Physician anesthesiologists face an unprecedented number of drug shortages, which directly impact patient safety and care.
Having a diminished supply, or no supply of critical drugs at all, can cause suboptimal pain control or sedation for patients. It also creates complex workarounds for health care staff leading to potential errors.
Shortages have resulted in delays and even cancellation of care.
ASA is a leader in the medical community on the drug shortage issue and works with other stakeholders, including federal agencies and Congress, to ensure the appropriate parties are aware of the impact shortages have on patient care.
The American Society of Health-System Pharmacists (ASHP) lists every drug shortage reported through their online report form as soon as it is investigated and confirmed, usually within 24 to 72 hours.
The U.S. Food and Drug Administration (FDA) only focuses on shortages of medically necessary drugs, as these have the potential to impact public health. A medically necessary drug is a product that prevents a serious disease or medical condition and for which there is no drug or alternative drug, available in adequate quantity that is judged by FDA’s medical staff to be an acceptable substitute. The FDA Drug Shortage Program Staff designates some drugs as medically necessary when the preferred therapy is in shortage.
What ASA Is Doing
Stakeholders meet periodically to discuss the state of shortages, and identify new problems and recommended solutions.
ASA works with ASHP and the FDA to track and monitor issues related to drug shortages.
ASA co-led a large bipartisan letter to the FDA on drug shortages from the House of Representatives and the Senate.
ASA shared a drug shortage survey of its membership to the FDA after receiving more than 2,000 responses about how their hospitals and practices have been affected by the drug shortages.
ASA urges Congress’ transparency regarding drug shortages, as well as improvements to manufacturing infrastructure.
ASA and other health care leaders hosted a summit, “Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Health Care Critical Infrastructure,” to examine vulnerabilities in the supply chain, U.S. dependence on foreign-sourced pharmaceutical ingredients, disaster planning and response efforts, and risk factors associated with pharmaceutical manufacturing and distribution.
ASA, as part of a coalition of health care groups, issued 19 recommendations to address the ongoing shortages of critical medications affecting patient care across the country, just prior to the U.S. Food and Drug Administration (FDA)’s “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions” public meeting on November 27, 2018.
ASA submitted comprehensive drug shortage solutions to the FDA, in response the agency's formal request for comments and input solicitated at a November 2018 public stakeholder meeting. The recommendations include regulatory, legislative, and marketplace solutions to stem drug shortages.