The 2017 Hormone Therapy Position Statement of The North American Menopause Society

The North American Menopause Society 2017 Hormone Therapy Position Statement Advisory Panel

Disclosures

The North American Menopause Society (NAMS). 2018;24(7):728-753. 

In This Article

Compounded Hormones

Government-approved bioidentical (similar to endogenous) HT, including estradiol, estrone, and MP, are regulated and monitored for purity and efficacy, sold with package inserts with extensive product information (based on RCTs), and may include black-box warnings for AEs. Compounded hormone therapies are prepared by a compounding pharmacist using a provider's prescription and may combine multiple hormones (estradiol, estrone, estriol, dehydroepiandrosterone [DHEA], testosterone, progesterone), use untested, unapproved combinations or formulations, or be administered in nonstandard (untested) routes such as subdermal implants, pellets, or troches.[33–36]

Compounded HT has been prescribed or dosed on the basis of salivary hormone testing; however, salivary testing for HT is considered unreliable because of differences in hormone pharmacokinetics and absorption, diurnal variation, and inter-individual and intraindividual variability.[37–39]

Prescribers should only consider compounded HT if women cannot tolerate a government-approved therapy for reasons such as allergies to ingredients or for a dose or formulation not currently available in government-approved therapies. With interim guidance on compounding safety and quality control from FDA, quality control of compounded HT may improve.[40]

Key Points

  • Compounded bioidentical HT presents safety concerns such as minimal government regulation and monitoring, overdosing or underdosing, presence of impurities or lack of sterility, lack of scientific efficacy and safety data, and lack of a label outlining risks.

  • Salivary hormone testing to determine dosing is unreliable.

  • Prescribers of compounded bioidentical HT should document the medical indication for compounded HT over government-approved therapies, such as allergy or the need for dosing or a formulation not available in FDA-approved products.

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