The warning signs are present. In 2023, some medical specialties are reporting the most severe drug shortages in recent memory (asamonitor.pub/3LkTVMd). These trends have sparked fervent discussions among lawmakers, regulators, and the health care community on how best to mitigate drug shortages as supply chain risks continue to threaten disruptions in patient care. Anesthesiology has been among the many specialties that have faced shortages of select medications before, during, and after the COVID-19 public health emergency. In recent months, ASA members have reported shortages of local anesthetics, analgesics, and sedatives, among other medications, and some have stated that local shortages are more acute in 2023 than they were at the height of the COVID-19 pandemic.
“Preparing workaround strategies for potential shortages and codifying procedures such as how to approach “look-alike” replacement vials can help reduce the likelihood of medication errors and support patient safety.”
Concerns of shortages were exacerbated in July 2023, when a tornado damaged a Pfizer manufacturing facility in Rocky Mount, North Carolina, which represents around 8% of the company's sterile injectable products (originally reported as 25%). Both Pfizer and the U.S. Food and Drug Administration (FDA) stated that no supply chain disruptions were expected as the facility damage was mostly limited to storage rather than manufacturing areas. Nevertheless, ASA asked its members to remain vigilant and actively engaged with physicians, government stakeholders, and other medical societies to develop policy recommendations for mitigating the effects of medication supply chain disruptions.
ASA takes action
In August, ASA submitted letters to the FDA and the Administration for Strategic Preparedness and Response (ASPR) expressing concern about the potential for more severe supply chain disruptions from the damage to Pfizer's Rocky Mount facility and offering guidance in government efforts to mitigate the effects of drug shortages on clinical care.
Not long afterward, ASA President Michael Champeau, MD, FASA, led a group of the society's staff and physician leaders in a call with FDA officials, including the agency's Chief Medical Officer, Dr. Hilary Marston. The call provided ASA with an opportunity to share the specialty-specific effects from drug shortages that anesthesiologists have been managing; these impacts include a greater burden on anesthesiologists in ambulatory, office-based, and small practice settings who must personally identify new suppliers for drugs in shortage and broader risks from acquiring replacement drugs with similar vials as other medications, so-called “look-alikes.” ASA will continue to communicate with the FDA and ASPR to provide updates on the challenges anesthesiologists are facing and advocate for actions to address these challenges.
Another opportunity for drug shortage advocacy emerged in recent months, when House Committee on Energy and Commerce Chair Rep. Cathy McMorris Rodgers released a discussion draft of the “Stop Drug Shortages Act.” The draft legislation proposed drug shortage mitigation actions ranging from exemptions on rebates for select generic medications under Medicaid to empowering the FDA to incentivize shelf-life extension studies. ASA submitted comments to Rep. Rodgers, advocating for policies that would encourage the use of 503B compounding facilities to produce replacement drugs and grant the FDA greater visibility into active pharmaceutical ingredient information for generic drugs, specifically country of origin, in order to better assess supply chain risks.
Many of ASA's foundational policy recommendations on mitigating drug shortages were developed in 2018 during a coalition summit that included the American Society of Clinical Oncology, the American Hospital Association, the American Society of Health-System Pharmacists, and the Institute for Safe Medication Practices. With the passage of the CARES Act in 2020, a number of the coalition's recommendations have already become law. In 2023, ASA assembled a drug shortages workgroup to develop an updated list of recommended policies. The workgroup, which also guided feedback on the Stop Drug Shortages Act, plans to explore re-convening the previous coalition of stakeholder groups to further refine ASA's drug shortage recommendations.
How to take action on drug shortages
ASA recommends that members engage with pharmacy and facility administrators on local policies for managing patient care when certain drugs are unavailable. Preparing workaround strategies for potential shortages and codifying procedures such as how to approach “look-alike” replacement vials can help reduce the likelihood of medication errors and support patient safety.
Members can also consult the FDA's drug shortage database to determine whether any high-use medications are in short supply or at risk of shortage (asamonitor.pub/41eZ3Hx). If you are currently experiencing a drug shortage, please complete ASA's survey to help our team track these shortages and communicate them with members (asamonitor.pub/45Rd14z).