TX-60 Management of Therapeutic Anticoagulation Therapy



CARE OF PATIENTSVA PUGET SOUNDMEMORANDUM TX-60HEALTH CARE SYSTEMMAY 2013SUBJECT: MANAGEMENT OF THERAPEUTIC ANTICOAGULATION THERAPYEXECUTIVE SUMMARY: To update policy and procedures for safe and effective management of patients receiving therapeutic anticoagulation therapy. This update reflects changes in education requirements, clarifies the use of a generic warfarin products, updates unfractionated heparin protocols attachments 3, 4 and 8, and updates terminology.POLICY: This policy covers the ordering, dispensing, administration, and monitoring of oral and parenteral anticoagulants, including heparin, low-molecular weight heparins (LMWH), fondaparinux, and warfarin in the VA Puget Sound Health Care System inpatient (INPT), outpatient (OUTPT), Community Living Center (CLC), Community Based Outpatient Clinics (CBOC), and Home Based Primary Care (HBPC) settings.Oral and parenteral anticoagulants, used to treat and prevent thromboembolic disease, are considered high-risk medications which carry significant potential for patient harm. Sub therapeutic levels may lead to thromboembolic complications, while therapeutic and supratherapeutic levels may lead to plex dosing and monitoring, patient health status changes, patient education and compliance, and significant food and drug interactions all increase the risk of adverse events related to anticoagulation.Laboratory monitoring is a key component of safe anticoagulant therapy management and includes measures to assess both the level of anticoagulation and other indicators of potential harm. Laboratory results, especially INR, may be dependent on the methods used, the competency of the person performing the test, and the accuracy of the testing equipment or device.Specific education of anticoagulation providers, other staff managing patients receiving therapeutic anticoagulation, staff involved in ancillary activities (laboratory monitoring), and patients and family are all critical to managing the complex nature of anticoagulation and achieving the desired outcome.Ongoing assessment of the quality of care provided will help identify opportunities for improvement, minimize patient risk, and is essential to a successful anticoagulation program.Delivery of safe and effective anticoagulation services is a multidisciplinary process that provides care to patients across the VA Puget Sound clinical spectrum. This process is best accomplished through the endorsement and utilization of standardized practices to ensure that all patients receive the same high level of care throughout the system.PROCEDURES: Anticoagulant dosage forms and methods of administration will be standardized to improve patient safety. All patients: VHA has established the potential for therapeutic differences between brands of warfarin. When warfarin is prescribed, one standard brand selected by the VHA/PBM will be dispensed. It is recognized that some patients may request to purchase warfarin in the community at a lower cost than their VA copay. Patients may purchase generic warfarin prescribed by a VA provider, however if the VA provider determines that the generic product leads to erratic lab values, the provider may require the patient to purchase one brand of warfarin. Inpatients: Only unit dose warfarin, unit of use pre-filled syringes of low-molecular weight heparin (LMWH) and fondaparinux, and vials of low-dose unfractionated heparin (UFH) will be dispensed for inpatient use. Commercially prepared pre-mixed IV UFH will be utilized whenever possible. The concentrations provided will be limited to those approved by the Pharmacy, Nutrition and Therapeutics (PN&T) Committee. Only programmable infusion pumps will be used for administration of UFH infusions. Smart pump technology with integrated patient safety software will include the approved UFH concentrations. When it is necessary to provide a non-standard concentration, the bag will be clearly labeled as a non-standard concentration. Availability of vials of UFH for bolus injections will be limited in size and concentration to meet the using area’s needs while minimizing risk and will be approved by the PN&T for ward stocking.Outpatients: Outpatients should generally receive only one tablet strength of warfarin, with the 5mg and 2mg preferred and utilized whenever possible. Outpatients receiving LMWH and fondaparinux should be dispensed unit of use syringes whenever possible to meet the patient’s needs.Anticoagulation Protocols: Evidence-based protocols for the initiation and maintenance of anticoagulation therapy appropriate to the medication used and the condition treated will be developed and kept current based on emerging evidence. Anticoagulation protocols will be reviewed, approved, and disseminated by the PN&T committee and will be used by those prescribing anticoagulant therapy.Laboratory Monitoring: Anticoagulant protocols will include baseline and ongoing laboratory monitoring tests recommended by nationally recognized guidelines and product labeling appropriate to the individual patient and medication. Prescribers of anticoagulants will be responsible for ensuring that current baseline and ongoing laboratory monitoring is completed, documented in the CPRS lab package or a current note, and used to individualize the dose of medication to achieve the desired outcome. When not recorded in the CPRS lab package, the prescriber will record the international normalized ratio (INR) in a current progress note along with the name, address, and telephone number of the laboratory reporting the result and the dates the lab was drawn and processed.Critical lab results: Critical lab results will be managed according to the medical center critical lab results policy.Warfarin: Baseline and ongoing monitoring labs will include CBC with platelets, and INR at intervals defined by medical center protocol (attachment A). Generally, INRs will be checked at intervals that do not exceed 4 weeks in stable patients; however a maximum 6 week interval may be used in stable outpatients if circumstances require (e.g. transportation or weather problems).INR: A current baseline INR will be available prior to starting warfarin. All INR results for patients receiving warfarin will be clinically reviewed no later than the close of the next business day. The current INR used to adjust the dose of warfarin will be available in CPRS. Point of Care Testing (POCT): VA Puget Sound does not utilize point of care testing or patient self-testing for measuring the INR and management of anticoagulation. If POCT is utilized in the future, a program will be developed within the medical center ancillary testing program to meet all required standards.Unfractionated Heparin (UFH): Baseline monitoring labs will include CBC with platelets and activated partial thromboplastin time (aPTT). Ongoing monitoring labs will include CBC (with platelets, hemoglobin, and hematocrit) and aPTT.LMWH and fondaparinux: Baseline monitoring labs will include CBC with platelets and serum creatinine. Ongoing monitoring labs for patients on long-term therapy will include CBC with platelets and serum creatinine every 30 days or more frequently if indicated.Outpatient Oral Anticoagulation: Every VA practitioner who prescribes oral anticoagulation will follow standards and recommendations established and approved by the medical center (attachment A). The standards will include, but are not limited to limiting the brand and tablet strengths of warfarin, minimum anticoagulation education and competency requirements for providers, patient monitoring requirements, maximum prescription quantities and refills permitted, and documentation, including lab values not recorded in the CPRS lab package. To ensure that all outpatients receiving warfarin are monitored at the intervals defined in this policy, the quantity of warfarin provided with each prescription will be limited to 60 days (or 30 days with 1 refill).Pharmacy: In the interest of patient safety, the pharmacy will not dispense outpatient anticoagulants which are not ordered consistent with the standards set forth in this policy. Nutrition and Food Services: NFS will be notified of all inpatients receiving warfarin who are also receiving meal services and will respond according to the established food and medication interaction program.Patient Education: All patients receiving warfarin will receive education necessary to understand the safe use of warfarin. Pharmacists will provide education to all patients discharged from the medical center on warfarin (excluding patients transferred to another health care setting) and efforts will be made to educate family and other caregivers whenever possible. When the necessary, (e.g. limited patient comprehension) a responsible caregiver will be identified and educated. The specific education components, patient’s understanding, barriers to education, and other pertinent information will be documented in a CPRS progress note. At a minimum, education will include:Warfarin tablet identification,Indication for anticoagulation,Potential drug interactions (drug, diet, and disease),Daily dosage,Monitoring requirements,Importance of medication compliance,Dangers of seeking care from different providers and using different pharmacies,Management of missed doses,Signs and symptoms of bleeding and thromboembolic events,Risks associated with falling and need to seek evaluation following fall or significant impact injury,Follow-up monitoring and management plans, andAll patients receiving other anticoagulants will receive education at the time of discharge or when the medication is dispensed to an outpatient which is appropriate to promote safe and effective use of the drug. The pharmacist will assess the patient’s ability to comply with instructions and will address barriers to safe drug use prior to dispensing the anticoagulant.Staff Education: All medical center staff involved in caring for patients receiving anticoagulant therapy will be provided education regarding anticoagulation therapy.Qualifications of anticoagulation providers: Any provider who is not a licensed independent practitioner (LIP) will hold a Scope of Practice which delineates the activities they may perform with respect to anticoagulation management. Specific initial and ongoing competencies will be established and assessed for all mid-level practitioners (e.g. pharmacists) involved in managing anticoagulation therapy. At a minimum, the competencies will include:Knowledge of standard anticoagulation terminology,Knowledge of established monitoring requirements,Appropriate initial dosing recommendations and adjustments,Common side effects of anticoagulants,Knowledge of and management of drug and food interactions, andDietary considerations related to anticoagulants.Quality of Care: VA Puget Sound will designate an Anticoagulation Therapy Program Coordinator who will be responsible for the development, implementation, and ongoing monitoring of a quality assurance plan to evaluate all anticoagulation services, identify opportunities for practice improvement, and implement recommendations. At a minimum the plan will monitor:INRs above the critical value,That appropriate action has been taken on critical INRs within 24 hours of INR testing and documentation that appropriate action has been taken,Bleeding events associated with anticoagulation,Thromboembolic events occurring in patients receiving anticoagulation,Frequency of sub-therapeutic INRs,Patient incidents, close-calls, and near misses associated with anticoagulants,Patients receive appropriate outpatient follow-up as defined by VA Puget Sound standards, including INR intervals and proper documentation in an easily retrievable format from CPRS, andPatient no-shows for clinic visits are documented and addressed according to medical center standards.Adverse Drug Events: Adverse drug events related to the use of anticoagulants will be reported through the medical center adverse drug reaction (ADR) reporting program with all sentinel events (as defined by The Joint Commission) also reported to Patient Safety or Quality Improvement. Significant incidents involving patients receiving anticoagulation will be reported as directed in the Patient Safety Policy as patient incident reports (PIR) or other established processes.Critical Drug Interactions: VA Puget Sound will utilize CPRS order-checks to alert all prescribers to potentially critical interactions between anticoagulants and other drugs. It is the responsibility of the ordering provider to obtain the information necessary to evaluate the potential impact of the drug interaction on the individual patient. Pharmacists will assist providers in identifying and evaluating drug interactions and recommending alternative drugs or developing management plans. A prescriber who chooses to order potentially critically interacting drugs will document actions appropriately within CPRS order check package and will implement the necessary plan to ensure safe use of the drugs, which may include dosage changes and ordering and evaluating follow-up labs. If the impact of the drug interaction will extend to the outpatient care of the patient, the prescriber will notify the patient’s anticoagulation provider of the potential interaction and management plan. This may be done with an anticoagulation clinic consult for patients already managed in an anticoagulation clinic or a CPRS progress note with the anticoagulation provider as a cosigner.Coding: Patients receiving long-term anticoagulation therapy will have the code V58.61 (Long-term (current) use of anticoagulants) added to the problem list to help identify and track these patients.Inpatient Oral Anticoagulation: As a teaching institution, inpatient providers are encouraged to gain experience and develop skill managing warfarin therapy. The provider will order and monitor warfarin according to approved VA Puget Sound protocols which establish monitoring requirements and provide suggestions for patient assessment, medication initiation, dose adjustment, and management of over-anticoagulation. Pharmacists will follow a service level standard operating procedure to ensure that every inpatient receiving warfarin is monitored according to VA Puget Sound standards (attachment B). Pharmacists will advise providers and document findings and recommendations in a current CPRS progress note template with the inpatient provider added as a cosigner. The inpatient provider is responsible for arranging appropriate outpatient follow-up care for the patient prior to discharge. When follow-up anticoagulation is not with a VA Puget Sound provider, the supply of warfarin provided at discharge should be limited to a 7 day supply with instructions to the patient to follow-up with the non-VA Puget Sound anticoagulation provider. In no case should a discharge supply of warfarin exceed a 30 day supply.Inpatient IV Unfractionated Heparin: Intravenous unfractionated heparin will be ordered and administered according to protocols for low-intensity, high-intensity, and no bolus heparin (Attachments C, D, and H). When administered outside a critical care unit, the physician will order labs at appropriate intervals and adjust the dose to ensure optimal outcome. When administered within a critical care unit, a registered nurse may administer boluses, adjust doses, and order labs according to the approved protocols and as permitted by nursing policy. Inpatient Venous Thromboembolism (VTE) prophylaxis with low-dose UFH, low-molecular weight heparin, and fondaparinux: A set of evidence based order menus, approved by the PN&T Committee and the Clinical Executive Board will be used to ensure that every patient admitted to VA Puget Sound is assessed for risk and receives appropriate VTE prophylaxis (attachment E). Inpatient management of Heparin Induced Thrombocytopenia (HIT): An evidence based protocol will be used for the management of patients who develop or are suspected of developing HIT (attachment F). Outpatient Parenteral Anticoagulation: Low-dose unfractionated heparin, low-molecular weight heparin, and fondaparinux ordered during the initiation of warfarin and for short-term bridge therapy will be limited to a 7-14 day supply. Long-term use will follow VA Puget Sound guidelines or criteria for use, or will be specifically approved by a hematologist or anticoagulation clinic provider. Appropriate lab monitoring for long-term use will be followed and prescription quantities will be limited to 30 day supplies. Inpatient and Outpatient Bridge Therapy: Evidence based guidelines will be used to provide perioperative and periprocedural bridge anticoagulation (attachment G). The inpatient provider may order bridge therapy while the patient is in the hospital and the primary care provider, in consultation with the surgeon or other provider doing a procedure, will order bridge therapy for outpatients. The primary care provider may request the anticoagulation clinic provider (via electronic anticoagulation clinic consult) manage the bridge therapy for patients already established in the clinic, in which case, the anticoagulation clinic provider will do so in consultation with the provider performing the procedure. The provider performing the procedure will be responsible for re-establishing anticoagulation after the procedure and will inform the anticoagulation provider of the plan of care in a timely manner. The prescription quantity for bridging medications will be limited to a 10 day supply.RESPONSIBILITIES:Chief of Staff: The Chief of Staff is responsible for ensuring that the following programs are in place:Competencies specific for anticoagulant therapy management are included in the competency plans for non-LIP staff practitioners involved in managing anticoagulation therapy. Competencies, at a minimum, must include:Knowledge of standard anticoagulation terminology,Knowledge of established monitoring requirements,Appropriate initial dosing recommendations and adjustments,Common side effects of anticoagulants,Dietary considerations related to anticoagulants, andKnowledge and management of drug and food interactions.Assessment of the competency of non-LIP staff practitioners involved in managing anticoagulation therapy.All staff performing ancillary testing (e.g., point of care INR testing) undergo competency assessment as defined in national and local Procedures (VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures).Director, Nursing Services: The Director of Nursing Service is responsible for ensuring:Programmable infusion pumps are used for the intravenous administration of petencies specific for anticoagulant therapy management are included in the competency plans for nursing staff involved in managing anticoagulation therapy. Competencies, at a minimum, must include:Knowledge of standard anticoagulation terminology,Knowledge of established monitoring requirements,Appropriate initial dosing recommendations and adjustments,Common side effects of anticoagulants,Dietary considerations related to anticoagulants, andKnowledge and management of drug and food interactions.Assessment of the competency of nursing staff practitioners involved in managing anticoagulation therapy.Nursing staff performing ancillary testing (e.g., point of care INR testing) undergo competency assessment as defined in national and local Procedures (see VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures).Director, Clinical Support Service: The Director, Clinical Support Service, is