Drug Shortages in US at 10-Year High

Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.

"The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country," said Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), in a statement. "I have heard from patients and practitioners who are directly experiencing the impact of these shortages."

As of earlier this month, there were 15 oncology drugs on the official US Food and Drug Administration (FDA) drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.

Factors blamed for the current shortages include expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies.

Knudsen emphasized that several of the oncology drugs now in short supply do not have an effective alternative. "As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer, and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes," she said.

The ACS has listed the following oncology drugs and supportive agents as being in short supply:

• Carboplatin injection used to treat triple negative breast cancer, ovarian, head, and neck cancers

• Fludarabine phosphate injection used for treating B-cell chronic lymphocytic leukemia

• Dacarbazine injection for treatment of skin cancer

• Amifostine injection

• Azacitidine injection

• Capecitabine tablets

• Cisplatin injection

• Cytarabine injection

• Dexamethasone sodium phosphate injection

• Hydrocortisone sodium succinate injection

• Leucovorin calcium lyophilized powder for injection

• Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) injection

• Methotrexate injection

• Pentostatin injection

• Streptozocin (Zanosar) sterile powder

Many of these drugs, such as cisplatin, are used in multiple regimens, so the issue is not limited to one specific cancer type.

In addition to these drugs, many products used in cancer care such as intravenous saline solutions are also in short supply, the ACS noted.

Two Decades of Shortages

Drug shortages in the United States have been a chronic problem for more than two decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.

The report further noted that the first quarter of 2023 marked the highest number of ongoing shortages by quarter since early 2018, with 301 active shortages as of March 31. For some drugs, the problem has become chronic, as more than 15 critical drug products have been in short supply for more than a decade, and 20 have been in shortage since at least 2015.

As previously reported by Medscape Medical News, a 2022 survey of oncology pharmacists at 68 organizations nationwide showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

Knudsen notes that the FDA is largely limited to working directly with the manufacturer on whatever issue is causing the shortage, as well as working with other manufacturers of the same product to urge them to ramp up production. 

"ACS CAN is urging Congress to look at longer-term solutions that change the fundamental underpinnings of the shortages," she said. "In the meantime, we urge the industry to work with medical practitioners to help identify alternatives where possible to ensure that cancer patients' treatments are not delayed."

Roxanne Nelson is a registered nurse and an award-winning medical writer who has written for many major news outlets and is a regular contributor to Medscape.

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Cite this: Drug Shortages in US at 10-Year High - Medscape - May 18, 2023.