The outbreak of fungal meningitis has claimed the lives of 20
individuals and caused 250 Americans to become ill. This epidemic is associated
with products originating from the New England Compounding Center (NECC). The
NECC is a Massachusetts based company that produces compound pharmaceutical
products. Unlike many drugs, compounding medications are exempt from FDA
regulation. The United States Supreme Court ruled in 2002 that these
medications are not new drugs and therefore do not need additional regulations.
While many compound medications are not harmful, veterans
should be cautious. Various VA Medical Centers provide compound medications to
patients, and recently VA has revealed that they purchased $20,000 in products
from NECC and $900,000 from Ameridose, a related company, over the past three
years. Veterans enrolled in services at VA medical centers and who have
recently received meningitis vaccinations have an increased risk of exposure to
the contaminated products. The U.S. Army Medical Command and Ameridose signed a
contract in June 2012 to provide pharmaceutical products for a pediatric
intensive care unit in Tripler Medical Center in Honolulu. The contract would
provide the Hawaii facility with drugs on an as-needed basis. Currently, Ameridose
has halted production of medication and NECC has recalled all of its products.
In response to the outbreak, the House Energy and Commerce
Committee is conducting inquiries at NECC and has requested records and
documents from the pharmacy. Members of Congress are petitioning for increased
regulation of compound medications, including requiring doctors to inform
patients of the differences between compound and FDA-approved products.
“To better ensure the safe production of these medications,
we also urge you to require that these compound products be clearly labeled as
such,” wrote Rosa L. DeLauro, D-Conn., and Sanford Bishop, Jr., D-Ga., in a
letter to the Department of Health and Human Services Secretary Kathleen
Sebelius and Department of Veterans Affairs Eric Shinseki. “Patients expect
their medications and products used in the health care setting to be safe,
effective, and overseen by the Food and Drug Administration.”
If you have received a meningitis vaccination recently,
please check with your provider to ensure that NECC products were not used
during your visit. For more information, please contact your primary care team
at your local VA facility.
(Photo: Senior Airman Anthony Velez, 332nd Medical Support Squadron pharmacy technician, pieces together a trauma kit. Photo by Senior Airman Julianne Showalter, courtesy of U.S. Air Force.)
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