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February 1, 2019  |  Volume 16  |  Issue 5
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Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
Pharmaceutical Compounding Questions and Answers

Question: What is "controlled room temperature (CRT)"? I see it a lot in storage conditions for drugs. What is the difference between CRT and room temperature (RT)?

Answer: Room temperature, also called "ambient temperature," is the temperature prevailing in a working environment.

Controlled room temperature is the temperature maintained thermostatically that encompasses the usual and customary working environment of 20�C to 25�C (68�F to 77�F).

The following conditions also apply:

  • The mean kinetic temperature (MKT) is not to exceed 25�C. Excursions between 15�C and 30�C (59�F and 86�F) that are experienced in pharmacies, hospitals, and warehouses, and during shipping are allowed.
  • Provided the MKT does not exceed 25�C, transient spikes up to 40�C are permitted as long as they do not exceed 24 hours. Spikes above 40�C may be permitted only if the manufacturer so instructs.

Articles may be labeled for storage at CRT, or at 20�C to 25�C, or other wording based on the same MKT.

An article for which storage at CRT is directed, may, alternatively, be stored and shipped in a cool place or refrigerated, unless otherwise specified in the individual monograph or on the label.

Next week, we will look at "What is meant by mean kinetic temperature (MKT)?"


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

Fake Walgreens Pharmacists Dispensed Over 700,000 Prescriptions
The California pharmacy board is investigating whether three Bay Area Walgreens stores allowed an employee without a pharmacist license to verify or dispense hundreds of thousands of prescriptions. For more than a decade, Kim T. Le handled hundreds of thousands of prescriptions. She administered vaccinations, ordered medications, counseled patients on their prescriptions, and supervised pharmacy technicians, state officials said.

State officials alleged that from November 2006 to September 2017, Le unlawfully signed off on or dispensed 745,355 prescriptions, many of which were verified electronically and remotely. More than 100,000 of those prescriptions were for controlled substances. The State Board of Pharmacy will determine whether the three Walgreens stores in Fremont, San Jose, and Milpitas should have their pharmacy licenses suspended or revoked.

Inspectors found out about Le and her alleged scheme two years ago on a routine visit to a Walgreens store in Fremont. The inspectors discovered the pharmacy had dispensed prescriptions for alprazolam but did not fully meet state requirements. Officials said the prescriptions were missing the "California Security Prescription" watermark, checked boxes that indicated the number of refills, and other necessary information.

California officials learned that Le had a pharmacist technician license, but that it expired in 2008. "Le had never been licensed as a pharmacist," the complaint said. According to the complaint, Le began working for Walgreens, the second-largest drugstore chain in the United States, as a cashier on September 20, 1999. Two years later, she began working as a pharmacy technician and an intern pharmacist. In 2006, she began working as a pharmacist. https://www.latimes.com/local/lanow/la-me-fake-pharmacist-walgreens-bayarea-20190130-story.html

Two Alzheimer's Drug Trials Dropped after Setback
Roche Holding and partner AC Immune SA stopped two late-stage clinical trials of their crenezumab drug for early Alzheimer's, the latest in a string of failures to find a treatment for the progressive brain disease. The announcement came after an interim analysis indicated it was unlikely to be effective.

About 5.7 million Americans are living with Alzheimer's and the number is projected to rise to nearly 14 million by 2050, according to the U.S. Alzheimer's Association. Drugmakers such as Eli Lilly, AstraZeneca Plc, and Johnson and Johnson have all abandoned trials testing their experimental drugs.

The trial failures have undermined the so-called amyloid beta, or abeta, treatment hypothesis in which protein plaques in the brain are believed to play a pivotal role in the disease.
https://www.reuters.com/article/us-roche-hldg-alzheimers-ac-immune/roche-ac-immune-drop-alzheimer-drug-trials-after-setback-idUSKCN1PO0GT

Not-for-profit Company to Offer 20 Generic Drugs this Year to Alleviate Shortages
A new "not-for-profit" supplier of generic drugs formed by a consortium of hospital systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock.

Since the start-up of Civica Rx, spearheaded by Intermountain Healthcare, was announced last January, the Utah-based company has raised more than $160 million from its members, which include HCA Healthcare Inc. hospital chain, the Mayo Clinic, the Catholic Health Initiatives, and others, which together represent about 800 hospitals.
https://www.reuters.com/article/us-usa-healthcare-generics/not-for-profit-to-offer-20-generic-drugs-in-2019-to-alleviate-shortages-idUSKCN1PI2PU

 

Did You Know ...

�that Walt Disney said the following?

"The way to get started is to quit talking and begin doing"!

 

Tip of the Week

How often have we dreaded starting on a project and kept putting it off, but finally just decided it has to be done, so we do it.

I don't know what our politicians are thinking by not doing what they were sent to Washington to do (i.e., do the will of the people); they have put it off long enough! The mess they have created and are in the middle of right now is more support for "term limits"�two terms and you're out! This doesn't mean two terms in the House AND two terms in the Senate; it is JUST TWO TERMS, total (Two terms in the House OR Senate or one term in each). We need to limit the time they have to develop their cushy financial relationships with lobbyists and others and limit the time they can be distanced from the people that elected them to represent them.

 

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Looking Back

Statistics prove,
Near and far,
That folks who
Drive like crazy---Are!
     Burma Shave

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