AuSPEN Micronutrient Guidelines Review Where we up to?

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Austin Blake
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Auckland Emma Osland Dietitian, Brisbane Mel Davis Pharmacist,

1 AuSPEN Micronutrient Guidelines Review Where we up to? Emma Osland AdvAPD On behalf of the AuSPEN Guidelines Working Group Azmat Ali Dietitian, Brisbane Lyn Gillanders Dietitian, Auckland Emma Osland Dietitian, Brisbane Mel Davis Pharmacist, Sydney Truc Nguyen Pharmacist - Auckland Liz Isenring Dietitian, Gold Coast Patrick Ball Pharmacist, Darwin

2 Background 1999 AuSPEN Micronutrient Guidelines 2012 ASPEN Position Paper Recommendations for PN provision of micronutrients for PN Based on the literature to 2009 ESPEN Guidelines 2009 Cover use of PN in a range of specialty areas (acute) as well as specific section on HPN Currently under review due for release soon Disease focused approach vs PN/micronutrient approach

3 Why AuSPEN has pursued local PN Guidelines? Limitations to applying ASPEN/ESPEN guidelines to the Australian and New Zealand context Specific consideration of baseline issues relevant to the Australian and New Zealand Particularly Iodine, Selenium and Vitamin D Different products licensed in Australia and New Zealand to other parts of the world Units of recommendations mmol/l vs mg/dl AuSPEN is the leading organisation in this region in this specialty area and our existing guidelines were out of date

4 1999 AuSPEN Micronutrient Guidelines Stage 1 of Review 2014 Trace Element Guidelines (Adults) Stage 2 of Review 2015/2016 Vitamin Guidelines (Adults) Stage 3 of Review Plans for the development micronutrient guidelines for paediatric and neonates

5 Trace element Guidelines Vitamin Guidelines Working Group Working group External Review (international content experts, consumers, end users) Multidisciplinary Steering committee Peer review Publication (AuSPEN website and APJCN) External review (international content experts, consumers, end users) Peer review Publication (AuSPEN website and APJCN)

Trace Element Guidelines Timeline and Process (2013-2014) March 2013 Working group convened by President of AuSPEN; Review of ASPEN Consensus document March-Sept 2013 Formulation of clinical

conjunction with local data Sept- Dec 2013 Data collated into report Review by working group members Strength of recommendations assessed using NHMRC matrix Jan-May 2014 External Review coordinated

6 Trace Element Guidelines Timeline and Process ( ) March 2013 Working group convened by President of AuSPEN; Review of ASPEN Consensus document March-Sept 2013 Formulation of clinical questions in accordance with AuSPEN Policy for Guideline Development and Endorsement Independent literature reviews data Recommendations made for the Australian and New Zealand context in conjunction with local data Sept- Dec 2013 Data collated into report Review by working group members Strength of recommendations assessed using NHMRC matrix Jan-May 2014 External Review coordinated by Clinical Practice Committee using AGREE II June- Nov 2014 External review feedback incorporated to final report (June 2014) Forwarded to PNDU Final report transformed into manuscript, published by APJCN December 2014

7 Vitamin Guidelines Timeline and Process ( /2016) Nov 2014 Stage 2 of review process begun by Trace Elements, now Vitamin, Working Group, with minor changes to membership Review of ASPEN Consensus document with relation to vitamins and vitamin like compounds Dec May 2015 Formulation of clinical questions in accordance with AuSPEN Policy for Guideline Development and Endorsement Independent literature reviews data with peer review of content Recommendations made for the Australian and New Zealand context in conjunction with local data Strength of recommendations assessed using NHMRC matrix July 2015 Data collated into draft report Peer reviewed by working group members Draft report sent to Multidisciplinary steering committee for comment/feedback Sept 2015 Draft updated with feedback from Steering Committee External Review coordinated by Clinical Practice Committee using AGREE II including experts in content knowledge, consumer groups (PNDU) and end users Next steps External review feedback incorporated to final report (Oct-Nov 2015) Final report to be transformed into manuscript for publication on website (full report) and published by APJCN (concise report)

8 Scope of Guidelines Guide maintenance doses recommendations of Trace Elements and Vitamins Does not specifically guide on replacement requirements or for specific clinical needs Does not negate clinical judgement Adult PN recipients (>15 years) Short term (<20 days) Long term (>20 days) Home (Long term, otherwise medically stable, PN provided in community/ambulatory setting) Audience: Primarily clinicians involved with the provision of PN (doctors, nurses, dietitians, pharmacists) Secondary Audience: Industry

Summary of Changes in Recommendations for PN TEs 1999 AuSPEN Guidelines 2014 AuSPEN Guidelines Zinc 50-100 µmol (3.3-6.5mg) 50-100 µmol (3.3-6.5mg) Copper 2-20 µmol (0.12-1.2mg) 5-8 µmol (0.32 0.