responsible for ensuring:Only unit dose products are dispensed for inpatients when these types of products are available.The number of concentrations and quantities of heparin vials stocked in patient care and procedural areas are limited to the minimum needed to meet patient care needs.Anticoagulants stored in automated dispensing devices will be managed and clearly labeled as high alert medications. Competencies specific for anticoagulant therapy management are included in the competency plans for mid-level pharmacy practitioners involved in managing anticoagulation therapy. Competencies, at a minimum, must include:Knowledge of standard anticoagulation terminology,Knowledge of established monitoring requirements,Appropriate initial dosing recommendations and adjustments,Common side effects of anticoagulants,Dietary considerations related to anticoagulants, andKnowledge of and management of drug and food interactions.Assessment of the competency of mid-level pharmacy practitioners involved in managing anticoagulation therapy.Pharmacy staff performing ancillary testing (e.g., point of care INR testing) undergo competency assessment as defined in national and local Pathology and Laboratory Medicine Service Procedures. Warfarin is included in Nutrition and Food Services’ (NFS) food and medication interaction program, NFS is notified of all inpatients receiving warfarin who are also receiving meal services, and those patients receive meals are provided education with focus on the impact of Vitamin K on warfarin’s efficacy and side effects.Director, Pathology and Laboratory Medicine Service: The Director, Pathology and Laboratory Medicine Service is responsible for:Educating staff providing clinical services in an outpatient anticoagulant clinic and staff involved in home anticoagulation therapy management on national and local Laboratory policies related to POCT and patient self-testing.Ensuring a critical INR value is established and listed in the Laboratory VistA software package.Establishing a Standard Operating Procedure for the communication of critical INR results from the laboratory to the provider.Ensuring the correct ISI value for the lot number of Thromboplastin, currently in use, is entered into the coagulation testing instrumentation.Ensuring there is documentation of periodic monitoring to ensure the entered value remains accurate.Ensuring the correct Geometric Mean PT is calculated for the current lot number of Thromboplastin and is entered into the coagulation testing instrumentation as required for calculation of the INR. Ancillary Testing Coordinator: The Ancillary Testing Coordinator is responsible for:Assessing the competency of staff involved in ancillary testing, and Documenting training, authorization and annual competence evaluation for all staff that perform ancillary testing.Chair, Pharmacy, Nutrition and Therapeutics Committee: The Pharmacy, Nutrition and Therapeutics committee is responsible for:The development, review, and dissemination of practice guidelines and protocols for the safe management of anticoagulation therapy. The guidelines will be based on high quality emerging evidence and major consensus statements.Updating practice guidelines and protocols to reflect current recommendations and practice standards.Review and approval of CPRS order menus designed to facilitate ordering anticoagulation based on the approved protocols and guidelines.Anticoagulant Therapy Program Coordinator: The Anticoagulant Therapy Program Coordinator is responsible for the ongoing monitoring of the facility anticoagulant quality assurance plan and reporting results to the P, N&T Committee for action.REFERENCES:Alaris Systems Data Set Report, VA Puget Sound P, N&T Committee January 2013.Reporting of Urgent and Critical Diagnostic Test Results, VA Puget Sound Memorandum TX-40, December 2009.Drug Nutrient Counseling, VA Puget Sound Memorandum PF-02, January 2010.VHA Directive 2010-020, Anticoagulation Therapy Management, May 14, 2010. Consensus Guidance to Insure the Safe Use of Anticoagulants, National VA Hi-Alert Anticoagulant Workgroup, VHA Pharmacy Benefits Management Service, and the Medical Advisory Panel, July 2008.RESCISSIONS: Memorandum TX-60, October 2010.FOLLOW-UP RESPONSIBILITIES: Director, Pharmacy and Nutritional Care Services.EXPIRATION: Last work day of May 2016.MICHAEL J. MURPHY, FACHEDirectorAttachments: 8 (approved by P&T committee)A - Outpatient Anticoagulation Clinics B - Inpatient warfarin monitoring Pharmacy SOP C - Low-intensity heparin protocol D - High-intensity heparin protocol E - VTE risk assessment and prophylaxis recommendations F - HIT management protocol G - Guidelines for Perioperative and Periprocedural management of patients receiving long-term anticoagulation with warfarin H - No bolus heparin protocolOutpatient Anticoagulation ClinicsPolicies and ProceduresVA Puget SoundSeptember 2010VA Puget Sound Outpatient Anticoagulation Clinics Policies and ProceduresTable of ContentsItemPagePurpose3Policy3Procedures4A. Service Description4B. Referral/Enrollment4C. Plan of Care6D. Scheduling6E. Initial Visit and Orientation6F. Subsequent anticoagulation clinic visits6G. Remote Labs7H. Documentation7I. Management of missed appointments7Management of Warfarin Therapy8A. Initiation of Warfarin Therapy8B. Warfarin Dosing Adjustments91. General Guidelines92. Warfarin Dose Adjustment Protocol93. Weekly Warfarin Dosing Schedule9C. Follow up monitoring9D. Communication with the patient10Management of Parenteral Anticoagulation10Other Functions of Anticoagulation Clinic Staff10AttachmentsReferral form – Electronic Consult12Therapeutic Range and Duration of Warfarin Therapy13Guidelines for Initiation of Warfarin Therapy Dosage15Patient Rights and Compliance Agreement16Patient and Family Education17CPRS anticoagulation clinic template18Clinic Patient Assessment Flowsheet19Patient Assessment Guide20Follow-Up INR Monitoring Schedule23Ordering Remote Labs for Anticoagulation Clinic24CPRS Template - Remote Lab Order Letter25Guidelines for Correction of Over-anticoagulation26Warfarin Dosage Adjustment Protocol27Dosing Recommendations for Parenteral Anticoagulants28References29VA Puget Sound Health Care SystemAnticoagulation ClinicsThe outpatient anticoagulation programs are operated and managed in the Primary Care Clinics (PCC) by licensed practical nurses (LPN), nurse practitioners (NP) and clinical pharmacists (RPh) with specific knowledge and training in anticoagulation therapy. The programs are overseen by Primary Care physicians. The responsibilities of the anticoagulation clinic staff are directed by a series of therapeutic guidelines intended as suggested approaches to care. It is anticipated that clinical judgment will be applied to all aspects of patient management, and that patient-specific management plans may require deviation from these guidelines. While these guidelines are primarily intended for the use of the anticoagulation clinic staff, they are also intended to be used to guide anticoagulation provided by other practitioners within the health care system.1.PurposeThe Purpose of the VA Puget Sound Health Care System – Anticoagulation Services are to improve patient care by ensuring drug efficacy and minimizing drug toxicity through a standardized program of outpatient warfarin therapy. The program will:A.Manage oral anticoagulant therapy by evaluating the prothrombin time and the International Normalized Ratio (INR).B.Manage parenteral anticoagulation therapy (low molecular weight heparin and fondaparinux) for short term use as part of an anticoagulation plan of care.C.Assess patients for possible complications related to anticoagulant therapy.D.Provide consistent drug dosing and smooth transition of warfarin dosing from inpatient to outpatient status.E.Provide comprehensive and ongoing education to patients and/or family members about anticoagulant therapy with specific attention to signs and symptoms to report, drug dosage forms, prothrombin time testing, drug interactions, food interactions, disease interactions, alcohol interactions, lifestyle changes and the need for careful follow up and watching for complications.F.Maintain an effective quality assurance/improvement program.G.Provide consultation for questions from the medical teams regarding anticoagulation.H.The clinic does not provide primary or episodic care of chronic or acute problems outside the arena of anticoagulation.2.PolicyA.All personnel assigned to the Anticoagulation Clinic will observe the written guidelines stated herein.B.All mid-level practitioners involved in managing anticoagulation therapy will have successfully completed specialty training in anticoagulation therapy management and will have a Scope of Practice which authorizes them to order labs, issue new prescriptions and manage prescription refills for anticoagulants. Pharmacy technicians and LPNs working in the clinics will provide care within their scope of practice, under the guidelines set forth in this document, and with the oversight of a licensed independent practitioner (LIP) or a mid-level provider with an approved scope of practice.C.Referral to the clinic will be by electronic consultation prior to enrollment (See Procedure 3.B.).D.Enrollment and follow-up are available only to ambulatory outpatients that are receiving primary care from a VA Puget Sound Provider through an established outpatient program. Patients receiving primary care through a VALOR clinic will receive anticoagulation management through the VALOR clinic.E.Patients enrolled in the clinic will meet criteria listed in Procedure3.B.F.Clinic visits will be by appointment only.G.Assessments of patients during clinic visits will be documented in the electronic medical record progress notes.3.ProceduresA.Service Description –Hours of Service.American Lake Division: Monday – Friday 0800-1600Seattle Division: Monday – Friday 0800-1600 B.Referral/Enrollment - Referral to the clinic will be by electronic consultation which needs to be made prior to admission to the anticoagulation program (attachment 1). Referrals for outpatient follow-up of inpatients are to be sent prior to the veteran’s discharge from the medical center. Patients will be followed by their medical providers until enrolled in the program. C.The electronic consult will include:(1)The indication for anticoagulation(2)Pertinent medical history(3)Desired INR range(4)Loading dose information and when warfarin started(5)Current warfarin dose(6)Estimated duration of anticoagulation(7)Is patient a candidate for cardioversion? If so, when?D.In addition, the following patient criteria must be met:(1)Patients must have demonstrated capability for self-administration of medication or have a caretaker who can supervise the medication(2)Patients must have a telephone or reliable telephone contact established(3)Patients must be compliant with the medical regimen and not abusing alcohol(4)Patients may be discharged from the clinic if they are abusing alcohol, are poorly compliant with their medication, fail to maintain communication, or fail to have INR checks as requested. Patients discharged from the program will be referred back to their primary care provider(5)Patients have a primary care provider who is responsible for maintaining prescriptions other than warfarin and ordering other services at the medical center(6)Patients are able and willing to attend outpatient clinic appointments. The clinic may establish a minimum number of annual face to face visits required for all patients. It is strongly recommended that those unable to travel outside a 50 mile radius be evaluated for care in their community E.The following patients will not be enrolled in anticoagulation clinic:(1)Homebound patients(2)Most renal dialysis patients(3)Patients followed by HBPC, with some exceptions for those patients who are able to come to clinic. Generally, HBPC patients will be followed by the HBPC physician director or the patient’s PCP(4)Patients followed by Visiting Nurse Service requiring lab draws at home. These patients are generally managed by the patient’s PCP. The clinic does not give dosing advice to visiting nurses(5)Patients discharged to or living in a skilled nursing facility. Patients living in adult assisted living facilities or adult homes may be followed in the clinic if there is no provider covering their care (VA PCP required)F.The following are considered absolute contraindications to enrollment in the clinic:(1)Recent history of a major bleeding episode(2)Acute or chronic alcoholism(3)History of repeated non-compliance (2x no show)(4)Severe uncontrolled hypertension(5)Uncontrolled behavioral disturbance(6)Pregnant or nursing women(7)No clinically valid indication for anticoagulationG.The following are considered relative contraindications to enrollment in the clinic:(1)Remote history of a major bleeding episode(2)Peptic ulcer disease(3)Hepatic cirrhosis(4)Recent surgery or trauma(5)Regular non-steroidal anti-inflammatory or high dose aspirin use(6)Inadequately confirmed indication for anticoagulation(7)High risk of traumaH.The additional actions should be taken by the referring provider:(1)Provide an initial 30 day supply of warfarin(2)Submit a follow-up INR in 3 days in provider’s name(3)Initiate dosingI.Plan of Care - The anticoagulation clinician receiving the referral consult will review the plan of care based on the information provided in the referral, the electronic medical record, and standard guidelines.(1)The chart will be reviewed for:(a)Pertinent past medical and surgical history(b)Hospital course(c)Medications(d)Allergies(e)Anticoagulation therapy received and date of initiation(f)Primary care provider(g)Patient telephone number, address, and emergency contact(2)The indication for anticoagulation, desired INR range, and duration of therapy will follow the American College of Chest Physicians (ACCP) guidelines (attachment 2). Deviations from published guidelines will be reviewed with referring provider if necessary and documented.(3)Initial dosing and monitoring regimen will be reviewed. Significant deviations from the standard average daily dose method (attachment 3) will be reviewed with referring provider if necessary and documented.J.Scheduling(1)After accepting the consult, the anticoagulation clinic staff will respond to the electronic referral consult acknowledging receipt.(2)New patients will be scheduled for their initial visit within one week of the consult or hospital discharge.(3)Established patients will be scheduled within a month of the consult and should be provided with a one month supply of warfarin and obtain a current INR.K. Initial Visit and Clinic Orientation - At the initial anticoagulation clinic visit, the provider will:(1)Review the plan of care, including the indication for, duration of and intensity of therapy and hemorrhagic risk assessment(2)Review the AC policies with the patient (3)Review and sign, with patient, the Patient Rights and Compliance Agreement (attachment 4) if necessary to ensure patient compliance at providers discretion(4)Provide supplemental patient education and appropriate materials (attachment 5)L.Subsequent anticoagulation clinic visits - With each patient interaction, the AC clinic provider will:(1)Provide an appropriate assessment of patient response to therapy and complete the CPRS template (attachment 6). The Clinic Patient Assessment Flowsheet (attachment 7) and Patient Assessment Guide (attachment 8) may be used as resources,(2)Adjust anticoagulation doses if necessary (see section 5. Management of Warfarin Therapy),(3)Schedule a next visit using the Follow-Up INR Monitoring Schedule (attachment 9),(4)Provide ongoing patient education, and(5)Document in CPRS:(a)An update of all baseline data(b)Current warfarin dose(c)Summary of subjective evaluation(d)Summary of objective data(e)Assessment of anticoagulation status(f)The plan for ongoing management of therapy.M.Remote labs for anticoagulation clinic patients (attachments 10&11)(1)The clinics may allow remote labs for patients established in the anticoagulation clinic with stable INR’s.? Some exceptions for patients with less stable INR’s who have great difficulty with traveling may be made at the discretion of the clinician.(2)Remote labs may be drawn VA at the following sites: (a)Bremerton CBOC (b)Port Angeles VA clinic (c)American Lake VA (d)Bellingham outreach. (3)Costs for remote labs done at all other sites are the responsibility of the patient to either self-pay, use private insurance, or Medicare. (4)On RARE occasions, the PCP may request Fee Services to pay for remote labs, however, it is unusual for Fee Services to approve payment for remote labs and the clinic will not offer this option to patients. N.Documentation - At each encounter, the ACC provider will document in CPRS:(1)An update of all baseline data(2)Current warfarin dose(3)Summary of subjective evaluation(4)Summary of objective data(5)Assessment of anticoagulation status(6)Plan for ongoing management of therapyO.Management of missed appointments - Anticoagulation Clinic staff are responsible for identifying methods to assist patients in complying with follow-up requirements. However, in patients with repeated non-compliance, the risks of anticoagulation may outweigh the benefits expected from therapy and it may be inappropriate for the Anticoagulation Clinic to continue to attempt management. In these cases, anticoagulation management will be referred to the primary care provider.P.The following procedures are intended to standardize the approach to patients who fail to follow-up for routine management. The anticoagulation provider may deviate from these procedures as necessary for individual patient circumstances. (1)When a patient fails to appear for a routine appointment without cancelling and rescheduling the appointment (no-show):(a)An attempt will be made to contact the patient by telephone as soon as possible to reschedule. This is usually done the same day, but within 14 days in all cases.(b)If the patient cannot be reached by telephone, a note is placed in CPRS indicating the urgency for follow-up, suggested time and date for a new appointment, and the clinic scheduler is added as a cosigner. The clinic scheduler will reschedule the patient and send a reminder letter to the patient.(c)If the patient “no-shows” a second consecutive time, steps 1 and 2 are repeated, the warfarin prescription is cancelled, and the patient is sent a letter informing them that the prescription is cancelled and asking them to contact the clinic as soon as possible.(d)If the patient “no-shows” a third consecutive time, step 1 is repeated and if the clinic is unsuccessful in contacting the patient by telephone, a note is placed in CPRS stating the patient should not be rescheduled and the primary care provider is added as a cosigner. Additionally, any warfarin prescriptions and lab orders placed by the clinic are cancelled. A clinic discharge letter will be sent to the patient explaining that the warfarin prescriptions have been cancelled and he/she will need to follow-up with the primary care provider.