July 25, 2018
ASA Concerned about how Final DEA Rule will Impact Drug Shortages
On July 11, the Department of Justice (DOJ) finalized a proposal from April 2018 that would allow the Drug Enforcement Administration (DEA) more control over annual production of opioids in the U.S. According to a press release from the DOJ, if the DEA finds that “a particular opioid or a particular company’s opioids are being diverted for misuse,” the DEA can “reduce the amount that can be produced each year.”
ASA, along with other health care delivery organizations, previously sent a letter to the DEA urging them to consider the impact of this new proposal on drug shortages in response to the agency’s proposed rule. The final rule remains largely unchanged from the original proposal.
Physician anesthesiologists and other providers are currently facing critical shortages of a number of injectable opioid medications, including morphine, hydromorphone, and fentanyl. ASA supports the DEA’s efforts to combat diversion but is concerned this final rule may have a negative impact on drug shortages. Injectable opioids dispensed in clinical settings pose a far lower risk of diversion than other dosage forms dispensed directly to patients. DEA should work with the FDA to obtain data regarding specific shortages broken down by dosage form. Knowing what dosage forms are in shortage can provide a clearer picture of the diversion risk and help guide DEA decision making around quota setting.
As DEA sets aggregate production quotas (APQs), ASA encourages the agency to consider drug shortages as a critical factor.
Learn more about ASA’s work around drug shortages.
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