How to cover the ongoing dilemma of drug shortages

The number of active drug shortages has reached 323, the highest number reported by the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service since those organizations began tracking shortage data. drugs in 2001. This exceeds the previous high of 320 drugs in 2014.

About 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, chief of pharmacy for shared services (including the Drug Information Service) at the University of Utah, told AHCJ. “[In] throughout 2023 we had over 300 absences – this was a first. There are some pretty obvious reasons why shortages aren’t being resolved as quickly, especially in the past year. But it’s worrying to have so many because it’s inconvenient for patients, and there’s a lot of work that goes on behind the scenes within pharmacies to really mitigate the impact on patients.”

Which drugs are in short supply?

Among the medicines in short supply are some cancer drugs, attention-deficit/hyperactivity disorder (ADHD) drugs, the powdered form of the antibiotic amoxicillin and newer glucagon-like peptide-1 (GLP-1) drugs used for weight. diabetes loss and control. Also on the list are drugs used in hospitals such as local anesthetics, painkillers and injectable drugs used during surgery, as well as an injection of penicillin suspension which is the only drug that can be given to pregnant women with syphilis.

“Most of these drugs are older and patented, except for GLP-1,” Fox said. “This is a huge demand problem. It is actually very rare to have large increases in absences due to demand. The last time we saw that was during COVID, when hospitals were trying to prepare to have hundreds of patients on ventilators.”

A deeper dive into this crisis

There are many reasons for drug shortages. Many occur as a result of a manufacturer’s plant experiencing a production delay or some kind of quality problem, and either there are no other suppliers, or the other suppliers can’t tell the difference, Fox explained: “If you’re making 20 or 30 products on the same production line, you can’t always cut them off without creating even more shortages.”

Fox added that in the wake of the opioid settlements, manufacturers cannot sell more than a specific amount of painkillers to hospitals. Hospitals have to request how much they need based on patient volumes, while a wholesaler determines what they think hospitals need and sends only that amount. This is also contributing to the shortage of 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 out of state and the U.S. Food and Drug Administration is behind in its inspections dating back to the COVID public health emergency, Michael Ganio, senior director of the practice and pharmacy quality in ASHP.

Also, the US Drug Enforcement Agency has strict quotas for injecting manufacturers of controlled substances, such as morphine and fentanyl. The DEA had provided producers with their quotas for a year, which allowed production to be planned.

Last year, the agency proposed changing it to quarterly, which made production planning more difficult, Ganio said. However, the agency has since revised 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 absences:

• In February 2023, Akorn Pharmaceuticals, a company that produced 75 generic drugs, filed for bankruptcy and closed its US operations. In some cases, the company was the sole supplier of particular products, NBC news reported.
• In July 2023, a tornado that hit North Carolina almost completely destroyed the warehouse of a large pharmaceutical factory Pfizer. The roof of the company’s Rocky Mount, NC, building was torn off and thousands of pallets of medicine were scattered across the facility and damaged by rain and wind, NBC news reported. The plant produces nearly 25% of all sterile injectable drugs used in hospitals. The facility also manufactures anesthetic drugs used during surgery and intubation, pain relievers, antibiotics and neuromuscular blockers used during surgery.

What is the resolution?

It’s complicated. Resolving the shortages will require a number of actions, including some manufacturers being able to increase production and the FDA being updated on inspections, as well as a change in the way manufacturers price their products. Generic drug manufacturers have tried to compete on price to increase their market share. This has driven prices lower and lower until some manufacturers choose to stop making these products because they can’t make a profit, Fox said.

It may also 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 fines on drug manufacturers who fail to 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 may try to purchase drugs from alternative suppliers or compounding facilities, purchase different sizes/strengths of drug bottles, or repackage larger size bottles into smaller doses. They may also try 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 are delayed in care.

Story ideas

There are many stories to report about drug shortages. You can interview patients trying to get the drugs they need, or talk to doctors or pharmacists about their solutions and efforts to bring their therapies to patients. You can also look at the rationale behind shortages, in particular drug classes and what needs to happen to try to alleviate those situations, and report on proposed policy adjustments and how they might help. Alternatively, you can dig into the number of pending manufacturing facility inspections, investigate how hospitals are managing to get the Schedule II drugs they need, or view proposed legislation.

Expert resources

• Erin Fox, PharmD, MHA, BCPS, FASHP, chief pharmacy officer for shared services (including the Drug Information Service) at the University of Utah: [email protected] or 801-587-3621
• Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP: c/o Aretha Hankinson, director of media relations, [email protected] or 301-664-8671
• Stephen Schleicher, MD, MBA, chief medical officer at Tennessee Oncology
• Emily Tucker, Ph.D., an assistant professor of industrial engineering at Clemson University
• Julie Gralow, MD, FACP, FASCO, 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

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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 absences, current absences, resolved absences and discontinued drugs.
• The US Food and Drug Administration also maintains a database of drug shortages that can be searched 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 a bill to combat prescription drug shortages.
• KSHLD published a blog post on November 2023 supply shortage damages written by Mary Chris Jaklevic