(e)A patient who has been discharged from the anticoagulation clinic due to non-compliance with any aspect of therapy will need to re-establish a pattern of compliance with the primary care provider for 2 months before the clinic will accept the patient again. The primary care provider will need to determine whether the patient can be safely anticoagulated. Re-enrollment in the anticoagulation clinic is initiated with a clinic consult. The anticoagulation clinic staff may waive the 2 month requirement if the clinic staff accepts that there were extenuating circumstances to explain the patient’s no-show pattern.4.Management of Warfarin TherapyA.Initiation of Warfarin Therapy - Initiation of warfarin in outpatients will generally be done using an average daily dosing method (attachment 3). Most patients will begin therapy with 5mg daily and the INR value checked within 3-5 days. Dosing adjustments will be made based on the response to the initiation of therapy. Patients who may be particularly sensitive to warfarin will begin therapy at 2.5mg daily.B.Warfarin Dosing Adjustments (1)General Guidelines: Patients will be assessed for signs or symptoms of thromboembolism, signs or symptoms of hemorrhage and whether the INR is within the target therapeutic range. (a)Is patient actively bleeding? If yes, refer to Guidelines for Correction of Overanticoagulation (attachment 12).(b)Does patient exhibit signs of thromboembolism? If yes, refer to MD.(2)Before adjusting the dose of warfarin, patient factors that alter INR must be ruled out. Consider repeat INR, or address underlying factors. In cases where the PT/INR is outside the therapeutic range, the following parameters will be assessed with action taken as appropriate (see attachments 7&8): (a)Test reliability may be questioned. All questionable INRs may be repeated up to three times.(b)Patient factors:i.Noncompliance – Verify with patient if they have missed any dose in the past 7 days. Educate as needed, and resume previous dose or adjust dose according to protocol.ii.Other risk factors (e.g. dietary changes) – Verify with patient. Address risk factors, educate as needed, and resume previous dose or adjust dose according to protocol.iii.Drug interactions – Contact physician. Suggest either an alternate drug therapy or an adjusted dose of warfarin as indicated. Repeat INR after adjustments.(3)Warfarin Dosage Adjustment Protocol: After consideration of patient condition, diet, and drugs, patients with stable INR out of range will be dosed according to the Dosage Adjustment Protocol (attachment 13). In general, adjustments will be made with consideration to the change in total weekly dose. (4)Weekly Warfarin Dosing Schedule: The dosing strategy will generally use a flexible weekly dosing pattern using single strength tablets whenever possible, the patient will only receive one strength warfarin tablet. In most cases 2mg or 5mg tablets will be used. Increases or decreases in the dose are based on a percentage of the total weekly dose and are estimated from the Warfarin Dosage Adjustment Protocol. C.Follow up monitoring -The patient will be scheduled for follow-up at appropriate intervals. The frequency of INR monitoring will be dictated by the dose response and current clinical information.(1)When initiating warfarin therapy, monitoring will be guided by the Guidelines for Initiation of Warfarin Therapy (attachment 3) until the therapeutic INR range is achieved and maintained for at least two consecutive periods. (2)When patients have achieved a stable therapeutic range INR, they will be monitored on a regular basis (attachment 9).munication with Patient – The patient is given written information indicating the new warfarin dosing schedule and indicating the number of tablets to take each day.5.Management of Parenteral AnticoagulationAnticoagulation clinicians will manage low molecular weight heparin and fondaparinux when necessary as part of the long-term management of anticoagulation, including initial dosing to attain therapeutic anticoagulation when initiating warfarin or “bridge” therapy to maintain anticoagulation during medical or surgical procedures that require interruption of anticoagulation. Use of parenteral anticoagulants will be based on recommendations by the American College of Chest Physicians, VA Formulary, manufacturers dosing recommendations for individual drugs, and other current evidence. Management of parenteral anticoagulants will be done in consultation with the referring provider or the provider performing the intervention requiring bridge therapy. When explicitly authorized by the provider, the anticoagulation may be managed by the anticoagulation clinic staff consistent with the clinician’s Scope of Practice. Hematology consultation is suggested when long term anticoagulation with parenteral agents is requested for non-cancer patients who are deemed inappropriate for warfarin. (Attachment 14) 6.Other functions of Anticoagulation Clinic StaffA.Outcome Analysis – The clinic will maintain a database with the information required to assess the quality of care provided. Periodic outcome analysis will be reported to the Pharmacy and Therapeutics Committee. Outcomes analysis may include the following:(1)Monitoring Outcomes (a)Therapeutic INRINR in range +/- 0.2 INR units(b)Subtherapeutic INR greater than 0.2 INR units below range(c)Supratherapeutic INRINR greater than 0.2 INR units above range(2)Clinical Outcomes (a)Thromboembolic eventsi.Thromboembolicany thromboembolic event, event regardless of interventionii. Fatal thromboembolicthromboembolic event event resulting in death (b) Hemorrhagic eventsi. Minor hemorrhagebleeding event requiring no interventionii. Intermediatebleeding event requiring interventionhemorrhage (including holding or reducing warfarin dose) but without hospitalizationiii. Major hemorrhagebleeding event requiring hospitalizationiv. Fatal hemorrhagebleeding event resulting in death(3)Resource Utilization Outcomes (a)Emergency Room visits i.Warfarin related ii.Warfarin unrelated (b)Hospitalizations i.Warfarin related ii. Warfarin unrelated(4)Explanations for INR out of range Change in medications Change in medical/health status Change in dietary Vitamin K Change in alcohol intake Change in activity level Noncompliance or incorrect use Initiation of therapy No clear explanation Response to change in previous warfarin dose Warfarin held intentionallyAttachments: 15Referral form – Electronic ConsultTherapeutic Range and Duration of Warfarin TherapyGuidelines for Initiation of Warfarin Therapy Patient Rights and Compliance AgreementPatient and Family EducationCPRS anticoagulation clinic templateClinic Patient Assessment Flowsheet Patient Assessment GuideFollow-Up INR Monitoring ScheduleOrdering Remote Labs for Anticoagulation ClinicCPRS Template - Remote Lab Order LetterGuidelines for Correction of OveranticoagulationWarfarin Dosage Adjustment ProtocolDosing Recommendations for Parenteral AnticoagulantsReferencesAttachment AReferral form – Electronic ConsultAttachment BTherapeutic Range and Duration of Warfarin TherapyBased on Antithrombotic and Thrombolytic Therapy: ACCP Evidence-Based Clinical Practice Guidelines 8th EditionINDICATIONINR TARGET(Range)DURATIONCOMMENTSAtrial Fibrillation (AF)/Paroxysmal AF (PAF)/Atrial FlutterWith prior history of stroke, TIA, or systemic embolism 2.5 (2.0-3.0)ChronicWith Risk Factors – age > 75, history HTN, diabetes, HF or moderate to severely impaired LVSF With No risk factorsNRASA 75-325mg daily With 1 risk factor2.5 (2.0-3.0)Chronicor ASA 75-325mg daily With 2 or more risk factors2.5 (2.0-3.0)ChronicWith Mitral Stenosis2.5 (2.0-3.0)ChronicWith Prosthetic Heart Valve – See BelowAtrial Fibrillation of known duration < 48 hours with planned cardioversionLong-term anticoagulation not suggested. IV unfractionated heparin or low-molecular weight heparin at presentation is suggested if patient has no contraindicationsAtrial Fibrillation ≥ 48 hours or unknown duration with planned cardioversion2.5 (2.0-3.0)3 weeks prior to cardioversion and 2.5 (2.0-3.0) 4 weeks after NSR has been maintainedMechanical Heart Valve ReplacementAortic Valve Bileaflet in NSR and w/o LA enlargement 2.5 (2.0-3.0)Chronic Medtronic Hall tilting disk, NSR2.5 (2.0-3.0)Chronic w/o LA enlargement Other (caged-ball, caged disk, etc)3.0 (2.5-3.5)Chronic Other risk factors for thromboembolism3.0 (2.5-3.5)ChronicConsider ASA 81mg/day (AF, anterior apical STEMI, LA enlargement, hypercoagulable state, low ejection fraction) Following resolution of valve thrombosis3.5 (3.0-4.0)Chronicand ASA 81mg/dayMitral Valve3.0 (2.5-3.5)Chronic Other risk factors for thromboembolism3.0 (2.5-3.5)ChronicConsider ASA 81mg/day*(AF, anterior apical STEMI, LA enlargement, hypercoagulable state, low ejection fraction) Following resolution of valve thrombosis4.0 (3.5-4.5)Chronicand ASA 81mg/daySystemic Embolism despite therapeutic INR Increase target INR 0.5and/or ASA 81mg/dayBioprosthetic Heart Valve ReplacementAortic Valve In NSR and with no other indicationsNRChronicASA 81mg/day Mitral Valve2.5 (2.0-3.0)3 monthsthen ASA 81mg/dayAortic or Mitral Valve with: Evidence of LA thrombus at surgery2.5 (2.0-3.0)Until documented thrombus resolution History of systemic embolism2.5 (2.0-3.0)3 months then clinical re-assessment Additional risk factors:2.5 (2.0-3.0)ChronicConsider ASA 81mg/day*(AF, hypercoagulable state, low ejection fraction)Thromboembolism (Deep Vein Thrombosis or Pulmonary Embolism)Long-term oral anticoagulation is initiated concurrently with parenteral anticoagulation (UFH, LMWH, or fondaparinux) which is continued for at least five days and until the INR is ≥ 2.0 for at least 24 hours).DVT or PE associated with: Transient or reversible risk factor2.5 (2.0-3.0)3 months Unprovoked first eventProximal DVT or PE2.5 (2.0-3.0) at least 3 months Chronic recommendedDistal DVT2.5 (2.0-3.0)3 months Unprovoked second event2.5 (2.0-3.0)Chronic Associated with cancer2.5 (2.0-3.0)See belowVTE associated with cancer is treated with 3 to 6 months LMWH followed by warfarin as long as the cancer remains active.Spontaneous superficial vein thrombosis4 weeks LMWH (P)or: 2.5 (2.0-3.0)4 weeksfollowing 5 days LMWH (P)Ischemic StrokeAcute stroke, with restricted mobilityNRLDUFH or LMWH (P) Noncardioembolic stroke or TIANRChronicAntiplatelet agentsCardioembolic stroke or TIA2.5 (2.0-3.0)Chronic Contraindication to anticoagulationNRChronicASA 75-325mg daily With aortic atherosclerotic lesionsNRChronicASA 81mg/day With mobile aortic arch thrombi2.5 (2.0-3.0)Chronicor ASA 81mg/day With mitral valve strands or prolapseNRChronicASA 81mg/dayCerebral Venous Sinus Thrombosis2.5 (2.0-3.0)up to 12 monthsValvular and Structural Heart DiseaseRheumatic mitral valve disease In NSR and without LA enlargementNR – unless other indication for anticoagulation (< 55mm) With risk factors2.5 (2.0-3.0)Chronic(AF, previous systemic emboli, LA thrombus, or LA diameter > 55mm) With AF and new systemic emboli or left atrial thrombus2.5 (2.0-3.0) Chronic add ASA 81mg/daywhile on therapeutic warfarin: or: 3.0 (2.5-3.5)ChronicMitral Valve Prolapse Without AF, systemic embolism,NR – unless other indication for anticoagulationTIA, or ischemic stroke With ischemic stroke or unexplained TIANRChronicASA 81mg/day With AF, systemic embolism,2.5 (2.0-3.0)Chronicrecurrent TIA while on ASAMitral annular calcification with: Systemic embolism, ischemicNRChronicASA 81mg/daystroke or TIA without AF AF or with recurrent event2.5 (2.0-3.0)Chronicdespite ASA therapyAortic valve disease Isolated calcific disease withoutNR – unless other indication for anticoagulationischemic stroke or TIA With ischemic stroke or TIANRChronicASA 81mg/dayInfective endocarditisNR – unless other indication for anticoagulation*Unless patient is at particularly high risk of bleed such as those with history of GI Bleed or older than 80 years.NR – Not recommended, LDUFH – Low dose unfractionated heparin, LMWH(P) – Prophylactic dose low molecular weight heparin, ASA – Aspirin, LA – Left Atrial, TIA – Transient Ischemic Attack.Attachment CGuidelines for Initiation of Warfarin TherapyInitiation of warfarin in outpatients will use an average daily dosing method. Most patients will begin therapy with 5mg daily and the INR value checked within 3-5 days. Dosing adjustments will be made based on the response to the initiation of therapy. Patients who may be particularly sensitive to warfarin will begin therapy at 2.5mg daily.The following guidelines are intended for outpatient initiation of low intensity (INR 2.0-3.0 range) anticoagulation from Day 1 through Day 7. Patients who are stable beyond Day 7 will be managed using the Warfarin Dosage Adjustment Protocol (Attachment 19).1.Obtain baseline lab tests, screen for drug interactions, contraindications and risk factors. Determine whether patient may be sensitive to warfarin. The following may suggest the patient may be warfarin sensitive. a.Age – Greater than 70 years of ageb.Weight – Lower weight (less than < 50 kg), especially combined with advanced age may result in lower dose requirementsc.Elevated baseline INRd.Fever – Prolonged elevated temperaturee.Diarrhea – Severe diarrhea (5-6 loose stools) for several daysf.End-stage renal failureg.Liver Function – Liver dysfunction may result in impaired Vitamin K production and lower dose requirementsh.Chronic Heart Failure – Clinical CHF may lead to unexpected elevations in prothrombin timei.Clinical hyperthyroidismj.Malignancyk.Malnutrition, decreased oral intake, nothing by mouth for more than 3 days.l.Dietary Vitamin K intake – especially important if significant changes have occurred m.Medications – Medications which inhibit metabolism of warfarin. 2.Day 1 and Day 2 a.Start 5mg daily if patient is < 70 years of age and has no obvious risk factors or indicators that he/she may be warfarin sensitive.b.Start 2.5mg daily if patient is likely to be warfarin sensitive.c.Start dose between 2.5-5mg (e.g. 4mg) daily if patient has moderate risk to be warfarin sensitive.3.Day 3a.Obtain INR on Day 3 before patient takes warfarin dose. If INR is not in range, adjust dose according to the following table through Day 7. If INR is not in range, recheck every 1-4 days according to the table until in range. DayINR RangeNotify MDAction3> 2YesHold Day 3 dose. Recheck daily until INR in range. Restart warfarin at a lower dose when INR falls into therapeutic range.≤ 22.5-5mg for day 3 and 4. Recheck at day 5.≤1.52.5-7.5mg for day 3 and 4. Recheck at day 5.5> 3.0YesHold Day 5 dose. Recheck daily until INR in range. Restart warfarin at a lower dose when INR falls into therapeutic range.≤2.05-7.5mg for Day 6 and 7. Recheck at Day 7.In range.Continue current dose. Recheck in 4 days.7> 3.0YesDecrease dose per Warfarin Dosing Adjustment Guidelines. Recheck in 4 days.≤2.0Increase dose per Warfarin Dosing Adjustment Guidelines. Recheck in 4 days.In rangeContinue current dose. Recheck in 4 days.Attachment DPatient Rights and Compliance AgreementI understand that, as a participant in the Anticoagulation Clinic who taking warfarin, it is necessary that I keep my appointments to have my blood work done. If I am unable to keep my appointment, I will notify the clinic as soon as possible at Insert Telephone Number to reschedule.I understand that I will call the anticoagulation clinic if I do not receive instructions within 48 hours after a blood test.I am willing to follow instructions provided by the anticoagulation clinic regarding warfarin dosing changes and administration, and diet and activity recommendations. I will call the anticoagulation clinic to notify them of changes to my medications or health.I am able to travel to the laboratory at the VA or I am able to travel to a designated laboratory for blood tests.I have access to a telephone and can be reached by telephone if necessary. I will provide the anticoagulation clinic with an updated phone number promptly if it ever changes.Warfarin is a medicine that must be monitored closely in order to help protect me from any complications. I understand that noncompliance with any of the above can result in serious health risks and I understand that if I fail to comply I may be dismissed from the anticoagulation clinic program.I am independent or have a reliable caretaker.I am willing and able to follow instructions.I am able to understand verbal and written instructions or have a reliable caretaker.Patient SignatureDateWitness SignatureDateAttachment EPatient and Family Education1.Patients receiving anticoagulation through the outpatient anticoagulation programs will receive education to include the followinga.The rationale for anticoagulation therapyb.How warfarin (or parenteral agent) works to benefit the patientc.Potential food and drug interactions and the patient’s responsibilities for minimizing the impact of interactionsd.Avoidance or minimization of the use of NSAIDse.Dietary considerations (including alcohol use)f.Laboratory monitoring used to adjust therapyg.Actions to take if a dose is missedh.Signs of over anticoagulationi.Signs of disease mon side effectsk.What to do in case of bleedingl.Planned length of therapym.Current dose and tablet strengthn. follow-up plan including next appointment and lab number2.Education will be documented in the patient medical record3.Education may include additional resources including the followinga. “Understanding your COUMADIN therapy” Bristol-Meyers Squibb, 2007b. Fragmin Patient Kit, Eisai Inc.c. “At home with LOVENOX”, Sanofi-Aventis U.S. LLCd. Arixtra Patient Starter Kit, GlaxoSmithKlineAttachment FCPRS Anticoagulation Clinic TemplateLOCAL TITLE: ANTICOAGULATION NOTE STANDARD TITLE: E & M OF ANTICOAGULATION NOTE DATE OF NOTE: ENTRY DATE: AUTHOR: EXP COSIGNER: URGENCY: STATUS: Anticoagulation Clinic Follow-UpS/O:? |PATIENT AGE| patient returns for follow-up anticoagulation.?????????????????????????????????????????????????????????? INR: |INR|?????????????????????????????????????????????????????????????????????????? ASSMESSMENT/PLAN (Discussed with patient):??????? therapeutic range INR for??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? RETURN TO CLINIC:???????????????????????????????????????????????????????????????????? ??Face to face time: ???minutes_____________________________________________________________________________? SUPPLEMENTAL INFORMATION These items have been reviewed by the pharmacist and any updates are documented above.Clinic Enrollment Date: Indication:? Duration: Goal INR (International Normalized Ratio):? 