The number of active drug shortages has reached 323, the highest tally reported by the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service since those organizations began tracking drug shortage data in 2001. This surpasses the previous high of 320 drugs in 2014.
Some 48 new shortages have been reported so far in 2024, about 46% of which are injectable drugs, ASHP reported in an April press release.
“It’s concerning that the problem isn’t getting better,” Erin Fox, associate chief pharmacy officer for shared services (including the Drug Information Service) at the University of Utah, told AHCJ. “[In] all of 2023 we had over 300 shortages — that was a first. There are some pretty clear reasons why shortages aren’t resolving as quickly, especially last year. But it is concerning to have so many because it’s inconvenient for patients, and there is a huge amount of work that goes on behind the scenes inside pharmacies to really mitigate the impact for patients.”
What drugs are in shortage?
Among the drugs in short supply are some anti-cancer medications, drugs for attention-deficit/hyperactivity disorder (ADHD), the powder form of the antibiotic amoxicillin, and newer glucagon-like peptide-1 (GLP-1) drugs used for weight loss and diabetes control. Also on the list are drugs used in hospitals such as local anesthetics, pain medications and injectable medications used during surgeries, and a penicillin suspension injection that is the only drug that can be given to pregnant people who contract syphilis.
“Most of these drugs are older and off patent, except the GLP-1s,” Fox said. “That’s a huge demand problem. It’s actually pretty rare to have huge spikes in shortages because of demand. The last time we saw that was during COVID, when hospitals were trying to prepare for having hundreds of patients on ventilators.”
A deeper dive into this crisis
There are multiple reasons for the drug shortages. Many occur as a result of one manufacturer’s factory experiencing a manufacturing delay or some kind of quality problem, and either there are no other suppliers, or the other suppliers can’t make up the difference, Fox explained: “If you’re making 20 or 30 products on the same manufacturing line, you can’t always interrupt those without creating even more shortages.”
Fox added that in the wake of the opioid settlements, manufacturers cannot sell more than a specific amount of pain medications to hospitals. Hospitals have to request how much they need based on patient volumes while a wholesaler determines what they think the hospitals need and sends just that amount. That also is contributing to the shortage in some ADHD medications as they are considered part of the same class of Schedule II controlled substances.
And some manufacturing facilities are aging, some are overseas and the U.S. Food and Drug Administration is behind on its inspections dating back to the COVID public health emergency, Michael Ganio, senior director of pharmacy practice and quality at ASHP said in an interview.
Also, the U.S. Drug Enforcement Agency has strict quotas on manufacturers’ production of controlled substance injections such as morphine and fentanyl. The DEA had been providing manufacturers with their quotas for a year at a time, which allowed for planning of production.
Last year, the agency proposed changing that to quarterly, which made it more difficult to plan production, Ganio said. However, the agency has since revisited that decision and announced it will return to an annual schedule for sterile injectable products and a semi-annual schedule for non-injectable products, ASHP reported.
In other events last year contributing to shortages:
- In February 2023, Akorn Pharmaceuticals, a company that produced 75 generic drugs, filed for bankruptcy and closed its U.S. operations. In some cases, the company was the only supplier of particular products, NBC news reported.
- In July 2023, a tornado that hit North Carolina nearly completely destroyed the warehouse of a major Pfizer pharmaceutical plant. The roof of the company’s Rocky Mount, N.C., building was ripped off, and thousands of pallets of medicine were strewn across the facility and damaged by rain and wind, NBC news reported. The plant produces nearly 25% of all sterile injectable medications used in hospitals. The facility also makes anesthesia drugs used during surgery and intubation, pain relievers, antibiotics, and neuromuscular blockers used during surgery.
What’s the resolution?
It’s complicated. Resolving the shortages will require a variety of actions including some manufacturers being able to ramp up production and the FDA getting up to date on inspections, as well as a shift in how manufacturers price their products. Generic drug manufacturers have been trying to compete on price to boost their market share. This has driven prices lower and lower until some manufacturers choose not to produce these products anymore because they can’t earn any profit, Fox said.
It also may require policy changes to fix some of the root causes. Last year, ASHP released its Policy Solutions to Address the Drug Shortage Crisis, a document that provides specific guidance to Congress and regulators about actions they can take to prevent shortages. They include imposing penalties on drug manufacturers who do not develop risk management plans or report manufacturing and supply chain issues as well as encouraging new manufacturers and new manufacturing sites.
The role of pharmacists
Pharmacists can try several tactics to manage drug shortages, Ganio wrote in a recent article in the AMA Journal of Ethics (I covered this as part of a recent story for Pharmacy Practice News). They can try to procure drugs from alternative suppliers or compounding facilities, purchase different vial sizes/concentrations of drugs, or repackage larger vial sizes into smaller doses. They also could attempt to convert patients to different dosage forms (such as from injections to pills). However, the work is “labor-intensive,” he wrote, and can present ethical challenges if patients receive second-line treatment or have care delayed.
Story ideas
There are plenty of stories to report on about drug shortages. You could interview patients trying to get the drugs they need, or talk to prescribers or pharmacists about their workarounds and efforts to bring patients their therapies. You could also look into the reasoning behind shortages, in particular drug classes and what needs to happen to try to mitigate those situations, and report on the proposed policy fixes and how those could help. Alternatively, you can delve into the backlog of inspections of manufacturing facilities, investigate how hospitals are faring getting the Schedule II drugs they need, or look into the proposed legislation.
Expert sources
- Erin Fox, PharmD, M.H.A., B.C.P.S., F.A.S.H.P., associate chief pharmacy officer for shared services (including the Drug Information Service) at the University of Utah: Erin.fox@hsc.utah.edu or 801-587-3621
- Michael Ganio, PharmD, M.S., B.C.P.S., FASHP, senior director of pharmacy practice and quality at ASHP: c/o Aretha Hankinson, director of media relations, ahankinson@ashp.org or 301-664-8671
- Stephen Schleicher, M.D., M.B.A., chief medical officer at Tennessee Oncology
- Emily Tucker, Ph.D., an assistant professor of industrial engineering at Clemson University
- Julie Gralow, M.D., F.A.C.P., F.A.S.C.O., chief medical officer and executive vice president of the American Society of Clinical Oncology (ASCO)
- Stephen Schondelmeyer, PharmD, Ph.D., professor of pharmaceutical care and health systems at the University of Minnesota College of Pharmacy
Recent coverage
- Drug shortages at highest since 2014: Chemo drugs, Wegovy, ADHD medications affected – USA Today
- Drug shortages reach record high in US – CNN.com
- ASHP Reports Drug Shortages Hit a 2-Decade High – Pharmacy Practice News
- US drug shortages reach record high with 323 meds now in short supply – Ars Technica
- Drug shortages may mean difference between life and death for some US patients – CNN.com
- How one U.S. drugmaker contributed to the escalating drug shortage crisis – NBCnews.com
- North Carolina tornado could lead to medication shortages after Pfizer plant was hit, expert warns – NBCnews.com
Additional resources
- ASHP maintains a database of Current Drug Shortages in partnership with the University of Utah Drug Information Service. It has drop-down tabs for all shortages, current shortages, resolved shortages and discontinued drugs.
- The U.S. Food and Drug Administration also maintains a Drug Shortages Database that is searchable by drug name and therapeutic category.
- The Department of Health and Human Services released a white paper in April 2024 focused on preventing drug shortages.
- The Senate Finance Committee in May 2024 released draft legislation to combat prescription drug shortages.
- AHCJ published a blog post on the harms of supply shortages in November 2023, written by Mary Chris Jaklevic
