Q&A: Current gynecologic oncology drug shortage a ‘public health crisis’

Key takeaways:

• Several gynecologic oncology drugs are in short supply in 2023, requiring strategies to allocate limited drugs to patients.
• Treat every patient either with curative intent or anticipated potential benefit.

So far in 2023, there has been an overwhelming shortage of chemotherapy drugs, of which several specifically impact gynecologic oncology providers and patients.

The FDA first reported platinum-based drug shortages on Feb. 10. Since then, 15 chemotherapy drugs have been in short supply including some important therapies for breast, ovarian, cervical and uterine cancers, among others.

Of drugs in short supply are cisplatin and carboplatin, two essential chemotherapy drugs used to treat gynecologic cancers. Other important gynecologic oncology drugs experiencing shortages are fluorouracil to treat breast cancer, methotrexate to treat gestational trophoblastic tumors — a rare type of uterine cancer, and breast cancers, and docetaxel to treat breast cancer.

According to an interview with Julie R. Gralow, MD, FACP, FASCO, chief medical officer and executive vice president of the American Society of Clinical Oncology, published in The Cancer Letter, this drug shortage was caused by the shutdown of a plant that produced raw materials for all FDA-approved U.S. manufacturers of cisplatin and carboplatin. In addition, Intas Pharmaceuticals in India, which was a source for five chemotherapy drug manufacturers, has temporarily suspended manufacturing essential cancer drugs after severe quality-control issues observed by the FDA.

On June 6, the Society of Gynecologic Oncology held a briefing in collaboration with the U.S. House Cancer Caucus to discuss the scope of the chemotherapy drug shortages, its impact on patients and patient perspectives and possible policy solutions.

Healio spoke with Angeles Alvarez Secord, MD, MHSc, president of the Society of Gynecologic Oncology, professor of obstetrics and gynecology at Duke University School of Medicine and moderator of the House Cancer Caucus briefing, about the impact of the current chemotherapy drug shortage on gynecologic oncology treatment, how providers are handling these shortages and ways to mitigate effects of the shortage.

Healio: In your experience in gynecologic oncology, have you seen drug shortages like this before?

Secord: No, I have not. Most of what I learned early on has now been released in the public domain. The drug shortage really had to do with a supply chain-related issue, but it’s more complex than that in terms of the number of generic manufacturers you have for the drugs that we’re talking about. When their supply chain was disrupted, it was essentially a house of cards, if you will, where the other manufacturers didn’t have the capacity to meet that demand. It’s a complicated situation.

Healio: How have the drug shortages affected your practice?

Secord: This is a public health crisis. Platinum drugs essentially serve as the backbone for the treatment of patients with newly diagnosed gynecologic cancers. So, for ovarian cancer, endometrial cancer, cervical cancer, vaginal cancer and vulvar cancer, these are our front-line drugs. That’s why this shortage is so challenging. We really have, in some cases, reduced our ability to give the standard of care in the front-line setting. The other reason it’s so challenging is the extent of the drug shortage, with currently at least 15 chemotherapy drugs used for treating a wide variety of cancers on shortage. It’s basically all the gynecologic cancers. There are about 115,000 patients with newly diagnosed gynecologic cancers each year, and then when you consider that these drugs are also used to treat patients who have recurrent disease, you’re talking about hundreds of thousands [of affected patients].

Healio: You said there were 15 overall chemotherapy drugs that are affected by the shortage. How many are specifically affecting gynecologic oncology?

Secord: There are probably at least five that I know of, and there’s possibly even more. In addition to cisplatin and carboplatin, there’s methotrexate, which is used to treat gestational trophoblastic neoplasia as well as ectopic pregnancies. Ectopic pregnancies aren’t cancer related, but that’s a very common gynecologic condition where there’s an abnormal pregnancy in the tube. The condition can be deadly if not treated appropriately. Other drugs on shortage are docetaxel and fluorouracil.

Healio: The Society of Gynecologic Oncology has outlined strategies for allocating limited drug supplies for gynecologic oncology. Could you summarize these strategies?

Secord: The Society of Gynecologic Oncology has developed a longitudinal survey, so we’ve been able to see how this problem has grown over time. That has been really useful. We now know that providers in at least 40 states have reported that they’ve had a shortage of chemotherapy drugs. A lot of hospitals will use what’s called “low-waste protocols.” Instead of wasting drug in a vial, you round down the dose or you can identify which patients are coming for chemotherapy that day and then maximize the supply that you’re getting from each vial. That way you’re not wasting any drug. Those are just two of the strategies a pharmacist can use.

