This is a very important presentation; in and of itself, an important quantitative public health safety signal.
It was very challenging to obtain guarantees that bulk chemical ingredients (active and inactive) were not adulterated and had the specifications required for the dosage forms I was asked to make, including spinal and respiratory drugs, now over 20 years ago--I am not sure if this has improved as many chemicals for compounding are advertised in a "use at your own risk" or "for research and development" manner. Insurers may not be aware of the status of product liability coverage for drugs made from chemical powders, on the basis of formulas that may also come with disclaimers on safety and effectiveness. Pharmacies and/or their business partners advertise and market the products, sometimes making claims the products are safe and effective based on preliminary, un-scruitinized studies (demand generation). But because pharmacists are not learned intermediaries, liability associated with marketing and sale of non-FDA approved products can sometimes be extended to other parties in the drug access chain--this may also implicate payers that cover the drugs in their formularies, if pharmacies do not obtain product liability insurance for the products they market and promote?
The multifaceted interventions developed by OptumRx will help protect the drug supply without compromising access to compounded drugs, where necessary.
It was very challenging to obtain guarantees that bulk chemical ingredients (active and inactive) were not adulterated and had the specifications required for the dosage forms I was asked to make, including spinal and respiratory drugs, now over 20 years ago--I am not sure if this has improved as many chemicals for compounding are advertised in a "use at your own risk" or "for research and development" manner. Insurers may not be aware of the status of product liability coverage for drugs made from chemical powders, on the basis of formulas that may also come with disclaimers on safety and effectiveness. Pharmacies and/or their business partners advertise and market the products, sometimes making claims the products are safe and effective based on preliminary, un-scruitinized studies (demand generation). But because pharmacists are not learned intermediaries, liability associated with marketing and sale of non-FDA approved products can sometimes be extended to other parties in the drug access chain--this may also implicate payers that cover the drugs in their formularies, if pharmacies do not obtain product liability insurance for the products they market and promote?
The multifaceted interventions developed by OptumRx will help protect the drug supply without compromising access to compounded drugs, where necessary.
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