Unpublished Study from Portland, Oregon

 

Abstract- by Mary Spiering, RN, MN, CNS.

 

Background:

Amiodarone is one of the most widely prescribed antiarrhythmics for treatment of atrial fibrillation with rapid ventricular response. Peripheral amiodarone infusion may cause pain during infusion and subsequent phlebitis. Left undetected, on-going infusion can result in severe chemical burns resulting in tissue necrosis. Furthermore, undetected ongoing pain, can contribute to complex regional pain syndrome, and require on-going treatment. Nurses on the cardiac telemetry unit reported on-going issues with amiodarone related pain and phlebitis, requiring repeated IV starts. Nurses had a limited understanding of the incidence of phlebitis and no guidelines for peripheral amiodarone infusion existed.

Purpose:

The purpose of this study was to reduce patient harm by implementing a standardized approach to infusing peripheral Amiodarone.

Methods:

In April, 2012, the clinical nurse specialist began tracking all patients with peripheral amiodarone infusions on the cardiac telemetry unit. Data collection included amiodarone concentration, visual inspection of the infusion site, and phlebitis grading.

An Amiodarone infusion guideline was developed by a multidisciplinary group which included pharmacy, IV therapy, cardiology, and nursing.

 In August, 2012, IRB approval was obtained and data collected post-guideline implementation. Patients were identified through a report from the EMR, and individual nurses notifying the Clinical Nurse Specialist for patients with Amiodarone infusions. Data were collected to compare pre and post implementation amiodarone phlebitis rates.

 

Results:

 

Guideline

Data Collection period

Total N

Phlebitis of 1 or more

Phlebitis Rate

% reduction

Pre Guideline

3/2/12-6/18/12

34

29

85%

 

Post Guideline

8/7/12- 1/2/13

34

13

35%

50% reduction

 

Conclusion: Implementation of a peripheral amiodarone infusion guideline helped reduce patient harm however further improvements are needed to reduce amiodarone related phlebitis rates even further. 


7.     At Guideline Attached

 

Amiodarone peripheral infusion phlebitis: A nursing intervention to reduce patient harm

AttachmentSize
Amiodarone Peripheral Infusion Guide FINAL 10.25.12.pdf86.16 KB

Any harm to applying heat to

Any harm to applying heat to an amiodarone associated thrombophlebitis? Until today, I was not aware that  there is a recommendation to treat phlebitis in relation to the drug infused. 

Thank you,

 

Nancy

Nancy Rose 

Thank you, Kathy. Found the reference

Precipitate Formation:
Dilution of amiodarone hydrochloride may cause precipitation, especially in concentrations between 45 mg/mL and 0.0025 mg/mL.Very large or very small dilutions are less subject to precipitation. Precipitation may occur in variable time frames; it may occur immediately upon mixing or after time has elapsed. Precipitation may also occur in the bloodstream and possibly contribute to phlebitis.
Reference: Trissel's™ 2 Clinical Pharmaceutics Database (Parenteral Compatibility).

 

 

 

Mary Spiering, RN, MN, CNS

Providence St. Vincent Medical Center

Portland, Oregon

mary.spiering@providence.org

precipitate comment found in 2013 Trissels

Mary

You will find the precipitate conmment in the 2013 Trissels

Pharmacy never tells us all that trissels states.  It is a new comment to my knowledge in Trissels as I do not remember it in previous editions of Trissels if my memory holds

Sorry to get back to you so late

kathy

Thank you, Lynn

Appreciate the references. Talked to the folks from University of Michigan and found that despite the reduction in thrombophlebitis, they were still finding significant issues with PIV Amiodarone.

Mary Spiering, RN, MN, CNS

Providence St. Vincent Medical Center

Portland, Oregon

mary.spiering@providence.org

 While doing work on PIV and

 While doing work on PIV and phlebitis, I came across these studies on amiodarone:

1. Boyce BA, Yee BH. Incidence and severity of phlebitis in patients receiving peripherally infused amiodarone. Critical care nurse 2012;32:27-34.

2. Iqbal FM, Chawla B, Koneru J, Bikkina M. Amiodarone-Induced Thrombosis: A Case Series and Brief Review of the Literature. Am J Ther.

3. Mowry JL, Hartman LS. Intravascular thrombophlebitis related to the peripheral infusion of amiodarone and vancomycin. Western journal of nursing research 2011;33:457-71.

4. Slim AM, Roth JE, Duffy B, Boyd SY, Rubal BJ. The incidence of phlebitis with intravenous amiodarone at guideline dose recommendations. Mil Med 2007;172:1279-83.

Lynn

Lynn Hadaway, M.Ed., RN, BC, CRNI

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

Thank you

Hi Kathy,

Thank you for your reference, indicating Amiodarone can precipitate when the drug enters the bloodstream, contributing to phlebitis.

You indicate this was a new fact we are not told about in Trissels- so did you find this in Trissels or another reference?

Thanks-

Mary Spiering, RN, MN, CNS

Providence St. Vincent Medical Center

Portland, Oregon

mary.spiering@providence.org

Amiodarone pH and Tonicity

The premise of using a cold pack is related to the pH of Amiodarone (Between 3 and 4, depending upon the product). We have observed that the redness and edema associated with Amiodarone related phlebitis is reduced when the cold pack is applied, however we do not have solid evidence to support our observations.  Patient comfort and reduced redness has been the driver.

Tonicity: Tonicity and osmolarity are used interchangeably when referring to IV infusions. The final solution osmolality of Amiodarone is approximately 255 mOsm/L to about 345 mOsm/L. Normal serum osmolality is between 285-295 mOsm/L. Hypotonic solutions have an osmolarity less than 250 mOsm/L and hypertonic solutions are more than 375 mOsm/L.  Based on this information, then Amiodarone could be considered an isotonic solution, since it sits in the "middle range." 

