Friday, January 4, 2013

Another Recommended Read: Pharmacy compounding primer for physicians: prescriber beware.

Pharmacy compounding primer for physicians: prescriber beware.

q-Vigilance LLC, North Barrington, IL, USA.
Drugs (impact factor: 4.23). 10/2012; 72(16):2043-50. DOI:10.2165/11640850-000000000-00000


Since the development of federal standards for drug approval, the practice of medicine has historically involved the compounding of medications based on a physician's determination that a US FDA-approved product either did not exist, or could not be used for medical reasons. Today, prescriptions for non-FDA-approved compounded drugs may be driven by fanciful and largely unregulated pharmacy advertisements to physicians and patients and/or payer reimbursement policies, thus placing prescribers in the backseat for clinical decision making. This article outlines essential differences between FDA-approved drugs and compounded drugs and reasserts the primary medical role of physicians for determining what medical circumstances may necessitate treatment with non-FDA-approved products. In addition, liability concerns when prescribing non-FDA-approved drugs are discussed. While representing a US perspective, underlying principles apply globally in the setting of magistral and extemporaneous formulations produced outside national regulatory frameworks.
Source: PubMed

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