Navigating Cisplatin Shortages and the Need for Legislation

Several factors have contributed to the ongoing cisplatin shortage, ranging from manufacturing issues, supply chain difficulties, and even prioritizing the production of other branded cancer therapies over generics, according to Kirollos Hanna, PharmD, BCPS, BCOP, FACCC.

During an interview with CancerNetwork^®, Hanna, director of Minnesota Oncology Pharmacy Services, and assistant professor of Pharmacy at the Mayo Clinic provided insight into why the shortages have occurred but also hypothesized potential solutions. In particular, he stated that regulatory authorities can learn from the current shortage and that legislation may play a role in avoiding future shortages.

Transcript:

This cisplatin shortage stemmed from [a quality control issue with] one of the largest manufacturers that make about 70% to 80% of the cisplatin in the country. The FDA had to shut down that plant, and [the manufacturer is] working with them. All of a sudden, [for] other generic manufacturers that were generally responsible for making about 20% of allocations for the country, the ask is much higher, and they can’t produce accordingly. We have seen numerous things that have led to shortages, sometimes pandemic related, sometimes pre-pandemic. We’ve been dealing with shortages for years now.

What I find interesting is if you look at [drugs like] Keytruda [pembrolizumab], Opdivo [nivolumab], or Darzalex [daratumumab], if you look at these branded therapeutics—these monoclonal antibodies where so much money is invested from these larger pharmaceutical companies—we will never find a shortage of these drugs. Why is it that these critical therapeutics that in many areas are tied to curative intent regimens [have shortages]? Why do we not invest in those plants, [and] organizations to alleviate the situation from ever happening?

Why don’t we partner with different manufacturers outside of the United States, similar to what we did with China to [help alleviate] the cisplatin shortage? Why do we wait until it gets so critical? For something of this magnitude, for there to be a true resolution, there needs to be something that comes down from legislation that is national and governs all. Sometimes because of the cheap cost of generic therapeutics, a lot of time and money, and effort aren’t invested in that because the ROI [return on investment], isn’t there, as you see with your big, branded products.

That’s where I do think that needs to happen from a national level for this situation to resolve now. As healthcare providers, the number of times we’ve seen this should have people think a little bit differently about shortages.