Ask OmniSure is a series that answers real risk and safety questions from policyholders and insurers all over the country.
Question: I came across a clinical service that a prospective insured organization offers called bioidentical hormone therapy. What risks should I be aware of when assessing this policy?
An emerging practice in medicine involves Nurse Practitioners setting up shops that offer bioidentical hormone, herbal, and alternative treatments. Physicians will occasionally even refer to the Nurse Practitioners when the patient is wanting alternatives; however, the prescribing doctor will typically continue to monitor the patient as well.
If you’ve found a policyholder in this situation, you should ask the Nurse Practitioner if they are collaborating with a primary care provider for each patient and providing progress notes to the primary care provider. To add another layer of “vigilance” or monitoring of the patient and decrease risk for the Nurse Practitioner. Even with this layer of coverage, there are a few things that you should be aware of.
Understanding compounding of bioidentical hormones
Some prescription forms of bioidentical hormones are pre-made by a drug company. Other forms are custom-made by a pharmacist based on a doctor’s order. This is called compounding. The US Food and Drug Administration (FDA) has approved a number of preparations of bioidentical estradiol and progesterone, which are molecularly identical to the structure of the hormones generated by the human body. They have been through testing for safety and purity and to be sure each dose has the same amount of hormones. The compounded forms have not been tested and approved by the FDA.
Safety of bioidentical hormones
Customized bioidentical hormones are often advertised as being a safer, more effective, natural, and an individualized alternative to conventional hormone therapy. However, these claims remain unsupported by any large-scale, well designed studies. Also, the lack of FDA oversight for compounded hormones generates additional risks regarding the purity and safety of custom compounded bioidentical hormones.
The bioidentical hormones that have been approved by the FDA have been tested for safety. They have passed the FDA’s very strict standards and have been shown to be safe for people to use.
The compounded hormones have not gone through the FDA’s testing. As yet, little research has been done on them. They have not been proven to be safe or unsafe. Many major medical groups do not support using them because not enough is known about their safety and long-term side effects.
What to ask your policyholder:
- Is your policyholder using compounded products?
- If yes, what due diligence have they done to assess the quality of the compounding pharmacy?
- What contractual language has the provider put in place to protect themselves from allegations about the compounded product?
- Website advertising: Is it inflammatory promoting safe care not supported by FDA?
- Is there informed consent clear in regard to risks, as it is well established any hormone replacement therapy increases risks for various cancers?
- Are there policies and procedures clearly in place for ongoing monitoring of the patient and their hormone levels, side effects, etc?