Medscape News: Pharmacy Compounding Primer for Physicians
Posted Dec 28 2012 11:33am
Since the fungal meningitis health scandal that rocked the compounding pharmacy industry in 2012, there have been rumblings among legislatures and lawmakers to increase federal regulatory oversight of compounding pharmacies.
I have been following this issue because compounding pharmacies provide bioidentical hormones for hundreds of thousands of women going through perimenopause. It is an issue that I believe we need to be paying close attention. Medcape News Today has published this article and several others on this topic that I think might be of great interest to The Perimenopause Blog readers.
I do not have permission to reprint the articles in their entirety (simply because I did not request it) and so, instead, I thought I would link to the Medscape site and let you read them for yourself there. You have to open an account with Medscape to have access to the articles, but it is free. It is something I highly recommend if you are interested in keeping up with medical news.
This is the abstract for one of the articles. You can click through below to go to Medscape for the rest of the article.
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.