Last week, we began our discussion on the possibility of "standardization" of strengths of some dosage forms and emphasized pediatric oral liquids. We'll continue with pediatric oral liquids this week and also look at some negative points.

Standardization "across the board" may not be appropriate in some cases, including:

• Large variation in dosing from infants to preteens
• Weight-based dosage calculations may require odd volumes to be measured
• Inability to enforce universally
• Volumes too difficult to administer (too large or too small)
• Lower concentration is desired by the prescriber
• Too difficult to compound a standard concentration for everyone
• A longer beyond-use date may be required if bulk compounded
• Cumbersome to change the current practice
• Electronic prescribing issues
• Teaspoons and other measuring devices will continue to be problematic

More points could probably be added to this list by pharmacists with a diverse array of experiences. Therefore, this list is open to additional points.

Generally, the majority of pharmacists believe that standardization of oral liquids compounded for pediatric patients improves the safety of these patients. This supports the need for stability studies supporting standardized pediatric formulations. With standardization, there should be fewer concentrations that need to be studied, and this should cost less. Also, with the additional data, batches can be compounded and a certain "economy of scale" may be achieved.

More next week.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

FDA Drug Shortages
There are over 110 drugs currently in short supply; don't forget to see the list of FDA Drug Shortages at:
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

The FDA Releases Proposed Rule on 503B Compounding from Three Bulk Substances
On August 28, 2018, the FDA released a proposed rule to exclude three substances-1) bumetanide, 2) nicardipine hydrochloride, and 3) vasopressin-from the list of substances that 503B outsourcing facilities can use when compounding from bulk (i.e., active pharmaceutical ingredient) based on a lack of "clinical need." If the proposed rule is finalized as is, 503B facilities will no longer be able to compound from these bulk substances, although they are not precluded from compounding from FDA-approved products containing these substances.
[Note: This does not affect 503A compounding pharmacies.]
https://www.federalregister.gov/documents/2018/08/28/2018-18614/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal

Did You Know ...

�that Walt Disney made the following statement�

"All the adversity I've had in my life, all my troubles and obstacles, have strengthened me�You may not realize it when it happens, but a kick in the teeth may be the best thing in the world for you."

�and that Charles Dickens wrote the following in his novel titled "The Personal History, Adventures, Experience and Observation of David Copperfield the Younger of Blunderstone Rookery"?

"I know your life has been hard, but you are what you are because of it."
(Agnes Wickfield to David Copperfield)

Tip of the Week

Rejection, inadequacy, and disappointments of all kind are a part of life. Are we not doing our kids an injustice by giving them a trophy just for showing up at a ballgame? Or a good grade for just showing up for class? I've yet to see a successful athlete that works out with marshmallows and noodles. It is the expenditure of energy, the weights, the resistance, the sweat, and the contact/hurting that builds up an athlete. In a profession, there are ups and downs, and if our response is correct to these obstacles, we will be better off as we continue to grow. We are facing a number of these obstacles now and the question is�How do we individually respond?

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Looking Back

He's the boy,
The gals forgot!
His line was smooth,
His chin was not!
     Burma Shave