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Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, August 28, 2014
Breaking News: Concierge Compounding Pharmaceuticals Inc. v. Express Scripts Inc.: A Lawsuit seeking to Stop Express Script from Terminating a Compounding Pharmacy from its Network-hearing set for tomorrow August 29, 2014
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View Complaint for Injunctive Relief
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3 comments:
Is this the pharmacy with registration hurdle in Idaho due to felony charge? See: http://bop.idaho.gov/board_meeting/2013-08-13and14_Minutes_Final_01-09-2014.pdf
Very very interesting case developing here. If chemical ingredients for mixing up largely experimental compounded drugs hold separate NDCs and are covered under tier II, separate co-pays should be required for each ingredient? Otherwise, pharmacies could compound multiple active ingredients in one dosage form for the sole purpose of avoiding co-pays, particularly if the AWPs for the ingredients are sufficiently inflated?
Hard to believe I just used the acronym AWP and chemical ingredient the same sentence--in the grand American tradition, this is compounding "super-sized."
The co-pay issue is in the self interest of the payer, i.e., controlling over utilization, but, there are other more troubling patient safety and supply chain security concerns related to paying for ingredients, versus finished pharmaceuticals.
Thinking in high-level marketing sound bites, it all sounds really good--the doctor orders a customized drug when a patient cannot use an FDA-approved product, partly the result of industry failing to invest in small market needs.
But if you scratch below the surface, there is a lot of missing information--does the doctor or insurer consider that the formulas haven't been evaluated for safety and efficacy? Even more troubling may be the chemical ingredients themselves--these white powders in jars, having traveled through global supply channels, may come with "certificates of analysis," that, at the high level marketing sound bite, sound really good too. But, displayed results may exclude criteria relevant to the dosage form made (residual solvents, microbial content), and for the criteria that are listed, the stated results may not be guaranteed by the seller. How does this white powder in a jar become a tier ii level Rx product?
You can't distill this level of necessary problem-solving, albeit for a sometimes necessary pharmacy practice, into a soundbite.
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