Exploring Efforts to Address Ongoing Drug Shortages and its Effects on Patient Care

Drug shortages continue to be a top concern for pharmacists, prescribers, other health care providers, and patients. Ensuring patient access to medications is an integral component of patient care; however, the ongoing drug shortage of various medications has presented clinicians and the health care system with numerous challenges in meeting the medication needs of many patients. These challenges can significantly impact the management of an array of medical conditions and clinical outcomes by contributing to delays in care, including initiation of therapies for a recently diagnosed medical condition and interruptions in the delivery of maintenance therapies for certain diseases. They can compromise health care delivery, especially in treating diseases that do not have alternative therapies.^1,2

The FDA defines a drug shortage as “a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.”³ While drug shortages are reported annually, according to a recent publication in the Journal of Medical Toxicology, authors indicated that drug shortages in the US are currently an epidemic, and these drug shortages have a significant impact on health care.⁴ The authors also indicated that additional work to address drug shortages adds to the work demands of health care workers.⁴

The American Society of Health-System Pharmacists (ASHP) indicates that in 2022, the mounting drift in new drug shortages resulted in the most significant degree of drug shortages in the US since 2014, and during the first quarter of 2022, the most noteworthy drug shortages documented included the following drug classes: certain antimicrobials, CNS drugs, fluids/electrolytes, hormones, and chemotherapy agents.⁵ In August 2023, the ASHP's Drug Shortages Resource Center reported “active, ongoing shortages of 309 drugs, the highest number in nearly a decade and close to the all-time recorded high of 320 shortages.”⁶

The American Pharmacists Association (APA) indicates that drug shortages can result from various factors, including delays in production, manufacturing issues, shortages of raw materials, and unexpected increases in demand.⁷ The APA also indicated that “Many drugs used in the United States are manufactured overseas, and supply chain disruptions or manufacturing issues in these countries can contribute to drug shortages.”⁷ In addition to the reasons above for drug shortages, the FDA notes that drug shortages can also result from drug discontinuations. Some manufacturers discontinue manufacturing older drugs to manufacture newer, more profitable drugs.³

The ASHP conducted a survey to gain insight into the severity and impact of ongoing drug shortages in their daily practice and patient care.^6,8 The survey was conducted between June 23 and July 14, 2023, and involved 1,123 of their members, of which 93% were pharmacists and 88% were employed in a hospital or health system setting. Survey results revealed the following:^6,8

• More than 99% of respondents indicated they were experiencing drug shortages.
• 32% of respondents stated the current drug shortages had a "critical" impact on patient care, while 63% noted a "moderate" effect.
• Regarding the degree of severity for specific drugs, 57% of participants stated, “Shortages of antineoplastic (chemotherapy) drugs had a critical impact, leading to delays in care and rationing of treatments.”
• More than 40% of health system pharmacists stated that they had to postpone or cancel treatments or procedures due to drug shortages.
• Shortages of other drugs, such as corticosteroids, hormones, and oral liquid drugs (lidocaine, ibuprofen, etc), had a more moderate impact on patient care.
• Other drug shortages reported as having a “severe impact” included 18% reported prefilled syringes for drugs typically found on “crash carts,” 17% reported cardioplegia solutions, 13% reported ICU and operating room drugs, 11% reported ADHD drugs, and 9% reported antimicrobials.^6,8

The survey results also revealed that strategies to manage current drug shortages included switching to alternative medications (97%), implementing rationing criteria (85%), or changing some medications to other dosage forms (84%).⁶ Lastly, the ASHP stated, “Managing drug shortages is a labor-intensive process and can divert time and resources away from clinical care."⁶

In January 2024, the American Medical Association (AMA) issued a press release to announce its recently adopted policy to address the ongoing drug shortages.⁹ The AMA Immediate Past President Jack Resneck Jr, MD, stated, “Drug shortages are the highest we’ve seen in a decade, making it more and more difficult for patients and physicians across the country to get necessary medications.” Dr Resneck Jr also said, “The nation’s drug supply shouldn’t be in constant turmoil because there aren’t enough manufacturers, or the profit margin is too thin to incentivize production. We must continue to push for actions to mitigate drug shortages that will help ensure the drug supply chain is more resilient and adaptable so our patients can get the medications they need when they need them.”⁹ More information on the recently adopted AMA policy can be found on its website.

Clinician Perspectives

Pharmacist in a hospital setting stated, “Our hospital pharmacy experiences several supply issues during the COVID-19 pandemic and there are still issues with drug shortages. For example, there have been issues with shortages of certain antibiotics, but fortunately, in some cases, we could work with prescribers and change to another antibiotic in that class. The concern is that sometimes there are no alternative therapies, and this is especially true for many patients being treated for cancer. The drug shortages of certain chemotherapy drugs caused changes to treatment plans, if possible, but that is not always an option, delays in care or last-minute cancellations due to unavailability of drugs which affected patient care.”

