Regulatory Focus™ > News Articles > With Drugs Scarce, Attention Turns to Labeling Regulations

With Drugs Scarce, Attention Turns to Labeling Regulations

Posted 17 February 2012 | By Alexander Gaffney, RAC 

Worsening shortages of some critical drugs are causing some groups to criticize US Food and Drug Administration (FDA) and Center for Medicare and Medicaid Services (CMS) regulations that the groups claim are causing providers to dispose of potentially useful medications.

MSNBC reports that "organizations such as the Institute for Safe Medication Practices and the American Society of Health-System Pharmacists are raising questions about federal rules they believe exacerbate a crisis that saw 267 drugs in shortage last year, up from 211 the year before, the most in U.S. history."

When drug products are approved by FDA, they have specific indications for handling and use that include storage needs, shelf life and reusability. MSNBC notes that it can be "costly and time-consuming" to seek a labeling update in light of new information that could prolong the shelf life of a product.

Regulations promulgated by CMS require providers to follow the labeling instructions on the product package, even if scientific literature indicates that the product is safe if used beyond that limit.

Providers are increasingly torn between cautiously adhering to CMS regulations and disregarding them to maintain supplies of scarce drugs.  "Am I afraid of harming the patient […] or am I afraid of regulatory authority?" asked one pharmacist interviewed by MSNBC.

FDA is not unfamiliar with the issue. The Strategic National Stockpile-a stockpile of drugs assembled by the US government to prepare for health emergencies-is routinely tested by FDA to ensure that its stock has not deteriorated after a product's labeling shows it to be expired. This is done to ensure the stockpile's integrity and reduce the need to cycle in new stock of the drugs, thereby saving money.

The current drug shortages, however, are not of the drugs held in reserve at the national stockpile, but instead include many common injectable oncology drugs, anesthetics and intravenous electrolytes.

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