SERVICE SPECIFICATION FOR PROVISION OF
ANTICOAGULANT MONITORING SERVICE BY PHARMACIST PRACTITIONERS
IN A PRIMARY CARE CLINIC AT THE KIRKBY HEALTH SUITE
AIMS OF SERVICE
Pharmacist Practitioners to provide optimal therapeutic control for patients prescribed
oral anticoagulants whilst minimising the risks associated with such therapy. Overall
responsibility for the organisation, supervision and adherence to quality assurance and
quality control standards within the primary care clinic, will be held by the Primary Care
Pharmacist with responsibility for the Anticoagulant Service.
1.
2.
SPECIFIC OBJECTIVES
1.1
To maintain anticoagulation within a prescribed range by dose adjustment,
anticipating changes and frequency of review.
1.2
To monitor therapy with reference to appointments and length of treatment.
1.3
To educate and inform patients.
1.4
To maintain documentation.
1.5
To perform quality control testing and routine maintenance of anticoagulant
monitoring equipment.
CLINIC ORGANISATION
2.1
Referral of Patients to Primary Care Anticoagulant Clinic
Patients will be referred to the Primary Care Anticoagulant Clinic by:
- Their General Practitioner after being stabilised by the University
Hospital Aintree NHS Trust Anticoagulant Service.
- Transferred directly to the Primary Care Anticoagulant Clinic by
University Hospital Aintree NHS Trust.
- Referrals from other Trusts will be accepted at the discretion of the
Anticoagulant Services Manager.
- Direct Referrals will not be accepted for housebound patients.
When patients are referred or transferred to the Clinic, relevant
documentation in the form of anticoagulant clinic records will be completed.
These records should contain the original prescription for therapy, which
will include indication for therapy, prescribed International Normalised
Ratio (INR) range, duration of treatment, drug history and concomitant
disease history, and any previous anticoagulant therapy records. Where
INR range is not specified, the pharmacist practitioner will apply an INR
range according to British Haematological Guidelines and bring this to the
attention of the Anticoagulant Services Manager.
2.2
Clinics
2.2.1 Patients will be seen by appointment in the designated room at the
Kirkby Health Suite by a pharmacist practitioner who has undergone
appropriate training.
2.2.2 The anticoagulant dose will be adjusted by the pharmacist
practitioner with reference to the patient's INR and any other
changes that may be identified during the appointment.
2.2.3 Under normal circumstances patients will be reviewed for INR
measurement and dosage adjustment, if necessary, at least every
12 weeks.
2.2.4 Adequate information will be provided to ensure General
Practitioners are kept informed of the progress of their patient.
2.2.5 Reception staff at the Kirkby Health Suite will document the date
and time of the next appointment in both the patient's record card
and the Health Suite anticoagulant appointments file.
2.2.6 If a patient fails to attend a clinic, the attached DNA policy will be
applied (appendix 1). A new appointment should be scheduled
within 2 weeks either by telephone or use of a standard letter to the
patient.
2.2.7 For regular non-attenders, the Anticoagulant Services Manager will
inform the GP in writing, and a decision made as to future
management of these patients.
2.3
Domiciliary Visits
2.3.1 Patients may be referred for domiciliary visits if they are existing
patients of the Kirkby Anticoagulant Service and due to unforeseen
circumstances can no longer attend the clinic.
2.3.2 The Home Visiting Policy (Appendix 4) will be adhered to at all
times.
2.3.3 Patients will be seen in their home by a pharmacist practitioner or
technician who has undergone appropriate training.
The anticoagulant dose will be adjusted by the pharmacist
practitioner. If the technician has visited the patient they will contact
the pharmacist over the telephone in order for the pharmacist to
dose the patient. The patient will be dosed with reference to the
patient's INR and any other changes that may be identified during
the appointment.
2.3.4 Under normal circumstances patients will be reviewed for INR
measurement and dosage adjustment, if necessary, at least every
12 weeks.
2.3.5 Adequate information will be provided to ensure General
Practitioners are kept informed of the progress of their patient.
2.3.6 The technician will document the date and time of the next
appointment in both the patient's record card and in the domiciliary
appointments file.
2.3.7 If a patient is not at home, the attached DNA policy will be applied
(appendix 1). A new appointment should be scheduled within 2
weeks either by telephone or use of a standard letter to the patient.
