{{org_field_logo}}

{{org_field_name}}

Registration Number: {{org_field_registration_no}}

---

Safe Management of Warfarin and Anticoagulant Therapy Policy

1. Purpose

The purpose of this policy is to ensure the safe, consistent and effective management of warfarin and other anticoagulant medicines for individuals living in {{org_field_name}}. Warfarin and other anticoagulants, including direct-acting oral anticoagulants (DOACs), are medicines associated with a significant risk of harm if they are not prescribed, administered, monitored or reviewed appropriately.

This policy supports compliance with the Regulation and Inspection of Social Care (Wales) Act 2016 and the Regulated Services (Service Providers and Responsible Individuals) (Wales) Regulations 2017, as amended, including Regulation 58 relating to the safe storage and administration of medicines. It must be read and implemented alongside CHW21 – Medication Management and Administration Policy and the home’s wider medicines-management procedures.

The service will have arrangements in place to ensure that anticoagulant medicines are administered safely; that accurate and up-to-date records are maintained; that appropriate monitoring requirements are known and acted upon; that changes in treatment are communicated and recorded promptly; and that staff involved in medicines management are trained and assessed as competent for the duties they undertake.

This policy also reflects applicable statutory guidance for service providers and responsible individuals in Wales and current national medicines-safety and clinical guidance, including relevant NICE guidance.

The purpose of these arrangements is to protect individuals from avoidable harm associated with bleeding, thrombosis, medicine interactions, incorrect doses, missed monitoring or failures in communication, while supporting each individual’s rights, choices, independence and personal outcomes.

2. Scope

This policy applies to all staff involved in any aspect of medication management, including the administration, storage, documentation, and monitoring of warfarin and other anticoagulants. It includes registered nurses, care staff with medication responsibilities, team leaders, managers, agency workers, and visiting healthcare professionals. It also informs family members and advocates who are involved in a resident’s care decisions.

3. Related Policies

This policy should be read in conjunction with:

• CHW11 – Safe Care and Treatment Policy
• CHW21 – Medication Management and Administration Policy
• CHW24 – Management of Accidents, Incidents, and Near Misses Policy
• CHW36 – Initial Assessment and Care Planning Policy
• CHW18 – Risk Management and Assessment Policy
• CHW17 – Infection Prevention and Control Policy
• CHW34 – Confidentiality and Data Protection Policy

4. Policy Implementation and Operational Guidance

4.1 Understanding Anticoagulant Therapy

Anticoagulants are prescribed to reduce the risk of harmful blood clots in individuals with conditions including atrial fibrillation, deep vein thrombosis, pulmonary embolism and mechanical heart valves.

Warfarin is a vitamin K antagonist anticoagulant and requires regular monitoring of the International Normalised Ratio (INR). The frequency of INR monitoring and any required dose adjustments are determined by the anticoagulation service, prescriber or other healthcare professional responsible for managing the individual’s anticoagulation.

Direct-acting oral anticoagulants (DOACs), including apixaban, rivaroxaban, dabigatran and edoxaban, do not require routine INR monitoring. However, they remain medicines associated with a significant risk of harm and require appropriate clinical review, monitoring and observation for adverse effects.

Staff must recognise that anticoagulant medicines can cause serious harm if doses are incorrect, omitted, duplicated, administered at the wrong time, inadequately monitored or affected by medicines interactions.

Staff must not independently start, stop, restart, omit or alter an anticoagulant dose unless this has been authorised by an appropriately qualified prescriber or is provided for within a lawful and applicable clinical direction.

4.2 Admission and Initial Assessment

On admission to the service, and whenever an individual returns following a transfer of care where their medicines may have changed, medicines reconciliation must be completed in accordance with CHW21 – Medication Management and Administration Policy.

For every individual receiving anticoagulant therapy, staff must ensure that the following information is obtained from an appropriate and reliable source and accurately recorded:

• the name, strength, formulation, dose, route and frequency of the anticoagulant;
• the clinical indication for anticoagulation, where this information is available;
• any known medicine allergies or intolerances;
• the date and time of the last dose where this is relevant to safe continuation of treatment;
• any recent change, interruption or planned restart of anticoagulant treatment;
• any specific instructions provided by the prescriber, anticoagulation service, hospital or other responsible healthcare professional;
• relevant monitoring requirements and the healthcare professional or service responsible for arranging and reviewing that monitoring; and
• the date of the next required review, blood test or other monitoring where this has been specified.

