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Prescribing Support for Primary Care

Standard Operating Procedure for

Prescribing Support ServicesPrimary Care

Anticoagulant Clinic

Original document approved by;

Dr Duncan Petty Version 1 Date: April 2009

Document reviewed and amended by;

Dr Caroline DixonPSS Anticoagulation team service manager Su WoodPSS Clinical Quality Director

Version 6 November 2015

Approved by: Dr Duncan Petty Service Director PSS anticoagulant services

Review Date: November 2016

Standard Operating Procedure: Anticoagulant Clinic Version 6 November 20151

Contents

1. Aims and Objectives

1.1 Aim1.2 Objectives

2. Roles and Responsibilities

2.1 Hospital2.2 General practice anticoagulant service

3. Patient Criteria

3.1 Inclusion criteria3.2 Exclusion criteria

4. Patient management

4.1 Patient assessment4.2 INR testing4.3 Warfarin dosing4.4 Recording results4.5 Interactions with drugs and food4.6 Referral to the GP4.7 Housebound patients4.8 Patient information4.9 Warfarin Supply4.10 Follow up of missed appointments4.11Booking/changing appointments4.12 Warfarin Initiation in patients with Atrial Fibrillation4.13 Warfarin reversal with Vitamin K4.14 Protocol for switching patients from warfarin to NOACs and vice versa

5. Call and recall

5.1. Frequency of monitoring5.2 Referral in and out of clinic

6. Training

7. Audit


8. Quality Control and Safety

8.1 Quality Control-Internal 8.2 Quality Control-External8.3 Data Protection/Information Governance8.4 Equipment Storage8.5 Cleaning of Machine8.6 Hand washing

9. Equipment Requirements

10. Troubleshooting

10.1 Incident Reporting

10.2 Adverse events

10.3 Holiday cover

Appendices


Appendix 1 General Information on warfarin use

Appendix 2 Aide Memoir for patients on anticoagulation

Appendix 3 New Patient Initial Assessment Form

Appendix 4 How to deal with a raised INR

Appendix 5 Examples of Clinic Letters

Appendix 6 Patient Satisfaction Questionnaire

Appendix 7 Warfarin Clinic Contacts

Appendix 8 Home visit protocol

Appendix 9 Warfarin initiation for patients with Atrial Fibrillation

Appendix 10 Warfarin reversal protocol

Appendix 11 Protocol for switching from warfarin to a NOAC or vice versa

Appendix 12 Audit report forms

Appendix 13 Significant Event Form

Appendix 14 Warfarin dose reminder chart

Appendix 15 Bridging protocol-draft guidelines from BRI

Appendix 16 Training log

Appendix 17 Useful additional references

Appendix 18 Clinic leaflet

Appendix 19 When should the INR be measured before a dental procedure?

Appendix 20 Handwriting requirements for anticoagulant booklet instructions

Appendix 21 Sharing a patient’s record on SystmOne

Appendix 22 Annual review

1. Aims and Objectives

1.1 Aim


To provide standardised and clinically effective anticoagulation management to patients in a primary care setting.

• To provide an initiation, stabilisation, monitoring and dosing “One Stop Shop” anticoagulant therapy management service in a community setting and to ensure patients receive anticoagulation therapy and monitoring promptly, in line with the National Service Framework for coronary heart disease12, the NICE clinical guideline CG361on AF, NICE CG498 and NICE quality standard 2910.

• To provide an effective and integrated local pathway for anticoagulation therapy that takes into account NICE recommendations for the non-vitamin K antagonist oral anticoagulants, patient safety, patient experience and timely access to assessment and treatment.

• To reduce inequalities in access to anticoagulation monitoring. • To improve anticoagulation control in patients, and reduce drug-associated

complications.

1.2 Objectives

• To measure and monitor the International Normalised Ratio (INR) of patients who are prescribed warfarin therapy by their GP, independent prescriber or hospital consultant and have been referred to the anticoagulant service.

• To maintain the patient’s INR within their therapeutic range by appropriately adjusting their warfarin dosage.

• To ensure a clinical review to determine continuing medical need for warfarin is performed annually or as appropriate and that patients no longer requiring warfarin have had treatment stopped.

• To counsel and educate patients in order for them to understand their treatment, with respect to their condition, target INR, the effects of over and under anticoagulation, diet, lifestyle and drug interactions.

• To ensure documentation is complete and accurate.

• To measure patient satisfaction annually by means of a questionnaire.

• To carry out audit procedures annually.

• To ensure the Standard Operating Procedure (SOP) is reviewed every year and changes made accordingly.

2. Roles and Responsibilities

2.1 Hospital clinicians and GPs


To refer appropriate patients on warfarin or needing warfarin therapy to the practice’s Anticoagulation Service, with the patient’s consent, and to provide the clinic with details of the patient’s condition, target INR range, duration of treatment, last three INR results and date next INR test is due.

Hospitals to inform general practitioners about patients the hospital continue to monitor and supply warfarin to.

2.2 Primary Care Anticoagulation Service

To measure the INR of patients registered in the service, receiving anticoagulation, using the Coagu-check XS plus system,

To use the INR Star N3® computerised database, along with clinical judgement, to predict warfarin dose.

To work with the patient to maintain the INR within the therapeutic range by appropriately adjusting the warfarin dosage.

To ensure standard operating procedures are adhered to. To ensure all necessary documentation is completed as appropriate. To ensure both internal and external quality control tests are carried out at

appropriate intervals. To order supplies of control solution, single use lancets, test strips, gloves

and other equipment, when necessary. Clinicians to carry out Continuing Professional Development (CPD)

associated with anticoagulation therapy.

3. Patient Criteria

3.1 Inclusion Criteria

The following patients will be managed by the Anticoagulation Service

All patients, including housebound patients, who have had their warfarin initiated and have been referred for management into the Primary Care clinic by either a hospital clinicians or GP.Each patient will be assessed by the clinic practitioner as to the appropriateness of the referral.

Patients with Atrial Fibrillation, who have been assessed by a GP or other specialist practitioner and need warfarin initiated in the Primary Care setting.

3.2 Exclusion Criteria

The following patients will not be monitored by the Anticoagulation Service.Patients who

are pregnant or breast feeding (as coumarins are contraindicated)


have suspected hypersensitivity or intolerance to anticoagulation are intravenous drug abusers are under 18 years of age

4. Patient management

Details of INR targets, warfarin doses and patient management using warfarin are given in Appendix 1.

4.1. Patient assessment

At the first clinic visit the initial assessment form should be filled in-see Appendix 2.

The practitioner running the clinic will assess any changes that may affect INR control and risk of bleeding. See Appendix 2 for patient risk assessment questionnaire.

At subsequent clinic visits the patient will be assessed using the form in Appendix 3 as a checklist.

4.2 INR Testing

The coagulation monitoring machine (e.g. CoaguCheck® XS Plus) will be set up for Near Patient Testing in accordance with the machine reference guide (to be kept with the machine).

Machine and test strips should be at ambient temperature. New batch code chip to be inserted (as per instructions) with each new box of

strips. Machine to be on level surface free from vibrations. Switch machine on and ensure no error messages. If error message occurs

consult machine procedural manual or manufacturer before using machine for INR tests.

Ensure batch code number displayed on machine, matches test strips batch code.

Ask patient to wash hands. Ensure finger is thoroughly dry. Put disposable gloves on. Open test strip container and insert strip into machine, in direction of arrows

with printed side up, until it stops. Replace lid immediately to prevent degradation of strips.

When alarm sounds, prick bottom side of fingertip with previously prepared lancet device.

Gently squeeze the patients hand from palm to finger as necessary to develop drop of blood. Test should be conducted with the first drop of blood. Apply blood directly from finger onto target area of test strip.

Wait for result, remove test strip and place lancet and test strip into sharps bin.

If reading is abnormally high and/or unexpected i.e. above 5, repeat the test and, if still high inform GP according to agreement with practice. Refer to Appendix 4 for further guidance.


4.3 Warfarin dosing

Dosing decisions are made using INR Star Version N3® along with clinical judgement.

Open the INR Star Version N3® program from the computer desktop using the Install key.Click on the “Patient” box and search for the patient using their surname.Answer the questions on the screen.Insert the current INR value and press return.The INR Star program will give a suggested dose and review period. Any reasons for dose or review period adjustments should be recorded in the “comments” section.For further instruction on how to use the INR Star N3® program refer to the training program or use the Help function.

4.4. Recording results

Record the relevant details of the consultation in;

the INR Star “comments” section – this will automatically go into the patient’s clinical record when the patient details are saved on INR Star N3

the patient’s hand held anticoagulation record (Yellow Book).

A record should be made in the New Journal consultation of any extra comments needed to clarify the dose given to the patient etc.

Patients Medical Records

The following information should be recorded in the Patient’s Medical Records i.e. in SystmOne- this will automatically come from filling in the INR Star database.

INR result at each visit INR target range Missed doses Relevant notes of each visit including specific advice/education given The dose of anticoagulant to be taken until next clinic visit Date of next appointment

Patient’s hand held record (Yellow anticoagulant book)

The following information should be recorded in the Patient’s hand held record


Indication for anticoagulation Duration of therapy (short or long-term) Therapeutic INR range/ target INR Dose of warfarin to be taken until next appointment- to be recorded in

milligrams and the colour and number of the tablets to be used should also be included

Date of next appointment TTR - if known (optional)

4.5 Interacting drugs and foods

All prescribers should consider the possibility of significant drug interactions. Interacting drugs should be avoided wherever possible. If this is not possible the prescriber who initiates or discontinues a prescription for an interacting medicine will be responsible for ensuring that the patient is informed that an interacting medicine has been commenced or discontinued. They should also tell the patient to arrange an INR test within 4 to 7 days of the start or discontinuation of the interacting medicine. This information needs to be documented in the patient’s notes.

4.6 Referral to GP

The practitioner running the anticoagulant clinic will refer patients back to the general practitioner or seek advice in the following circumstances, if appropriate.

Any relevant new symptoms/problems that have developed Any unexpected bleeding or potential side effects Any problems with taking warfarin that cannot be resolved Any new medicines prescribed that might interact with warfarin or increase

bleed risk Any relevant change in lifestyle and occupation that will affect INR control

and cannot be resolved. Any significant changes in the patient’s ability to take warfarin safely. The patient has not had an annual clinical review. Patients that “do not attend” (DNA) twice in succession or have compliance

issues that cannot be resolved.

4.7 Housebound patients (see Appendix 8- home visit protocol)

Housebound patients will be visited to have their INR checked. They will be advised of any dose change during the visit and the INR result and dose of warfarin to be taken will be recorded in the patient’s warfarin book and a further appointment given.After a home visit the patient can be phoned with the next appointment time and date if unknown at the time of the visit. INR results should be recorded on INRStarN3® and in the consultation notes, as per patients attending clinics. The home visit box on INRStarN3® should also be ticked.4.8 Patient information

Patients will be given verbal and written information at the start of treatment, at discharge from the hospital service and at the first anticoagulant clinic appointment.


When discussing warfarin initiation patient discussion tools such as CHADSVASC and HAS-BLED can be used to further educate the patient about their stroke and bleed risk and the importance of understanding and complying with their warfarin treatment.

Written information will be in the form of the NPSA anticoagulant pack, which includes;

Anticoagulant alert card Patient held information (yellow) booklet General information about the safe use of warfarin

The first clinic appointment should be booked as a double appointment to ensure enough time is given to patient education.

