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NEL LMCs position statement on DOACs monitoring
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Dear
<<First name>>,
Purpose of this document
This
paper sets out the position of North East London LMCs regarding the
ongoing monitoring of patients prescribed direct oral
anticoagulants (DOACs).
The
paper is intended to inform discussions between NEL ICB, NHS
England London Region, Londonwide LMCs, providers and system
partners.
It
addresses:
- the clinical nature
of DOAC monitoring;
- the contractual
position in general practice;
- why QOF and local
quality schemes do not create a contractual obligation to
provide unfunded monitoring;
- examples of other
areas where DOAC monitoring is commissioned locally; and
- the options
available to NEL ICB if it wishes general practice to deliver
this work safely and consistently.
Executive summary
DOAC
monitoring is clinically necessary, safety-critical, and
increasingly high-volume work. It includes more than the issuing of
a repeat prescription. It requires identification of the eligible
cohort, maintenance of a register, recall, blood testing, calculation
of creatinine clearance using an appropriate method, review of
weight, renal function and bleeding risk, assessment of adherence
and adverse effects, dose adjustment where required, management of
abnormal results, patient counselling, coding, and clear
arrangements for escalation.
Across
North East London, the LMCs understand that approximately 33,000
patients are prescribed DOACs. Each of these patients requires
regular monitoring, with many requiring more than annual monitoring
because of age, frailty, renal impairment, comorbidity or
interacting medication.
The
LMCs' position is that DOAC monitoring is not funded as part of the
core GMS/PMS/APMS contract. It requires a defined, structured,
safety-critical medicines monitoring service. Where commissioners
want general practice to deliver this service at scale, it should
be commissioned and resourced through an appropriate local enhanced
service or locally commissioned service.
QOF
does not resolve this issue. QOF is a voluntary incentive scheme
and does not convert non-core or unfunded work into a contractual
requirement. QOF indicators relating to atrial fibrillation and
anticoagulation incentivise aspects of prescribing and recording;
they do not constitute a comprehensive funded service specification
for ongoing DOAC monitoring.
Similarly,
a local quality framework or prescribing incentive cannot be used
to imply that practices are already funded to provide a
comprehensive anticoagulation monitoring service. If such a
framework generates additional activity, clinical responsibility,
patient recall, monitoring, coding, reporting and escalation, then
the activity must be properly specified and funded.
The
ICB therefore has a clear choice. It can either:
- commission general
practice to provide DOAC monitoring through a properly funded
LCS; or
- commission another
provider, such as community anticoagulation, haematology,
pharmacy or another suitable provider, to provide the service.
However,
where there is no commissioned community service, ongoing
monitoring and prescribing responsibility cannot safely be assumed
to sit with practices by default. General practice has never
delivered anticoagulation services as part of its core contract;
the default position is therefore for the service to be delivered
by secondary care haematology services.
The clinical reality of DOAC monitoring
DOACs
do not require INR monitoring in the way warfarin does. However,
they are not “no monitoring” medicines.
Safe
DOAC prescribing requires:
- baseline assessment
before initiation;
- assessment of renal
function using creatinine clearance, not simply eGFR;
- review after
initiation and/or dose change;
- ongoing monitoring
once stable;
- more frequent
review for patients with renal impairment, frailty, advanced
age, intercurrent illness, hepatic impairment, interacting
medicines, bleeding risk or other clinical concerns;
- dose review
according to indication, renal function, age, weight and
drug-specific criteria;
- review of
adherence, bleeding, anaemia, thromboembolic symptoms, adverse
effects and drug interactions;
- patient counselling
and safety-netting;
- action on abnormal
results, including dose change, treatment interruption,
referral or specialist advice where needed.
This
is structured medicines monitoring and clinical review. It is not
simply an administrative repeat-prescribing task.
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The core GP contract requires
practices to provide essential primary medical services to
registered patients. It does not contain a specific anticoagulation
monitoring service specification and does not set out the
infrastructure, call/recall, safety standards, review intervals,
coding, reporting, escalation, or payment arrangements required for
DOAC monitoring.
A
practice may, in the course of ordinary clinical care, identify
risks, respond to abnormal results, prescribe safely, and act in a
patient’s best interests. That does not mean that the commissioner
can require the practice to operate a population-level
anticoagulation monitoring service without specification or
funding.
The
LMCs' position is therefore:
- safe prescribing
remains a professional obligation for any clinician issuing a
prescription;
- practices should
not knowingly issue unsafe repeat prescriptions;
- however, the
establishment and operation of a systematic DOAC monitoring
service is not automatically funded under core GMS/PMS/APMS;
- where the system
requires practices to undertake proactive monitoring, recall,
review, coding, reporting and escalation for a defined DOAC
cohort, this should be commissioned as an enhanced or locally
commissioned service;
- alternatively, both
monitoring and prescribing may take place, by default, in a
secondary care haematology service.
QOF does not fund or mandate DOAC monitoring
The
ICB has suggested that existing mechanisms such as QOF and local
quality frameworks provide sufficient support for this work. The
LMCs do not agree.
