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Advisor
Posts: 19
Registered: ‎07-13-2016
0

Ditiazem Drip BUD

I would like your collective opinion on this.

 

Due to the current IV flluid shortages, we are considering batching ditiazem drips.

 

LexiComp, MIcromedex, Global RPh, and the package insert all list the stabillty  of diltiazem in NS or D5W, at a maximum concentration of 1mg/ml, as 24 hours refrigerated.

 

I find one study from 2012 which concluded that "Diltiazem hydrochloride diluted to 1 mg/mL in 5% dextrose injection was stable for 30 days when stored at -20 °C, 2-6 °C, and 22-25 °C."

 

Can I use this one study to extend the BUD of this pharmacy compounded product (in D5W) to 14 days refrigerated (if we consider it to be low risk) or 9 days refrigerated (if we consider it medium risk)?

 

Thanks for your help.

Occasional Visitor
Posts: 1
Registered: ‎01-11-2018
0

Re: Ditiazem Drip BUD

Wondering if you were able to get any answer for information on this subject.  We are in the same situation where we are running out of add-vantage bags for our diltiazem drips.  Thank you for your help.

 

Kathryn Schwartz, R.Ph.

Pharmacy Technology Coordinator

Phone: 215.345.2569

Fax: 215.345.2433

email: kschwartz@dh.org

Advisor
Posts: 19
Registered: ‎07-13-2016
0

Re: Ditiazem Drip BUD

No responses to my original question yet.

Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: Ditiazem Drip BUD

kkamenet,

 

What journal was this study published in?  Did you evaluate the robustness of the data and did they use a stability indicating method when they tested the drug? Can you upload the article so everyone can look it over? 

 

Trissel has published five rules that need to be checked when evaluating a study.  They are:

 

Trissel Stability Criteria

  • Materials, test conditions and methods are completely described
  • A Stability-Indicating Assay is used
  • An Analytical Determination is performed at the outset
  • A time-zero determination of drug concentration is essential
  • Replicate assays at adequate /appropriate intervals since single point assays are not robust and do not control for the effects of assay variability and human error
  • Make sure the conclusions drawn fit the results obtained
Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 19
Registered: ‎07-13-2016
0

Re: Ditiazem Drip BUD

http://www.ajhp.org/content/70/10/894?sso-checked=true

 

That is a link to the study.

 

Even if the rules are met, is one study enough to support a BUD extension?

 

 

Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: Ditiazem Drip BUD

If the study is robust and scientifically sound, why not? 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Advisor
Posts: 19
Registered: ‎07-13-2016
0

Re: Ditiazem Drip BUD

Point taken. All of this changing things around to accomodate IV fluid shortages has me second guessing myself.

Thanks for your help.

Karen

Highlighted
Expert
Posts: 1,167
Registered: ‎02-23-2010
0

Re: Ditiazem Drip BUD

Hi Karen,

 

I understand but you know your stuff.  Keep fighting the good fight. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.