For individuals prescribed warfarin, the service must additionally obtain and record:

• the current prescribed warfarin dose or dosing schedule;
• the individual’s target INR range, where specified;
• the most recent available INR result;
• the date on which that INR was measured;
• the date of the next INR test or instructions for arranging the next test; and
• the contact details of the GP, anticoagulation clinic or other healthcare professional responsible for warfarin dosing and monitoring.

Warfarin must not be administered where staff do not have sufficiently clear, current and authorised dosing instructions to determine the dose safely. Where the prescription, MAR chart, anticoagulation record, discharge information or other instructions are incomplete, inconsistent or unclear, staff must seek clarification from the prescriber, anticoagulation service, pharmacist or other appropriate healthcare professional before administration.

The provider assessment and personal plan must identify anticoagulant-related risks relevant to the individual. These may include:

• previous or current bleeding;
• falls or increased risk of falls;
• cognitive or communication difficulties which may affect safe medicines use or reporting of symptoms;
• swallowing difficulties;
• kidney or liver impairment where relevant;
• concurrent medicines which may increase the risk of bleeding or otherwise interact with anticoagulant treatment;
• alcohol intake where clinically relevant;
• the individual’s ability and wish to self-administer their medicine; and
• any previous problems with adherence, monitoring or anticoagulant treatment.

The individual’s personal plan must contain sufficient information to enable staff to provide safe day-to-day care and must identify:

• the anticoagulant being taken;
• relevant monitoring requirements;
• signs and symptoms of bleeding or thrombosis which staff must observe for;
• any individual-specific risk-reduction measures;
• what action staff must take if a dose is refused, omitted, vomited, administered incorrectly or cannot be given;
• what action staff must take following a fall or head injury;
• who staff must contact for clinical advice; and
• any arrangements for supporting the individual to understand and participate in decisions about their anticoagulant therapy.

4.3 Safe Storage and Administration

Anticoagulants must be managed as medicines with a significant potential to cause harm. Storage, administration, recording and disposal must comply with CHW21 – Medication Management and Administration Policy and the home’s medicines-management procedures.

The service must ensure that:

• anticoagulant medicines are stored securely and in accordance with the manufacturer’s instructions and applicable medicines-storage requirements;
• the correct individual’s medicine is selected and the current prescription and MAR record are checked before administration;
• staff administering anticoagulants have access to all information needed to determine the correct dose safely;
• where warfarin or another medicine has a separate dosing or administration record, the MAR record contains a clear cross-reference to that record;
• variable-dose warfarin is administered only against current, clear and authorised dosing instructions;
• administration is recorded as soon as possible after the medicine has been administered;
• refusals, omissions, administration errors and other medicines-related problems are recorded and acted upon in accordance with the home’s medicines policy;
• staff do not alter, omit, delay, withhold or administer an additional anticoagulant dose unless this is authorised by an appropriately qualified prescriber or is provided for within a lawful and applicable clinical direction;
• an anticoagulant prescribed for one individual is never used for another individual; and
• any discrepancy between the medicine label, MAR chart, anticoagulation record, discharge information or other prescribing instruction is resolved with the prescriber, pharmacist, anticoagulation service or other appropriate healthcare professional before the medicine is administered.

Where the home operates an additional checking procedure for warfarin or other high-risk medicines, staff must follow that procedure consistently. Any second check must be meaningful and must not replace the responsibility of the person administering the medicine to ensure that the correct medicine and dose are given to the correct individual.

Staff must also consider whether newly prescribed, discontinued or changed medicines, over-the-counter preparations, herbal products or nutritional supplements could affect anticoagulant treatment. Where there is uncertainty, advice must be obtained from the prescriber, pharmacist or anticoagulation service before the additional medicine or product is given.

