Compounding Academy: Recommendations on Compounded Bioidentical Hormone Therapy

Brooks Rogers, Pharm.D. Compounding Academy President

Recommendations on the Safety, Effectiveness and Use of Compounded Bioidentical Hormone Therapy

As I begin my tenure as the APA Compounding Academy President, I wanted to begin by introducing myself. I am a 3rd generation pharmacist at Don’s Pharmacy in Little Rock alongside my Dad, brother, cousin and uncle. Our store has grown into a hybrid of sorts. We are a combo pharmacy that services retail and long-term care patients, while we also have a non-sterile compounding lab. Our front end is primarily focused on DME, wound care and surgical supplies. I was born and raised in Little Rock. I did my undergraduate at the University of Arkansas (during ‘the Bobby Petrino era’), and graduated from the UAMS College of Pharmacy in 2014. My wife and I have two boys, ages 3 and 1.

In my first article, I wanted to draw your attention to a study that was recently published by the National Academies of Science, Engineering, and Medicine (NASEM) titled “The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness and Use.” I want to share the conclusions released by NASEM with the membership because if you’re a compounding pharmacy, I am certain you compound bioidentical hormone therapy (BHT). BHT is a big deal for compounding pharmacies, but more importantly for the patients we serve.

The study concludes with 6 recommendations in regards to BHT safety, effectiveness, and use.

Recommendation 1: Restrict the use of BHT preparations. Prescribers should limit BHT preparations to patients with a known allergy or a required dosage form other than what is commercially available. Also, they recommend that compounded BHT doses should not exceed those of FDA-approved hormone therapy products.

Recommendation 2: The Pharmacy Compounding Advisory Committee should examine certain BHT for the FDA’s Difficult to Compound List: estradiol, estrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate. Recommendation 3: There should be an increase in education for prescribers and pharmacists who market, prescribe, compound, and dispense BHT preparations. For prescribers, the committee recommends they receive a certification at the state level if they are want to begin or continue prescribing BHT compounds. For pharmacists, the committee recommends more in depth training on BHT compounds.

Recommendation 4: Further federal and state oversight is needed to improve public health and clinical concerns regarding the safety and effectiveness of BHT.

Recommendation 5: All conflicts of interests should be gathered and released. Conflicts of interest should be open to the public in a publicly available source maintained by state licensing boards.

Recommendation 6: Evidence of the safety, effectiveness and use of BHT compounds needs to be strengthened and developed.

I share these conclusions with you to ensure compounding pharmacies are conscious that they are always under fire. Keep in mind, this is just the latest study of many to have targeted BHT over the years. It may or may not have much weight and perhaps very little effect on your compounding business, but it’s certainly something to be aware of in the ever-changing compounding pharmacy landscape. As we say at Don’s Pharmacy, “it’s always something.” §