NHSCANCER                                             NHS Improvement                                                     ...
2 www.improvement.nhs.uk/heart/anticoagulationAnticoagulation for Atrial FibrillationA simple overview to support commissi...
3 www.improvement.nhs.uk/heart/anticoagulationPatients on anticoagulants therefore require      • Service access and waiti...
4 www.improvement.nhs.uk/heart/anticoagulation                                                         Acknowledgements   ...
5 www.improvement.nhs.uk/heart/anticoagulation7. Ensure that dental practitioners manage      6. Percentage of patients th...
NHS                                                                                NHS Improvement              NHS Improv...
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Anticoagulation for atrial fibrilation - a simple overview to support the commissioning of quality services


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Anticoagulation for Atrial Fibrilation - a simple overview to support the commissioning of quality services
This guide sets out to help commissioners develop quality anticoagulation services by emphasising evidence based practice and measurable outcomes. It predominantly aims to highlight that quality of anticoagulation is important, that this varies between clinics and that this variation in effectiveness will influence the outcome of stroke prevention. It also aims to provide some guidance as to the most important markers to look at in assessing quality amongst the myriad of markers in previous guidelines.

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Anticoagulation for atrial fibrilation - a simple overview to support the commissioning of quality services

  1. 1. NHSCANCER NHS Improvement HeartDIAGNOSTICS NHS Improvement - Heart Anticoagulation forHEART Atrial Fibrillation A simple overview to support the commissioning of qualityLUNG servicesSTROKE
  2. 2. 2 www.improvement.nhs.uk/heart/anticoagulationAnticoagulation for Atrial FibrillationA simple overview to support commissioning of quality servicesStroke is the third largest cause of death in commissioned. It further aims to provide • British Committee for Standards inEngland and costs the NHS £2.8 billioni. some guidance as to the most important Haematology Guidelines on OralAtrial Fibrillation (AF) is a known risk factor markers to look at in assessing the quality of anticoagulation (warfarin): thirdfor stroke, increasing its risk and severity; it a service amongst the myriad of markers in edition (2005 update)xis estimated that 12,500ii strokes per year existing guidelines. These guidelines are to update thoseare attributable to AF. The related cost per written in 1998 and provide indicationsAF associated stroke is estimated at In particular it draws on the established for oral anticoagulation and suggested£11,900ii in the first year alone following recommendations and actions from the arrangements for the management of anstroke occurrence. following documents: anticoagulation service. They promote service participation in regular audit ofIn order to reduce the risk of stroke in • NICE Anticoagulation Therapy Service; national quality assessment schemes andpatients with AF, anticoagulation therapy is Commissioning Guide (Dec 2007)viii clinical practice. These guidelines haverequired. In the UK, there are approximately The guide was written to support local specific recommendations on the use of500,000 patients currently prescribed oral implementation of the 2006 NICE clinical anticoagulation including managinganticoagulant drugs, with warfarin being guideline for AF, and acts as a resource to bleeding, drug interactions, assessingthe most frequently prescribed (at an help commission an effective contraindications and point of careaverage annual cost around £383iii). anticoagulation therapy service. It provides testing. support to determine local service levelsAnticoagulants are classed as a high risk and requirements, as well as providing A web resource to support this guidegroup of medicines, with warfarin methods to ensure corporate and quality is available at:associated with incidents in prescribing, assurance. www.improvement.nhs.uk/heart/anticoagulationdispensing and monitoringiv. It is therefore where copies of the above documents andimperative that healthcare organisations • National Patient Safety Agency (NPSA) further article references and additionaltake steps to manage the associated risks of Alert 18; Actions that can make useful information can be accessed.anticoagulation therapyv. anticoagulant therapy safer (2007)v This safety alert was developed in Anticoagulation - An OverviewWhen anticoagulation therapy is collaboration with the British Society for In order to prevent AF related strokes, theappropriately used and monitored, it is Haematology and further input from other recommended course of action is to initiatehighly effective, lowering stroke risk by clinical and patient advisors. Written in anticoagulation therapyxi. When this therapyabout two thirdsvi. However, anticoagulation response to a series of reports of patient is appropriately used and monitored, it isservices vary in quality1 and effectiveness safety incidents involving anticoagulants highly effective, lowering stroke risk byacross the country2 and there are many