2.4
Referring Patients for Medical Advice
2.4.1 Occasionally patients may seek medical advice from the
pharmacist practitioner. In these circumstances patients will
be advised to consult their General Practitioner.
2.3.2 Patients presenting with the following medical
complications of their anticoagulant treatment will be
referred immediately to the local hospital A & E
department. If necessary further advice will be sought from
Dr Ade, Consultant Haematologist, Aintree Hospitals (NHS)
Trust, or the patient’s GP.
INR greater than 8.0 and / or they have signs or
symptoms of bleeding or signs or symptoms of
thromboembolic episodes or if thought to be at
high risk of bleeding or thromboembolism.
If INR > 8.0 and there is absence of both bleeding and
risk factors for thromboembolism, any decision not to
refer a patient to an A&E Department can only be
taken with the agreement of the patient’s GP.
2.5 Confidentiality
2.5.1 In the course of your employment you may come across
confidential information regarding patients, staff or the
business dealings of Knowsley PCT. Unauthorised disclosure
of such information will be considered gross misconduct and
will lead to disciplinary action being taken against you.
2.5.2 Immediately upon termination of your employment you must
return to us all documents, forms, papers or other records
relating to your employment (including copies).
2.5.3 After termination of your employment a breach of
confidentiality by you may render you liable for legal action.
This does not affect your statutory rights under the Public
Interest Disclosure Act 1998.
2.6 Fraud and Probity
2.6.1 The trust is committed to the elimination of fraud, to the
vigorous investigation of any such cases and where fraud or a
criminal act is proven to ensure that wrong doers are appropriately
dealt with. The trust will take appropriate steps to recover any
assets lost as a result of fraud.
2.6.2 Employees found in breach of the Trust Fraud and Probity
Policy and procedures will be considered to have committed an act
of gross misconduct and will, therefore, be subject to disciplinary
action.
2.7 Health and safety
2.7.1 Anticoagulant practitioners are required to follow all applicable
rules an procedures relating to Health and Safety at Work and take
reasonable precautions to avoid accidents.
2.8 Documentation
2.8.1 Strict confidentiality will be maintained. The file will be kept in
a lockable filing cabinet in the designated room for anticoagulant
monitoring at the Kirkby Health Suite. The room will be accessible
only to keyholders. Suitable arrangements will exist for access in the
interests of patient safety.
2.8.2 A patient record will be maintained for each patient. This
record will be updated at each clinic visit and will contain:
a) The original referral form.
b) The INR result at each visit.
c) The dose of anticoagulant.
d) The number of weeks to next appointment
e) Relevant notes of each visit.
f) Correspondence concerning the individual patient.
g) List of current medication
h) Any near miss forms
2.8.3 The patient-held anticoagulant treatment card must be
updated at each visit. If this is not available, a temporary record
booklet must be completed and given to the patients.
2.8.4 The pharmacist practitioner should record the number of
attenders, non-attenders and home visits in the designated file and
record for each clinic session the number of patients within, above
and below specific ranges, the average number of weeks since the
last appointment and the results of quality control tests. See
Appendix 2.
2.8.5 All files will be kept for 10 years after a patient leaves the
care of the anticoagulant service.
2.5
End of Treatment
2.5.1 Two weeks before the end of a specified period of treatment the
pharmacist practitioner in consultation with the Anticoagulant
Services Manager will notify the GP, detailing a summary of recent
clinic appointments. Following a case review by the GP,
anticoagulant therapy will either be extended or stopped. The
Anticoagulant Services Manager will forward a summary copy of the
INR results and dosage of warfarin to the GP for inclusion in patient
records.
3.
TRAINING
3.1
Before working in an unsupervised capacity the pharmacist practitioner
must demonstrate that she/he is suitably qualified and experienced to
comply with the specification and must have completed an approved
course for pharmacist practitioners undertaking anticoagulant monitoring in
primary care and the Knowsley PCT Anticoagulant Pharmacy
Competencies. The competencies include key competencies which are to
be demonstrated to the satisfaction of the Anticoagulant Services Manager
are as follows:
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Operation of analyser
Quality control proceedures
Determination of quality control results
Obtaining of adequate blood sample
Determination of INR results
Compliance with an established clinical management protocol for
action on INR results
Understanding of range of problems likely to be encountered in
interpreting INR results.
