TMC PULSE

May 2019

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30 t m c » p u l s e | m ay 2 0 1 9 "It's a chess game," Berg said. "If there is a shortage of something important, we spend a lot of time moving the pieces so that the patients don't get affected." Texas Children's has a team ready to make moves when necessary, but not all hospitals have those resources. "It's a lot of manpower and it takes a lot of work and a lot of people," Bernhardt said. "So there's a lot of interest in coming up with early detection—how, on an institutional level, you can prevent and mitigate the risk to patients." Those risks can manifest in delayed adminis- tration of lifesaving therapies and, in at least one published case, inferior outcomes. In a 2012 paper published in the New England Journal of Medicine, researchers found that an alternative treatment for pediatric patients with Hodgkin's lymphoma resulted in a decreased survival rate. Specifically, when mechlorethamine (Mustargen) supplies ran short, the clini- cians switched to the drug cyclophosphamide (Cytoxan) because the medications were sup- posed to be interchangeable. But Cytoxan was only associated with a 2-year event-free survival rate of 75 percent, as opposed to an 88 percent survival rate with Mustargen. "No one wants to say, 'We can't provide our patients with the very best care,' so people are leery of raising the issue," Berg said. "It's really like any other safety concern. Until you are able to be transparent about what the risks are, you can't make it any better." And this problem isn't limited to pediatric oncology. "We see it in critical care, pain management, OB-GYN," Berg said. "You could find other short- age stories around the medical center of other kinds of drugs where you would say, 'Are you kidding me?'" Supply and demand The list proposed by Berg and Bernhardt includes approximately 40 anticancer drugs and 35 sup- portive care medicines, Berg said. Not all are in short supply, but all are medicines the researchers believe to be essential to a hospital or clinic treat- ing pediatric cancer patients. Their hope is that the list can begin a conversation about shortages and incite policy or industry change that would ensure reliable access to these drugs and forecast shortages far in advance. "It wasn't our goal to make the ultimate list. It was to show what it would look like as a starting point," Berg explained. "The list by itself doesn't do anything except draw attention, but I think underpinning the idea of the list is the concept that health care, and therefore cancer care, is a right and should be available to everybody." So how could institutions or policymakers put that into practice? "Right now, there is no mechanism. There's no rule that says a company has to make a drug and there's really no rule that says the company has to tell you when you're going to run out," Berg said. Bernhardt said her hope is that manufacturers would work harder to track demands for certain drugs and respond with a more coordinated system for ensuring their output meets those demands. 7228-Pomona_GrandOpening_PrintAdS_8.75x5.8125_MECH.pdf 1 4/12/19 11:55 AM When I've spoken with drug companies, the gap is with them understanding what the demand is in order for them to make the right amount and for them to know that they're going to have purchasers of that product. — BROOKE BERNHARDT, PHARM.D. Assistant professor of pediatrics in the hematology and oncology department at Baylor College of Medicine

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