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
Friday, September 5, 2014
Question of the Day September 5, 2014 If PRBs and Insurance Companies enter into agreements with Preferred Provider Networks who include compounding pharmacies that violate state and federal law what type of liability (civil and criminal) will this place on the PBMs and the insurance companies? Is this something that PBMS and insurance companies need to be very careful about considering?
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I expect that most insurance companies have conducted or are conducting corporate fiscal due diligence and risk assessments in this area, particularly relevant for publicly-traded companies, that include careful vetting of:
1. grey markets for ingredient trade (see NABP presentation by FDA here: http://www.nabp.net/meetings/assets/FDA%20Update.pdf)
2. the listing of ingredients (versus FDA-approved finished dosage forms) in formularies which creates an "inventory" for facilitating payments for potentially dangerous or ineffective drugs and/or mixtures of drugs
3. the application of un- or under tested and warranty-less recipes/formulas
4. challenges with monitoring and detecting potential compounded drug-induced illness or inefficacy in a largely distributed drug manufacturing and dispensing model, including lack of identifiers and lack of surveillance, sampling and testing programs
5. Potential for serious harm to public health where hypotheses for treatment can be "as large as one's imagination," and where drug development, marketing, national launch and population use can occur almost overnight while at the same time escaping our national, and global, drug safety and security frameworks.
I believe some of these factors played into recent payer decision-making, and very early on, why groups like BCBS TX established policy findings including: "Drug compounding, the process of mixing, combining or altering of ingredients to create a customized medication is considered experimental, investigational and unproven".
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