2/8/2021 Constant Contact

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ABOUT US

COMPOUNDING

STERILE COMPOUNDING

HOW TO WRITE FOR A Thank you for entrusting in the compounding services at Madison COMPOUNDED RX Medical Compounding Pharmacy to help meet the unique medication needs of your patients. We are excited to share our PRESCRIBER FORUM monthly newsletter with you and look forward to working with you. Please don't hesitate to let us know how we can assist you and your practice. LeAnn Chambers, Pharm.D. and Matthew Chambers, Pharm.D.

The Value of Compounded Bioidentical Hormone Therapy

After the results of the Women’s Health Initiative trials were first published in 2002, patient and professional interest in potential options to conventional hormone therapy grew, and the number of prescriptions for compounded hormones (cBHT) significantly increased.

Compounding is the preparation of a custom formulation of a medication to fit a patient’s unique needs which cannot be met with commercially available products. Estradiol, estriol, progesterone, and testosterone have been widely used and clinically accepted internationally since the 1940s, both as manufactured products and compounded preparations. Millions of women rely on bioidentical hormones for menopausal issues, fertility challenges, and other hormonal imbalances, and men benefit from therapy as well.

Even though there have been dozens of hormone-containing products evaluated for safety and efficacy and approved by the FDA, there is still a need for individual compounded preparations for millions of patients. Compounding permits the dose, dosage form, and route of administration to be customized and titrated to obtain the desired clinical effect in each individual patient while minimizing any potential side effects. This is why so many patients prefer cBHT as compared to manufactured products available only in limited dosage forms and strengths.

Many, if not most, patients have already tried FDA-approved products without the desired clinical response and so they change to cBHT. These patients have a significant therapeutic https://app.constantcontact.com/pages/campaigns/email-details/details/activity/389b5f0f-0a1f-4b63-97a5-bbf6ed295a6c 1/3 2/8/2021 Constant Contact need and often compliance and outcomes can improve with customized medications.

QUALITY COMPOUNDING

For decades, pharmacists around the world have compounded cBHT using the highest quality ingredients which are identical to those used in manufacturing FDA-approved products. Pharmacists are required to compound from an existing FDA-approved drug product or use bulk drug substances known as active pharmaceutical ingredients (API) that meet US Pharmacopeia-National Formulary (USP-NF) standards in applicable monographs. USP is a non-profit organization that sets standards for the identity, strength, quality, and purity of ingredients used to make drugs.

HORMONE TESTING

Many compounding pharmacists recommend and health care providers prescribe saliva or serum testing to confirm that dosing of cBHT is appropriate to maintain therapeutic levels and reduce the risk of side effects from excessive doses. There are often misconceptions regarding the most accurate way to test for hormone levels and the variation between salivary, capillary, and serum/plasma hormone concentrations based on the route of administration of the hormones (topical, oral, or parenteral). “Measurement of extremely low levels of hormones such as E2 [estradiol] in saliva requires a modification to the assay such as a preceding purification step. For example, ZRT Laboratory in Beaverton, OR utilizes an extraction step to purify E2 prior to its quantification by an antigen-excess enzyme immunoassay (EIA).”1

“The accumulation of topically administered progesterone in body tissues in the absence of a demonstrable change in serum levels strongly suggests that salivary levels of progesterone are more clinically relevant than serum levels in women using topical progesterone creams… In contrast to salivary E2 levels, the levels of progesterone are considerably higher and can be measured by a well-validated EIA. Salivary progesterone levels are approximately 10-fold greater than those observed in serum in postmenopausal women treated with an 80-mg dose of topical progesterone cream. Thus, tissue levels of progesterone may be very high, but this is not reflected in [serum] levels. This is a concern because progesterone is transformed into many metabolites, some of which are active, e.g. neurosteroids such as allopregnanolone. Therefore, excessive intake of progesterone may cause adverse effects such as hormonal imbalance and mood swings.1

