Record High Drug Shortages In The US: Causes & Impact

Karena Peterson, 12/22/24

Within the first quarter of 2024, the American Society of Health-System Pharmacists (ASHP) recorded a record-high number of drug shortages in the United States of America, reaching 323. The previous recorded high stood at 320, in 2014 (ASHP). While shortages of drugs are not an uncommon occurrence, the sheer number and the lengthening periods of which the shortages last have alarmed multiple organizations, prompting action.

What Are Drug Shortages?

Drug shortages are defined by the U.S. Food and Drug Administration (FDA) as a “period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug.” Drug shortages affect a variety of medications, and include both basic and life-saving drugs. Recent shortages have included critical medicines such as cancer chemotherapy drugs and emergency medications. A full list can be viewed on ASHP's website.

Why Do Drug Shortages Occur?

The answer to why shortages occur is multifaceted. They are typically caused by quality concerns, low prices, manufacturing complexity, and geographic concentration, according to the U.S. Pharmacopeia’s (USP) Medicine Supply Map, which is described as “a tool that uses artificial intelligence and predictive analytics to identify, characterize, and predict risk in the complex medicine supply chain” (USP). Other sources also list production delays, product discontinuations, and seasonal changes.

In a Q&A conducted by the FDA, Emily Thakur, an active-duty Pharmacist officer serving in the United States Public Health Service Commissioned Corps, says, "Manufacturing quality issues are the major reason for drug shortages.” Drug production is highly regulated and often undergoes inspections. When a facility raises issues during inspections, it may limit the availability of the drug.

Emily Thakur also highlights one source of shortages as production discontinuations. According to her, manufacturers may choose to stop producing a drug for multiple reasons, such as low profits. The FDA cannot require a company to keep producing a certain drug, so manufacturers have the freedom to choose when to tap out or replace old drugs with newer ones. The downside, of course, is that it can be difficult for the remaining companies to raise production rates and keep the drug in stock.

Lastly, Emily Thakur states that, “Supply issues are also generally more common in winter — we’ve seen seasonal problems for more than a decade.” (FDA, The Latest in Drug Shortages). In an article titled How To Navigate Medication Shortages by Beth Israel Lahey Health, they discuss how a rise in cases of the flu, COVID, RSV, and other respiratory illnesses as the winter progresses can cause a lack of medication. This is one explanation for why shortages tend to rise in the winter.

Lower prices for drug medications, while making them more affordable, increase the likelihood of shortages. According to an analysis done by the USP, “the average price of sterile injectable medicines in shortage was nearly 8.5 times lower than those not in shortage.” (U.S. Pharmacopeia, U.S. drug shortages reach decade-high and last longer). This is mainly due to manufacturers no longer being able to support the price of producing with such small profits. As such, manufacturers may stop production of certain drugs or shift focus to more profitable ones.

Geographic concentration is another issue that is brought up by the USP. They state, “Drugs in which the active pharmaceutical ingredient (API) and/or finished dose are made in a single or few locations are more at risk of shortage.” (U.S. Pharmacopeia, U.S. drug shortages reach decade-high and last longer).

Manufacturing complexity is also an issue; the harder a particular drug is to make, the harder it is to keep the drug in high supply. This makes drugs with complicated production, such as many antibiotics, vulnerable to shortage.

On a similar note, manufacturing delays can also be a factor. Delays can occur for multiple reasons, such as a stall in obtaining the company's materials for production. Currently, production delay is listed as a cause for quite a few of the drugs within shortage listed by ASHP. An example would be the injectable drug known as bevacizumab-bvzr, or Zirabev. Used in combination with other chemotherapy drugs, Zirabev is used to treat multiple types of cancer. Despite its important applications, ASHP has stated, “Pfizer has Zirabev on shortage due to manufacturing delays,” as the cause for its small supply.

How Long Do Drug Shortages Last?

The number of shortages isn’t the only thing increasing- the length of which they last is too. While in 2020 the average shortage lasted two years, the average now lies at three (USP). Furthermore, ASHP’s data reveals that, “Fifty percent of active shortages have persisted for two or more years,” in their statistical report titled Drug Shortages Statistics.

What is the Impact?

According to a study conducted to analyze the impact of three different shortages, “Drug shortages can have severe consequences for patients, including high costs, delayed care, and potential medication errors or unintended side effects when using alternative or unfamiliar drugs.” (Assistant Secretary for Planning and Evaluation, Impact of Drug Shortages on Patients in the United States: A Case Study of Three Drugs).

Lack of access to the correct medication can be consequential to patients' conditions. In a testament to the U.S. House Ways and Means Committee urging them to find solutions, Dr. Stephen Schleicher shares a heartbreaking story, saying, “Unfortunately, after needing to stop carboplatin because we ran out of supply, her condition deteriorated rapidly, and she died soon after.” He continues to say that it is impossible to know whether or not the access to carboplatin would’ve saved her life.

In addition to health reasons, shortages are expensive too. In The U.S Department of Health and Human Services (HHS) white paper (an informational document to outline an organization’s position or solution to a topic) they report that “According to estimates, hospitals can spend at least $600 million per year managing shortages and diverting essential personnel who are needed for direct patient care to find alternative treatments for patients.” (U.S Department of Health and Human Services, Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States).

Potential Solutions

The pressure is high to get shortages back under control. Several organizations are working to address the issue. For starters, USP has written that their organization, “calls for market and policy solutions that address both short-term and long-term needs and include risk mitigation strategies, public and private investment and partnerships, payment reform to reward reliability and manufacturing quality, coordination and accountability.” (U.S. Pharmacopeia, U.S. drug shortages reach decade-high and last longer)

FDA’s Center for Drug Evaluation and Research (CDER) also has been working towards solutions. While CDER does not manufacture drugs, they do monitor production and try to mitigate future issues, in some cases by encouraging companies to produce or produce more of a particular drug.

The American Hospital Association (AHA) has also taken action. Through a statement submitted on February 6th, 2024, to the Committee on Ways and Means of the U.S. House of Representatives, AHA recommends certain legislation to be passed for:

“Diversifying manufacturing sites as well as sources of critical raw materials…”
“Increasing end-user inventories and incentivizing additional cushion.”
“Requiring the FDA to develop ratings…”
“Requiring drug manufacturers to disclose to the FDA the locations where their products are manufactured…”
“Requiring drug manufacturers to notify the FDA of unusual spikes in demand…”
“Requiring the FDA to identify those essential drugs…”

(American Hospital Association, Statement of the American Hospital Association for the Committee on Ways and Means of the U.S. House of Representatives “Examining Chronic Drug Shortages in the United States”)

Similarly, the U.S. Department of Health and Human Services (HHS) has given a white paper consisting of what the department has done to mitigate drug shortage and what they believe lawmakers should consider in the future.

As of Early December 2024

The record-breaking number of 323 was recorded within the first quarter of 2024 and has since decreased. ASHP’s Drug Shortage Statistics report from September noted that the number had decreased to 277.