So, by using the cold to help reduce the inflammation/pain,perhaps that is an appropriate approach at this point.

Lynn-

Your thoughts ?

 

Reference:

Mosher et al. US Patent application publication. June 7, 2012. US 2012/0142768 A1.

Hadaway, L. & Chamallas, S. Vancomycin. New Perspectives on an Old Drug. Journal of Infusion Nursing. 2003 (26)5; 278-284.

 

Thank you,

Mary Spiering, RN, MN, CNS

Providence St. Vincent Medical Center

Portland, Oregon

mary.spiering@providence.org

 Hyaluronidase is an antidote

 Hyaluronidase is an antidote for the treatment of infiltration or extravasation. It is not indicated for the treatment of phlebitis. Frequently there is confusion between infiltration and phlebiits because phlebitis can also produce edema. Use of cold is always indicated when the infiltrated fluid is hypertonic, although I am not certain of the tonicity of Aminodarone as this would depend upon the amount and type of diluent. For phlebitis treatment, cold would be for reducing pain and increasing comfort. Usually this is changed to heat to remove all of the cellular products of inflammation. Lynn

 

Lynn Hadaway, M.Ed., RN, BC, CRNI

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

questions about Guide

I have two questions:

1) the guide states to apply a cold pack, is this to "hold infiltrated/extravisation in that tissue or for comfort?

2) Does Hyaluronidase help with this drug?

 

Moira

Moira McErlean

questions about Guide

I have two questions:

1) the guide states to apply a cold pack, is this to "hold infiltrated/extravisation in that tissue or for comfort?

2) Does Hyaluronidase help with this drug?

 

Moira

Moira McErlean

Lynn, why was the 5%

Lynn,

why was the 5% phlebitis statement removed from the 2011 INS Standards? Are most facilities using that rate as the standard currently?

I hate this drug for PIV's

pH is 4.08 - not a surprise (Trissels)

I have a hard tme for some stupid reason pronouncing it.

Trissels says concentrations greater than 2mg/ml require a dedicated CVC period

Intravenuous infuison at concentrations of 1 to 6 mg.ml is performed using a volumetric pump and a dedicated CVC yes CVC it says with an inline filter if possible (Trissrels)

and here is a new fact many of us are not told in Trissels:

"amiodarone hydrochloride may precipitate when diluted.  Studies found litt or no precipoitation when the forumulatin was diluted to very small or very large concentrations.  In the middle range, however, at concetrations between 45 mg/ml (90% amiodarone hydrochloride formulaiton) and about 0.0025 mg/ml in phosphate buffer (pH 7.4), the drug concentration exceeds the solubility of amiodarone hydrochloride inthe mixture.  Precipitation may occur immediatley or on standing.  Such precipitation may occur when the drug enters the bloodstream contributing to the phlebitis associated wth amiodarone hydrochloride"

"Manufacturers recommend that all infusions longer than two hours be made from glass or pololefin containers only" (Trissels)  due to loss of sorption to PVC infusion sets and containers (bags)

"The use of an inline filter during administration is recommended" (Trissels)

No substitute for this drug.  Growing in popularity.  Tissue necrosis no surpirse.  High phlebitis.  Does not match INS PIV adminstrations standards of care due to pH alone

 

Kathy Kokotis

 

 

 That 5% phlebitis statement

 That 5% phlebitis statement was removed from the 2011 INS Standards. it is not in the Phlebitis standards. Lynn

Lynn Hadaway, M.Ed., RN, BC, CRNI

Lynn Hadaway Associates, Inc.

126 Main Street, PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

Avoiding patient harm

Appreciate your comments- no need to do a study if you know patients are suffering harm. Implementing best practice is a key component of nursing. Keep persisting and you should be able to find the right person to help you lead efforts to implement best practice.

Amiodarone is challenging to infuse peripherally. Despite all our efforts, we still have phlebitis rate of 30-40%.The Infusion Nursing Society standard indicates that the acceptable peripheral –short catheter phlebitis rate should be 5% or less in any given patient population so we have a long way to go to meet the acceptable rate. We are currently working with pharmacy to determine if dilution will help reduce the phlebitis rate but the real culprit is the pH of the product. For example, the Baxter pre-mixed Nexterone has a reported pH of 3.3-3.9 and the product we are currently using has a pH of 4-4.2.

The other question is - why are we using this? Is there another agent that would address Afib with RVR after valve surgery? At this time, the answer seems to be no but working with the manufactuer may help lead the way for a better product- stay tuned !

Mary

Mary Spiering, RN, MN, CNS

Providence St. Vincent Medical Center

Portland, Oregon

mary.spiering@providence.org

Excellant

 Thank you for a well written infusion guide. We have had the same problems for years and I made the same recommendations.  I got ignored.  Great job. Oh and by the way, I have copies of the recommendations I made and who I sent them to.  I am not going to sacrifice my license for a facility that ignores me.  Things are starting to get better though.  Maybe I will get to readress this problem again.  At the first sign of rhythm problems post op our chest surgeon orders PICC placement.  He approached me about the problem when things were hot and heavy and complained to me.  I told him what recommendations I had made and to who and told him no one wanted to try the suggestions.The filter has helped a little.   I didn't have the resources or support to pull together a study.  Good job.

 

Mary Penn RN

 

This is excellent

This is something I can use immediately, thank you very much!

 Jill Nolte, BSN RN CRNI VA-BC