In January 2021, Townsend Letter published an article by David T. Zava, Ph.D. which noted "The use of saliva and finger-prick capillary blood (dried blood spot – DBS) for testing sex steroid hormones (estradiol, progesterone, testosterone) was developed out of the need to circumvent some of the problems and inconveniences of collecting venipuncture blood. Comparison of saliva and capillary DBS has shown that when these hormones are produced endogenously, they show excellent correlation with serum/plasma tests and to some extent urine sex steroid metabolites. While the quantitative equivalencies of saliva, capillary blood, and serum/plasma are excellent when hormones are produced endogenously, we and others have shown that with topical (percutaneous) delivery of sex hormones, saliva and capillary DBS levels of hormones are strikingly different from conventional venipuncture serum and urine levels of the supplemented hormones. Topical steroid hormone therapy with increasing dosage results in very little, or only a very slight, dose-related increase in conventional venipuncture serum or urine metabolite levels of the dosed hormone. In striking contrast, topical dosing results in a relatively linear dose-dependent escalation of hormone in saliva and capillary blood DBS… Most noteworthy and often unappreciated is that physiological dosing with the sex hormones, meaning that the dose used topically is equivalent to the amount of sex hormone produced daily by the ovaries, testes, and/or adrenal glands, leads to physiological levels in saliva and capillary blood, but has little effect on increasing serum or urine levels from low menopausal/andropausal to healthy levels seen in young females and males... From pharmacokinetic studies, we know that when a steroid hormone is delivered as a cream or gel to the surface of the skin, it takes about two-to-six hours before it peaks in saliva or capillary blood from the fingertip, and then begins to slowly decline to baseline within 12-36 hours." 2

NASEM REPORT

The FDA commissioned a study from the National Academies of Sciences, Engineering, and Medicine (NASEM) on the safety, effectiveness and use of cBHT. The study committee included respected healthcare professionals but did not include a pharmacist with patient- facing experience, a compounding pharmacist, or a physician with substantive experience in https://app.constantcontact.com/pages/campaigns/email-details/details/activity/389b5f0f-0a1f-4b63-97a5-bbf6ed295a6c 2/3 2/8/2021 Constant Contact BHT. The peer reviewers included one former FDA employee (and current FDA contractor) who is a long-time, well-known opponent of pharmacy compounding.3

NASEM recommended “that prescribers restrict the use of cBHTs to two circumstances: when a patient is allergic to an ingredient in an FDA-approved hormone product, and when a patient requires a specific dosage form not available for an FDA-approved product.”4

Loyd V. Allen, Jr., PhD, RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding, responded that “when one looks at the conclusions of the NASEM report, it is apparent that many of these are the requirements for mass-manufacturing of FDA-approved drugs and not for an individual patient. Even though there have been dozens of hormone- containing products evaluated for safety and efficacy and approved by the FDA, there is still a need for individual compounded preparations for millions of patients… One needs to consider enhancing patient compliance and outcomes using various dosage forms, patient-specific doses and dose variations, different routes of administration, [and] different product components to achieve the patients desired response, etc… It should also be noted that cBHT formulations have been successfully compounded for decades and are not difficult to compound.”5

We know that FDA-approved therapies do not meet the therapy goals of many patients and that limiting access to cBHT as NASEM recommends would have far-reaching consequences for many patients. Our professional staff is happy to answer your questions.

Ask our pharmacist for more information about compounded hormone therapy and other customized medications to meet specific patient needs.

References: 1 Climacteric. 2021 Feb;24(1):38-45. 2 https://www.townsendletter.com/article/450-topical-therapy-estradiol-zava/ 3 https://a4pc.org/APC/Advocacy/Federal-advocacy/NASEM-cBHT.aspx 4 https://www.nationalacademies.org/news/2020/07/prescribers-should-restrict-the-use-of- non-fda-approved-compounded-bioidentical-hormones-except-for-specific-medical- circumstances 5 Compounding Today Newsletter. 9/25/20

Help protect your access to cBHT! The FDA is considering restrictions on cBHT and we need to show how cBHT has helped millions of people. Join the campaign and share your testimonial about how cBHT has affected YOU or your PATIENTS at a4pc.org/cbhtandme.

Madison Medical Compounding Pharmacy | 111 Fountains Blvd, Bldg B, Suite 2, Madison, MS 39110

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