Name, Title, Affiliation Phil Ayers, PharmD, BCNSP ... - ASPEN

Name, Title, Affiliation Phil Ayers, PharmD, BCNSP, FASHP Chief, Clinical Pharmacy Services, Mississippi Baptist Medical Center Associate Clinical Professor, University of Mississippi School of Pharmacy

Presentation Title Lipid Injectable Emulsions (ILE) Do's and Don'ts

Disclosures Speakers Bureau: Fresenius Kabi, Janssen

Presentation Overview/Summary ? In 2017, the ASPEN Parenteral Nutrition Safety Committee conducted a ILE Survey with Gap

Analysis. The survey revealed a number of institutions do not filter their ILE's and infusion times vary from published recommendations.

Learning Objectives ? Learning objectives for the presentation.

At the conclusion of the presentation, the learner will be able to: 1. Summarize the 2017 ASPEN ILE survey and gap analysis.

Key Takeaways/Fast Facts ? The results of this survey conducted in late 2016 found a wide variation in practice, particularly

across patient age groups. Conclusion: These findings demonstrate the need for ongoing dissemination and education on standardized safe practices for ILE use.

Learning Assessment Questions

1. Question 2: 2-in-1 PN will have intravenous lipid emulsion (ILE) piggybacked along with the PN. What is the appropriate hang time for ILE when piggybacked with a 2-in-1 PN? A. 8 hours B. 12 hours C. 18 hours D. 24 hours

Learning Assessment Answers: 1. Answer = B; Rationale: Current recommendations state that ILE within a TNA should have a maximum hang time of 24 hours. Recommendations also state than ILE piggybacked into a 2in-1 PN solution should have a maximum hang time of 12 hours. Tubing should also be changed every 12 hours when ILE is piggybacked with 2-in-1 PN. These recommendations also state that if ILE is to be infused separately over > 12 hours, the dose should be divided into two parts with a new container and tubing every 12 hours.

References: 1. Christensen ML, Ayers P, Boullata. at.el. Lipid injectable emulsion survey with gap analysis. NCP. 2017;32(5):694-702.

? 2019 ASPEN | American Society for Parenteral and Enteral Nutrition. All Rights Reserved. ? 2019 ASPEN | American Society for Parenteral and Enteral Nutrition. All Rights Reserved.

ASPEN 2019 Nutrition Science & Practice Conference

2017 ASPEN ILE Survey With Gap Analysis

Phil Ayers, PharmD, BCNSP, FASHP Chief, Clinical Pharmacy Services Mississippi Baptist Medical Center Clinical Associate Professor

University of Mississippi School of Pharmacy Jackson, MS

Disclosures

? Fresenius Kabi Speakers Bureau

Learning Objectives

Upon completion of this session, the learner will be able to....

1. Summarize the 2017 ASPEN Lipid Survey and Gap Analysis.

Lipid Injectable Emulsion Survey With Gap Analysis

ASPEN EDUCATION PROGRAM OUTLINE TEMPLATE

Kathleen M Gura, PharmD, BCNSP, Manager Pharmacy Clinical Research Program, Boston Children's Hospital, Boston MA

The Use of Alternative ILEs in the Pediatric Population

Disclosures

Pharmaceutical advisory board B Braun Baxter

Consultant B Braun Fresenius Kabi Pfizer Pediatric Center of Excellence Xellia Pharmaceuticals Northsea Therapeutics Alcresta Otsuka Pharmaceutical Factory

Patents/royalties for use of Omegaven

Presentation Overview/Summary

For more than 50 years, soybean oil lipid emulsions were the mainstay of therapy in the pediatric patient. In 2016 a mixed oil emulsion was approved for use in adults and 2018 a pure fish oil emulsion became available for pediatric patients with PN associated liver disease. This session will discuss the approved and unapproved uses of these ILEs in pediatric patients and discuss potential the pros and cons of each product.

