ASA Urges DEA to Consider Drug Shortages in Setting Controlled Substances Quotas - American Society of Anesthesiologists (ASA)

FDA & Washington Alerts

ASA Urges DEA to Consider Drug Shortages in Setting Controlled Substances Quotas

On May 4, the American Society of Anesthesiologists (ASA) and other health care delivery organizations sent a joint letter urging the Drug Enforcement Administration (DEA) urging the DEA to consider drug shortages as aggregate production quotas (APQ) are set and adjusted. APQ are allocations or estimated quantities of schedule I and II controlled substances that may be manufactured in the United States to provide for the “estimated medical, scientific, research, and industrial needs” of the country.

The letter was in response to a proposed rule that would modify the quota system for controlled substances, as well as strengthen control over diversion. ASA and others cautioned that while they support DEA’s efforts to combat diversion, they are concerned that the proposed rule is focused on diversion to the exclusion of another critical factor— drug shortages. Hospitals and other health care providers are currently facing critical shortages of a number of injectable opioid medications (IV), including morphine, hydromorphone, and fentanyl.

According to the DEA, the proposed rule is meant to ensure “adequate supplies to the United States’ legitimate needs,” while combatting diversion of controlled substances. In the letter to DEA, ASA and others noted that shortages create legitimate needs. The signatories also encouraged the DEA to work with the FDA to obtain up-to-date data on current shortages so that they can be better equipped to calculate APQs that meet those needs.

In a previous letter sent to the DEA in February, ASA and other drug shortage stakeholders commented that APQ flexibility is necessary while shortages for IV opioids continue. Since then, the DEA has made adjustments in production quotas for two drug manufacturers. ASA took this step in the rulemaking process as an opportunity to thank the DEA for the work they have done to help alleviate current shortages.

As the nation struggles with an ongoing opioid crisis, IV opioids are a fundamental pain management component during and after surgery and pose a significantly lower risk of diversion than other forms of opioids dispensed to directly to patients. ASA hopes that DEA will consider our concerns and amend the proposed rule to specifically include drug shortages as a factor in the quota setting process.

ASA continues to support the work of federal agencies and Congress in addressing the opioid crisis. As a leader in pain medicine and patient safety, ASA will remain committed to ensuring legitimate access to opioid medications.

 

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