ASCO issues clinical guidance for alternative treatments during oncology drug shortages
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To address ongoing chemotherapy drug shortages, ASCO convened a multidisciplinary panel of oncologists, ethicists and patient advocates to expedite clinical guidance for navigating care where rationing or alternative therapies are needed.
“ASCO’s first position paper on drug shortages was in 2011 and 2012, when there were severe shortages of pediatric cancer drugs,” Julie R. Gralow, MD, FACP, FASCO, chief medical officer for ASCO, told Healio. “Since that time, we’ve had our ups and downs, but nothing like what happened in the past year with carboplatin and cisplatin. These are two very common drugs across different cancer types, and the shortage has lasted such a long period of time. This is the first time we’ve had anything of this magnitude.”
Cancer community ‘didn’t see this coming’
The shortage occurred after the unexpected shutdown of one major manufacturer of cisplatin. A subsequent shortage of carboplatin occurred in an effort to meet the demand caused by the cisplatin shortage, Gralow said.
“The cancer community didn’t see this coming, and we had no idea how long it would last — we started diving into it back in the late fall and early winter [of last year],” Gralow said. “They’d had to shut down the facility in India that made the active pharmaceutical ingredients. Nobody understood at that time just how much of the U.S. supply of cisplatin was dependent on that one plant. We realized that this wasn’t going to resolve itself any time soon.”
To address the ongoing scarcity, ASCO assembled an advisory group of 44 experts to develop general strategies for managing patient care amid cancer drug shortages. Additionally, the panel divided into subgroups to develop disease site-specific guidance.
“We quickly created some general ethical principles around what to do when you don’t have enough drug, and we also addressed how to use every last drop of the supply you have,” Gralow said. “We then pulled together a group of our guideline committee members as leads of the key guidelines for specific sites — lung cancer, head and neck cancer, breast cancer, and more — and they worked to develop this guidance, using evidence where it existed and expert opinion where it didn’t.”
General guidance
ASCO’s multidisciplinary panel developed the following prioritization strategies for antineoplastic medications during a shortage:
- Reconsider nonessential use of antineoplastic agents that are in limited supply; when appropriate, opt for an alternative agent with comparable safety and efficacy that is in adequate supply rather than ordering the limited agent.
- Increase the time period between cycles or decrease the overall dose when clinically acceptable. In cases where nationally recognized guidelines stipulate a range for cycle duration, choose the longer end of that range, and where guidelines specify a dosing range, choose the lowest therapeutically appropriate dose.
- Reduce or exclude the limited drug for recurrent, treatment-resistant cancers.
- Reduce waste by making the most of vial size, dose rounding and choosing multiuse vials.
- Develop working multidisciplinary usage committees at institutions to track drug shortages, convey internal policies on utilization and serve as an independent authority to promote the fair use of drugs in limited supply.
- If adequate supplies of an agent are unavailable, choose an evidence-based alternative regimen, and consider obtaining a second opinion from hematology/oncology colleagues to discuss disease site-specific options.
- Offer counseling referrals to patients impacted by anxiety related to drug shortages.
According to Gralow, ASCO published the guidelines quickly to aid in navigating treatment decisions during a shortage.
“Our job was to support our members and their patients during uncomfortable times and offer guidance in making some very hard decisions about how to use limited supplies,” she said. “We wanted to give some information about where we could safely substitute other agents, and where there was really no good alterative.”
Site-specific recommendations
Gralow discussed the ASCO recommendations by specific cancer site, noting that although some cancers can be treated with alternative regimens, others do not have equally safe and effective options.
“I’m a breast medical oncologist, and although we do use lots of platinum agents in breast cancer, there are regimens that have been shown to be equivalent in clinical trials, where platinum agents are not needed,” she said. “However, for testicular cancer, for example, we have regimens that result in incredibly high cure rates, and we don’t have a substitute. The consequences of not having the platinum agent could mean a real reduction in cure rate.”
Gralow also highlighted the issue of maldistribution during the shortage, noting that sites that used a “buy and bill” model to meet short-term supply needs were at a disadvantage compared with those that anticipated the shortage and purchased more of the drugs.
“Some groups were buying more, and other groups weren’t able to get it,” she said. “So, we’ve got to work on that maldistribution piece and increase awareness of that.”
Reference:
For more information:
Julie Gralow, MD, FACP, FASCO, can be reached at ASCO, 2317 Mill Road Suite 800, Alexandria, VA 22314; email: julie.gralow@asco.org.
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