Learning Objectives

At the conclusion of the presentation, the learner will be able to: 1. Understand when lipid restriction protocols can be safely used 2. Discuss the concerns of using a mixed oil IVLE in a pediatric patient 3. List which patients should not receive fish oil monotherapy

Key Takeaways/Fast Facts 1. Pure soybean oil emulsions may be an appropriate alternative to the newer lipid emulsions

in certain patients with limited venous access and multiple intravenous medications.

2. Monitoring essential fatty acid status is important in patients receiving an alternative IVLE. 3. Lipid restriction protocols should not be used with alternative IVLEs.

Learning Assessment Questions

Question 1: (True/false) Pure fish oil lipid emulsions contain only omega-3 fatty acids. A. True B. False

Question 2: According to the Holman Index, biochemical essential fatty acid deficiency occurs then the triene;tetrane ratio is:

A. > 0.05 B. < 0.05 C. >0.2

ASPEN EDUCATION PROGRAM OUTLINE TEMPLATE

D. >0.4

Question 3: (true/false) Pure fish oil emulsions are FDA approved for use in preventing PN associated cholestasis in children.

A. True B. False

Question 4: (true/false) Under the right circumstances, soy/MCT/olive/fish oil lipid emulsions can cause EFAD.

A. True B. False

Question 5: (true/false) Fish oil monotherapy has been shown to be ineffective as a treatment of acetaminophen toxicity.

A. True B. False

Learning Assessment Answers:

1. Answer: B (false). Fish oil contains both omega-3 and omega-6 fatty acids and when dosed appropriately, can provide sufficient essential fatty acids to prevent deficiency.

2. Answer: C. According to the Holman Index, biochemical evidence of EFAD occurs when the triene:tetraene ratio is greater than 0.2. Physical signs occur when the ratio is greater than 0.4. Other laboratory ranges have been used to describe what is observed in healthy individuals eating a typical Western diet.

3. Answer: B (false). Pure fish oil emulsions are only FDA approved as a source of essential fatty acids and calories in children with PN associated cholestasis. It is not approved for preventing PNAC.

4. Answer: A (true). In patients who are totally PN dependent, lower doses of these mixed oil emulsions have been associated with EFAD. Monitoring of EFA status is necessary to ensuring adequate doses are being provided.

5. Answer: A (true) In animal models, fish oil monotherapy has been shown not to be effective in treating the hepatic damage seen with acetaminophen toxicity.

References

1.de Meijer VE, Le HD, Meisel JA, Gura KM, Puder M. Parenteral fish oil as monotherapy prevents essential fatty acid deficiency in parenteral nutrition?dependent patients. J Pediatr Gastroenterol Nutr. 2010;50:212-218. 2.Puder M, Valim C, Meisel JA, et al. Parenteral fish oil improves outcomes in patients with parenteral nutrition?associated liver injury. Ann Surg. 2009;250:395-402. Lee SI, Valim C, Johnston P, et al. Impact of fish oil?based lipid emulsion on serum triglyceride, bilirubin, and albumin levels in children with parenteral nutrition?associated liver disease. Pediatr Res. 2009;66(6):698-703.

ASPEN EDUCATION PROGRAM OUTLINE TEMPLATE

3.Diamond IR, Sterescu A, Pencharz PB, Kim JH, Wales PW. Changing the paradigm: omegaven for the treatment of liver failure in pediatric short bowel syndrome. J Pediatr Gastroenterol Nutr. 2009;48:209-215. 4.de Meijer VE, Gura KM, Meisel JA, Le HD, Puder M. Parenteral fish oil monotherapy in the management of patients with parenteral nutrition? associated liver disease. Arch Surg. 2010;145:547551. 5.Vanek VW, Seidner DL, Allen P, Bistrian B, Collier S, Gura K, Miles JM, Valentine CJ, Kochevar M; Novel Nutrient Task Force, Intravenous Fat Emulsions Workgroup; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors .A.S.P.E.N. position paper: Clinical role for alternative intravenous fat emulsions. Nutr Clin Pract. 2012 Apr;27(2):150-92. 6.Nehra D, Fallon EM, Carlson SJ, Potemkin AK, Hevelone ND, Mitchell PD, Gura KM Puder M. Provision of a Soy-Based Intravenous Lipid Emulsion at 1 g/kg/d Does Not Prevent Cholestasis in Neonates. JPEN J Parenter Enteral Nutr. 2012 Jul 5.

