It is no surprise that current drug shortages are negatively affecting the medical outcomes for patients. When most people think about the impacts of drug shortages they imagine older people and people with chronic conditions who rely more consistently on drugs and medications to maintain a functioning way of life. Now, a recent analysis of the impacts of the drug shortages highlights the negative outcomes among young children.
A study, hosted by St. Jude Children’s Research Hospital in Memphis, compared the effects of switching Hodgkin lymphoma treatment from mechlorethamine (Mustargen) to cyclophosphamide (Cytoxan). Over two years and follow-up, switching the Hodgkin lymphoma treatments caused a 13 percent decrease in the event-free survival over two years, going from 88 percent (with mechlorethamine only) to 75 percent (with switching treatments) (P=0.01).
In the study, 221 patients with Hodgkin lymphoma were enrolled. 40 patients’ treatments were affected by the drug shortage and their treatment switched from mechlorethamine (Mustargen) to cyclophosphamide (Cytoxan). The patient outcomes were then compared against 181 patients, whose treatments did not change.
No patients died during the study, but relapses were reported and these patients received more aggressive therapies that were later linked to higher risks of infertility and other health complications. Before the study, these two treatments options were considered interchangeable due to the fact there was not a randomized comparison between the two treatments.
The results of study emphasize the importance of comparing “substitute” regimens before fully adopting an interchangeable drug treatment design. In this case, the cancer drugs physicians were using interchangeably.
The mechlorethamine drug shortage started in 2009 when Lunbeck, the sole manufacturer of the injectable drug, changed its manufacturing site. This led to a delay in the drug’s production and today its supply has not returned to its normal levels.
The supply of the drug mechlorethamine is finally growing after almost three years. However, there are many other drugs there remain on the Food and Drug Administration’s (FDA) drug shortage list, including thirteen drugs for cancer treatment.
Unfortunately, other drug shortages are found among pediatric leukemia drugs. This includes cytarabine (Cytosar-U), daunorubicin (Cerubidine), and methotrexate (Trexall). These drug shortages have now been resolved by utilizing strategies of prioritizing access and use of equivalent agents.
In 2010, 23 cancer drugs and treatments reported shortages. Drug companies reported production reductions due to manufacturing problems and low profit margins for the drugs. In some cases, when a generic version of a drug is available, the initial founder of the drug will stop producing the drug because another company is able to sell the drug at a cheaper rate. This eliminates the incentive for the initial drug company to produce the drug; however, this creates a lag time between the initial company stopping production and the generic versions becoming widely available.
Hodgkin lymphoma is a type of cancer that attacks the lymph system. This type of cancer is common among children and it makes up about six percent of all childhood cancers. In the U.S., around 90 percent of patients with Hodgkin lymphoma are able to successfully combat cancer and grow up to be long-term survivors.
The study was published in the New England Journal of Medicine.
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