QOF
is a voluntary incentive scheme. It rewards achievement against
defined indicators. It does not create a general contractual
obligation to deliver all associated clinical work, nor does it
provide a comprehensive service specification for medicines monitoring.
Practices may choose to decline to undertake the work associated
with QOF and forfeit the incentive payments.
The
current AF anticoagulation indicator concerns whether eligible
patients with atrial fibrillation are prescribed a DOAC, or where
unsuitable or declined, a vitamin K antagonist. That is not the
same as funding an anticoagulation monitoring service.
A
DOAC monitoring service requires, at minimum:
- a maintained DOAC
register;
- identification of
monitoring intervals;
- patient recall;
- blood tests;
- weight review;
- Cockcroft-Gault
creatinine clearance calculation;
- review of dose
appropriateness;
- review of bleeding
risk and adverse effects;
- action on abnormal
results;
- coding and
documentation;
- escalation routes;
- patient information
and safety-netting;
- governance and
audit.
QOF
does not specify or fund that service.
Local quality frameworks cannot redefine core
contract
The
same principle applies to any NEL local quality or proactive care
framework. Such schemes may incentivise quality improvement or
prescribing optimisation. They cannot, by implication, redefine the
core GP contract or require practices to accept unfunded clinical
responsibility for a complex medicines monitoring pathway.
If
a NEL quality scheme asks practices to undertake DOAC searches,
reviews, dose optimisation, coding, recalls or monitoring, then it
should be treated as commissioned activity and funded accordingly.
The
LMCs would be particularly concerned by any attempt to use a local
quality indicator to suggest that practices have accepted
responsibility for the entire DOAC monitoring pathway. Agreement to
participate in a quality improvement scheme is not the same as
agreement to provide an unfunded anticoagulation monitoring
service.
Patient safety risks if the service is not
commissioned
The
current position creates avoidable clinical risk.
Without
a commissioned service, monitoring becomes dependent on variable
local capacity, goodwill, prescribing workflows, medicines
management searches and opportunistic review. That is not a robust
system for a high-risk medication cohort.
Risks
include:
- patients remaining
on inappropriate doses after renal function changes;
- eGFR being used
instead of creatinine clearance;
- frail or older
patients not being monitored frequently enough;
- weight changes not
being captured;
- interacting
medicines not being reviewed;
- abnormal
haemoglobin, liver function or renal function not being acted
on consistently;
- unclear
responsibility between GP, hospital specialist,
anticoagulation service and pharmacy;
- unsafe assumptions
that “the GP is monitoring” when no funded pathway exists;
- inequity between
boroughs and practices; and
- increased
medicolegal risk for practices and individual prescribers.
The
LMCs' concern is not theoretical. DOACs are high-risk medicines.
The system must be clear about who is responsible for monitoring,
how patients are recalled, how results are reviewed, and how
abnormal findings are escalated.
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Examples from other areas
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The
BMA recognises the monitoring of DOACs
as a service that requires commissioning from practices.
Until
recently, NEL ICB commissioned a DOAC monitoring service from
general practice in Tower Hamlets. This service was withdrawn at
the end of March 2026.
Other
ICB systems have recognised that DOAC monitoring is legitimate
locally commissioned activity. Examples include the following:
North
Central London has a Direct Oral Anticoagulant Locally
Commissioned Service. Its stated aims include improving DOAC
initiation and monitoring in primary care, maintaining a register
of patients on DOAC therapy, providing patient information,
ensuring safe initiation and maintenance, identifying vulnerable
patients, and providing at least annual monitoring review.
North
West London has included DOAC review and optimisation
within its single offer enhanced service arrangements, including
review of patients prescribed DOACs for atrial fibrillation,
confirmation that dose is optimised in line with recent renal
function, and specified coding requirements.
Both
Surrey and Sussex ICBs have commissioned a Direct Oral Anticoagulant LCS with
payments for DOAC monitoring.
Kent
and Medway have also moved towards a commissioned response following
challenge from general practice and the LMC, including discussion
of a DOAC monitoring service and interim payment in lieu of the
shared care and DOAC monitoring service.
These
examples demonstrate that NEL’s current position is not aligned
with other ICBs. Other systems have accepted that DOAC monitoring
requires commissioning, specification and resource.
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Proposed minimum service specification
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If NEL ICB wishes general practice
to provide DOAC monitoring, the LMCs recommend that the ICB
commissions a DOAC Monitoring LCS with the following minimum
components.
Eligible patients
All
registered patients prescribed a DOAC by the practice, including
apixaban, rivaroxaban, edoxaban and dabigatran, for any
indication where ongoing prescribing and monitoring has been
accepted by the practice.
The
specification should distinguish between:
- patients
initiated in general practice;
- patients
initiated in secondary care and transferred to general
practice;
- patients under
active specialist follow-up;
- patients with
complex indications or unstable clinical status;
- patients for whom
monitoring should remain with a specialist anticoagulation
service.
