January 01, 0001
ASA and Stakeholders Urge DEA to Consider Drug Shortages while Setting Controlled Substances Quotas
On October 15, the American Society of Anesthesiologists (ASA), along with several stakeholder organizations sent a joint communication to the Drug Enforcement Administration (DEA) requesting the agency to reconsider the extent of the cuts to aggregate production quotas (APQs) for drugs that are currently in shortage in response to its proposed rule regarding controlled substances quotas. APQs 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.
In comments to the agency, the organizations expressed support for the DEA’s efforts to combat diversion of controlled substances. However, the group also voiced that it is crucial drug shortages are taken into consideration as APQs are set and adjusted in order to ensure legitimate medical needs are met as well as safeguarding patient health and safety.
Hospitals and other providers continue to face critical shortages of many injectable opioid medications, including fentanyl, sufentanil, and hydromorphone. ASA and the stakeholders urged for additional adjustments to APQs to ensure adequate supplies are available for legitimate medical purposes.
Furthermore, ASA along with the American Society of Health-System Pharmacists and the American Medical Association sent a formal communication to the DEA, as part of a task force working to address opioid abuse and misuse. The communication expressed that intravenous opioids are critical for treating pain for patients undergoing certain procedures. Additionally, intravenous opioids are subject to strict diversion control procedures and thus, diversion risk differs from that of opioids in pill or tablet form. In the comments, the organizations encouraged the DEA to coordinate with agencies such as the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC) for input on setting the APQ and to revise the proposed rule accordingly.
In addition to urging DEA action, ASA continues to urge Congress to find a lasting solution to the ongoing issue of drug shortages.