Myth: Bioidentical hormone replacement therapy (BHRT) is unregulated.
Fact: Bioidentical hormones, like all compounded medications, derive from FDA- and USP-registered materials. This means materials with a known quantity of drug ingredients as well as materials with safe and effective standards when considering a drugs intended use. State board pharmacies regulate all pharmacies that compound medications, including bioidentical hormones. They are responsible for overseeing all pharmacy practices in each state. In addition, all compounded medications have to meet national standards and guidelines, with ingredients regulated at the federal level with the U.S. Pharmacapeia providing additional oversight.
Myth: Because compounded bioidentical hormones are not FDA-approved, they are unsafe.
Fact: Instead of being mass produced, compounded medications are customized to meet the unique needs of patients. While the FDA approval process oversees the mass-production of manufactured drugs, the state boards of pharmacy regulate compounded medications. If the FDA holds compounded medications to the same standards, the compounded drugs availability diminishes. Similar to products prescribed for off-label use, prescribing compounded medications is at the discretion of the physician.
Myth: BHRT is considered unsafe and ineffective.
Fact: Differing from commercial drugs, compounded medications do not market as safe or effective because they are not subject to FDA approval. FDA-approved drugs require warnings to consumers about the risks, whereas compounded drugs do not have this information, as they create drugs specific to the clients needs. Although, bioidentical hormones lack national warnings, it does not mean they are unsafe and ineffective. There are regulations in place that stop pharmacies from making claims without contradictions or to overstate the health benefits of products they promote.
Myth: All hormone replacements are the same quality.
Fact: Man-made chemical compounds create synthetic hormones, where as chemicals from plant sources create bioidentical hormones. The human body produces hormones identical to the chemical structures of artificial hormones. They are created to mimic the hormones in the human body and are used in treatment of individuals who have low or unbalanced hormones. These hormones received the name “bioidentical” due to their identical chemical structures. Due to these hormones replicating natural hormones, bioidentical hormones are more accurate.
Myth: Bioidentical hormones are only necessary for individuals over 45 years old.
Fact: Tailored to the specific needs of patients, compounded drugs are unique. Therefore, for many patients, manufactured synthetic products are effective, but not for all. Therefore, compounded medications are necessary for some individuals. Some ways that compounded medications fit a patients need include:
- Some doctors may determine that the patient needs a lower dose than what is available commercially.
- Other times, doctors find that changing combinations of hormones in ways that are not commercially available may best alleviate their patients’ symptoms.
- It is also common that doctors find that different deliver forms are more effective for an individual patient.
- Sometimes, patients experience severe side effects from manufactured drug products, causing the switch to compounded drugs.
- Allergies are common among individuals, often being a leading cause of prescribing a compounded medication versus the manufactured product.
If you seek further information or have questions regarding bioidentical hormones, ask your pharmacist today!