4.4 INR Monitoring and Warfarin Dosage Adjustment

Where an individual is prescribed warfarin:

• INR monitoring must take place at the frequency determined by the anticoagulation service, prescriber or other healthcare professional responsible for managing the individual’s anticoagulation;
• the service must have a clear system for identifying when the next INR test is due and who is responsible for arranging the test;
• staff must follow up overdue INR monitoring promptly and must not assume that another organisation has done so where responsibility is unclear;
• the result of each INR test, the date of the test, the current prescribed warfarin dose or dosing schedule and the next monitoring date must be available to staff involved in administration and recorded or cross-referenced in the individual’s medicines and care records;
• staff must not independently calculate, increase, decrease, omit or otherwise change a warfarin dose on the basis of an INR result;
• dose decisions must be made by an appropriately authorised prescriber or anticoagulation service;
• a new or changed warfarin dose must be supported by a clear authorised instruction from the prescriber or anticoagulation service and incorporated into the appropriate medicines record;
• where an instruction is communicated remotely, the member of staff receiving it must record the name and professional role of the person giving the instruction, the date and time, the exact instruction received and the identity of the member of staff receiving it, in accordance with the home’s medicines policy;
• written or electronically transmitted confirmation of a remotely communicated instruction must be obtained as soon as possible in accordance with the prescribing organisation’s arrangements and current medicines guidance;
• if an instruction is incomplete, ambiguous, inconsistent with existing records or cannot be authenticated, staff must seek clarification before administering the dose;
• an INR result outside the individual’s stated therapeutic range must be referred to the anticoagulation service, prescriber or other responsible healthcare professional in accordance with the individual’s clinical instructions and the urgency of the situation;
• where the individual develops bleeding, suspected thrombosis or another acute clinical concern, staff must not wait for routine anticoagulation review but must obtain urgent medical assistance appropriate to the individual’s condition; and
• where a medicine is started, stopped or changed and it could interact with warfarin or affect anticoagulation, staff must ensure that the prescriber, pharmacist or anticoagulation service is informed where this has not already occurred and that any resulting monitoring instructions are followed.

4.5 Monitoring of Direct-Acting Oral Anticoagulants

Direct-acting oral anticoagulants, including apixaban, rivaroxaban, dabigatran and edoxaban, do not require routine INR monitoring. This must not be interpreted as meaning that no clinical monitoring or review is required.

For individuals prescribed a DOAC, the service must:

• accurately record the medicine, dose, frequency and indication where known;
• administer the medicine at the prescribed time and frequency, recognising the importance of avoiding unintended missed or duplicate doses;
• record and escalate refusals, omissions, vomiting after a dose or administration errors in accordance with the home’s medicines policy and seek clinical advice where required;
• monitor the individual for signs or symptoms of bleeding, anaemia, thrombosis or other adverse effects;
• ensure that any clinical monitoring or medication review requested by the GP, prescriber or other responsible healthcare professional is arranged or supported as required;
• ensure that relevant healthcare professionals are informed of significant changes in the individual’s health which may affect the safe use of the medicine, including acute illness, dehydration, significant deterioration, bleeding or changes in kidney or liver function where these are known;
• check that medication changes, including newly prescribed medicines and over-the-counter or complementary products, are considered for potential interactions by an appropriate healthcare professional where required; and
• ensure that anticoagulant therapy is included during medication reconciliation following hospital attendance, hospital discharge or other transfer of care.

Care staff must not alter a DOAC dose or dosing frequency on the basis of age, weight, renal function, bleeding risk or any other clinical factor. Any change to treatment must be authorised by an appropriately qualified prescriber.

4.6 Monitoring for Adverse Effects and Emergency Response

Staff must remain alert to signs and symptoms of bleeding, thrombosis and other complications associated with anticoagulant therapy.

Possible signs of bleeding include:

• unexplained or extensive bruising;
• persistent or recurrent nosebleeds;
• bleeding from the gums;
• prolonged bleeding from cuts or wounds;
• blood in the urine;
• red blood in the stools or black, tarry stools;
• vomiting or coughing blood;
• unexplained pallor, weakness, dizziness, breathlessness or collapse;
• persistent or severe headache;
• new confusion, reduced consciousness or other neurological change;
• unexplained abdominal, back or joint pain where internal bleeding may be suspected; and
• any other unusual or persistent bleeding.

