April 08, 2020
ASA Urges Federal Government to Take Action on Drug Shortages
Continues to Collaborate with FDA on Drug Shortages during Pandemic, DEA Responds
As COVID-19 is straining hospital systems across the country, the American Society of Anesthesiologists (ASA) has been in frequent communication with the Food and Drug Administration (FDA) and their drug shortages team. ASA has shared concerns from members about drug shortages of critical drugs necessary for providing care to patients impacted by the virus. ASA has been able to confirm that some of the highest priority drugs are either on FDA’s drug shortages list or are in the category of being monitored closely.
This week, ASA sent a correspondence to provide the FDA drug shortages team with additional information, sharing a comprehensive list of drugs that are of the most concern (PDF), including certain sedatives, opioids, neuromuscular blocking drugs, resuscitative drugs and reversal agents. ASA also asked the FDA to facilitate enhanced guidance to physicians on waste reduction, including working with manufacturers to extend expiration dates of critical products.
Similarly, ASA, along with the American Society of Health-System Pharmacists, American Hospital Association, Association for Clinical Oncology, and the American Medical Association, sent a communication to the Drug Enforcement Administration (DEA) last week, requesting assistance with increased demand of controlled substances (CII) during the COVID-19 pandemic (PDF). The stakeholder group explained that CIIs are necessary to mechanically ventilate patients safely and effectively, and asked DEA to immediately ensure that manufacturers and 503B outsourcing facilities receive increased annual production quota (APQ) allocations to allow them to meet legitimate and critical patient care needs.
Yesterday, DEA announced it is taking additional steps to allow increased production of controlled substances in COVID-19 care. DEA has agreed to increase the 2020 aggregate production quota (APQ), by 15 percent for fentanyl, morphine, hydromorphone, codeine, ephedrine, pseudoephedrine, and certain controlled substance intermediates which are essential to their production. DEA will also increase the APQ for methadone to ensure that opioid treatment programs have sufficient supplies to treat patients suffering from opioid use disorder.
ASA greatly appreciates the work of the FDA drug shortages team and the action by DEA to ensure patients have necessary drugs for treatment during COVID-19. ASA will continue to monitor drug shortages and communicate with federal agencies regularly.