Updated: Sep 13
In recent years, the use of compounded prescription bioidentical hormone therapy (BHT) drug products for the treatment of menopausal symptoms has seen a steady increase in North America. This trend has raised questions about the safety, efficacy, and regulation of these products. While proponents argue for the benefits of "natural" treatments, there are concerns about the lack of scientific consensus, limited safety data, and inconsistent
practices in the world of BHT. In this blog, we will explore the various aspects of BHT, including its definitions, types, concerns, and regulatory issues, to provide a comprehensive understanding of this complex topic.
To start, the use of the term "bioidentical" can be somewhat controversial because there is no standardized definition in medical literature, and its recognition by regulatory authorities like the FDA in the US and Health Canada is limited. Basically, bioidentical hormones refer to all hormones that are similar to those made in the body. This may include such things as 17β-estradiol, estrone, and estriol, progesterone, and testosterone. Many of these are available in commercial prescriptions in the United States and Canada and meet the definition of bioidentical hormones as they are chemically like hormones produced by the body. However, bioidentical has become a term that is used to mean the custom mixture, or compound, prepared in a compounding pharmacy. Compounding pharmacies offer compounded hormone drugs, which are tailored to individual patients based on their healthcare provider's prescription. Often these compounded prescriptions are based on hormone levels either from blood or saliva, which fluctuate a great deal and are not always accurate or necessary in the care of women in the menopause transition (See blog: Do I Need Hormone Levels to Diagnose & Treat Menopause?), These formulations can include different hormones, dosages, and modes of administration. (1,2)
Unlike commercially produced medications, the regulation of compounded prescription drugs in the United States is murky. The regulation of compounded prescription drugs primarily falls under state medical or pharmacy boards, leading to variations in oversight and standards. FDA's role in regulating compounded drugs is limited. The regulation of compounded BHT is complex and varies by jurisdiction. The FDA has limited jurisdiction over compounding pharmacies unless certain conditions are met, such as the compounding of copies of FDA-approved drugs or situations posing significant risks to patient safety. (1,2) In Canada, compounded prescriptions aren't approved or regulated by Health Canada. (3)
The surge in prescriptions for BHT that can be attributed to several factors. The Women's Health Initiative (WHI), research released in the early 2000s, confirmed risks of the use of hormone therapy. The widely publicized results of the WHI study led to a significant shift in hormone therapy choices, with many women seeking alternatives to traditional hormone therapy, including BHT. Some individuals are suspicious about conventional medicine and choose what they perceive as more "natural" alternatives, and some patients prefer alternative treatments, without realizing that the hormones used in BHT are also present in many commercial prescriptions. Finally, a lack of clear regulation has led to a range of prescribers, some of whom promote BHT without substantial safety and efficacy data. Finally, the internet has played a significant role in the promotion of BHT. (1)
Despite the appeal of personalized therapy, there are concerns associated with custom-compounded BHT. Compounded hormone drugs are not subjected to the rigorous testing and quality control required for FDA and Health Canada-approved medications. This raises questions about their safety and efficacy. Compounded formulations may lack the consistency and standardized manufacturing processes found in commercial products, potentially leading to variations in hormone levels and effectiveness. There is limited research of the safety and effectiveness of compounded BHT and no robust clinical trial data. This lack of evidence poses risks to patients who choose these therapies. BHT products are sometimes marketed as safer and more effective than government-approved alternatives, even though these claims lack substantial scientific backing. Describing a product as ‘natural’ doesn’t mean it’s safe to use. Compounded BHT often lacks standardized labeling and patient package inserts, leaving women unaware of potential risks and making informed decisions challenging. Finally, compounded BHT can be expensive, and obtaining cost information is often difficult. Diagnostic tests performed by some providers are not covered under provincial or medical insurance plans and the patient may have to pay. In addition, prescriptions for commercial menopause hormone therapy may be covered on a patient’s drug plan. (1,2)
Given all of this, you may wonder what role BHT may play in treatment of women with menopause symptoms. There are some circumstances when BHT is appropriate, such as when a patient has an allergy to a component of commercially available medication, if a different mode of administration is required, or a dose other than that available in commercially prepared prescriptions is needed. (4).
Bioidentical hormone therapy is a multifaceted and controversial topic in women's health. Patients have the right to make their own decisions but should be informed about potential harms and, while the concept of personalized hormone treatments is appealing to many, concerns about safety, efficacy, and regulation persist. It is essential for women and healthcare providers to make informed decisions about BHT based on the available evidence and to engage in open discussions about the potential benefits and risks of these therapies. As the regulatory framework evolves and research continues, we can expect a more comprehensive understanding of bioidentical hormone therapy in the years to come.
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1. Patsner, B. (n.d.). Compounded Bioidentical Hormones: What's the Harm?
2. NAMS. (2019). Menopause Practice. A Clinician’s Guide. 6th Ed.
3. Health Link BC. (2021). Bioidentical Hormones. https://www.healthlinkbc.ca/health-topics/bioidentical-hormones#:~:text=Compounded%20bioidentical%20hormones%20may%20be,they%20can%20vary%20in%20quality.
4. Stueknel, C. (December 8, 2020). Compounded Bioidentical Hormone Therapy: New Recommendations From the 2020 National Academies of Sciences, Engineering, and Medicine. NAMS Practice Pearls.