in unit-doses are unopened such as in blister or bubble packs and where the pills are kept in a cool, dry environment and have not yet expired, recycling medicines should not trigger consumer safety concerns. These prescription drugs are unused only because patients have died, changed their prescription, or been transferred out of the nursing home. As long as no breach in the chain of custody exists, these drugs can still be useful.

A compelling reason for creating an infrastructure to recycle unused prescription drugs is that it makes good economic sense. The Office of Fiscal Analysis in Connecticut estimates that recycling unused prescription drugs could save Medicaid and private insurers in the state $7 million a year. Medicare and Medicaid, government programs funded by the taxpayers, spend large sums of money on prescription drugs including those drugs that are discarded. Savings produced by increasing the efficiency of the drug distribution system could be used to expand prescription drugs benefits, lower out-of-pocket drug costs, or provide coverage for other health services.

Rather than requiring the destruction of unused drugs, states could provide incentives to pharmacies that would allow nursing homes to either return the drugs to the dispensing pharmacy for reimbursement, at which point the drugs could be reused, or allow the unopened drugs to be donated to charitable pharmacies or to foreign countries in need of such medicines.

The FDA CPG could hinder state efforts to promote the reuse of drugs, but it is unclear how the courts would construe policy based on the CPG, a now 20-year old rule, and whether the rule would be enforced. In response to an inquiry by the American Medical Association (AMA), the FDA issued an informal opinion on February 25, 2000 that stated returning medication to dispensing pharmacies for reuse, assuming AMA and FDA requirements are met, would not be objectionable. (See AMA News at http://www.ama-assn.org/sci-pubs/amnews/pick_00/hlsb0403.htm)

Some states seem to be moving in the right direction. Oklahoma considered legislation in 1999, H.B. 2162 and H.B. 2593, that would allow these unused medicines from long-term-care facilities to be dispensed to indigent patients. Other states have followed suit, but significant progress in creating state programs to recycle drugs has not yet been made. States need to do more. It makes absolutely no sense that much-needed medicines that could benefit many sick and suffering people are sent off to the dumpster.

11/29/00