2-3Current Dose: WarfarinTablet size:|PRIMARY CARE PROVIDER|SUBJECTIVE:Over-the-Counter Meds:???????????????????????? Yes/NoHerbals (egg, green tea):????????????????????? Yes/No ETOH:?????????????????????????????????????????Yes/NoTobacco:??????????????????????????? ???????????Yes/NoHave you had any unusual bleeding or bruising? Yes/NoRecent medication changes:???????????????????? Yes/No Any recent hospital visits or procedure??????? Yes/NoAny missed or extra doses Warfarin???????????? Yes/No Do you need a warfarin refill today??????????? Yes/No Any recent falls?????????????????????????????? Yes/NoAny nausea, vomiting, or diarrhea????????????? Yes/No?? LABS:BP:|BLOOD PRESSURE||PULSE||INR LAST 3|HCT |HCT||SGOT||SGPT|PMH:|ACTIVE PROBLEMS|Allergies/ADR:? |ALLERGIES/ADR|????????????????????????????????????????????? ??????????????????????????????????????????????????????????????????????????????? |MEDS OUTPATIENT| ??????????????????????????????????????????????????????????? |MEDS PENDING/HOLD|?????????????????????????????????????????????????????????????????????????????? |MEDS EXPIRED|????????????????????????????????????????????????????????????????? ??????????????????????????????????????????????????????????????????????????????? |MEDS NON VA| |REMOTE MEDS|Attachment GLaboratory Error Suspected or Verified?NOYESRepeat INRSigns or Symptoms of Thromboembolism?NOYESManage per MD instructionsSigns or Symptoms of Hemorrhage?NOYESMajor or Intermediate HemorrhageUnresolved or recurrent minor hemorrhageResolved or minor hemorrhageChanges in Current Medications?NOYESLong term deletionLong term additionShort term addition/deletionConsider non-interacting substituteConsider influence on INR and warfarin doing requirementsChanges in underlying medical condition?NOYESConsider influence on INR and warfarin doing requirementsChanges in dietary Vitamin K or Alcohol Intake?NOYESConsider influence on INR and warfarin doing requirementsVerify current dose. Non-compliance or Incorrect use suspected or verified?NOYESConsider influence on INR and warfarin doing requirementsDuration of therapy completed?NOYESContact MD to consider discontinuation of therapyAberrant Result in Normally Stable Patient?Elevated INRLow or slightly elevated INRHold 0-1 doseContinue current doseNOYESINR outside of therapeutic range?Schedule Return AppointmentAdjust dose per guidelinesNOYESLaboratory Error Suspected or Verified?NOYESRepeat INRSigns or Symptoms of Thromboembolism?NOYESManage per MD instructionsSigns or Symptoms of Hemorrhage?NOYESMajor or Intermediate HemorrhageUnresolved or recurrent minor hemorrhageResolved or minor hemorrhageChanges in Current Medications?NOYESLong term deletionLong term additionShort term addition/deletionConsider non-interacting substituteConsider influence on INR and warfarin doing requirementsChanges in underlying medical condition?NOYESConsider influence on INR and warfarin doing requirementsChanges in dietary Vitamin K or Alcohol Intake?NOYESConsider influence on INR and warfarin doing requirementsVerify current dose. Non-compliance or Incorrect use suspected or verified?NOYESConsider influence on INR and warfarin doing requirementsDuration of therapy completed?NOYESContact MD to consider discontinuation of therapyAberrant Result in Normally Stable Patient?Elevated INRLow or slightly elevated INRHold 0-1 doseContinue current doseNOYESINR outside of therapeutic range?Schedule Return AppointmentAdjust dose per guidelinesNOYESAttachment HPATIENT ASSESSMENT GUIDE1.Is laboratory error suspected?reliable lab using the INR reporting methodproper method used for venopuncture or fingerstickintegrity of sample (proper volume, storage, etc)type of laboratory equipment usedappropriate quality of control processISI of thromboplastin < 1.52.Are there any signs or symptoms of thromboembolism?STROKE / TIASudden numbness or weakness of the face, arm or leg, especially on one side of the bodySudden confusion, trouble speaking or understandingSudden trouble seeing in one or both eyesSudden trouble walking, dizziness, loss of balance or coordinationSudden severe headache with no known causeDVTSwelling, pain and/or tendernessDiscoloration of the affected limb (pallor, cyanosis or erythema)Homan’s sign (pain behind the knee or calf with dorsiflexion of foot)PEDyspneaTachypneaPleuritic chest painTachycardiaCoughRalesHemoptysisApprehensionPost Phlebitic SyndromeDeep Vein ThromboticPain“not as bad as when I had the clot”, “worse after I’ve been on my feet”, “dull ache”“just like the first time”“worst it has ever been”Swellingusually will ↓ after feet are elevatedpresent at all timesAppearancechronic changesred, hot3.Are there any signs or symptoms of bleeding?a.definitions of bleeding complications(1)minor bleeding:no intervention required(2)intermediate bleedingintervention required, without hospitalization(3)major bleedinghospitalization requiredb.assessment questions(1)excessive or spontaneous bruising(2)nosebleeds (how long did it last?)(3)gum bleeding(4)eye hemorrhage(5)hematoma(6)excessive menstrual bleeding(7)throwing up blood(8)coughing up blood(9)any falls(10)head trauma(11)blood in stool (dark, tarry vs bright red; history of hemorrhoid or polyps)(12)blood in urine (pink, rust, or cola colored)4.Are there changes in medication use?a.evaluate current prescription drug use(1)for all medications, determine:(a)brand/generic name(b)dosage form and dose(c)frequency(d)indication(e)compliance(f)prescriber(2)consider the following questions(a)does anyone at home help you with your medications?(b)what do you do when your symptoms increase or decrease?(c)do you ever miss a dose, why, what happens?(d)do you ever take more, why, what happens?(e)do you ever take anyone else’s medication?(f)do you not take any medications currently prescribed?(g)do you take any medications not prescribed to you?b.evaluate current nonprescription drug usecompound to consider(a)over-the-counter medications(b)vitamins(c)nutritional supplements(d)herbal products(e)homeopathic agents(f)naturopathic agents(g)home remedies(2)considerations(a)patient’s definition of medication vs. drug vs. other(b)“by systems” / “by indication” approach(c)frequency, duration, most recent use of non-Rx productsc.further observations(1)have patients bring all Rx and non-Rx products to clinic(2)review administration devices, reminder techniques, etc(3)compare bottle labels to actual administration(4)compare product on label to contents of vial(a)Changes in underlying disease states?i.thyroid statusii.congestive heart failureiii.malignancy (↓ plts, chemo, radiation, N/V, etc)iv.liver diseasev.diarrheavi.fevervii.activity level(b)Any changes in diet or alcohol intake?i.vegetarian diet started or stoppedii.current harvest of regional, local, or home cropsiii.oils in foodsiv.alcohol intakev.herbal or green teasvi.chewing tobaccovii.other sources of vitamin K5.Current dose verified?a.Non-compliance suspected or verified?b.verify mg dose versus number of tablets per dosec.check tablet by color and shaped.patient or caregiver able to recite dosee.missed dosesf.switch from brand to generic productg.written instructions versus verbal instructionsh.use of compliance aids6.Any changes in risk: benefit ratio?a.duration of therapy completedb.major bleeding eventc.new risk factors for bleeding or thromboembolismAttachment IFollow-Up INR Monitoring SchedulePatients who have achieved a stable therapeutic range INR after initiation may be monitored on a regular basis according to the following guidelines:Initiation of TherapyAfter stabilization with average daily dosing method – Within one week then weekly x 2 weeks and every 1-2 weeks for the first two months.After hospital discharge – Within 3-5 days if stable or 1-3 days if unstable. After stabilization, within one week then weekly x 2 weeks and every 1-2 weeks for the first two months.Maintenance TherapyDose held today in patient with significant over anticoagulation – Within 1-5 days.Minor dosage change today – Within 2-3 weeks (or less if appropriate)*Major dosage change today – Within 1-2 weeks (or less if appropriate)**Dosage change ≤ 2 weeks ago – Within 2-4 weeksRoutine follow-up of medically stable and reliable patients – Every 4 weeksRoutine follow-up of medically unstable or unreliable patients – Every 1-2 weeks.* Minor change is defined as ≤ 14% change in weekly dose.** Major change is defined as ≥ 15% change in weekly dose.Attachment JOrdering Remote Labs for Anticoagulation ClinicREMOTE LABS for Anticoagulation Clinic:?? Make an appointment for anticoagulation lab clinic (38000) for the appropriate date and note in chart.? This may be the only way we have to track down results, so an appointment is critical.1.The clinics may allow remote labs for patients established in the anticoagulation clinic with stable INR’s.? Some exceptions for patients with less stable INR’s who have great difficulty with traveling may be made at the discretion of the clinician, but this involves more telephone care. 2.On rare occasion one time remote labs for NEW patients with worrisome INR’s requiring close follow-up may be reviewed by the anticoagulation clinic staff when patients cannot make it to clinic may be allowed, however patients are not enrolled in the clinic until they have been seen as a NEW patient, so the burden of care rests on the referring provider until the patient can be seen in the clinic.? 3.Remote labs may be drawn VA at the following sites:a.Bremerton CBOC b.Port Angeles VA clinic c.American Lake VA d.Bellingham outreach. 4.Costs for remote labs done at all other sites are the responsibility of the patient to either self-pay, use private insurance, or Medicare. 5.On RARE occasions, the PCP may request Fee Services to pay for remote labs. It is unusual for Fee Services to approve payment for remote labs and the clinic will not offer this option to patients.6.For patients using outside labs, the VA clinical will order labs using the following procedures. a.Obtain the name and phone number of the lab, including FAX number and note on order if possible. b.Use the remote labs template with NPI number (see template Attachment 19) c.If the patient is in clinic, give a printout of the order to the patient d.If by phone, print a copy of the order to PCCACOG-12 for Jennie to Fax (include phone number and FAX) 7.For patients using VA facilities, a lab order for STAT PT/INR must be given to patient for each lab draw.? The remote lab template is not necessary for using the above VA facilities.? Patients do not need to be enrolled at the location where their labs are drawn (e.g.? A patient with a PCP at Seattle PCC can have lab work done at other VA facilities listed above). a.Bremerton CBOC:? lab draws are scheduled and picked up by courier at 3 pm and brought to Seattle VA for processing.? Results are available late evening.? Critical results are called to ER MOD, otherwise results are received by the anticoagulation clinic the next day. b.Port Angeles VA clinic:? lab draws are scheduled between 8 am-12 noon, picked up by courier and brought to Seattle VA, results available next day.? c.American Lake VA:? lab draws are unscheduled, can be drawn during business hours and available same day.? d.Bellingham outreach: lab draws are by appointment only and are generally on the first Saturday of each month.? Results available late evening.? Critical results are called to ER MOD, otherwise results are received by the anticoagulation clinic the following Monday (or Tuesday if a Monday holiday). 8.Results of therapeutic range remote labs are communicated by letter, out of range results or patients requiring close follow-up are communicated by telephone.? All contacts with patients must be documented in the chart.Attachment KCPRS Template - Remote Lab Order Letter|PATIENT NAME||PATIENT ADDRESS|Anticoagulation ClinicPuget Sound VA Health Care SystemSeattle Division1660 S. Columbian WaySeattle, WA 98108Fax (206) 277-4889|TODAY'S DATE|To Whom It May Concern:|PATIENT NAME| is receiving anticoagulation therapy for:() Atrial Fibrillation 427.31() CAD414.00() PVD443.9() DVT453.8() Coagulation defect286.9() Heart valve prosthesis V43.3() CVA436.0() TIA435.9Please draw this patient's PT/INR monthly and fax to: 206-277-4889, Attention: ANTICOAGULATION CLINIC. This order is valid for venous blood lab specimens only; no whole blood fingerstick lab results will be accepted. This clinic will be responsible for notifying the patient of these results and adjusting the warfarin dosage.Please honor this as a standing order for 6 months. Start date is the date of this letter, stop date is six months from the date of this letter. My NPI # is, and may only be used for current orders.Sincerely,Attachment LGuidelines for Correction of over anticoagulationBased on Antithrombotic and Thrombolytic Therapy: ACCP Evidence-Based Clinical Practice Guidelines 8th EditionINRClinical SettingRecommendations> therapeutic range, but < 5.0Not bleedingPer Dosage Adjustment Protocol Attachment 13< 5.0Rapid Reversal RequiredHold warfarin. Vitamin K 1 or 2.5mg PO. Recheck INR in 24 hours.5.0 to < 9.0Not bleedingNotify MDHold warfarin (1-2 doses) until INR therapeutic, then reinstitute at lower dose. Consider Vitamin K 1 - 2.5mg PO x1.5.0 to < 9.0Rapid Reversal RequiredRefer to MDHold warfarin. Vitamin K 1 – 5 mg PO. Recheck INR in 24 hours.≥ 9.0Not bleedingRefer to MDHold warfarin. Vitamin K 2.5 or 5 mg PO . Recheck INR in 24-48 hours. Reinstitute warfarin at lower dose when INR is therapeutic.≥ 9.0Rapid Reversal RequiredRefer to MDHold warfarin. Vitamin K 1-5mg IV*. Recheck INR in 6-24 hours.Serious BleedingAny INRRefer to MDHold warfarin. Vitamin K 10mg IV*. Consider fresh frozen plasma or prothrombin factor concentrates. Recheck INR every 6 hours until in range. Repeat Vitamin K every 12 hours as needed.*IV vitamin K should generally only be administered if oral intake and absorption is impaired or the patient is experiencing a serious bleed. Because of the potential for hypersensitivity or anaphylactic reaction to intravenous Vitamin K, it should be given as a slow IV infusion over 20-30 minutes. Reduction in INR following oral vitamin K generally occurs within 24-48 hours. Attachment MWarfarin Dosage Adjustment ProtocolAfter consideration of patient condition, diet, and drugs, patients with stable INR out of range will be dosed according to the Dosage Adjustment Protocol. The Weekly Warfarin Dosing Schedule will be used to determine the actual daily dose prescribed.Warfarin Dosing Adjustment ProtocolA. LOW INTENSITY (INR = 2.0-3.0)INRHOLD / RELOADCHANGE IN WEEKLY DOSE (%)< 2.0Increase by 5-15%2.0-3.0No Change3.1-3.5Decrease by 0-15%3.6-4.0Hold 0-1 doseDecrease by 5-15%> 4.1Hold 0-2 doses or until therapeuticDecrease by 10-20%> 6.0Notify MDSee Reversal ProtocolHIGH INTENSITY (INR = 2.5-3.5)INRHOLD / RELOADCHANGE IN WEEKLY DOSE (%)< 2.0Reload onceIncrease by 10-20%2.0-2.4Increase by 5-15%2.5-3.5No Change3.6-4.6Decrease by 5-15%4.7-5.2Hold 0-1 doseDecrease by 10-20%> 5.2Hold 0-2 dosesDecrease by 10-20%> 6.0Notify MDSee Reversal ProtocolAttachment NDosing Recommendations for Parenteral Anticoagulants1.Dalteparin (Fragmin?) for subcutaneous injectionUsual treatment dose is 200 units/kg once daily or 100 units/kg twice dailyDose for patients with VTE and cancer is 200 units/kg once daily or 100 units/kg twice daily for one month followed by 150 units/kg daily for two additional monthsDose is based on total body weight (TBW)Maximum weight (TBW) used for dosing is 190 kgConsideration of commercially available pre-filled syringe sizes should be made in dosing recommendation to minimize potential for patient errorUse with caution in patients with renal dysfunction (CrCl < 60ml/min)use cautiously in patients with CrCl 30-60 ml/min, consider reduced dosedo not use in severe renal dysfunction (CrCl < 30ml/min)Consider intravenous unfractionated heparin for obese patients (> 190 kg) or patients with renal dysfunction2.Enoxaparin (Lovenox?) for subcutaneous injectiona.Usual treatment dose is 1mg/kg twice daily or 1.5mg/kg once daily (indication specific)b.Dose is based on total body weight (TBW)c.Maximum weight (TBW) used for dosing is 144 kgd.Consideration of commercially available pre-filled syringe sizes should be made in dosing recommendation to minimize potential for patient errore.Use with caution in patients with renal dysfunction (CrCl < 60ml/min)f.use cautiously in patients with CrCl 30-60 ml/min, consider reduced doseg.do not use in severe renal dysfunction (CrCl < 30ml/min)h.Consider dalteparin for obese patients > 144 kg and up to 190 kg or intravenous unfractionated heparin for obese patients (> 190 kg) or patients with renal dysfunction3.Fondaparinux (Arixtra?) for subcutaneous injectiona.Usual treatment dose is 7.5mg once daily for patients weighing 50-100 kg and 10mg once daily for patients weighing > 100 kg.b.Dose is based on total body weight (TBW)c.Use with caution in patients with renal dysfunction (CrCl < 50ml/min)Attachment OReferences:1.Ansell JE, Oertel LB, and Wittkowsky AK. Managing Oral Anticoagulation Therapy: Clinical and Operational Guidelines. 2.Veteran’s Administration, American Lake Anticoagulation Clinic October, 20033.VA Puget Sound Health Care System-Seattle Division, Anticoagulation Program Policies and Procedures, September 2, 20044.Pharmacist Prescriptive Authority for Warfarin in Anticoagulation Clinic, Anticoagulation Clinic Monitoring and Treatment Guideline, Franciscan Health System, Keith Sinay, R.Ph. August 20045.University of Washington Medical Center Anticoagulation Clinics, with permission.6.Manual of Acute & Chronic Oral Anticoagulation Management, Virginia Mason, Guidelines from the Anticoagulation Clinic Virginia Mason Medical Center, Cardiology Section, 20007.Spokane VAMC Anticoagulation Clinic Guidelines8.Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition)9.Ambulatory Care Pharmacists Advanced Scope of Practice, Anticoagulation. Department of Veterans Affairs VA Puget Sound Health Care System (Seattle and American Lake Divisions)VA Puget Sound Health Care SystemClinical Support ServicesPharmacy Standard Operating Procedure #001July 2008SUBJECT: INPATIENT PHARMACY ORAL ANTICOAGULATION MONITORING1.PURPOSE: To describe oral anticoagulation monitoring activities and responsibilities for inpatient pharmacists assigned to all inpatient patient care areas; including medicine, surgery, intensive care, long-term care, mental health services, and specialty areas.2.POLICY:a.The goal of the inpatient oral anticoagulation monitoring program is to ensure that all patients receive warfarin which is appropriately dosed based on standard protocols for initiation and monitoring to maximize therapeutic outcomes and minimize adverse events. Additionally, it is to help promote continuity of care after discharge, by assuring patients have a documented plan of care for follow-up, including appropriate monitoring and patients and caregivers receive necessary education regarding the use oral of and outpatient parenteral anticoagulation.b.Pharmacists assigned to the inpatient patient care areas will be responsible for monitoring all inpatients receiving oral anticoagulation therapy. Monitoring will include:(1)Documentation of the indication for anticoagulation and target INR as established by the provider prior to initiation of warfarin and baseline or current INR in a progress note. Comparison of the target INR with established guidelines for anticoagulation based on indication and discussion of significant deviations with the provider.(2)Evaluation of the initial dose of warfarin as compared to the patient’s current dose or compared to standard protocols for initiation or adjustment of doses and discussion of significant deviations with the provider.(3)Evaluation of follow-up lab monitoring intervals for adherence to standard results protocol. The pharmacist may order labs as needed.(4)Review of lab results at appropriate intervals and making dose adjustment and monitoring recommendations based on established protocol. (5)Recommendations for dose adjustments or increased monitoring at any time based on changes to the patients clinical status, including initiation or discontinuation of drugs which significantly interact with warfarin.(6)Clarification of post-discharge plans for follow-up anticoagulation management and evaluation of appropriateness of plans for safe and effective use of anticoagulation.(7)Patient and caregiver education for safe and effective use of anticoagulation prior to discharge.