Hands should be washed: - Ashcroft Surgery (Bradford, UK)



952500Prescribing Support for Primary CareStandard Operating Procedure for Prescribing Support ServicesPrimary Care Anticoagulant ClinicOriginal document approved by;Dr Duncan Petty Version 1Date: April 2009Document reviewed and amended by; Dr Caroline DixonPSS Anticoagulation team service manager Su WoodPSS Clinical Quality DirectorVersion 6November 2015Approved by:Dr Duncan Petty Service Director PSS anticoagulant servicesReview Date:November 2016ContentsAims and ObjectivesAimObjectivesRoles and ResponsibilitiesHospitalGeneral practice anticoagulant service3.Patient Criteria3.1 Inclusion criteria3.2 Exclusion criteria4. Patient management4.1 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 versa5. Call and recall5.1.Frequency of monitoring5.2Referral in and out of clinic6. Training 7. Audit8. 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 washing9. Equipment Requirements10. Troubleshooting10.1 Incident Reporting10.2 Adverse events10.3 Holiday coverAppendicesAppendix 1 General Information on warfarin useAppendix 2 Aide Memoir for patients on anticoagulationAppendix 3 New Patient Initial Assessment FormAppendix 4 How to deal with a raised INRAppendix 5 Examples of Clinic LettersAppendix 6 Patient Satisfaction QuestionnaireAppendix 7 Warfarin Clinic ContactsAppendix 8 Home visit protocolAppendix 9 Warfarin initiation for patients with Atrial FibrillationAppendix 10 Warfarin reversal protocolAppendix 11 Protocol for switching from warfarin to a NOAC or vice versaAppendix 12 Audit report formsAppendix 13 Significant Event FormAppendix 14 Warfarin dose reminder chartAppendix 15 Bridging protocol-draft guidelines from BRIAppendix 16 Training logAppendix 17 Useful additional referencesAppendix 18 Clinic leafletAppendix 19 When should the INR be measured before a dental procedure?Appendix 20 Handwriting requirements for anticoagulant booklet instructionsAppendix 21 Sharing a patient’s record on SystmOneAppendix 22 Annual review1. Aims and ObjectivesAimTo 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. ObjectivesTo 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 GPsTo 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 ServiceTo 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 Criteria3.1 Inclusion CriteriaThe 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 CriteriaThe following patients will not be monitored by the Anticoagulation Service.Patients whoare pregnant or breast feeding (as coumarins are contraindicated)have suspected hypersensitivity or intolerance to anticoagulation are intravenous drug abusersare under 18 years of age4. Patient managementDetails of INR targets, warfarin doses and patient management using warfarin are given in Appendix 1.4.1. Patient assessmentAt 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 dosingDosing 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 resultsRecord 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 N3the 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 RecordsThe 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 visitINR target rangeMissed dosesRelevant notes of each visit including specific advice/education givenThe dose of anticoagulant to be taken until next clinic visitDate of next appointmentPatient’s hand held record (Yellow anticoagulant book)The following information should be recorded in the Patient’s hand held recordIndication for anticoagulationDuration of therapy (short or long-term)Therapeutic INR range/ target INRDose 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 includedDate of next appointmentTTR - if known (optional)4.5 Interacting drugs and foodsAll 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 GPThe 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 effectsAny problems with taking warfarin that cannot be resolvedAny new medicines prescribed that might interact with warfarin or increase bleed riskAny 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 informationPatients 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 cardPatient held information (yellow) bookletGeneral information about the safe use of warfarinThe 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/reenforced. The counselling should be comprehensive to ensure that patients are fully aware of their treatment and should include:The name of the drug and current dose; The reason they are taking the drug; Therapeutic goal and target range;The anticipated length of treatment;What to do in the event of a missed dose; Symptoms of under dose/overdose and action to take if these occur.Drug/drug and drug/food interactions; Clinic arrangements and how to obtain further medicine supplies.What to do if dental treatment/surgery is required.What to do if a surgical procedure is required/ indicated. 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 supplyWarfarin 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 upAt 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 appointmentsThis 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 protocol4.13 Warfarin reversal protocol-See Appendix 10 for protocol4.14 Protocol for switching from warfarin to a NOAC or vice versa – See Appendix 11 for protocol5. Call and recall1.