50% of active drug shortages in the United States last two or more years

Although the number of active shortages fell to 277 in the second quarter of 2024 from an all-time high of 323 in the second quarter of 2023, 50% of active shortages in the United States lasted two or more years, as reported by the American Society of Health-System Pharmacists . Additionally, the report shows that 95 new drug shortages were identified in 2024, 48% of which are injectables.¹

“These serious and persistent shortages, particularly critical drug shortages, have steadily increased in both number and intensity over the past decade. This results in additional time and expense, additional challenges in care management, and the need to explore therapeutic alternatives. It can potentially even delay patient care and increase the possibility of resorting to less effective medications or more expensive alternatives,” said Alfred L'Altrelli, PharmD, CDMC, senior director of pharmacy at UPMC Presbyterian-Shadyside, in an interview. “We often hear claims that increased demand is a driving factor. People wonder why usage is increasing so much. While spikes in demand are real, they tend to have short-term effects. The more severe and persistent shortages are largely due to economic factors that people often overlook. Several economic forces contribute to the complexity of the drug shortage problem.”²

According to the report, the top five drug classes experiencing shortages as of September 30, 2024 include central nervous system (CNS) medications, antimicrobials, hormonal agents, chemotherapy and cardiac therapies. The number of shortages of antibiotics, chemotherapy, cardiovascular, CNS, gastrointestinal and hormonal drugs increased from 2022 to 2023. Only cardiovascular and ear, nose and throat therapies fell below the 2019 deficiency level from 2023 onwards.¹

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

In a July 2023 ASHP survey, investigators determined the severity and impact of ongoing drug shortages, with approximately 99% of 1,123 respondents reporting they were experiencing drug shortages. At the time of the survey, there were 309 ongoing drug shortages. The survey was conducted from June 23 to July 14, 2023 via an online questionnaire. Of those surveyed, 93% were pharmacists, 5% were pharmacy technicians, 1% were pharmacy residents, and 1% were other pharmacy technicians. Additionally, 88% were in the hospital or health system setting, 6% were in the outpatient clinic or related setting, 4% were in another setting (including long-term care, home infusion, and home care), and 2% were in the outpatient or specialty pharmacy setting.³

Approximately 32% of respondents indicated that the drug shortage condition involved rationing, delaying, or cancellation of treatments and procedures (critically important), and 63% indicated that the drug shortage had a moderate impact. In addition, 87% responded that manufacturer and product quality are very important when making purchasing decisions. 69% preferred purchasing from manufacturers that met a predefined quality standard, and 85% would be willing to spend 5% or more above their annual injectable generic drug budget for the preferred quality of the drug.³

Approximately 97% of respondents reported switching to therapeutic alternatives, 85% reported implementing rationing, and 84% reported switching to other dosage forms. In operations management, 91% said they would purchase different vial sizes/concentrations, 83% said they would centralize or consolidate inventory, and 70% said they would change products into trays/carts.³

Recently, the FDA added three drugs to the Drug Shortage Database, including Dextrose 70% Intravenous (IV) Solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution. The shortage is related to the impact of Hurricane Helene on Baxter's production and facilities, with the FDA stating that the products “are not commercially available in sufficient quantities to meet national demand.”⁴

“This is a manufacturing facility that supplied more than 60% of the major IV fluids in the United States. What I think is particularly notable about this shortage is that it involves large-volume intravenous fluids, which are the lifeblood of many healthcare systems. “This has a catastrophic impact on these health systems that want to ensure the continued availability of these fluids so they can continue to care for their patients,” says Farah Towfic, PharmD, MBA, RPh, executive director of the Center of Excellence for Quality and Safety in Healthcare from the US Pharmacopeia in an interview.⁵

On October 11, 2024, the FDA released guidance providing regulatory and enforcement guidelines for the manufacturing of drugs currently in short supply due to the impacts of Hurricane Helene and Hurricane Milton. The guidelines will remain in effect for the duration of the supply interruption related to the public health emergency or for such other period as FDA announces.⁴

“In a time of drug shortages, compounding becomes an even more important solution to mitigate the effects of these shortages because, as mentioned, these are large intravenous fluids and the effects of compounding on them are quite significant,” Towfic said.⁵

93 percent of all oncologists reported drug shortages and resulting delays in administering chemotherapy or changing patient treatment. Additionally, 85% reported issues related to costs and reimbursement.⁶

Pharmacy staff are critical in managing medication shortages. This includes following plans or algorithms that can increase the chances of finding a viable replacement and reduce stress for everyone 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 hours. Opioid drug shortages impact patients and healthcare 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 hours. October 18, 2024. Accessed October 29, 2024. https://www.pharmacytimes.com/view/fda-adds-intravenous-fluids-to-list-of-drug-shortages

5. Pharmacy hours. Addressing IV fluid shortages after Hurricane Helene: Insights from USP on compounding and preservation 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 address ongoing drug shortages. Pharmacy hours. September 17, 2024. Accessed October 29, 2024.