9 Summary of Changes in Recommendations for PN TEs 1999 AuSPEN Guidelines 2014 AuSPEN Guidelines Zinc µmol ( mg) µmol ( mg) Copper 2-20 µmol ( mg) 5-8 µmol ( mg) Selenium µmol (35-120μg) µmol (60-100μg) Iron 20 µmol (1.1mg) 20 µmol (1.1mg) Manganese 5 µmol (275μg) 1 µmol (55μg) Chromium µmol (10-20μg) µmol (10-15μg) Molybdenum 0.4 µmol (38μg) 0.2 µmol (19μg) Iodine 1.0 µmol (126μg) 1.0 µmol (126μg)

10 Vitamin Guidelines Recommendations taken from lack of adverse outcomes associated with current routine provision doses, vs evidence around dosing Minimal studies particularly in PN patient populations, and those that are exclusively in HPN or long term PN Consideration of issues that affect the delivery of PN vitamins Method and speed of administration In bag delivered over total infusion time, with potential interactions that may denature vitamins Piggy back delivered more rapidly as a separate infusion, with the potential for increased excretion Light degradation of vitamins from UV, fluorescent, LED lights, impacted by administration practices/timing

11 Vitamin D Most vulnerable nutrient for Australian and New Zealand is Vitamin D 23-58% Australian general population Vitamin D deficient or insufficient similar in NZ Mixed evidence as to whether increased supplementation improves outcomes 200IU RDI for general population (oral) 200IU provided in PN supplements may not be adequate for long term HPN pts in Australia and NZ, requires case by case consideration oral supplementation may improve serum levels in some patients Annual monitoring of 25OH-cholecalciferol levels for HPN pts

12 Vitamin K Recommendations for Vitamin K supplementation remains as case by case basis Routine supplementation in Australia and NZ allows for nil provision (Cernevit ) or 150ug daily (Vitalipid N ) Recent study (Forchielli et al, 2015) has demonstrated that contemporary lipids provide between ~35ug/500mL (Omegaven ) and ~50ug/500mL (Clinoleic, SMOF ) However, further consideration may be required for Those with malabsorption, especially those with impaired bile acid reabsoprtion (PBS, SBS in absence of colon) Those receiving lipid free PN for an extended duration Those not receiving PN daily Pregnant women receiving PN If supplementing, doses should be regular and close to physiological requirements

13 Water Soluble Vitamins Less research on water soluble vitamins than fat soluble vitamins Not considered to be an issue if replacement provided with PN solutions Clinical suggestion of deficiency of one water soluble vitamin should be regarded as suspicion of broader water vitamin soluble deficiency, and treated as such.

14 Summary of recommendations for PN vitamins 1999 AuSPEN Guidelines 2015 AuSPEN Guidelines 2012 ASPEN Position Paper Vitamin A 1000μg RE 3500IU (1190μg RE) 3300IU (990μg RE) Vitamin D 5μg 200IU (5.5μg) 200IU (5μg) Vitamin E 10mg 10mg 10mg Vitamin K No recommendation made No recommendation made: 150μg Individual assessment recommended. Thiamine 3mg 3mg 6mg Riboflavin 3.6mg 4-5mg 3.6mg Niacin 40mg 40-47mg 40mg Pantothenic 15mg 16-17mg 15mg Acid Pyridoxine 4mg 3mg 6mg Vitamin B12 5μg 5-6μg 5μg Folic acid 400μg 400μg 600μg Vitamin C 100mg mg 200mg Biotin 60μg 60μg 60μg

15 Take home messages from the AuSPEN Micronutrient (Vitamins and Trace Elements) Guidelines Review Micronutrients are essential components of PN and should be given daily from the commencement of PN All patients receiving PN should be individually assessed to ensure standard parenteral multivitamin provision is adequate for their individual clinical circumstances. Micronutrient monitoring has many limitations and in general should be limited to stable longer term PN patients, and always with a CRP level to provide interpretative context Consider clinical context before ordering Expense ($$, inconvenience to pt) vs benefit (how it will change your practice) Many areas for research identified

16 Recommendations for research Trace Elements TE contamination profile associated with contemporary PN handling and storage practices; Surveillance of changes to TE deficiency and toxicity patterns in longer term and HPN patients with contemporary handling and storage practices of PN components; Development of reliable methods for TE assessment and monitoring; and Validation of earlier poor quality studies into safe and adequate provision of TE in short, longer term and HPN patients. Vitamins Vitamin D status in long term PN pts in Australian and NZ; Relationship between Vitamin D status/provision and MBD in long term PN recipients; Role of Vitamin K in the bone health in long term PN through prospective studies; Role of choline and carnitine in the development of metabolic abnormalities including PNALD in long term PN; Impact of different types of light sources on the photodegradation of PN vitamins; and Clarification of the most effective method/s to administer parenteral vitamin preparations.

17 Strengths and Limitations of the guidelines Nature of nutritional studies Few RCTs and high level methodology Most literature on PN micronutrients is >20yrs old Contemporary practices (plastic vs glass; syringe-less vs syringe systems) Most research on PN micronutrients has been conducted outside of Australia and New Zealand Different products, populations and baseline sufficiency Limitations and challenges of micronutrient monitoring HOWEVER Robust and systematic methodology utilised Multidisciplinary group (working group, external reviewers +/- steering committee involved)

18 Acknowledgements AuSPEN Ibolya Nyulasi (President) Liz Purcell (Clinical Practice Committee) Expert Reviewers Mette Berger (TE and Vit) Alan Shenkin (TE and Vit) Patrick Ball (Vit) Consumer feedback Parenteral Nutrition Down Under (PNDU) End User Reviewers TE Ra eesa Doola (DN) Kath Angstmann (PN CN) Truc Nguyen (Pharm) Steering Committee for Vitamin Guidelines Kath Angstmann (PN CN) Ruth Hodgson (GE) Bryan Parry (Surg, Dir NIFS NZ)

ESPEN Congress The Hague 2017

ESPEN Congress The Hague 2017 Meeting nutritional needs of acute care patients Micronutrients in parenteral nutrition T. Nguyen (NZ) Micronutrients in Parenteral Nutrition Truc Nguyen Counties Manukau