At the first appointment education should be given/re-enforced. The counselling should be comprehensive to ensure that patients are fully aware of their treatment and should include:

a. The name of the drug and current dose; b. The reason they are taking the drug; c. Therapeutic goal and target range;d. The anticipated length of treatment;e. What to do in the event of a missed dose; f. Symptoms of under dose/overdose and action to take if these occur.g. Drug/drug and drug/food interactions; h. Clinic arrangements and how to obtain further medicine supplies.i. What to do if dental treatment/surgery is required.j. What to do if a surgical procedure is required/ indicated. k. Who to contact regarding any worries or concerns relating to their

anticoagulation management during clinic times and out of hours.

A clinic service information leaflet should be given to the patient, if available. (See Appendix 18)

4.9 Warfarin supply

Warfarin should be prescribed on the general practice’s prescribing system, either as a repeat prescription or as an acute depending on the wishes of the GPs.

Prescriptions are signed by the general practitioner or independent prescriber. Warfarin should be prescribed with the directions “to be taken as directed in your yellow anticoagulant book”. An indication on the prescribed medication e.g. in script notes, should also be added as to where the patient’s INR is being monitored.

4.10 Follow up

At the beginning of each clinic a search will automatically be run by INR Star N3® to find all outstanding warfarin diary dates and patients will be highlighted in an


“overdue list”. These patients need to be followed up to check why they have not attended. Patients who fail to attend should be phoned or written to and given an appointment for later that day or the following week- this will be determined by the urgency of re-checking the INR. If patients cannot be contacted during the clinic the Prescribing Support Services (PSS) office can be informed to try to contact the patient at a later date.

At the end of each clinic a check should be made that all patients (including home visits) have been dosed. DNA patients should attempt to be contacted. Again, if necessary, the PSS office can be informed so further attempts can be made to contact the patient.

For medico-legal reasons an entry of all attempts to contact the patient should be made in the clinical record.

In extreme cases, where the patient fails to attend two or more INR checks in succession, the GP should be informed. The GP would then need to arrange to see the patient, to discuss the risks and benefits of not being monitored and a decision made as to whether to continue treatment or not.

4.11 Booking/changing appointments

This should only be done by the clinic practitioner or the PSS administration staff (after seeking advice from the PSS clinicians). A receptionist should not book/change appointments without prior agreement with clinic staff.

4.12 Warfarin initiation in patients with Atrial Fibrillation- See Appendix 9 for protocol

4.13 Warfarin reversal protocol-See Appendix 10 for protocol

4.14 Protocol for switching from warfarin to a NOAC or vice versa – See Appendix 11 for protocol


5. Call and recall

1. Frequency of monitoring – use Computerised Decision Support System (INR Star N3®) and information below to determine this.

For patients in whom no new factors (See Appendix 1) have arisen, the frequency of monitoring can be determined by the criteria shown in the table below

Warfarin therapy: maximum recall periods during maintenance therapy.

One INR high Recall in 7-14 days (stop treatment for 1-3 days) (maximum 1 week in prosthetic valve patients)

One INR low Recall in 7-14 days

One INR therapeutic Recall in 7-14 days

Two INRs therapeutic Recall in 2-4 weeks Three INRs therapeutic Recall in 4-6 weeks (maximum

6 weeks for prosthetic valve patients)

Four INRs therapeutic Recall in 6-8 weeks. (maximum 6 weeks for prosthetic valve patients)

Five or more INRs therapeutic Recall in 8-10 weeks (maximum 6 weeks for prosthetic valve patients)Recall period can be increased in a step-wise fashion to a maximum of 12 weeks between appointments if stable.

NB. Patients seen after discharge from hospital with prosthetic valves may need more frequent INRs in the first few weeks

Based on data from Ryan et al (1989) British Medical Journal 299, 1207-1209

When a situation known to cause alteration in the dose requirement of warfarin occurs e.g. a potentially interacting drug is prescribed or stopped, or the patient has an acute inter-current illness, frequency of monitoring should be increased.


2. Referral in and out of the clinic

From a GP

A referral from a GP will be accepted if the patient fits the inclusion criteria (see Section 3). The patient’s consent to be accepted into the clinic will be sought in writing (See Appendix 5 for example letter). This consent form will be scanned onto the patients clinical record.

GPs must complete an electronic referral form that details the patient’s name, address and contact details, the indication for anticoagulation, the target INR range and the duration of treatment (See Appendix 9). If an electronic referral cannot be made then a referral form can be faxed to the PSS help line fax number or handed directly to the anticoagulant clinician. The referral form in these cases must be scanned into the patient’s record.Urgent referrals (patients to be seen within 5 days) must be accompanied by a call to the help line or a direct conversation with the clinic practitioner.

Referrals into the clinic should not be assumed to have been accepted until confirmation is sent to the referring clinician from the anticoagulant clinic.

Patients being seen in a surgery that is not their registered doctors will need to provide consent for a record share. The record share allows the clinic to see relevant clinical details, to make appointment bookings and to make clinical entries. At the registered doctors surgery a shared record allows GPs to see the anticoagulant clinic entries.

The GP must also re-provide this referral data annually as confirmation that anticoagulant treatment is to continue. This is the Annual Anticoagulation Review.

From secondary care

Patients will be accepted into the Primary Care service if they fit the inclusion criteria.

A completed medical and medication history must be provided (See Appendix 5 for example letter) including;

a) Indications for anticoagulationb) Proposed duration of anticoagulant therapyc) Previous 3 INR results, dates and dosingd) Name of consultant who initiated therapye) Date on which the next INR is due, if known

The General Practice Anticoagulation Service provider must acknowledge referrals by completing the section of the hospital’s referral form or by sending an acceptance letter (Appendix 5) back to secondary care as confirmation of acceptance. Until a written acceptance form has been received from the primary care service, patients remain the responsibility of the secondary care hospital anticoagulation clinic. Alternatively a telephone call to the clinic administrator could be made.


To secondary care

Patients will be referred from the general practice clinic to the secondary care service where they meet exclusion criteria listed in section 3.2.If a patient needs to be referred back to the hospital clinic a referral form should be completed (Appendix 5). The hospital anticoagulation clinic must acknowledge referrals by completing the bottom of the referral form and faxing the letter back as confirmation of acceptance. Until an acceptance form has been received from the hospital clinic, patients remain the responsibility of the primary care anticoagulantprovider. Alternatively a telephone call to the clinic practitioner can be made.

Discharge from the clinic

Patients will be discharged from the anticoagulant clinic when treatment is discontinued. Only a GP or consultant (or their team) can discontinue treatment and the instructions to do so must be given in writing e.g. an entry by the GP in the patient’s clinical record, a hospital discharge advice note or letter.

Where patients wish to stop their anticoagulant, the clinic practitioner will discuss the risks and benefits with the patient, and then refer the patient to their GP for a further discussion. This must be clearly documented in the notes. The patient’s record should be inactivated on INR Star N3® when warfarin has been discontinued.

When a patient is at the end of a previously defined length of treatment the original prescriber should be written to in order to let them know that the patient has come to the end of their treatment and will shortly be stopping warfarin. (Appendix 5)This is to allow time for the prescriber to alter the treatment length if circumstances have changed and they feel it is appropriate. GP’s can be tasked when treatment is due to be discontinued for the same reasons mentioned above.

6. Training

Practitioners running the service will have had training and be able to show competency in the following areas;

Safe and effective use of anticoagulants Indications and target ranges for anticoagulation Significant drug/food and disease interactions and how these should be

managed Use and calibration of Coagucheck XS Plus and the INR Star N3® equipment/

software Record keeping Knowledge of the recommendations from the British Committee for

Standards in Haematology and the NPSA (Alert 18) Actions that can make anticoagulation therapy safer.

Quality Control procedures Incident reporting Audit


A patient satisfaction questionnaire will be used to inform the providers about any further developments needed from the service and any training requirements (See Appendix 6)

A list of Warfarin Clinic contacts-pharmacists and non-pharmacists has been created for peer support. (See Appendix 7).

A peer support group has been set up and meetings are held on a bimonthly basis.

CPD should be carried out in accordance with the practitioners professional requirements.

Regular peer support meetings are also held between the Practitioners running the clinic and difficult cases are routinely discussed.

Peer review will take place involving visits to other anticoagulant clinics outside the practitioner’s own clinic.

Quarterly Clinical Governance meetings will be held by the local Anticoagulation clinic group.

Annual appraisals will be held.

7. Audit – see Appendix 12 –audit report forms

NPSA audit to be carried out six monthly.

Benchmarking against BSH safety indicator set annually

Patient satisfaction questionnaire to be carried out six monthly

Warfarin risk reduction audit to be carried out six monthly

Six monthly report to be submitted by all Providers to the Commissioner

8. Quality Control and Safety

8.1 Quality Control- Internal

Internal quality control should be carried out at the start of each clinic or with every new box of test strips used (approximately every 48 tests), whichever is more appropriate. This involves testing control reagents with known INRs with the clinic Coagu-check meter. If the result is within the expected range then this gives a degree of confidence that the equipment is calibrated correctly and is working accurately. The outcome of the internal quality control must be recorded in the control log or on INR Star N3®.See Coagucheck User’s manual for instructions on carrying out quality control tests.


8.2 Quality Control - External

National External Quality Assurance Scheme – NEQAS - is a National scheme to monitor the accuracy of NPT machines. This quality control test is carried out on a quarterly basis on set dates. A control sample is sent, an INR reading obtained and returned. The practice’s performance is then assessed against practices across the whole country.

8.3 Data Protection/Information Governance

The service will run according to the data protection policy. All staff sign a data protection statement, undergo mandatory training in data protection, information governance and confidentiality and annual refreshers are undertaken with evidence of completion captured.

We will ensure that we treat personal information lawfully and correctly. All data will be recorded within the electronic patient record, no patient data will ever leave the practice. To this end we fully endorse and adhere to the Principles of Data Protection as set out in the Data Protection Act 1998. These principles are legally enforceable.

We will, through appropriate management and the use of strict criteria and controls:

a) observe fully conditions regarding the fair collection and use of personal information;

b) meet our legal obligations to specify the purpose for which information is used;

c) collect and process appropriate information and only to the extent that it is needed to fulfil operational needs or to comply with any legal requirements;

d) ensure the quality of information used;e) apply strict checks to determine the length of time information is held;f) shall be accurate and where necessary, kept up to date;g) shall not be kept for longer than is necessary for that purpose or those

purposes;h) shall be processed in accordance with the rights of data subjects under the

Act;i) shall be kept secure i.e. protected by an appropriate degree of security;

In addition, we will ensure that:

j) everyone managing and handling personal information understands that they are contractually responsible for following good data protection practice;

k) methods of handling personal information are regularly assessed and evaluated;

8.4 Equipment Storage

Test strips are valid until the manufacturer’s expiry date. They are stored at room temperature. Once open, the strips can be kept at room temperature for up to 60 days.


Control solutions must be refrigerated between 2oC and 8oC. Once open, the control solution can be kept at room temperature for up to 30 minutes.

8.5 Cleaning of Machine

The machine needs to be cleaned regularly. For details on how to clean the Coagu-check machine refer to the User’s manual.

8.6 Hand washing

Hands should be washed:

Before and after each contact with the client. After handling clinical waste (body fluids, soiled dressings), linen, clients'

wash equipment, emptying bins etc. Before handling food, eating or drinking. After using the toilet. After removal of protective clothing (gloves/aprons). After blowing the nose or sneezing. If the hands look or feel dirty.

This is to prevent cross-infection between patients and also for self-protection.


