Monday, December 24, 2012
States admit they need FDA help regulating pharmacies
State pharmacy boards admitted last week that they need help in regulating compounding and pharmacy labs and they hope that aid will prevent the next deadly outbreak linked to a contaminated drug.
In late-August of 2012, a noticeable amount of people began developing fungal meningitis. Some of those cases proved to be fatal and eventually, the source of the outbreak of the disease was identified as a contaminated epidural steroid painkiller injection drug. The drug, methylprednisone acetate, was mixed at New England Compounding Center.
NECC is a company regulated by Massachusetts’ Board of Pharmacy and is one of several similar companies in that state and like hundreds more nationwide. These companies most often take already-approved pharmaceuticals and mix them for new treSouratments as ordered by doctors or hospitals.
A lack of funding – and some political cronyism – caused NECC and many others in Massachusetts, alone, to operate for months and possibly years without adhering to state regulations, especially those concerning product safety and facility sterility.
A fungus contaminated these injection drugs leaving NECC and were shipped to more than 70 pain management and health care facilities in 23 states. As many as 14,000 vials of the drug were shipped and only a few thousand were recovered when they were eventually recalled. Hundreds fell seriously ill and 39 people have died after contracting fungal meningitis after receiving the drug.
Last week, representatives from each state’s pharmacy regulation boards met with officials at the Food and Drug Administration to discuss the agency providing some help in keeping companies like NECC above the board and operating without putting the public’s health at risk.
Conditions inside NECC showed how and why its epidural drugs were contaminated. Standing water and mold growth in labs where drug were compounded or mixed were discovered during inspections. The company also keep poor records, making the tracking of the contaminated drugs that much more difficult.
Source found here