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STANDING ORDERS FOR THE MANAGEMENT OF WARFARIN
Dose adjustment and INR testing frequency
Applicable to: Pharmacists Issued by: Pharmacy warfarin management project medical Standing Order used for the Pharmacy based anticoagulant management Project. Dr Paul Harper, Consultant Haematologist, Palmerston North Hospital To improve the safety of Warfarin management by providing anticoagulant control through a pharmacist led service using point of care testing (CoaguChek XS Plus) and online computer decision support (INR Online Ltd). Accredited pharmacists who are participating in the Community Pharmacy Anticoagulation Management (CPAM) Service. The standing order is required to enable pharmacists to supervise anticoagulant management. Name of Medicine
Indications
Anticoagulation therapy initiated or confirmed by a doctor for: 1. Atrial Fibril ation 2. Deep vein thrombosis 3. Pulmonary Embolus 4. Tissue Heart valve 5. Mechanical Heart valve 6. Mural thrombus 7. Transient ischaemic attack 8. Post myocardial infarction Method of Administration: Oral
Dosage : see below
High risk of haemorrhage: active ulceration, overt bleeding of gastrointestinal, genitourinary or respiratory tracts, cerebrovascular haemorrhage, cerebral aneurysm. Side effects
High incidence of drug interactions Haemorrhage; GI upset; fever; dermatitis; urticaria; alopecia. hypersensitivity. Warfarin Standing Orders CPAM Services V2.0 Al patients must be referred to the pharmacist anticoagulant management service by the prescribing doctor. Al patients must give informed consent Al patients are to be asked about signs and symptoms of bleeding (haematuria, blood in bowel motions, severe bruising, mucosal haemorrhage etc). - If there is minor bleeding the doctor should be informed and the patient reviewed if necessary. - If the patient has significant bleeding the doctor should be informed Al patients are to be asked about new medication including OTC medications and/or other complementary medicines since the previous INR test. - If a significant interaction is identified the doctor should be informed and the patient reviewed if necessary. Al patients are to be asked about warfarin compliance. - If a significant number of doses have been omitted the doctor should be Al patients are to be asked if they have been admitted to hospital since their previous INR test. Details of the reason for admission wil be recorded. Criteria for referral of Referral criteria for new patients
In general, patients who have recently started on warfarin require stable control before referral to the community pharmacy service. Stable control is defined as: - Patients must have at least two INR measurements within the therapeutic range appropriate for their condition at least 1 week apart. This level of control would normal y be achieved after 4 to 6 weeks of treatment. For patients transitioning from heparin to warfarin stable control is defined as patients achieving two consecutive INRs between 2.0 and 3.0 (or 2.5 and 3.5 for mechanical heart valves) at least 24 hours apart.1 Referral to the service is at the discretion of the General Practitioner. If the doctor believes a specific patient requires close supervision, the doctor should indicate this to the pharmacist and arrange a process of individualised "shared care". This could involve more frequent consultation with the doctor during the period of instability. Criteria for discontinuing services and referral back to general practice
1 Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Parareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008 Jun; 133 (6 Suppl): 160S-95S. Warfarin Standing Orders CPAM Services V2.0 Once a patient is referred to the CPAM service it is best practice that they remain with pharmacist management unless the doctor or pharmacist elects to remove them, or the patient chooses an alternative service, or the medication is discontinued or The patient should only be referred back to the GP after consultation between the GP and pharmacist. The reasons for referral back to the GP care are most likely to relate to poor control or poor compliance. Where possible, a shared care arrangement with close supervision should be considered. Dose recommendation
Dose recommendation and interval to next INR test to be determined using INR Online software at the time an INR result is entered from the point of care device (CoaguChek XS Plus with direct data connection). The recommended dose can be accepted by the supervising pharmacists if the INR is within a specified range Parameters for warfarin adjustment
• Al patients must have a specified target INR and treatment range • An upper and lower INR value that wil trigger a REVIEW must be set for • The default values: lower INR – 1.5 upper INR – 4.0 wil be used unless otherwise specified by the doctor. • The pharmacist can accept the dose recommendation made by INR Online for INR values between the lower and upper limits. • INR values outside the upper and lower limits wil be referred for review by • An INR >4.5 wil automatical y advise the patient to miss 1 dose of warfarin and recommend a test the fol owing day. • The pharmacist can contact the supervising doctor and discuss any dose recommendation if he or she believes that the dose recommendation is inappropriate for the patient. • The pharmacist must document in the notes box in INR Online the reasons for any deviation in dose recommendation Test interval
• A maximum test interval must be set for each patient. The default value of 28 days wil be used unless otherwise specified by the doctor. For stable patients the maximum interval can be increased to 42 days after consultation with the doctor. • The test interval varies depending on the patient's anticoagulant control. • The system automatical y reduces the test interval when the INR is outside the treatment range. The test interval increases in a step wise manner if the INR remains in range up to the maximum (42 days). • The pharmacist can recommend a shorter test interval at anytime if he or she Warfarin Standing Orders CPAM Services V2.0 believes an earlier test is appropriate. • The pharmacist must document in the notes box in INR Online the reasons for any deviation in the test interval recommendation. The pharmacist wil provide the patient with advice about the warfarin dose and the date of the next INR test, and provide a printed dosing calendar. Starting warfarin
