The Clinical Utility of Compounded Bioidentical Hormone Therapy A Review of Safety, Effectiveness, and Use (2020) / Chapter Skim
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In recent decades, an increasing number of health care providers and patients have turned to custom-formulated, or compounded, drug preparations as an alternative to FDA-approved drug products for hormonerelated health concerns. These compounded hormone preparations are often marketed as "bioidentical" or "natural" and are commonly referred to as compounded bioidentical hormone therapy (cBHT)
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However, recent years have seen an expanded supply of and demand for compounded medications, as well as the emergence of large-scale compounding pharmacies that produce and sell greater volumes of compounded preparations in preset formulations, sometimes across state lines. This change in the compounding landscape prompted Congress to create a separate category of compounding facility -- called an "503B outsourcing facility" -- that is subject to an increased level of federal oversight, although not as strict as FDA oversight for
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The resulting Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy was charged with reviewing the uses of cBHT preparations and the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations.3 The committee was also asked to assess whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and to identify patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT. Over the course of the study, the committee held nine meetings, five of which were information-gathering sessions open to the public.
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Clinical Utility of cBHT: Safety and Effectiveness The committee assessed components of clinical utility, safety, and effective ess of cBHT by examining peer-reviewed evidence relevant to the n 10 prioritized steroid hormones evaluated for this study. The committee also reviewed the public health protections offered by the current federal and state-level oversight of compounded preparations, as well as the reported number, types, and severity of adverse events related to use.
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Given the lack of high-quality clinical evidence to demonstrate safety and effectiveness, there is a public health concern regarding prescribing, compounding, dispensing, and use of cBHT. Current federal and state oversight of the formulation, marketing, dispensing, surveillance, and adverse event reporting of compounded preparations are insufficient to identify and then communicate the risks assumed by patients when using cBHT.
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These exemptions provide opportunities for ambiguous instructions for use, incomplete listing of active and inactive ingredients, or an omission of potential contraindications, all of which creates the potential for patients and prescribers to be inadequately informed about possible safety concerns related to the use of these medications. Clinical Utility of cBHT: Therapeutic Need FDA-approved BHT products are primarily indicated to treat vasomotor symptoms and symptoms of vulvar and vaginal atrophy associated with menopause, and for men, to treat symptoms of male hypogonadism or testosterone deficiency.
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The committee was unable to identify any clinical guidelines that recommend the use of compounded hormone treatments, of any hormone, to treat FSD (including hypoactive sexual desire disorder or female 6 Anecdotally, a commonly discussed exception is when a potential patient with a peanut allergy would be in need of a single-agent progesterone product. 7 Female sexual dysfunction (FSD)
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Specifically, the committee identified several factors that may influence preference for cBHT including the early analysis and science communication efforts related to the Women's Health Initiative study; FDA requirements for labeled indications and boxed warnings for certain FDA-approved BHT products; cBHT marketing; physician practices and perspectives; patient mistrust of the health care industry and commercial pharmaceutical industry; interest in the "natural" movement; and prescription costs. The committee knows little about how patients are first introduced to cBHT as a treatment option; however, available sources suggest that many rely on media outlets (e.g., social media, books, television commercials)
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Based on the precautionary principle, medical practitioners prescribing hormone therapy have a duty to engage in practice informed by evidencebased clinical guidelines and to educate patients to ensure that their decision making is informed by evidence-based health information. Health literacy and its reliance on evidence is foundational to autonomous patient decision making, and patients must have ready access to the best available evidence that is easy to understand and use as they weigh the risks and benefits of therapeutic options.
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In general, the potency of cBHT doses should not exceed those of FDA approved hormone therapy products because of potential safety con cerns. Any use of cBHT, including therapy for gender dysphoria, should align with established clinical guidance and require documentation of shared decision making and rigorous monitoring for long-term risks.
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To ensure the appropriate clinical use of cBHT, the committee recom mends the following for prescribers and pharmacists: • S tate boards of pharmacies, National Association of Boards of Pharmacy, Pharmacy Compounding Accreditation Board, local and regional schools of pharmacies, and nonprofit 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, AMA, Endocrine Society, North American Menopause Society) should develop path ways to support and incentivize the attainment of more in-depth training on complex compounding of hormone preparations.
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, dos age strength and form, statement of compliance to current good manufacturing practices or United States Pharmacopeia (USP) standards, beyond-use date, contraindications, side ffects, caution for potential adverse effects, and instructions e on how to report adverse events.
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, like those used in FDA-approved drug products with boxed warnings to educate the user about potential health risks. • A ll 503A compounding pharmacies should increase their surveil lance capacity by monitoring, recording, and annually reporting the types, formulations, payer, and dispensing rates of cBHT prepa rations.
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, like those used in FDA-approved drug products with boxed warnings to educate the user about potential health risks. • odify the standard MedWatch form to adequately collect and M track adverse events data related to cBHT use, including but not limited to: o active pharmaceutical ingredients and excipients in the All cBHT formulation.
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o 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.
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