In October 2012, the Centers for Disease Control and Prevention reported contamination at a pharmaceutical compounding facility in Framingham was to blame for a meningitis outbreak that killed or sickened dozens of patients nationwide.
The New England Compounding Center had been previously warned by the U.S. Food & Drug Administration about operational issues that could result in drug contamination. Authorities continue to worry about drug contamination at the 7,500 American pharmacies that specialize in customized concoctions of medications. While the drugs used are FDA approved, the end result is not subjected to the same government scrutiny.
The NECC recalled nearly 18,000 vials of the steroid methylprednisolone acetate, which were distributed to more than 75 clinics in 23 states. Health facilities that received the drug were ordered to start notifying patients. In the first week of the outbreak, more than 25 deaths and a number of strokes were reported and hundreds of patients were infected.
Meningitis, which infects the membrane around the spine and brain, is a medical emergency that requires immediate hospitalization and medical care – brain damage and death may result even with the proper medical care.
Back injections may be a particularly effective way of spreading infection and health officials voiced concerns about the possibility of a widespread outbreak.
Symptoms of meningitis include:
- Chills or fever
- Headaches and stiff neck
- Changes in mental status, agitation, decreased consciousness
- Poor eating
- Rapid breathing, fast heart beat
Fungal meningitis is rare and aspergillus meningitis, which we are dealing with here, is extremely rare and must be taken very seriously. It is diagnosed through a lumbar puncture, which draws cerebrospinal fluid for testing, and is treated with high doses of intravenous medications.
The Massachusetts Health Department reports the company entered into an agreement with government agencies in 2006 after health and safety issues with the company’s processing of medications in 2002 and 2003.
Media reports indicated another area pharmacy, Ameridose, shared the same owners and had also agreed to suspend operations for 12 days while the government investigated. In 2011, Ameridose moved out of its Framingham facility near NECC’s operations, and into a modern 70,000 square foot facility near Westborough. One of the owners is a pharmacist whose license has reportedly been restricted.
Formed in 2006, Ameridose has become one of the nation’s leading providers of prefilled syringes and epidural pain medications. In 2008, the FDA found significant problems with the company’s medical records, procedures and drug testing, according to the Boston Globe. The company previously recalled fentanyl, the injectable painkiller, amid concerns it was too potent.
Despite shared ownership, Ameridose has distanced itself from New England Compounding since the outbreak. Massachusetts Governor Deval Patrick said NECC may have deceived state officials and done work not authorized by its state license.
Clinics with New England Compounding products should cease using them immediately and should contact the FDA or the CDC for more information.