The INR Online software provides a protocol to assist with warfarin loading and initial This stage of treatment can be supervised by the pharmacist but close consultation with the supervising doctor is recommended. Review process
Where the INR is outside the specified range, the INR-Online software wil automatical y set the result for review • The pharmacist can accept the recommended dose from INR Online and advise the patient that the result has been sent for review by their doctor. • The patient is advised to continue on the recommended dose unless they are informed otherwise. If their doctor wishes to modify the dose they wil be informed of the change either by e-mail or by telephone by the pharmacist. Medical review
If a patient has an INR result outside the specified safe range, the supervising doctor wil be informed by e-mail. The contents of the message wil include • The latest INR result • The recommended dose • The date of the next test • A graph showing recent warfarin control • A list of previous results to enable the doctor to appropriately review the new • A link to open INR Online on the appropriate page to enable the doctor to edit the dose or date of the next test. The doctor has two options on reviewing the result 1. Acknowledge result If the doctor agrees with the recommendation made by the INR Online software or the pharmacists, the doctor wil need to acknowledge that the result has been seen by clicking on a link in the email. No further action wil need to be taken. The patient wil have been informed of the dose and the date of the next test. 2. Modify the recommendation If the doctor wishes to modify the dose or date of next test a web-page link is provided in the review message to take the doctor directly to the review The doctor can then change the dose or date of the next test and confirm the change. Warfarin Standing Orders CPAM Services V2.0 The pharmacist who entered the result wil automatical y be notified by e-mail that the dose or date has been changed. If the patient has e-mail the patient wil also be informed. The doctor does not need to take any further action The responsibility to inform the patient rests with the pharmacist. The review must be completed within 24 hours of the INR test. Warfarin Reversal Managing High INR Results
• Al INR results >4.0 wil trigger a review message to the doctor • If the INR is >4.5 INR Online wil recommend missing a dose and repeating a test the fol owing day • If the INR is >5.0 o INR Online wil provide advice for warfarin reversal in line with the Australasian Guidelines (Appendix 2). o Al results should be discussed with the supervising doctor o If the guidelines recommend treatment with vitamin K, this must be discussed with the supervising doctor. Vitamin K can only be given with authorization from the supervising doctor. • IF A PATIENT HAS SIGNIFICANT BLEEDING o Refer to the hospital immediately. o Inform the supervising doctor. o Consider giving 10mg oral vitamin K if there is significant travel time to the nearest hospital. Vitamin K can only be given with authorization from the supervising doctor. NB: Significant bleeds include: Blood in the urine, Blood in the bowel motions, A prolonged nose bleed, large bruises (bigger than 4cm in diameter) Many patients on warfarin have minor bleeds, such as gum bleeding, spotting from the nose, or easy bruising. These do not need urgent attention Recording results
The INR result, dosage of warfarin and testing interval are to be recorded in the INR-
Online software and the same information wil be sent automatical y to the doctor's
patient management system and the Laboratory Test Respository, if available, via
HealthLink.
INR Online automatical y records the date, time and user, when results are entered
or any changes made.
Adverse events are recorded during the assessment prior to each test and additional
information can be recorded in a notes field with each INR test.
Countersign period The Doctor initiating anti-coagulation therapy wil sign off treatment. Sign off wil take place every 3 months at the time a new warfarin prescription is provided. Warfarin Standing Orders CPAM Services V2.0 Prior to administering Warfarin dose titration under this Standing Order, Accredited pharmacists are required to have: Attended a Standing Order education session. Completed the INR-Online training session. Completed CoaguChek XS Plus Competency Training
Process for audit and The correct operation of this Standing Order wil be reviewed once per year
review
The individual pharmacists competency in applying the order accurately wil be assessed Adverse events related to Standing Orders wil be monitored by Dr Paul Harper and reported to CARM or other relevant body. Responsibility for Dr Paul Harper is responsible for the review of this Standing Order.
Review Time period for This Standing Order is valid until it is replaced by a new Standing Order or cancel ed which the Standing This standing order only applies to Pharmacists who are accredited to provide community pharmacy-based anticoagulant management services and who have a current agreement with the DHB to provide community pharmacy services. Standing order prepared by Dr P L Harper. MD, FRCP, FRACP, MRCPath. Consultant Haematologist, Palmerston North Hospital Honorary Senior lecturer, Auckland University. In collaboration with Prof John Shaw, Head of School of Pharmacy, Auckland University Prof Les Toop, Head of Dept Public Health and General Practice, University of Otago Elizabeth Plant, President, Pharmaceutical Society of New Zealand Richard Townley, CEO, Pharmaceutical Society of New Zealand Dale Griffiths, Pharmacist Ian McMichael, Pharmacist Amanda Kiss, Clinical facilitator. Warfarin Standing Orders CPAM Services V2.0 By signing this standing order you are consenting to al owing patients at this practice to continue management of their warfarin using a Pharmacy based
anticoagulant management service.
I confirm I have read these Standing Orders, and consent to
referring selected patients in the practice to
Pharmacy for Community Pharmacy
Anticoagulation Management Services.
(Use another page if necessary) GENERAL PRACTICE: _ Warfarin Standing Orders CPAM Services V2.0
Appendix 1

