Presentation on theme: "Director, Vascular Medicine"— Presentation transcript:
1 Director, Vascular Medicine Anticoagulation Issues at University Hospitals Case Medical Center AKA – ALMOST everything you need to know for successful AC managementTeresa L. Carman, MDDirector, Vascular MedicineCase Medical CenterPager 33515Office 41261
2 Discussion Use of the heparin protocol Anti-Xa assay vs. aPTT monitoringAnticoagulation quality measuresSafe warfarin dosingSafe discharge of patientsAnticoagulation monitoring service referrals
4 IV Heparin Protocol Diagnosis / Weight Based Dosing Low intensity dosingACS, StrokeHigh intensity dosingVTE, CVT, AfibNurse Driven TitrationTitration table based on 4 hr anti-xa lab value obtained after initial dosing or titration changesWith the change in monitoring the titration table will change to reflect a 6 hr interval for required titrations
5 IV Heparin Protocol Initial Loading Bolus Full Protocol Includes:Initial Loading BolusTitrated Drip – know the drip rateAdditional (Repeat) Bolus (as required)
6 IV Heparin Protocol Ordering Choose the “Loading Dose” to order the initial bolus
7 IV Heparin Protocol Ordering Choose “Continuous Infusion” to order the dripIncludes standard nurse driven titration protocol
8 IV Heparin Protocol Ordering Choose the “Repeat Bolus” for nursing to give a bolus based on Q 4 hr aPTT (anti-Xa) lab valueX
9 IV Heparin Protocol Why order the full protocol? Clinical Results: If the full protocol is NOT ordered39 hr average time to therapeuticFull protocol ordered11 hr average time to therapeuticAll patients were either therapeutic or supratherapeutic within 6 hrs
10 IV Heparin Protocol Why the 4 hour dosing change to the protocol? With a 6 hour protocol it usually takes 8 hours between dose adjustmentsThe 4 hour protocol should decrease this interval to approximately 6 hoursThis should allow patients to a reach consistent therapeutic range sooner thus impact the risk for recurrent events
12 Overview of aPTTThe aPTT is used in most clinical laboratories to monitor coagulation and specifically monitor anticoagulants ie. intravenous unfractionated heparin and direct thrombin inhibitorsClinicians have familiarity with assayReadily automatedCurrent targets were established based on data from a post-hoc analysis of a 1972 study which suggested times aPTT control reduced risk the of recurrent thromboembolismEikelboom JW. Thromb Haemost 2006;96:Francis JL. Pharmacotherapy 2004;24:108S-19S.
13 Disadvantages of Using aPTT to Monitor Heparin aPTT has variable a response to heparin determined by the different coagulometers and the reagentsThere is no aPTT “standard”When the tissue thromboplastin lot changes, a new therapeutic range needs to be established for the new lot of reagentTest may be affected by numerous factors other than heparin concentrationBaseline elevated aPTT makes titration difficult and inaccurateEikelboom JW. Thromb Haemost 2006;96:Francis JL. Pharmacotherapy 2004;24:108S-19S.
14 Conditions that May Prolong the Baseline aPTT Lupus anticoagulantsOther antiphospholipid antibodiesPrekallikrein, High Molecular Weight Kininogen LevelLow levels (<40%) of:FibrinogenProthrombinFactors V, VIII, IX, X, XI, and XIIEikelboom JW. Thromb Haemost 2006;96:Francis JL. Pharmacotherapy 2004;24:108S-19S.
15 Current Recommendations from CHEST Guidelines Each coagulation laboratory determines the therapeutic range for their aPTT reagent that correlates with a heparin assay level of 0.3 to 0.7 international units (IU)/mL (by anti-Factor Xa assay)Each laboratory must determine its own therapeutic range for heparin for the aPTT whenever the aPTT reagent changes or with a change in instrumentationTherefore, the range changes almost annuallyHirsh J. Chest 2008;133:141-59
17 Update on MonitoringAs of summer 2011 the “aPTT” is not available for monitoring IV unfractionated heparin therapy at University Hospitals Case Medical Center. (no correlations have been done; no target range exists)The “aPTT” has been replaced by anti-Xa monitoring using the “heparin assay, UFH”The use of the “heparin assay, UFH” will standardize IV unfractionated heparin monitoring and make the use of the aPTT inaccurate
18 Heparin AssaySpecifically determines anticoagulant activity of IV unfractionated heparin by measuring ability of heparin-bound antithrombin to inhibit a single enzymeMore specific than aPTT since it measures inhibition of a single enzymeMajor advantage is lack of biologic factors that affect its resultEikelboom JW. Thromb Haemost 2006;96:Francis JL. Pharmacotherapy 2004;24:108S-19S.