Possible signs of thrombosis or embolism include:

• sudden chest pain;
• sudden or unexplained shortness of breath;
• coughing blood;
• unilateral swelling, pain, redness or warmth of a leg;
• sudden facial weakness, arm weakness or speech disturbance;
• sudden loss or change of vision; or
• other sudden neurological symptoms.

Staff must respond according to the severity and urgency of the individual’s condition.

Emergency medical assistance must be obtained immediately by calling 999 where the individual has signs or symptoms suggesting a life-threatening bleed, stroke, pulmonary embolism, severe deterioration, collapse, loss of consciousness or another medical emergency.

For non-life-threatening but urgent concerns, staff must obtain prompt clinical advice from the individual’s GP, out-of-hours medical service, anticoagulation service, NHS 111 Wales or another appropriate healthcare professional.

Falls and Head Injury

Any actual or suspected head injury in an individual taking an anticoagulant must be treated as clinically significant because anticoagulation increases the risk associated with intracranial bleeding.

Following a head injury:

• staff must undertake an immediate assessment within the limits of their training;
• emergency assistance must be requested immediately where there is loss of consciousness, reduced consciousness, seizure, vomiting, neurological symptoms, severe or worsening headache, significant deterioration or any other emergency feature;
• where there are no immediately life-threatening features, staff must nevertheless seek prompt medical assessment or advice and clearly inform the healthcare professional that the individual is receiving anticoagulant treatment;
• staff must follow the advice given regarding transfer to an emergency department, observation or further monitoring;
• the individual must not simply be observed in the care home without appropriate clinical advice because they appear initially well; and
• the event, observations, advice obtained, action taken and outcome must be fully recorded.

Staff must not independently omit or discontinue anticoagulant treatment following a fall, injury or episode of bleeding unless instructed to do so by an appropriately authorised healthcare professional.

All adverse effects, symptoms, observations, clinical advice and actions taken must be documented in the individual’s care record and, where applicable, medicines and incident records.

4.7 Communication and Interdisciplinary Coordination

Effective communication and transfer of accurate information are essential to the safe management of anticoagulant therapy.

The service must ensure that:

• current anticoagulant treatment and relevant monitoring requirements are communicated to staff who need the information to provide safe care;
• any authorised change to the anticoagulant, dose, dosing schedule or monitoring arrangements is incorporated promptly into the relevant medicines and care records;
• staff involved in administration are informed promptly of changes and have access to the current authorised instruction;
• medicines reconciliation is completed following admission, return from hospital or another transfer of care where medicines may have been started, stopped or changed;
• discrepancies between hospital discharge information, prescriptions, MAR records, anticoagulation records or other instructions are clarified with an appropriate healthcare professional before administration;
• relevant information is shared promptly with GPs, pharmacists, anticoagulation services, registered nurses and other healthcare professionals involved in the individual’s treatment where this is necessary for safe care;
• when an individual attends hospital, an outpatient appointment, dental treatment or another healthcare service, relevant information about anticoagulant therapy is made available to the receiving healthcare professional where appropriate;
• when the individual is temporarily away from the care home, appropriate arrangements are made for safe continuation of their medicines and relevant dosing information accompanies them where necessary; and
• individuals and, where appropriate, their representatives are informed and involved in decisions about anticoagulant treatment in accordance with the individual’s wishes, consent, mental capacity and lawful decision-making arrangements.

All significant communications concerning anticoagulant treatment, monitoring, dose changes or clinical advice must be recorded in the individual’s care and medicines records.

4.8 Incident Management

Any incident or near miss involving anticoagulant therapy must be responded to promptly in order to protect the individual from harm.

This includes, but is not limited to:

• administration of an incorrect anticoagulant;
• administration of an incorrect dose;
• administration at an incorrect time where this may be clinically significant;
• a missed or omitted dose;
• a duplicate dose;
• administration to the wrong individual;
• administration contrary to a current prescription or dosing instruction;
• failure to obtain or act upon required anticoagulation monitoring;
• failure to communicate or implement an authorised dose change;
• loss of medicine or inability to account for stock;
• suspected adverse drug reaction;
• significant bleeding;
• suspected thrombosis; and
• a fall or injury where anticoagulant treatment may increase the risk of harm.

