Staying in the Know: Pharmacists, Drug Shortages, and What Lies Ahead

Drug shortages, a critical problem pharmacists encounter, limit medication options for patient treatment. Local shortages can quickly snowball into a national deficit of medication. In April 2024, the American Society of Health-System Pharmacists (ASHP) reported 323 active drug shortages. This was the highest number in almost a decade.^1,2 By comparison, there were 176 active shortages from 2016 to 2017. For the past year and a half, there have been 300 or more shortages.² Drug shortages can occur for many reasons and affect a wide breadth of conditions. Specifically, medications impacted can range from different concentrations of saline vials to chemotherapy drugs. Pharmacists need to be able to stay up to date with what is currently available and unavailable. Pharmacists should also be aware of the current discussion, attempted fixes, and expected length of each shortage.

Drug Shortage, Pharmacy Students, Pharmacist | Image Credit: Yana Demenko | adobe.stock.com

As of June 2024, 300 drugs were reported in shortage by ASHP.² Although downtrending from the recent peak, pharmacists should remain wary of impending supply changes. The FDA provides access to an up-to-date database on its website that shows verified reports of new, updated, and resolved shortages. This database also reports if a medication is discontinued by a manufacturer. If a new shortage is identified, it should be reported to the FDA using the respective portals and contact information. The FDA provides separate contact information for the general public than for those reporting from within the pharmaceutical industry. The database is updated daily but is dependent on receiving verifiable reports to confirm that there is a true shortage.³

In regard to shortage trends, common classes of medications in active shortage are antimicrobials, chemotherapies, central nervous system agents, electrolytes, fluids, and hormonal therapies.² If a manufacturer cannot meet demand or if there is a flaw in following good manufacturing practices that could impact sterility or stability of the drug, this could cause problems in supplying the market. Even if the manufacturer tries to increase production, that may make it more difficult to follow good manufacturing practices.⁴ Generic, injectable, less expensive, and older medications are typically also impacted by shortages. Of these, shortages of generic injectables are very common. This can be due to high market demand, decreased supply, and delays by manufacturers.

Drug shortages can harm patients not only due to lack of proper medication, but also by increasing potential errors and adverse effects from substitution and lack of care.

Wholesalers and group purchasing organizations buy in bulk, which limits the manufacturer’s ability to raise costs. Reimbursement for the sale of generic medication is equal for all versions of a drug, which leads to buyers purchasing the least expensive products to save money.⁴ As a result, companies may not see production of cheaper medications as profitable in higher volumes. This can disrupt the supply chain when production decreases.⁴

There have been multiple propositions to try to remedy these issues, with researchers and members of Congress presenting similar ideas. Discussions around potential remedies for drug shortages have increasingly focused on the possibility of offering monetary incentives toward maintaining stockpiles of medication. Hernandez et al proposed the idea of a value-based reimbursement system to motivate manufacturers and purchasers to stabilize their supply chains. This would widen sales margins of what manufacturers might earn making these generic medications, thus making production more profitable.⁴ Members of Congress have made similar proposals to reduce the issue. In June 2024, a draft of the Drug Shortage Prevention and Mitigation Act was presented to Congress.⁵ This would utilize Medicare to pay incentives to hospitals to keep a well-stocked supply of needed medications and prompt manufacturers to sustain better production while maintaining good manufacturing practices. If this legislation is passed, manufacturers will have to consider which drugs to stockpile, where to store them, and how much to order. Hospitals will likely have to analyze their most used and unavailable medications. They will have to calculate how much to purchase based on prescribing habits. This legislation would especially apply to generic injectable medications, first focusing on those that are not self-administered. Starting in 2027, the legislation could apply to drugs 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 Ernest Mario School of Pharmacy who is passionate about applying new knowledge toward patient care.

In addition to being cognizant of shortage trends, pharmacists should also familiarize themselves with extended beyond-use dating for drugs affected by shortages. Dependent on testing to ensure medication safety and stability, the FDA can recommend using a drug past its expiration date.^6,7 Also, ASHP provides helpful guidelines for how institutions should manage shortages.

Drug shortages can harm patients not only due to lack of proper medication, but also by increasing potential errors and adverse effects from substitution and lack of care. As a result, they can worsen patient outcomes and complicate treatment plans. Pharmacists need to be able to navigate these issues to improve patient care overall.

REFERENCES

1. ASHP reports record high number of drug shortages. News 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 is not 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 dating 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. Search list of extended use dates to assist with drug shortages. FDA Updated August 12, 2024. Accessed September 24, 2024. https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages#table