Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and Security Act
Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and ... President & CEO of the International Academy of Compounding Pharmacists.
Rock Hill Herald - 3 mins ago
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While doctors and pharmacists are front-line medical risk management experts, the purpose of the Food Drug and Cosmetic Act and its enforcement is to identify and protect the public against health risks, both large and small, that may go unnoticed doctors and pharmacists.
Section 503B provides a mechanism to access sterile injectables produced according to federal GMPs--anything less will transfer an added burden of risk to patients for whom we are charged with, above all else, doing no harm.
Importantly, risks associated with an unapproved, non-GMP produced drugs are impossible to disclose, evaluate or weigh in an informed decision-making process with patients, if doctors and pharmacists are unaware the risks exist in the first place.
Even readily identifiable potential risks may go unnoticed; for example, pharmacies may source powder chemicals relying on certificates of analysis, but for which the suppliers of the chemicals include disclaimers on the very purity and potency measurements listed on the certificates. Information asymmetries like this fall across a broad and deep benefit-risk range--complicated thinking with high cognitive demands is necessary, but will not occur if unapproved drugs are sourced through purchasing transactions for office use.
Congressional intent for Section 503A is found in the 1997 Conference report.
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