NECC also acted like a manufacturer by advertising specific products as safe and effective for use in populations (not to meet the specific need of an individual patient who required a tailored medication). If pharmacists knowingly make drugs under substandard conditions, they are endangering the lives of patients. But, if pharmacists are unaware of the risks they may be building into products, i.e. the types of risks that are identified during drug development, and in environments where federal surveillance and oversight is required, and through mandated reporting and signal detection, shouldn't the fact that they are at a disadvantage for even knowing and understanding risks be disclosed? Pharmacists do or should know that the chemicals they buy may have disclaimers on their certificates of analysis (purity results listed may not be guaranteed by sellers) and they do know that there are disclaimers on many of the formulas published or purchased for compounding, disclosing that safety and efficacy are undetermined, and they do know that non-sterile ingredients have a great degree of uncertainty regarding their ability to be cleared of harmful viable and non-viable organisms, and that forcing liquids through fine filters may create shear force stress that does not destroy filter integrity but that changes the shape of bacteria allowing for passage into purportedly sterile products. They also are likely to know whether or not the products they market carry product liability insurance. Still, the marketing momentum continues, without disclosures to purchasers or prescribers. These information asymmetries may continue to be exploited for financial gains.
Anonymous said...
And if the SC ruling confirmed a right to advertise specific compounded products, with that right must come certain responsibilities?