Another strategy that providers can use is reducing the dose size slightly. We don’t think that impacts how effective the drug is, and you can also go from a cycle that’s every 3 weeks to every 4 weeks. So, there are a lot of different strategies that we can use to try to preserve drug and maximize ability to give all the patients who need treatment these options. We developed these guidelines in collaboration with the Gynecologic Oncology Group Foundation and the Foundation for Women’s Cancer, and these guidelines have now been endorsed by the American Society of Clinical Oncology. We really value these partnerships and working together to help our patients during these challenging times.

Healio: Should providers expect additional shortages of other gynecologic oncology drugs in the coming months?

Secord: This is a problem that is not going to go away anytime soon. We need to look at short-term strategies and long-term strategies. Unfortunately, I can’t answer your question directly because there’s not a lot of transparency regarding the drug shortages. What I can say is that it appears that we’re going to be able to get some importation of cisplatin and carboplatin. In fact, I’ve already heard that may have been successful this past week, but I’m waiting for confirmation regarding that shipment. I do believe that everything’s being done on the manufacturing side, for the manufacturer that did have to decrease production to really ramp things back up again, as well as other manufacturers stepping up and supplying more of these drugs.

Healio: What might gynecologic oncologists not already know about this drug shortage?
I would just urge them to treat their patients. I’ve heard of stories where pharmacies or hospitals are trying to increase their storage of drug to a 30- or 45-day supply before they start to treat patients. We’re recommending that you treat patients, and don’t try to create storages of drug on hand. Use just-in-time drug amounts recognizing that drug shipments will continue albeit in smaller amounts. Treat those with curative intent, as well as patients who you think have anticipated potential for benefit. For example, if your patient has a platinum-sensitive recurrence, and you think there’s a potential for benefit, then please treat those patients. My biggest message is don’t try to get a large storage or hoard of drugs, please treat your patients. And if they need help getting drugs, the Angels for Change foundation can try to help get patients and providers access to drug at communiations@angelesforchange.org. Laura Bray and her team at Angels for Change have really been amazing.

Healio: Is there anything that the overall clinical community can do?

Secord: Absolutely. The Society of Gynecologic Oncology, in collaboration with the Gynecologic Oncology Group Foundation, put out a call to legislators, so please reach out to your senators and representatives. Some of these long-term solutions are only really going to be fixed by changes made at that congressional level. We need to get the stories out there of patients not having access to treatment and for providers, how that may change their practice. We don’t know the long-term effects that the shortage is going to have on our patients in terms of survival outcomes. Thus, we need to address the short-term issues, and to look at the long-term solutions. We don’t want these shortages to continue to happen. We believe that every patient deserves to have access to chemotherapy. No patient should be left behind. No patient should be told that the right chemotherapy to treat their cancer is not available.

Editor ’ s Note: On June 2, the FDA announced temporary authorization to Qilu Pharmaceutical to import and distribute the cisplatin injection in the U.S.

For more information:

Angeles Alvarez Secord, MD, MHSc, can be reached at angeles.secord@duke.edu.

References:

• ASCO’s Julie Gralow: At least 100,00 (and up to 500,000) cancer patients affected by cisplatin, carboplatin shortage. cancerletter.com/the-cancer-letter/20230526_2/. Published May 26, 2023. Accessed June 1, 2023.
• DHCP Letter: Temporary importation of CISplatin injection with non-U.S. labeling to address drug shortage. www.fda.gov/media/169001/download. Published May 24, 2023. Accessed June 7, 2023.
• FDA Drug Shortages. www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Accessed May 31, 2023.
• House Cancer Caucus Briefing on Chemotherapy Shortages. Obgyn.duke.edu/news/house-cancer-caucus-briefing-chemotherapy-shortages. Published June 6, 2023. Accessed June 25, 2023.
• SGO Statement: Carboplatin and Cisplatin Shortages. www.sgo.org/news/drugshortage/#:~:text=Currently%2C%20a%20U.S.%20shortage%20of,)%20on%20February%2010%2C%202023. Published April 21, 2023. Accessed May 31, 2023.