Using Balanced Fluids in Paediatrics: Implementing NICE Guidance without breaking the bank

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1 Using Balanced Fluids in Paediatrics: Implementing NICE Guidance without breaking the bank Adam Sutherland Senior Clinical Pharmacist, RMCH Clinical Lecturer, University of Manchester NIHR MClinRes Trainee, UoM 2015/16

2 Outline Policy influencing practice NPSA NICE Regulatory limitations The lack of licensed products for children Cost assessment and modelling How much you can save Common questions Unexpected hurdles

3 Conflicts of Interest NONE

4 Policy and Practice Key recommendations: Remove 4% glucose and 0.18% sodium chloride Introduce guidelines and monitoring 24hrly Fluid balance and electrolytes

5 Policy and Practice Removal of 0.18 saline and 4% glucose Uptake of 0.45% and 5% glucose Implementation of guidelines and policies Monitoring

6 Impact of Policy on Practice

7 Impact of policy and practice MA of hyponatraemia MA severe hyponatraemia

8 Impact of policy and practice Local impact: Observational audit, convenience sample (n=20) over 2 months at RMCH Only 30% of patients received isotonic fluids Only 50% of patients had their U&Es check every 24hrs Only 1 patient had their glucose checked Only 50% of patients had their IVF reviewed every day % Dextrose 0.9% NaCL & 10mmol KCL 0.45% NaCl, 10% Dex, 10mmol KCL 0.45% NaCl, 5% Dex, 10mmol KCL 0.45% NaCl & 10% Dextrose 0.45% NaCl & 5% Dex Plasma-lyte % NaCl & 5% Dex Plasma-lyte 148 & 5% Dex 0 Peri & Post Poerative Gastric & Diahrohheal Losses GI and Surgical Losses Chronic Conditions

9 New policy and practice Key recommendations: Isotonic fluids mmol/L sodium Fluid balance monitoring 12-24hrly Prescription review 24hrly Electrolyte monitoring 24hrly

10 Likely impacts of NICE Change in fluid: 0.9% sodium chloride (+/- glucose) Hartmann s Solution (+/- glucose) Other products? Change in cost: Resource impact report, section 2.4 Overall costs are not anticipated to increase

11 Relevant fluids available Product Type Cost ( ) Regulatory 0.45% sodium chloride + 5% glucose Hypotonic 0.75 Licensed 0.45% sodium chloride + 5% glucose with 10mmol potassium 0.45% sodium chloride + 5% glucose with 20mmol potassium Hypotonic 4.50 Unlicensed Hypotonic 4.50 Unlicensed Hartmanns Isotonic 0.79 Licensed Hartmanns + 3% glucose Isotonic 7.70 Unlicensed 0.9% sodium chloride + 5% glucose Isotonic 0.75 Licensed 0.9% sodium chloride + 5% glucose with 10mmol potassium 0.9% sodium chloride + 5% glucose with 20mmol potassium Isotonic 7.50 Unlicensed Isotonic 7.50 Unlicensed

12 Relevant fluids available Plasmalyte-148 Balanced crystalloid Fully licensed (with 5% glucose)

13 Financial Impact of NICE guidance RMCH Usage Fluid Volume (L) Units (500ml bags) Cost 0.45 and 5 (plain) and 5 with K ,000

14 Financial Impact of NICE guidance Fluid Volume (L) Units (500ml bags) Cost 0.9 and 5 (plain) and 5 with K ,000 Fluid Volume (L) Units (500ml bags) Cost 0.9 and 5 (plain) , and 5 with K ,000

15 Balanced Isotonic Fluids Fluid Volume (L) Units (1000ml bags) Cost Plasma-Lyte and , and 5 with K ,500 Plasmalyte would be suitable for 70-80% of patients in acute care The use of 1000ml bags is innately efficient

16 Dealing with your Formulary Committee 1. It s hypertonic therefore not appropriate 2. Why can t you just use Hartmann s? 3. Where s the evidence? 4. What about training? 5. The company will just increase the price later

17 It s hypertonic Calculated osmolality = 600mOsm/L Should not be administered peripherally WRONG Same labelling as 0.9 and 5 Calculated value based on glucose concentration Glucose is irrelevant in vivo

18 Why not Hartmann s? 1) There s no Hartmann s and glucose that s cost effective 2) Is lactate the best buffer for acidosis? Accumulates in hepatic dysfunction Obscures acid:base assessment Probably as bad as chloride

19 Hypokalaemia 1/3 of Plasmalyte has potassium added in ICU 30% of those were (are?) despite normokalaemia Prior to balanced fluids ~80% of patients had supplemented maintenance Patients on Plasmalyte maintain their potassium Whether its normal or abnormal

20 Where s the evidence? N = 25 Uncontrolled observational study of infants and children drinking cow s milk 3mmol/kg/d sodium, 2mmol/kg/day potassium and 2mmol/kg/day chloride Isotonic fluids Half as much STOP as soon as possible

21 Where s the evidence? Lower risk of hyponatraemia with balanced crystalloid (OR 0.31, 95%CI ) Lower incidence of seizures in balanced group (1 vs 7 but?confounders) Incidence of hyponatraemia in the hypotonic group 20.6% (5.1% in isotonic) Number needed to HARM (plasma Na <135mmol/L) with hypotonic fluid = 7

22 What about training?

23 There ll just be a price hike later IV fluids are contracted NATIONALLY Co-ordinated monitoring and oversight Centralised negotiation Competitive tender It s very difficult for companies to increase prices of products in this case Market share of product increasing Justification and scrutiny

24 Unexpected hurdles

25 Unexpected hurdles Challenging 60 years of medical dogma The influence of nursing staff in fluid selection It s only IV Fluids. What s the big deal? Education, Education, Education

26 SUMMARY NICE guidelines should be welcomed Driving system-wide practice change that will make children safer Dismissing the notion that children need less sodium and more water Careful consideration of choice of isotonic fluid NICE don t presume which fluid you will use NHS guidelines on addition of potassium may drive your costs UP Don t be complacent about unlicensed medicines You should really only use unlicensed products when there s no alternative available Your choice of isotonic fluid may make your patients hypokalaemic