(8)Documentation of all findings and recommendations in the progress notes of the electronic medical record.3.PROCEDURE:a.Each day, a pharmacist from each inpatient care area will run a list of all patients who have received warfarin in the previous 24 hours (attachment A). Pharmacist responsible in respective areas:(1)American Lake: inpatient pharmacist(2)Seattle 1st floor: Zone 1 pharmacist(3)Seattle 7th floor: Zone 7 pharmacist(4)Seattle 2nd and 4th floors: Zone 4 0730am pharmacist(5)Seattle 3rd floor: Zone 3 0600 SICU pharmacistb.Within 24 hours of initiation of warfarin, a pharmacist will record the indication for anticoagulation and target INR (established by provider), current INR, and current warfarin dose in a standard format in a progress note in the patient’s medical record (attachment B). The pharmacist will compare the recommended target INR with established guidelines for anticoagulation based on indication (attachment C) and discuss significant deviations with the provider. The reason for deviation will be documented in the note. c.The pharmacist will record additional information necessary to evaluate anticoagulation therapy including trended INR values, trended warfarin dosing changes, additional anticoagulant or antithrombotic drugs, other potentially interacting drugs, and other information as available from the medical record to indicate signs and symptoms of either over- or under-anticoagulation in the progress note. Information regarding potentially significant drug interactions will be obtained from CPRS order checks, Micromedex?, other drug interaction references, and primary literature.d.Based on guidelines for initiation of warfarin (attachment D) and protocols for adjustments of doses in stable patients (attachment E), the pharmacist will evaluate the current dose and INR and make recommendations including increasing, decreasing, holding or no change to the dose of warfarin. When a change in dose is recommended, the pharmacist will communicate the recommendation to the patient’s provider. Based on the protocol a follow up INR will be ordered for the appropriate interval (attachment F). The pharmacist may place the order for the INR if necessary. All recommendations will be documented in the progress note. A physician on the patient’s inpatient care team will be added as a cosigner to the progress note.e.The pharmacist will verify the physician has been notified of all INR’s > 6.0 and will offer recommendations for management of over anticoagulated patients as needed (attachment G).f.The patient’s provider institutes all medication changes and other recommendations made by the pharmacist if deemed appropriate.g.Prior to discharge the pharmacist will clarify the post-discharge plans for anticoagulation management with the provider or discharge planning team. The pharmacist will document the post-discharge plans in the discharge progress note.h.Prior to discharge the pharmacist will provide education to the patient and/or caregivers to allow safe and effective use of anticoagulation. If significant barriers to understanding which would not allow safe use of anticoagulants are determined by the pharmacist, the provider will be notified. The pharmacist will document education in the discharge progress note (attachment H). 4.RESPONSIBILITY:a.Director, Clinical Support Service: overall programb.Inpatient Clinical Program Manager: clinical program development, implementation and clinical pharmacy direction. c.Inpatient Pharmacy Program Manager will be responsible for administrative supervision of the pharmacist(s) assigned to the patient care areas.d.Inpatient Pharmacists: will be responsible for monitoring the oral anticoagulation therapy for all patients who are in their care area and have received warfarin in the previous 24 hours, communicating findings and recommendations to the patient’s provider, and for documenting findings and recommendations in the patient’s progress note of the electronic medical record. e.Inpatient providers continue to evaluate therapeutic indications, determine therapeutic treatments and endpoints for the patient, placing medication orders to implement dosing recommendations, and establish the post-discharge plan of care. 5.REFERENCES: University of Washington Anticoagulation Service April, 2008.6.RECISSION: None7.FOLLOW-UP RESPONSIBILITY: Director, Clinical Support ServicesFrank J Yunker, PharmD, MBADirectorAttachments:Queuing List of Warfarin patients in VISTACPRS Templated Progress NoteTherapeutic Range and Duration of Warfarin TherapyMethods for Initiation of Warfarin Therapy for InpatientsWarfarin Dosage Adjustment Protocol for stable patientsINR Monitoring ScheduleGuidelines for Correction of over anticoagulationAttachment AVA Puget Sound Health Care SystemClinical Support ServicesPharmacy Standard Operating Procedure #001Queuing List of Warfarin patients in VISTASelect Inpatient Pharmacy Menu (Pharmacist) Option: ^PSD Patients on Specific Drug(s)Enter start date: T-1 Enter stop date: T List IV orders, Unit Dose orders, or All orders: ALL// Unit Dose Do you wish to sort by (P)atient or (S)tart Date: Patient// Patient List by (O)rderable Item, (D)ispense Drug, or (V)A Class of Drugs: Orderable Item Select PHARMACY ORDERABLE ITEM NAME: WARFARIN TAB Dispense Drugs for WARFARIN are:WARFARIN (COUMADIN) NA 5MG TABWARFARIN (COUMADIN) 0.5MG [HALF 1MG TAB]WARFARIN (COUMADIN) NA 2.5MG TABWARFARIN (COUMADIN) NA 2MG TABWARFARIN (COUMADIN) NA 7.5MG TABWARFARIN (COUMADIN) NA 10MG TABWARFARIN (COUMADIN) 1.25MG [HALF 2.5 TABWARFARIN (COUMADIN) NA 1MG TABWARFARIN (COUMADIN) 3.75MG [HALF 7.5 TABSelect PHARMACY ORDERABLE ITEM NAME: Select number of matches: 1//1 Select PRINT DEVICE: Your PrinterAttachment BCPRS Templated Progress NoteLOCAL TITLE: PHARMACY WARFARIN MONITORING AND RECOMMENDATIONS STANDARD TITLE: PHARMACY E & M OF ANTICOAGULATION NOTE DATE OF NOTE: Date ENTRY DATE: Date AUTHOR: EXP COSIGNER: URGENCY: STATUS: COMPLETED Indication for warfarin:Warfarin initiation date:[ ] if > one year ago or,Date: _________ if < one year ago.Baseline INR: _______ on admission if admitted on warfarin or, _______ at time of initiation of warfarin.Expected duration:Target INR (International Normalized Ratio) range: Inpatient care provider: Outpatient primary care site:Subjective: Objective: Blood Pressure:SBP/DBP (date time)Last 7 INR: Laboratory test: INR; specimen: PLASMA (date)value – (INR) (date)value – (INR) (date)value – (INR) (date)value – (INR) (date)value – (INR) (date)value – (INR) (date)value – (INR)Plt: value K/uL (date time)Hct:value % (date time)SGOT date time value SGPT date time value Date Warfarin Dose INR Assessment: Recommendations: Recommended dose:Recommended next INR date:Discharge Planning:Attachment CTherapeutic Range and Duration of Warfarin TherapyORAL ANTICOAGULATION THERAPEUTIC RANGE AND DURATIONVA Puget Sound Healthcare System, 2008Based on Antithrombotic and Thrombolytic Therapy: ACCP Evidence-Based Clinical Practice Guidelines 8th EditionINDICATIONINR TARGET(Range)DURATIONCOMMENTSAtrial Fibrillation (AF)/Paroxysmal AF (PAF)/Atrial FlutterWith prior history of stroke, TIA, or systemic embolism 2.5 (2.0-3.0)ChronicWith Risk Factors – age > 75, history HTN, diabetes, HF or moderate to severely impaired LVSF With No risk factorsNRASA 75-325mg daily With 1 risk factor2.5 (2.0-3.0)Chronicor ASA 75-325mg daily With 2 or more risk factors2.5 (2.0-3.0)ChronicWith Mitral Stenosis2.5 (2.0-3.0)ChronicWith Prosthetic Heart Valve – See BelowAtrial Fibrillation of known duration < 48 hours with planned cardioversionLong-term anticoagulation not suggested. IV unfractionated heparin or low-molecular weight heparin at presentation is suggested if patient has no contraindicationsAtrial Fibrillation ≥ 48 hours or unknown duration with planned cardioversion2.5 (2.0-3.0)3 weeks prior to cardioversion and 2.5 (2.0-3.0) 4 weeks after NSR has been maintainedMechanical Heart Valve ReplacementAortic Valve Bileaflet in NSR and w/o LA enlargement 2.5 (2.0-3.0)Chronic Medtronic Hall tilting disk, NSR2.5 (2.0-3.0)Chronicw/o LA enlargement Other (caged-ball, caged disk, etc)3.0 (2.5-3.5)Chronic Other risk factors for thromboembolism3.0 (2.5-3.5)ChronicConsider ASA 81 mg/day (AF, anterior apical STEMI, LA enlargement, hypercoagulable state, low ejection fraction) Following resolution of valve thrombosis3.5 (3.0-4.0)Chronicand ASA 81mg/dayMitral Valve3.0 (2.5-3.5)Chronic Other risk factors for thromboembolism3.0 (2.5-3.5)ChronicConsider ASA 81mg/day*(AF, anterior apical STEMI, LA enlargement, hypercoagulable state, low ejection fraction) Following resolution of valve thrombosis4.0 (3.5-4.5)Chronicand ASA 81mg/daySystemic Embolism despiteIncrease target INR 0.5and/or ASA 81mg/day therapeutic INR Bioprosthetic Heart Valve ReplacementAortic Valve In NSR and with no other indicationsNRChronicASA 81mg/day Mitral Valve2.5 (2.0-3.0)3 monthsthen ASA 81mg/dayAortic or Mitral Valve with: Evidence of LA thrombus at surgery2.5 (2.0-3.0)Until documented thrombus resolution History of systemic embolism2.5 (2.0-3.0)3 months then clinical reassessment Additional risk factors:2.5 (2.0-3.0)ChronicConsider ASA 81mg/day* (AF, hypercoagulable state, low ejection fraction)Thromboembolism (Deep Vein Thrombosis or Pulmonary Embolism)Long-term oral anticoagulation is initiated concurrently with parenteral anticoagulation (UFH, LMWH, or fondaparinux) which is continued for at least five days and until the INR is ≥ 2.0 for at least 24 hours).DVT or PE associated with: Transient or reversible risk factor2.5 (2.0-3.0)3 months Unprovoked first eventProximal DVT or PE2.5 (2.0-3.0) at least 3 months Chronic recommendedDistal DVT2.5 (2.0-3.0)3 months Unprovoked second event2.5 (2.0-3.0)Chronic Associated with cancer2.5 (2.0-3.0)See belowVTE associated with cancer is treated with 3 to 6 months LMWH followed by warfarin as long as the cancer remains active.Spontaneous superficial vein thrombosis4 weeksLMWH(P)or: 2.5 (2.0-3.0)4 weeksfollowing 5 days LMWH(P)Ischemic StrokeAcute stroke, with restricted mobilityNRLDUFH or LMWH(P)Noncardioembolic stroke or TIANRChronicAntiplatelet agentsCardioembolic stroke or TIA2.5 (2.0-3.0)Chronic Contraindication to anticoagulationNRChronicASA 75-325mg daily With aortic atherosclerotic lesionsNRChronicASA 81mg/day With mobile aortic arch thrombi2.5 (2.0-3.0)Chronicor ASA 81mg/day With mitral valve strands or prolapseNRChronicASA 81mg/dayCerebral Venous Sinus Thrombosis2.5 (2.0-3.0)up to 12 monthsValvular and Structural Heart DiseaseRheumatic mitral valve disease In NSR and without LA enlargement (< 55mm)NR – unless other indication for anticoagulation With risk factors2.5 (2.0-3.0)Chronic(AF, previous systemic emboli, LA thrombus, or LA diameter > 55mm) With AF and new systemic emboli or left atrial thrombus while on therapeutic warfarin:2.5 (2.0-3.0) Chronic add ASA 81mg/day or: 3.0 (2.5-3.5)ChronicMitral Valve Prolapse Without AF, systemic embolism,NR – unless other indication for anticoagulation TIA, or ischemic strokeWith ischemic stroke orNRChronicASA 81mg/day unexplained TIA With AF, systemic embolism,2.5 (2.0-3.0)Chronic recurrent TIA while on ASAMitral annular calcification with: Systemic embolism, ischemicNRChronicASA 81mg/day stroke or TIA without AF AF or with recurrent event2.5 (2.0-3.0)Chronicdespite ASA therapyAortic valve disease Isolated calcific disease withoutNR – unless other indication for anticoagulationischemic stroke or TIA With ischemic stroke or TIANRChronicASA 81mg/dayInfective endocarditisNR – unless other indication for anticoagulation*Unless patient is at particularly high risk of bleed such as those with history of GI Bleed or older than 80 years.NR – Not recommended, LDUFH – Low dose unfractionated heparin, LMWH(P) – Prophylactic dose low molecular weight heparin, ASA – Aspirin, LA – Left Atrial, TIA – Transient Ischemic Attack.Attachment D1.Methods for Initiation of Warfarin Therapy for Inpatientsa.Loading doses of warfarin are not recommended. In most patients initial doses of 5mg achieve INRs within a stable therapeutic range as rapidly as larger initial doses, with less over anticoagulation. Initial dose of 10mg should be considered only in young healthy patients with no known risk factors for warfarin sensitivity and in some patients taking drugs known to significantly increase the metabolism of warfarin (e.g. rifampin) or with a history of requiring large doses.b.Initiation of warfarin in inpatients may use an average daily dosing method or a flexible dosing method. The average daily dosing method uses less intensive monitoring and dose titration and may be suitable for ambulatory patients using subcutaneous unfractionated heparin or low-molecular weight heparin, or when stabilization will be continued post-discharge. The flexible dosing method requires more intensive daily lab monitoring and dose adjustment, but may be useful for hospitalized patients.2.Patient considerations prior to starting warfarina.Obtain baseline lab tests, screen for drug interactions, allergies, contraindications and risk factors. Baseline labs should include INR, Hgb/Hct, and CBC. Also consider liver function tests, TSH, and serum creatinine. b.Determine whether patient may be sensitive to warfarin. The following may suggest the patient may be warfarin sensitive. (1)Age – Greater than 70 years of age(2)Weight – Lower weight (less than < 50 kg), especially combined with advanced age may result in lower dose requirements(3)Elevated baseline INR(4)Fever – Prolonged elevated temperature(5)Diarrhea – Severe diarrhea (5-6 loose stools) for several days(6)End-stage renal failure(7)Liver Function – Liver dysfunction may result in impaired Vitamin K production and lower dose requirements(8)Chronic Heart Failure – Clinical CHF may lead to unexpected elevations in prothrombin time(9)Clinical hyperthyroidism(10)Malignancy(11)Malnutrition, decreased oral intake, nothing by mouth for more than 3 days.(12)Dietary Vitamin K intake – especially important if significant changes have occurred(13)Medications – Medications which inhibit metabolism of warfarin. (See Micromedex and Hansten and Horn).3.Average Daily Dosing method of initiating warfarina.The following guidelines are intended for initiation of low intensity (INR 2.0-3.0 range) anticoagulation from Day 1 through Day 7. Patients who are stable beyond Day 7 will be managed using the Warfarin Dosing Adjustment Protocol for Stable Patients (attachment D).b.Most patients will begin therapy with 5mg daily and the INR value checked within 3-5 days. Dosing adjustments will be made based on the response to the initiation of therapy. Patients who may be particularly sensitive to warfarin will begin therapy at 2.5mg daily. A final dosing schedule based on the use of 5mg and 2.5mg doses is desired to minimize the number of tablet strengths required for outpatient dispensing.(1)Day 1 and Day 2 (a)Start 5mg daily if patient is < 70 years of age and has no obvious risk factors or indicators that he/she may be warfarin sensitive.(b)Start 2.5mg daily if patient is likely to be warfarin sensitive.(2)Day 3Obtain INR on Day 3 before patient takes warfarin dose. If INR is not in range, adjust dose according to the following table. If INR is not in range, recheck every 2-3 days according to the table until in range. Non-Sensitive PatientsSensitive PatientsInitial Dose5mg qd2.5mg qdFirst INR3 days3 days< 1.57.5mg qd5mg qd1.5 - 1.95mg qd2.5mg qd2-32.5mg qd1.25mg qd3.1-41.25mg qd0.5mg qd>4holdholdNext INR2 to 3 days2 to 3 daysSource: ?University of Washington Anticoagulation Service April, 2008, with permission.4.Flexible Initiation Dosing MethodThe flexible dosing method requires daily dose adjustments based on the daily rate of change in the patient’s INR. Patients with risk factors for warfarin sensitivity, especially interacting medications, chronic heart failure, or chronic alcohol abuse may be at greater risk of over anticoagulation with this method.5mg INITIATION10mg INITIATIONDayINRDOSEDOSE1–5mg10mg2< 1.55mg7.5mg - 10mg1.5-1.92.5mg2.5mg2.0-2.51.0 - 2.5mg1.0 - 2.5mg> 2.5003< 1.55-10mg5 - 10mg1.5-1.92.5 - 5mg2.5 - 5mg2.0-2.50 - 2.5mg0 - 2.5mg2.5-3.00 - 2.5mg0 - 2.5mg> 3.0004< 1.510mg10mg1.5-1.95 - 7.5mg5 - 7.5mg2.0-3.00 - 5mg0 - 5mg> 3.0005< 1.510mg10mg1.5-1.97.5 - 10mg7.5 - 10mg2.0-3.00 - 5mg0 - 5mg> 3.0006< 1.57.5 - 12.5mg7.5 - 12.5mg1.5-1.95 - 10mg5 - 10mg2.0-3.00 - 7.5mg0 - 7.5mg> 3.000Source: ?University of Washington Anticoagulation Service April, 2008, with permission.Attachment EWarfarin Dosage Adjustment Protocol for stable patientsAfter consideration of patient condition, diet, and drugs, patients with previously stable INR (as defined in attachment F) now out of range, will be dosed according to the Dosing Adjustment Protocol. The total weekly dose should be considered when making dose adjustments for chronically anticoagulated patients.Warfarin Dosing Adjustment ProtocolA. LOW INTENSITY (INR = 2.0-3.0)INRHOLD / RELOADCHANGE IN WEEKLY DOSE (%)< 2.0Increase by 5-15%2.0-3.0No Change3.1-3.5Decrease by 0-15%3.6-4.0Hold 0-1 doseDecrease by 5-15%> 4.1Hold 0-2 doses or until therapeuticDecrease by 10-20%> 6.0Verify MD has been notifiedSee Reversal ProtocolB.HIGH INTENSITY (INR = 2.5-3.5)INRHOLD / RELOADCHANGE IN WEEKLY DOSE (%)< 2.0Reload onceIncrease by 10-20%2.0-2.4Increase by 5-15%2.5-3.5No Change3.6-4.6Decrease by 5-15%4.7-5.2Hold 0-1 doseDecrease by 10-20%> 5.2Hold 0-2 dosesDecrease by 10-20%> 6.0Verify MD has been notifiedSee Reversal ProtocolAttachment F1.INR Monitoring Schedulea.Initiation of Therapy – Unstable patient(1)Average Daily Dosing Method – Every 2-3 days until stable, then at least once per week for stable patients not in long-term care.(2)Flexible Initiation Dosing Method – Daily through at least day 4 or until stable, then at least once per week for stable patients not in long-term care.b.Stable Patient – Defined by at least 2 consecutive INRs at appropriate intervals within target range with no changes in warfarin dose.(1)Patient not in long-term care unit, at least once per week.(2)Patient in long-term care unit, at least once per week x 2 weeks, if patient remains stable, may reduce to at least once every 2 weeks for the first two months, then may reduce to every 4 weeks if the patient remains stable.c.Stable Patient – Change in clinical statusA significant change in patients clinical status, including medical conditions, INR, addition or removal of potentially interacting drugs, diet, etc will require increased monitoring appropriate to the change in condition.(1)Dose held today in patient with significant over anticoagulation, within 1-2 days.(2)Minor dose change today – within one week.*(3)Major dose change today – within 3-5 days. *** Minor change is defined as ≤ 14% change in weekly dose.** Major change is defined as ≥ 15% change in weekly dose.d.Discharge Follow-up(1)New patient not stabilized, within 1-4 days.(2)New patient stable, within 5-7 days.(3)Chronic stable patient, within 7-14 days.Attachment GGuidelines for Correction of over anticoagulationINRClinical SettingRecommendations> therapeutic range, but < 5.0Not bleedingPer Dosage Adjustment Protocol Attachment 13< 5.0Rapid Reversal RequiredHold warfarin. Vitamin K 1 or 2.5mg PO. Recheck INR in 24 hours.5.0 to < 9.0Not bleedingNotify MDHold warfarin (1-2 doses) until INR therapeutic, then reinstitute at lower dose. Consider Vitamin K 1 - 2.5mg PO x1.5.0 to < 9.0Rapid Reversal RequiredRefer to MDHold warfarin. Vitamin K 1 – 5 mg PO. Recheck INR in 24 hours.≥ 9.0Not bleedingRefer to MDHold warfarin. Vitamin K 2.5 or 5 mg PO . Recheck INR in 24-48 hours. Reinstitute warfarin at lower dose when INR is therapeutic.≥ 9.0Rapid Reversal RequiredRefer to MDHold warfarin. Vitamin K 1-5mg IV*. Recheck INR in 6-24 hours.Serious BleedingAny INRRefer to MDHold warfarin. Vitamin K 10mg IV*. Consider fresh frozen plasma or prothrombin factor concentrates. Recheck INR every 6 hours until in range. Repeat Vitamin K every 12 hours as needed.