Although the clinical fallout from the largest outbreak of illness ever tied to a pharmacy compounder is alarming, in many ways it is the most straightforward part of the crisis to document. By mid-October, nearly 350 patients treated with an injectable steroid prepared by the New England Compounding Center (NECC) had been infected, with 24 fatalities reported in the 18 states affected, according to health officials.
But those numbers haven’t helped clear up several far more challenging questions. How, for example, could the Framingham, Mass., facility have been allowed to continue to produce massive amounts of compounded drugs and ship them across state lines, seemingly in violation of state pharmacy laws prohibiting such large-scale manufacturing? And why was NECC allowed to continue to operate despite a history of safety violations—some involving the same steroid that has been implicated in the current outbreak?
State boards of pharmacy, the FDA and compounding pharmacy trade associations have been cast variously as villains in allowing this regulatory morass to persist. With no concrete fixes likely to emerge anytime soon—aside from NECC ceasing operations and Ameridose, a company with shared ownership, still shuttered at press time due to an ongoing investigation of its manufacturing facilities—a more immediate, practical question now looms for pain clinics and health systems that still need to buy compounded medications:
Whom can you trust?
“That’s certainly one of the key questions we have been asking” during ongoing conference calls between pharmacy directors in Massachusetts and state health officials, according to the director of a multihospital health-system in the northeast who asked to remain anonymous due to the sensitive nature of the discussions. The consensus, the director said, was this: If you can purchase compounded drugs from an FDA-approved and inspected facility, “that’s who you should go with; it’s really the safest bet.”
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