Briefing: New England Compounding Center
The story has changed almost daily since Framingham's New England Compounding Center became linked to a fungal meningitis outbreak late last month, which has now spread to 17 states. More than 20 people have died as a result of the rare infection. More than 300 people have become ill.
The infection was spread through contaminated steroid shots that 14,000 patients in 23 states received near their spines. On Oct. 3, NECC recalled all its products and ceased operations. Last week, the Massachusetts Board of Registration in Pharmacy permanently revoked the pharmacy's license as well as the licenses of its three principal pharmacists. Meanwhile, Ameridose of Westborough and Alanus Pharmaceutical of Framingham temporarily ceased operations Oct. 10 because they shared owners with NECC.
How did the contamination happen?
Investigators from the Massachusetts Department of Public Health (DPH) and the U.S. Food and Drug Administration found that lab workers at NECC didn't follow protocol for sterilizing products and equipment, and didn't test sterilization equipment. They said other possible causes for contamination were that mats used to trap contaminants from shoes before workers entered the clean room were "visibly soiled with assorted debris" and there was a leaking boiler adjacent to the room.
Did NECC have violations in its past?
NECC is accused of operating as a mass manufacturer, which it's not licensed to do. Compounders produce individual, patient-specific medications with prescriptions. According to the DPH, NECC has a history of complaints and investigations into its practices and the sterility of its labs, resulting in a 2006 agreement with the state to improve its practices.
What happens next?
The investigation into NECC and its sister companies is ongoing. Last week, Gov. Deval Patrick said the pharmacy board will start conducting unannounced inspections — at least annually — of compounding pharmacies that prepare injectable medications. The pharmacies will also be required to submit annual production, volume and medication distribution reports. n
(This report contains information from State House News Service.)
Read more
Briefing: CSX And Commuter Rail
Briefing: Argo's Marlborough Move
Drug Compounders Fill Role Major Firms Cannot
State Officials Sift For Answers At NECC Hearing
Westborough Optimistic Ameridose Will Reopen
WBJ Web Partners
Most Recent
Most Recent
0 Comments