Sarah Sellers, PharmD, MPH, Wulf Utian, MD
DisclosuresDec 19, 2012
Editor's Note
The issue of compounding exploded into the news in late 2012, with an outbreak of fungal meningitis linked to contaminated products from the New England Compounding Center. Concerns have been raised about regulatory failures at the state and federal levels. Officials at the Centers for Disease Control and Prevention have scrambled to educate both the public and clinicians about the recognition and management of suspected meningitis cases. Little attention, however, has been paid to the unique risks to prescribers who write the orders for compounded products. This important article, reprinted with permission from Drugs, explores the critical issues that prescribers must consider in ordering these products.
The issue of compounding exploded into the news in late 2012, with an outbreak of fungal meningitis linked to contaminated products from the New England Compounding Center. Concerns have been raised about regulatory failures at the state and federal levels. Officials at the Centers for Disease Control and Prevention have scrambled to educate both the public and clinicians about the recognition and management of suspected meningitis cases. Little attention, however, has been paid to the unique risks to prescribers who write the orders for compounded products. This important article, reprinted with permission from Drugs, explores the critical issues that prescribers must consider in ordering these products.
Abstract
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 Food and Drug Administration (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.
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