1. Paediatric Cardiac Pharmacist Bristol Royal Hospital for Children
HOME INR MONITORING FOR PAEDIATRIC CONGENITAL HEART DISEASE PATIENTS- IS IT SAFE?
Susie Gage
Paediatric Cardiac Pharmacist
Bristol Royal Hospital for Children

2. Warfarin Is used to help prevent clots from forming
Too little warfarin
Risk of suffering a blood clot
Too much warfarin
Risk of haemorrhage
So, INR monitoring is crucial…maybe we should audit it!

3. Objective of the audit
To establish whether warfarin is correctly prescribed and monitored for children, on home anticoagulation therapy using the Caoguchek® machine, with support and advice from the paediatric cardiac team. This will be assessed by reviewing compliance with the relevant NPSA (Alert 18) safety indicators.

4. What is the Coaguchek® machine?
Takes 1 minute to get an INR result
Portable and battery powered
1 drop of capillary blood needed
Memory of 100 tests with date and time record
On board quality control on each strip
Measures INR between 0.8 to 8
Electrochemical detection system
Easy to use
“Self-monitoring of anticoagulation therapy is an example of an innovation that has been developed but not disseminated to its full potential” NHS Briefing Pack, 2009

5. ‘ACTIONS THAT CAN MAKE ANTICOAGULANT THERAPY SAFER’
NPSA Alert 18
‘ACTIONS THAT CAN MAKE ANTICOAGULANT THERAPY SAFER’
Written with the British Society for Haematology (BSH)
Anticoagulants identified as causing preventable harm and admission to hospital
Objective is to reduce the risk of patients being harmed in the future
Aim to promote safe practices and manage the risk associated with
Prescribing
Administration
Dispensing
Also highlighted the need for education and training & the need for written protocols.
The NPSA identified inadequate clinical audit of anticoagulation services, and failure to act on audit results to improve the service.

6. Our service This service has been running for about 15 years
Only for paediatric congenital heart disease patients
across the South-West
90 patients in our region on warfarin
Also we find we get a lot more questions about non-warfarin related questions are we are in close contact with these families.
We know when medication has been added/removed.
Telephone service run primarily by the cardiac nurse specialists with support from the paediatric cardiac team

7. Audit method
An audit form was designed which included safety indicators from NPSA Alert 18
Retrospective study
Between 1st July 2009 and 31st May 2010
Included all paediatric congenital heart disease patients on warfarin
On home INR monitoring using Coaguchek®
Managed by our paediatric cardiac team
So excluded patients managed by community nursing teams and GPs.

8. Audit standards CRITERIA TARGET (%) SOURCE1
Target INR range should be documented
100%
NPSA Alert 18 2
Children should be monitored by telephone weekly for the first 3 months after discharge
2004 Trust Guidelines 3
Children should be monitored by telephone 3-4 weekly, >3 months after discharge, if in range 4
% INRs in range 5
% INRs >5.0 0% 6
%INRs > 8.0 7
% INRs 1.0 unit below patient’s target range 8
All children should be seen in the coagulation clinic for an annual review 9
Any episodes of major bleeding
This data was collected from from the patient’s medical notes, the paper anticoagulation records and cardiac database

9. Patient Population 50 patients 8 months to 18 years Indication varied:
Mechanical valves/ Fontan circulations(TCPC)/
cardiomyopathy/previous thrombus
Duration: ranged from 3 months to lifelong treatment
Varied population-age/indication/duration

10. Results CRITERIA TARGET (%) OUTCOME (%) 1
Target INR range should be documented
100% 2
Children should be monitored by telephone weekly for the first 3 months after discharge 3
Children should be monitored by telephone 3-4 weekly, >3 months after discharge, if in range
92% 4
% INRs in range
66% 5
% INRs >5.0 0%
0.06% 6
%INRs > 8.0
0.02% 7
% INRs 1.0 unit below patient’s target range 8
All children should be seen in the coagulation clinic for an annual review
84% 9
Any episodes of major bleeding

11. Audit conclusion Yes it is safe Annual clinic review could be improved
no major bleeding episodes
few INR results 1.0 unit below target range
few INR results >5.0 & >8.0
Annual clinic review could be improved
external quality control of Coaguchek® machine
continuing education & counselling
But 66% INR results in range?!
but by how much?...this was not audited

12. Challenges
Warfarin management in this paediatric population is challenging due to
intercurrent illness
childhood development
concurrent medication
NPSA safety indicators are adult based and it is difficult to make these standards strictly fit this “complex cardiac” paediatric population
Whya are there so many INRs not in range

13. Benefits of home INR monitoring
Independence
Accurate and reliable
No venous sampling
Takes a minute to get a result
Intervene in a more timely fashion
Increased quality of life
Decrease in adverse events
Lowering costs of care???

14. Service Model for other areas?
Home INR monitoring with proper education and liaison provides a safe and effective treatment option for cardiac children requiring warfarin
Choice of patients for this approach is important
But could funding could be the stumbling block?

15. Special thanks to
E Moore/Dr J Forsey/C Harrington/Dr A Tometzki