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Compounding This Week Newsletter from www.CompoundingToday.com
Our Compounding Knowledge, Your Peace of Mind
July 10, 2020  |  Volume 17  |  Issue 28
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
NASEM Report

The Clinical Utility of Compounded Bioidentical Hormone Therapy (cBHT)

Note: For those that have not read the entire 300+ page report, we will briefly present the recommendations of the report over the next few weeks. This week, we will present the titles of the six recommendations and the explanations on the first two recommendations, with details to follow on the remaining four in the next two weeks..

The public briefing on the conclusions and recommendations from the report on The Clinical Utility of cBHT was held on July 1, 2020. The recommendations from that report are to be provided to the FDA. You are encouraged to obtain a free copy of the materials and read them thoroughly!

RECOMMENDATION 1

Prescribers and compounding pharmacists should restrict the use of cBHT preparations.

Use of cBHT should be restricted to patients with:

  • A documented allergy to an active pharmaceutical ingredient or excipient of an FDA-approved drug product or a documented requirement for a different dosage form.

  • Patient preference alone should not determine the use of cBHT preparations.

Prescribed dosage strengths:

  • Should not exceed those of FDA-approved hormone therapy products because of potential safety concerns. Any use of cBHT, including therapy for gender dysphoria, should align with established clinical guidance and require documentation of shared decision making and rigorous monitoring for long-term risks.

Informed decisions:

  • Prescribers and compounding pharmacists should clearly explain the limited evidence-based information about the safety and effectiveness of cBHT preparations. They should inform patients that compounded preparations are not FDA approved.


RECOMMENDATION 2

The (FDA) Pharmacy Compounding Advisory Committee should review select bioidentical hormone therapies and dosage forms as candidates for the FDA Difficult to Compound List.

Candidates:

  • Estradiol, estrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate

  • Pellet dosage forms

RECOMMENDATION 3

Improve education for prescribers and pharmacists who market, prescribe, compound, and dispense compounded bioidentical hormone therapy (cBHT) preparations.


RECOMMENDATION 4

Additional federal and state-level oversight should be implemented to better address public health and clinical concerns regarding the safety and effectiveness of compounded bioidentical hormone therapy (cBHT).


RECOMMENDATION 5

Collect and disclose conflicts of interest.


RECOMMENDATION 6

Strengthen and expand the evidence base on safety, effectiveness, and use of compounded bioidentical hormone therapy (cBHT) preparations

It should be explained that the report states:

"As discussed in Chapter 1 of this report, 'clinical utility is a multi-dimensional, context-dependent term for which no standardized definition exists'"
and then follows up with the approach of the committee to perform this task.

More details coming each week.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition

Resources:
https://www.nationalacademies.org/news/2020/07/prescribers-should-restrict-the-use-of-non-fda-approved-compounded-bioidentical-hormones-except-for-specific-medical-circumstances



https://www.nap.edu/catalog/25791/the-clinical-utility-of-compounded-bioidentical-hormone-therapy-a-review

Editor's Comment: W: Well, the fake news is already at it...calling compounded bioidentical hormone preparations as "neither natural nor safe"! The NASEM study is cited, but the media appears to be taking it upon themselves to launch another smear campaign against compounding that consists of lies and misrepresentations written by either poorly educated or noneducated journalists in the area of pharmacy for a "quick headline" and a few minutes of fame, at the cost of smearing pharmacists dedicated to individualizing drug products for their patients. We all need to be prepared to respond to patient's questions and explain to them that the preparations compounded for them are of the highest quality ingredients (identical to those used in manufacturing FDA-approved products) and are prepared specifically for them whereas manufactured products are for a "one-size-fits-all" consumer (with some variability in dosing but in very limited dosage forms).

And...in case you didn't know, if the APIs listed in Recommendation #2 above are placed on the Difficult to Compound list by the FDA, that removes them from being able to be used in compounding!

 

Did You Know ...

...on "Leadership," that Walt Disney said the following?

"Courage is the main quality of leadership in my opinion, no matter where it is exercised. Usually it implies some risk-especially in new undertakings. Courage to initiate something and to keep it going, pioneering and adventurous spirit to blaze new ways, often, in our land of opportunity!"

 

Tip of the Week

To go along with what Walt Disney said, Nelson A. Rockefeller stated the following:

"The nourishing of the American system requires a sense of responsibility, not only on the part of individual citizens, but especially on the part of America's leadership. I am not speaking alone of political leaders, but of the leaders of all phases of our society as well.

To the extent that they do not exercise their power and influence in the direction of the common good, they are undermining the very system that has given them that power and influence."

 

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Looking Back

Don't take a curve
At 60 per,
We hate to lose,
A customer!
     Burma-Shave

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