Compounded bioidentical hormone products, a path forward

Area of Science:

• Pharmacology
• Endocrinology
• Regulatory Science

Background:

• Compounded bioidentical hormone therapies (cBHT) are widely used by millions of individuals.
• The use of cBHT products is reportedly increasing annually.
• Current data on the safety, efficacy, and clinical utility of cBHT remains insufficient.

Purpose of the Study:

• To document the extensive utilization of cBHT.
• To define clinical utility and highlight the lack of evidence supporting cBHT.
• To propose actionable recommendations for pharmacists and regulators to enhance cBHT safety.

Main Methods:

• Review of current literature and market trends for cBHT.
• Analysis of factors contributing to consumer demand for cBHT.
• Examination of formulation challenges and comparative costs.

Main Results:

• Widespread and increasing use of cBHT products nationwide.
• Identified lack of robust evidence for the clinical utility of cBHT.
• Examples of consumer motivations, costs, and formulation complexities are presented.

Conclusions:

• Despite advancements like the Drug Supply Chain Security Act, continued efforts are necessary to improve cBHT safety and transparency.
• Pharmacists and regulators must collaborate to promote safer practices and initiate studies on cBHT.
• Further investigation is crucial to establish the evidence base for cBHT.