RECOMMENDATION 5

Collect and disclose conflicts of interest.

Prescribers and compounders of cBHT may have conflicts of interest arising from financial relationships (e.g., ownership or investment interests held in specific cBHT formulations or companies), and such conflicts should be transparent, publically available, and disclosed to patients at the point of care. In addition, state licensing boards should collect and archive information on such financial relationships in a publicly accessible repository.

RECOMMENDATION 6

Strengthen and expand the evidence base on safety, effectiveness, and use of compounded bioidentical hormone therapy (cBHT) preparations

As the field of personalized medicine continues to expand, interest in compounded medication is likely to grow. Ensuring the safe and appropriate dosing of cBHT formulations requires the evaluation of the bioavailability of all active ingredients included in the preparation.

To develop a comprehensive evidence base on the potential health benefits and risks of specific cBHT preparations, public (e.g., the National Institutes of Health) and philanthropic funding agencies should establish, provide, or increase funding for clinical, epidemiologic, and health services research to address gaps in the evidence base.

Other stakeholders, including the FDA, USP, 503A compounding pharmacies and 503B outsourcing facilities, state medical boards, state boards of pharmacy, nonprofit professional societies and organizations within the medical and pharmaceutical sectors, pharmaceutical industries, and clinical and public health research groups should advocate for and support these research initiatives. Stakeholders should also develop a strategic plan to support precompetitive research projects and activities.

Prioritized research objectives should include, but not be limited to, the following:

• Data collection and surveillance
  • Accurate and consistent collection of adverse event data for each cBHT preparation, by formulation and compounder.
  • Accurate determination of volume, scope, and financial costs of prescribed cBHT preparations in the United States.
• Clinical research on safety and efficacy.
• Conduct additional well-controlled trials (with or without active comparators) for commonly prescribed cBHT preparations and dosage forms, including formulations that include estrone, estradiol, estriol, progesterone, or testosterone, to examine effects on safety and symptoms associated with perimenopause and menopause.
• Generate bioavailability data for all active ingredients in the most commonly prescribed cBHT preparations, to inform safe and effective dosing practices. Studies that include FDA-approved hormone therapy products with comparable active ingredients and dosage forms may help to inform clinical practice.
• Develop observational studies of genetic and lifestyle variation (smoking, alcohol, diet) in cBHT responses, including adverse events.