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

NONE

Conflicts of Interest

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

0

2

4

6

8

10

12

Peri & PostPoerative

Gastric &Diahrohheal

Losses

GI andSurgicalLosses

ChronicConditions

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

New policy and practice

Key recommendations:

• Isotonic fluids – 131-154mmol/L sodium

• Fluid balance monitoring 12-24hrly

• Prescription review 24hrly

• Electrolyte monitoring 24hrly

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…”

Likely impacts of NICE

Product Type Cost (£) Regulatory

0.45% sodium chloride + 5% glucose Hypotonic 0.75 Licensed

0.45% sodium chloride + 5% glucose

with 10mmol potassium

Hypotonic 4.50 Unlicensed

0.45% sodium chloride + 5% glucose

with 20mmol potassium

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

Isotonic 7.50 Unlicensed

0.9% sodium chloride + 5% glucose

with 20mmol potassium

Isotonic 7.50 Unlicensed

Relevant fluids available

• Plasmalyte-148

– Balanced crystalloid

– Fully licensed (with 5% glucose)

Relevant fluids available

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

RMCH Usage 2013 - 2014

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

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

Dealing with your Formulary Committee

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

It’s hypertonic…

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

Why not Hartmann’s…?

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

Hypokalaemia

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…?

• 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

There’ll just be a price hike later…

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