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
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
Conflicts of Interest NONE
Policy and Practice Key recommendations: Remove 4% glucose and 0.18% sodium chloride Introduce guidelines and monitoring 24hrly Fluid balance and electrolytes
Policy and Practice Removal of 0.18 saline and 4% glucose Uptake of 0.45% and 5% glucose Implementation of guidelines and policies Monitoring
Impact of Policy on Practice
Impact of policy and practice MA of hyponatraemia MA severe hyponatraemia
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 12 10 8 6 4 2 10% 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 148 0.9% NaCl & 5% Dex Plasma-lyte 148 & 5% Dex 0 Peri & Post Poerative Gastric & Diahrohheal Losses GI and Surgical Losses Chronic Conditions
New policy and practice Key recommendations: Isotonic fluids 131-154mmol/L sodium Fluid balance monitoring 12-24hrly Prescription review 24hrly Electrolyte monitoring 24hrly
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
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
Relevant fluids available Plasmalyte-148 Balanced crystalloid Fully licensed (with 5% glucose)
Financial Impact of NICE guidance RMCH Usage 2013-2014 Fluid Volume (L) Units (500ml bags) Cost 0.45 and 5 (plain) 350 700 525 0.45 and 5 with K 3000 6000 27,000
Financial Impact of NICE guidance Fluid Volume (L) Units (500ml bags) Cost 0.9 and 5 (plain) 350 700 525 0.9 and 5 with K 3000 6000 45,000 Fluid Volume (L) Units (500ml bags) Cost 0.9 and 5 (plain) 1350 2700 2,025 0.9 and 5 with K 2000 4000 30,000
Balanced Isotonic Fluids Fluid Volume (L) Units (1000ml bags) Cost Plasma-Lyte and 5 2750 2750 2,300 0.9 and 5 with K 500 1000 7,500 Plasmalyte would be suitable for 70-80% of patients in acute care The use of 1000ml bags is innately efficient
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
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
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
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
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
Where s the evidence? Lower risk of hyponatraemia with balanced crystalloid (OR 0.31, 95%CI 0.16-0.61) 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
What about training?
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
Unexpected hurdles
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
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