9. Equipment Requirements

Coagu-chek XS plus machineControl solutionsAccuchek test stripsNPSA packsQC log bookDisposable glovesSteretsSharps bin/bio-waste bagCotton wall ballsTissues PlastersSingle use lancetsScissorsClinic diaryClinic file-to include written guidelines and protocolsSink access

10. Troubleshooting

10.1 Incident Reporting-use reporting system on PSS website- see Appendix 13 for Significant Event Form. All clinic staff (including those in practise that run their own clinics must inform PSS (the contract holder) of incidents who will, in turn, and if considered appropriate, after discussion with the practice inform the CCG and CQC

10.2 Adverse events-use INRStarN3® reporting system- include wrong dosing due to discharge letter inadequacies and hospital admissions possibly related to warfarin.

10.3 Holiday cover-this should be planned and arranged in advance to prevent problems. The cover arrangements need to be agreed with the Clinic supervisor.

Appendix 1:


General information about Warfarin therapy

Warfarin

Warfarin is an anticoagulant given orally to reduce the risk of embolism. It is 100% bio available and is absorbed quickly from the gastro-intestinal tract. The peak concentration occurs within an hour of ingestion. Due to the mechanism of action the peak pharmacological effect does not occur until approximately 48 hours after ingestion. The pharmacological effect of a single dose occurs 12-16 hours after ingestion and lasts 4-5 days.Warfarin acts by inhibiting the carboxylation of the vitamin K-dependent clotting factors II, VII, IX and X. It is metabolised by the Cytochrome P450 system with its half-life varying from patient to patient (average 40 hours).

INR

The effect of warfarin is monitored by measuring prothrombin time and is expressed using the International Normalised Ratio (INR).

The prothrombin time is the time taken for clotting to occur in a sample of blood to which calcium and thromboplastin have been added. A prolonged prothrombin time compared with control indicates a deficiency of coagulation factors, which are required with calcium and thromboplastin, to convert prothrombin to thrombin in the final stages of coagulation.

ISI (International sensitivity index) is the index of sensitivity for the thromboplastin reagent used for the test. Different batches of thromboplastin have a different ISI. For this reason, it is recommended that patients receiving warfarin should be monitored by calculating the INR.

Indications for treatment


(

) x

INR =

Patient prothrombin time

Control prothrombin time

ISI

The target INR and duration of therapy depends on the indication for anticoagulation.

Table 1Indication INR Range*

Recurrent DVT 2-3Recurrent PE 2-3Treatment of TIA 2-3Prophylaxis in mechanical heart valves

3-4.5

Prophylaxis in AF 2-3Bradford Royal Infirmary Guidelines* This may vary depending on the referring consultant/GP

Warfarin is given as a tablet for oral administration. It should be taken once daily (5-6pm is an ideal time for compliance and to ensure that if the dosage is changed at an appointment the new dosage can be started that evening).

Tablet strengths are 0.5mg (white)1 mg (brown)3 mg (blue)5 mg (pink)

For patients in whom no new factors (see 3.4 for factors) have arisen, the frequency of monitoring can be determined by the criteria shown in Table 2.

Table 2

Warfarin therapy: maximum recall periods during maintenance therapy


One INR high Recall in 7-14 days (stop treatment for 1-3 days) (maximum 1 week in prosthetic valve patients)

One INR low Recall in 7-14 daysOne INR therapeutic Recall in 7-14 daysTwo INRs therapeutic Recall in 2-4 weeks Three INRs therapeutic Recall in 4-6 weeks

(maximum 6 weeks for prosthetic valve patients)

Four INRs therapeutic Recall in 6-8 weeks. (maximum 6 weeks for prosthetic valve patients)

Five or more INRs therapeutic Recall in 8-10 weeks (maximum 6 weeks for prosthetic valve patients)Recall period can be increased in a step-wise fashion to a maximum of 12 weeks between appointments if stable.

NB Patients seen after discharge from hospital with prosthetic valves may need more frequent INRs in the first few weeksBased on data from Ryan et al (1989) British Medical Journal 299, 1207-1209

When a condition known to cause alteration in the dose requirement of warfarin occurs (e.g. a potentially interacting drug), or the patient has an acute inter-current illness, frequency of monitoring should be increased.


Factors that may affect warfarin control

The following information is for reference only and is not exhaustive.

Drug interactions

A variety of drugs and food are known to interact with warfarin leading to an alteration in INR levels (see BNF)

Disease States

The following disease states may affect INR

Table 3

Increase in INR Decrease in INR Liver dysfunction/

Cholestasis/ Biliary Obstruction

Heart Failure Hyperthyroidism Infection/ Pyrexia Renal Failure Malnutrition/ Weight Loss Carcinoma/Radiation

Therapy

Hypothyroidism Diabetes mellitus Oedema Hyperlipidemia

Missed doses

Missed doses may affect the INR result. Due to the pharmacological properties of warfarin the effects may be delayed and not reflected immediately in the INR result. A missed dose must be recorded. The dose should be taken within six hours or counted as ‘missed’ and normal dosing schedule resumed the next day. Patients should be informed not to double doses or try to make up for missed doses. A note of which days have been missed needs to be recorded in the patient’s hand held record (yellow book) as these may affect the INR result.

Alcohol

Alcohol enhances the effect of warfarin and can precipitate bleeding. Alcohol intake should be limited to no more than one or two units per day as this has little effect on the INR. Intermittent, occasional or binge drinking tends to raise the INR. Saving up all the drinks for the week to have at the weekend may lead to serious adverse consequences. Daily alcohol use of three or more units induces liver enzymes increasing the metabolism of warfarin and therefore decreasing the INR. If the patient suddenly reduces the amount they drink then the INR will rapidly increase, increasing the risk of bleeding. Large amounts of alcohol may irritate the GI tract causing bleeding that may be difficult to reverse.


Illness

Illness, such as bacterial and viral infections, can affect INR results. Patients should be advised to be especially vigilant for bruising and bleeding during periods of illness.

Bruising and Bleeding

It is important that patients take care not to knock, cut or bruise themselves whilst taking warfarin. The practitioner should be informed of any unexplained bruising and bleeding suffered. Special care should be taken when brushing teeth or shaving. The use of a soft toothbrush and careful use of dental floss is advised. An electric shaver should be used where possible.

If the patient is suffering from any of the following then the practitioner should refer the patient for further investigation:

Melaena – Passage of dark tarry stools containing blood, usually an indication of bleeding in the upper part of the alimentary canal.Haematuria – Presence of blood in the urine.Rectal BleedingHaemoptysis – Production of blood from the respiratory tract

The practitioner should use their professional judgement to determine whether it is appropriate to refer them to their GP or to the A&E department.


Appendix 2:

New Patient Initial Assessment Form

–use on first visit and keep a copy in Patient File/scan onto SystmOneThis form is to assess the patient’s understanding of treatment and to reinforce information previously provided at the secondary care clinicDetails Comments Any IssuesName

D/O/B

NHS Number

Reason for anticoagulant

Drug and Dose

Current tablets (colour) taken

Therapeutic Goal/target range

Anticipated Length of Treatment

What to do if a dose is missed

Symptoms to look out for

Drug/Food interactions

How to obtain further medicine supplies

Advice if having dental treatment or surgery

Who to contact if worries or concerns

Do you have a Yellow Information Booklet


RISK ASSESSMENT FOR INDIVIDUALS NEEDING ANTICOAGULATION- use on first visit and then when necessary

NAME. D.O.B

ADDRESS GP.NHS NO.ICS NO.

VISION YES (please tick) NO (please tick)Has this person good sight?If not are glasses worn to correct this?Do they help?If NO is answered to any of the above state measures put in place to help with medication managementHEARINGIs this person’s hearing good?Do they wear hearing aids to correct this?Do they help?Can they hear a conversation adequately over the phone?If NO to any of the 4 questions above state measures put in place to help with medication management

COGNITIONDoes this person understand what their anticoagulation medication is for?Is this person able to differentiate between different anticoagulation doses i.e. warfarin 0.5/1mg/3mg/5mg?Can this person determine the correct time of day, and correctly identify when their medication needs to be taken?If NO is answered to any of the 3 questions above indicate what measures have been put in place to help with medication management

Signature of Assessor

Date risk assessment completed


Appendix 3:

Aide Memoir for patients on anticoagulation- to use at each clinic visit

YES (Please tick)

NO (Please tick)

FURTHER DETAILS

Have you taken your last regime as prescribed?

Have you missed any doses?

Have you taken your anticoagulant at the same time each day?

Can you confirm there has been NO change in any of your medication since your last INR was done? This includes no additions or removal of medicines either prescribed or bought OTC.

Checklist at each clinic visit-

any new symptoms/problems that have developed any unexpected bleeding or potential side effects any problems with taking warfarin any new medicines prescribed that might interact with warfarin or increase

bleed risk any change in lifestyle and/or occupation any change in their ability to take medicines safely e.g. cognition, vision

changes any future planned dental or surgical procedures any missed doses


any extra dosesAppendix 4: How to deal with raised INRs and bleedsN.B. When INR > 5 repeat the test

Major Bleeding1 Inform GP urgently. Stop warfarin. Prompt attendance at hospital is recommended. This should be arranged with a paramedic ambulance. The patient should not be advised to take themselves to hospital. Vitamin K will be given by slow IV injection2 along with other appropriate supportive measures.

INR >8.0Minor bleeding

Consult with GP. Stop warfarin.Attendance at hospital recommended as Vitamin K administration by slow IV injection will probably be required.

INR >8.0No bleeding

Consult with GP.Stop warfarin.Check INR by venous blood test to determine an accurate INR level.3

Give oral Vitamin K (phytomenadione)4 1-5mg;If INR>8 give 1mg of oral Vitamin K and check INR in 24hrs If INR>10 give 2mg of oral Vitamin K and check INR in 24hrs If INR>12 give 5mg of oral Vitamin K and check INR in 24hrs If INR still too high after 24hr give a further dose of oral Vitamin K (doses as above) according to current INR. Restart warfarin when INR <5.0

INR 5.0-8.0Minor bleeding

Consult with GPStop warfarin. Advice should be sought from on-call haematology regarding the use of IV or oral Vitamin K (Phytomenadione). Patients need to be referred to hospital if IV Vitamin K is warranted. Oral Vitamin K 1mg (Neokay) can be administered at home if the GP requires this.5

Recheck INR at 24hr Restart warfarin when INR < 5.0

INR 5.0 - 8.0No bleeding

Consult with GPWithhold one or more doses of warfarin and reduce subsequent doses of warfarin. Recheck INR at 24 or 48 hrs or as appropriate and restart warfarin when INR < 5.0

INR > 3.0 and <5.0 (target 2.5) orINR >4.0 and < 6.0 (target 3.5) and No bleeding

Reduce or stop warfarin; restart when INR <5.0If INR measure not possible before next clinic (7 days) -Use as a rule -one missed dose is equal to one point INR reduction

NOTES:1.What constitutes Major Bleeding? Consider this as any unexplained bleeding e.g. signs and symptoms suggestive of an intracranial haemorrhage; haematuria; haematemesis; epistaxis; fresh blood in stools, or prolonged bleeding e.g. a nose bleed for more than 10 minutes.Unexpected bleeds - Always investigate the possibility of an underlying cause. The BHS guidelines state that haematuria (at therapeutic levels) is not a feature of anticoagulation and patients with this symptom at therapeutic levels should be investigated for possible bladder and renal tract malignancy. 2. Intravenous vitamin K produces a more rapid correction of the INR than oral vitamin K and should be used in preference in the bleeding patient. Significant correction of the INR is seen within 6–8 h after intravenous vitamin K use. Anticoagulation reversal for non-major bleeding should be with 1–3 mg intravenous Vitamin K.