Making dosage adjustments
Recognition of instances where it is necessary to seek further
advice
The giving of information and advice to patients
4.
3.2
As part of their training, pharmacist practitioners and student pharmacist
practitioners may work in the service under the direct supervision of a
qualified Anticoagulant Pharmacist.
3.3
Pharmacist practitioners will be required to demonstrate good practice
through audit and participation in peer review which will be the overall
responsibility of the Anticoagulant Services Manager. Pharmacist
practitioners will also be required to demonstrate a commitment to
continuing education organised through their professional body or other
approved method.
3.4
Pharmacist practitioners will undertake fire safety and evacuation
procedures on an annual basis and will receive training in cardiopulmonary resuscitation.
QUALITY
4.1
General Standard
The pharmacist practitioner will exercise professional skill and care in
providing the anticoagulant monitoring service.
4.2
Service Quality
The pharmacist practitioner must provide the services in a manner which
assures safety, confidentiality, comfort, courtesy, dignity and privacy to the
patient and shows responsiveness to patients’ needs.
4.3
Non-Discrimination
The pharmacist practitioner must not discriminate in his/her provision of
services on the basis of race, gender, religion, or disability.
4.4
Statutes
The pharmacist practitioner must comply with all applicable statutes,
regulations, EC directives and guidelines of the Department of Health and
NHS Executive.
4.5
Complaints
All complaints will be brought to the attention of the Anticoagulant Services
Manager in the first instance. Unresolved complaints will be submitted by
the Anticoagulant Services Manager to the Complaints Manager at
Knowsley Primary Care Trust, who will investigate the complaint. A record
of the number of complaints dealt with locally will be collated by the
Anticoagulant Services Manager and submitted to the Complaints
Manager.
4.6
Risk Management
Records of near miss incidents should be brought to the attention of the
Anticoagulant Services Manager within 1 working day and recorded in the
notes and on the database. The incident report should be forwarded to the
Primary Care Trusts nominated officer within 5 working days.
4.7
Quality Assurance and Control System
The pharmacist practitioner will comply with the quality assurance and
control system established by the Anticoagulant Services Manager and
described in Appendix 3.
4.8
Health & Safety
Pharmacist practitioners should be fully immunised against Hepatitis B.
4.9
Clearances
All practitioners must consent to and undergo a CRB check and medical.
References must also be provided on request.
5.
INSURANCE AND INDEMNITY
5.1
Indemnities
The pharmacist practitioner must indemnify and keep indemnified
Knowsley Primary Care Trust against all costs, claims, damages, liabilities
or losses which the Trust may suffer arising out of or in connection with the
provision of the said anticoagulant monitoring services.
5.2
Insurance
The pharmacist practitioner must warrant Knowsley Primary Care Trust
that there is in force professional indemnity insurance covering his/her
liabilities in respect of any negligent act or omission in connection with the
provision of the said anticoagulant monitoring services under this contract
with a limit of indemnity of not less than £500,000. The pharmacist
practitioner must maintain such insurance throughout the period of this
contract and will provide evidence of such insurance and the payment of all
premiums if requested so to do by Knowsley Primary Care Trust.
6. ACCOUNTABILITY
6.1
Practitioners are responsible and accountable for their own actions
(including advice and amending dosages) in the anticoagulation
management of patients attending clinics.
7. DISCIPLINE AND GRIEVANCE PROCEDURES
7.1
8.
A copy of Knowsley PCT’s Discipline and Grievance procedures are
available from the HR department.
TERMINATION
8.1
The Trust will be entitled to terminate this Agreement forthwith in the event
that the pharmacist practitioner commits a serious irremediable breach of
his/her obligations hereunder. Under statutory notice requirements:
1 month – 2 years service - 1 weeks notice
2 years – 12 years service - 1 weeks notice for each complete year
More than 12 years service - 12 weeks notice
8.2
Without prejudice to paragraph 6.1 in the event that the pharmacist
practitioner commits any breach of this Agreement, the Trust will be
entitled to serve a notice specifying such breach and requiring it to be
remedied forthwith. Should the said notice not be complied with the Trust
will be entitled to treat the said breach as a serious and irremediable one
for the purposes of paragraph 6.1 hereof.