received from all sectors of the NHS, this about two thirdsvi. However, despite thepeople not being prescribed anticoagulation NPSA alert gives key mandatory actions clear benefits of warfarin and the presencewhen indicated, and many others receiving and a set of indicators to help ensure the of guidelines for its use and management insub-optimal therapyvii. Effective safety of anticoagulation services for stroke prevention, current data indicatescommissioning of anticoagulation services patients. Available in appendix A. that the management of AF is still sub-will make improvements in the number of optimal, with many of those receivingpatients receiving appropriate • Recommendations and Safety anticoagulation not consistently in theanticoagulation as well as ensuring a high Indicators from the British Committee optimal therapeutic range. Recent clinicalquality service is delivered. for Standards in Haematology and trials have supported a relationship between National Patient Safety Agency (2006)ix anticoagulant control and benefit ofThese improvements will reduce the number This document compliments the existing anticoagulationvii, with the longer time spentof strokes suffered, save lives, reduce guidelines developed by the BCSH 1990 in therapeutic range reducing the chance ofdisability and generate cost savings for the (updated in 1998 & 2005) and was embolic stroke.NHS and social care. written to provide a set of governance and safety indicators for oral Patients receiving oral anticoagulation are atAims anticoagulation. Using the risks and risk of under-anticoagulation, which canThis guide sets out to help commissioners recommendations identified from the result in thrombosis, and over-develop high quality anticoagulation3 NPSA risk assessment, these anticoagulation which can result inservices by emphasising evidence based recommendations propose a number of haemorrhage, both of which can be fatal.practice and measurable outcomes. It safety indicators for inpatient and The risk of haemorrhage whilst on long-predominantly aims to highlight that quality outpatient oral anticoagulation care. It is term anticoagulation varies between 1-15%of anticoagulation services is important, that the recommendation that monitoring per year, with the risk of death rising withquality can vary between clinics and will these indicators will help to identify the increasing international normalised ratioinfluence the outcome of any stroke risks and promote appropriate action to (INR)xii.prevention programme being minimise risk. Available in appendix B.1 For the purpose of this document, quality refers to the 3 domains of effectiveness, patient experience and patient safety, as outlined in the NHS outcomes framework2 Data to support the variation in anticoagulation services can be found at: www.improvement.nhs.uk/heart/anticoagulation3 The majority of the main principles and quality indicators identified in the current guide will potentially be applicable to other clinical indications for anticoagulation. It should be noted however that the main focus and evidence base of this guide is aimed at atrial fibrillation
  3. 3. 3 www.improvement.nhs.uk/heart/anticoagulationPatients on anticoagulants therefore require • Service access and waiting time – as • Service specification – a number ofmonitoring and frequent dose adjustment in anticoagulation requires frequent models exist for the delivery oforder to maintain the desired therapeutic monitoring it is imperative that patients anticoagulation services such as fullaction and to minimise these adverse receive timely and equitable access to provision in primary care, secondary care,bleeding events. Regular monitoring of INR anticoagulation services – for both domiciliary, self-management and mixedis necessary to capture and monitor the initiation and monitoring. models of the above. It is thereforetherapeutic benefit of warfarin. suggested that services set clear • Communication – successful and safe specifications for monitoring and assuringAn accepted indicator of the standard of anticoagulation services rely on having quality from an anticoagulation service,care provided is the achievement of time effective communication systems in place. ensuring the service model meets localwithin the target INR range (Rosendaal et al, This includes ensuring that appropriate needs and requirements. For more1993). The percentage of time spent in communication can occur between information see the NICE commissioningtherapeutic range varies and this variation clinician and patientxiii, as well as guideviii which provides an outline ofhas a major impact on the effectiveness of facilitating access to patient results across service specification considerations andwarfarinvii. the potential different information systems quality assurance indications. and between clinicians responsible forBased on the relation derived time in their care.therapeutic range and effectiveness of Key Indicators for Commissioningstroke prevention it can be estimated that a • Point of care (POC) testing – INR testing Quality Anticoagulation Services5% improvement in time in therapeutic undertaken outside laboratories utilising Commissioners need to ensure that therange across UK anticoagulation clinics POC devices should apply the same services they commission offer the bestwould