ASHP has begun the first phase of a multiyear effort to help outsourcing facilities respond more quickly when patients risk losing access to critical medications due to shortages.
As part of the project, ASHP will convene a multidisciplinary, multi-specialty committee to develop a priority list of medications most vulnerable to shortages. ASHP is naming a dozen clinicians and supply chain experts to the committee, including pharmacists from multiple specialties, which will establish a matrix score that prioritizes medications based on supply chain vulnerability and clinical need.
ASHP received a $3 million grant from the Food and Drug Administration (FDA) to undertake the work.
“This idea of getting multiple specialties together to talk through how to prioritize these drugs is something that could broadly apply to other government initiatives,” said Michael Ganio, ASHP’s senior director of pharmacy practice and quality. Those initiatives include building a reserve of strategic active pharmaceutical ingredients and investing in domestic manufacturing.
As part of the project’s second phase, ASHP will identify medications from the prioritized list that are suitable for compounding by 503B outsourcing facilities. A second expert panel will issue requests for proposals and award funding to facilities that proactively research formulations to compound these medications.
ASHP will maintain a public library of formulations available to 503B outsourcing facilities interested in compounding drugs that eventually go into shortage.
"This effort isn't just about chasing supply,” said Brian Cohen, ASHP’s director of pharmacy supply chain resilience. “It is about identifying the most vulnerable medications, weighing their clinical importance, and being thoughtful about what can be safely compounded during shortages.”
Hospitals and clinics use 503B outsourcing facilities to ensure a more reliable supply of compounded and ready-to-administer drugs. Under law, the facilities can also compound copies of commercially available drugs that are on the FDA drug shortages list.
But only about 20% of outsourcing facilities’ total production is comprised of drugs in shortage, according to the FDA.
Significant challenges — from high costs to research demands — limit their ability to respond to shortages effectively. Facilities often need six months to a year to bring products to market — and by then, the medication may have come off the FDA shortages list. Meanwhile, patients face delays in their care.
“Our goal is to cut that time substantially,” said Ganio.
The project will also include an review of prioritized drugs to determine whether there is a risk of counterfeit activity during a period of shortage.
For more than two decades, ASHP has actively monitored drug shortages, developed strategies to help members minimize the effects of shortages on pharmacy operations and patient care, and urged policymakers to adopt solutions. ASHP, which publishes quarterly national drug shortages reports, will continue to keep members informed about the progress of the new FDA-funded project.
