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.)