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Saturday, December 28, 2013
Florida DOH v. John Foster, MD (solutions pharmacy acted as an unlicensed wholesaler for compounded SottoPelle BHRT pellets)
The doctor only got a "letter of concern" and a $5,000 fine.
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PA Disciplined for implanted compounded bHRT pellets
You will want to read this disciplinary action found here. Below is a summary provided by Dr. Kenneth Woliner of the case:
This physician assistant basically "played doctor" by "renting a MD supervising physician (who never showed up to "Millennium Medical Spa" which she owned)" by paying him $500/month (even though he never showed up). She implanted compounded bHRT pellets (specifically SottoPelle, made by "Solutions Pharmacy" of Chatenooga, TN)
Inserting pellets under local anesthesia is considered "surgery", and this physician assistant was clearly practicing beyond scope. Regardless, the patient was majorly overdosed on these hormones, having testosterone levels as high as a man. The patient didn't get a call back from the PA for a few days, then had a medication called in under the supervising physician's name (without his knowledge), and when the patient continued to have adverse effects and was rebuffed when she tried to speak to the non-existent MD, she went to her OB/GYN for treatment. Old records obtained including a falsified consent for procedure form. This is BAD. (As an aside, the supervising physician, David Larkin, MD, got his license revoked in 2008 for aiding the unlicensed practice of medicine in his hair transplant business.)
This physician assistant basically "played doctor" by "renting a MD supervising physician (who never showed up to "Millennium Medical Spa" which she owned)" by paying him $500/month (even though he never showed up). She implanted compounded bHRT pellets (specifically SottoPelle, made by "Solutions Pharmacy" of Chatenooga, TN)
Inserting pellets under local anesthesia is considered "surgery", and this physician assistant was clearly practicing beyond scope. Regardless, the patient was majorly overdosed on these hormones, having testosterone levels as high as a man. The patient didn't get a call back from the PA for a few days, then had a medication called in under the supervising physician's name (without his knowledge), and when the patient continued to have adverse effects and was rebuffed when she tried to speak to the non-existent MD, she went to her OB/GYN for treatment. Old records obtained including a falsified consent for procedure form. This is BAD. (As an aside, the supervising physician, David Larkin, MD, got his license revoked in 2008 for aiding the unlicensed practice of medicine in his hair transplant business.)
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1 comment:
I hope state boards of medicine and boards of pharmacy are listening.
Kenneth Woliner, MD
www.holisticfamilymed.com
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Q: Under the new law, does a pharmacy wishing to compound a sterile non-patient specific product have to register under 503B?
A: Exact quote from Jane Axelrad:
“Section 503A was not changed by the new law and patient specific prescriptions are required under Section 503A. As you know, as you observe, 503B provides a pathway in which hospitals and health care professionals can purchase compounded drugs without prescriptions.”
Q: Only under 503B can you provide non-patient specific product?
A: Exact quote from Jane Axelrad: “If you want to qualify for the exemption under 503A.”