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Our Compounding Knowledge, Your Peace of Mind
April 7, 2017  |  Volume 14  |  Issue 14
IN THIS ISSUE
 
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ABOUT COMPOUNDINGTODAY
 
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Triova - A Company Built with You in Mind!
Serving Compounding Pharmacy Facilities with supplies for compounding equipment & facility preparation. Disinfectants, cleaners, garments, gloves, etc. www.yourcleanroomsupplier.com
IJPC's USP <800> Article Series Saves You Money!
Learn more about USP <800> Compliance at https://www.medisca.com/products/hazardous-compounding
 
Loyd V. Allen, Jr., Ph.d., R.Ph Letter from the Editor
Pharmacogenomics and Compounding Pharmacists, Part VI

Steps to Implementing Pharmacogenomics (PGx) in Your Practice

PGx and Prodrugs

Patient X is a 24 year-old white female who just delivered a baby 3 days ago and is breastfeeding her infant. She was discharged with a Rx for APAP with Codeine 300/30 with instructions to take one or two tablets every 4 to 6 hours as needed for pain.

A few days later she presents the baby experiencing:

  • labored breathing and
  • minimal bowel movements

Patient X also states that she, herself, tends to be:

  • sleeping a lot
  • feeling drowsy and itchy

She undergoes genetic testing and is found to be a CYP2D6 Ultrarapid Metabolizer (UM), expressing multiple copies of the *2 allele, resulting in enhanced conversion of codeine, a prodrug, to the active form, morphine.

Patient X rapidly metabolizes the codeine to morphine resulting in higher than normal levels and since morphine is distributed also in the breastmilk, the infant receives it during feeding. Both individuals are essentially being overdosed with morphine.

In this case, there are two reasonable options:

1. Reduce the dose of codeine, or better
2. Use a different analgesic

For more information on codeine and PGx testing, go to:
https://www.pharmgkb.org/guideline/PA166104996

Next week, we will look at the FDA labeling requirements concerning pharmacogenomics.


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

 

Update

The USP <800> Hazardous Drug Consensus Statement (HDCS) has been updated with additional group member profiles. For a free copy:

Go to CompoundingToday.com website; then

  • On the left column about half way down, select USP Compliance.
  • Fill in the:
    • Email address
    • First Name
    • Last Name
    • Company/Organization
  • Click "Submit" and a link for the free HDCS will be sent to you for the free download.

As an added note: There are now actually FOUR free documents that can be downloaded: one on USP <795>, one on <797>, and two on <800>.

Coming soon will be an 800 alternative resource for state boards of pharmacy that do not incorporate USP <800> by reference and prefer to develop their own.

 

News

CRO's Medicines from India Hit with EMA Suspension as Tests Stated to be "Unreliable"
The European Medicines Agency (EMA) wants to suspend around 300 marketed generic medicines and applications coming out of Indian CRO Micro Therapeutic Research Labs. This is related to concerns over "misrepresentation of study data and deficiencies in documentation and data handling."

Austrian and Dutch authorities inspected the sites a year ago and were concerned that the company was not accurately describing study data and was causing problems with its paper work and handling of trial data. The EMA conducted its own review and said that data from studies, which were made at the sites between mid-2012 and to the summer of 2016, "are unreliable and cannot be accepted as a basis for marketing authorization in the EU."
http://www.fiercebiotech.com/cro/indian-cro-s-meds-hit-suspension-as-ema-dubs-tests-unreliable

 

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Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/video or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.

 

Did You Know ...

�that�
"America is great because she is good.
If America ceases to be good,
America will cease to be great."
    -Tocqueville (1805-1859)

 

Tip of the Week

It seems America is considered "good" after a time of trial and difficulty, such as after WWII. During that time period, people worked hard to develop this nation, were family centered, and lived according to family values. Something has happened over the past 50 years and one wonders if America is really still "good." No question that a lot of it certainly is�but a lot of it is not. What has caused the decline in morals and "goodness"? Anytime a "good" activity is removed from practice (society, schools, churches, politics, etc.), there is less "good" taught and cultivated, and this gives rise to "ungood" (yes it is a word from the past).

 

Looking Back

It covers a multitude of chins!
     Burma Shave

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