Limited supply of chemotherapy agent that treats several pediatric cancers may lead to rationing of doses.
A shortage of vincristine, a vital chemotherapy agent used to treat several pediatric cancers, has health care providers concerned about the potential implications for vulnerable patient populations.
According to The New York Times, which first reported on the shortage, physicians shared concerns that dwindling supplies of the essential drug may lead to the need to ration doses for their patients.1
Vincristine production was discontinued by Teva in early June 2019, leaving Pfizer as the sole supplier of the medication. Teva notified the FDA during this time that it had “made a business decision to discontinue the product.” In an emailed statement to FiercePharma, Teva commented that its decision to leave the market was not the cause of the shortage, citing data that demonstrated the company’s low market share.2
According to the FDA, deliveries of vincristine are expected to resume by late October, but the shortage could continue until at least December.3
Drug shortages are not an uncommon issue, but chemotherapy shortages are especially concerning due to the frequent lack of appropriate alternatives. With no substitutions for vincristine, this situation has shed light on how drug shortages can impact patients.
In this case, Yoran Unguru, MD, a pediatric oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai Baltimore, emphasized how damaging the repercussions could be, telling The New York Times that “you either have to skip a dose or give a lower dose—or beg, borrow, or plead.”1
Vincristine is approved for the treatment of several types of blood cancers, including acute lymphoblastic leukemia (ALL), one of the most common childhood cancers. And although ALL has a survival rate of approximately 90%, 8 of the 10 drugs most commonly used for this disease have been temporarily unavailable at some point in time over the past decade.4
Medications that experience supply challenges are typically injectable products that are off-patent and have few suppliers. With fewer manufacturers making older sterile injectable drugs, there are a limited number of production lines that can make these medications. This factor, combined with long lead times and the complexity of manufacturing, makes these medications particularly vulnerable to shortages, according to the FDA.5
“In cases like vincristine, where this is only 1 supplier for a drug, any production issues will likely result in a shortage,” Douglas J. Scheckelhoff, MS, FASHP, senior vice president of practice advancement at the American Society of Health System Pharmacists (ASHP), wrote in an email to Pharmacy Times®. “Vincristine is commonly used in pediatric patients. There are no alternative therapies. Shortages of chemotherapy drugs mean that patients experience delays in treatment, receive reduced doses, and experience potentially less than optimal outcomes.”
A study published in 2017, which included a survey of pediatric hematologists and oncologists, showed that approximately 65% of responders had patients who were affected by drug shortages. Many of these responders were informed about shortages from pharmacists or other physicians, with the pharmacist being the most commonly cited decision-maker for shortage drug distribution. One-third did not know whether there was a program or policy for handling drug shortages at their institution.6
Not only do shortages impact patients, but they cost hospitals as well. A survey conducted by Vizient found that on average, hospitals in the United States dedicate more than 8.6 million hours of additional labor hours annually to manage drug shortages and this financial impact adds up to just under $360 million.7
On how to minimize the negative impacts of the shortage, Scheckelhoff noted that providers need to know how many of their patients require vincristine and must check their inventory to estimate the period of time it will cover.
“ASHP does not advise hoarding or ordering products ‘just in case’,” he wrote. “Carefully monitor your inventory, so you have an accurate picture of your need for the product.”
Peter C. Adamson, MD, chair of the Children’s Oncology Group (COG) and professor of pediatrics and pharmacology at Perelman School of Medicine, University of Pennsylvania, wrote in a published letter that government intervention is needed to combat future drug shortages.8 In a call to action, Adamson pushed for advocacy and suggested additional steps, such as “potentially allowing importation of vincristine from other countries.”
Another commonly suggested solution would be to adopt an essential medicines list for chemotherapy and supportive care agents, and to ensure that these medicines remain in adequate supply at all times, Unguru wrote in a special communication published in JAMA Pediatrics.9
ASHP, along with other health care organizations, such as the American Hospital Association, the American Society of Anesthesiologists, and the American Society for Clinical Oncology, has also identified a set of policy changes designed to reduce the frequency and severity of drug shortages, according to Scheckelhoff.
Some of these ideas include establishing incentives to encourage manufacturers to produce drugs in shortage, or at risk of shortage, and requiring manufacturers to provide the FDA with more information on the causes of shortages and expected durations.
Providers can follow several recommendations to help prepare and plan for a shortage crisis. In addition, pharmacists can stay updated on drug shortages by regularly visiting ASHP (ashp.org/Drug-Shortages) and FDA (fda.gov/drugs/drug-safety-and-availability/drug-shortages) websites.