Most nursing home residents are on 10-20 medications a month. Instead of disposing the medication, a few long term care pharmacies actively recycle them. In order to recycle the pills/tablets are removed from blister packs by hand, often in an unsterile environment. Once the pills/tablets are removed, there are no identifiable lot numbers or expiration dates available to associate with each pill.
Expiration dates are determined by stability assessments that follow scientifically based technical procedures that have been approved by the FDA. Expiration dates only apply when the drug product is stored in the manufacturer’s original, unopened container under defined conditions. The expiration dates associated with pills and tablets that sit exposed in large, dirty bins/buckets, for multiple days, are not reliable. These pills and tablets often recycled into successive blister packs for use by second (and possibly third or fourth) patients are subject to degradation and spoilage, putting the patient who takes them at risk.
From a legal standpoint, the pharmaceuticals become “adulterated” (due to degradation etc.) and/or “misbranded” (lots mixed up, false expiration dates, etc.), with resulting pharmaceutical fraud. The law forbids distribution in interstate commerce of drugs that are “adulterated.” A drug is adulterated if it is represented as a drug of the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium.
While in certain limited circumstances, specially packaged unused drugs paid for by Government Healthcare Programs can be returned to long-term care pharmacies and resold, such returns and resales must be consistent with provisions of federal and state law, and the pharmaceuticals cannot be adulterated. If the pharmaceuticals are adulterated or repackaged in violation of other federal law, or state law, then the claims for such pharmaceuticals may be submitted in violation of the False Claims Act.
Potential whistleblowers with knowledge of Medicare fraud involving long-term care pharmacies may be confronted with this not too uncommon unfortunate situation.