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 belowWarfarin therapy: maximum recall periods during maintenance therapy.One INR highRecall in 7-14 days (stop treatment for 1-3 days) (maximum 1 week in prosthetic valve patients)One INR lowRecall in 7-14 daysOne INR therapeuticRecall in 7-14 daysTwo INRs therapeuticRecall in 2-4 weeks Three INRs therapeuticRecall in 4-6 weeks (maximum 6 weeks for prosthetic valve patients)Four INRs therapeuticRecall in 6-8 weeks. (maximum 6 weeks for prosthetic valve patients)Five or more INRs therapeuticRecall 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, 1207-1209When 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 clinicFrom a GPA 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 carePatients 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 knownThe 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 carePatients 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 clinicPatients 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. TrainingPractitioners running the service will have had training and be able to show competency in the following areas;Safe and effective use of anticoagulantsIndications and target ranges for anticoagulationSignificant drug/food and disease interactions and how these should be managedUse and calibration of Coagucheck XS Plus and the INR Star N3? equipment/ softwareRecord keepingKnowledge 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 proceduresIncident reporting AuditA 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 formsNPSA audit to be carried out six monthly.Benchmarking against BSH safety indicator set annuallyPatient satisfaction questionnaire to be carried out six monthlyWarfarin risk reduction audit to be carried out six monthlySix monthly report to be submitted by all Providers to the Commissioner8. Quality Control and Safety8.1 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 - ExternalNational 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:observe fully conditions regarding the fair collection and use of personal information;meet our legal obligations to specify the purpose for which information is used;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;ensure the quality of information used;apply strict checks to determine the length of time information is held;shall be accurate and where necessary, kept up to date;shall not be kept for longer than is necessary for that purpose or those purposes;shall be processed in accordance with the rights of data subjects under the Act;shall be kept secure i.e. protected by an appropriate degree of security;In addition, we will ensure that:everyone managing and handling personal information understands that they are contractually responsible for following good data protection practice;methods of handling personal information are regularly assessed and evaluated;8.4 Equipment StorageTest 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 MachineThe 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 washingHands 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 RequirementsCoagu-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 access10.Troubleshooting10.1 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 CQC10.2 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 therapyWarfarinWarfarin 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).INRThe 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. ?(?) x?INR =Patient prothrombin time Control prothrombin time ISI????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 treatmentThe target INR and duration of therapy depends on the indication for anticoagulation.Table 1IndicationINR Range*Recurrent DVT2-3Recurrent PE2-3Treatment of TIA2-3Prophylaxis in mechanical heart valves3-4.5Prophylaxis in AF2-3Bradford Royal Infirmary Guidelines* This may vary depending on the referring consultant/GPWarfarin 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 2Warfarin therapy: maximum recall periods during maintenance therapyOne INR highRecall in 7-14 days (stop treatment for 1-3 days) (maximum 1 week in prosthetic valve patients)One INR lowRecall in 7-14 daysOne INR therapeuticRecall in 7-14 daysTwo INRs therapeuticRecall in 2-4 weeks Three INRs therapeuticRecall in 4-6 weeks (maximum 6 weeks for prosthetic valve patients)Four INRs therapeuticRecall in 6-8 weeks. (maximum 6 weeks for prosthetic valve patients)Five or more INRs therapeuticRecall 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, 1207-1209When 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 controlThe following information is for reference only and is not exhaustive.Drug interactionsA 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 INRTable 3Increase in INRDecrease in INRLiver dysfunction/ Cholestasis/ Biliary ObstructionHeart FailureHyperthyroidismInfection/ PyrexiaRenal FailureMalnutrition/ Weight LossCarcinoma/Radiation TherapyHypothyroidismDiabetes mellitusOedemaHyperlipidemiaMissed dosesMissed 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.AlcoholAlcohol 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.IllnessIllness, 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 BleedingIt 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 tractThe 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 clinicDetailsCommentsAny IssuesNameD/O/BNHS NumberReason for anticoagulantDrug and DoseCurrent tablets (colour) takenTherapeutic Goal/target rangeAnticipated Length of TreatmentWhat to do if a dose is missedSymptoms to look out forDrug/Food interactions How to obtain further medicine suppliesAdvice if having dental treatment or surgeryWho to contact if worries or concernsDo you have a Yellow Information BookletRISK ASSESSMENT FOR INDIVIDUALS NEEDING ANTICOAGULATION- use on first visit and then when necessaryNAME.D.O.BADDRESSGP.NHS NO.ICS NO.VISIONYES (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 managementCOGNITIONDoes 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 managementSignature of AssessorDate risk assessment completedAppendix 3:Aide Memoir for patients on anticoagulation- to use at each clinic visitYES (Please tick)NO (Please tick)FURTHER DETAILSHave 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 developedany unexpected bleeding or potential side effectsany problems with taking warfarin any new medicines prescribed that might interact with warfarin or increase bleed riskany change in lifestyle and/or occupationany change in their ability to take medicines safely e.g. cognition, vision changesany future planned dental or surgical proceduresany missed dosesany extra dosesAppendix 4: How to deal with raised INRs and bleedsN.B.When INR > 5 repeat the testMajor Bleeding1Inform 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 bleedingConsult 