APRIL 22, 2024
Originally published by our sister publication Specialty Pharmacy Continuum
By Karen Blum
The number of active drug shortages has reached 323, the highest tally ASHP has recorded since it began tracking these data with the University of Utah Drug Information Service in 2001, according to a new report from ASHP. Unresolved shortages have been hovering above 300 for more than a year, experts said.
Products in shortage include basic and lifesaving drugs such as oxytocin, Rho(D) immune globulin,
Originally published by our sister publication Specialty Pharmacy Continuum
By Karen Blum
The number of active drug shortages has reached 323, the highest tally ASHP has recorded since it began tracking these data with the University of Utah Drug Information Service in 2001, according to a new report from ASHP. Unresolved shortages have been hovering above 300 for more than a year, experts said.
Products in shortage include basic and lifesaving drugs such as oxytocin, Rho(D) immune globulin, standard-of-care chemotherapy, pain and sedation medications, and medications for attention-deficit/hyperactivity disorder. Generic sterile injectables are plentiful on the list.
“It’s concerning that there have been multiple attempts over the years to address the problem, and clearly the approaches that have been implemented have not been successful in keeping the overall number down,” Michael Ganio, PharmD, BCPS, FASHP, the senior director of pharmacy practice and quality at ASHP, told Pharmacy Practice News. “Probably the most impactful policy enacted was the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. That basically created the drug shortage process within FDA, … and there was a steep drop-off [in shortages] after that time.
“We had been trending downward,” he said, “and then slowly have been creeping back up with new shortages by year. The challenge is that shortages are not resolving as quickly as they’re happening.”
Forty-eight new shortages have been reported so far in 2024, according to the ASHP report. About 46% of those are injectable drugs.
There is growing concern at ASHP regarding sterile injectables, particularly Schedule II drugs such as fentanyl, hydromorphone and morphine. The Drug Enforcement Administration restructured their quota process within the past year from annually to quarterly, Dr. Ganio said, which makes it difficult for manufacturers to plan their production schedule: “We’ve received some signals that some manufacturers are concerned with their ability to continue producing at the times and the volumes that they feel they need to maintain market availability.”
As of March 31, the top five drug classes with active shortages were central nervous system (CNS) drugs (66 medications), antimicrobials (43 medications), hormone agents (34 medications), chemotherapy agents (32 medications) and fluids/elytes (25 medications). Shortages in these classes, as well as autonomic, cardiovascular, EENT (eyes, ears, nose and throat) and gastrointestinal drugs, have been the most common types over the past five years, the report noted.
CNS agents include the Schedule II opioids hydrocodone and oxycodone, which could explain the reason for the shortage, Dr. Ganio said. Strict manufacturing controls for agents such as beta-lactams and chemotherapy drugs also may contribute, while fluids and electrolytes are frequently sterile injectables.
In 2023, the reasons manufacturers reported for shortages included issues with supply/demand (14%), manufacturing (12%) or raw materials (2%), or business decisions (12%), according to an investigation by the University of Utah Drug Information Service. Still, 60% of shortages resulted from reasons unknown or that manufacturers would not provide.
The workload that’s required to manage shortages may add to the trials of pharmacy staff shortages, the report noted. Multiple surveys by ASHP have shown that pharmacy technician staffing in hospitals—especially for those who have sterile compounding experience—is challenging, Dr. Ganio said. Typically hospital cleanroom staff help make up the difference in drug shortages, such as preparing some injectables typically available in a premixed bag, he said.
Pharmacists can manage drug shortages through operational and clinical changes, Dr. Ganio said and wrote about in a recent article (AMA J Ethics 2024;26[4]:E327-333). For example, they can procure drugs from alternative suppliers or compounding outsourcing facilities, source different vial sizes/concentrations, or repackage larger vials into smaller doses. Clinically, they could convert to other dosage forms (i.e., from injection to oral tablet) or other routes of administration. However, the work is “labor-intensive,” he said, and can present ethical challenges if patients receive second-line treatment or have care delayed.
For an updated list of drug shortages, see ASHP’s Current Drug Shortages website or the FDA’s drug shortages database.
Dr. Ganio reported no relevant financial disclosures.
