Legal Considerations in Bioidentical Hormone Replacement Therapy: Anticipating Future Challenges in Medical Liability.

Abstract: New pharmaceutical formulations containing multiple active pharmaceutical ingredients have entered the market, combined to form compounded Bioidentical Hormone Replacement Therapy (cBHRT). The rise of alternative therapies is due to a large amount of misinformation about hormone replacement therapy and unexplained fears among the female population. This commentary reviews the impact of cBHRT on the current post-menopausal syndrome. Compounded Bioidentical Hormone Replacement Therapies are formulations of well-known active pharmaceutical ingredients (APIs) derived from plants. In fact, users report that these products seem to be safer and more effective than FDA-approved hormonal replacement therapy. A literature research was performed to address common questions posed by physicians and patients with climacteric syndrome about cBHRT. This study raises several questions about cBHRT. First of all, no safety and security studies of individual cBHRT formulations have been performed. The efficacy of a cBHRT formulation based on personalized treatment appears to be ineffective. The costs of individual galenic preparations do not justify the efficacy and risks of cBHRT. On the medico-legal issue, galenic preparations have two types of possible risks: generic and specific. A generic risk is connected to the preparation, operator-dependent errors, and hygienic precautions. The specific risk of collateral effects is the possible drug-to-drug interactions, which have not been studied yet. The lack of scientific information exposes the prescribing physician to accusations of improper prescription and possible preventable risks. Caution in the prescription of cBHRT is always warranted.