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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DIAGNOSTICS NHS Improvement - Heart
Anticoagulation for
HEART Atrial Fibrillation
A simple overview to support
the commissioning of quality
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STROKE

2. 2 www.improvement.nhs.uk/heart/anticoagulation
Anticoagulation for Atrial Fibrillation
A simple overview to support commissioning of quality services
Stroke is the third largest cause of death in commissioned. It further aims to provide • British Committee for Standards in
England and costs the NHS £2.8 billioni. some guidance as to the most important Haematology Guidelines on Oral
Atrial Fibrillation (AF) is a known risk factor markers to look at in assessing the quality of anticoagulation (warfarin): third
for stroke, increasing its risk and severity; it a service amongst the myriad of markers in edition (2005 update)x
is estimated that 12,500ii strokes per year existing guidelines. These guidelines are to update those
are attributable to AF. The related cost per written in 1998 and provide indications
AF 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 an
stroke occurrence. following documents: anticoagulation service. They promote
service participation in regular audit of
In order to reduce the risk of stroke in • NICE Anticoagulation Therapy Service; national quality assessment schemes and
patients with AF, anticoagulation therapy is Commissioning Guide (Dec 2007)viii clinical practice. These guidelines have
required. In the UK, there are approximately The guide was written to support local specific recommendations on the use of
500,000 patients currently prescribed oral implementation of the 2006 NICE clinical anticoagulation including managing
anticoagulant drugs, with warfarin being guideline for AF, and acts as a resource to bleeding, drug interactions, assessing
the most frequently prescribed (at an help commission an effective contraindications and point of care
average annual cost around £383iii). anticoagulation therapy service. It provides testing.
support to determine local service levels
Anticoagulants are classed as a high risk and requirements, as well as providing A web resource to support this guide
group of medicines, with warfarin methods to ensure corporate and quality is available at:
associated with incidents in prescribing, assurance. www.improvement.nhs.uk/heart/anticoagulation
dispensing and monitoringiv. It is therefore where copies of the above documents and
imperative that healthcare organisations • National Patient Safety Agency (NPSA) further article references and additional
take 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 Overview
When anticoagulation therapy is collaboration with the British Society for In order to prevent AF related strokes, the
appropriately used and monitored, it is Haematology and further input from other recommended course of action is to initiate
highly effective, lowering stroke risk by clinical and patient advisors. Written in anticoagulation therapyxi. When this therapy
about two thirdsvi. However, anticoagulation response to a series of reports of patient is appropriately used and monitored, it is
services vary in quality1 and effectiveness safety incidents involving anticoagulants highly effective, lowering stroke risk by
across the country2 and there are many received from all sectors of the NHS, this about two thirdsvi. However, despite the
people not being prescribed anticoagulation NPSA alert gives key mandatory actions clear benefits of warfarin and the presence
when indicated, and many others receiving and a set of indicators to help ensure the of guidelines for its use and management in
sub-optimal therapyvii. Effective safety of anticoagulation services for stroke prevention, current data indicates
commissioning 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 receiving
patients receiving appropriate • Recommendations and Safety anticoagulation not consistently in the
anticoagulation as well as ensuring a high Indicators from the British Committee optimal therapeutic range. Recent clinical
quality service is delivered. for Standards in Haematology and trials have supported a relationship between
National Patient Safety Agency (2006)ix anticoagulant control and benefit of
These improvements will reduce the number This document compliments the existing anticoagulationvii, with the longer time spent
of strokes suffered, save lives, reduce guidelines developed by the BCSH 1990 in therapeutic range reducing the chance of
disability 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 at
Aims anticoagulation. Using the risks and risk of under-anticoagulation, which can
This 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 in
services 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 with
quality can vary between clinics and will these indicators will help to identify the increasing international normalised ratio
influence 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 framework
2 Data to support the variation in anticoagulation services can be found at: www.improvement.nhs.uk/heart/anticoagulation
3 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 www.improvement.nhs.uk/heart/anticoagulation
Patients on anticoagulants therefore require • Service access and waiting time – as • Service specification – a number of
monitoring and frequent dose adjustment in anticoagulation requires frequent models exist for the delivery of
order to maintain the desired therapeutic monitoring it is imperative that patients anticoagulation services such as full
action 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 mixed
is necessary to capture and monitor the initiation and monitoring. models of the above. It is therefore
therapeutic benefit of warfarin. suggested that services set clear
• Communication – successful and safe specifications for monitoring and assuring
An 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 local
within the target INR range (Rosendaal et al, This includes ensuring that appropriate needs and requirements. For more
1993). The percentage of time spent in communication can occur between information see the NICE commissioning
therapeutic range varies and this variation clinician and patientxiii, as well as guideviii which provides an outline of
has a major impact on the effectiveness of facilitating access to patient results across service specification considerations and
warfarinvii. the potential different information systems quality assurance indications.
and between clinicians responsible for
Based on the relation derived time in their care.
therapeutic range and effectiveness of Key Indicators for Commissioning
stroke prevention it can be estimated that a • Point of care (POC) testing – INR testing Quality Anticoagulation Services
5% improvement in time in therapeutic undertaken outside laboratories utilising Commissioners need to ensure that the
range across UK anticoagulation clinics POC devices should apply the same services they commission offer the best
would result in the prevention of 400-500 standards of total quality management as clinical outcomes for patients. Clinics
strokes 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, and
Considerations for Anticoagulation trained personnel with support from an those without a clear clinical governance
Therapy Services external quality assessment scheme; either structure, could potentially result in the
Due to the therapeutic nature and a national scheme (such as NEQASxiv) or delivery of ineffective and unsafe care. It
monitoring requirements of anticoagulants, local hospital laboratory. See MHRA is acknowledged that commissioners may
there are a number of clinical and service guidance on Management and Use of IVD not be in a position to collate this
considerations which have a potential POC Test Devicesxv and the guidelines for information and as a result may be
impact on the quality of anticoagulation POC testing in haematologyxvi for further unable to benchmark good or bad
services 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 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 have
Summary Nurse, University of Birmingham Hospital updated the patient-held information
Drawing 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 prescribers
important 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 Normalised
anticoagulation services. Specific evidence Cardiovascular Medicine, UCL Ratio, INR) is being monitored regularly
based recommendations are provided to Undergraduate Centre and that the INR level is safe before
help commissioners ensure the best clinical Professor Leon Poller, EAA Project Leader, issuing or dispensing repeat
outcomes 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 clinically
is in place to monitor and act upon these Specialist, Medicines & Healthcare Products significant interacting medicines for
outcomes 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 additional
reducing the likelihood of adverse events University Hospitals of Coventry & INR blood tests, and to inform the
such 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, but
4
nonetheless the model of where review is to take place should be clearly agreed and stated.

5. 5 www.improvement.nhs.uk/heart/anticoagulation
7. 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 unknown
9. 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 NICE
Committee for Standards in Haematology
(2006); Safety indicators for anticoagulant guidance in England.
iv NPSA (2007) Risk assessment of anticoagulation therapy
services 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 in
Safety 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 Over
anticoagulation:
Antiplatelet Therapy in Atrial Fibrillation Depends on the Quality of International Normalized Ratio
1. 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): third
3. 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.asp
5. 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

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