3. The CoaguChekPlus point of care testing machine only accurately measures INRs up to 8.0.

4. The use of vitamin K results in more rapid reduction in INR than discontinuation of the warfarin alone. In the non-bleeding patient, oral administration of vitamin K is preferred over the intravenous route as equal correction is achieved at 24 hr. Patients with INR higher than 8 are at a significantly high risk of bleeding. Crowther et al (2010) have demonstrated that patients with INR of >10 can be managed with 2.5 mg of oral vitamin K without the need for blood products or in many cases, hospitalization. Baker et al (2006) observed good correction with 2.5mg of oral vitamin K for patients with INR of 8.0–12.0 and 5 mg for those with INR >12.0, with only 8% and 21% achieving an INR of <2.0 the day after vitamin K administration. It is recommended that all patients with INR of >8.0 should receive 1–5 mg of oral vitamin K. At these doses overcorrection is infrequent and resistance to re-anticoagulation does not occur (Baker et al, 2006).

5. It is reasonable to consider giving oral vitamin K to patients with an INR of 5-8 if they are judged to be at high risk of bleeding, but it is not necessary to offer this routinely to all patients.

Record keepingDocument what was investigated, possible causes of the raised INR and the action taken in the INR STAR N3 patient record and the patient’s clinical record.Obtaining supplies of oral vitamin KA supply of oral Vitamin K- as Neokay1mg (phytomenadione) oral capsules is kept at Pharmacy 4 Homes (Pegasus House, 90 Otley Road, Shipley BD18 2BH.Tel 01274 305123 Fax 01274 738981). This is a prescription only medicine so an FP10 is required. Prescribe “Neokay 1mg. Take xxx mg orally”. This is an internet pharmacy so patients cannot collect directly. The prescription will be delivered.Reference- Guidelines on oral anticoagulation with warfarin – fourth edition . British Journal of Haematology. doi:10.1111/j.1365-2141.2011.08753.x


Appendix 5:

Examples of Clinic Letters;

Invitation to clinic letter;

Practice Letterhead

Dear

We are pleased to be able to tell you about a service at your Surgery which should make things more convenient for you.The practice is able to offer a Warfarin (Anticoagulant) Monitoring Service.I understand that you are currently managed by the St Lukes anticoagulant service. St Lukes are happy to handover your long term anticoagulant care to the practice, with your permission. If you choose to have your warfarin monitored by us then you will need to attend for an INR check in the same way as you did at St Lukes. This is usually an appointment every 1-12 weeks, depending on your INR result. We will take a finger prick blood test and advise you of your warfarin dose at the same time. The appointment will be no more than 15 minutes, although your first appointment could take up to 30 minutes.Anticoagulant (warfarin) monitoring clinics are being held at your practice on xxxx and xxxx mornings.Housebound patients can be visited at home.

We anticipate that most of your monitoring will be done by us. However, in some circumstances we may need to hand back your care to St Lukes, for instance if patients become pregnant or develop other more complicated problems.

If you would like your anticoagulant care transferring to xxxx Surgery, please fill in the attached form and return it to the surgery. Once we have received your consent, we will contact you to arrange an appointment.Please indicate the date of your next appointment with St Lukes, so we can work out when you need to be seen.

Yours sincerely

Primary Care Anticoagulation Clinic Practitioners


Patient Consent letter: City CCG

Practice Letterhead

Consent for transfer of Anticoagulant Monitoring Service

Name (in full) ……………………………………………………

Date of Birth …………………………………………………….

Address ………………………………………………………….. .…………………………………………………………..

Name of GP ………………………………………………………

Site you would like to attend

[ ] Undercliffe Health Care Centre, 17 Lowther Street, BD24RA

[ ] Whetley Medical Centre, 2 Saplin Street, BD89DW

[ ] Dr Gilkar Surgery, Little Horton lane Medical Centre, 392, Little Horton Lane, BD5 0NX

Date of next anticoagulant monitoring appointment ……………..

* I give my consent for my anticoagulant care to be transferred to the Primary Care Anticoagulation Clinic

*I do not give my consent for my anticoagulant care to be transferred to the Primary Care Anticoagulation Clinic based * delete as appropriate

Signed …………………………………………………………..

Date ……………………………………………………………..

Please return this form to your doctor’s surgery


Patient Consent letter: District CCG

Practice Letterhead

Consent form for transfer of Anticoagulant Monitoring

Name (in full) ……………………………………………………

Date of Birth …………………………………………………….

Address ………………………………………………………….. .…………………………………………………………..

Name of GP ………………………………………………………

Date of next anticoagulant monitoring appointment ……………..

* I give my consent for my anticoagulant care to be transferred to thePrimary Care Anticoagulation Clinic based at my doctors surgery.

* I do not give my consent for my anticoagulant care to be transferred to the Primary Care Anticoagulation Clinic based at my doctor’s surgery.

* delete as appropriate

Signed …………………………………………………………..

Date ……………………………………………………………..

Please return this form to your surgery


Letter to prescriber re. discontinuation of warfarin treatment

Practice Letterhead

Dear

Re:

Our patient is nearing completion of anticoagulation therapy for the condition shown below. We shall advise the patient to discontinue warfarin around the specified date unless we hear from you to the contrary.

Anticoagulant: Warfarin

Diagnosis:

Target INR Range:

Duration:

Should you wish to extend this patient’s therapy, please complete the section below and return this letter to us.

I confirm that the patient’s therapy should be extended until (date): _______________

Name: ______________________________________ Date: _______________

Thank you for your help in ensuring the safe and effective treatment of our patient.

Yours sincerely

XXXXX Surgery

Transfer of anticoagulation care from secondary to primary care letter;


Practice letterhead

Pharmacy Anticoagulant ClinicSt Lukes HospitalLittle Horton LaneBradfordBD5 0NA

Dear Colleague

Re.

XXXX Surgery is approved to offer a Primary Care Anticoagulation service. The patient named above has given their consent to be transferred to the Primary Care Anticoagulation Clinic at xxxx Surgery.

We would be grateful if you could pass on full information including, indication for treatment, target INR range, the last 3 INRs and dates, and their next appointment date, using the tear off slip below.

Yours sincerely,

Primary Care Anticoagulation Clinic Practitioners…………………………………………………………………………………………

Referral to Primary Care Anticoagulation Clinic

Patient’s name ……………………………………………………………………Date of Birth ………………………………………………………………………Address …………………………………………………………………………….....................................................................................................................Name of anticoagulant- Warfarin/ PhenindioneConsultant initiating treatment.........................................................................Indication for treatment …………………………………………………………….Any relevant medical history ...........................................................................

Target INR range ………………………………Duration of treatment.........……Last 3 INRS (1) ………………….. Date ………………..Dose................

(2) …………………… Date ………………..Dose................(3) …………………… Date ………………..Dose................

Next appointment date ……………………………………….

Referral to


Undercliffe Health Centre Whetley Medical Centre Dr Gilkar (Little Horton Lane)

c/o Prescribing Support ServicesWindhill Green Medical PracticeThackley Old Road, Shipley BD181QBTel: 01274 800821 Fax: 01274 738981

Patient’s detailsNHS Number: Hospital number:

Ethnicity: English Speaker?

YES NO

Name: DOB

Address: Tel

Postcode: Mob

Home visit required? NO YES

Patient’s GP

Name Tel

Address Fax

Postcode

Risk factors identifiedLiver function Renal function Impaired memory or cognition Falls

Alcohol units/week Adherence with treatment Adherence with appointments Current/History of drug abuse Planning for pregnancy


Treatment DetailsUrgent referral to be seen within 5 days NO YES

Non urgent referral to be seen within 14 days NO YES

INR Range Please tick2.0 to 2.5 2.0 to 3.0 3.0 to 4.5 Other-please specify range …………………….. Indication for anticoagulation is:Treatment (DVT) Prophylaxis (High risk surgery) Treatment (PE) Proph.(Hip/fractured femur surgery) Treatment (Recurrent DVT) Prophylaxis (Mech heart valves) Treatment (Recurrent PE) Prophylaxis (Atrial Fibrillation) Treatment of TIA Other (please specify) ……………….

Maintain anticoagulation for the next;…………. weeks ……… months Long term (with an annual review) [ ]

Concurrent treatment with antiplateletsNot applicable Name antiplatelet’s that are to continue with anticoagulant Antiplatelet(s) ……………………………. Duration ………………………..Indication ………………………………….

Recent Warfarin TherapyDate INR Dose mg

mg mg mg mg

Shared Record consent obtained NO YES

ReferrerName Clinic/Practice/Hospital stamp:

Tel: Fax:

SignatureReferral date

Received: ___ / ___ / ___


Referral toAshcroft Bowling Hall Horton Bank Leylands Oak Glen Saltaire Wibsey and Queensbury

Ashwell Farrow Idle Moorside Rockwell/WroseSpringfield Windhill Green

Bingley Highfield Low Moor Newton Way Rooley Lane Tong

c/o Prescribing Support SerrvicesWindhill Green Medical PracticeThackley Old Road, Shipley BD181QBTel: 01274 800 821 Fax: 01274 738981

Patient’s detailsNHS Number: Hospital number:

Ethnicity: English Speaker?

YES NO

Name: DOB

Address: Tel

Postcode: Mob

Home visit required? NO YES

Patient’s GP

Name Tel

Address Fax

Postcode

Risk factors identifiedLiver function Renal function Impaired memory or cognition Falls

Alcohol units/week Adherence with treatment Adherence with appointments Current/History of drug abuse Planning for pregnancy


Treatment DetailsUrgent referral to be seen within 5 days NO YES

Non urgent referral to be seen within 14 days NO YES

INR Range Please tick2.0 to 2.5 2.0 to 3.0 3.0 to 4.5 Other-please specify range …………………….. Indication for anticoagulation is:Treatment (DVT) Prophylaxis (High risk surgery) Treatment (PE) Proph.(Hip/fractured femur surgery) Treatment (Recurrent DVT) Prophylaxis (Mech heart valves) Treatment (Recurrent PE) Prophylaxis (Atrial Fibrillation) Treatment of TIA Other (please specify) ……………….

Maintain anticoagulation for the next;…………. weeks ……… months Long term (with an annual review) [ ]

Concurrent treatment with antiplateletsNot applicable Name antiplatelet’s that are to continue with anticoagulant Antiplatelet(s) ……………………………. Duration ………………………..Indication ………………………………….

Recent Warfarin TherapyDate INR Dose mg mg mg mg mgShared Record consent obtained NO YES

ReferrerName Clinic/Practice/Hospital stamp:

Tel :Fax:

SignatureReferral date

Received: ___ / ___ / ___


Prescribing Support for Bradford CCGs

Acceptance of patient from secondary care into primary care clinic letter;

Practice Letterhead

DatePharmacy Anticoagulant ClinicSt Lukes HospitalLittle Horton LaneBradfordBD5 0NA

Pharmacy Anticoagulant ClinicAiredale General HospitalSkipton RoadSteaton RoadKeighleyBD20 6TD

Dear Colleague

Re. …Name, address, DOB…………………………………………………………………………………………………………………………………………….…………………………………………………………………………………….…………………………………………………………………………………….……………………………………………………………………………………..

XXX Surgery is approved to offer a Primary Care Anticoagulation service. The patient/s named above has/have now been accepted into our clinic.

Yours sincerely,

Primary Care Anticoagulation Clinic Practitioner


Referral back to secondary care letter;

Practice Letterhead

DatePharmacy Anticoagulant ClinicSt Lukes HospitalLittle Horton LaneBradfordBD5 0NA

Dear Colleague

Re. …Name, address, DOB…………………………………………………………………………………………………………………………………………XXX Surgery is approved to offer a Primary Care Anticoagulation service. The patient named above no longer fits our clinic inclusion criteria. We therefore need to ask you to take this patient back into your service.