result in the prevention of 400-500 standards of total quality management as clinical outcomes for patients. Clinicsstrokes per yearvii. practiced in hospital-based laboratories. unable to report on and compare their The devices should only be used by services with those of similar type, andConsiderations for Anticoagulation trained personnel with support from an those without a clear clinical governanceTherapy Services external quality assessment scheme; either structure, could potentially result in theDue to the therapeutic nature and a national scheme (such as NEQASxiv) or delivery of ineffective and unsafe care. Itmonitoring requirements of anticoagulants, local hospital laboratory. See MHRA is acknowledged that commissioners maythere are a number of clinical and service guidance on Management and Use of IVD not be in a position to collate thisconsiderations which have a potential POC Test Devicesxv and the guidelines for information and as a result may beimpact on the quality of anticoagulation POC testing in haematologyxvi for further unable to benchmark good or badservices being delivered: information. The Medicines & Healthcare practice. Products Regulatory Scheme (MHRA) is• Clinical governance – establishing an the regulatory body for POC testing and It is therefore advised that commissioners active clinical governance structure is of should be notified of any adverse ensure services delivering anticoagulation particular importance for anticoagulation incidentsxvii. therapy have an active clinical services as it will support the delivery of a governance process in place to monitor quality and effective service. For example, • Self testing and self dosing – patient (for example by audit and questionnaire) it will ensure that appropriate staff are use of POC devices for INR monitoring is and regulate the implementation of recruited and trained to deliver the becoming more widespread. Patients existing guidelines (particularly the BCSH service, can effectively handle adverse should conduct POC tests within a and NPSA guidelines), with particular incidents, enable multidisciplinary working managed programme, be assessed for emphasis on the following: and promote ongoing support for the capability and only patients considered patient. competent to follow procedures should • Proportion of patient-time in complete training and undertake POC therapeutic range (if this is not• Patient Safety – The National Patient testing. See BSCH guidelines for patient measurable because of inadequate Safety Agency (NPSA) has produced self monitoringxviii. decision/support software then a Patient Safety Alert 18v that gives key secondary measure of % of INRs in mandatory actions and a set of indicators • Computer aided dosage – assistance in range should be used) to help ensure the safety of anticoagulation dosing using computer anticoagulation services for patients. The software is very common. There is • Percentage of patients missed to follow implementation of these actions and use evidence that anticoagulant dosing up (and risk assessment of process for of the indicators should form a software helps to maintain the INR levels identifying patients lost to follow-up) fundamental part of any commissioning within the therapeutic range, facilitate • Referral to treatment time contract for anticoagulation services. auditv as well as being cost effectivexix. • Patient treatment and satisfaction.
  4. 4. 4 www.improvement.nhs.uk/heart/anticoagulation Acknowledgements Appendices and References When considering individual patients, This document was written in collaboration Appendix A: NPSA Patient Safety Alert 18; clinics should have systems in place for: with a specialist clinical reference group, Actions that can make anticoagulation safer including contribution from: (2007) • Assessing an individual patient’s time in therapeutic range and considering that Dr Roopen Arya, Consultant 1. Ensure all staff caring for patients on if this falls below 65% anticoagulation Haematologist, King’s College, London anticoagulant therapy have the may be sub-optimal and therefore no Caroline Baglin, Nurse Consultant, necessary work competences. Any gaps longer effective Addenbrookes Hospital in competence must be addressed Dr Campbell Cowan, Consultant through training to ensure that all staff • As a minimum, an annual patient Cardiologist, Leeds Hospital & NHS Heart may undertake their duties safely. review4 to: Improvement Clinical Lead 2. Review and, where necessary, update • confirm that the risk/benefit ratio for Thelma Daly, National Improvement Lead, written procedures and clinical protocols the patient remains favourable for NHS Improvement for anticoagulant services to ensure they continuation of anticoagulation Steve Davidson, Anticoagulation Nurse, reflect safe practice, and that staff are • identify any new medical, Nottingham University Hospitals trained in these procedures. behavioural or social condition Dr Matthew Fay, GP & NHS Heart 3. Audit anticoagulant services using • assess the individual’s time in Improvement Clinical Lead BSH/NPSA safety indicators as part of therapeutic range to assess that a Neil Gammack, Senior Pharmacist, the annual medicines management therapeutic benefit of Gateshead Hospital audit programme. The audit results anticoagulation is being achieved Jennifer