ACCC Statement on Chemotherapy Drug Shortages

Recent years have seen alarming shortages of several anti-cancer drugs that serve as mainstays of treatment. Currently, the Association of Community Cancer Centers (ACCC) is highly concerned about the ongoing shortages of platinum-based chemotherapy agents (e.g., cisplatin and carboplatin), two medications that (individually or in combination) treat and cure a wide range of cancers, including but not limited to gastric, pancreatic, colorectal, esophageal, cervical, and ovarian. These shortages are occurring across treatment settings and geographies, including community cancer centers, hospital-based programs, and private practices. The widespread and critical nature of the shortage has already forced clinicians to choose between and among patients eligible for curative and supportive therapies. Hence, the quality of care for patients with cancer and their very lives are at stake.

“An ACCC member program recently shared how drug shortages were essentially forcing oncologists to ‘prioritize’ patients receiving curative treatment over those receiving palliative care,” said ACCC Chief Medical Officer and Deputy Executive Director, Leigh Boehmer, PharmD, BCOP. “That is not a decision any cancer care provider wants to—or should need to—make.”

Platinum drug shortages were first reported to the U.S. Food and Drug Administration (FDA) on February 10, 2023¹. In a recent survey by the National Comprehensive Cancer Network (NCCN), released on June 7, 93% of NCCN centers surveyed reported a shortage of carboplatin and 70% reported a shortage of cisplatin. These types of shortages are demonstrative of broader challenges with prescription drug manufacturing integrity in the U.S., stemming from production delays, unavailability of raw ingredients, and/or quality deficiencies, among other factors.

ACCC is pleased that the FDA has worked with Qilu Pharmaceutical Co. Ltd. (Qilu) and its distributor Apotex Corp. to allow for the temporary importation of cisplatin during the shortage. Only Qilu and Apotex Corp. are allowed to import or distribute Qilu’s cisplatin injection in the U.S. Qilu issued a “Dear Healthcare Professional” letter that highlights some labeling changes and clarifies certain safety questions that may arise from the importation and distribution of its product in the U.S. ²

ACCC stands behind its members as they work with stakeholders across the health care system, including federal and state governments, the pharmaceutical industry, payers, cancer care team members, and patients and caregivers, to find solutions to the current shortages. The Association also supports its members’ efforts to develop longer term solutions to avoid recurrences of these and other anti-cancer drug shortages. Such life-threatening challenges to the provision of high-quality cancer care simply must not continue. ACCC is committed to partnering with our members and other organizations to aggregate experiences, resources, education, and advocacy efforts to help the cancer care community respond to this urgent challenge in the service of its patients.

ACCC and its managed oncology state society chapters are encouraging members to report any drug shortages to the FDA. The more reports the agency receives, the better understanding it will have of where these shortages are occurring. Shortage notifications and updates may be reported to the FDA at drugshortages@fda.hhs.gov.

Contact

Sarah Shelson

sshelson@riesterinfluence.com

610.844.8366

References

1. Society of Gynecologic Oncology, “SGO Statement: Carboplatin and Cisplatin Shortages,” April 21, 2023, https://222.sgo.org/news/drugshortage/.

2. Qilu Pharmaceutical Co., Ltd., Dear Healthcare Professional Letter, “Subject: Temporary Importation of CISplatin Injection with non-U.S. Labeling to Address Drug Shortage,” May 24, 2023.