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.3Give 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 <5.0INR 5.0-8.0Minor bleedingConsult 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.5Recheck INR at 24hr Restart warfarin when INR < 5.0INR 5.0 - 8.0No bleedingConsult 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 < 5.0INR > 3.0 and <5.0 (target 2.5) orINR >4.0 and < 6.0 (target 3.5) and No bleedingReduce 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 reductionNOTES: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 LetterheadDear 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 sincerelyPrimary Care Anticoagulation Clinic PractitionersPatient Consent letter: City CCGPractice LetterheadConsent 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 0NXDate 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 appropriateSigned …………………………………………………………..Date ……………………………………………………………..Please return this form to your doctor’s surgeryPatient Consent letter: District CCGPractice LetterheadConsent 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 appropriateSigned …………………………………………………………..Date ……………………………………………………………..Please return this form to your surgeryLetter to prescriber re. discontinuation of warfarin treatmentPractice LetterheadDear 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:WarfarinDiagnosis: FORMTEXT ?????Target INR Range: FORMTEXT ?????Duration: FORMTEXT ?????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 SurgeryTransfer of anticoagulation care from secondary to primary care letter;Practice letterheadPharmacy Anticoagulant ClinicSt Lukes HospitalLittle Horton LaneBradfordBD5 0NADear ColleagueRe. 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 ClinicPatient’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 toUndercliffe Health Centre FORMCHECKBOX Whetley Medical Centre FORMCHECKBOX Dr Gilkar (Little Horton Lane) FORMCHECKBOX c/o Prescribing Support ServicesWindhill Green Medical PracticeThackley Old Road, Shipley BD181QBTel: 01274 800821 Fax: 01274 738981Patient’s detailsNHS Number: Hospital number: FORMTEXT ?????Ethnicity:English Speaker? YES FORMCHECKBOX NO FORMCHECKBOX Name:DOBAddress:TelPostcode:MobHome visit required? NO FORMCHECKBOX YES FORMCHECKBOX Patient’s GPNameTelAddressFaxPostcodeRisk factors identifiedLiver function FORMCHECKBOX Renal function FORMCHECKBOX Impaired memory or cognition FORMCHECKBOX Falls FORMCHECKBOX Alcohol units/week FORMCHECKBOX Adherence with treatment FORMCHECKBOX Adherence with appointments FORMCHECKBOX Current/History of drug abuse FORMCHECKBOX Planning for pregnancy FORMCHECKBOX Treatment DetailsUrgent referral to be seen within 5 days NO FORMCHECKBOX YES FORMCHECKBOX Non urgent referral to be seen within 14 days NO FORMCHECKBOX YES FORMCHECKBOX INR Range???????????????????????????? Please tick2.0 to 2.5 ??????????????????????????????? FORMCHECKBOX 2.0 to 3.0???????????????????????????????? FORMCHECKBOX 3.0 to 4.5???????????????????????????????? FORMCHECKBOX Other-please specify range????? ……………………..?Indication for anticoagulation is:Treatment (DVT)??????????????????? FORMCHECKBOX Prophylaxis (High risk surgery)??? ? ? FORMCHECKBOX Treatment (PE)????????????????? ????? FORMCHECKBOX Proph.(Hip/fractured femur surgery) FORMCHECKBOX Treatment (Recurrent DVT)?? FORMCHECKBOX Prophylaxis (Mech heart valves)? ??? FORMCHECKBOX Treatment (Recurrent PE)????? FORMCHECKBOX Prophylaxis (Atrial Fibrillation)?? ????? FORMCHECKBOX Treatment of TIA??????????????????? ? FORMCHECKBOX Other (please specify) ……………….?Maintain anticoagulation for the next;…………. weeks??? ……… months?????????? Long term (with an annual review)?? [?? ]Concurrent treatment with antiplateletsNot applicable FORMCHECKBOX Name antiplatelet’s that are to continue with anticoagulant Antiplatelet(s) ……………………………. Duration ………………………..Indication ………………………………….Recent Warfarin TherapyDate FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????INR FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Dose FORMTEXT ?????mg FORMTEXT ?????mg FORMTEXT ?????mg FORMTEXT ?????mg FORMTEXT ?????mgShared Record consent obtained NO FORMCHECKBOX YES FORMCHECKBOX ReferrerNameClinic/Practice/Hospital stamp:Tel: Fax: SignatureReferral dateReceived: ___ / ___ / ___Referral toAshcroft FORMCHECKBOX Bowling Hall FORMCHECKBOX Horton Bank FORMCHECKBOX Leylands FORMCHECKBOX Oak Glen FORMCHECKBOX Saltaire FORMCHECKBOX Wibsey and Queensbury FORMCHECKBOX Ashwell FORMCHECKBOX Farrow FORMCHECKBOX Idle FORMCHECKBOX Moorside FORMCHECKBOX Rockwell/Wrose FORMCHECKBOX Springfield FORMCHECKBOX Windhill Green FORMCHECKBOX Bingley FORMCHECKBOX Highfield FORMCHECKBOX Low Moor FORMCHECKBOX Newton Way FORMCHECKBOX Rooley Lane FORMCHECKBOX Tong FORMCHECKBOX c/o Prescribing Support SerrvicesWindhill Green Medical PracticeThackley Old Road, Shipley BD181QBTel: 01274 800 821 Fax: 01274 738981Patient’s detailsNHS Number: Hospital number: FORMTEXT ?????Ethnicity:English Speaker? YES FORMCHECKBOX NO FORMCHECKBOX Name:DOBAddress:TelPostcode:MobHome visit required? NO FORMCHECKBOX YES FORMCHECKBOX Patient’s GPNameTelAddressFaxPostcodeRisk factors identifiedLiver function FORMCHECKBOX Renal function FORMCHECKBOX Impaired memory or cognition FORMCHECKBOX Falls FORMCHECKBOX Alcohol units/week FORMCHECKBOX Adherence with treatment FORMCHECKBOX Adherence with appointments FORMCHECKBOX Current/History of drug abuse FORMCHECKBOX Planning for pregnancy FORMCHECKBOX Treatment DetailsUrgent referral to be seen within 5 days NO FORMCHECKBOX YES FORMCHECKBOX Non urgent referral to be seen within 14 days NO FORMCHECKBOX YES FORMCHECKBOX INR Range???????????????????????????? Please tick2.0 to 2.5 ??????????????????????????????? FORMCHECKBOX 2.0 to 3.0???????????????????????????????? FORMCHECKBOX 3.0 to 4.5???????????????????????????????? FORMCHECKBOX Other-please specify range????? ……………………..?Indication for anticoagulation is:Treatment (DVT)??????????????????? FORMCHECKBOX Prophylaxis (High risk surgery)??? ? ? FORMCHECKBOX Treatment (PE)????????????????? ????? FORMCHECKBOX Proph.