Wednesday, July 23, 2014

Two comments made to Ed Silverman's article "FDA Spars With Recalcitrant Compounding Pharmacy, Again "-Reader claims Texas Board of Pharmacy behaves like a fraternity; Sarah Sellers makes suggestion for Texas Medical Board Rules to be Extended and Adopted Nationally

Sarah Sellers wrote:
I agree with the previous comment, but, the Board of Pharmacy is a “sharp end” on the supply side of multi-layered, error-prone decision-making pathway. That health professionals would knowingly step outside the contemporary U.S. (and essentially global) framework for drug approval, safety and oversight and fuel a supply-and-demand cycle for non-FDA approved drugs with little or no discussion of intended benefits and potential risks with individual patients is remarkable—in one finding alone, sterility failures were identified in 19 batches of medication.
On the demand side, the TX Medical Board Rules prohibit doctors from misrepresenting material facts that cannot be substantiated–this principle could be extended and adopted nationally to help guide the development of criteria to inform medical decision-making that may lead to the sometimes necessary, but hopefully rare, prescribing or use of unapproved medications that, by their very nature, impose greater risk burdens to patients.
    • The blame for this situation rests squarely with the Texas Board of Pharmacy. If they behaved like an oversight agency instead of a fraternity, this situation could have been avoided.
      Next step: any patients who are prescribed and supplied drug products from NuVision should sue the hospital that administered the drugs to them.

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