Compounding medications is the “roots” of pharmacy… it was slowly phased out after WWII by the commercial pharmaceutical manufacturer started producing standardized products and the FDA was created.
Compounding, since its inception is basically, “personalized therapy” and is exempt from any FDA oversight and under the over sight of the various state Boards of Pharmacy.
The more and more information that is being published about NECC ( New England Compounding Center ) suggests that they were producing thousands and thousands of doses of various medications… where does one draw the line between “personalized therapy” and producing thousands and thousands of doses to be given to thousands and thousands of different patients?
I can assure you that NECC is not the only entity out there doing virtually the same thing… which is claiming they are compounding “personalized therapy” to avoid all the requirements that pharmaceutical manufacturers must meet and claim that only the state Board of Pharmacy has over sight of them.
With each passing day since this was first announced, the number of patient affected and potentially affected keeps growing as does the number of deaths.
I wonder who is going to be “hung out to dry” or “thrown under the bus” over this… my money.. says it won’t be one of the execs of NECC.. but… some poorly trained tech will get blamed and some over worked Pharmacists – that was suppose to be checking the tech’s work – will be thrown into this three ring circus …for the BOP’s and a gaggle of attorneys to financially tear limb from limb.
If anything does see the light of day.. I will be very surprised… patients and survivors will be offered HUGE settlements with confidentially agreements attached.. and it will all just “vanish” into the sunset…
Filed under: General Problems
I have worked in several compounding pharmacies over my career and have felt, in general, that they provide a valuable service to a very small select group of patients. This appears to me to be a case of money over medicine and I would put my money on some MBA bean counting dimwit at NECC coming up with this manufacturing scam.
The pharmacists and technicians involved obviously have some responsibilty here, but the person who should be hung out to dry is the one (pharmacist or non-pharmacist) that knowingly put patients at risk for profit.
We now, unfortunately, have a measurable new metric. Injured or killed for profit.
This is a nightmare for the patients and their families and a black eye for pharmacy. I have to wonder too about the physicians who would purchase a compounded epidural injection from an out-of-state pharmacy. Epidural injections are high risk.
They are a small pharmaceutical company. If they are giving the same dose to more than 100 patients a month, then it should be called manufacturing. The states’ Board of Pharmacy should have some sort of regulation. We also need some provisions from the NABP.