Core activity
The
service should fund:
- maintenance of a
DOAC register;
- identification of
patients due monitoring;
- call and recall;
- blood tests,
including FBC, U&Es/creatinine and LFTs;
- weight recording
where required for dose assessment;
- Cockcroft-Gault
creatinine clearance calculation;
- dose review
according to indication, renal function, age, weight and
drug-specific criteria;
- adherence review;
- bleeding and
anaemia review;
- review of
thromboembolic symptoms;
- review of adverse
effects and drug interactions;
- patient
counselling and written information;
- coding;
- repeat
prescribing governance;
- referral or
specialist advice where required; and
- annual audit or
reporting proportionate to the service.
Review frequency
The
service should fund annual review as a minimum, with more
frequent monitoring for higher-risk patients, including patients
who are older, frail, have renal impairment, have hepatic
impairment, have interacting medicines, or have intercurrent
illness affecting renal or hepatic function.
The
service must recognise that some patients will need two, three or
more reviews per year, not simply one annual review.
Exclusions and escalation
The
service should specify when responsibility remains with or
returns to specialist care, including:
- unstable renal
function;
- severe renal
impairment;
- significant
hepatic impairment;
- suspected
bleeding or unexplained anaemia;
- recurrent
thrombosis or embolic events;
- complex
indications;
- uncertainty about
dose or drug choice;
- patients
requiring specialist anticoagulation advice;
- patients in whom
DOAC therapy may be contraindicated.
Payment model
The
payment model should reflect both fixed infrastructure and
variable workload. Options include:
- a fixed annual
practice payment for register maintenance, search work,
governance and reporting; plus
- a per-patient
payment for annual DOAC review; plus
- an additional
payment for higher-risk patients requiring more frequent
monitoring; plus
- separate payment
where initiation or switching is requested.
A
simple single per-patient payment risks underfunding older,
frailer, renal-impaired and complex patients. Any payment should
reflect actual workload and should not assume that all DOAC
patients require the same level of review.
Data and reporting
Reporting
should be proportionate and based on data practices can
reasonably record and extract. It should not become a separate
administrative burden greater than the clinical work itself.
Suggested
indicators include:
- number of
patients on DOAC register;
- percentage with
creatinine clearance recorded within appropriate interval;
- percentage with
DOAC dose reviewed;
- percentage with
FBC/LFT/U&E monitoring completed within appropriate
interval;
- number
referred/escalated for specialist advice;
- exception
reporting for non-attendance or patient refusal.
Recommended system position
The
LMCs recommend that London Region support the following position.
- DOAC monitoring
is clinically necessary and safety-critical.
- It is not
equivalent to ordinary repeat prescribing.
- It is not
comprehensively funded or specified through QOF.
- Neither QOF nor
local quality indicators can redefine the core GP contract.
- Where the ICB
wants practices to deliver this work systematically, it
should commission a properly specified LCS.
- In the absence of
such a service, the ICB must identify the provider
responsible for ongoing monitoring and make that pathway
clear to practices, patients, community pharmacies and
secondary care.
- The ICB should
not rely on unfunded practice goodwill to mitigate a known
medicines safety risk.
Practical asks of NEL ICB
NEL
LMCs therefore ask NEL ICB to:
- confirm in
writing whether it accepts that DOAC monitoring requires a
defined pathway;
- confirm whether
it wishes general practice to provide that pathway;
- if yes,
co-develop a DOAC Monitoring LCS with Londonwide LMCs;
- if no, identify
the commissioned alternative provider responsible for
monitoring;
- issue clear
guidance to secondary care, community pharmacy and practices
about where responsibility sits;
- confirm that QOF
and PCQOF participation will not be treated as acceptance of
unfunded DOAC monitoring responsibility;
- agree a safe
transition period while arrangements are put in place; and
- ensure that any
service is funded at a level reflecting the real workload
and risk.
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Suggested wording for practices
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Until
the position is resolved, practices should continue to act in
patients’ best interests and should not knowingly issue unsafe
prescriptions. However, practices are not required to absorb an
unfunded anticoagulation monitoring service by default.
Where
a patient requires structured DOAC monitoring and no commissioned
general practice service exists, practices may reasonably ask the
ICB to confirm the appropriate commissioned monitoring pathway.
Where specialist advice or review is clinically required, patients
should be referred or signposted according to the available local
pathway.
The
LMCs will continue to engage with NEL ICB and London Region to seek
a safe, funded and contractually clear solution.
Conclusion
DOAC
monitoring is important work. It prevents avoidable harm and
supports safe anticoagulation. But important work is not
automatically core work, and patient safety cannot depend on
unfunded, implied transfer of responsibility to general practice.
NEL
ICB should either commission general practice to deliver DOAC
monitoring properly, or commission another provider to do so. What
is not acceptable is an ambiguous position in which practices are
expected to carry the workload and risk without a service
specification, without funding, and without clear system
accountability.
Best
wishes,
North
East London LMCs
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