*IV vitamin K should generally only be administered if oral intake and absorption is impaired or the patient is experiencing a serious bleed. Reduction in INR following oral vitamin K generally occurs within 24-48 hours. Because of the potential for hypersensitivity or anaphylactic reaction to intravenous Vitamin K, it should be given as a slow IV infusion over 20-30 minutes. Attachment HPHARMACY INPATIENT WARFARIN EDUCATION NOTE: This patient has received formal instruction on the use of warfarin. Topics that were discussed include: Rationale for therapyHow warfarin works to benefit patient Potential drug and food interactions Avoidance or minimizing use of NSAIDsDietary considerations (including alcohol use)Laboratory monitoring What actions to take if a dose is missedSigns of over anticoagulationSigns of disease recurrenceCommon side effectsWhat to do in case of bleedingPlanned length of therapy Warfarin dose at discharge: X mg daily This patient was dispensed with warfarin X mg tablets. The patient has received the following materials (CHECK ALL THAT APPLY): Written patient information on warfarin therapyBooklet on "Understanding your COUMADIN therapy" (Bristol-Meyers Squibb, 2006), Follow-up anticoagulation appointment reminder, INR lab #123456 Comments: ---------------------------------------------------------------------- Active Outpatient Medications (including Supplies): Active Non-VA Medications Status=====================================================================1) Listed medicationsVA Puget Sound - Low Intensity Heparin Protocol PT-001-0808Indications: Cardiology patients, prevention of thromboembolism, atrial fibrillation, surgical patients or patients requiring peri-procedural anticoagulation, defibrillator/pacemaker implantation.Dosing:[ ] Weight = _________ kg (Use actual patient weight)[ ] No bolus (surgical patients or patients requiring peri-procedural anticoagulation)[ ] Bolus (round to nearest 500 units) (maximum 10000 units)Atrial fibrillation: 60 units/kg = _______ units IV once Unstable Angina/NSTEMI 60-70 units/kg = _______ units IV once (maximum 5000 units)Unfractionated Heparin in Conjunction with fibrinolytic agent for Myocardial Infarction60 units/kg = _______ units IV once (maximum 4000 units)Other bolus = ________ units IV once (in 500 unit increments)[ ] Infusion rate: 12 units/kg/hr = _________ units/hr IV (round to nearest 100 units) (Initial infusion rate maximum 2300 units)[ ]Infusion Rate Unstable Angina/NSTEMI: 12-15 units/kg/hr = _________ units/hr IV (round to nearest 100 units) (Initial infusion rate maximum 2300 units)Heparin infusion (Standard = Heparin 25,000units / 500mL D5W = 50units/mL)Baseline labs:[ ] aPTT and PT[ ] CBC[ ] aPTT to be drawn 6 hours after start of infusionADJUST HEPARIN INFUSION BASED ON NOMOGRAM BELOW USING APTTaPTT (seconds)BolusRate ChangeDraw a new aPTT< 35 80 unit/kg bolusIncrease 250 units/hr6 hrs after rate change36-6440 unit/kg bolusIncrease 150 units/hr6 hrs after rate change65-100*Therapeutic Range-No bolus No ChangeRecheck in 6 hrs. If within range x 2 checks, daily aPTT in AM101-119No bolusDecrease by 150 units/hr6 hrs after rate change> 120No bolus-Hold infusion for 1hrDecrease by 200 units/hr6 hrs after rate change>2001. If blood draw was potentially contaminated (drawn from heparinized line), repeat STAT aPTT using peripheral blood draw or proper line technique. If repeat aPTT < 200, follow protocol above for aPTT. If repeat aPTT > 200, Hold infusion and follow #3 below.2. If blood draw improperly timed (< 6 hours after bolus), recheck aPTT at correct time (6 hours after bolus). If repeat draw < 200, follow protocol above for aPTT. If repeat aPTT > 200, Hold infusion and follow #3 below.3. If properly timed, non-contaminated blood aPTT > 200, Hold infusion and recheck STAT aPTT every hour until aPTT < 102. Then (when aPTT < 102) restart infusion at a rate which has been decreased by 300units/hr from last infusion rate and recheck aPTT in 6 hours.*aPTT range corresponding to anti-Xa activity of 0.3 to 0.7 Units/mlMonitoring:[ ] aPTT 6 hours after any dose change[ ] aPTT daily after 2 consecutive aPTT within therapeutic range[ ] CBC dailyIf significant bleeding occurs (including, but not limited to bright red blood per rectum, bloody emesis, neurological changes, rapid drop in hematocrit/hemoglobin, progressive bleeding from IV sites, epistaxis, hematomas, and guaiac positive stool:STOP heparin infusion immediatelyOrder STAT aPTTNotify physicianReferences:(1)Anderson JL, et al. ACC/AHA 2007 Guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction. Circulation 2007;116:e148-e304.(2)Antman EM, Hand M, Armstrong PW, et al. 2007 Focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction. Circulation 2008;210-247.(3)Badawi O, Oyen LJ, Haines ST. Reviews of therapeutics: dosing of unfractionated heparin in acute coronary syndromes. Pharmacotherapy 2004;24 (12):1681-1691.(4)Harrington RA, Becker RC, Ezekowitz M, et al. Antithrombotic therapy for coronary artery disease: The seventh ACCP conference on antithrombotic and thrombolytic therapy. CHEST 2004;126:513S-532S.(5)Hirsh J, Bauer K, et al. Parenteral Anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). 2008; 133(Suppl 6): 141-159.(6)Menon V, Harrington RA, Hochman JS, et al. Thrombolysis and adjunctive therapy in acute myocardial infarction: The seventh ACCP conference on antithrombotic and thrombolytic therapy. CHEST 2004;126:549S-570S.(7)Singer DE, Albers GW, Dalen JE, Go AS, Halperin JL, Manning WJ. Antithrombotic therapy in atrial fibrillation. CHEST 2004; 126:429S-456S.(8)Tahir R. A Review of Unfractionated Heparin and Its Monitoring. US Pharm 2007;32(7); hs26-36.(9)Spruill WJ, Wade WE, Huckaby WG, Leslie RB. Achievement of anticoagulation by using a weight-based heparin dosing protocol for obese and nonobese patients. American Journal of Health-System Pharmacists 2001;58:2143-6.(10)Yee WP, Norton LL. Optimal weight base for a weight-based heparin dosing protocol. American Journal of Health-System Pharmacists 1998;55:159-62.Updated by:VA Puget Sound Pharmacy and Therapeutics CommitteeOctober 2012VA Puget Sound - High Intensity Heparin Protocol PT-002-0808Indications: Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)Dosing:[ ] Weight = _________ kg (Use actual patient weight)IV HEPARIN?? ?[??] Bolus Heparin[??] No bolus[ ] 80 units/kg = ______units IV once (round to nearest 500 units) (maximum 10000 units) [??] Heparin infusion Rate: ?[ ] 18 units/kg/hr = _______units/hr IV (round to nearest 100 units) (maximum 2300 units)Heparin infusion (Standard = Heparin 25,000 units / 500mL D5W = 50 units/mL)Baseline labs:[ ]aPTT and PT[ ]CBC[ ]aPTT to be drawn 6 hours after start of infusionADJUST HEPARIN INFUSION BASED ON NOMOGRAM BELOW USING APTTaPTT (seconds)BolusRate ChangeDraw a new aPTT< 35 80 unit/kg bolusIncrease 250 units/hr6 hrs after rate change36-6440 unit/kg bolusIncrease 150 units/hr6 hrs after rate change65-100*Therapeutic Range-No bolus No ChangeRecheck in 6 hrs. If within range x 2 checks, daily aPTT in AM101-119No bolusDecrease by 150 units/hr6 hrs after rate change> 120No bolus-Hold infusion for 1hrDecrease by 200 units/hr6 hrs after rate change>2001. If blood draw was potentially contaminated (drawn from heparinized line), repeat STAT aPTT using peripheral blood draw or proper line technique. If repeat aPTT < 200, follow protocol above for aPTT. If repeat aPTT > 200, Hold infusion and follow #3 below.2. If blood draw improperly timed (< 6 hours after bolus), recheck aPTT at correct time (6 hours after bolus). If repeat draw < 200, follow protocol above for aPTT. If repeat aPTT > 200, Hold infusion and follow #3 below.3. If properly timed, non-contaminated blood aPTT > 200, Hold infusion and recheck STAT aPTT every hour until aPTT < 102. Then (when aPTT < 102) restart infusion at a rate which has been decreased by 300units/hr from last infusion rate and recheck aPTT in 6 hours.*aPTT range corresponding to anti-Xa activity of 0.3 to 0.7 Units/mlMonitoring:[ ] aPTT 6 hours after any dose change[ ] aPTT daily after 2 consecutive aPTT within therapeutic range[ ] CBC dailyIf significant bleeding occurs (including, but not limited to bright red blood per rectum, bloody emesis, neurological changes, rapid drop in hematocrit/hemoglobin, progressive bleeding from IV sites, epistaxis, hematomas, and guaiac positive stool:STOP heparin infusion immediatelyOrder STAT aPTTNotify physicianReferences:(1)Raschke R, Reilly BM, Srinivas S, et al. The weight based heparin dosing nomogram versus a standard care nomogram: a randomized controlled trial. Ann Intern Med 1993;119:874 – 881.(2)Hirsh J, Bauer K, et al. Parenteral Anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). 2008; 133(Suppl 6): 141-159.(3)Hull RD, Raskob GE, Rosenbloom D, Lemaire J, Pineo GF, Baylis B, et al. Optimal therapeutic level of heparin therapy in patients with venous thromboembolism. Arch Intern Med. 1992; 152:1589-95.(4)Cruickshank MK, Levine MN, Hirsh J, Roberts R, Siguenza M. A standard heparin nomogram for the management of heparin therapy. ?Arch Intern Med. 1991;151:333-7.(5)Tahir R. A Review of Unfractionated Heparin and Its Monitoring. US Pharm 2007;32(7); hs26-36.(6)Spruill WJ, Wade WE, Huckaby WG, Leslie RB. Achievement of anticoagulation by using a weight-based heparin dosing protocol for obese and nonobese patients. American Journal of Health-System Pharmacists 2001;58:2143-6.(7)Yee WP, Norton LL. Optimal weight base for a weight-based heparin dosing protocol. American Journal of Health-System Pharmacists 1998;55:159-62.Prepared by:Updated by:VA Puget Sound Pharmacy and Therapeutics CommitteeOctober 2012VTE risk assessment and prophylaxis recommendations1.Opening menu. This is what the provider will initially see.Thromboembolism Risk Assessment and Prophylaxis RecommendationsEach patient admitted to the medical center should be assessed for risk of developing venous thromboembolism (VTE) while hospitalized. <<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors Select One:Patient is on chronic anticoagulation which will be continued while inpatient <<ORDER>> “Patient is chronically anticoagulated for ___________and will continue anticoagulation while hospitalized.” Provider will enter indication for chronic anticoagulationLow VTE Risk – Patient is fully mobile and has no risk factors (including age and medical conditions) for VTE. This will be a minority of patients; most will have at least moderate VTE risk.<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”Moderate VTE Risk – Most patients admitted for elective or emergent non-orthopedic surgery, medically ill patients, patients not ambulating independently outside of room at least twice daily, and others assigned to bed rest who do not have a risk factor for placement in a high risk group. Most inpatients will have at least moderate VTE risk.<<ORDER>> “Patient is at moderate risk of VTE and will receive pharmacologic thromboprophylaxis.”And, <<GO TO>> DVT PROPHYLAXIS RECOMMENDATIONSModerate VTE Risk with high risk of bleeding – Patients defined as Moderate Risk as above with high risk for bleeding.<<ORDER>> “Patient is at moderate risk of VTE with high risk of bleeding and will receive mechanical thromboprophylaxis.”And, <<GO TO>> DVT PROPHYLAXIS RECOMMENDATIONSHigh VTE Risk – Hip or knee arthroplasty, hip fracture surgery, major trauma, recent spinal cord injury, or acute medical patients with a primary diagnosis or condition which includes chronic heart failure, pneumonia, respiratory failure, sepsis, renal failure, or malignancy.<<ORDER>> “Patient is at HIGH risk of VTE and will receive pharmacologic thromboprophylaxis.”And, <<GO TO>> DVT PROPHYLAXIS RECOMMENDATIONSHigh VTE Risk with high risk of bleeding – Patients defined as High Risk as above with high risk for bleeding.<<ORDER>> “Patient is at HIGH risk of VTE with high risk of bleeding and will receive mechanical thromboprophylaxis.”And, <<GO TO>> DVT PROPHYLAXIS RECOMMENDATIONSModerate or High VTE risk with NO prophylaxis – Patients defined as having a moderate or high risk of developing VTE while hospitalized for whom mechanical or pharmacologic prophylaxis will not be ordered.<<ORDER>> “Patient is at risk of VTE and specific prophylaxis is not ordered at this time because:” Provider will enter reason2.Main DVT Prophylaxis menuDVT PROPHYLAXIS RECOMMENDATIONSSelect One:Acutely ill Medical PatientsCritical Care GuidelinesCancer Patient GuidelinesSpinal Cord Injury (Acute) GuidelinesSurgery General Surgery GuidelinesOrthopedic Surgery GuidelinesUrologic Surgery GuidelinesNeurosurgery GuidelinesLaparoscopic Surgery GuidelinesGynecologic Surgery GuidelinesVascular Surgery GuidelinesReferences: Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.3.Acutely ill Medical Patients MenuAcutely ill Medical Patients VTE Prophylaxis MenuRisk Factors for venous thromboembolism in acutely ill medical patients admitted to the hospital include, but are not limited to:Acute neurologic diseaseAdvanced ageBed restCancer COPD exacerbationHeart FailureHip fractureInflammatory bowel diseasePneumoniaRenal FailureSepsisSevere respiratory diseaseStroke with lower extremity weaknessTraumaPrevious VTEPharmacologic Prophylaxis is recommended for all acutely ill medical patients admitted to the hospital with risk factors for VTE. Mechanical prophylaxis is recommended if there is a contraindication to anticoagulation.Order Baseline or Additional Chem 7, CBC, PT/INR, PTTSelect One:<<ORDER>> Heparin 5000 units SC Q12H and CBC on Day 4<<ORDER>> Heparin 5000 units SC Q8H and CBC on Day 4If history of documented Heparin Induced Thrombocytopenia (HIT):Patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min<<ORDER>> Fondaparinux 2.5 mg SC QDIf High Risk of Bleed or h/o HIT and not eligible for fondaparinux:<<ORDER>> Mechanical ProphylaxisIf mechanical prophylaxis is selected due to high risk of bleed, pharmacologic prophylaxis should be substituted or added when the bleeding risk decreases.Patient is at low risk of VTE with none of the above risk factors:<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”References: Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.4.Critical Care GuidelinesCritical Care VTE Prophylaxis MenuUpon admission to a critical care unit all patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. MOST CRITICAL CARE PATIENTS SHOULD RECEIVE THROMBOPROPHYLAXIS.VTE RISK FACTORS include, but are not limited to: acute MI, ischemic stroke, severe COPD, malignancy, extremity paresis, CHF, chronic central venous access, admission from a nursing home, prolonged bed rest (>72 hours), superficial venous thrombosis, active inflammatory bowel disease, prior venous thromboembolism, advanced age, recent trauma, pneumonia or other severe respiratory disease, sepsis, and renal failure.Order Baseline or Additional Chem 7, CBC, PT/INR, PTTSelect One:ICU patients at moderate risk for FTE (e.g. medically ill or postoperative):<<ORDER>> Heparin 5000 units SC Q12H and CBC on Day 4<<ORDER>> Heparin 5000 units SC Q8H and CBC on Day 4ICU patients with additional risks from surgical or spinal cord co-morbidities:<<GO TO>> DVT Prophylaxis RecommendationsIf history of documented Heparin Induced Thrombocytopenia (HIT):Patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min<<ORDER>> Fondaparinux 2.5 mg SC QDIf High Risk of Bleed or h/o HIT and not eligible for fondaparinux:<<ORDER>> TED hose<<ORDER>> SCD’sIf mechanical prophylaxis is selected due to high risk of bleed, pharmacologic prophylaxis should be substituted or added when the bleeding risk decreases.Patient is at low risk of VTE with none of the above risk factors:<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”References: Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.5.Cancer MenuCancer Patient VTE Prophylaxis GuidelinesOrder Baseline or Additional Chem 7, CBC, PT/INR, PTTSelect One:Hospitalized cancer patients bedridden with acute medical illness:Routine VTE prophylaxis as for other high risk medical patients is recommended<<GO TO>> Acutely Ill Medical Patient GuidelinesHospitalized cancer patients undergoing surgical procedures:Aggressive VTE prophylaxis appropriate to the type of surgery is recommended<<GO TO>> DVT Prophylaxis Recommendations Menu to select type of surgeryHospitalized cancer patients with indwelling CVC and no other VTE risk factors (surgery or acute medical illness):VTE prophylaxis to prevent catheter related thrombosis is not recommended<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”Hospitalized cancer patients with no other VTE risk factors (surgery or acute medical illness):Routine VTE prophylaxis in cancer patients undergoing chemotherapy or hormonal therapy with no additional risk factors is not recommended<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”References: Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.6.Spinal Cord Injury – NewAcute Spinal Cord Injury VTE Prophylaxis RecommendationsOrder Baseline and Weekly Chem 7, CBC, PT/INR, PTTSelect One:Motor complete (ASIA A or B):<<ORDER>> Dalteparin 5000 units SC QDAY x 8 weeksMotor complete (ASIA A or B): <<ORDER>> Dalteparin 5000 units SC QDAY x 12 weeksIndications for 12 week treatment include: lower limb fracture, previous thrombosis, cancer, heart failure, obesity, age > 70If history of documented Heparin Induced Thrombocytopenia (HIT):Patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min<<ORDER>> Fondaparinux 2.5 mg SC QDIf High Risk of Bleed or h/o HIT and not eligible for fondaparinux:<<ORDER>> Mechanical ProphylaxisIf mechanical prophylaxis is selected due to high risk of bleed, pharmacologic prophylaxis should be substituted or added when the bleeding risk decreases.References: Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S7.Spinal Cord Injury – ChronicChronic Spinal Cord InjuryPatients admitted to the hospital with a chronic spinal cord injury should receive venous thromboembolism prophylaxis which is appropriate for the patient’s risk level based on acute and chronic medical conditions or surgical status. The following acute and chronic medical conditions may increase the risk of VTE while the patient is hospitalized:Acute neurologic diseaseAdvanced ageBed restCancer COPD exacerbationHeart FailureHip fractureInflammatory bowel diseasePneumoniaRenal FailureSepsisSevere respiratory diseaseStroke with lower extremity weaknessTraumaPrevious VTEMany SCI patients with unplanned admissions may be moderate to high risk. Please return to the following menu to assess the patient’s risk and select appropriate therapy:<<GO TO>> DVT PROPHYLAXIS RECOMMENDATIONSMedically stable patients, including those admitted for scheduled rehab or annual evaluation who have no other significant chronic medical conditions, may be at low risk of developing venous thromboembolism. Patient is at low risk of VTE with no risk factors:<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage mobilization.”8.Inpatient General SurgeryGeneral Surgery VTE Prophylaxis GuidelinesAll General Surgery patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. Refer to the following menu for risk factors:<<Acutely ill Medical Patients VTE Prophylaxis Menu>>LOW RISK: minor procedure in patient < 40 yo with NO other risk factors<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage early and aggressive ambulation for VTE prevention.”Order Baseline or additional CBC, PT/INR, PTTMODERATE RISK: minor procedure in patient < 40 yo WITH risk factors, minor procedure in patient 40-60 yo with NO risk factors, major procedure in patient < 40 yo with NO risk factors:<<ORDER>> Ambulate, Heparin 5000 units SC Q12H x 7D for VTE prophylaxis, CBC in 4 daysHIGH RISK: minor procedure in patient 40-60 yo WITH risk factors, minor procedure in patient > 60 yo with NO risk factors, major procedure in patient > 40 yo with NO risk factors or major procedure in pt < 40 yo WITH risk factors:<<ORDER>> Ambulate, Heparin 5000 units SC Q8H x 7D for VTE prophylaxis, CBC in 4 daysHIGH RISK PATIENT WITH MULTIPLE RISK FACTORS:ORDER>> Ambulate, TEDS/SCD, Heparin 5000 units SC Q8H x 7D for VTE prophylaxis, CBC in 4 daysGENERAL SURGERY PATIENTS WITH HIGH RISK OF BLEEDING:<<ORDER>> Ambulate, TEDS, SCDsIf mechanical prophylaxis is selected due to high risk of bleed, pharmacologic prophylaxis should be substituted or added when the bleeding risk decreases.HIGH RISK PATIENTS WHO HAVE UNDERGONE MAJOR CANCER SURGERY:<<ORDER>> Ambulate, Dalteparin 5000 units SC QDAY for VTE prophylaxis, CBC in 4 days.In patients who have undergone major cancer surgery, especially those with other risk factors for VTE or history of previous VTE, consider continuing thromboprophylaxis with dalteparin after discharge for up to 28 days.MODERATE AND HIGH RISK PATIENTS WITH A HISTORY OF HIT (heparin induced thrombocytopenia) AND patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min:<<ORDER>> Ambulate, Fondaparinux 2.5mg SC QDAY x 7D for VTE prophylaxisOTHER ORDERS:Hold HEPARIN dose scheduled for ____for removal of epidural catheter at least 4 hours after last dose and at least 1 hour before next dose.References: (1)Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.