Prescription Drug Shortages may occur for many reasons. Some of these reasons include manufacturing and quality problems, delays, and discontinuations. The US Food and Drug Administration (FDA) works together with manufacturers to prevent drug shortages or help reduce the impact of of these shortages.

The drug shortages, which includes sterile injectable products such as chemotherapy drugs, began to increase markedly in the mid-2000s. [1]  The impact of these shortages results in some cases, a declines in utilization: 4% for doxorubicin and fluorouracil; 2.9% for oxaliplatin; and about 1% for cytarabine, dacarbazine, and leuprolide. [1]

Testifying before congress
Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer & Executive Vice President of the Association for Clinical Oncology (ASCO), testified before the full House Committee on Ways and Means on the crisis of ongoing cancer drug shortages.

Today, more than 15 cancer drugs continue to remain on the FDA’s drug shortage list, with several losing additional supply. Gralow shared the firsthand experiences of ASCO members managing clinical care in the face of severe shortages. She will also urge Congress to take action to help mitigate the problem.

Impossible choices
“Every day we hear from oncologists around the country about the challenges cancer patients and their providers are facing amid some of the worst oncology drug shortages to date,” Gralow said.

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“This crisis is forcing providers to make impossible choices, including having to decide which patients receive lifesaving and life-prolonging oncology drugs on schedule and in the established doses—and which ones won’t.”

Approximately half of newly diagnosed cancer patients are over 65 years old, which makes Medicare the largest payer for cancer care in the country. As such, ASCO is urging Congress to take immediate action in three areas:

  • Payment—Congress could explore alternative payment methodologies that would provide relief from artificially low generic reimbursement rates, thereby encouraging a more reliable supply of drugs. Payment reforms should factor in quality and reliability of supply.
  • Manufacturing—Congress could encourage the adoption of advanced technology, for example continuous manufacturing for critical drugs. There could also be incentives such as tax credits or government contracts to increase manufacturing in the U.S.
  • Quality—Congress could consider stronger requirements for risk management plans and incentives for purchasers to contract with manufacturers who demonstrate quality and the ability to provide reliable supply.

“The shortage of critical cancer drugs is a crisis. We must act. Cancer patients, and their families, deserve to know that they will get the care they need without delay, and for as long as they need it,” Gralow noted

“ASCO stands ready to collaborate with Congress to advance comprehensive solutions that ensure individuals with cancer receive the lifesaving and life-prolonging treatments they require.”

Reference
[1] Alpert A, Jacobson M. Impact of Oncology Drug Shortages on Chemotherapy Treatment. Clin Pharmacol Ther. 2019 Aug;106(2):415-421. doi: 10.1002/cpt.1390. Epub 2019 Apr 8. PMID: 30739322; PMCID: PMC6663594.

Featured image courtesy National Cancer Institute/Unsplash. Used with permission

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