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Lessons From the Chemotherapy Shortages: Invest in Generics

— We need more sustainable solutions to ensure treatment access

MedpageToday
A photo of a glass jar of chemotherapy medication connected to intravenous tubing.
Teplinsky is a breast and gynecologic medical oncologist.

In July, Eleonora Teplinsky, MD, wrote about our unprecedented chemotherapy shortages, which prevented many oncologists from being able to provide patients with potentially lifesaving medications. As part of our review of the past year's biggest events, Teplinsky shares an update on the state of the shortages and what's needed to address the ongoing issue.

In 2023, chemotherapy drug shortages have drastically affected how oncologists and medical teams have been able to provide care to patients throughout the country. The initial shortages were primarily with the platinum agents -- carboplatin and cisplatin -- but have now expanded to several other anti-neoplastic agents.

A of National Comprehensive Cancer Network (NCCN) cancer centers was published in June 2023, followed by an conducted in September. The findings from the initial survey showed that 93% of those centers surveyed were experiencing a carboplatin shortage and 70% of the centers were experiencing a cisplatin shortage. As the platinum shortages lessened, the follow-up survey showed that while the number of centers with platinum shortages had decreased, 60-70% of centers still did not have indication from manufacturers or suppliers as to when carboplatin or cisplatin would be readily available. During this time, a significant concern raised was whether insurance companies would cover substitutions. Fortunately, 100% of surveyed cancer centers in the September survey stated there had been no treatment delays resulting from the prior authorizations required due to treatment plan modifications, and that none of the modified treatment plans had been denied by payers. Perhaps what was most striking was the list of other drugs in short supply, including but not limited to methotrexate, 5-fluorouracil, fludarabine, vinblastine, liposomal doxorubicin, and capecitabine -- drugs used to treat a wide variety of cancers.

Multiple have required oncologists, including myself, to ration medications, to rapidly identify possible alternative substitutions, and to have difficult conversations with patients about changes and potential delays in their treatment plans.

Patients have been faced with uncertainties about how these adjustments will impact their cancer care and long-term prognosis. We still do not have the answers to those questions. Beyond concerns about our patients' physical health, this has led to tremendous mental health impacts -- a topic not often discussed. The uncertainty of it all and the inability to provide lifesaving treatment in certain situations has been incredibly frustrating and challenging.

The ongoing chemotherapy drug shortages have been driven by several factors. The initial platinum drug shortage originated when a pharmaceutical company for quality issues and other pharmaceutical companies were unable to respond to the increased demand posed by the shutdown. Short-term fixes ultimately did increase the platinum supply, but we need more sustainable long-term solutions to prevent recurring shortages. One major issue is that over the years, many pharmaceutical companies shifted production or decreased or stopped generic drug production due to loss of profit. Furthermore, some are investing into quality control and improvement for generics abroad. This is a significant concern as generic drugs make up of all medications used in the U.S.

So, where do we go from here? Moving into 2024, incentives to improve generic drug production, early identification of potential future shortages, and contingency plans to address active shortages are critical.

The American Society of Health-System Pharmacists conducted a from June to July where 87% of respondents involved with purchasing decisions considered manufacturer and product quality to be very important. Of those respondents, 85% would be willing to spend 5% or more above their generic drug budget to buy from manufacturers achieving quality recognition. This is a critical point as we begin to address the loss of profit from generic drugs.

As we reach the end of 2023, we are grateful for the improvement that we have seen, but many antineoplastics are still in short supply and this is an issue that we must continue to address on a broad scale. Access is variable throughout the U.S. and supply in rural areas remains an especially significant concern.

There have been many calls to overhaul the generic drug market, and long-term solutions will require that multiple stakeholders come together to begin to address the supply chain issues, which should not topple to the ground on the basis of one pharmaceutical company.

While I am fortunate that I am currently able to treat my patients with breast and gynecologic cancers with the platinum drugs that they desperately need, many of my colleagues treating other types of tumors are sitting across from patients telling them they cannot provide evidence-based care due to the lack of necessary drugs.

It is our collective hope that as we move forward into the new year, we will do so with the knowledge that we are working on improvements in drug access so that our patients can get the lifesaving treatments they deserve.

is head of Breast and Gynecologic Medical Oncology for Valley-Mount Sinai Comprehensive Cancer Care in Paramus, New Jersey. She is a member of the American Society of Clinical Oncology Advisory Group for the drug shortages.