(Hip/fractured femur surgery) FORMCHECKBOX Treatment (Recurrent DVT)?? FORMCHECKBOX Prophylaxis (Mech heart valves)? ??? FORMCHECKBOX Treatment (Recurrent PE)????? FORMCHECKBOX Prophylaxis (Atrial Fibrillation)?? ????? FORMCHECKBOX Treatment of TIA??????????????????? ? FORMCHECKBOX Other (please specify) ……………….?Maintain anticoagulation for the next;…………. weeks??? ……… months?????????? Long term (with an annual review)?? [?? ]Concurrent treatment with antiplateletsNot applicable FORMCHECKBOX Name antiplatelet’s that are to continue with anticoagulant Antiplatelet(s) ……………………………. Duration ………………………..Indication ………………………………….Recent Warfarin TherapyDate FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????INR FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Dose FORMTEXT ?????mg FORMTEXT ?????mg FORMTEXT ?????mg FORMTEXT ?????mg FORMTEXT ?????mgShared Record consent obtained NO FORMCHECKBOX YES FORMCHECKBOX ReferrerNameClinic/Practice/Hospital stamp:Tel :Fax: SignatureReferral dateReceived: ___ / ___ / ___0-126365Prescribing Support for Bradford CCGs Acceptance of patient from secondary care into primary care clinic letter;Practice LetterheadDatePharmacy Anticoagulant ClinicSt Lukes HospitalLittle Horton LaneBradfordBD5 0NAPharmacy Anticoagulant ClinicAiredale General HospitalSkipton RoadSteaton RoadKeighleyBD20 6TDDear ColleagueRe. …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 PractitionerReferral back to secondary care letter;Practice LetterheadDatePharmacy Anticoagulant ClinicSt Lukes HospitalLittle Horton LaneBradfordBD5 0NADear ColleagueRe. …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 ClinicWe confirm that we have accepted the patient named below back into the Anticoagulant Clinic held at St Luke’s HospitalPatient’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 clinicBefore the appointmentAre appointments available at a day convenient to you? YES FORMCHECKBOX NO FORMCHECKBOX If NO, what would be a better day ? ………………………………………………Are appointments available at a time convenient to you? YES FORMCHECKBOX NO FORMCHECKBOX If NO, what would be a better time? ………………………………………………Do you find the GP surgery based clinic more convenient than the hospital clinic?YES FORMCHECKBOX (add a reason)………………………………………………………………………NO FORMCHECKBOX (add a reason)………….…………………………………………………………..At the appointmentAppointment time-were you seen on time YES FORMCHECKBOX NO FORMCHECKBOX or within5 10 15 20 25 30 minutes of your appointment time?Is the amount of waiting time acceptable for you? YES FORMCHECKBOX NO FORMCHECKBOX If your appointment time was delayed (by more than 10 minutes) were you told why you had to wait?YES FORMCHECKBOX NO FORMCHECKBOX Appointment was not delayed FORMCHECKBOX How do you find the length of time for this appointment?Not long enough FORMCHECKBOX Just about right FORMCHECKBOX Too long FORMCHECKBOX During your appointment, did you have enough time to ask questions? YES FORMCHECKBOX NO FORMCHECKBOX I did not need to ask any questions FORMCHECKBOX During your appointment did you feel you were given enough information/advice? YES FORMCHECKBOX NO FORMCHECKBOX If no, what would you have liked advice on? If you were given advice, was the advice given clear and understandable? YES FORMCHECKBOX NO FORMCHECKBOX After the appointmentWere you satisfied with the arrangements made for your follow up appointment?Very satisfied FORMCHECKBOX Satisfied FORMCHECKBOX Not very satisfied FORMCHECKBOX Not satisfied FORMCHECKBOX I was uncertain about the follow up arrangements FORMCHECKBOX How long have you used this anticoagulant monitoring service?Less than one month FORMCHECKBOX 1-6 months FORMCHECKBOX 6-12months FORMCHECKBOX 12-18months FORMCHECKBOX 18-24 months FORMCHECKBOX more than 2 years FORMCHECKBOX General questionsHow would you rate the care you received at the clinic?Poor FORMCHECKBOX Fair FORMCHECKBOX Good FORMCHECKBOX Very good FORMCHECKBOX Excellent FORMCHECKBOX Did you find the Reception staff helpful?Not at all helpful FORMCHECKBOX Not very helpful FORMCHECKBOX Helpful FORMCHECKBOX Very helpful FORMCHECKBOX Did you find the Clinic practitioner helpful?Not at all helpful FORMCHECKBOX Not very helpful FORMCHECKBOX Helpful FORMCHECKBOX Very helpful FORMCHECKBOX What do you like about the clinic?Location FORMCHECKBOX Easy to park FORMCHECKBOX Friendly staff FORMCHECKBOX Waiting time FORMCHECKBOX Length of appointment time FORMCHECKBOX Being able to ask questions FORMCHECKBOX Quality of advice FORMCHECKBOX Support material provided FORMCHECKBOX 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 onlyXXXX Anticoagulation clinicQuestions 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? ............................ weeksDid you understand the explanation of what was wrong with you? YES FORMCHECKBOX NO FORMCHECKBOX Any comments .............................................................................................................Was your need for anticoagulation therapy explained to you? YES FORMCHECKBOX NO FORMCHECKBOX Any comments .............................................................................................................Were the possible side effects of treatment(s) explained in a way you could understand? YES FORMCHECKBOX NO FORMCHECKBOX Any comments .............................................................................................................Were you involved as much as you wanted to be in decisions about which treatment(s) you would have? YES FORMCHECKBOX NO FORMCHECKBOX Any comments .............................................................................................................Do you feel supported to manage your Warfarin treatment? YES FORMCHECKBOX NO FORMCHECKBOX Any comments .............................................................................................................Before the appointmentAre appointments available at a day convenient to you? YES FORMCHECKBOX NO FORMCHECKBOX If NO, what would be a better day ? ………………………………………………Are appointments available at a time convenient to you? YES FORMCHECKBOX NO FORMCHECKBOX If NO, what would be a better time? ………………………………………………Do you find the GP surgery based clinic more convenient than the hospital clinic?YES FORMCHECKBOX (add a reason)………………………………………………………………………NO FORMCHECKBOX (add a reason) ……….