October 29th, 2012
The New Hampshire DHHS (DHHS) Division of Public Health Services (NH DPHS), the Centers for Disease Control and Prevention (CDC), and the federal Food and Drug Administration (FDA) are conducting investigations of New England Compounding Center (NECC) located in Framingham, Massachusetts. The investigations concern tainted medications produced by NECC that have been linked to a fungal meningitis outbreak nationwide. Fungal meningitis is not contagious.
Q. What does the NECC produce?
A. A compounding company takes base medications and combines them into specific drugs, which are then purchased by hospitals and physician practices.
Q. What occurred with the recall?
A. Initially high-risk products such as injectible steroids compounded after May 21, 2012 were recalled. Then, all medications compounded by NECC after May 21, 2012 were recalled.
Q. Did New London Hospital (NLH) purchase any products from NECC?
A. Yes. Over the last year NLH purchased two specific medications from NECC: LET (topical lidocaine), used to numb an area for repair of a laceration was purchased in 2012. This was used in the Emergency Department at NLH. The second medication was sterile glycerol, last ordered in 2011, an injectible used in certain surgical procedures. Neither of the products was implicated in the recall.
Q. Were either of these two medications used on NLH patients?
A. The injectible sterile glycerol was used for one patient in 2011, outside of the recall period. It is a patient specific medication, ordered only when the surgeon has a specific procedure and patient for whom he is considering using the medication.
Q. Why is NLH listed on the FDA list of hospitals that purchased medications from NECC, but was not on the original list issued by the NH Department of Health & Human Services?
A. The DHHS list covered only injectible medications compounded at NECC since May 21, 2012. Since NLH had not purchased the injectible sterile glycerol since 2011, DHHS did not include NLH.
The FDA list of hospitals, revised just this week, is based on the shipping manifests from NECC of all compounds shipped to hospitals in the past ten months, which would include the LET NLH received in June 2012.
Q. What is FDA doing to ensure this kind of incident will not happen again?
A. The FDA is looking at regulating compounding companies more stringently. Since compounding companies do not manufacture drugs, they have not been subject to the same regulations and inspections that are in place for drug manufacturers. NLH is participating in conference calls with the FDA and CDC and met with the NH FDA inspector this week to discuss how we have handled the medications we purchased from NECC.
NLH has a due diligence process in place for all contracts with compounding companies and will continue to enforce the procedures.
Q. Is there reason to be concerned about independent physicians (non-employed tenants) using tainted medications?
A. DHHS and the FDA have alerted hospitals and independent providers about the tainted medications. If you have any concerns, call your provider to get more information.