A Question of Quality, Part 2
Major medical organizations, such as the American College of Obstetricians and Gynecologists (ACOG) and the American Association of Clinical Endocrinologists (AACE), have a very different position on the role of bioidentical hormones. And this is where a degree of confusion creeps in, because "bioidentical hormone replacement therapy is not really an FDA-recognized term," says Jennifer Hofmann Ribowsky, MS, RPA-C, Academic Faculty/Pre-clinical Coordinator of the Pace University–Lenox Hill Hospital Physician Assistant Program in New York. "It's more a term used for marketing purposes."
That said, bioidentical hormones are essentially plant-derived hormones that are chemically similar or structurally identical to those produced by the body. And there are FDA-approved estrogen and progesterone products that are technically considered naturally occurring or bioidentical.
But traditionally, the term bioidentical hormones has referred to compounded preparations. The reservations, if not downright concerns, of groups such as ACOG and AACE generally relate to two factors: the origins of the bioidentical hormones (FDA-approved products vs compounded products) and how they are used.
Compounding is performed by a licensed pharmacist to specifications prescribed by a health care provider. But compounded products are not regulated by the FDA (they are regulated by the states), and by their nature are not standardized (though the raw materials are US Pharmacopeia–approved products). Therefore, issues of quality—purity and potency—may arise, and there is a lack of safety and efficacy data.
"We don't necessarily know whether the compounded products, the vehicle, will provide the amount that is required or necessary, as prescribed by the provider," Ribowsky says.For example, when a clinician prescribes an estradiol patch in a dosage of "0.05 mg per 24 hours," that is precisely what the patient will receive from an FDA-approved product. "It's standardized, so you have that level of comfort that when you're prescribing a certain amount, that's what the patient is getting," Ribowsky says. "That's not always the case with compounded products."
In an August 2012 opinion paper, committees from ACOG and the American Society for Reproductive Medicine concluded that evidence in favor of bioidentical (ie, compounded) HRT was insufficient: "Patients should be counseled that menopausal hormone therapies that are proved to be safe and effective by the FDA are more appropriate for their use than individual pharmacy-compounded preparations."
But in practice, there may be additional considerations. "I leave it up to the patient whether they want compounded bioidentical hormones or FDA-approved bioidentical hormones," Egan says (though she recommends bioidenticals over synthetics). "If a patient doesn't have insurance and has to pay out of pocket, obviously it's financially feasible to get them compounded."