George, National Improvement should inform local actions to improve with treatment. Lead, NHS Improvement the safe use of anticoagulants, and • consider the possible role of Julie Harries, Director, NHS Improvement should be communicated to clinical alternative anticoagulants which may Dr Richard Healicon, National governance, and drugs and therapeutics become available in the future. Improvement Lead, NHS Improvement committees (or equivalent).. Dr Steven Kitchen, Scientific Director, 4. Ensure that patients prescribed It is recommended that the above National External Quality Assessment Service anticoagulants receive appropriate indicators are applicable to all for Blood Coagulation verbal and written information at the anticoagulation services, regardless of Dr John Luckit, Consultant Haematologist, start of therapy, at hospital discharge, location and service model used. North Middlesex University Hospital on the first anticoagulant clinic Dr Rhona Maclean, Consultant appointment, and when necessary Haematologist, Sheffield University Hospitals throughout the course of their Dr Ellen Murray, Senior Lecturer & Practice treatment. The BSH and the NPSA haveSummary Nurse, University of Birmingham Hospital updated the patient-held informationDrawing on key anticoagulation guidelines, Bunis Packham, Consultant Anti- (yellow) booklet.this document summarises a number of Coagulation Nurse, Barnet and Chase Farm 5. Promote safe practice with prescribersimportant factors that need to be taken into Hospitals and pharmacists to check that patients’consideration when commissioning quality Professor David Patterson, Professor of blood clotting (International Normalisedanticoagulation services. Specific evidence Cardiovascular Medicine, UCL Ratio, INR) is being monitored regularlybased recommendations are provided to Undergraduate Centre and that the INR level is safe beforehelp commissioners ensure the best clinical Professor Leon Poller, EAA Project Leader, issuing or dispensing repeatoutcomes for patients. It is important that European Action on Anticoagulation, prescriptions for oral anticoagulants.commissioners and service providers work University of Manchester 6. Promote safe practice for prescribers co-together to ensure an appropriate structure Dr Rosalind Polley, Senior Medical Device prescribing one or more clinicallyis in place to monitor and act upon these Specialist, Medicines & Healthcare Products significant interacting medicines foroutcomes in order to increase the quality of Regulatory Agency patients already on oral anticoagulants;anticoagulation service delivered, thereby Dr Peter Rose, Consultant Haematologist, to make arrangements for additionalreducing the likelihood of adverse events University Hospitals of Coventry & INR blood tests, and to inform thesuch as embolic stroke or haemorrhage. Warwickshire anticoagulant service that an interacting Dr Bruce Warner, Associate Director of medicine has been prescribed. Ensure Patient Safety, National Patient Safety that those dispensing clinically Agency significant interacting medicines for Patricia Young, Patient Safety Design these patients check that these Specialist, National Patient Safety Agency additional safety precautions have been taken.This review may take a number of forms and might, for example, be undertaken by the general practitioner and not specifically in an anti-coagulant clinic, but4nonetheless the model of where review is to take place should be clearly agreed and stated.
  5. 5. 5 www.improvement.nhs.uk/heart/anticoagulation7. Ensure that dental practitioners manage 6. Percentage of patients that were not 2. Percentage of INRs > 5.0 patients on anticoagulants according to issued with patient held information and 3. Percentage of INRs > 8.0 evidence-based therapeutic guidelines. written dose instructions at start of 4. Percentage of INRs > 1.0 INR unit below In most cases, dental treatment should therapy. target (e.g. percentage of INRs < 1.5 for proceed as normal and oral 7. Percentage of patients that were patients with target INR of 2.5) anticoagulant treatment should not be discharged from hospital without an 5. Percentage of patients suffering adverse stopped or the dosage decreased appointment for next INR measurement outcomes, categorised by type, e.g. inappropriately. or for consultation with appropriate major bleed.8. Amend local policies to standardise the health care professional to review and 6. Percentage of patients lost to follow up range of anticoagulant products used, discuss treatment plan, benefits, risks (and risk assessment of process for incorporating characteristics identified and patient education. identifying patients lost to follow up). by patients as promoting safer use. 8. Percentage of patients with 7. Percentage of patients with unknown9. Promote the use of written safe practice subtherapeutic INR when heparin diagnosis, target INR or stop date. procedures for the administration of stopped (fast loading patients only, e.g. 8. Percentage of patients with anticoagulants in social care settings. It treatment of acute VTE). inappropriate target INR for diagnosis, is safe practice for all dose changes to high and low. be confirmed in writing by the Safety indicators for patients established on 9. Percentage of patients without written prescriber. A risk assessment should