The following information may be useful to you-Indication for treatment………………………………………………………Target INR range……………………………………………………………..Last 3 INRs ………… 1…………………….Date………………….Dose………… 2……………………Date…………………. Dose………... 3……………………Date…………………. Dose………… Next appointment date …………………………………………………..

Reason for transfer back to secondary care ………………………………………….

Yours sincerely,

Primary Care Anticoagulation Clinic Practitioner…………………………………………………………………………………………

Referral back to Secondary Care Anticoagulation Clinic

We confirm that we have accepted the patient named below back into the Anticoagulant Clinic held at St Luke’s Hospital

Patient’s name ……………………………………………………………………Date of Birth ………………………………………………………………………Address ……………………………………………………………………………

Name of anticoagulant- Warfarin/ Phenindione Indication for treatment …………………………


Anticoagulant clinic non- attendance letter;

To GP-

Dear “Doctor”,

Your patient failed to attend their anticoagulant monitoring appointment today.If you prescribe the patient’s anticoagulant we recommend that you contact the patient to come into your surgery for an INR check. We will continue to see the patient at their next due anticoagulant clinic date.

If we prescribe the anticoagulant we will contact the patient to make another appointment. If they fail to attend the second appointment we will inform you and ask that you inform us if the anticoagulant is to continue.

To Patient-

Dear “Patient,

We have noted that you failed to attend your anticoagulant monitoring appointment today.In order for us to continue to treat you with your anticoagulant we need to be able to test your blood regularly.If you fail to attend your clinic appointments we will be unable to continue prescribing the anticoagulant for you as it would be unsafe to do so.Please contact the clinic and make another appointment as soon as possible.If you have stopped taking your anticoagulant for a particular reason, please also inform us.


Appendix 6:Patient Satisfaction Questionnaire-

Established clinic patients (>3 months in clinic)

XXXX Anticoagulation clinic

Before the appointment

Are appointments available at a day convenient to you? YES NO

If NO, what would be a better day ? ………………………………………………

Are appointments available at a time convenient to you? YES NO

If NO, what would be a better time? ………………………………………………

Do you find the GP surgery based clinic more convenient than the hospital clinic?

YES (add a reason)………………………………………………………………………

NO (add a reason)………….…………………………………………………………..

At the appointment

Appointment time-were you seen on time YES NO or within

5 10 15 20 25 30 minutes of your appointment time?

Is the amount of waiting time acceptable for you? YES NO

If your appointment time was delayed (by more than 10 minutes) were you told why you had to wait?

YES NO Appointment was not delayed

How do you find the length of time for this appointment?

Not long enough Just about right Too long

During your appointment, did you have enough time to ask questions?

YES NO I did not need to ask any questions

During your appointment did you feel you were given enough information/advice? YES NO

If no, what would you have liked advice on? If you were given advice, was the advice given clear and understandable?


YES NO

After the appointment

Were you satisfied with the arrangements made for your follow up appointment?

Very satisfied Satisfied Not very satisfied Not satisfied

I was uncertain about the follow up arrangements

How long have you used this anticoagulant monitoring service?

Less than one month 1-6 months 6-12months12-18months 18-24 months more than 2 years

General questions

How would you rate the care you received at the clinic?

Poor Fair Good Very good Excellent

Did you find the Reception staff helpful?

Not at all helpful Not very helpful Helpful Very helpful

Did you find the Clinic practitioner helpful?


What do you like about the clinic?

Location Easy to park Friendly staff

Waiting time Length of appointment time Being able to ask questions

Quality of advice Support material provided

Any other comments- if we were to review the service, is there anything we could do/add to make it better for you?

……………………………………………………………………………………………

Thank you for taking the time to fill in this questionnaire. Please return the completed questionnaire to the Anticoagulation/Warfarin clinic via the Practice Reception November 2014 Appendix 6:


Patient Satisfaction Questionnaire-NEW patients only

XXXX Anticoagulation clinic

Questions about starting on anticoagulation (warfarin) treatment-

How long was it from the time you first thought something might be wrong with you, until you first had anticoagulation therapy? ............................ weeks

Did you understand the explanation of what was wrong with you? YES NO

Any comments .............................................................................................................

Was your need for anticoagulation therapy explained to you? YES NO

Any comments .............................................................................................................

Were the possible side effects of treatment(s) explained in a way you could understand? YES NO

Any comments .............................................................................................................

Were you involved as much as you wanted to be in decisions about which treatment(s) you would have? YES NO

Any comments .............................................................................................................

Do you feel supported to manage your Warfarin treatment? YES NO

Any comments .............................................................................................................

Before the appointment

Are appointments available at a day convenient to you? YES NO

If NO, what would be a better day ? ………………………………………………

Are appointments available at a time convenient to you? YES NO

If NO, what would be a better time? ………………………………………………

Do you find the GP surgery based clinic more convenient than the hospital clinic?

YES (add a reason)………………………………………………………………………

NO (add a reason) ……….…………………………………………………………….

At the appointment


Appointment time-were you seen on time YES NO

or within 5 10 15 20 25 30 minutes of your appointment time?

Is the amount of waiting time acceptable for you? YES NO

If your appointment time was delayed (by more than 10 minutes) were you told why you had to wait?

YES NO Appointment was not delayed

How do you find the length of time for this appointment?

Not long enough Just about right Too long

During your appointment, did you have enough time to ask questions?

YES NO I did not need to ask any questions

During your appointment did you feel you were given enough information/advice? YES NO If no, what would you have liked advice on?

If you were given advice, was the advice given clear and understandable?

YES NO

After the appointment

Were you satisfied with the arrangements made for your follow up appointment?

Very satisfied Satisfied Not very satisfied Not satisfied

I was uncertain about the follow up arrangements

How long have you used this anticoagulant monitoring service?

Less than one month 1-2 months 2-3months

General questions


How would you rate the care you received at the clinic?

Poor Fair Good Very good Excellent

Did you find the Reception staff helpful?


Did you find the Clinic practitioner helpful?


What do you like about the clinic?

Location Easy to park Friendly staff

Waiting time Length of appointment time

Being able to ask questions Quality of advice

Support material provided

Any other comments- if we were to review the service, is there anything we could do/add to make it better for you?

…………………………………………………………………………………………

…………………………………………………………………………………………

Thank you for taking the time to fill in this questionnaire.

Please return the completed questionnaire to the Anticoagulation/Warfarin clinic via Practice Reception

November 2014

Appendix 7:


Members of Anticoagulant Peer Support Group

Clinician Contact Number

E-mail address Clinic details

Caroline Dixon

07941258046 [email protected]@bradford.nhs.uk

Wrose- Monday 8.30-12.30

Debbie Scanlon

07902494224 [email protected] Leylands/ Wibsey/ Queensbury/Dr Gilkhar/Tong

Lorna Moor

07715541362 [email protected] Bowling HallRooley LaneBingleySpringfieldOak Glen

Samina Ashraf

07737158663 [email protected]

Highfield City practices Ashwell Farrow

Berny Hutton

0793279460001274637076 (Ashcroft surgery)

[email protected]

Ashcroft- Tuesday 1-6

Elector Shamba

0781052364707725764631

[email protected] Low MoorHorton Bank Thursday am

Tracey Gaston

01274237583 [email protected]

Catherine Kniveton

01274-64357607853335748

catherine.kniveton@ bradford.nhs.uk

Moorside Surgery Tues and Weds 9-12.15

Sarah Harrison

01274-643576

[email protected]

Moorside Surgery Thurs 9-12.15

Anita Vose

[email protected]

Helena Catley

[email protected]

Kilmeny Surgery Thurs am

Sarah Benn

07980451306 [email protected] Windhill Surgery Tuesday+ Wed am Baildon

Helen Wilson

07796951034 Helena.wilson2@ bradford.nhs.uk

Mayfield Medical Centre

Isha Hussain

07771347178 Isha.hussain@ bradford.nhs.uk

Dr Wilson +Partners

Noshi 07515278437 [email protected]


mailto:[email protected]

IqbalImran Ashraf

07984561359 Imran_ashraf01@ [email protected]

Idle medical Practice Fridays 9-6

Clarence Ricketts

07956659550 [email protected] Haworth Medical Centre

AQP self delivery site anticoagulant clinicians

Practice Nurse GPSaltaire NA Asma Faruque

Ian LivingstoneNewton Way Elaine Thompson

Carol WaringCarolyn Gomersall

Stephen Patterson

Windhill Sarah Benn Jane PettyMoorside Catherine Kniveton

Anita VoseJohn Sullivan

Rockwell and Wrose Alison Kaye Karen Morley

Derek Parker

PSS admin

Ruth Asher [email protected]

Anticoagulation helpline number- 01274-800821

Other useful numbers

Provider Address Numbers

PSS Help line 01274 800821

Emily Smith

Pharmacy Anticoagulant clinic

Airedale General Hospital

Pharmacy Anticoagulant clinic

Airedale General Hospital

Skipton Road

Steeton BD20 6TD

01535 652511

Emily’s bleep 3266

[email protected]

[email protected]

Stan Dobranski

St Lukes

BRI-bleepSt Lukes hospital clinic01274-382474

[email protected]

Appendix 8: Home visit protocol-







Introduction

The anticoagulant clinician (nurse or pharmacist) is responsible for maintaining the register of patients receiving anticoagulant monitoring at each clinic site. This includes all patients seen at the clinic site and those requiring a home visit. The clinician is responsible for deciding the warfarin dose each patient is to receive and the date of the next INR test. The clinician is also responsible for recording the consultation within SystmOne and on INRStarN3®. The clinician is responsible for following up all missed appointments.Domiciliary visits can be made by the clinician or by a Health Care Assistant (HCA). HCA can make INR checks but cannot decide warfarin doses (see below).

Procedure for domiciliary reviews for anticoagulant clinics when an HCA is to be involved.

Each HCA will be responsible for the domiciliary visits from an agreed clinic site. The HCA will be provided with a list of patients requiring a home visit by the clinic practitioner or the PSS office. A print out showing patients names, addresses and telephone numbers is needed. Once the visits have been completed these lists must be disposed of safely (i.e. by placing into confidential waste).The HCA will then plan the most efficient way of visiting their patient list that day. If necessary the HCA will phone the patient to confirm that they are in and to agree an approximate time for the visit.The clinician or PSS office might also need to phone the HCA directly with more urgent appointments that are needed that day. The clinician as well as phoning the HCA will make an entry into the clinic sites SystmOne appointments register.

Safety

The clinician will know where the HCA is visiting that day from the clinic list. If the HCA decides to visit a patient not on the clinic appointment list they must inform the anticoagulant clinic clinician or PSS office so that somebody knows their whereabouts.

Contacting the clinician with INR values

Once the patient’s INR value has been obtained with the Coagucheck meter they will phone the anticoagulant clinician.The clinician will record the INR value and ask the patient questions on factors that might affect their warfarin control (see SOP).The clinician will log onto the patient’s clinic site on SystmOne, make a consultation entry and determine the warfarin dose using INRStarN3 (see SOP).

The dose and date of the next appointment will be communicated to the patient and the HCA. The HCA will make an entry into the patient’s yellow anticoagulant book. The clinician will record the date of the next appointment in the appointment section of SystmOne.

Managing patients not in at time of visit

If a home visit patient cancels their appointment or does not answer the door then the HCA must inform the clinician. The clinician will decide what action is to be taken.