When an incident occurs, staff must:

• first assess the individual’s immediate condition and take any necessary emergency action;
• inform the senior person on duty or Registered Manager in accordance with the home’s escalation arrangements;
• obtain timely advice from an appropriate healthcare professional, pharmacist, anticoagulation service, NHS 111 Wales or emergency service according to the nature and urgency of the incident;
• provide the healthcare professional with accurate information about the anticoagulant, prescribed dose, dose actually administered or omitted, timing and relevant clinical information;
• follow any clinical advice received;
• not administer an additional, replacement or compensatory dose unless specifically instructed to do so by an appropriately authorised healthcare professional;
• record the incident accurately in the individual’s care and medicines records;
• complete the home’s incident or near-miss reporting process in accordance with CHW24 – Management of Accidents, Incidents and Near Misses Policy; and
• ensure that the incident is reviewed to identify contributory factors, required actions and learning.

CIW Notification

An anticoagulant-related incident must be notified to Care Inspectorate Wales where the circumstances meet a statutory notification requirement under Regulation 60 and Schedule 3 of the Regulated Services (Service Providers and Responsible Individuals) (Wales) Regulations 2017, as amended.

A medicines error or near miss must not be treated as automatically notifiable to CIW solely because harm could potentially have occurred.

The Registered Manager and/or Responsible Individual must consider the actual circumstances and determine whether the event falls within a statutory notification category, including where it has resulted in a serious accident, injury, illness, death, abuse or another event specified within Schedule 3.

Where a CIW notification is required, it must be submitted without delay in accordance with the Regulations and current CIW notification arrangements.

Where an incident raises a safeguarding concern, the Wales Safeguarding Procedures and the service’s safeguarding policy must also be followed and the appropriate safeguarding referral made without delay.

Where a medicines incident raises concerns regarding the practice, competence or conduct of a member of staff or registered professional, the service must consider and make any referral required to the relevant professional regulator, Disclosure and Barring Service or other statutory body.

Anticoagulant-related incidents and near misses must be included within the service’s quality-assurance processes so that patterns, trends, learning and required improvements can be identified and acted upon.

4.9 Staff Training and Competence

Only staff who have received the medicines-management training required for their role and have been assessed as competent may administer anticoagulant medicines.

Before a member of staff undertakes anticoagulant-related medicines duties without direct supervision, the service must be satisfied that the member of staff has the knowledge, skills and competence required for the tasks they are expected to perform.

Training and competency assessment relevant to anticoagulant therapy must include, according to the member of staff’s role:

• safe administration and recording of anticoagulant medicines;
• the particular risks associated with warfarin and DOACs;
• recognition and escalation of signs and symptoms of bleeding and thrombosis;
• the importance of correct timing and avoidance of missed or duplicate doses;
• safe management of variable-dose warfarin;
• understanding the purpose of INR monitoring and the limits of the care worker’s role;
• checking and following authorised dose changes;
• recognising when information is incomplete, contradictory or unsafe and obtaining clarification before administration;
• medicine, over-the-counter preparation, complementary product and food interactions relevant to anticoagulant therapy;
• action following a fall or head injury in an individual receiving anticoagulants;
• management and reporting of refusals, omissions, errors and adverse events;
• medicines reconciliation and communication during transfers of care; and
• the requirement not to independently adjust, stop, restart or compensate for an anticoagulant dose.

Competence must be assessed before the member of staff carries out the relevant medicines task and must include observation of practice where appropriate.

Staff involved in managing or administering medicines must have their medicines-related knowledge, skills and competence reviewed at least annually.

Competence must be reviewed sooner where there is:

• a medicines-related safety incident;
• a concern about practice;
• a significant change in duties;
• new medicines-management equipment or systems; or
• another reason to question whether the member of staff remains competent.

Where a member of staff has not demonstrated the necessary competence, they must not undertake the medicines task concerned unless and until additional training, supervision and reassessment have demonstrated that they are competent.

Registered professionals remain accountable to the requirements of their professional regulator and applicable professional standards.

Any delegated healthcare activity involving anticoagulant therapy must be undertaken in accordance with current national guidance, professional requirements and the service’s delegation arrangements.

