Drug shortages continue to be a persistent and complex U.S. public health issue that the AMA has been actively monitoring and responding to developments as needed. Now, though, drug shortages are at their highest level in a decade, including several widely publicized cases such as shortages of sterile IV fluid in the aftermath of Hurricane Helene’s shutting down a Baxter manufacturing facility, as well as other brand and generic drugs in shortage.
The AMA is closely tracking the sterile IV fluid shortage and has assembled a devoted webpage to help physicians address and manage drug shortages, and now the House of Delegates—meeting this week in Lake Buena Vista, Florida—has adopted new policy aimed at preventing and mitigating future drug shortfalls.
“Drug shortages in the U.S. continue to frustrate physicians and are increasingly jeopardizing patient safety and the quality of health care patients receive. Along with manufacturing issues and supply chain disruptions that have led to drug shortages over the years, now bad actors are using deceptive marketing practices to prioritize profits over patient well-being—leading to prolonged drug shortages that make it challenging for patients with valid prescriptions to obtain the medications and treatments they need,” said AMA Trustee Alexander Ding, MD, MS, MBA.
“The AMA will continue to adopt policies and support initiatives to help alleviate drug shortages to ensure patients have timely and continuous access to their medications,” Dr. Ding added.
To further address drug shortages, the AMA House of Delegates modified existing policy to:
- Urge drug manufacturers to accelerate the adoption of advanced manufacturing technologies such as continuous pharmaceutical manufacturing and support the use of incentives such as prioritized regulatory review, reduction of user fees and direct grant opportunities for manufacturers seeking to invest in manufacturing processes to build redundancy and resiliency.
- Oppose increasing drug prices or waiving fee exemptions in a manner that incentivizes a drug manufacturer to have its drug be declared in shortage.
- Oppose the use of punitive fees on physician practices that do not maintain buffer supplies of drugs.
- Encourage the Food and Drug Administration, the Federal Trade Commission or other relevant oversight entities to examine the practice of compounding pharmacies and the entities that utilize them advertising drugs actively in shortage, particularly when targeted to new patients.
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Delegates also adopted policy that calls on the AMA to:
- Oppose laws, regulations or business practices which create artificial scarcity of drugs, such as limitations on pharmacy procurement or restrictions on which pharmacies a patient can use, which prevent the filling of an otherwise valid prescription from their physician.
- Advocate for pharmacies and distributors subject to the national opioid- litigation settlement to make public the specific metrics, formulas, data sources, algorithms, thresholds and other policies and analyses that are used to delay or deny orders to pharmacies, restrict physicians’ prescribing privileges and other actions that impede patients’ access to medication.
- Advocate for pharmacies and distributors to provide physicians with all due- process rights and opportunities to contest any decision to restrict a physician’s prescribing privileges based on a pharmacy or distributor metric, formula, algorithm or other policy before such restriction is put into effect.
The AMA also is engaged in ongoing advocacy on the issue, participating in a coalition with U.S. Pharmacopeia on drug shortages.
An urgent public health crisis
In a separate action, delegates adopted policy to “support the development of strategies and technologies to strengthen supply chain networks, including economic incentives for building climate and disaster resiliency and redundancy into new or updated facilities, increasing emergency stockpiles of key products, and incentivizing the innovation and adoption of reusable medical products to resist the impact of supply chain disturbances.”
The AMA has previously declared drug shortages to be an urgent public health crisis and a national security threat. In a Leadership Viewpoints column published ahead of the Helene-related problems, AMA President Bruce A. Scott, MD, outlined the multifaceted approach that is needed to combat drug shortages.
Delegates also directed the AMA to “urge the Centers for Medicare & Medicaid Services to implement policies to temporarily halt financial and other penalties for affected quality metrics during periods of documented medication and IV fluid shortages as well as in other emergencies in order to prevent physicians and hospitals from being penalized for circumstances beyond their control.”
Watch this “AMA Update” episode about drug shortages, why they're happening, how to prevent them and what physicians can do to help their patients.
Read about the other highlights from the 2024 AMA Interim Meeting.
