In early 2023, the FDA’s announcement of a shortage of two critical generic platinum chemotherapy drugs, cisplatin and carboplatin, alarmed the medical community. These drugs have been essential in the treatment of various advanced cancers for over 30 years, particularly lung, head and neck, breast, bladder, ovarian, uterine, and testicular cancers. The shortage raised concerns about the potential impacts on patient mortality, especially for those with advanced cancers relying on these first-line therapies. Addressing these concerns, researchers from the University of Pennsylvania’s Perelman School of Medicine and Penn Medicine’s Abramson Cancer Center embarked on a study to assess the real-world impact of this shortage on patient outcomes.
The Scope of the Shortage
The shortage of cisplatin was first announced in February 2023, with carboplatin following in April. These platinum-based chemotherapies are central to the treatment regimens for numerous types of cancers, underscoring the critical nature of their supply. The shortage brought to light a broader issue of generic drug supply chain disruptions, which can significantly affect patient care. Researchers, led by Jacob B. Reibel, MD, sought to examine the tangible effects of this shortage by analyzing data from 11,797 adults with advanced solid cancers who began treatment either in the year before or during the shortage.
This cohort provided a comprehensive view of how the chemotherapy shortage influenced usage rates and patient outcomes. Initial fears centered on the idea that patients with advanced cancers might suffer the most, given that these drugs were being prioritized for individuals with more curable conditions.
Analyzing the Impact on Mortality Rates
Interestingly, despite the initial concerns, the study uncovered that there was no significant difference in mortality rates between the periods before and during the shortage. Prescription rates for cisplatin and carboplatin did fall by a modest 2.7%, equating to approximately 137 fewer patients receiving these treatments from February 2023 through January 2024. The most noticeable decline happened in June 2023, with a 15.1% decrease in prescriptions compared to the previous year.
The research included a median follow-up of 7.6 months post-treatment, revealing that the mortality rate remained unaffected. This outcome was surprising, given how crucial these drugs are in the treatment of advanced cancers. The ability to maintain mortality rates despite the drug shortages shows the resilience and adaptability within the oncology field.
The Role of Substitute Therapies
One key factor in maintaining patient care during this shortage was the implementation of substitute therapies. Medical societies recommended alternative treatments, including immune checkpoint inhibitors, targeted therapies, and other chemotherapy drugs. These substitutes likely cushioned the impact of the reduced availability of platinum-based chemotherapies, ensuring that patients continued to receive potentially life-saving treatments during this challenging period.
However, the study did not deeply address the potential financial burdens or different side effects posed by these alternatives. The use of costlier non-generic options and their associated side effects could have significant implications for patient care and quality of life. This aspect remains an important consideration for healthcare providers and policymakers moving forward.
Resilience and Adaptability in Oncology Care
The study underscores the resilience and adaptability inherent within the oncology sector when faced with significant supply chain disruptions. The strategic prioritization of drug usage and the availability of effective alternative treatments played a critical role in maintaining high standards of patient care. Oncologists prioritized cisplatin and carboplatin for patients with curable conditions, ensuring that those with advanced cancers still received effective therapies despite the shortage.
Dr. Ronac Mamtani, a senior author of the study, emphasized the importance of relying on “standard-of-care” medications like cisplatin and carboplatin due to their cost-effectiveness and proven efficacy over time. The goal is to minimize instances where patients cannot receive their preferred treatments due to supply chain issues. This sentiment reinforces the need for robust and strategic planning to continue providing optimal patient care even in the face of logistical challenges.
Moving Towards Recovery
There was a silver lining in the situation as the FDA marked the cisplatin shortage as resolved by the end of June 2024. Although carboplatin remains on the shortage list, prescription levels are reportedly normalizing, indicating a phase of recovery from the crisis. This recovery reflects the oncology field’s ability to adapt and maintain patient care standards even during challenging times, illustrating the sector’s resilience.
The study, funded by the National Institutes of Health (T32CA009679), also highlights the critical need for uninterrupted supply chains for generic drugs. These medications form the backbone of affordable and effective cancer treatment, and their consistent availability is essential for maintaining high standards of patient care. As healthcare continues to face supply chain disruptions, this study provides a detailed understanding of the chemotherapy shortage’s impact and underscores the importance of preparedness and strategic responses to these challenges.
Conclusion
In early 2023, the FDA announced a shortage of two key generic platinum chemotherapy drugs, cisplatin and carboplatin, causing significant alarm in the medical community. These medications have been crucial in treating a wide range of advanced cancers for over 30 years, including lung, head and neck, breast, bladder, ovarian, uterine, and testicular cancers. The shortage sparked serious concerns about its potential impact on patient mortality, particularly for those relying on these first-line therapies for their advanced cancers. In response to these fears, researchers from the University of Pennsylvania’s Perelman School of Medicine and Penn Medicine’s Abramson Cancer Center launched a study to evaluate the real-world effects of this shortage on patient outcomes. Their goal was to understand the broader implications and find ways to mitigate any negative consequences on cancer patients who depend on these crucial drugs for their treatment regimens.
