Calls for Government Oversight of Compounding Pharmacies After Meningitis Outbreak
The compounding company responsible for the meningitis outbreak that has affected up to 14,000 people, including 15 deaths, is not alone. In fact, according to new media reports, other compounding companies have had their own brush with contaminated drugs.
The New England Compounding Center, which is the company at the heart of the fungal meningitis infection which has infected 198 people as of Monday, had shipped vials of infected steroid injections to 23 states. The NECC is under greater scrutiny as reports have discovered the company acted like a drug manufacturer.
As a compounding center, the NECC was only allowed to remove elements of medicine for allergies or dilute drugs based on a filed prescription. Recently, there have been reports that NECC has sold drugs to doctors, a clear violation of state regulations. Because of the outbreak, there have been calls for more oversight and there is evidence that compounding centers have had outbreak scares in the past.
A report published by Minnesota Public Radio highlights the potential dangers of contaminated drugs. According to officials at the Fairview Compounding Pharmacy, the company has dealt with contaminated drugs in the past but luckily safety measures caught the infected batches before they were shipped to the public. The Fairview Compounding Pharmacy ships 20,000 doses of medicine to six hospitals in Minneapolis and around 40 different clinics.
While Fairview avoided an outbreak, other Minnesota-based compounding centers have not been so lucky. In 2005, Richfield-based Custom-RX compounding pharmacy had to recall products after they were linked to eye infections.
There have been other incidents of infected medicines reaching the public, although not on the scale as the current meningitis outbreak. A Florida compounding pharmacy sent out contaminated medicines that led to dozens of eye infections. In 2011 an Alabama-based compounding pharmacy sent infected batches of intravenous nutrition which led to nine deaths.
With compounding pharmacies being in a tricky situation, being more than a pharmacy but not a manufacturer, it is easy for the companies to, perhaps, violate state regulations. According to Allen Vaida, executive vice president of the Institute for Safe Medication Practices, state regulators are overworked and regulation boards are understaffed.
"The state boards of pharmacy really don't have the manpower, the funding and the expertise to inspect some of the operations that these compounding pharmacies are performing," Vaida said to MPR. He hopes that the Food and Drug Administration will step in and have more oversight of compounding pharmacies to limit the risk of contaminated medicines and possible national outbreaks.