Rowan Carr, 4, was diagnosed with cancer after her parents took her into urgent care for a fever in 2010. A blood test showed her blood cell and platelet counts were low, and doctors informed her parents that Rowan suffered from acute lymphatic leukemia, or ALL, which typically affects children between the ages of 2 and 5 and can spread to the lining of the spine and brain.
“At the time, she had a high fever – no other symptoms,” said Rowan’s mother, Brenda Carr. “She was just tired. She didn’t have cold or flu symptoms, or anything to indicate a sinus infection. The doctor ran a barrage of tests, and finally, a blood test. They said all her counts are low, and you need to go to Children’s Hospital in Minneapolis today. They’re expecting you.”
Rowan, who is from Minnesota, was immediately started on a chemotherapy treatment, including the drug methotrexate. Injected directly into the spinal fluid, the drug has been proven in multiple studies to have the best results in preventing the spread or re-occurrence of ALL.
Nearly two years later, Rowan’s cancer is in remission, and she is in the ‘long-term maintenance’ phase of treatment, which focuses on preventing relapse with periodic injections of methotrexate.
However, recent reports have emerged that the chemotherapy drug is in danger of running out in hospitals across the country—potentially within two weeks.
Hospital supplies have dwindled after Ben Venue Laboratories, one of the nation’s largest suppliers of methotrexate, suspended operations at its Bedford, Ohio, plant in November.
The company cited “significant manufacturing and quality concerns” as the reason for the production suspension.
“Luckily, Rowan just had her spinal tap yesterday [during which she received methotrexate], so we had no problems getting it for her procedure,” Carr said. “But in three months, when she’s supposed to go back in for another injection, who knows what’s going to happen?”
“All I’ve been reading is there’s only a two-week supply, and manufacturers may not have any after that, so it’s a little nerve-wracking,” Carr added. “You’re told what drugs you have to take and when, and they have found this way has a 90-95 percent survival rate. Who knows what the outcome is when you have to substitute drugs or not do the procedure at the correct time interval – what if the survival rate drops to 80-85 percent?”
Dr. Bruce Bostrom, a pediatric oncologist at Children’s Hospitals and Clinics of Minnesota, said currently, the hospital is not experiencing a shortage of methotrexate, but their supply could run out within weeks if the drug becomes completely unavailable.
“We don’t hoard it,” Bostrom said. “I would suspect if we don’t get it within a few weeks we would probably run out.”
One of the issues with methotrexate, Bostrom explained, is that manufacturers cannot add preservatives because the preservative can cause neurological problems or paralysis when injected into the spinal fluid.
Therefore, once a vial of the drug is opened, it must be used within 6 to 8 hours to prevent contamination.
“The dosage depends on the size of the patient,” Bostrom said. “With a small patient, you may not use the whole vial. Anything you can’t use you have to throw away.”
Not the first chemo shortage
Now with the possibility of the methotrexate supply running out so soon, hospitals are attempting to reschedule patients to receive treatment on the same day – thus reducing waste. Carr said she had heard this practice was already occurring with other children through an online support group to which she belongs.
Bostrom also said hospitals may have to delay therapy or resort to other drugs.
“The best way to handle the situation would be to give methotrexate later in the course of therapy, but before the first year of treatment is up,” Bostrom said. “We usually give it starting the fourth or fifth month of treatment, but sometimes we can delay it and give it the fifth or sixth or seventh or eighth month of treatment. Hopefully by doing that, we can get it in within the first year.”
This isn’t the first shortage to hit the hospital – and other hospitals worldwide. Bostrom said within the past few months, the hospital has already experienced additional chemotherapy shortages, as well as shortages of anti-nausea medications and other supportive care medicines.
Carr said she has experienced issues tracking down certain medications for Rowan—an anti-nausea prescription, for example, took her more than a week for their pharmacy to track down, and other pharmacies she called had the medication in back-order as well.
“The group I’m a part of, there are moms in Canada and Australia, and they say if it affects us in the U.S., it affects them as well,” Carr added. “So we’re starting to hear of drug shortages in their area as well.”
Bostrom said the drug shortages are a problem that seems to be increasing over the years.
“Back in early 2001-2002, it was about 2 to 4 drugs a year reported in shortage,” according to Bostrom. “Now in 2010-2011, it was 22 to 23. I’m sure we’re going to break that record in 2012.”
In the mean time, to deal with the methotrexate shortage, Valerie Jensen, associate director of the Food and Drug Administration associate director of the Food and Drug Administration’s drug shortages program, told the New York Times there are four other manufacturers of methotrexate in the U.S., which are all trying to increase production.
The FDA is also searching for a foreign supplier to provide emergency imports while domestic companies work to meet current demands.
“I hate relying on hope…it’s disheartening,” Carr said. “To have this taken out of everybody’s hands – out the doctors’, parents’, and patients’ hands – we already have enough uncertainty. I want to make sure everything we can do for Rowan is done, and not having a clear path on whether or not this drug is available really makes me sad.”