…………………………………………………………….At the appointmentAppointment time-were you seen on time YES FORMCHECKBOX NO FORMCHECKBOX or within 5 10 15 20 25 30 minutes of your appointment time?Is the amount of waiting time acceptable for you? YES FORMCHECKBOX NO FORMCHECKBOX If your appointment time was delayed (by more than 10 minutes) were you told why you had to wait?YES FORMCHECKBOX NO FORMCHECKBOX Appointment was not delayed FORMCHECKBOX How do you find the length of time for this appointment?Not long enough FORMCHECKBOX Just about right FORMCHECKBOX Too long FORMCHECKBOX During your appointment, did you have enough time to ask questions? YES FORMCHECKBOX NO FORMCHECKBOX I did not need to ask any questions FORMCHECKBOX During your appointment did you feel you were given enough information/advice? YES FORMCHECKBOX NO FORMCHECKBOX If no, what would you have liked advice on? If you were given advice, was the advice given clear and understandable? YES FORMCHECKBOX NO FORMCHECKBOX After the appointmentWere you satisfied with the arrangements made for your follow up appointment?Very satisfied FORMCHECKBOX Satisfied FORMCHECKBOX Not very satisfied FORMCHECKBOX Not satisfied FORMCHECKBOX I was uncertain about the follow up arrangements FORMCHECKBOX How long have you used this anticoagulant monitoring service?Less than one month FORMCHECKBOX 1-2 months FORMCHECKBOX 2-3months FORMCHECKBOX General questionsHow would you rate the care you received at the clinic?Poor FORMCHECKBOX Fair FORMCHECKBOX Good FORMCHECKBOX Very good FORMCHECKBOX Excellent FORMCHECKBOX Did you find the Reception staff helpful?Not at all helpful FORMCHECKBOX Not very helpful FORMCHECKBOX Helpful FORMCHECKBOX Very helpful FORMCHECKBOX Did you find the Clinic practitioner helpful?Not at all helpful FORMCHECKBOX Not very helpful FORMCHECKBOX Helpful FORMCHECKBOX Very helpful FORMCHECKBOX What do you like about the clinic?Location FORMCHECKBOX Easy to park FORMCHECKBOX Friendly staff FORMCHECKBOX Waiting time FORMCHECKBOX Length of appointment time FORMCHECKBOX Being able to ask questions FORMCHECKBOX Quality of advice FORMCHECKBOX Support material provided FORMCHECKBOX 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 GroupClinicianContact NumberE-mail addressClinic detailsCaroline Dixon07941258046dxn200@caroline.dixon@bradford.nhs.ukWrose- Monday 8.30-12.30Debbie Scanlon07902494224d.scanlon@Leylands/ Wibsey/ Queensbury/Dr Gilkhar/TongLorna Moor07715541362L.moor@Bowling HallRooley LaneBingleySpringfieldOak GlenSamina Ashraf07737158663Samina.ashraf@bradford.nhs.ukHighfield City practices Ashwell FarrowBerny Hutton0793279460001274637076 (Ashcroft surgery)Berny.hutton@bradford.nhs.ukAshcroft- Tuesday 1-6Elector Shamba0781052364707725764631Shamba81@Low MoorHorton Bank Thursday amTracey Gaston01274237583tracey.gaston@bradford.nhs.ukCatherine Kniveton01274-64357607853335748 catherine.kniveton@ bradford.nhs.ukMoorside Surgery Tues and Weds 9-12.15Sarah Harrison01274-643576sarah.harrison@bradford.nhsukMoorside Surgery Thurs 9-12.15Anita VoseAnita_vose@Helena CatleyHelena.catlin@bradford.nhs.ukKilmeny Surgery Thurs amSarah Benn07980451306Sarah.benn@bradford.nhs.ukWindhill Surgery Tuesday+ Wed am BaildonHelen Wilson07796951034Helena.wilson2@ bradford.nhs.ukMayfield Medical CentreIsha Hussain07771347178Isha.hussain@ bradford.nhs.ukDr Wilson +PartnersNoshi Iqbal07515278437Noshi.iqbal@bradford.nhs.ukImran Ashraf07984561359Imran_ashraf01@ Imran.ashraf@bradford.nhs.ukIdle medical Practice Fridays 9-6Clarence Ricketts07956659550rickettsclarence@Haworth Medical CentreAQP self delivery site anticoagulant cliniciansPracticeNurseGPSaltaireNAAsma FaruqueIan LivingstoneNewton WayElaine ThompsonCarol WaringCarolyn GomersallStephen PattersonWindhillSarah BennJane PettyMoorsideCatherine KnivetonAnita VoseJohn SullivanRockwell and WroseAlison Kaye? Karen Morley Derek ParkerPSS adminRuth Asher HYPERLINK "mailto:ruthasher@"ruthasher@ Anticoagulation helpline number- 01274-800821Other useful numbersProviderAddressNumbersPSS Help line01274 800821Emily SmithPharmacy Anticoagulant clinicAiredale General HospitalPharmacy Anticoagulant clinicAiredale General HospitalSkipton RoadSteeton BD20 6TD01535 652511Emily’s bleep 3266Emily.smith@anhst.nhs.ukWarfarin.agh@nhs.ukStan DobranskiSt LukesBRI-bleepSt Lukes hospital clinic01274-382474stan.dobrzanski@bthft.nhs.ukAppendix 8: Home visit protocol-IntroductionThe 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. SafetyThe 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 valuesOnce 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 visitIf 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 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.The patient’s previous and current medical history for any contraindications or risks to starting warfarin therapy should be checked.The patient’s current medication regimen for any potential drug interactions should be checked.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.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.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. 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 SettingIn 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. 