Retail pharmacist stated, “The ongoing drug shortages have caused some anxiety and concern for some of my patients. Patients see the stories on the news about drug shortages and then call or come to the pharmacy because they are concerned that their maintenance medication will be affected by the ongoing drug shortages. One of my patients has experienced delays in cancer treatment because of drug shortages, and it is very disheartening to see someone dealing with cancer have the added burden of drug shortages.”

Retail pharmacist stated, “Our pharmacists have encountered many patients concerned about drug shortages, and we have experienced shortages in both Rx and OTC drugs. We get several calls every day from patients about drug shortages, and many are frustrated about the uncertainty of drug supplies. We have received prescriptions for certain medicines and then have to call the prescriber to inform the prescriber about a drug shortage, which typically results in trying to find an alternative therapy when feasible.”

Physician assistant practicing in an oncology/hematology clinic stated, “We have experienced drug shortages in drugs used to treat prostate cancer and neuroendocrine tumors, which have caused delays in patient care, and often we are not informed, so patients come in for appointments and don’t get treatment and then have to come back for another appointment. The drug shortages have added to the patient’s burden with regard to delays in therapy and added travel time to come back at another time.”

Conclusion

The ongoing drug shortages impose significant burdens on the health care system and patient care and must be addressed. Hopefully, the expanding awareness about this issue will spark positive results to resolve the problem and prevent further drug shortages. Approaches to drug shortages must be proactive to prevent or minimize the negative impact on patient care and added burdens on clinicians, patients, and the health care system.

In a recent press release regarding the ongoing drug shortages, ASHP Chief Executive Officer Paul W. Abramowitz, PharmD, ScD (Hon), FASHP, stated, "Pharmacists have been managing drug shortages routinely for decades, but we’re now seeing longer, more persistent shortages. We’re facing shortages for more than 300 drugs, and that trajectory is growing. This reality is unsustainable for hospitals and patients alike."¹⁰

Ongoing efforts are directed at identifying and addressing drug shortages, and health care providers, especially pharmacists, are diligently working each day to implement effective measures to lessen the impact on patient care by working in conjunction with prescribers to find alternative evidence-based therapies, if possible, keeping prescribers and patients up to date about ongoing drug shortages and using their drug expertise to implement strategies to maintain delivery of quality health care to patients. The solution to the continuing drug shortage issue will be a challenging and quick remedy, but through collaborative efforts, identifying and addressing the underlying causes with effective measures can be instrumental in mitigating this serious issue that impacts patient care due to delays or interruptions in therapy.

• A current list of drug shortages can be found on the FDA website
• Real-Time Drug Shortages can be found on the ASHP website
• The APA provides a valuable resource highlighting the role of pharmacists in managing drug shortages on its website
• The ASHP Guidelines on Managing Drug Product Shortages can be found on its website

References

1. Fox ER, Mclaughlin MM. ASHP guidelines on managing drug product shortages. Am J Health Syst Pharm. 2018;75(21):1742–50.
2. Mazer-Amirshahi M, Fox ER, Nelson LS, Smith SW, Stolbach AI. ACMT position statement on prescription drug shortages. J Med Toxicol. 2020;16(3):349–51.
3. Frequently asked questions about drug shortages. FDA. October 11, 2023. Accessed January 30, 2024. https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages
4. Routsolias, JC, Webb, AN. Drug shortages negatively impact health systems and bedside patient care. J Med Toxicol. 19, 246–247 (2023). doi:10.1007/s13181-023-00950-6
5. AMA strengthens policy to address growing national drug shortages. News release. American Medical Association. Published November 13, 2023. Accessed January 30, 2024. https://www.ama-assn.org/press-center/press-releases/ama-strengthens-policy-address-growing-national-drug-shortages
6. New ASHP survey: Critical shortages of cancer drugs pose dangers to patient care. ASHO. August 10, 2023. Accessed January 30, 2024. https://news.ashp.org/-/media/assets/drug-shortages/docs/ASHP-2023-Drug-Shortages-Survey-Report.pdf
7. Carson-Marino M. Experts give the scoop on drug shortages. Pharmacy Today. https://www.pharmacist.com/Publications/Pharmacy-Today/Article/experts-give-the-scoop-on-drug-shortages
8. How drug shortages are affecting hospitals, in 4 charts. Advisory Board website. August 14, 2023. Accessed January 30, 2024. https://www.advisory.com/daily-briefing/2023/08/14/drug-shortages
9. O’Reilly K. Time for new ideas to address rising drug shortages. AMA. January 3, 2024. Accessed January 30, 2024. https://www.ama-assn.org/delivering-care/public-health/time-new-ideas-address-rising-drug-shortages
10. Can we turn the corner on drug shortages? ASHP. December 4, 2023. Accessed January 30, 2024. https://news.ashp.org/News/Midyear/2023/12/04/drug-shortages-looking-back