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The Clinical Utility of Compounded Bioidentical Hormone Therapy (cBHT)
Note: For those that have not read the entire 300+ page report, we will briefly present the recommendations of the report over the next few weeks. Each week, we will present the titles of the six recommendations. This week, we provide the explanations provided for Recommendation 3.
RECOMMENDATION 1
Prescribers and compounding pharmacists should restrict the use of cBHT preparations.
RECOMMENDATION 2
The (FDA) Pharmacy Compounding Advisory Committee should review select bioidentical hormone therapies and dosage forms as candidates for the FDA Difficult to Compound List.
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RECOMMENDATION 3
Improve education for prescribers and pharmacists who market, prescribe, compound, and dispense compounded bioidentical hormone therapy (cBHT) preparations.
To ensure the appropriate clinical use of cBHT, the committee recommends the following for prescribers:
- State medical boards, the Federation of State Medical Boards, and medical professional societies and associations (e.g., American Medical Association, Endocrine Society, and the North American Menopause Society) should advocate for a state-level certification for individuals who are seeking to begin or continue to prescribe cBHT. Formal clinical education should be offered in parallel to continuing medical education courses.
- Non-profit professional societies and organizations within the medical sectors (e.g., American Medical Association) should expand and promote evidence-based guidelines and best practices for clinicians who prescribe or compound cBHT preparations. These guidelines should include not only evidence-based conclusions on the potential benefits and risks, but also practical steps of when to consider cBHT in lieu of FDA-approved products, which potential formulations should be considered, and contraindications associated with the treatment.
To ensure the appropriate clinical use of cBHT, the committee recommends the following for prescribers and pharmacists:
- State boards of pharmacies, the National Association of Boards of Pharmacy, Pharmacy Compounding Accreditation Board, local and regional schools of pharmacies, and non-profit professional societies and organizations within the medical and pharmaceutical sectors with a particular focus in epidemiology and women's health (e.g., American Association of Colleges of Pharmacy, American Medical Association, Endocrine Society, North American Menopause Society) should develop pathways to support and incentivize the attainment of more in-depth training on complex compounding of hormone preparations.
The courses should do the following:
- Be conducted by schools of pharmacies or non-profit professional societies and organizations within the medical and pharmaceutical sectors.
- Include a review of the compounding process, including complexities of formulation science.
- Examine the current peer-reviewed, evidence-based conclusions on the safety and effectiveness of commonly prescribed cBHT preparations.
- Review the potential risks and reported adverse effects associated with the use of cBHT and FDA-approved products with the same active ingredients.
- Describe potential conflicts of interest that exist within the prescribing, compounding and treatment sectors of pharmaceutics.
- Additional continuing medical education courses hosted by for-profit organizations should not substitute for this training.
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RECOMMENDATION 4
Additional federal and state-level oversight should be implemented to better address public health and clinical concerns regarding the safety and effectiveness of compounded bioidentical hormone therapy (cBHT).
RECOMMENDATION 5
Collect and disclose conflicts of interest.
RECOMMENDATION 6
Strengthen and expand the evidence base on safety, effectiveness, and use of compounded bioidentical hormone therapy (cBHT) preparations
More details coming each week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
Resources:
https://www.nationalacademies.org/news/2020/07/prescribers-should-restrict-the-use-of-non-fda-approved-compounded-bioidentical-hormones-except-for-specific-medical-circumstances
https://www.nap.edu/catalog/25791/the-clinical-utility-of-compounded-bioidentical-hormone-therapy-a-review
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