3/8/2019

The Use of Alternative ILEs in the Pediatric Population

Kathleen M. Gura Pharm.D., BCNSP, FASHP, FPPAG FASPEN Center for Advanced Intestinal Rehabilitation (CAIR) Boston Children's Hospital

Assistant Professor of Pediatrics, Harvard Medical School Kathleen.Gura@childrens.harvard.edu

Disclosures

? Pharmaceutical advisory board ? B Braun ? Baxter

? Consultant ? B Braun ? Fresenius Kabi ? Pfizer Pediatric Center of Excellence ? Xellia Pharmaceuticals ? Northsea Therapeutics ? Alcresta ? Otsuka Pharmaceutical Factory

? Patents/royalties for use of Omegaven

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Disclosures

A licensing agreement exists between Boston Children's Hospital & Fresenius Kabi for the use

of Omegaven in PNALD. I will be discussing off labeled indications and products that are currently not FDA approved.

Learning Objectives

At the end of this session, participants will be able to: ? Understand when lipid restriction protocols

can be safely used ? Discuss the concerns of using a mixed oil

IVLE in a pediatric patient ? List which patients should not receive fish

oil monotherapy

Deciding When to Use Which Lipid Emulsion When.....

Soybean Oils

Recommendation: Based on 2 level 2 studies, in critically ill patients who are not malnourished, are tolerating some EN, or when parenteral nutrition is indicated for short term use (< 10 days), withholding lipids high in soybean oil should be considered.

? insufficient data to make a recommendation about withholding lipids high in soybean oil in critically ill patients who are malnourished or those requiring PN for long term (> 10 days)

10.2 Strategies to Optimize Parenteral Nutrition and Minimize Risks: Use of lipids March 2013

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Intestinal Failure (IF)

? Definition:

? PN dependence > 3 mo.

? Over 60% of infants with IF develop cholestasis (direct Bilirubin > 2 mg/dL)

? Before 2004:mortality was 37.5% due to liver failure and or sepsis (Boston Children's Hospital)

? 78% mortality if bilirubin >3 mg/dL for 3 months

? Approach 90% mortality if cholestasis and remain on PN for > 1 year

? 1.4% of all deaths of children 4 years of age and under

3/8/2019 Prevention of IFALD

Impact of Soybean Lipid Dose

Lipid Restriction 1g/kg/day

Rollins et al J Pediatr Surg. 2013 Jun;48(6):1348-56 ? Pilot study n=28 ? Prospective RCT ? Infants > 26 weeks GA on >50%

total calories from PN ? Compared 1g/kg/d to 3g/kg/d ? Results:

? Ave PN duration 5.4 weeks ? Tot increase in dbili from baseline

less in low dose group (p=0.04) ? Weight z-score increased more in

3g/kg/d group ? No EFAD ? CONCLUSION: ? Markers of cholestasis rose at a

slower rate using 1g/kg/d IFE

Prophylactic Lipid Restriction 1g/kg/day

Sanchez et al J Pediatr Surg. 2013 Mar;48(3):573-8

? Surgical neonates (n=82) receiving 1g/kg/d retrospectively compared to control cohort (2g/kg/d) (n=132)

? Results: PNLAD less in 1g/kg/d group (22% vs. 43% p=0.003)

? Omegaven rescue used in 4 infants in standard dose vs. 2 infants in low dose group

Severe Lipid Restriction

Current Opinion in Organ Transplantation 2010, 15:330?333

? Protocol:

? 1 g/kg/d twice weekly

? If EFAD develops: 1g/kg/day 3x/week

? If the EFAD persists: 2g/kg/day 3x/week

? Preliminary results indicate IFE restriction resulted in a statistical significant reduction in total bilirubin without impacting growth or causing EFAD

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