(2)VISN 20 Formulary Guidelines: Low Molecular Weight Heparin, Fondaparinux9.Orthopedic SurgeryORTHOPEDIC SURGERY VTE PROPHYLAXIS MENUAll Orthopedic Surgery patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. Refer to the following menu for risk factors:<<Acutely ill Medical Patients>>ELECTIVE HIP ARTHROPLASTY:SCDs and TEDS (routine)Consider One (Order duration at least 10 days, consider up to 35 days if high risk)<<ORDER>> Dalteparin 2500 units SC 4-6hrs post-op then 5000 units SC QDAY x10D starting POD #1<<ORDER>> Enoxaparin 40mg SC QDAY x 10D starting 12-24hrs after surgery<<ORDER>> Adjusted Dose Warfarin (Target INR 2.5, Range 2.0-3.0) starting evening before or evening after surgery.Patient with history of HIT – See Fondaparinux belowELECTIVE KNEE ARTHROPLASTY:SCDs and TEDS (routine)Consider One (Order duration at least 10 days, consider up to 35 days if high risk)<<ORDER>> Dalteparin 5000 units SC QDAY x10D starting POD #1Patient with history of HIT – See Fondaparinux belowHIP FRACTURE SURGERY:SCDs and TEDS (routine)Consider One (Order duration at least 10 days, consider up to 35 days if high risk)<<ORDER>> Dalteparin 5000 units SC QDAY x10D starting POD #1<<ORDER>> Enoxaparin 40mg SC QDAY x10D starting POD #1<<ORDER>> Fondaparinux 2.5mg SC QDAY x 10D starting 6-8hrs after surgery (patient weight ≥ 50kg and Creatinine Clearance ≥ 30ml/min). <<ORDER>> Adjusted Dose Warfarin (Target INR 2.5, Range 2.0-3.0) starting evening before or evening after surgery.HIP FRACTURE SURGERY - DELAYED:SCDs and TEDS (Routine)Consider One:<<ORDER>> Heparin 5000 units SC Q8H<<ORDER>> Dalteparin 5000 units SC QDAY<<ORDER>> Enoxaparin 40mg SC QDAYPatient with history of HIT – See Fondaparinux belowHIP OR KNEE SURGERY AND HISTORY OF HIT (Heparin Induced Thrombocytopenia) AND patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min<<ORDER>> Fondaparinux 2.5mg SC QDAY x 10D starting 6-24hrs after surgeryKNEE ARTHROSCOPYRoutine pharmacologic thromboprophylaxis in patients without other risk factors is not recommended. Early and frequent mobilization is recommended.<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”ISOLATED LOWER-EXTREMITY INJURY DISTAL TO THE KNEERoutine thromboprophylaxis in patients without other risk factors is not recommended. VTE prophylaxis should be guided by the patients other risk factors including prolonged bed rest or immobility. Early and frequent mobilization is recommended.<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”MAJOR TRAUMA INCLUDING PELVIC OR FEMORAL FRACTUREThrombopropylaxis with a low-molecular weight heparin should begin in trauma patients once primary hemostasis has been achieved. Contraindications to early initiation of LMWH include presence of intracranial bleeding, ongoing uncontrolled bleeding elsewhere, and incomplete SCI associated with suspected or proven spinal hematoma.<<ORDER>> Dalteparin 5000 units SC QDAY<<ORDER>> Enoxaparin 40mg SC QDAYPatients with active bleeding or high risk for clinically important bleeding<<ORDER>> SCDs or TEDsOTHER ORDERS:Hold HEPARIN dose scheduled for ____for removal of epidural catheter at least 4 hours after last dose and at least 1 hour before next dose.Order Baseline or additional CBC, PT/INR, PTTReferences: (1)Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.(2)VISN 20 Formulary Guidelines: Low Molecular Weight Heparin, Fondaparinux10.Urologic Surgery GuidelinesUROLOGIC SURGERY VTE PROPHYLAXIS MENUAll Urologic Surgery patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. Refer to the following menu for risk factors:<<Acutely Ill Medical Patients VTE Prophylaxis Menu>>Additional VTE risk factors for patients undergoing urologic surgery include advanced age, malignancy, open (vs. transurethral) procedures, pelvic surgery with or without lymph node dissection, and the use of the lithotomy position intraoperatively.Transurethral and other Low-Risk ProceduresRoutine thromboprophylaxis in patients without other risk factors is not necessary. Early and frequent mobilization is recommended.<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”Major, Open Urologic Procedure<<ORDER>> Ambulate, Heparin 5000 units SC Q12H x7D for VTE prophylaxis, CBC in 4 daysMajor, Open Urologic Procedure in Patient with Multiple Risk Factors:<<ORDER>> Ambulate, TEDS/SCDs, Heparin 5000 units SC Q8H x7D for VTE prophylaxis, CBC in 4 daysMajor, Open Urologic Procedure in patient with a history of HIT (heparin induced thrombocytopenia) AND patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min<<ORDER>> Ambulate, Fondaparinux 2.5mg SC QDAY x 7D for VTE prophylaxisUrologic Surgery Patient with High Risk of Bleeding:<<ORDER>> Ambulate, TEDS, SCDs initiated just prior to surgery and used continuously until patient is ambulating. If mechanical prophylaxis is selected due to high risk of bleed, pharmacologic prophylaxis should be substituted or added when the bleeding risk decreases.OTHER ORDERS:Hold HEPARIN dose scheduled for ____for removal of epidural catheter at least 4 hours after last dose and at least 1 hour before next dose.Order Baseline or additional CBC, PT/INR, PTTReferences: (1)Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.(2)VISN 20 Formulary Guidelines: Low Molecular Weight Heparin, Fondaparinux11.NeurosurgeryNEUROSURGERY VTE PROPHYLAXIS MENUAll Neurosurgery patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. Refer to the following menu for risk factors:<<Acutely Ill Medical Patients VTE Prophylaxis Menu>>Additional risk factors for patients undergoing neurosurgery include intracranial (vs. spinal) surgery, malignancy, prolonged procedures, leg weakness, and advanced age.Routine thromboprophylaxis for patients undergoing major neurosurgery is recommended.<<ORDER>> Ambulate, SCDs<<ORDER>> Heparin 5000 units SC Q12H and CBC on Day 4<<ORDER>> Heparin 5000 units SC Q8H and CBC on Day 4OTHER ORDERS:Hold HEPARIN dose scheduled for ____for removal of epidural catheter at least 4 hours after last dose and at least 1 hour before next dose.Order Baseline or additional CBC, PT/INR, PTTReferences: (1)Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.(2)VISN 20 Formulary Guidelines: Low Molecular Weight Heparin, Fondaparinux12.Laparoscopic SurgeryLaparoscopic Surgery VTE Prophylaxis MenuAll Laparoscopic Surgery patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. Refer to the following menu for risk factors:<<Acutely ill Medical Patients VTE Prophylaxis Menu>>Laparoscopic Procedure in patient WITH NO risk factors:Routine thromboprophylaxis in patients without other risk factors is not necessary. Early and frequent mobilization is recommended.<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”Order Baseline or additional CBC, PT/INR, PTTLaparoscopic procedure in patient WITH risk factors:<<ORDER>> Ambulate, Heparin 5000 units SC Q12H x 7D for VTE prophylaxis, CBC in 4 daysLaparoscopic procedure in patient WITH risk factors and WITH a history of HIT (heparin induced thrombocytopenia) AND patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min:<<ORDER>> Ambulate, Fondaparinux 2.5mg SC QDAY x 7D for VTE prophylaxisLaparoscopic procedure in patient with high risk of bleeding:<<ORDER>> Ambulate, TEDS, SCDsIf mechanical prophylaxis is selected due to high risk of bleed, pharmacologic prophylaxis should be substituted or added when the bleeding risk decreases if indicated.OTHER ORDERS:Hold HEPARIN dose scheduled for ____for removal of epidural catheter at least 4 hours after last dose and at least 1 hour before next dose.References: (1)Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.(2)VISN 20 Formulary Guidelines: Low Molecular Weight Heparin, Fondaparinux13.Gynecologic SurgeryGYNECOLOGIC SURGERY VTE PROPHYLAXIS MENUAll Gynecologic Surgery patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. Refer to the following menu for risk factors:<<Acutely ill Medical Patients VTE Prophylaxis Menu>>Additional VTE risk factors for patients undergoing gynecologic surgery include abdominal (vs. vaginal) surgical approach, malignancy, older age, previous VTE, perioperative blood transfusion, and prior pelvic radiation therapy. Gynecologic oncology patients have a particularly high risk.Brief procedure < 30 minutes for benign disease:Routine thromboprophylaxis in patients without other risk factors is not necessary. Early and frequent mobilization is recommended.<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”Laparoscopic procedure in patient WITHOUT VTE risk factors:Routine thromboprophylaxis in patients without other risk factors is not necessary. Early and frequent mobilization is recommended.<<GO TO>> Acutely Ill Medical Patient Guidelines to review risk factors OR<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”Laparoscopic procedure in patient WITH VTE risk factors:<<ORDER>> Ambulate, Heparin 5000 units SC Q12H for VTE prophylaxis, CBC in 4 daysMajor gynecologic surgery for benign disease WITH NO risk factors:<<ORDER>> Ambulate, Heparin 5000 units SC Q12H for VTE prophylaxis, CBC in 4 daysMajor gynecologic surgery for malignancy or major surgery WITH risk factors:<<ORDER>> Ambulate, TEDS, SCDs, Heparin 5000 units SC Q8H for VTE prophylaxis, CBC in 4 daysMajor gynecologic surgery for malignancy in patient > 60 yo or who have previously experienced VTE:<<ORDER>> Ambulate, TEDS, SCDs, Heparin 5000 units SC Q8H for VTE prophylaxis, CBC in 4 days, Warfarin at dischargeLaparoscopic procedure in patient with risk factors or major gynecologic surgery in patient with history of HIT (heparin induced thrombocytopenia) AND patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min<<ORDER>> Ambulate, Fondaparinux 2.5mg SC QDAY for VTE prophylaxisOTHER ORDERS:Hold HEPARIN dose scheduled for ____for removal of epidural catheter at least 4 hours after last dose and at least 1 hour before next dose.Order Baseline or additional CBC, PT/INR, PTTReferences: (1)Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.(2)VISN 20 Formulary Guidelines: Low Molecular Weight Heparin, Fondaparinux14.Vascular SurgeryVASCULAR SURGERY VTE PROPHYLAXIS MENUAll Vascular Surgery patients should be assessed for acute and chronic medical illnesses which increased risk of venous thromboembolism. Refer to the following menu for risk factors:<<Acutely ill Medical Patients VTE Prophylaxis Menu>>Additional risk factors for VTE following vascular surgery include advanced age, limb ischemia, long duration of surgery, and intraoperative local trauma, including possible venous injury. Atherosclerosis may be an independent risk factor.Vascular Surgery in patient with NO additional risk factors:Routine thromboprophylaxis in patients without other risk factors is not necessary. Early and frequent mobilization is recommended.<<ORDER>> “Patient is at low risk of VTE and does not require specific thromboprophylaxis. Encourage ambulation.”Major procedure in vascular surgery patients WITH additional risk factors:<<ORDER>> Ambulate, Heparin 5000 units SC Q12H x 7D for VTE prophylaxis, CBC in 4 daysMajor procedure in vascular surgery patients WITH additional risk factors and WITH a history of HIT (heparin induced thrombocytopenia) AND patient weight ≥ 50kg and Creatinine Clearance ≥ 30 ml/min:<<ORDER>> Ambulate, Fondaparinux 2.5mg SC QDAY x 7D for VTE prophylaxisOTHER ORDERS:Hold HEPARIN dose scheduled for ____for removal of epidural catheter at least 4 hours after last dose and at least 1 hour before next dose.Order Baseline or additional CBC, PT/INR, PTTReferences: (1)Gerts WH, et al. Prevention of Venous Thromboembolism. Chest 2008; 133(6): 381S-453S.(2)VISN 20 Formulary Guidelines: Low Molecular Weight Heparin, FondaparinuxPrepared by:VA Puget Sound Anticoagulation Subcommittee of the P&TMarch 2009Approved by:VA Puget Sound CEB and P&T committeesApril 2009Clinical Management of Suspected Heparin-Induced Thrombocytopenia VA Puget SoundDecember 2008PT-003-1208These recommendations are intended as guidelines only. Clinical judgment must be used in decision making regarding treatment and testing of the thrombocytopenic patient. Hematology consultation is available for management of patients with past history of heparin induced thrombocytopenia (HIT), uncertain diagnosis or significant bleeding risks. Criteria for the evaluation of suspected acute HIT≥ 50% drop in baseline platelet count (even if > 150,000 platelets/?L), orVenous or arterial thrombotic event occurring within 5-14 days of heparin initiationNote: A self-limiting, asymptomatic fall in platelet count (rarely < 100,000 platelets/?L) occurs in heparin-associated thrombocytopenia that is not immunologically mediated. No treatment is required. Heparin discontinuation is not required.Initial Orders for Suspected or Confirmed Acute HIT1.Discontinue all heparin, low-molecular weight heparin and warfarin administration by any route, including heparin flushes and heparin coated catheters.2.Consult hematology service if not already done.3.Obtain baseline activated partial thromboplastin time (aPTT), serum creatinine (SrCr), complete blood cell count (CBC), and Chem 7 immediately if not available.4.Obtain the HIT Immunoglobulin G (HIT-IgG) antibody assay to confirm diagnosis.5.Avoid intramuscular injections; contact the physician to change intramuscular injection orders.6.Check for bleeding and signs of thrombosis once per shift: order testing of all suspicious stools for occult blood.7.Avoid prophylactic platelet transfusions.8.If patient was on warfarin at time of diagnosis of HIT, consider use of Vitamin K (10 mg orally or 5 – 10 mg IV).A.Patient WITH ACUTE THROMBOSIS (Outpatients should be admitted) 1.Treat immediately with a direct thrombin inhibitor (DTI). See Treatment Options. 2.If initial heparin antibody ELISA negative, recheck in 5-7 days for confirmation. 3.Avoid transition to warfarin therapy until platelet count has recovered to avoid venous limb gangrene. When platelet count has recovered to > 150,000 platelets/?L consider starting transition to warfarin. See individual DTI recommendations and medical center warfarin protocol for transition guidance. 4.Continue warfarin a.for 3-6 months (acute thrombosis) b.long term (another indication for long-term oral anticoagulation) B.Patient WITHOUT ACUTE THROMBOSIS 1.Treat immediately with a direct thrombin inhibitor (DTI). See Treatment Options.2.Check heparin antibody ELISA assay a.ELISA NEGATIVE and low clinical suspicion of HIT (1)HIT ruled out, resume heparin if indicatedb.ELISA NEGATIVE and high clinical suspicion of HIT - Continue DTI and recheck ELISA in 5-7 days(1)Repeat ELISA NEGATIVE – HIT ruled out, resume heparin if indicated(2)Repeat ELISA POSITIVE(a)Patient Pregnant – Consult Hematology service(b)Patient not Pregnant and has another indication for anticoagulation – When platelet count has recovered to > 150,000 platelets/?L, consider starting transition to warfarin. See individual DTI recommendations and medical center warfarin protocol for transition guidance. (c)Patient not Pregnant and does not have another indication for anticoagulation. Order a LE duplex study (and UE if patient has an indwelling central venous catheter). When platelet count has recovered to > 150,000 platelets/?L, consider starting transition to warfarin. See individual DTI recommendations and medical center warfarin protocol for transition guidance.(d)Initiate warfarin and continuei.for 1 month ( no acute thrombosis) ii.for 3-6 months (acute thrombosis) iii.long term (another indication for long-term oral anticoagulation) c.ELISA POSITIVE and low clinical suspicion of false positive (1)Patient has another indication for anticoagulation – When platelet count has recovered to > 150,000 platelets/?L, consider starting transition to warfarin. See individual DTI recommendations and medical center warfarin protocol for transition guidance.(2)Patient does not have another indication for anticoagulation. Order a LE duplex study (and UE if patient has an indwelling central venous catheter). When platelet count has recovered to > 150,000 platelets/?L, consider starting transition to warfarin. See individual DTI recommendations and medical center warfarin protocol for transition guidance.(3)Initiate warfarin and continue(a)for 1 month ( no acute thrombosis) (b)for 3-6 months (acute thrombosis) (c)long term (another indication for long-term oral anticoagulation)d.ELISA POSITIVE and high clinical suspicion of false positive (e.g. cardiopulmonary bypass) or unknown risk with use of DTI (e.g. pregnancy)(1) Check Serotonin Release Antibody (SRA) assay(a)SRA Negative - HIT ruled out, resume heparin if indicated(b)SRA Positive and patient has another indication for anticoagulation When platelet count has recovered to > 150,000 platelets/?L, consider starting transition to warfarin. See individual DTI recommendations and medical center warfarin protocol for transition guidance.(c)SRA Positive and patient does not have another indication for anticoagulation. Order a LE duplex study (and UE if patient has an indwelling central venous catheter). When platelet count has recovered to > 150,000 platelets/?L, consider starting transition to warfarin. See individual DTI recommendations and medical center warfarin protocol for transition guidance.(2)Initiate warfarin and continue(a)for 1 month ( no acute thrombosis) (b)for 3-6 months (acute thrombosis) (c)long term (another indication for long-term oral anticoagulation) C.Baseline Data for determining HIT Therapy1.Height (in) and weight (kg)2.Serum Creatinine (mg/dl)3.Estimated Creatinine Clearance (CrCl) (ml/min)4.Aspartate transaminase (AST) (units/L)5.Alanine transaminase (ALT) (units/L)6.aPTTD.Treatment Options for Acute HIT1.Lepirudin – Criteria for UseThe following criteria must be met:a.Serum Creatinine < 6mg/dLb.Initial aPTT ≤ 2.5 x baseline before initiation of therapyc.Absence of hirudin hypersensitivity, major bleeding, and hemophiliaNote: Antibody formation occurs in 44-74% of patients. This may result in delayed clearance and reduced dosage requirements. Serious anaphylactic reactions have occurred during initial or repeat administration. Vigilant monitoring is recommended, especially in patients receiving repeat courses of lepirudin.Lepirudin is primarily eliminated renally (T ? = 80 minutes). Significant dose adjustments are required in patients with renal dysfunction. Patients with hepatic dysfunction may be at increased risk of bleeding due to reduced production of hepatic coagulation factors. 