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 rmation taken from Xarelto (Rivaroxaban SPC)Converting from Vitamin K Antagonists (VKA) to Xarelto/RivaroxabanFor 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 rmation taken from Eliquis/Apixaban SPCSwitching from Vitamin K antagonist (VKA) therapy to Eliquis/ApixabanWhen 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 therapyWhen 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 FormsAudit report forms to be finalised but will include;Patient Satisfaction Questionnaire (Appendix 6)Quarterly report to Commissioners, which will include information on;IndicatorIndicator DescriptionThe following parameters are the suggested quarterly indicators for providers to report to commissioners with (where appropriate) suggested achievement percentagesTotal number of patients monitored for INRPercentage of cohort and indications for treatment (eg 70% AF etc)Annual point prevalence and TTR averagePercentage/number of patients who require referral back to acute care and clinical reason for referralPercentage/number of bleeding episodes that require admission or referral to acute carePercentage of patients whose INR is over or under 0.5 of their targetPercentage of patients with a consistently high INR of >5.0Percentage of patients with and INR >8 Percentage of patients who DNA versus total population of patients treated?Number of recorded critical incidents/untoward eventsThe provider must be able to benchmark the performance of the service against the British Committee for Standards in Haematology safety indicator setBenchmarking must be able to compare the service to other providersMean % time in range >72% Point prevalence >70%28Referral to treatment time as indicated in section 2.4 of the Service Specification (see Schedule 2 The Services; A Service Specification)Service outcomesPercentage of patients with a record that they are taking their anticoagulation treatment as prescribedAll INR monitoring and any events as a result of test outcomes to be recorded within the patient’s healthcare recordsSecure 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 alteredIn 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 NPSAProvider to record the percentage of patients provided with written information about managing their INR level and offered ongoing education and supportBi-annual or annual report will include;IndicatorIndicator DescriptionFrequencyThe following parameters are the suggested quarterly indicators for providers to report to commissioners with (where appropriate) suggested achievement percentagesSix-monthly record to be made of the NPSA (or equivalent) auditBi-annually Service delivery Number of home visits per year as a percentage of the total number of patients treated with anticoagulationAnnual 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-template safety alert 18Actions that can make anticoagulant therapy saferAudit checklistDate:Audit checklist prepared by:Name of organisation:1. Review of training and competenceRecommended actionSuggested evidenceAssessment Comment/further action requiredEnsure 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 pliance ornon-compliance2. Procedures and clinical protocolsRecommended actionSuggested evidence Compliance (Yes/No)Comment/further action requiredHealthcare 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.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 productsPromotion 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.3. Audit of safety indicatorsRecommended indicatorSuggested evidence Audit resultComment/further action requiredSafety indicators for patients starting oral anticoagulant treatmentPercentage 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. Results from anticoagulant clinic(s) over 12 months.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.Results from anticoagulant clinic(s) over 12 months.Safety indicators for patients established on oral anticoagulant treatmentProportion of patient-time in range or percentage of INRs. Results from monitoring service over 12 months.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).Results from monitoring service over 12 months.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 of process management for identifying patients lost to follow-up).Results from anticoagulant clinic(s) over 12 months.Percentage of patients with unknown diagnosis, target INR or stop date.Results from anticoagulant clinic(s) over 12 months.Percentage of patients with inappropriate target INR for diagnosis, high and low.Results from anticoagulant clinic(s) over 12 months.Percentage of patients without written patient educational information.Results from anticoagulant clinic(s) over 12 months.Percentage of patients without appropriate written clinical information, e.g. diagnosis, target INR, last dosing record.Results from anticoagulant clinic(s) over 12 months4. Review of patient safety incident data involving anticoagulants for preceding 12 monthsClinical outcomeNumber of reportsDeathSevere (permanent harm)Moderate (significant, but not permanent harm, requiring increase in treatment)Low (temporary harm, requiring extra observation or minor treatment)No harmTotalType of reportNumber of reportsPrescribingDispensing/medicine preparation AdministrationMonitoringTotalType of incidentNumber 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 directionsOtherTotal5. Overall comments and actions recommended by Drugs and Therapeutics CommitteeSignature of Drugs and Therapeutics Committee Chair:Name of Drugs and Therapeutics Committee Chair:Date: Next review date:Anticoagulant risk reduction audit (PSS protocol) Anticoagulant risk reduction - report formObjectives: To reduce the risk of adverse effect to the patient when prescribing anticoagulantsRationale/ 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 etcProcess: 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 homeNumber with a Dosette boxNumber on concurrent interacting drugsNumber referred back to the warfarin clinic. Any other criteria recorded:Appendix 13:Significant event and ‘near miss’ analysisSummary & 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' Analysis1. 