As a pharmacist, one could imagine that the issue of compounding a medicine for which there is widespread patient need would be an opportunity, not a problem.
Pharmacists of a “certain age” spent a lot of time when we were in pharmacy school in the compounding lab learning how to perform a function that was a cornerstone to our profession; making the medicine the doctor ordered for the patient. Fast forward: there is very little emphasis on compounding in pharmacy schools and most pharmacists spend very little time compounding the medicines their doctors prescribe.
Pharmacists focus most of their time on helping patients make the best use of their medicines, not making them. We rely of the well-established pharmaceutical industry to create, develop, and manufacture medicines that formerly were compounded.
What concerns me is the widespread, large-scale preparation of commercially available medicines under the guise of “compounding” in “compounding pharmacies.” These enterprises are skirting FDA oversight by functioning as surrogate manufacturers with none of the regulations that assure patient safety with products from the pharmaceutical industry. Substandard practices and errors that can and have occurred in these unregulated compounding pharmacies can and have resulted in patient harm, including deaths.
As a pharmacist, I am NOT caught in the debate about strengthening oversite over compounding pharmacies.
The recently announced FDA crackdown on compounding pharmacies and legislative initiative including the SAFE Drug Act are encouraging developments that will protect the public from the harm than can result from an affront to the Oath of the Pharmacist that states: “I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.”
By Philip Schneider, MS FASHP FFIP
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