As we saw last week in the NASEM cBHT report, there is no standard definition of "clinical utility," and the FDA did not provide one. Therefore, the NASEM committee was faced with preparing their definition. It's interesting that the FDA paid a lot of money to a private organization to do something which they did not define. Nonetheless, NASEM's own definition of "clinical utility" is:

Clinical utility is a multidimensional construct that reflects evidence about safety, effectiveness, and therapeutic need. Patient preference is also a component of clinical utility, and it reflects patients' individual decision-making related to benefits and risks.

Just for curiosity, let's look at the six separate recommendations made to the FDA and determine if they clearly match up with the committee's own developed definition of "clinical utility."

The individual components of the NASEM definition include "evidence" about:

• Safety^a
• Effectiveness^b
• Therapeutic need^c
• Patient preference^d

Obviously, each of us may have different opinions and interpretations, but this does provide a visual presentation of whether or not all the recommendations are supported by the various SETP components of NASEM's definition of "clinical utility."

• How many of each symbol do you have?
• Are all the recommendations appropriate for the FDA to consider and within their scope of responsibility?
• As we know, studies and articles can be selectively used to support just about anything, as we are experiencing now with masks, social distancing, and especially therapeutics for the current pandemic.

^abcWith millions of patients successfully and effectively using cBHT daily for decades and with hundreds of FDA-approved commercial products using the bioidentical hormones over the years, the above chart is not surprising. Bioidentical hormones have been approved by the FDA in products as safe and effective and also compounded for decades.

Let's now look at when bioidentical hormones were evaluated and first approved for inclusion in the USP. What is surprising is the following:

Just for interest sake, conjugated estrogens were introduced into USP XVIII in 1970 and medroxyprogesterone acetate in USP XVII in 1965.

So, for about 20 to 25 years prior to the 1970 and 1965 introduction of conjugated estrogens and medroxyprogesterone acetate, bioidentical hormones have been official in the USP. In other words, for over 70 years they have been widely used safely and effectively.

Since none of the above are "pre-1938 grandfathered drugs," their products have all gone through the FDA evaluation as drug products and deemed to be "safe and effective"; otherwise, they should not be on the market. Granted, the FDA approves "drug products" and not "drug substances," but the drug substance is inherently evaluated for safety and efficacy within the FDA-approval process.

^dIt is quite obvious that commercially manufactured BHT drugs do not meet the needs of all patients, therefore, cBHT is a necessity. In fact, the Report even explains that compounded medications are important. Due to the large number of physicians prescribing, patients requesting, and pharmacists compounding, it is quite evident that a large population of patients require cBHT for a better quality of life.

More next week

Did You Know ...

...that the following was a quote on a pharmacist's t-shirt?

"Be nice, I'm in charge of the happy pills!"

Thought of the Week

For six months, we have been challenged with the pandemic that has affected the entire world. Looking back at history, there have been numerous similar and many much worse along with many wars and other challenging times. Actually, here in the U.S., we have been spared so much adversity that when something is "uncomfortable," we tend to complain and gripe a lot. However, a kind word, a showing of understanding and help, and seeing others helping others is far better than the "happy pills" and makes us all feel better!

Join the CNL!

IJPC would like to invite all compounding pharmacists and technicians to join the Compounders' Network List (CNL) - an e-mail-based resource for sharing compounding information with your peers.

Go to the following website for more information and to join.

https://ijpc.com/cnl

Looking Back

Every Sheba,
Wants a Sheik,
Strong of muscle
Smooth of cheek!
     Burma-Shave