AHA: DEA Proposed Rule on Quotas Should Factor in Drug Shortages

AHA today urged the Drug Enforcement Administration to include drug shortages as a factor when setting and adjusting aggregate and individual manufacturers’ production quotas for controlled substances. Commenting on the agency’s proposed rule on controlled substances quotas, AHA also recommended that DEA routinely consult with the Food and Drug Administration’s drug shortage staff when establishing and adjusting quotas. “As the DEA is well aware, hospitals and health systems continue to experience critical shortages of a number of injectable opioid medications, such as morphine, hydromorphone and fentanyl, due to both a slowdown in production and a component problem at a major manufacturing facility,” AHA wrote. “These intravenous opioids are widely used and essential to appropriate patient care in hospitals and in other practice settings for the treatment of acute and chronic pain, and for sedation purposes.” AHA also joined with the American Society of Health-System Pharmacists, America’s Health Insurance Plans, American Society of Clinical Oncology, American Society of Anesthesiologists, and Institute for Safe Medication Practices in a letter to DEA requesting similar changes to the proposed rule.