Massachusetts Board of Pharmacy director James Coffey was recently fired after a failing to provide enough pharmacy oversight before the deadly fungal meningitis outbreak that has sickened hundreds and killed around 30.
Officials say that Coffey failed to disclose a complaint against the New England Compounding Center (NECC) from Colorado. The complaint was filed this past July by the Colorado Board of Pharmacy, which also contacted the FDA, according to a statement from the Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith.
"The information shared by Colorado showed that NECC had distributed manufactured drugs to many hospitals in that state between 2010 and 2012 without patient -specific prescriptions, in violation of NECC's Colorado and Massachusetts licenses," Smith said.
Colorado officials complained that the specialty compounding pharmacy was acting more like a manufacturer than a compounding pharmacy. According to the American Pharmacist Association, the difference between a pharmaceutical manufacturer and a compounder is the existence of the "triad relationship" between a pharmacist, prescriber and a patient.
A compounder's production is supposed to be controlled by the existence of this special triad relationship and a compounder should only produce drugs that are responsive to a patient's specific needs. Conversely, a drug manufacturer mass produces drugs for sale and resale without specific knowledge of a patient's needs.
The relationship difference is important because many of a compounder's products are not sterile or meant to be stored for long periods of time. This means that the products are highly likely to become unsafe to use when they are not ordered to treat a specific, immediate patient need.
Studies into the NECC outbreak found that the contaminated drugs were made more harmful because they were improperly kept for far longer than their safe shelf life, allowing fungus and bacteria to flourish.
"I find the actions of NECC reprehensible," said interim DPH Interim Commissioner Smith. "We have the right to expect that all companies producing medication for use in delivering health care to comply with laws designed to protect patient safety. But I also expect the staff charged with oversight to perform their duties to the highest standards. That failed to happen here."
Source: Reuters, "James Coffey, Massachusetts Board Of Pharmacy Director, Fired After Meningitis Outbreak," Nov. 7, 2012