Summary of the testing process
The patient will attend their allocated pharmacy.
The patient will be interviewed by the pharmacist.
The patient will be identified on INR Online (search by NHI or name)
Safety questions
Bleeding complications New medication - Drugs recorded - Potential interactions identified Adverse events - Hospital admission: Date of admission: Performed on CoaguChek XS Plus. NHI number recorded on the device Result automatically transferred to INR Online Automatically calculate recommended dose and date of next test INR within safe
INR outside safe range
• Recommendation reviewed by pharmacists and accepted if appropriate • Calendar printed • Recommendation reviewed by pharmacists and accepted if • Patient informed that result has been sent to their doctor for review and • Calendar printed • The patient should continue with the recommended dose unless told • Consultation complete Data storage
INR Result, Test date, Dose and date of next test sent to GP PMS Review by doctor
• The GP will receive an email stating the INR result is outside the safe • The email will display the latest result and recommended dose and a list of recent results. • There will be a link taking the doctor directly to the review page. • The doctor will have the option to alter the result or make no change If result changed
• If the patient has requested email notification – the patient will receive • Otherwise an email will be sent to the allocated pharmacy Data storage
Amended result sent to GP PMS Warfarin Standing Orders CPAM Services V2.0 Appendix 2

Warfarin Standing Orders CPAM Services V2.0 Appendix 3

Procedure to manage patients when unable to communicate with INR Online

The fol owing procedure should be fol owed if access to INR Online is interrupted due to local computer problems,
lost internet connection, problems with the INR Online server, or the INR Online program stops running.
1. Interview patient and record as a hard copy any missed medication, history of bleeding since the last visit, new medication since the last visit and any hospital admissions. 2. Perform the INR test as usual on the CoaguChek XS Plus. Enter the NHI number if known.If the patient does not know their NHI Number perform the INR test without a reference number. 3. Record the fol owing information as a hard copy • Patient's name, • NHI number (if known) or date of birth • Present warfarin dose • INR result • Patient's GP details
INR within the therapeutic range

If the INR is within the therapeutic range, advise the patient to continue on the same dose and recommend a dose
interval the same as the previous interval.
Record the dose recommended and the date of the next test
If the INR Is outside the therapeutic range
Warfarin dosing is the responsibility of the patient's general practitioner. You should therefore contact the GP
practice, advise them that you are unable to contact INR Online and require dosing advice.
The dose recommendation from the doctor and the date of the next test should recorded and the patient should be
contacted with this information.
If the INR is >4.5, advise the patient to miss a warfarin dose and repeat the INR the next day.
When access is resumed
The missing results should be entered into INR online.
Enter the results by using the add result tab on the top of the left-hand column on the overview page.
This wil ensure that the results are sent to the doctor's PMS and an e-mail wil be sent to the patient.
When you enter a result the computer wil recommend a new dose. Edit this to the dose you gave and edit the
recommended date of the next test to the date you recommended. Then confirm the result.
DO NOT ENTER THE MISSING RESULT USING THE EDIT RESULT TAB. If you do, the result wil not be sent to
the doctor's PMS and the patient wil not receive an e-mail.
Warfarin Standing Orders CPAM Services V2.0 Appendix 4

Procedure for the management of non-compliant patients

Note: The responsibility for the patient's warfarin management rests with the supervising doctor.
It is important that the supervising doctor is informed if a patient is a regular poor complier. It may be appropriate
for the doctor to reassess the risks and benefits of warfarin in such cases and may recommend discontinuing
warfarin if the risk of poor compliance is assessed to be potential y dangerous.
The fol owing is a recommended procedure for managing non-attenders. Where possible we suggest this is
fol owed but individual patient circumstances must be considered with these recommendations. It is important to
document al deviations from the procedure and to maintain good communication with the supervising doctor.
Procedure if patient fails to attend for INR testing on the specified date

• As a general rule the patient should go no more than 6 weeks between tests. • If the patient fails to attend within 3 days of the specified test date, the patient should be contacted by phone to remind the patient that the test is due. • If the patient fails to attend within 4 to 6 days of the first reminder, a second cal should be made to the • If the patient fails to attend within 1 week of the second reminder, the patient should be contacted a third time and the patient's doctor should be informed that the test is 2 weeks over due and a maximum of 6 weeks since the last test and you wil only send further reminders at the doctor's request. Further fol ow up of the patient is the responsibility of the doctor. • Each contact with the patient and the doctor should be documented in INR Online. • If a patient presents for a test more than 2 weeks after the expected date of the test, the test should be performed and the doctor should be informed. • If a patient regularly fails to attend on time, discuss management with the supervising doctor. Warfarin Standing Orders CPAM Services V2.0

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