Reforms needed to alleviate persistent drug shortages


Shortages of prescription drugs, and in some cases over-the-counter medicines, continue to plague our nation’s health system. These shortages pose a serious threat to public health and hamper physicians’ ability to follow the evidence-based treatment plans that work best for our patients. There are all-too-many devastating reports in recent months of physicians having to ration care or scramble to find alternatives for the first-line chemotherapies that cancer patients have relied upon for decades.

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On a personal note, I cannot count the number of times I have walked into my own hospital only to learn that we have no clindamycin, no amoxicillin, or that our supply of saline is dangerously low. The fact that I continue to encounter serious shortages of basic, life-saving medications is both infuriating and intolerable. The AMA continues to work closely with fellow stakeholders and Congress to improve both the manufacturing technology and the quality of prescription drugs, while also boosting global supply chain resiliency.

The  AMA Council on Science and Public Health (CSAPH) is charged with evaluating the factors driving national drug shortages and reporting on progress toward solutions to the House of Delegates (HOD) each year, which it has done for more than a decade. CSAPH staff are currently preparing a 2023 update for delivery at the delegates’ 2023 AMA Interim Meeting this fall.

The Council’s 2022 report on this subject found that while the number of new drug shortages has trended downward in recent years, the overall number of active drug shortages has remained relatively steady—which suggests that individual shortages are taking more time to resolve. Unfortunately, a surge in new drug shortages in 2023, combined with the complexity of resolving even a single drug shortage, has resulted in severe stress to the supply chain.

The University of Utah Drug Information Service, which has tracked drug shortages since 2001, reports that active drug shortages in 2023 are at their highest level in a decade. Its data on real-time shortages are posted regularly on a website hosted by the American Society of Health-System Pharmacists. The five classes of drugs most frequently in short supply are central nervous system drugs, fluids and electrolytes, antimicrobials, chemotherapies, and hormones.

While identifying which drugs are hardest to obtain is fairly straightforward, figuring out precisely why that’s the case is another matter entirely. A drug-shortage task force established by the Food and Drug Administration reported that supply disruptions caused by economic factors played a key role in triggering shortages. In the case of sterile generic injectables, these drugs are much more difficult to manufacture as opposed to medications in tablet or capsule form, but often carry razor-thin profit margins due to the need to maintain competitive pricing.

Manufacturing quotas established and enforced by the Drug Enforcement Agency (DEA) also come into play. As part of the closed-system regulatory authority the DEA holds under the Controlled Substances Act, it oversees the manufacture of all Schedule I and II drugs as well as List 1 chemical agents including ephedrine and pseudoephedrine. This oversight includes a strict quota on the quantity of controlled pharmaceuticals that can be manufactured over a certain time period.

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But as CSAPH’s 2022 report noted, these quotas have factored into shortages of vitally important medications. This is just what happened as the COVID-19 pandemic took hold in the first half of 2020; a 2019 DEA proposal to slash the manufacture of Schedule II opioids by more than half did not anticipate the tremendous surge in demand for injectable opioids among patients on ventilators.

The AMA has long been concerned with the role that pharmacy benefit managers (PBMs) may play in driving drug shortages, given the immense influence they maintain over the price and accessibility of prescription medications and the opaque nature of their negotiations as intermediaries between pharmaceutical manufacturers and health insurers.

Changes may be coming, however. An investigation into PBM business practices —particularly those of vertically integrated PBMs—by the Federal Trade Commission is proceeding, while legislation to bring far greater levels of transparency and disclosure has advanced in both the House and Senate this year with bipartisan support.

For example, the Pharmacy Benefit Manager Reform Act of 2023 would force PBMs to disclose the prices they have negotiated with drug manufacturers as well as the fees they remit to pharmacists to dispense medications, and also to pass along (rather than retain) any discounts or renumeration they have received from manufacturers. Additionally, this bill would require PBMs to disclose information about drugs dispensed under a health plan by pharmacies that are owned in whole or part by a PBM.

Because drug shortages continue to inflict widespread harm to patients who may not receive appropriate care in every circumstance, the AMA intends to work closely with our fellow stakeholders, and with legislators and policymakers, to mitigate their impact. This includes exploring ways to expand investment in production capacity for medications in short supply, while working with the FDA and other federal agencies to ensure a continuity of supply to minimize production disruptions.

Further, the AMA strongly supports a more efficient regulatory review of prescription drugs and greater scrutiny of contracting practices by market participants in competition, as well as the business practices of PBMs, group purchasing organizations and others as they relate to new and ongoing shortages. Also, pharmaceutical supply chains need to become much more resilient and redundant, and quality control measures and overall product quality must be transparent and shareable.

Our nation cannot allow widespread drug shortages to persist in their current form, let alone grow more severe. Now is the time for regulators and policymakers to act decisively on this ongoing threat to public health.