The Clinical Utility of Compounded Bioidentical Hormone Therapy A Review of Safety, Effectiveness, and Use (2020) / Chapter Skim
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9 Clinical Utility and Recommendations
9 Clinical Utility and Recommendations
Pages 217-228
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From page 217... ...
In this final chapter of the report, the committee summarizes its key findings and conclusions regarding the clinical utility of cBHT preparations, and notes the critical importance of evidence-based clinical guidance and its use by clinicians to support positive health outcomes for patients.
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From page 218... ...
In consideration of this guidance, for the purpose of this report, the committee has defined clinical utility as a multidimensional construct that reflects evidence about safety, effectiveness, and therapeutic need.1 Patient preference is also a component of clinical utility, and it reflects patients' individual decision making based on variable acceptance of benefits and risks. In its approach to examine the clinical utility of prescribing cBHT to patients, the committee systematically reviewed the available evidence relevant to each component of this definition.
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From page 219... ...
The committee concluded there are insufficient data to support that cBHT preparations are as safe as or safer than FDA-approved hormone therapy, and that inadequate oversight and reporting of adverse events are a public health concern. Similarly, the committee concluded there are insufficient data to support that cBHT preparations are as effective as or more effective than FDA-approved hormone therapy.
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From page 220... ...
• urrently, cBHT preparations are not adequately labeled. Missing C information includes, but is not limited to, a description of the preparation's instructions for use, contraindications, potential adverse effects, boxed warnings, and the identity of the person and company responsible for a compounded preparation's quality and safety.
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From page 221... ...
These obligations include respecting patient autonomy -- meaning the right of patients to choose -- while at the same time ensuring that patients' decision making is informed by the best available evidence and supported with shared decision making. Based on the precautionary principle, physicians who prescribe hormone therapy, both FDA-approved drug products and compounded preparations, have a duty to engage in practice informed by evidence-based clinical guidelines and to educate patients to ensure their decision making is
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From page 222... ...
Patient preference alone should not determine the use of cBHT preparations. In general, the potency of cBHT doses should not exceed those of FDA approved hormone therapy products because of potential safety con cerns.
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From page 223... ...
The Pharmacy Compounding Advisory Committee should consider all compounded bioidentical hormone therapy preparations formulated in pellet dosage form as candidates for FDA's Difficult to Compound List. Recommendation 3: Improve education for prescribers and pharmacists who market, prescribe, compound, and dispense compounded bioiden tical hormone therapy (cBHT)
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From page 224... ...
o Examine the current peer-reviewed, evidence-based conclusions on the safety and effectiveness of commonly prescribed cBHT preparations. o Review the potential risks and reported adverse effects associ ated with the use of cBHT and FDA-approved products with the same active ingredients.
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From page 225... ...
o Include information on the person responsible for the quality and safety of the dispensed cBHT preparation, such as the estabishment's supervising pharmacist or other designated indi l vidual, and the name and contact information for the pharmacy. • ll cBHT preparations dispensed from 503A compounding phar A macies should include boxed warnings for potential adverse effects for compounded prescriptions that include estrogens (estradiol, estriol, estrone)
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From page 226... ...
, like those used in FDA-approved drug products with boxed warnings to educate the user about potential health risks. • M odify the standard MedWatch form to adequately collect and 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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From page 227... ...
, the United States Pharmacopeia, 503A compounding pharma cies 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.
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From page 228... ...
228 THE CLINICAL UTILITY OF cBHT All clinical trials or observational studies related to the safety, effec tiveness, and use of cBHT should register with and be approved by an appropriate institutional review board, as well as obtain informed consent from all patients and study participants.
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