Prescribing of U.S. Food and Drug Administration-Approved and Non-Approved Compounded Menopausal Hormone Therapy Differs by Specialty [25].

INTRODUCTION: Use of U.S. Food and Drug Administration (FDA)-approved menopausal hormone therapy (HT) has decreased, whereas use of compounded non-FDA-approved menopausal HT has increased. Recently, legislation was enacted to curb prescriptions of compounded products when FDA-approved products exist.

METHODS: A total of 9,001 U.S. physicians were invited to participate in a survey to collect their menopausal HT-prescribing patterns. Of 893 respondents, 440 were eligible based on menopausal HT prescriptions of FDA-approved and compounded non-FDA-approved to more than six patients per month and 425 were categorized as general practice, internal medicine and family practice (n=171); obstetrician-gynecologists (ob-gyns) (n=170); or wellness physicians (n=84). Wellness physicians were those whose specialty or practice was "antiaging and wellness or regenerative medicine."

RESULTS: Of the total menopausal HT prescriptions, the percentages of FDA-approved to compounded prescriptions were 93%/7% for ob-gyns, 88%/12% for general practitioners, and 72%/28% for wellness physicians. Menopausal symptoms were the leading reason for menopausal HT prescription (more than 90%) among all specialties; however, wellness physicians were more likely to prescribe menopausal HT for general or cardiovascular health (26%). Therapy was titrated based predominately on symptom relief among all specialties, although wellness physicians also used blood (64%) or saliva testing (22%) for dose adjustment.

CONCLUSION AND IMPLICATION: Prescriptions for menopausal HT are needed by many postmenopausal women with substantial numbers of physicians of all specialties continuing to prescribe menopausal HT. Although all groups prescribe menopausal HT, there are differences in prescriptions by medical specialty or practice with ob-gyns and general practitioners more commonly using FDA-approved regimens and wellness physicians also commonly prescribing compounded agents. Given new regulations and enforcement regarding compounding, new FDA-approved agents may be needed to fulfill prescribers' and patients' needs.