ACA Pharmacy seems to have been. . . largely. . . out of control, in Music City. Mailing meds to wrong addresses; some of which were not the genuine med, at all. Here's the story -- a very worthwhile and sobering read, from The Wa Po, origninally (but via our commenter, I've provided an non-paywalled version):
. . .The orders for custom weight-loss drugs flooded into ACA Pharmacy in Nashville, where white bins holding prescriptions were stacked as tall as the staffers filling them.
Over several months in 2023, ACA produced tens of thousands of its own variety of prescription weight-loss medications. A FedEx truck arrived regularly to ship the chilled boxes across the nation. Wall-mounted TV monitors inside the specialized pharmacy displayed its rising monthly revenue. Then, in late July, it all came crashing down. . . .
Ned Ashley, chief executive of ACA's parent company, Rx Partners, said in a statement that closing ACA was a "nuanced and multifaceted" decision, adding that the death of its chief operating officer "played a large part." The death was a suicide, according to public records.
Ashley said questions submitted by The Post about ACA's finances, operations and regulatory problems contained "various inaccuracies" but declined to elaborate. ACA has no record of receiving any reports of serious patient harm linked to its compounded weight-loss medications, he said, adding that he has no knowledge of employees using the pharmacy's drugs without a prescription. . . .
"It's apparent they were having issues maintaining sterility," said Dan Troy, a former FDA chief counsel who's now a managing director at Berkeley Research Group who reviewed the disciplinary order. . . .
नमस्ते
another thing~~~where is the accountability on the Drs ordering/using this service?
ReplyDeleteTo be certain, I hear you.
ReplyDeleteI have no evidence one way or the other for this notion, but it is possible that individual doctors ordering compounded product from ACA Pharmacy didn't know, or even have reason to know, until late in the game. . . that the place was sending non-sterile meds, and entirely ersatzs ones.
I'd suspect that they trusted the parent, Rx Partners, as a national brand -- but locally in Nashville, the ACA subsidiary operation went way, way off the rails.
But you are right, the doctor is the one who decided to contract with the compounder, and have the scrips filled by these jokers.
In some ways, there is a regulatory "empty space" here, because the compounders are exempt from certain provisions of the FDA rules -- with the state pharmacy boards holding primary oversight authority over compounders who do no more than mix, or remix, and bottle or load a known, approved FDA cleared medicine or biologic.
But as my graphic indicated, ACA was also shipping non-sterile homeopathics, including oils and liquids, out of its single facility. It is a near certainty that cross contamination (into the filling ops, for syringes of even genuine semaglutide), form the oils. . . occurred.
But yes, a doctor does, and should bear responsibility if/when s/he specifies that a unique formulation (even of an FDA approved drug) must be filled at a specific compounder. To be clear, I don't know if any MD actually required, on the pad, that the dose be sourced from ACA.
I just don't know.
This was an excellent pickup -- as I was apparently travelling in July of last summer, when the news broke.
Thanks so much!
Onward. . . .
I don't know about the state in question. But it's illegal in some states for a physician to purposely direct someone to a specific pharmacy or to have a concoction with a coded name that only the physician and specific pharmacies know what it refers to so that only the specific pharmacy can fill it. (This is specifically directed at compounding.) This is separate from any kickback statutes.
ReplyDeleteThis is excellent input!
ReplyDeleteAnd I don’t know the precise answer either here.
Namaste. . . .