Appendix 9:

Protocol for the Initiation of Warfarin Therapy

Warfarin therapy will only be initiated when a referral has been received from a Hospital Doctor or a General Practitioner.Patients requiring non-rapid anticoagulation e.g. patients with atrial fibrillation, cardioversion patients and those restarting therapy after major surgery will be covered by this protocol.

The following protocol should be followed for warfarin initiation:

a. A referral form must be completed by the appropriate Hospital Doctor or General Practitioner. This must include; the indication for oral anticoagulation, the appropriate target therapeutic range and the proposed duration of treatment. This form needs to be signed by the referrer and scanned into the medical records.

b. The patient’s previous and current medical history for any contraindications or risks to starting warfarin therapy should be checked.

c. The patient’s current medication regimen for any potential drug interactions should be checked.

d. Baseline blood samples – FBC, coagulation screen including INR, U+Es, LFTs, gamma GT- should be obtained before initiating therapy. Results from up to 3 months previously can be accepted.

e. The patient should be fully counselled regarding warfarin use and safety, and appropriate patient information literature, including the National Patient Safety Booklet (the yellow book), should be provided.

f. The patient should be seen in the warfarin clinic following counselling and receipt of blood tests, the INR should be rechecked and warfarin can then be initiated at doses in accordance with INR Star N3 software (and depending on the clinical situation). The usual initiation dose for non-rapid anticoagulation is 2mg daily for the first week with review after 7 days.

g. The INR needs to be reviewed at intervals specified on the INR star system or as dictated by clinical judgement. Doses can be increased by 0.5/1mg weekly as appropriate.

.


Appendix 10:

Warfarin reversal protocol- see Appendix 4 for how to deal with a raised INR in the Primary Care Setting

In general the primary care anticoagulation service do not automatically reverse the INR of patient’s with INRs >8. The service will refer to secondary care for advice and treatment.In certain cases e.g. where a patient refuses to attend secondary care, oral Vitamin K could be given after discussion with and approval from the patient’s GP.

Refer to – Oxford Haemophilia and Thrombosis Centre Protocols for out-patient oral anticoagulation with Vitamin K antagonists.

http://ouh.oxnet.nhs.uk/anticoagulation

The information below is taken from this document and is a guide to what might happen in secondary care.

Management of bleeding and of high INR in the absence of bleeding

For a patient with bleeding check the APTT as well as the INR. An APTT > 50s associated with a therapeutic INR suggests there may be another problem such as a low factor VIII due to acquired haemophilia or (in a male) a very low factor IX due to an Ala -10 mutation. The cause of the elevated INR as well as the source of bleeding should always be investigated.

Major bleeding

Major bleeding in terms of anticoagulation reversal can be defined as limb or life-threatening bleeding or any bleeding that requires complete reversal of anticoagulation within 6-8 hours. .

• stop warfarin

• give PCC (30 units/kg, round to nearest vial, max 3000 units) and

• give vitamin K 5 mg IV

The dose of PCC refers to the factor IX content of the concentrate. PCC (Prothrombin Complex Concentrate)

PCCs are pooled plasma products which contain factors II, VII, IX, and X. The use of a PCC is much more effective than FFP in restoring coagulation to normal. PCC is stocked in blood bank. Beriplex or Octaplex might be used.



A typical dose will be 2000 units in 80 ml. This would mean giving Beriplex over 10min or Octaplex over 30 min. Although the datasheet says to give Octaplex at the rate indicated usually a clinical decision will be made that the advantage of faster administration outweighs any theoretical risk.

Non-major bleeding

IV vitamin K produces a more rapid correction of the INR than oral vitamin K and should be used in preference in the bleeding patient. Give IV vitamin K 1-3mg vitamin K which should have an effect within 6-8 hours.

High INRs in non-bleeding patients

The cause of the elevated INR should be investigated

INR >/= 5.0 and < 8.0

• stop warfarin for 1-2 days and reduce maintenance dose

INR >/= 8.0

• stop warfarin until INR< 5.0

• give vitamin K

INR 8 – 11.9 INR = 12

Oral phytomenadione* 2.5 mg 5 mg

* Liquid - if available. The colloidal formulation of phytomenadione injection (Konakion MM) 10 mg/ml is used orally. Phytomenadione doses should ideally be measured using the oral syringes supplied with the 2mg amps, Omnican® F syringes or BBraun brand syringes (non-siliconised). Standard syringes can be used in the outpatient setting provided that the dose is given within 5 minutes.

Oral vitamin K will have an effect within 16-24 hours

Unexpected bleeding at therapeutic levels—always investigate possibility of underlying cause e.g. unsuspected renal or gastro-intestinal tract pathology


Appendix 11:

Protocol for switching from warfarin to NOAC and vice versa.

Information taken from Xarelto (Rivaroxaban SPC)

Converting from Vitamin K Antagonists (VKA) to Xarelto/Rivaroxaban

For patients treated for prevention of stroke and systemic embolism, VKA treatment should be stopped and Xarelto therapy should be initiated when the International Normalized Ratio (INR) is ≤ 3.0.For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the INR is ≤ 2.5.When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto. The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used.

Converting from Xarelto/Rivaroxaban to Vitamin K antagonists (VKA)

There is a potential for inadequate anticoagulation during the transition from Xarelto to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that Xarelto can contribute to an elevated INR.In patients converting from Xarelto to VKA, VKA should be given concurrently until the INR is ≥ 2.0. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing. While patients are on both Xarelto and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Xarelto. Once Xarelto is discontinued INR testing may be done reliably at least 24 hours after the last dose.

Information taken from Eliquis/Apixaban SPC

Switching from Vitamin K antagonist (VKA) therapy to Eliquis/Apixaban

When converting patients from Vitamin K antagonist (VKA) therapy to Eliquis, discontinue warfarin or other VKA therapy and start Eliquis when the international normalized ratio (INR) is < 2.0.

Switching from Eliquis to VKA therapy

When converting patients from Eliquis to VKA therapy, continue administration of Eliquis for at least 2 days after beginning VKA therapy. After 2 days of coadministration of Eliquis with VKA therapy, obtain an INR prior to the next scheduled dose of Eliquis. Continue coadministration of Eliquis and VKA therapy until the INR is ≥ 2.0.


Appendix 12:

Audit Report Forms

Audit report forms to be finalised but will include;

Patient Satisfaction Questionnaire (Appendix 6)

Quarterly report to Commissioners, which will include information on;

Indicator Indicator Description

The following parameters are the suggested quarterly indicators for providers to report to commissioners with (where appropriate) suggested achievement percentages

Total number of patients monitored for INR

Percentage of cohort and indications for treatment (eg 70% AF etc)

Annual point prevalence and TTR average

Percentage/number of patients who require referral back to acute care and clinical reason for referral

Percentage/number of bleeding episodes that require admission or referral to acute care

Percentage of patients whose INR is over or under 0.5 of their target

Percentage of patients with a consistently high INR of >5.0

Percentage of patients with and INR >8

Percentage of patients who DNA versus total population of patients treated

Number of recorded critical incidents/untoward events

The provider must be able to benchmark the performance of the service against the British Committee for Standards in Haematology safety indicator set

Benchmarking must be able to compare the service to other providers

Mean % time in range >72%

Point prevalence >70%28


Referral to treatment time as indicated in section 2.4 of the Service Specification (see Schedule 2 The Services; A Service Specification)

Service outcomes

Percentage of patients with a record that they are taking their anticoagulation treatment as prescribed

All INR monitoring and any events as a result of test outcomes to be recorded within the patient’s healthcare records

Secure digital back-up of the tests: results and specific individual patient events should be stored electronically in such a way that the data cannot be easily lost/corrupted or altered

In ensuring computer software is used to assist dosing decisions, the service provider must:o Ensure the most up to date clinical version of the software is usedo Ensure that all staff using the software receive training and are competent to do soo Ensure all data stored on the computer system is subject to the requirements of a comprehensive data protection policyo The service provider is required to carry out clinical audit in the care of patients as set out in criteria recommended by the British Committee for Standard in Haematology and the NPSA

Provider to record the percentage of patients provided with written information about managing their INR level and offered ongoing education and support


Bi-annual or annual report will include;

Indicator Indicator Description Frequency

The following parameters are the suggested quarterly indicators for providers to report to commissioners with (where appropriate) suggested achievement percentages

Six-monthly record to be made of the NPSA (or equivalent) audit

Bi-annually

Service delivery

Number of home visits per year as a percentage of the total number of patients treated with anticoagulation

Annual

Percentage of patient questionnaires returned, complaints about the services and actions planned as a result of the report outcomes (annual reports to be compiled from the results of the patient questionnaire comments (see Quarterly Performance Report; Information Requirements for Anticoagulation; Appendix 1)

Annual

Patient satisfaction and resultant actions as indicated in the Local Quality Requirements (see Quarterly Performance Report; Information Requirements for Anticoagulation; Appendix 1)

Annual

NPSA checklist NRLS-0440-Anticoagulants-audit-templatehttp://www.medicinesresources.nhs.uk/upload/documents/Communities/SPS_E_SE_England/NRLS-0440-Anticoag-audit-template%5B1%5D.pdf


http://www.medicinesresources.nhs.uk/upload/documents/Communities/SPS_E_SE_England/NRLS-0440-Anticoag-audit-template%5B1%5D.pdf

http://www.medicinesresources.nhs.uk/upload/documents/Communities/SPS_E_SE_England/NRLS-0440-Anticoag-audit-template%5B1%5D.pdf

1. Review of training and competence

Recommended action Suggested evidence Assessment Comment/further action required

Ensure all staff caring for patients on anticoagulant therapy have the necessary work competences to undertake their duties safely.

Copy of: • training programme for

foundation year doctors and others;

• system of clinical supervision, where senior staff oversee and assess work competences of less experienced staff;

• training records and competence assessment for healthcare professionals involved in anticoagulation.

Compliance ornon-compliance


Patient safety alert 18Actions that can make anticoagulant therapy safer

Audit checklist

Name of organisation: Date:

Audit checklist prepared by:

57

Recommended action Suggested evidence Compliance (Yes/No)

Comment/further action required

Healthcare organisations should have written procedures and clinical protocols for the safe use of oral and injectable anticoagulant therapy. These procedures should include guidance on the following:

Copy of: • procedures;• clinical protocols;• date of Drugs and

Therapeutics Committee approval;

• review date.

Risk assessing the benefits vs the risks of anticoagulant therapy for individual patients.

Providing information to the patient before anticoagulant therapy is commenced, prior to hospital discharge, on first visit to the anticoagulant clinic and when necessary throughout the course of the treatment.

How to safely initiate anticoagulant loading doses, including the use of low dose loading for patients with atrial fibrillation.

How to monitor anticoagulation and adjust dosage to achieve target INR range.

Safe systems for documenting results and treatment.


2. Procedures and clinical protocols

58



Effective communication systems when clinical responsibility for anticoagulant therapy is being transferred, e.g. on discharge from hospital.

That safe practice is promoted with prescribers and pharmacists to check that patient’s INR is being monitored regularly and that the INR level is safe before issuing or dispensing repeat prescriptions for oral anticoagulants.

That safe practice is promoted with prescribers co-prescribing one or more clinically significant interacting medicines for patients already on oral anticoagulants, to make arrangements for additional INR blood tests, and inform the anticoagulant service that an interacting medicine has been prescribed. To promote safe practice that those dispensing clinically significant interacting medicines for those patients check that these additional safety precautions have been taken.

That dental practitioners manage patients on anticoagulants according to evidence-based therapeutic guidelines.

Annual clinical review of patients on oral anticoagulants.