4.10 Audit and Quality Assurance

The Registered Manager {{org_field_registered_manager_first_name}} {{org_field_registered_manager_last_name}} must ensure that anticoagulant medicines are included within the service’s medicines-management audit and quality-assurance arrangements.

Auditing must include, where applicable:

• accuracy and completeness of MAR records;
• availability and accuracy of separate warfarin dosing or administration records;
• appropriate cross-referencing between MAR records and separate anticoagulation records;
• evidence that the correct current warfarin dose has been administered;
• recording of INR results, next-test dates and authorised dose changes;
• action taken in response to overdue or abnormal monitoring;
• recording and management of refused, omitted, delayed or incorrect doses;
• medicines reconciliation following admission and transfer of care;
• storage and stock-control arrangements;
• anticoagulant-related incidents and near misses;
• evidence that required clinical advice has been sought and acted upon;
• staff training and competency records; and
• implementation and completion of actions arising from previous audits or incidents.

Any identified shortfall that could compromise an individual’s safety must be addressed promptly according to the level of risk.

Anticoagulant-related medicines errors, near misses, adverse events, monitoring failures and audit findings must be analysed for patterns and trends and used to improve practice.

The Responsible Individual must ensure that relevant information from medicines audits, incidents, near misses and other quality-assurance activity is considered within the service’s quality-of-care review arrangements.

In accordance with Regulation 80 of the Regulated Services (Service Providers and Responsible Individuals) (Wales) Regulations 2017, as amended, the quality of care and support must be reviewed as often as required and at least every six months.

Actions arising from audit or quality review must identify:

• the action required;
• the person responsible for completing the action;
• the timescale for completion; and
• how completion and effectiveness will be checked.

4.11 CIW Compliance and Inspection Readiness

The service must be able to demonstrate through its records and practice that anticoagulant therapy is managed safely and in accordance with the Regulated Services (Service Providers and Responsible Individuals) (Wales) Regulations 2017, as amended, applicable statutory guidance, current national guidance and the service’s own medicines policies and procedures.

Evidence available for regulatory inspection must include, where applicable:

• accurate and up-to-date personal plans for individuals receiving anticoagulant therapy;
• accurate MAR records and any separate anticoagulant or warfarin dosing records;
• clear evidence of the current authorised dose and monitoring arrangements;
• INR results and follow-up arrangements where warfarin is prescribed;
• evidence that medicines reconciliation has occurred where required;
• records of relevant communications with prescribers, anticoagulation services, pharmacists and other healthcare professionals;
• records demonstrating appropriate management of refusals, omissions, errors, adverse events and head injuries;
• medicines audit records and evidence that identified actions have been completed;
• staff medicines training and competency assessments;
• incident and near-miss records and evidence of learning from these events; and
• evidence that statutory notifications have been made to CIW where the relevant notification criteria have been met.

The Registered Manager and Responsible Individual must ensure that identified medicines-management risks or deficiencies are acted upon promptly and that improvements are monitored for effectiveness.

5. Policy Review

This policy will be formally reviewed at least annually and earlier whenever necessary to ensure that it remains current, accurate and effective.

An earlier review must be undertaken where relevant following:

• a change in legislation or statutory guidance;
• a change in applicable NICE, medicines-safety, professional or other national guidance;
• a change in CIW regulatory requirements relevant to this policy;
• a significant anticoagulant-related medicine incident or identified pattern of incidents;
• a safeguarding concern related to medicines management;
• an audit, complaint, inspection or quality review which identifies a deficiency in this policy or its implementation;
• a material change in the service’s medicines-management systems or arrangements; or
• evidence that staff are unclear about, or are not consistently following, the policy.

The Responsible Individual must ensure that suitable arrangements are in place for this policy to be kept up to date. The Registered Manager must ensure that staff who are required to follow the policy have access to the current version, understand the requirements relevant to their role and are informed of material changes.

Changes to this policy must be communicated to relevant staff and incorporated into training, competency assessment, personal plans, medicines procedures and audit arrangements where applicable.

---

Responsible Person: {{org_field_registered_manager_first_name}} {{org_field_registered_manager_last_name}}
Reviewed on: {{last_update_date}}
Next Review Date: {{next_review_date}}
Copyright © {{current_year}} – {{org_field_name}}. All rights reserved.