Pharmacy Expert Details Causes of Carboplatin/Cisplatin Shortage in the U.S.

CancerNetwork^® spoke with Michael Ganio, PharmD, MS, BCPS, FASHP, in an interview regarding the causes of an ongoing chemotherapy shortage impacting many treatment centers across the United States.

Ganio, senior director of Pharmacy Practice and Quality at the American Society of Health-System Pharmacists, described how an Indian manufacturing facility halted production of chemotherapy products following an inspection from the FDA. As a result, supply of the chemotehrapy agents, including cisplatin and carboplatin, have been limited in the United States.

According to findings from a survey conducted by the National Comprehensive Cancer Network (NCCN) Best Practices Committee across 27 NCCN Member Institutions, 93% and 70% of centers are experiencing a shortage of carboplatin and cisplatin, respectively.

Transcript:

Cisplatin and carboplatin had been in short supply for a couple of months, now. The triggering event was an FDA inspection of a facility in India [that’s] a manufacturer of the product for here in the United States, and that inspection did not go well. There were some concerning findings from the FDA, and they've been working with that manufacturer to resolve those findings. In the meantime, they've been slowly releasing some of the products that had already been manufactured. But the manufacturing has not resumed either, so what's been released from that manufacturer has undergone additional testing to make sure it's of suitable quality.

But as of the last time I heard, production had not resumed. That's not good news for the longer term for both of these shortages. The manufacturer had about half of the market for cisplatin and about 20% of the market for carboplatin. Unfortunately, we're now seeing the effects of that inspection and the product that has not been released. There was a recent survey of the National Comprehensive Cancer Network that found that almost all the organizations that responded were experiencing a carboplatin shortage.

While 20% of the market doesn't seem like a lot, it's probably the first thing that clinicians would go to as an alternative to the cisplatin shortage. Between the 2 drugs, it's making it very difficult to give patients the regimens that are either first-line or second-line for their cancer depending on which treatment they would normally receive.

Reference

NCCN releases statement addressing ongoing chemotherapy shortages; shares survey results finding more than 90% of cancer centers are impacted. News release. National Comprehensive Cancer Network. June 7, 2023. Accessed July 26, 2023. https://shorturl.at/ERY27