NCPA - National Center for Policy Analysis

Amid Shortages, Rules Force Hospitals to Trash Scarce Drugs

February 21, 2012

Hospitals and pharmacies across the country face a growing issue of chronic drug shortages.  Due to various circumstances including unexpected production halts by manufacturers and simple oversubscription, many pharmacists must make difficult decisions about who gets treatment and who does not.  This problem is further complicated by government regulations, says

The difficulty of shortages, especially for drugs that treat life-threatening conditions, is that they are exacerbated by regulations that require pharmacists to dispose of expired medicine, specifically medicine that has been open for too long.  Regulators argue that drugs can become contaminated and pose a safety risk.

Detractors respond, however, that by throwing out life-saving drugs, those who comply with the regulations are doing more harm than good.

Additionally, it is crucial to reexamine the designation "expired."  The Centers for Medicare & Medicaid Services (CMS) have stipulated that distributors must abide by the standards communicated by the manufacturer when assessing the medicine's continued quality.  However, there is good reason to believe that manufacturers' stated warnings are inaccurate.

  • Because it is difficult to gain approval from the U.S. Food and Drug Administration for new labeling, many of the inserts for drugs' key information are believed to be out of date.
  • Updated scientific studies suggest that previously supplied standards were overly conservative -- the neuromuscular blocker succinylcholine, for example, carried a warning that it expires after two weeks, but researchers have found the figure to be between three and four weeks.
  • In a random sample of 50 drugs on the national shortage list, a report found that a third lacked basic information about compatibility with diluents and half lacked information about stability, storage and expiration dates after dilution.

Nevertheless, many pharmacists are forced to throw away drugs that are in precious short supply because, as CMS dictates, they are expired per the manufacturer's warning.  This further irritates shortages and puts lives at risk.

Source: JoNel Aleccia, "Amid Shortages, Rules Force Hospitals to Trash Scarce Drugs,", February 15, 2012.

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