be oral anticoagulant treatment: patient educational information. undertaken on the use of Monitored 1. Proportion of patient-time in range (if 10. Percentage of patients without Dosage Systems for anticoagulants for this is not measurable because of appropriate written clinical information, individual patients. The general use of inadequate decision/support software e.g. diagnosis, target INR, last dosing Monitored Dosage Systems for then a secondary measure of percentage record. anticoagulants should be minimised as of INRs in range should be used). dosage changes using these systems are more difficult. i NICE cost impact and commissioning assessment: quality standard for stroke (2010)Appendix B: NPSA and the British ii Department of Health Atrial Fibrillation Cost-Benefit Analysis. Marion Kerr (2008) iii NICE (2006) Atrial Fibrillation: the management of AF. Costing report. Implementing NICECommittee for Standards in Haematology(2006); Safety indicators for anticoagulant guidance in England. iv NPSA (2007) Risk assessment of anticoagulation therapyservices v NPSA Alert 18 – Actions that can make anticoagulant therapy safer (2007) vi Hart, R., Pearce, L., Aguilar, M (2007). ‘Meta analysis: antithrombotic therapy to prevent strokes inSafety Indicators for patients starting oral patients who have non-valvular atrial fibrillation.’ Ann Intern Med, 146, 857-867. vii Connolly, S., et al on behalf of the ACTIVE W Investigators (2008) ‘Benefit of Oral Anticoagulant Overanticoagulation: Antiplatelet Therapy in Atrial Fibrillation Depends on the Quality of International Normalized Ratio1. Percentage of patients following a Control Achieved by Centers and Countries as Measured by Time in Therapeutic Range,’ Circulation, loading protocol appropriate to 118, 2029-2037 indication for anticoagulation. viii NICE Clinical guideline 36 Anticoagulation therapy service. Commissioning Guide (2007)2. Percentage of patients developing INR > ix Baglin, T., Cousins, D., Keeling, L., Perry, D & Watson, H (2006) ‘Recommendations from the BCSH and 5.0 within first months of therapy. NPSA’, Journal of Haematology, 136, 26-29. x Baglin,, T., Keeling, D., and Watson, H (2005) ‘Guidelines on oral anticoagulation (warfarin): third3. Percentage of patients in therapeutic edition – 2005 update’, British Society for Haematology, 132, 277–285 range at discharge (for inpatients being xi NICE AF Guideline (2006) and the European Society of Cardiology Guidelines for the Management transferred to outpatient care). of AF (2010). xii Oden & Fahlen (2002) ‘Oral anticoagulation and risk of death; a medical linkage study.’4. Percentage (incidence) of patients suffering a major bleed in first month of BMJ, 325, 1073-1075 xiii NICE clinical guideline 76 (2009) ‘Medications Adherence. Involving patients in decisions about therapy and percentage suffering major prescribed medications and supporting adherence’. bleed with INR above therapeutic range. xiv http://www.ukneqas.org.uk/content/pageserver.asp5. Percentage of new referrals to xv MHRA guidance on Management and Use of IVD Point of Care Test Devices, Device Bulletin (2010) xvi Briggs c et al, (2008) ‘Guidelines for point of care testing:haematology,‘ British Journal of Haematology, anticoagulant service (hospital or 142: 904-915 community-based) with incomplete xvii http://www.mhra.gov.uk information, e.g. diagnosis, target INR xviiiFitzmaurice, DA., Gardiner, C., Kitchen, S., Mackie, I., Murray, ET., and Machin, S. (2005) ‘An evidence- or inappropriate target with reference to based review and guidelines for patient self-testing and management of oral anticoagulation’, British BCSH guidelines, stop date for Journal of Haematology, 131, 156-165 xix S Jowett, S Bryan, L Poller, AMHP van den Besselaar, FJM van der Meer, G Palareti, C Shiach, A Tripodi, anticoagulant therapy, dose of warfarin M Keown, S Ibrahim, G Lowe, M Moia, AG Turpie, J Jespersen. The cost-effectiveness of computer- on discharge, list of other drugs on assisted anticoagulant dosage: results from the European Action on Anticoagulation (EAA) multicentre discharge. study. J Thromb Haemost 2009;7:1482-90 NHS National Patient Safety Agency This publication was produced in association with the National Patient Safety Agency
  6. 6. NHS NHS Improvement NHS Improvement NHS Improvement has over 10 years improvement experience. With our practicalCANCER knowledge and ‘how to’ approach we help improve the quality and productivity of services through using innovative approaches as well as tried and tested improvement methodology.DIAGNOSTICS Over the last 12 months we have tested, implemented, sustained and spread improvements with over 250 sites to assist in improving services in cancer, diagnostics, heart, lung and stroke. Working closely with the Department of Health, trusts, clinical networks, other health organisations and charities we have helped deliver key strategies and policies to improve the delivery andHEART implementation of improved services for clinical teams and their patients across the NHS.LUNGSTROKE NHS Improvement 3rd Floor | St John’s House | East Street | Leicester | LE1 6NB Telephone: 0116 222 5184 | Fax: 0116 222 5101 www.improvement.nhs.uk Delivering tomorrow’s improvement agenda for the NHS ©NHS Improvement 2011 | All Rights Reserved Publication Ref: IMP/comms014 - April 2011