Pharmacists, drug shortages and what lies ahead

Drug shortages, a critical issue faced by pharmacists, limit drug options for patient treatment. Local shortages can quickly lead to a nationwide drug shortage. In April 2024, the American Society of Health-System Pharmacists (ASHP) reported 323 active drug shortages. That was the highest number in almost a decade.^1.2 In comparison, there were 176 active shortages from 2016 to 2017. There have been 300 or more shortages in the last year and a half.² Drug shortages can have many causes and affect a wide range of diseases. Specifically, the drugs affected can be various concentrations, from saline ampoules to chemotherapy drugs. Pharmacists need to be able to stay up to date on what is currently available and unavailable. Pharmacists should also be aware of the current discussion, attempts to resolve it, and the expected duration of each deficiency.

As of June 2024, ASHP reported 300 drug shortages.² Although the trend is down from recent peaks, pharmacists should continue to be alert for impending supply changes. The FDA provides access to a current database on its website that contains verified reports of new, updated, and resolved shortages. This database also reports when a drug is discontinued by a manufacturer. If a new deficiency is identified, it should be reported to FDA through the appropriate portals and contact information. The FDA provides different contact information to the general public than to those reporting from the pharmaceutical industry. The database is updated daily but relies on receiving verifiable reports to confirm that a deficiency actually exists.³

In terms of shortage trends, antimicrobials, chemotherapy, central nervous system agents, electrolytes, fluids, and hormonal therapies are common drug classes experiencing active shortages.² If a manufacturer cannot meet demand or there is a failure in following good manufacturing practices that could impact the sterility or stability of the drug, this could lead to market supply issues. Even if the manufacturer tries to increase production, this can make it difficult to adhere to good manufacturing practices.⁴ Generic, injectable, lower-cost, and older medications also tend to experience shortages. There are very often shortages of generic injection preparations. This may be due to high market demand, lower supply and delays from manufacturers.

Medication shortages can harm patients not only due to the lack of appropriate medications, but also by increasing potential errors and adverse effects due to substitution and lack of care.

Wholesalers and buying groups purchase in bulk, which limits the manufacturer’s ability to increase costs. Compensation for selling generic drugs is the same for all versions of a drug, leading buyers to purchase the cheapest products to save money.⁴ As a result, companies may not see producing cheaper drugs in larger quantities as profitable. This can disrupt the supply chain if production declines.⁴

There have been several proposals to solve these problems, with researchers and members of Congress putting forward similar ideas. Discussions about possible remedies for medication shortages are increasingly focusing on the possibility of offering financial incentives for stockpiling medications. Hernandez et al. proposed the idea of ​​a value-based compensation system to motivate manufacturers and buyers to stabilize their supply chains. This would increase the sales margins that manufacturers could make producing these generics, making production more profitable.⁴ Members of Congress have made similar proposals to curb the problem. In June 2024, a draft of the Drug Shortage Prevention and Mitigation Act was submitted to Congress.⁵ This would use Medicare to incentivize hospitals to maintain a well-stocked supply of needed medications and encourage manufacturers to maintain better production while maintaining good manufacturing practices. If this law passes, manufacturers will have to think about what drugs to stock, where to stock, and how much to order. Hospitals will likely need to analyze their most commonly used and unavailable medications. They need to calculate how much to buy based on prescribing habits. This legislation would specifically apply to generic injectable medications, initially focusing on those that are not self-administered. From 2027, the legislation could apply to medicines or injectables that are at high risk of supply disruption or shortage.⁵

About the author

Olivia Riggi is a sixth-year student at Rutgers University’s Ernest Mario School of Pharmacy who is passionate about applying new knowledge to patient care.

In addition to being aware of shortage trends, pharmacists should also become familiar with extended dating beyond time-of-use for drugs affected by shortages. Depending on testing to ensure drug safety and stability, the FDA may recommend using a drug after its expiration date.^6.7 In addition, ASHP provides helpful guidelines on how institutions should address shortages.

Medication shortages can harm patients not only due to the lack of appropriate medications, but also by increasing potential errors and adverse effects due to substitution and lack of care. As a result, they can worsen patient outcomes and complicate treatment plans. Pharmacists must be able to address these issues to improve overall patient care.

REFERENCES

1. ASHP reports high levels of medication shortages. Press release. American Hospital Association. April 4, 2024. Accessed September 24, 2024. https://www.aha.org/news/headline/2024-04-12-ashp-reports-record-high-number-drug-shortages

2. Drug shortage statistics. ASHP. Accessed September 20, 2024. https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics?loginreturnUrl=SSOCheckOnly

3. Drug shortages. FDA. Reviewed September 5, 2024. Accessed September 24, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages

4. Hernandez I, Sullivan SD, Hansen RN, Fendrick AM. Cheaper Isn’t Always Better: Drug Shortages in the United States and a Value-Based Solution to Alleviate Them. J Manag Care Spec Pharm. 2024;30(7):719-727. doi:10.18553/jmcp.2024.30.7.719

5. Drug Shortage Prevention and Mitigation Act, 42 USC 1395x, Sec 1899c (2024). https://www.nance.senate.gov/imo/media/doc/050124_sfc_drug_shortages_discussion_draft_legislative_text.pdf

6. Expiration date extension. FDA. Updated July 25, 2024. Accessed September 24, 2024. https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policyframework/expiration-dating-extension

7. Browse the extended use dates list to help with medication shortages. FDA updated August 12, 2024. Accessed September 24, 2024.