How patients should have their anticoagulant therapy discontinued.




That all strengths of warfarin tablets should be used to best meet the needs of individual patients. Not all patients will need all strengths of tablets.

That oral anticoagulant doses should be expressed as mg and not as number of tablets.

Dosage recommendations should:• use the least number of tablets each day;• use constant daily dosing and not alternate day

dosing;• not require the use of half tablets. Patients find

it difficult to break tablets and instead, when necessary, would rather use 0.5mg tablets.

Where infusions of sodium heparin are used, a standard, ready-to-use presentation of 1000 units in 1ml is used. Changes in daily dose should be made by adjusting the rate of administration.

Ward stock locations and purchasing records of heparin>1000unit/ml products

Promotion of the use of written safe practice procedures for the use of anticoagulants in care homes, including the safe practice recommendation for written confirmation of dose changes from prescribers, and the minimised use of monitored dosage systems for anticoagulants.


Recommended indicator Suggested evidence

Audit result Comment/further action required

Safety indicators for patients starting oral anticoagulant treatment

Percentage of patients following loading protocol.

Results of prospective observational audit of prescription charts over one month.

Percentage of patients developing INR > 5.0.

Results from monitoring service over 12 months.

Percentage of patients in therapeutic range at discharge.

Results of prospective observational audit of prescription charts over one month.

Percentage (incidence) of patients suffering a major bleed in first month of therapy and percentage suffering major bleed with INR above therapeutic range.

Results from hospital admissions and clinical data over 12 months.

Percentage of new referrals to anticoagulant service (hospital or community based) with incomplete information.

Results from anticoagulant clinic(s) over 12 months.

Percentage of patients that were not issued with patient-held information and written dosage instructions at start of therapy.



3. Audit of safety indicators

61



Percentage of patients that were discharged from hospital without an appointment for next INR measurement or for consultation with appropriate healthcare professional to review and discuss treatment plan, benefits, risks and patient education.


Safety indicators for patients established on oral anticoagulant treatment

Proportion of patient-time in range or percentage of INRs.


Percentage of INRs > 5.0. Results from monitoring service over 12 months.

Percentage of INRs > 8.0. Results from monitoring service over 12 months.

Percentage of INRs > 1.0 INR unit below target (e.g. percentage of INRs < 1.5 for patients with target INR of 2.5).


Percentage of patients suffering adverse outcomes, categorised by type, e.g. major bleed.

Results from hospital admissions data over 12 months.

Percentage of patients lost to follow-up (and risk assessment



3. Audit of safety indicators3. Audit of safety indicators

62



of process management for

identifying patients lost to follow-up).

Percentage of patients with unknown diagnosis, target INR or stop date.


Percentage of patients with inappropriate target INR for diagnosis, high and low.


Percentage of patients without written patient educational information.


Percentage of patients without appropriate written clinical information, e.g. diagnosis, target INR, last dosing record.

Results from anticoagulant clinic(s) over 12 months


3. Audit of safety indicators3. Audit of safety indicators

63

Clinical outcome Number of reports

DeathSevere (permanent harm)Moderate (significant, but not permanent harm, requiring increase in treatment)Low (temporary harm, requiring extra observation or minor treatment)No harmTotalType of report Number of reportsPrescribingDispensing/medicine preparation AdministrationMonitoringTotalType of incident Number of reportsWrong dose Wrong frequencyOmitted medicine/doseWrong drugWrong quantityMismatching of patient and their medicineWrong/transposed/omitted medicine labelWrong/omitted/passed expiry dateWrong storageWrong routeContraindicationPatient allergic to treatmentWrong formulationWrong method of preparation/supplyAdverse drug reaction – when used as intendedWrong or omitted verbal patient directions


4. Review of patient safety incident data involving anticoagulants for preceding 12 months

64

OtherTotal

Signature of Drugs and Therapeutics Committee Chair:

Name of Drugs and Therapeutics Committee Chair:

Date: Next review date:


5. Overall comments and actions recommended by Drugs and Therapeutics Committee

65

Anticoagulant risk reduction audit (PSS protocol)

Anticoagulant risk reduction - report form

Objectives: To reduce the risk of adverse effect to the patient when prescribing anticoagulants

Rationale/ scope: The National Patient Safety Agency (NPSA) state that anticoagulants are one of the classes of medicines most frequently identified as causing preventable harm and admission to hospital. Managing the risks associated with anticoagulants can reduce the chance of patients being harmed in the future. The NPSA has recommendations, guidelines, audit templates, competencies etc

Process: review of all patients currently taking an anticoagulant and check on any alternative clinics that may be providing monitoring or supply for any patients in the practice.

Practice …………………………………….

Date initially audited………………… by…………………………………….

Date completed………………………..by…………………………………….

Results:

Number identified with warfarin/ acenocoumarol/ phenindione on their med listNumber identified as taking an anticoagulant but not on the med listNumber needing the dose instructions changingNumber in a care home

Number with a Dosette box

Number on concurrent interacting drugsNumber referred back to the warfarin clinic.

Any other criteria recorded:


Appendix 13:

Significant event and ‘near miss’ analysis

Summary & Standard Report Format

What is a Significant Event?

“Any event thought by anyone in the healthcare team to be significant in the care of patients or the conduct of the organisation”.

SEVEN STEPS to Significant Event Analysis:

STEP ONEIdentify and prioritise the significant event.

STEP TWOCollect the facts.

STEP THREEArrange a meeting to discuss.

STEP FOURUndertake a structured analysis.

STEP FIVEMonitor agreed change.

STEP SIXWrite it up.

STEP SEVENPeer Review.

1. What happened?(Describe what actually happened in detail. Consider, for instance, how it happened, where it happened, who was involved and what the impact or potential impact was on the patient, the team, organisation and/or others).

2. Why did it happen?(Describe the main and underlying reasons – both positive and negative – contributing to why the event happened).

3. What has been learned? (Demonstrate that reflection and learning have taken place on an individual or team basis and that relevant team members have been involved in the analysis of the event.)

4. What has been changed? (Outline the action(s) agreed and implemented, where this is relevant or feasible. Consider, for instance: if a protocol has been amended or introduced. It is also good practice to attach any documentary evidence of change e.g. a letter of apology to a patient or a new protocol).


Significant Event and ‘Near Miss' Analysis

1. What happened?

2. Why did it happen?

3. What did you learn?

4. What changes will/ have you made?

In broad terms, how would you classify the event?

Systems Failure Human Error Patient Factors Equipment Failure Communication Failure Inadequate Training Clinical Error Ethical Problem Other

Please send form to Clinical Governance Lead (Su Wood)

PSS SEA event number………….....date added to record………...………….

Appendix 14:


Warfarin Dose Reminder Chart

Patient : _________________

Date

DAY Number and colour of tablets

Dose Comments

TUES

WED

THURS

FRI

SAT

SUN

MON

TUES

WED

THURS

FRI

SAT

SUN

MON

TUES

Appendix 15:


Draft bridging protocol guidelines-BRI- June 2014

17. PERI-OPERATIVE ANTI-COAGULATION

Oral anticoagulants are frequently prescribed for long-term prevention of venous or arterial thromboembolism for at risk patients

In the peri-operative period risks and consequences of thrombosis need to be weighed against risk and consequences of excess perioperative and postoperative bleeding

There are 3 options for the peri-operative management of anti-coagulantso Continue warfarin (with INR monitoring pre-procedure) or other novel oral

anticoagulants – this is for minor superficial procedures Cataract surgery, minor superficial dermatological procedures, minor dental

procedures, low-risk endoscopic (diagnostic +/- biopsies, biliary or pancreatic stenting, diagnostic EUS)

o Temporary cessation of anticoagulation for a period pre- and post-operativelyo Temporarily withhold warfarin or other novel oral anticoagulants pre-operatively,

bridging anticoagulation therapy with LMWH or IV Heparin The option chosen is determined by

o The primary indication for anticoagulation and risk assessment of thromboembolismo The type of procedure or surgery o The risk of perioperative bleeding

Pre-operative bridging carries a low risk of bleeding, but use of post-operative bridging carries high risk of bleeding and requires careful consideration

o In high bleeding risk surgery it is recommended that post-operative bridging is not commenced until at least 48hrs postoperatively

A thorough risk assessment must be made and the appropriate plan discussed with the patient PRIOR to their surgery

Patients with complex anticoagulation problems Some complex patients may require referral to the haematologists for an individualised surgical management plan during the perioperative period.When patients require a plan, please phone/email Susan Smith, Haematology CNS on 382511 [email protected] OR phone the Haematology coagulation Registrar via switchboard or Ward 7.Patient notes should be sent to Susan Smith at Pathology offices (opposite Ward 4) and should be booked out to Dr Sam Ackroyd.

The following information should be included: Date and type of procedure Admitting ward Consultant Patient’s weight Advise who plan and notes should be returned to



RISK ASSESSMENT OF ANTI-COAGULATED PATIENTS UNDERGOING ELECTIVE SURGERY

Reason for anti-coagulation

Higher thrombosis risk

Medium thrombosis risk

Lower thrombosis risk

Atrial fibrillationCHADS2 scoreCongestive failure = 1 pointHypertension = 1 pointAge > 75 years = 1 pointDiabetes = 1 pointStroke/TIA = 2 points

CVA/TIA < 3 mths ago

CHADS2 score 5-6 Rheumatic valvular

heart disease

CHADS2 score 0-4 (NO previous CVA/TIA)

Mechanical heart valves (MHV)

All prosthetic mitral valves

Caged ball or tilting disc aortic valve (prosthetic)

CVA/TIA in last 6 months

Bi-leaflet aortic valve with any risk factor for stroke

AF HPT CVA/TIA Diabetes >75 years

Bi-leaflet aortic valve with NO risk factors for stroke and >3 months post insertion

Venous thromboembolism

VTE < 3 months ago (if surgery cannot be deferred IVC filter to be considered eg Cancer surgery)

VTE with high risk thrombophilia – always discuss ATIII with haematologist

Recurrent VTE whilst anti-coagulated i.e. INR range 3-4

Active cancer with VTE < 6 mths ago

VTE previous 3-12 mths

Recurrent VTE

VTE > 12 months ago with NO other risk factors


PERI-OPERATIVE RECOMMENDATIONS FOR ANTI-COAGULATION AGENTS

WARFARIN PRE-OPERATIVE

When to stop pre-operatively

Bridging anti-coagulationHigher thrombosis risk Medium

thrombosis riskLower thrombosis risk

5 days prior to procedure

D6 pre-op = last dose warfarin

D5 pre-op = warfarin stopped

D3 pre-op check INR start Therapeutic dose

LMWH when INR below lower end of target range – give at 5pm

D2 pre-op = therapeutic dose LMWH at 5pm

D1 pre-op = prophylactic dose LMWH at 5pm

(needs to be minimum 12 hours prior to spinal/epiural)

D0 = no LMWH pre-op; Check INR<1.5

D6 pre-op = last dose warfarin

D5 pre-op = warfarin stopped

D3 pre-op = start prophylactic dose LMWH at 5 pm



(needs to be minimum 12 hours prior to spinal/epiural)D0 = no LMWH pre-op; Check INR<1.5

Stop warfarin but NO pre-operative LMWH bridging required

WARFARIN POST-OPERATIVE


POST OPERATIVE

HIGH BLEED RISK MAJOR SURGERYHigher AND Medium Thrombosis Risk

Lower thrombosis risk

Delay starting LMWH until haemostasis secured

D0 = prophylactic dose LMWH 6-12 hours post op

D+1 post op = prophylactic dose LMWH at 5pm

D+2 post-op = start therapeutic dose LMWH at 5pm in a split twice daily regimen (i.e. ½ full dose BD)

