Drug Shortages
Sonya Collins
Drug shortages reached an all-time high in 2024. During the first quarter, 323 drugs were in active shortage, according to an American Society of Health-System Pharmacists (ASHP) analysis. These shortages make health systems and—more importantly—patients vulnerable. The problem, while not new, seems to be growing and sheds light on the need for health-system preparedness.
“Health systems that are best at managing shortages have the best infrastructure to quickly switch product in the health system and across the automated platforms and electronic databases,” said Erin Fox, PharmD, associate chief pharmacy officer at University of Utah Health. “If you can do that well you’re going to do better in a shortage.”
Planning for the unforeseeable
It’s nearly impossible for a health system to pre-plan its response to a drug shortage. National emergencies, such as the COVID-19 pandemic, and natural disasters like Hurricane Maria can be predictors of an impending shortage. But it doesn’t take such a significant event to trigger a shortage.
The U.S. Pharmacopeia has outlined a few risk factors for a drug to plunge into short supply. Injectable drugs, low-priced drugs, and those that require complex manufacturing or complex chemical synthesis are among the most vulnerable. But, for the most part, “Predicting shortages is challenging because of the opacity of the supply chain,” said Michael Ganio, PharmD, senior director of pharmacy practice and quality at ASHP.
Health systems and community pharmacies may only learn of a shortage when their supply of the drug runs out or just before that time. A health system may receive warning that it’s set to receive a partial shipment, but they may not know how short their shipment will be until it arrives.
The available alternative to a shortage medication is not predictable either, making it difficult to plan even a hypothetical response.
Regardless, too much advance warning could exacerbate the problem, said Fox. “An early warning system would be good, but it would depend on infrastructure to prevent hoarding.”
Call for more research
Drug shortages, by nature, may hurt patients when the only solution is for some patients to receive the drug while others go without. But inconsistent responses to shortages from one health system to the next can exacerbate the problem.
As Fox and colleague’s recent paper in the AMA Journal of Ethics described, one system may use up the existing supply before taking action; another may decide which patients need it most; another may refuse new patients that might need the drug; another may transfer patients needing the drug to another system.
This approach, Fox said, “provides a different experience for patients, which can be uneven. Whenever possible, consulting the actual clinical data regarding which patients benefit the most from this drug and basing decisions on that evidence is best.”
Guidance from national organizations, such as the American Heart Association and the American Society for Parental and Enteral Nutrition would facilitate health systems in devising an evidence-based response to each drug shortage as it arises. But it’s not always available.
“That’s all we have in a drug shortage,” Fox said. “We need more comparative effectiveness research to understand which medications truly are better for some patients.”
Look to the future
Research and piloting are underway to develop methods to produce small batches of shortage drugs at the point of care much more quickly than mass manufacturers could replenish the pipeline.
“We’re inventing new chemical and formulation processes for old drugs and deploying the processes closer to the point of care, which closes the gap between the people that make the medicines and the people that use the medicines to make patients better,” said John Lewin, PharmD, CMO of On Demand Pharmaceuticals.
Point of care production would allow for an agility that large plants don’t have.
As part of a pilot study, On Demand Pharmaceuticals has a mobile clean room housing its proprietary equipment and software system in the parking lot of North Mississippi Health Services. There, more than 10,000 doses of sterile injectables in active shortage have been compounded from non-sterile API under 503A. On Demand’s software guides the drug compounding process and automates the equipment and guides the human steps.
Ultimately, On Demand’s goal is to have small permanent systems inside hospitals rather than in mobile clean rooms in hospital parking lots.
Other tech companies are also researching and developing on-site solutions to address ongoing drug shortages. Once this type of technology is perfected and more widespread, it could be used to produce buffer inventories of drugs at risk of landing on the shortage list and to manufacture precision medication regimens for individual patients.
Call for preparedness
Until health systems can replace dwindling drug supplies on the spot, they must continue to ration and swap.
While they cannot write up protocols for every foreseeable drug shortage in advance, they can have a response team ready to activate. Health systems should determine, Fox advised, which physicians, pharmacists, and ethicists, among others, will be on that team and what actions they’ll take.
“You have to get your infrastructure in place so that when you have a shortage, it’s as streamlined as possible. Do you have your go-to physicians? Who will handle communication; who will gather the data; track the information across your health system; organize the meetings; and who’s the backup when those people aren’t there?” said Fox.
Pharmacists must be key players on this team.
“Pharmacists’ expertise can be leveraged to understand operational supply chain issues, as well as clinical understanding of which populations are better suited for prioritizing medications,” said Ganio. ■