Hormone Replacement
The meeting follows a September 26, 2018, US Food and Drug Administration (FDA) announcement that the NASEM would conduct two studies relate to compound drugs in collaboration with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation. The studies are intend “to help inform the public and the agency’s policies regarding compounded drugs,” the agency said in a news release.
The Committee on Clinical Utility of Treating Patients With Compound “Bioidentical Hormone Replacement Therapy” is examining issues such as the active and inactive ingredients in these products; so dosage forms, administration routes, and strengths. For their report, they will evaluate the scientific evidence relate to these issues; also make recommendations on the clinical utility of compound BHRT products in comparison to that of FDA approve drug products.

Patients are unable to swallow

Settings in which a compound product be need include those in which patients are unable to swallow a pill; so as well as for the treatment of children and of pain patients who require a medication dose different from what is commercially available. Compound BHRT products, including progesterone and testosterone; hence are sometimes use instead of products approved by the FDA.

Jim Hrncir, RPH, Las Colinas Pharmacy (503A compounding pharmacy); hence said during the session that it is possible to get much higher concentrations of the active pharmaceutical ingredient in a smaller pill or a smaller amount of liquid. The manufacture testosterone gel requires 5 to 10 mL to be apply to the skin and they can put that dose in ½ to 1 mL.

In compound products, bioavailability data are available on the active ingredients; but compound products are not test in humans. Several speakers at the meeting emphasize that the FDA has not assess the quality; safety, efficacy, and bioavailability of compound BHRT products.

Salivary hormone testing to determine dosing is unreliable,” the North American Menopause Society said in a 2017 position statement. Compound products must be made in an FDA-register facility; however, there was some question by attendees about what that means. Compounding pharmacies must register with the FDA, but that is a separate process from the FDA approval process.

The little scientific evidence

The Endocrine Society writes in a position statement that although compound BHRT products; so such as estrogen and progesterone have market as be safer and more effective than FDA approve products; there is little scientific evidence to support these claims. Although it is usually possible to determine where a compounding pharmacy; so obtaine a particular active pharmaceutical ingredient, it can be difficult to trace an ingredient further back in the chain.
The North American Menopause Society recommends against the use of compound BHRT and says that if it is prescribe; clinicians should document the indication for prescribing; so it rather than a government approve BHRT, such as allergy, a medical need for a lower dose than is available, or the need for a different preparation.
The American College of Obstetricians and Gynecologists Committee on Gynecologic Practice; also the Practice Committee of the American Society for Reproductive Medicine wrote, “Despite claims to the contrary; so evidence is inadequate to support increase efficacy or safety for individualize hormone therapy; hence regimens base on salivary, serum, or urinary testing” in a committee opinion publish in August 2012 and reaffirm in 2018.