8.3
If a pharmacist practitioner wishes to terminate the Agreement then they
must notify the service manager in writing and serve a notice period of a
minimum period of two months.
8.4
If the service manager wishes to terminate the Agreement for any other
reason other than stated above they will notify the practitioner in writing
providing a notice period of a minimum of two months.
This employment is exempt form the provision of the Rehabilitation of Offenders Act
1974. You are therefore not entitled to withhold information requested by us about any
previous conviction you may have, even if under the circumstances they would have
been regarded as 'spent' under the Act
Concealment of such information may result in your dismissal
You are also required to tell us of any convictions or offences with which you are
charged whilst you are providing a service for us.
Both parties agree to the aforementioned terms and conditions of this contract.
Amendments and variations of the contract may occur from time to time and any such
changes will be notified in writing.
Signed ………………………..
Dated
Chief Executive Knowsley PCT
Signed ……………………….
Dated
Pharmacist Practitioner
APPENDIX 3
ANTICOAGULANT MONITORING SERVICE IN PRIMARY CARE CLINIC
QUALITY ASSURANCE AND CONTROL SYSTEM
Quality must be assured across all aspects of the service, including clinical supervision,
INR testing, dosage advice, record keeping, patient held records and quality control
records and testing, information giving and education. The pharmacist practitioner must
complete all documentation required and record any action taken which is outside the
service protocol.
The Anticoagulant Services Manager will be responsible for the monitoring of: 
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Quality Assurance of stored reagents
Equipment calibration and maintenance
Analytical quality control
Compliance with clinical management protocols
Maintenance of staff competencies
The Anticoagulant Services Manager will: 
Be responsible for the selection, installation, maintenance and planned
replacement of each analyser.
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Ensure that the calibration and maintenance of each analyser is in
accordance with the manufacturer's recommendations. A logbook will
document standard operating procedures, faults, repairs and a
maintenance schedule.
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Document the batch numbers and shelf life of reagents used.
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Ensure that the analytical process is subject to both internal and external
quality control in accordance with national guidelines. Analysers will be
registered by the Anticoagulant Services Manager with the National Quality
External Assurance Scheme or through an accredited laboratory which
may provide additional external quality control exercises. There will be a
written procedure for assuring a back up service in the event of analyser
failure or quality control results falling outside predefined limits.
The Anticoagulant Services Manager will ensure the following are evaluated through
internal and external audit on a regular basis:
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clinical outcomes
patient waiting times
validity of clinical management protocol
frequency of patient reviews
acceptability of service for patients
quality of INR control
Appendix 1
POLICY ON FOLLOW-UP OF PATIENTS WHO DNA
The aim of this policy is to ensure:
 Patients who DNA are followed-up appropriately
 There is prioritisation of appointments which should ensure minimum of additional
pressure on clinic appointments
 The possibility of deceased patients and those in hospital receiving letters is
decreased
Action required upon a FIRST DNA
At the end of each clinic, - FOR EACH PATIENT who did not attend:
1. Reception should inform the pharmacist undertaking the clinic of any patients who have
failed to attend. Where a patient has failed to attend twice (i.e. in last few weeks) this
should be specifically brought to the attention of the pharmacist.
2. The pharmacist undertaking the clinic should inspect the record for each patient who has not
attended.
3. The pharmacist is responsible for informing reception on when the patient should receive
their next appointment – usually this will need to be either inside a week, a week, or the first
available appointment the week after
4. Reception staff are responsible for issuing the ‘standard’ anticoagulant clinic DNA letter.
Additional Action required upon a SECOND DNA
Before the end of each clinic, - FOR EACH PATIENT who has DNA twice or more as seen on
the appointment sheet (No. of DNAs)

The clinic pharmacist should inform SARAH as the services manager who will be responsible
for further action. Sarah will then inform reception of the outcome within 48 hours.
ACTION REQUIRED FOR PATIENTS WHO REGULARLY MISS THEIR APPOINTMENTS
i.e. very irregular attendance without good reason
Reception staff should notify SARAH of the details of any such patients. Sarah will take responsibility for
discussing this with patient’s GP.