[EXTERNAL] List Digest, Aug 24, 2019

Sean Ross

[EXTERNAL] List Digest, Aug 24, 2019
Good morning Tom,


Where could I read more about this? I find it interesting.


Thanks.


Sean Ross

WVUH, Ruby

CCP-S

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Subject: [EXTERNAL] [PerfList Discussion Forum] - List Digest, Aug 24, 2019

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The following posts were made on Aug 24, 2019

1. RE: 4:1 "Del Nido" - (Thomas N Muziani, PA-C, CP)

1. RE: 4:1 "Del Nido" (Thomas N Muziani, PA-C, CP<mailto:[login to unmask email]>)
From: Thomas N Muziani, PA-C, CP
Subject: RE: 4:1 "Del Nido"

Peter,

Although this issue has been discussed before ( using del Nido in variations other than what has been published) "modifying" the solution seems to have gained traction over the last year.

The bottom regarding customizing any cardioplegia is this;

Modifying the solution in configurations other than what Dr. del Nido has published, exposes you, your institution and your surgeon to a whole world of hurt:

1. It can no longer be considered a "del Nido cardioplegia" and your safest and most obvious avenue is to drop the "del Nido" moniker immediately.
2. The days of customizing your cardioplegia without voluminous research, animal testing and documentation are over. A court of law will demand hard documentation and without that you are fully exposed.
3. Due to a small compounding company, New England Compounding Pharmacy, producing a contaminated spinal solution causing several deaths, a Federal law has mandated that ALL compounded solutions have to undergo testing for Stability, Sterility and Endotoxins. This may very well be the first reason your Pharmacy has refused to compound the solution for you.
4. I could go on, but I will end it with this; If you ever experience an unintended consequence and your patient suffers, do not rely on your surgeon or institution to take the bullet if it's "custom" cardioplegia. And, it would be wise to check with your insurance provider to see if they cover you acting as a Pharmacist.

Please know I am certainly on your side for utilizing the benefits of Lidocaine, magnesium and a low potassium formula in a 4:1 format. It is a wonderful cocktail. But the days of you customizing a solution without proper documentation and empirical data are effectively over.

Warm regards, T. N. Muziani

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Thomas N Muziani, PA-C, CP

RE: [EXTERNAL] List Digest, Aug 24, 2019
(in response to Sean Ross)

Hello Sean,

To access more information on the issues I have addressed regarding compounding cardioplegia, you may want to start with an article that Mr. Chris Lomax, one of the Chief Pharmacists' for B Braun- Central Admixture Pharmacy Services (CAPS) wrote on the subject for our AmSECT Journal several months back.

Also, the Federal law that I quoted came from the new mandate: Drug Quality and Security Act (DQSA) regarding ANY compounded solution having to undergo Test, Hold and Release for Stability, Sterility and Endotoxins. This requires a lag time between manufacture and release.

Also; since perfusion has been operating in a bubble regarding drug compounding and injection of drugs for the past fifty years, another issue needs to be addressed- Injecting any drug into a pre-prepared cardioplegia bag (i.e. potassium or bicarb etc.).

By doing so, the perfusionist needs to be apprised;

  1. You have now voided the warranty from the compounder (in-house or external) on sterility. In essence, you just bought the bag.
  2. Any issue of contamination will fall directly on perfusion shoulders
  3. If, by some chance, your surgeon has directed you to do so (i.e. "Add more K+") chart it with the inclusion of "upon surgeons orders". This will not absolve you, but you will not be isolated either.
  4. If you need to inject any drug, a safer route would be to inject into the oxygenator. Please keep in mind, no oxygenator can function as a Cuisinart...it has no "mixing" setting. It is best to inject your drugs slowly.

As Mr. Lomax will tell you, since the days of the New England Compounding Pharmacy debacle with contaminated solutions, perfusion, nursing, surgeons and pharmacies must adhere to a whole new set of guidelines. This is a major reason why Mr. Gary Grist's articles on failure scenarios should be mandatory reading.

I hope this helps. Please let me know if I may be of further assistance.

Warm regards, T

Thomas N Muziani 

Thomas N Muziani, PA-C, CP

Dr. Chris Lomax article on Compounding Aug 24, 2019
(in response to Thomas N Muziani, PA-C, CP)

Sean, This is the article I mentioned from Chris Lomax. Mr. Gary Grist was kind enough to forward it to me. He is, by far and away, much brighter than I am. T

Attachments

  • Lomax Compounding article AmSECT_AmSECToday[7035].PDF (4336.6k)

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