Survey: 50% of Active Drug Shortages in the United States Persist for 2 or More Years

Although the number of active shortages decreased to 277 in the second quarter of 2024 from an all-time high of 323 in the second quarter of 2023, 50% of the active shortages in the United States persisted for 2 or more years, as reported by the American Society of Health-System Pharmacists. Furthermore, the report shows that 95 new drug shortages, 48% of which are injectables, were identified in 2024.¹

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“These severe and prolonged shortages, particularly critical drug shortages, have been consistently growing both in number and intensity over the past decade or so. This results in added time, expense, supply management challenges, and the need to explore therapeutic alternatives. It can even potentially delay patient care and increase the possibility of resorting to less effective medications or more costly alternatives,” Alfred L’Altrelli, PharmD, CDMC, senior director of pharmacy at UPMC Presbyterian-Shadyside, said in an interview. “We often hear claims that increased demand is a driving factor. People wonder why there's such a surge in usage. While demand spikes are indeed real, they tend to have short-term effects. The more severe and persistent shortages are predominantly driven by economic factors, which people often overlook. Various economic forces contribute to the complexity of the drug shortage issue.”²

The top 5 drug classes in active shortage as of September 30, 2024, include central nervous system (CNS), antimicrobials, hormone agents, chemotherapy, and cardiology therapies, according to the report. The number of shortages of antibiotics, chemotherapy, cardiovascular, CNS, gastrointestinal, and hormone drugs increased from 2022 to 2023. Only cardiovascular and ears, eyes, nose, and throat therapies from 2023 dropped below the shortage levels of 2019.¹

Of note, investigators reported that 60% of drug shortages were either unknown or not provided by the manufacturers, with the next significant reason being supply and demand (14%), manufacturing (12%), business decision (12%), and raw material issue (2%).¹

In an ASHP survey from July 2023, investigators determined the severity and impact of ongoing drug shortages, with approximately 99% of 1123 respondents reporting that they experienced a drug shortage. At the time of the survey, there were 309 ongoing drug shortages. The survey was conducted from June 23 through July 14, 2023, via an online questionnaire. Individuals surveyed were 93% pharmacists, 5% pharmacy technicians, 1% pharmacy residents, and 1% other pharmacy professionals. Further, 88% were in the hospital or health system setting, 6% were in the ambulatory clinic or related setting, 4% were in another setting (including long-term care, home infusion, and home care), and 2% were in outpatient or specialty pharmacy.³

Approximately 32% of respondents reported that the state of drug shortages included rationing, delaying, or canceling treatments and procedures (critically impactful), and 63% reported that drug shortages were moderately impactful. Additionally, 87% responded that manufacturer and product quality were very important when considering purchases, with 69% preferred to buy from manufacturers that met a predefined quality standard and 85% would be willing to spend 5% or more above their annual generic injectable drug budget for the preferred quality of the drug.³

Approximately 97% of respondents said they changed to therapeutic alternatives, 85% said they were implementing rationing, 84% said they were converting to different dosage forms. In operational management, 91% said they were purchasing other vial sizes/concentrations, 83% said they were centralizing or consolidating inventory, and 70% said they were changing products in trays/carts.³

Recently, the FDA has added 3 drugs to the Drug Shortage Database, including Dextrose 70% intravenous (IV) solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution. The shortage is linked to the impact of Hurricane Helene on Baxter manufacturing and facilities, with the FDA stating the products are not “commercially available in adequate supply to meet national demand.”⁴

“This is a manufacturing plant that provided more than 60% of large IV fluids across the United States. And I think particularly of note with this shortage is that these are large volume IV fluids, they are the lifeblood of many health systems. So, as a result, there's catastrophic impact upon these health systems that are looking to ensure the continued availability of these fluids so that they can continue to take care of their patients,” Farah Towfic, PharmD, MBA, RPh, senior director of the Healthcare Quality and Safety Center of Excellence at US Pharmacopeia, said in an interview.⁵

On October 11, 2024, the FDA released a guidance that includes regulatory and enforcement policies for the compounding drugs that are currently in shortage due to the impacts of Hurricane Helene and Hurricane Milton. The policies will remain in effect for the duration of the supply disruption related to the public health emergency, or for another duration of time if the FDA announces.⁴

“Now during a time of a drug shortage, that's when compounding becomes an even more important solution in order to be able to help mitigate the impact of those shortages, because—as I mentioned—these are large IV fluids, the compounding implications upon them are quite significant,” Towfic said.⁵

Ninety-three percent of all oncology practitioners reported drug shortages and subsequent delay in administration of chemotherapy or a change in patient’s treatment. Additionally, 85% reported challenges related to cost and reimbursement.⁶

Pharmacy staff are essential in managing drug shortages, including following plans or algorithms that can increase the odds of finding viable replacement and reducing stress for all parties involved.⁶

REFERENCES

1. ASHP. National Drug Shortages 2001 – September 2024. October 2024. Accessed October 23, 2024. https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics

2. Pharmacy Times. Opioid Drug Shortages Affect Patients, Health Systems. September 28, 2023. Accessed October 29, 2024. https://www.pharmacytimes.com/view/opioid-drug-shortages-affect-patients-health-systems

3. ASHP. Severity and Impact of Current Drug Shortages. June 2023. Accessed October 23, 2024. https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-2023-Drug-Shortages-Survey-Report.pdf

4. Gallagher A. FDA Adds Intravenous Fluids to List of Drug Shortages. Pharmacy Times. October 18, 2024. Accessed October 29, 2024. https://www.pharmacytimes.com/view/fda-adds-intravenous-fluids-to-list-of-drug-shortages

5. Pharmacy Times. Navigating IV Fluid Shortages Post-Hurricane Helene: Insights From USP on Compounding and Conservation Strategies. October 24, 2024. Accessed October 29, 2024. https://www.pharmacytimes.com/view/navigating-iv-fluid-shortages-post-hurricane-helene-insights-from-usp-on-compounding-and-conservation-strategies

6. Wick JY. Pharmacists and Pharmacy Technicians Need Tricks and Tools to Manage Ongoing Drug Shortages. Pharmacy Times. September 17, 2024. Accessed October 29, 2024. https://www.pharmacytimes.com/view/pharmacists-and-pharmacy-technicians-need-tricks-and-tools-to-manage-ongoing-drug-shortages