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 OtherPlease 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 TUESWEDTHURSFRISATSUNMONTUESWEDTHURSFRISATSUNMONTUESAppendix 15: Draft bridging protocol guidelines-BRI- June 201417. PERI-OPERATIVE ANTI-COAGULATIONOral anticoagulants are frequently prescribed for long-term prevention of venous or arterial thromboembolism for at risk patientsIn the peri-operative period risks and consequences of thrombosis need to be weighed against risk and consequences of excess perioperative and postoperative bleedingThere are 3 options for the peri-operative management of anti-coagulantsContinue 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)Temporary cessation of anticoagulation for a period pre- and post-operativelyTemporarily withhold warfarin or other novel oral anticoagulants pre-operatively, bridging anticoagulation therapy with LMWH or IV HeparinThe option chosen is determined byThe primary indication for anticoagulation and risk assessment of thromboembolismThe type of procedure or surgery The risk of perioperative bleedingPre-operative bridging carries a low risk of bleeding, but use of post-operative bridging carries high risk of bleeding and requires careful considerationIn high bleeding risk surgery it is recommended that post-operative bridging is not commenced until at least 48hrs postoperativelyA 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 HYPERLINK "mailto:susan.smith@bthft.nhs.uk"susan.smith@bthft.nhs.uk 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 procedureAdmitting wardConsultant Patient’s weightAdvise who plan and notes should be returned toRISK ASSESSMENT OF ANTI-COAGULATED PATIENTS UNDERGOING ELECTIVE SURGERYReason for anti-coagulationHigher thrombosis riskMedium thrombosis riskLower thrombosis riskAtrial fibrillationCHADS2 scoreCongestive failure = 1 pointHypertension = 1 pointAge > 75 years = 1 pointDiabetes = 1 pointStroke/TIA = 2 pointsCVA/TIA < 3 mths agoCHADS2 score 5-6Rheumatic valvular heart diseaseCHADS2 score 0-4 (NO previous CVA/TIA)Mechanical heart valves (MHV)All prosthetic mitral valvesCaged ball or tilting disc aortic valve (prosthetic)CVA/TIA in last 6 monthsBi-leaflet aortic valve with any risk factor for stroke AFHPTCVA/TIADiabetes>75 yearsBi-leaflet aortic valve with NO risk factors for stroke and >3 months post insertionVenous thromboembolismVTE < 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 haematologistRecurrent VTE whilst anti-coagulated i.e. INR range 3-4Active cancer with VTE < 6 mths agoVTE previous 3-12 mthsRecurrent VTE VTE > 12 months ago with NO other risk factorsPERI-OPERATIVE RECOMMENDATIONS FOR ANTI-COAGULATION AGENTS WARFARIN PRE-OPERATIVEWhen to stop pre-operativelyBridging anti-coagulationHigher thrombosis riskMedium thrombosis riskLower thrombosis risk5 days prior to procedureD6 pre-op = last dose warfarinD5 pre-op = warfarin stopped D3 pre-op check INRstart Therapeutic dose LMWH when INR below lower end of target range – give at 5pmD2 pre-op = therapeutic dose LMWH at 5pmD1 pre-op = prophylactic dose LMWH at 5pm(needs to be minimum 12 hours prior to spinal/epiural)D0 = no LMWH pre-op; Check INR<1.5D6 pre-op = last dose warfarinD5 pre-op = warfarin stoppedD3 pre-op = start prophylactic dose LMWH at 5 pmD2 pre-op = prophylactic dose LMWH at 5pmD1 pre-op = prophylactic dose LMWH at 5pm(needs to be minimum 12 hours prior to spinal/epiural)D0 = no LMWH pre-op; Check INR<1.5Stop warfarin but NO pre-operative LMWH bridging requiredWARFARIN POST-OPERATIVEPOST OPERATIVEHIGH BLEED RISK MAJOR SURGERYHigher AND Medium Thrombosis RiskLower thrombosis riskDelay starting LMWH until haemostasis securedD0 = prophylactic dose LMWH 6-12 hours post opD+1 post op = prophylactic dose LMWH at 5pmD+2 post-op = start therapeutic dose LMWH at 5pm in a split twice daily regimen (i.e. ? full dose BD)D+3 post op = restart warfarin give 2x usual patient dose (max. 10mg warfarin) Continue split therapeutic dose LMWHD+4 post op = give warfarin patient usual dose and check INR dailyContinue split therapeutic dose LMWH until INR >2 for 2days Check daily INREnsure anticoagulation clinic booked on dischargeDelay starting LMWH until haemostasis securedD0 = prophylactic dose LMWH 6-12 hours post opD+1 post op= prophylactic dose LMWH at 5pmD+2 post op = prophylactic dose LMWH at 5pmD+3 post op = restart warfarin give 2x usual patient dose (max. 10mg warfarin)Prophylactic dose LMWH at 5pmD+4 post-op = give warfarin patient usual dose and check INR dailyprophylactic dose LMWH at 5pmcontinue prophylactic dose LMWH until INR >2 for 2 daysCheck daily INREnsure anticoagulation clinic booked on dischargePOST OPERATIVELOW BLEED RISK MINOR SURGERYHigher AND Medium Thrombosis riskLower Thrombosis Risk5 days prior to procedureDelay starting LMWH until haemostasis securedD0 = prophylactic dose LMWH 6-12 hours post opD+1 post op = restart warfarin give 2x usual patient dose (max. 15mg warfarin)Prophylactic dose LMWH at 5pmD+2 post-op = give warfarin patient usual dosetherapeutic dose LMWH at 5pm D+3 post op =give warfarin as per INR Continue therapeutic dose LMWH until INR >2 for 2 daysCheck daily INRConsider discussing with anticoagulation clinic to help early discharge with monitoring INR while on LMWHBook anticoagulation clinic on dischargeDelay starting LMWH until haemostasis securedD0 = prophylactic dose LMWH 6-12 hours post opD+1 post op = restart warfarin give 2x usual dose (max.15mg warfarin)Prophylactic dose LMWH at 5pmD+2 post-op = give warfarin patient usual dose and continue this dose dailyProphylactic dose LMWH at 5pmD+3 to D+7 post op = continue prophylactic dose LMWHCheck has anticoagulation clinic booked on D+3 to D+7 post operativeNote: Patients can be discharged on D0 if considered appropriate by the surgical team and patient able to follow postoperative anticoagulation planBook anticoagulation clinic on dischargeDABIGATRANStop Dabigatran before elective surgeryRenal function (CrCl mL/min)High risk of bleeding or major surgery or neuraxial blockStandard risk of bleeding or no neuraxial block≥8050 – 7930 -49<302 days pre-operatively3 days pre-operatively4 days pre-operativelyDabigatran contraindicated24 hours pre-operatively24 – 48 hours pre-operatively48 – 72 hours pre-operativelyDabigatran contraindicatedCheck clotting screen and thrombin time (TT) on day of surgery