D+3 post op = restart warfarin give 2x usual patient dose (max. 10mg warfarin)

Continue split therapeutic dose LMWH

D+4 post op = give warfarin patient usual dose and check INR daily

Continue split therapeutic dose LMWH until INR >2 for 2days

Check daily INR

Ensure anticoagulation clinic booked on discharge



D+1 post op= prophylactic dose LMWH at 5pm

D+2 post op = prophylactic dose LMWH at 5pm


Prophylactic dose LMWH at 5pm D+4 post-op = give warfarin patient

usual dose and check INR daily prophylactic dose LMWH at 5pm continue prophylactic dose LMWH

until INR >2 for 2 days Check daily INR

Ensure anticoagulation clinic booked on discharge

POST OPERATIVE

LOW BLEED RISK MINOR SURGERYHigher AND Medium Lower Thrombosis Risk


Thrombosis risk5 days prior to procedure




Prophylactic dose LMWH at 5pm

D+2 post-op = give warfarin patient usual dose

therapeutic dose LMWH at 5pm

D+3 post op =give warfarin as per INR

Continue therapeutic dose LMWH until INR >2 for 2 days

Check daily INR Consider discussing

with anticoagulation clinic to help early discharge with monitoring INR while on LMWH

Book anticoagulation clinic on discharge



D+1 post op = restart warfarin give 2x usual dose (max.15mg warfarin)

Prophylactic dose LMWH at 5pm D+2 post-op = give warfarin patient

usual dose and continue this dose daily

Prophylactic dose LMWH at 5pm D+3 to D+7 post op = continue

prophylactic dose LMWH Check has anticoagulation clinic

booked on D+3 to D+7 post operative

Note: Patients can be discharged on D0 if considered appropriate by the surgical team and patient able to follow postoperative anticoagulation plan

Book anticoagulation clinic on discharge

DABIGATRANStop Dabigatran before elective surgery

Renal function (CrCl mL/min)

High risk of bleeding or major surgery or neuraxial block

Standard risk of bleeding or no neuraxial block

≥8050 – 7930 -49<30

2 days pre-operatively3 days pre-operatively4 days pre-operativelyDabigatran contraindicated

24 hours pre-operatively24 – 48 hours pre-operatively48 – 72 hours pre-operativelyDabigatran contraindicated

Check clotting screen and thrombin time (TT) on day of surgery

RIVAROXABAN and APIXIBANStop before elective surgery

Renal function (CrCl mL/min)



>3015-30<15

2 days pre-operatively3 days pre-operativelycontraindicated

24 hours pre-operatively48 hours pre-operativelycontraindicated

Check clotting screen on day of surgery

Therapeutic LMWH




Last full therapeutic dose Day 2 pre-operatively at 5pm (i.e. >48 hours previous)

Give Prophylactic dose Day 1 pre-operatively at 5 pm

Last full therapeutic dose 24 hours pre-operatively

Unfractionated Heparin infusion Stop 6 hours pre-operatively on day of surgery Check APTT 2 hours pre-operativelyGuideline produced by Dr S Ackroyd (Consultant Haematologist) and Dr S Kitzinger (Consultant Anaesthetist)Guideline agreed by Thrombosis Committee Nov 2013

REFERENCES

1. Keeling D et al, Guidelines on oral anticoagulation with warfarin – fourth edition. BJH 2011, 1365-2141

2. Douketis JD. Perioperative management of patients who are receiving warfarin therapy: an evidence-based approach and practical approach. Blood 2011, 117 (19): 5044-9

3. Management of perioperative anticoagulation in adult elective surgery. Betsi Cadwaladr University Health Board: Anaesthetics, critical care and pain management CPG – Pre-operative assessment clinic

4. Guidelines for the perioperative management of oral anticoagulation in patients undergoing elective procedures. Leeds Teaching Hospitals NHS Trust. July 2012.

5. Guidelines for prescribing of Dabigatran (Pradaxa) and Rivaroxaban (Xarelto) inpatients with non-valvular AF. Cardiac and Stroke Networks in Lancashire and Cumbria. Lancashire and Cumbria Health Economy New Medicines and Treatments Group. September 2012.

6. http://www.medicines.org.uk/emc/7. http://www.ema.europa.eu8. http://dig.pharm.uic.edu/faq/2011/dec/faq2.aspx


Appendix 16:

Example Training Log-

Date Activity

20.7.11 Peer support group meeting15.9.11 Fire safety and Health and Safety training21.9.11 Peer support group meeting22.9.11 Pharmacy team meeting29.9.11 CPR training19.10.11 Pharmacy team meeting16.11.11 Peer support group meeting17.11.11 Pharmacy team meeting14.12.11 Pharmacy team meeting18.1.12 Peer support group meeting23.2.12 Pharmacy team meeting14.3.12 Peer support group meeting14.3.12 Pharmacy team meeting17.4.12 Pharmacy team meeting16.5.12 Peer support group meeting

May 2012 PCT visit from Tracey GastonMay 2012 Pharmacy team meeting

14.6.12 CPD passed by GPhC21.6.12 Pharmacy team meeting

June 2012 Clinic training with Imran AshrafJuly 2012 Coagucheck training-update session17.7.12 Peer support group meeting26.7.12 PLT session with Leylands GPs13.9.12 Pharmacy team meeting14.9.12 Clinic training with Imran Ashraf19.9.12 Peer support group meeting21.9.12 Clinic training with Imran Ashraf4.10.12 CPR update10.10.12 CCG accreditation completed for 3 years21.11.12 Peer support group meeting5.2.13 60 minute Make over-Anticoagulation in AF-Mercure

Hotel, Bradford6.2.13 Stroke and TIA-Crow Trees Primary Care Training

Centre2.3.13 Anticoagulation-Ensuring Good Care-Leeds Met

University20.3.13 Peer support group meeting24.4.13 AF-Quality Improvement education event-Douglas

Mill16.5.13 Peer support group meeting

July 2013 Peer support group meetingSept 2013 Peer support group meeting


2.10.13 OAC decision support clinics- Kathryn Griffith20.11.13 CPWY meeting – Anticoagulation and thrombosis-

Katherine Stirling-Leeds Teaching hospital23.11.13 Practicalities of using the NOACs for Stroke

prevention in AF-Nicholas Hough-BMS- evening Peer Support group meeting

Dec 2013 Leylands stroke risk management clinicsJan 2014 Peer support group meetingFeb 2014 Moorside stoke risk management clinics26.2.14 Stroke prevention and AF Meeting- Dr Youssef Beaini

March 2014 Stroke risk clinics –feedback to Moorside SurgeryMarch 2014 Peer support group meeting-Apixaban medical

information representative21.5.14 Apixaban for the prevention of Stroke in Non-valvular

AF- Dr Youssef BeainiJune 5/6 2014 University of Birmingham Anticoagulation Conference

9.7.14 Peer support group meeting

Ongoing Ongoing discussions during clinics with Catherine Kniveton-Moorside surgery

Ongoing Ongoing discussions during clinics with Berny Hutton-Ashcroft surgery


Appendix 17:

Useful references;

Oxford Haemophilia and Thrombosis Centre Protocols for out-patient oral anticoagulation with Vitamin K antagonists.




Appendix 18: Patient information about the clinic

Add a leaflet to your copy of the SOP


Appendix 19 : When should the INR be measured before a dental procedure? The INR must be measured prior to dental procedures, ideally within 24 hours before the procedure. However, this is sometimes difficult to achieve in primary care dental practice. For patients who have a stable INR, an INR measured within 72 hours before the procedure is acceptable.

Patients will need either to co-ordinate their dental treatment with their next planned INR measurement or have an extra INR measurement within 72 hours of their planned dental treatment.

N.B. The INR is valid only for patients who have stable anticoagulant therapy. Patients presenting with an INR much higher than their normal value, even if it is less than 4.0, should have their procedure postponed and should be referred back to the clinician maintaining their anticoagulant therapy.


Appendix 20: Handwriting requirements for anticoagulant booklet instructions

Established patients- be consistent and leave things as they like them.New patients- follow guidelines below.

General points:

Home visit entries need to be the same standard as clinic entries. Always write clearly. No crossing out/scribbling- rewrite the whole line. Do NOT use “half” or “1/2” Always include the tablet colours. Use two lines if necessary. Use “every day” not “daily”.

Examples:

1. 5.5mg daily

Take 5.5mg every day (One PINK and one WHITE)2. 4mg for 5 days and 3.5mg for 2 days

Take 4mg Monday to Friday (one BLUE and one BROWN) and 3.5mg on Saturday and Sunday (one BLUE and one WHITE)

3. 2mg for 6 days and 3mg for 1 day

Take 2mg every day (Two BROWN) EXCEPT 3mg every Sunday (One BLUE)


Appendix 21: Sharing a patient’s record on SystmOne

When a patient is seen at a practice which is not their registered surgery a “record share” will need to be set up. This is for three reason:

Allows clinicians to book anticoagulant appointments Allow the clinician to check relevant patient history that might affect warfarin

control Allows clinicians to enter details of the anticoagulation consultation so that

GPs at the patient’s surgery can see that a consultation and dosing has taken place.

Patients consent is need to set a record share. If they do not want to consent then they cannot be managed in the PSS clinic.Process;

1. The referring practice must set up a share to allow the anticoagulant clinic to see the record

Go to adminGo to record share

Right click


Click Sharing out - Yes share data with other organisationsSharing in - Consent given

1. The anticoagulant clinic must set up a share to allow the patients practice to see the consultation details

Follow the same process as above.For further details see the TPP guide (in SOP) or available by pressing F1 when SystmOne open. This will open up the help file. Scroll down to record sharing.

2. Cancelling a record share.

If a patient leaves the service cancel the record share. How ????

3. Tasking GP

As well as making an entry in the record you may wish to task the GP to let them know there patient has been seen or if you have a non urgent query. To do this go to tasks and click on drop down menu of organisations. The pick the staff member you want the task to go to by selecting highlighting the “staff member” drop down list


Appendix 22: Annual reviews of patient in the anticoagulant clinics

It is a requirement that all patients who have their anticoagulation therapy monitored in a PSS anticoagulant clinic have an annual reauthorisation by their GP.

1. The PSS office will print off from INR STAR N3 a summary for each patient reaching their annual review date. This print off includes information on:

Patients’ identification details Anticoagulant indication Target INR Time in Therapeutic Range (TRR) Most recent INR dosing dates and INR values

2. The form will be given to the GP who most often sees or knows the patient best.

3. The GP will be asked to review this information and other information they have about the patient and if satisfied that the anticoagulant can be reauthorized they need to make an entry in the record using the code

Annual warfarin Assessment (XaL33)

This entry will provide evidence that the GP has reauthorised the warfarin for a further year.

4. If the GP has concerns about the ongoing prescribing of warfarin they should arrange to discuss this with the clinic practitioner (e.g. low TTR value or a high bleed risk that now outweigh benefits of being on warfarin).

Annual review by the clinic clinician

When a patient reaches their annual review date the suitability for continuing warfarin or converting to an alternative agent should be accessed. Clearly it is not good practice to wait a whole year to check these things, they should be considered each time the patient is seen but if not already considered they should be assessed at the annual review:

Time in Therapeutic Range (TTR)

Number of DNAs and affect on ability to monitor INR safely

Any INRs > 8

Number of INRs > 5

Number of INRs < 1.5

In addition LFTs and U+Es should be requested if not recently measured.


hands should be washed: · web viewproduces a more rapid correction of the inr than oral vitamin k...

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