What does "Clinical Utility" mean? Is it the same as safety and effectiveness? Actually, there is no standard definition of "clinical utility." Let's look at the NASEM report.

Clinical utility is a multi-dimensional, context-dependent term for which no standardized definition exists.

Given this, the committee searched

• the literature,
• position statements and
• guidances issued by
• professional medical societies and associations,
• stakeholder testimony, and
• submitted resources

Based upon the committee's efforts from the literature, "clinical utility" has been described as being able to:

• optimize treatment and short- and long-term health outcomes,
• affect diagnostic testing processes,
• assist with patients' decision making,
• offer psychological benefits to the patient, including improved health literacy, and
• improve society.

The report goes on to mention that clinical utility components are not confined to randomized controlled trials, rather, it takes into account a broad range of factors, including:

• the current standard of care,
• the care setting,
• costs of care and tests, and
• the nature of what is being evaluated for clinical utility.

The committee determined that these were not necessarily all-inclusive and that the phrase may include other components.

The committee then defined clinical utility as:

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.

One of the next steps for compounding pharmacists is to:

Look at the six separate recommendations made to the FDA that evolved from the committee's deliberations utilizing their definition and determine if they clearly match up with the committee's own developed definition of "clinical utility."

RECOMMENDATION 1
Prescribers and compounding pharmacists should restrict the use of cBHT preparations.
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.
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 is needed to better address public health and clinical concerns regarding the safety and effectiveness of 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.

Capping and Crimping Survey - Participants Needed

The Compounders' Network List would like to invite all to participate in a brief, 3-minute survey about capping and crimping practices in your compounding pharmacy. You may see the collected data in a future journal article. Or you can receive a copy of the results, if you wish. Please use this link to participate no later than Friday, August 14, 2020.

https://www.surveymonkey.com/r/9D3YD36

Did You Know ...

...that George Washington said the following?

"If freedom of speech is taken away, then dumb and silent we may be led, like sheep to the slaughter."

Thought of the Week

Discipline for Freedom:

Lovers of freedom often overlook this paradox: There is no true freedom without discipline. An ordered and disciplined life gives us freedom to do the things we want to do.

Life offers a choice between self-discipline and imposed discipline. The advocates of dictators would have all discipline imposed by outside force to produce efficient lives. But those of us who love the freedom of democracy do not care to have our lives regulated by some dictator. Yet discipline is essential. Have it we must, whether we like it or not. If we do not want dictators, we must impose upon ourselves discipline to bring order out of social chaos. (Anon)

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

Goodbye! Shaving brush,
Half a pound for half a dollar,
Very fine for the skin,
Druggists have it,
Cheer up face, the war is over!
     Burma-Shave