RIVAROXABAN and APIXIBANStop before elective surgeryRenal function (CrCl mL/min)High risk of bleeding or major surgery or neuraxial blockStandard risk of bleeding or no neuraxial block>3015-30<152 days pre-operatively3 days pre-operativelycontraindicated24 hours pre-operatively48 hours pre-operativelycontraindicatedCheck clotting screen on day of surgery Therapeutic LMWHHigh risk of bleeding or major surgery or neuraxial blockStandard risk of bleeding or no neuraxial blockLast full therapeutic dose Day 2 pre-operatively at 5pm (i.e. >48 hours previous)Give Prophylactic dose Day 1 pre-operatively at 5 pmLast full therapeutic dose 24 hours pre-operativelyUnfractionated Heparin infusionStop 6 hours pre-operatively on day of surgeryCheck APTT 2 hours pre-operativelyGuideline produced by Dr S Ackroyd (Consultant Haematologist) and Dr S Kitzinger (Consultant Anaesthetist)Guideline agreed by Thrombosis Committee Nov 2013REFERENCESKeeling D et al, Guidelines on oral anticoagulation with warfarin – fourth edition. BJH 2011, 1365-2141Douketis JD. Perioperative management of patients who are receiving warfarin therapy: an evidence-based approach and practical approach. Blood 2011, 117 (19): 5044-9Management of perioperative anticoagulation in adult elective surgery. Betsi Cadwaladr University Health Board: Anaesthetics, critical care and pain management CPG – Pre-operative assessment clinicGuidelines for the perioperative management of oral anticoagulation in patients undergoing elective procedures. Leeds Teaching Hospitals NHS Trust. July 2012.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. 16:Example Training Log- DateActivity20.7.11Peer support group meeting15.9.11Fire safety and Health and Safety training21.9.11Peer support group meeting22.9.11Pharmacy team meeting29.9.11CPR training19.10.11Pharmacy team meeting16.11.11Peer support group meeting17.11.11Pharmacy team meeting14.12.11Pharmacy team meeting18.1.12Peer support group meeting23.2.12Pharmacy team meeting14.3.12Peer support group meeting14.3.12Pharmacy team meeting17.4.12Pharmacy team meeting16.5.12Peer support group meetingMay 2012PCT visit from Tracey GastonMay 2012Pharmacy team meeting14.6.12CPD passed by GPhC21.6.12Pharmacy team meetingJune 2012Clinic training with Imran AshrafJuly 2012Coagucheck training-update session17.7.12Peer support group meeting26.7.12PLT session with Leylands GPs13.9.12Pharmacy team meeting14.9.12Clinic training with Imran Ashraf19.9.12Peer support group meeting21.9.12Clinic training with Imran Ashraf4.10.12CPR update10.10.12CCG accreditation completed for 3 years21.11.12Peer support group meeting5.2.1360 minute Make over-Anticoagulation in AF-Mercure Hotel, Bradford6.2.13Stroke and TIA-Crow Trees Primary Care Training Centre2.3.13Anticoagulation-Ensuring Good Care-Leeds Met University20.3.13Peer support group meeting24.4.13AF-Quality Improvement education event-Douglas Mill16.5.13Peer support group meetingJuly 2013Peer support group meetingSept 2013Peer support group meeting2.10.13OAC decision support clinics- Kathryn Griffith20.11.13CPWY meeting – Anticoagulation and thrombosis- Katherine Stirling-Leeds Teaching hospital23.11.13Practicalities of using the NOACs for Stroke prevention in AF-Nicholas Hough-BMS- evening Peer Support group meetingDec 2013Leylands stroke risk management clinicsJan 2014Peer support group meetingFeb 2014Moorside stoke risk management clinics26.2.14Stroke prevention and AF Meeting- Dr Youssef BeainiMarch 2014Stroke risk clinics –feedback to Moorside SurgeryMarch 2014Peer support group meeting-Apixaban medical information representative21.5.14Apixaban for the prevention of Stroke in Non-valvular AF- Dr Youssef BeainiJune 5/6 2014University of Birmingham Anticoagulation Conference9.7.14Peer support group meetingOngoingOngoing discussions during clinics with Catherine Kniveton-Moorside surgeryOngoingOngoing discussions during clinics with Berny Hutton-Ashcroft surgeryAppendix 17:Useful references;Oxford Haemophilia and Thrombosis Centre Protocols for out-patient oral anticoagulation with Vitamin K antagonists. 18: Patient information about the clinicAdd a leaflet to your copy of the SOPAppendix 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 instructionsEstablished 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: 5.5mg dailyTake 5.5mg every day (One PINK and one WHITE)4mg for 5 days and 3.5mg for 2 daysTake 4mg Monday to Friday (one BLUE and one BROWN) and 3.5mg on Saturday and Sunday (one BLUE and one WHITE)2mg for 6 days and 3mg for 1 dayTake 2mg every day (Two BROWN) EXCEPT 3mg every Sunday (One BLUE)Appendix 21: Sharing a patient’s record on SystmOneWhen 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 appointmentsAllow the clinician to check relevant patient history that might affect warfarin controlAllows 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;The referring practice must set up a share to allow the anticoagulant clinic to see the recordGo to adminGo to record shareRight clickClick Sharing out -Yes share data with other organisationsSharing in - Consent givenThe anticoagulant clinic must set up a share to allow the patients practice to see the consultation detailsFollow 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.Cancelling a record share.If a patient leaves the service cancel the record share. How ????Tasking GPAs 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 listAppendix 22: Annual reviews of patient in the anticoagulant clinicsIt 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 detailsAnticoagulant indicationTarget INRTime in Therapeutic Range (TRR)Most recent INR dosing dates and INR values2. 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 codeAnnual 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 clinicianWhen 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 safelyAny INRs > 8Number of INRs > 5Number of INRs < 1.5In addition LFTs and U+Es should be requested if not recently measured. ................
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