By April Segal, PharmD, BCPS, APh
Remedy Pharmacist + Founder
Today we will be wrapping up our three-part series on Bioidentical Hormone Replacement Therapy (BHRT) and discussing the differences between commercially available HRT and compounded HRT. Check out Part 1 on the differences between bioidentical vs conventional hormones and Part 2 which is a deep dive on estrogen and progesterone if you haven't yet.
Compounded BHRT products are individualized to each patient and are made by a compounding pharmacy based on a doctor's order. They are custom made for the patient. They are not FDA approved because they are so individualized.
In contrast, commercially available HRT products are made in bulk by a pharmaceutical company. They have gone through the FDA approval process. They include hormones that are NOT bioidentical and others that are.
Remedy is a compounding pharmacy and we believe there are specific advantages of compounded BHRT. Notable advantages of our compounded products include:
Opportunity for customized doses - The option to do customized dosing may offer additional safety benefits in that you are able to use lower amounts of hormones based on a patient's blood levels.
Combination products - Since these are made to order and based on blood tests, your doctor may decide to replace more than just estrogen. They can include combo products such as DHEA, testosterone, progesterone, and estrogen.
Reduced exposure to preservatives and other additives - If a patient has a reaction to an additive or preservative in a commercially available product, such as parabens or propylene glycol, compounded products can be made without preservatives and with more natural inactive ingredients such as glycerin. This is especially important given the new findings of the damage such inactive ingredients can cause to the vaginal microbiome. Ongoing research in this field will help us determine the severity of the disruption these products can cause. Since compounded hormones are made to order and typically have a 30-90 day shelf life, they can be made without preservatives.
Alternate routes of administration - Compounded options include creams (vaginal or topical), sublingual drops and troches. More recent research suggests that the safety of estrogen may be dependent on the route of administration, with topical and sublingual having better safety profiles than oral tablets or troches (more info below). For more about this check out Part 2.
Altered Release - Beyond manipulations in dosing and routes of administrations, a compounding pharmacy can also include certain inactive ingredients that help the efficacy of the formulation. An example of this is our altered release progesterone capsules. Since this product slowly releases progesterone, it is much more effective in helping with insomnia that many women experience as a result of hormonal changes.
Sometimes you will see information on the negatives or disadvantages of medications made at compounding pharmacies. These concerns would also include BHRT made at compounding pharmacies. In the below sections we will face those head-on.
The potential disadvantages of compounded BHRT include:
Less widely covered by insurance companies - Insurance companies make deals with drug companies to have their products preferred over other products. The rationale that insurance companies will typically use to not cover compounded products is that they do not cover products that are not FDA approved. Since customized medications would never be able to go through the level of testing and clinical trials that a commercially available generic product does, compounded products can not be FDA approved. However, In some scenarios, such as a documented medical need for a compounded product over a commercial one, insurance companies will pay for compounds.
Shorter shelf lives - Compounded products often do not contain the preservatives that commercially available products contain. The longest shelf life possible for a compounded product is 6 months, but typically with the more natural bases, the shelf life is 30 days after compounding. This can be inconvenient for some patients as it requires more trips to the pharmacy. However, we believe, as stated above, that this is truly an advantage as it allows you to avoid potentially irritating chemicals.
Potential quality issues - The FDA does not regulate compounds but that does not mean that compounding pharmacies are not regulated. Compounding pharmacies practices are overseen by the state’s board of pharmacy and also must comply with the standards set in place by the United States Pharmacopeia, which were recently revised to include stricter standards. Compounded BHRT falls under USP 800 standards. The best way a patient can determine the quality of a pharmacy is to ask the pharmacy questions such as: Where do you source your ingredients from? Have you ever had to recall any compounded products? Have you ever failed an inspection? What are your quality checks? If they can’t answer these questions for you, you may want to look elsewhere.
This concludes our three-part series on BHRT. We hope you found this information helpful! We are happy to answer more in-depth questions on compounded medications including Remedy’s stringent quality standards. Please stop by and speak with our knowledgeable pharmacists!