2.Argatroban – Criteria for UseThe following criteria must be met:a.Absence of clinically significant hepatic disease and AST and ALT levels are < 3 times the upper limit of normalb.Absence of hypersensitivity to argatroban, major bleeding, or hemophiliaArgatroban is primarily eliminated hepatically (T ? = 40-50 minutes). Dose adjustments are required in patients with elevated total bilirubin. E.Treatment Options for thrombosis in patients with subacute or resolved HIT not fully anticoagulated with warfarinNote: Subacute HIT = HIT IgG antibody positive with recovered platelet count (≥100,000-150,000 platelets/?L) and resolved HIT = HIT antibody negative with recent or remote HIT history.1.Lepirudin – per above criteria2.Argatroban – per above criteria3.Fondaparinux – Criteria for UseThe following criteria must be met:a.CrCl ≥ 30 ml/minb.If transitioning from a DTI, initiate fondaparinux 4 hours after lepirudin or argatroban discontinuationFondaparinux is primarily eliminated renally with a longer half-life than other options (T ? = 17-20 hours). F.Treatment options for full-dose prophylaxis of thrombosis in patients with a history of HIT without current thrombosis (reference 2,3,4)1.Lepirudin – per above criteriaa.Bolus and low dose continuous infusionb.No bolus and low dose continuous infusion2.Argatroban – per above criteria3.Fondaparinux – per above criteriaG.Dosing, administering, and monitoring specific drugsH.Lepirudin Dosage, Administration, and MonitoringDosage and administration: 5mg/ml standard concentration for bolus and 0.4mg/ml standard concentration for continuous infusion.*If weight > 110 kg administer bolus and infusion based on 110 kg weight.Bolus: Administer in case of perceived life- or limb- threatening thrombosis, otherwise consider omitting.Bolus______ mg (0.2mg/kg) IV over 15-20 seconds followed by Infusion: Rate dependent on renal functionNormal renal function (Serum Creatinine < 1.0 mg/dL): continuous infusion ______ mg/hr (0.1 mg/kg/hr)Decreased renal function (Serum Creatinine > 1.0 mg/dL): continuous infusion______ mg/hr based on creatinine clearance 0.05 mg/kg/hr (Serum creatinine 1.0 – 1.6 mg/dL)0.01 mg/kg/hr (Serum creatinine 1.6 – 4.5 mg/dL)0.005 mg/kg/hr (Serum creatinine 4.5 – 6.0 mg/dL)Monitoring: Target aPTT 1.5-2.0 times baseline. VA Puget Sound Baseline = 35 seconds (July 2008).a.Obtain aPTT value 4 hours after infusion is initiated. Repeat every 4 hours until in goal range twice consecutively.b.Measure the aPTT value daily unless an increased bleeding risk or prior lepirudin treatment indicates the need for more frequent monitoring. Indicate frequency if more frequent monitoring necessary.c.Monitor renal function at least once daily. Indicate the frequency and type of panel needed (e.g., Chem 7).d.Indicate the frequency of CBC monitoring.1.Dosage Adjustments:Supratherapeutic aPTT: For a confirmed aPTT > 88 seconds (2.5 x baseline) stop infusion for 2 hours, restart the infusion at 50% of the initial infusion rate, and recheck the aPTT 4 hours after the infusion is restarted.Subtherapeutic aPTT: For a confirmed aPTT < 50 seconds (1.5 x baseline) increase the infusion rate in increments of 20% and recheck the aPTT 4 hours after each dosage change. Caution: Do not exceed an infusion rate of 0.21 mg/kg/hr without checking for coagulation abnormalities.2.Therapy discontinuation and/or transition to warfarin:Lepirudin may slightly increase the INR/prothrombin time in a dose dependent manner when aPTT values are within therapeutic range. If not transitioning to warfarin therapy: Discontinue lepirudin once the platelet count recovers (>150,000 platelets/?L).If transitioning to warfarin therapy: a.Do not transition to warfarin until platelet count has recovered to > 150,000 platelets/?L.b.Reduce the infusion rate gradually to achieve an aPTT of approximately c.50 seconds (1.5 x baseline).d.Initiate warfarin according to medical center protocol. Do not use loading dose (5mg maximum initial dose).e.Continue lepirudin for a minimum 5 days and until the INR remains therapeutic for at least 2 days. There may be a slight reduction in INR after discontinuation of lepirudin.Argatroban Dosage, Administration, and Monitoringa.Dosage and administration: 1000 mcg/ml standard concentrationNormal hepatic function: continuous infusion ______mg/hr (2 mcg/kg/min)Moderately decreased hepatic function (total serum bilirubin > 1.5 mg/dl): continuous infusion ______mg/hr (0.5mcg/kg/min)Consider reduced infusion rate for patients with heart failure, multiple organ system failure, severe anasarca, or who are post-cardiac surgery (0.5 – 1.2 mcg/kg/min).Monitoring: Target aPTT 1.5-3 times baseline. VA Puget Sound Baseline = 35 seconds (July 2008)1.Obtain aPTT value 2 hours after infusion is initiated. Repeat every 2 hours until in goal range twice consecutively.2.Measure the aPTT value daily unless an increased bleeding risk or indicate alternative frequency if risk of bleeding is increased.3.Indicate the type and frequency of hepatic monitoring.4.Indicate the frequency of CBC monitoring.a.Dosage Adjustments:Supratherapeutic aPTT: For a confirmed aPTT > 105 seconds (3 x baseline) stop infusion for 2 hours, restart the infusion at 50% of the initial infusion rate, and recheck the aPTT 2 hours after the infusion is restarted.Subtherapeutic aPTT: For a confirmed aPTT < 50 seconds (1.5 x baseline) increase the infusion rate in increments of 20% and recheck the aPTT 2 hours after each dosage change. Do not exceed an infusion rate of 10mcg/kg/min or an aPTT value of 100 seconds. b.Therapy discontinuation and/or transition to warfarin:If not transitioning to warfarin therapy: Discontinue argatroban once the platelet count recovers (>150,000 platelets/?L).If transitioning to warfarin therapy: (1)Do not transition to warfarin until platelet count has recovered to > 150,000 platelets/?L.(2)Reduce the infusion rate gradually to achieve an aPTT of approximately 50 seconds (1.5 x baseline).(3)Initiate warfarin according to medical center protocol. Do not use loading dose (5 mg maximum initial dose).*Note: Argatroban can significantly increase INR.c.Continue argatroban-warfarin co-therapy for a minimum 5 days, with duration dependent on the INR result:(1)If the argatroban dose is ≤ 2mcg/kg/min, measure INR daily without adjusting argatroban dose.(2)If the argatroban dose is > 2mcg/kg/min, decrease the infusion to 2 mcg/kg/min and check the INR 6 hours later, then resume the previous argatroban infusion rate.d.Daily INR interpretation with argatroban and warfarin co-therapy:(1)For INR values < 4, continue argatroban infusion.(2)For INR values ≥ 4, stop argatroban infusion and repeat the INR in 6 hours.(3)For repeated INR values < 2, restart argatroban infusion after the last dose and repeat the monitoring and interpretation steps.(4)For repeated INR values ≥ 2, do not restart argatroban. Adjust warfarin dose if above the therapeutic range.e.The argatroban order may be discontinued after 2 consecutive days of INR values ≥ 2 and a minimum 5 days of overlapping therapy.4.Fondaparinux dosage and administrationConsultation with hematology service is required prior to initiation of fondaparinux for management of a thrombocytopenic patient with HIT due to uncertainty regarding the appropriate dosing. It may be useful to assist in the transition between a DTI (lepirudin or argatroban) and warfarin in patients with HIT- associated thrombosis in a two stage process. When platelet count has recovered during initial DTI therapy ( > 150,000 platelets/?L) the DTI is replaced by fondaparinux at full therapeutic doses. Warfarin is initiated after fondaparinux is begun and continued for a minimum 5 days overlap with fondaparinux. Fondaparinux may be discontinued when the INR is within the therapeutic range for 2 consecutive days.Weight < 50kg: 5.0 mg subcutaneously dailyWeight 50-100kg: 7.5 mg subcutaneously dailyWeight > 100kg: 10 mg subcutaneously dailyReferences:1.UWMC VTE Safety Toolkit , Clinical Management of Suspected Heparin-Induced Thrombocytopenia, November 2005.2.Standardizing the management of heparin-induced thrombocytopenia. Am J Health-Syst Pharm. 2008;65:334-9.3.The management of patients with heparin-induced thrombocytopenia who require anticoagulant therapy. Chest. 2005;127 suppl(2):1s-8s.4.The approach to heparin-induced thrombocytopenia. Semin Respi Crit Care Med. 2008;29:66-74.5.Treatment and Prevention of Heparin-Induced thrombocytopenia: American College of Chest Physicians Evidence Based Clinical Practice Guidelines (8th Edition). Chest 2008;133(6) Suppl.:340s-380s.Prepared by:VA Puget Sound Anticoagulation Subcommittee of the P&TNovember 2008Approved by:VA Puget Sound Pharmacy and Therapeutics CommitteeDecember 2008VA Puget Sound Guidelines for perioperative and periprocedural management of patients receiving long-term anticoagulation with warfarin.The following recommendations are intended as general guidelines for the perioperative and periprocedural management of patients anticoagulated with warfarin. While they are intended to provide a standard approach to the management all VA Puget Sound patients, each individual patient’s risks for thromboembolism and bleeding should be considered to select the most appropriate course of action.A.Summary of recommendations1.When normalization of the INR is required for surgery or a procedure, stop warfarin 5 days prior to surgery or procedure to allow adequate time for INR to normalize. It is recognized that some procedures and operations do not require complete normalization of the INR, and can be safely conducted at an INR range of 1.5 to 1.7.2.When warfarin has been interrupted before surgery or a procedure, it should be resumed 12 to 24 hours (the evening of or the next morning) after the procedure when there is adequate hemostasis.3.When complete normalization of the INR prior to surgery or a procedure is essential, and the INR remains elevated (≥ 1.5) 1 to 2 days before the procedure, low-dose oral vitamin K (1 to 2.5 mg) should be administered to normalize the INR.4.When to stop heparin:a.For therapeutic-dose SC LMWH – The last dose prior to the procedure should be administered 24 hours prior to the procedure and at 50% of the usual total daily dose.b.For therapeutic-dose IV UFH – The UFH infusion should be stopped 4 hours prior to the procedure.5.Patients receiving warfarin anticoagulation who require urgent reversal of anticoagulation for a surgical or other invasive procedure should receive low-dose IV or oral vitamin K 2.5 to 5 mg. If more immediate reversal of anticoagulation is required, fresh-frozen plasma or another prothrombin concentrate may be administered in addition to vitamin K.6.Resumption of LMWH or UFH following surgery or a procedure should be based on the anticipated bleeding risk and adequacy of postoperative hemostasis in individual patients.7.Routine use of anti-factor Xa levels to monitor LMWH’s during bridging therapy is not recommended.B.Procedures that do not routinely require suspension of warfarin anticoagulation.1.Minor dental procedures, which may include single or multiple tooth extractions and endodontic (root canal) procedures. Coadministration of oral prohemostatic agents may be considered.2.Minor dermatologic procedure, which may include excisions of basal cell and squamous cell carcinomas, actinic keratoses, and malignant or premalignant nevi.3.Cataract removal.C.Classifying the Patient’s Risk of Peri-procedural ThromboembolismStratification of patients according to their risk for perioperative thromboembolism is based on the patient’s clinical indication for antithrombotic therapy and the presence of comorbidities.Indication for WarfarinRisk StratumMechanical Heart ValveAtrial FibrillationVTEHighAny mitral valve prosthesis.CHADS-2 Score 5 or 6.Recent (≤ 3 mo) VTEOlder (caged-ball or tilting disc) aortic valve prosthesis.Recent (≤ 3 mo) stroke or TIA.Severe thrombophilia (eg. Deficiency of protein C, protein S, or antithrombin, antiphospholipid antibodies, or multiple abnormalities.Recent (≤ 6 mo) stroke or TIA.Rheumatic valvular heart disease.ModerateBileaflet aortic valve prosthesis and one of the following: atrial fibrillation, prior stroke or TIA, hypertension, diabetes, congestive heart failure, or age > 75 yr.CHADS-2 Score 3 or 4.VTE within the past 3 to 12 months.Moderate risk thrombophilic conditions (eg. Heterozygous factor V Leiden mutation, heterozygous factor II mutation).Hx of recurrent VTE.Active cancer (treated within 6 months or palliative).LowBileaflet aortic valve prosthesis without atrial fibrillation and no other risk factors.CHADS-2 Score 0 to 2 (and no prior stroke or TIA).Single VTE occurred > 12 months ago and no other risk factors.CHADS-2 Score - The Congestive Heart Failure-Hypertension-Age-Diabetes-Stroke (CHADS-2) score is a tool used to stratify patients with non-valvular atrial fibrillation according to their annualized risk for stroke. Note that a patient’s risk stratification (based on CHADS-2 score) for annualized risk of stoke may be different than risk stratification for perioperative thromboembolism. Score:Recent CHF (1 point)___Hypertension (1 point)___Age ≥ 75 yr (1 point)___Diabetes (1 point)___Prior Hx Stroke/TIA (2 points)___Total___D.Perioperative Anticoagulation Treatment RegimensTherapeutic-Dose SC Low-Molecular Weight Heparin (LMWH)a.The dose of LMWH may need to be reduced in patients with renal dysfunction and LMWH should not be used in patients with a history of heparin induced thrombocytopenia (HIT). The last pre-operative dose should be administered approximately 24 hours prior to the procedure and at a dose which is 50% of the total daily dose. b.Therapeutic-dose SC LMWH options include:Dalteparin 200 units/kg SC once dailyDalteparin 100 units/kg SC twice dailyEnoxaparin 1mg/kg SC twice daily2.Therapeutic-Dose Intravenous (IV) Unfractionated Heparin (UFH)This option may be preferred when the opportunity for rapid suspension or reversal of anticoagulation in the postoperative period is needed. Dose-adjusted IV UFH is administered to achieve a target activated partial thromboplastin time (aPTT) approximately 1.5 to 2.0 times the control aPTT value. The infusion is stopped approximately 4 hours prior to the procedure and resumed following the procedure when adequate hemostasis has been attained.See VA Puget Sound Low-Intensity IV Heparin Protocol3. Low-dose SC UFH or SC LMWHOptions include:UFH 5000 units SC Q12H or Q8HDalteparin 2500 units SC once dailyDalteparin 5000 units SC once dailyE. Selection of Perioperative RegimenClass of Risk for ThromboembolismGeneral Recommendations for BridgingHigh Risk1. Therapeutic-dose SC LMWH, or2. IV UFHModerate Risk1. Therapeutic-dose SC LMWH, or2. IV UFH, or3. Low-dose SC LMWHLow Risk1. Low-dose SC LMWH, or2. No bridging during temporary interruption of warfarin.F.Resumption of postoperative or postprocedural LMWH or UFHThe decision if or when to resume therapeutic-dose anticoagulation with LMWH or UFH following the procedure should be based on the individual patient’s anticipated bleeding risk and adequacy of postoperative hemostasis. In general:1.Patients undergoing a minor surgical or other invasive procedure who are receiving therapeutic-dose LMWH bridging therapy may resume the regimen approximately 24 hours after the procedure.2.In the cases of patients undergoing major surgery or a high bleeding risk surgery, clinicians may wish to consider any of the following options:a.delay the initiation of therapeutic-dose bridging heparin for longer than 24 hours, and/or until hemostasis is assured, or b.avoid low-dose LMWH or UFH after surgery, and resume warfarin.G.References:1.Douketis JD, Berger PB, Dunn AS, et al. The Perioperative Management of Antithrombotic Therapy, The American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). CHEST 2008; 133:299-339S.2.Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001; 285:2864-2870.3.VA Puget Sound Low Intensity Heparin Protocol PT-001-0808.Prepared by:VA Puget Sound Anticoagulation Subcommittee of the P&TMarch 2009Approved by:VA Puget Sound Pharmacy and Therapeutics CommitteeApril 2009VA Puget Sound – No Bolus Heparin Protocol Indications: This algorithm is intended for post-surgical patients who require therapeutic anticoagulation but are at a higher risk of bleeding. It should NEVER be used for a patient with a new thromboembolic event.Dosing:[ ] Weight = _________ kg (Use actual patient weight)[ ] Infusion rate: 12 units/kg/hr = _________ units/hr IV (round to nearest 100 units) (Initial infusion rate maximum 1500 units)Goal aPTT: 60-80 secondsHeparin infusion (Standard = Heparin 25,000units / 500mL D5W = 50units/mL)Baseline labs:[ ] aPTT and PT[ ] CBC[ ] aPTT to be drawn 4 hours after start of infusionADJUST HEPARIN INFUSION BASED ON NOMOGRAM BELOW USING APTTaPTT (seconds)BolusRate ChangeDraw a new aPTT< 35 No bolusIncrease 200 units/hr4 hrs after rate change36-59No bolusIncrease 100 units/hr4 hrs after rate change60-80*Therapeutic Range-No bolus No ChangeRecheck in 4 hrs. If within range x 3 checks, recheck aPTT every 12 hours81-100No bolusDecrease by 100 units/hr4 hrs after rate change101-120Hold infusion for 30 minutesDecrease by 150 units/hr4 hrs after rate change121-160Hold infusion for 60 minutesDecrease by 200 units/hr4 hrs after rate change161-199Hold infusion for 60 minutesDecrease by 250 units/hr4 hrs after rate change>2001. If blood draw was potentially contaminated (drawn from heparinized line), repeat STAT aPTT using peripheral blood draw or proper line technique. If repeat aPTT < 200, follow protocol above for aPTT. If repeat aPTT > 200, Hold infusion and follow #3 below.2. If blood draw improperly timed (< 6 hours after a bolus), recheck aPTT at correct time (6 hours after a bolus). If repeat draw < 200, follow protocol above for aPTT. If repeat aPTT > 200, Hold infusion and follow #3 below.3. If properly timed, non-contaminated blood aPTT > 200, Hold infusion, Notify Physician and recheck STAT aPTT every hour until aPTT < 80. Then (when aPTT < 80) restart infusion at a rate which has been decreased by 300 units/hr from last infusion rate and recheck aPTT in 4 hours.*aPTT range corresponding to anti-Xa activity of 0.3 to 0.7 Units/mlMonitoring:[ ] aPTT 4 hours after any dose change[ ] aPTT every 12 hours after 3 consecutive aPTT within therapeutic range[ ] CBC dailyIf significant bleeding occurs (including, but not limited to bright red blood per rectum, bloody emesis, neurological changes, rapid drop in hematocrit/hemoglobin, progressive bleeding from IV sites, epistaxis, hematomas, and guaiac positive stool:STOP heparin infusion immediatelyOrder STAT aPTTNotify physicianReferences:Garcia D, Baglin T, et al. Parenteral Anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (9th Edition). 2012; 141(Suppl 2): e24s-e43s.Tahir R. A Review of Unfractionated Heparin and Its Monitoring. US Pharm 2007;32(7); hs26-36.Approved by:VA Puget Sound Pharmacy and Therapeutics Committee, May 2012 ................
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