AKRON, Ohio - At Akron Children’s Hospital, there is concern a drug shortage will prevent doctors from treating children suffering from cancer.
Shari Meglich's 2-year-old daughter, Payton, has acute myeloid leukemia. The Akron toddler has been through five rounds of chemotheraphy. She has one more treatment scheduled for late April.
The chemo drug, Cytarabine, is critical to her treatment, but it's in desperate, short supply.
"When you have a child that has cancer, you never think of a shortage. You always think that they have enough of the medicine," Meglich said.
Dr. Jeffrey Hord, Director of Hematology-Oncology at Akron Children’s Hospital, is particularly worried about the limited supply of Cytarabine, used to fight the two most common pediatric cancers - acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL). This drug is especially important for treating AML, as the children who have this cancer need high doses of chemo. There is no equivalent to cytarabine.
Laurie Schueler, spokesperson for Akron Children’s, said there are two AML patients who will need Cytarabine in a couple weeks to continue their chemotherapy and the hospital is running very low on that drug. In addition, if new patients present with AML, Schueler said Akron Children’s does not have the ability to treat them now.
"Children's cancer is highly treatable and we treat all children with the intent to cure them, but we can't do that if we don't have the drugs that have shown to be effective," said Dr. Steven Kuerbitz, from the division of Pediatric Hematology-Oncology at Akron Children's Hospital.
The FDA released the following statement to NewsChannel5 related to Cytarabine:
"There are 3 US manufacturers of cytarabine: Bedford, APP, and Hospira. The shortage began in fall of 2010 due to manufacturing delays and FDA worked with the firms to increase production. However, the shortage worsened in February due to the firms experiencing new manufacturing issues, including a recall by one firm (APP) due to crystallization in the vials. FDA has been working closely with all 3 manufacturers on addressing their manufacturing issues and Hospira has released cytarabine 2 gram vials this week. The manufacturers are planned to have additional supplies released in the coming weeks. We also have worked with the firms on their ongoing production plans and all 3 have releases planned and so if all goes as planned this will be continuing to improve with resolution anticipated soon. When the shortage began worsening in January we looked for an overseas manufacturer willing and able to temporarily import cytarabine to help meet patient needs as we did with propofol in 2010 and are currently doing with foscarnet and ethiodol. When FDA uses regulatory discretion to temporarily import a drug due to medical need and drug shortage, it's important to note that the overseas product is evaluated so that there is no safety, efficacy or quality risk for US patients. Unfortunately for cytarabine it took longer than usual to find a firm willing to import. We do finally have a firm willing and able to do the importation, and we are proceeding with this since we believe it's important to have a back up in case the plans of the 3 US manufacturers change in any way.
Again, we are doing everything possible to assist the 3 US manufacturers with release and new production and we will continue to do so. Once additional information about the upcoming releases as well as availability of imported cytarabine is made public we will be posting this on the FDA website: http://1.usa.gov/fJl1wS "
Last year, more than 240 drugs were either in short supply or completely unavailable anywhere in the U.S., and shortages continue for many of the products, according to a report issued at the end of March by the Premier Health Care Improvement Alliance based in Charlotte.
Premier’s survey of 311 pharmacy officials, representing 228 hospitals along with outpatient treatment centers, retail pharmacies and long term care facilities, found that nearly 90 percent had experienced at least one drug shortage in the last half of 2010 that may have caused a safety issue that affected patient care. More than half said they experienced six or more such shortages.
Click here to see a list of current drug shortages.
More than three-quarters of the drugs that have been in short supply are generic products delivered by injection or intravenous lines, and tend to be used in sedation and pain relief, chemotherapy and emergency care.
The American Society of Health System Pharmacists said there are 150 “medically necessary” drugs in short supply, double the number typically reported five years ago.
“It is as bad as it’s ever been, definitely a crisis,’’ said Bona Benjamin, who directs the society’s medication supply monitoring efforts.
Experts said there are a number of reasons for the shortfalls: a decline in the number of manufacturers from four or five for each product down
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