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

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!

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.

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

‘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.

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

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.

Audit standards CRITERIA TARGET (%) SOURCE 1 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

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

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

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

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

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???

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?

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