19 Comparison of Monitoring with aPTT vs. Anti-Factor Xa Assay Prospective, single-center study268 patients on IV heparin for variety of indicationsUtilizing anti-Factor Xa assay led to fewer tests and dose adjustmentsCost increase of $1.09/day more using anti-Factor Xa assayP<0.0001P<0.0001Rosborough TK. Pharmacotherapy 1999;19:
20 Current “High-Intensity Therapeutic Heparin” Anticoagulation Orders Using Heparin Assay for Adult Patients (VTE etc)
21 Current “Low-Intensity Therapeutic Heparin” Anticoagulation Orders Using Heparin Assay for Adult Patients (ACS, stroke)
22 No Changes for the Monitoring of Other Anticoagulants Prothrombin time/INR is still used to monitor warfarinTherapeutic monitoring of direct thrombin inhibitors (bivalirudin and argatroban) still use the aPTTSpecial monitoring for enoxaparin (Lovenox®) is done by Heparin assay, Lovenox
23 Summary #1UH uses the heparin assay, UFH for monitoring all intravenous unfractionated heparin therapy.The order set will change to reflect the therapeutic ranges for “High-dose” and “Low-dose” indications“high-dose” anti-Xa = IU/ml“low-dose” anti-Xa = IU/mlThe time between adjustments and monitoring will decrease to 4 hours in an effort to shorten the time to therapeutic
25 What are Core Measures ?Evidence based clinical measures that assess quality of careImpact large populations of patientsTracks outcomes over timeFramework to rate healthcare performancePublicly reportedComparison data availableCurrently used in pay for performance initiativesA and C4/13/2017University Hospitals Case Medical CenterQuality Assurance/Peer Review Report Privileged Pursuant to O.R.C. Section , .251, .2522525
26 Where is Data Publicly Reported? Hospital CompareThe Joint CommissionOhio Department of HealthLeapfrogHealth GradesA and C4/13/2017Quality Assurance/Peer Review Report Privileged Pursuant to O.R.C. Section , .251, .25226
27 VTE Core Measure New Core Measure for 2013 Includes: VTE prophylaxis within 24 hours of arrivalICU VTEIncidence of potentially preventable VTEPlatelet monitoring for unfractionated heparinAnticoagulation overlap therapyComprehensive discharge instructionsAlso part of Meaningful Use
28 Anticoagulation Committee ApproachFit compliance into current clinician workflowNo additional resourcesNo retrospective chart abstractionSusan
29 Basic EssentialsAll patients require DVT prophylaxis screen on admissionThe proper prophylaxis is ordered or an appropriate reason for omission is documentedHospital acquired VTE is considered a “never event”VTE treatment transition must meet current guidelines and this is documented and supported by the discharge orders
30 VTE Quality MeasureTo meet certain care standards to prevent and treat DVT/PEMust complete the DVT Risk Assessment Screening on admissionHelps determine DVT risk: low, moderate, high or very highIncludes orders based on risk score for both pharmacologic and mechanical prophylaxisBe sure to enter omission reason if choosing not to order prophylaxis
37 Summary #2 All patients are risk stratified on admission All patients have prophylaxis ordered – or – a specific indication for not ordering prophylaxis is required.
38 UFH, LMWH, Fondaparinux Overlap with Warfarin to a Therapeutic INR Rational for a 5 Day Overlap and Discharging Patients on Warfarin
39 Anticoagulation Caveats When short-acting parenteral anticoagulants are chosen as the starting therapy a minimum of 5 days of overlap between parenteral, short-acting drugs and warfarin is required to complete anticoagulationUnfractionated heparin (UFH)LMWHLovenox/enoxaparin, Fragmin/dalteparin, Innohep/tinzaparinFondaparinux (Arixtra)The target INR is typically 2.5 (range 2-3)The INR must be > 2 on 2 consecutive days before stopping the parenteral agent
40 Warfarin Anticoagulant effect (VII, IX) vs. Antithrombotic effect (X, II)Anticoagulant effect can be seen within 2 daysAntithrombotic effect takes minimum of 4-5 days due to the t ½ of prothrombin (24-48 hours)
41 Parenteral Anticoagulant to Warfarin Conversion The anticoagulant effect of warfarin on the INR can be seen within 2 days of initiating warfarin therapy.Laboratory prothrombin time effect due to FVII depletionDoes not equate to therapeutic anticoagulationThe antithrombotic effect of warfarin takes minimum of 5 days overlap between the drugs.Minimum time required to achieve a therapeutic level of anticoagulation and reliable thrombin depletion
42 Warfarin Effects Water soluble, readily absorbed from the GI tract Interferes with Vitamin K dependent γ-carboxylationCoagulant factorsII, VII, IX, and XAnticoagulantsprotein C and S
43 How Does Warfarin Work?Warfarin inhibits the production of active clotting factors in the bodyInhibits the activity of Vitamin KDoes not effect the activity of clotting factors that have already been made by the bodyMay take several days to see effectsNeed overlap therapy with an immediate acting anticoagulant if rapid response is desiredHeparin, Lovenox, Arixtra
44 Parenteral Anticoagulant to Warfarin Conversion Due to the long half-life of prothrombin (60-72 hours) and the need to fully delete preformed circulating thrombin and replace it with terminally modified prothrombin protein the minimum time to complete anticoagulation is 5 days.INR rises before this time DO NOT reflect therapeutic anticoagulation.
45 Summary FVII is a vitamin K dependent protein It has the shortest t½ of all the vitamin K dependent coagulant proteinsFVII activation initiates the prothrombin time reactionThe initial rise in the INR may be due to rapid depletion of FVIIThis does not correlate with depletion of FX and FII (prothrombin)FX and prothrombin have long t½ and take 4-5 days to be adequately depleted – hence the need for 5 days of overlap therapy
46 Parenteral Anticoagulant to Warfarin Conversion In addition, to ensure consistency the INR must be >2 on 2 consecutive days before the parenteral agent is stopped.Therefore the MINIMUM time to achieve a therapeutic INR is 5 days.Most patients will require approximately 7 days to complete anticoagulant conversion to a stable INR on warfarin.
47 Anticoagulation Medication Reconciliation New drop down box specific to anticoagulant drugsShow screen shot of the drop downWill include a question about whether the patient had a DVT or PE confirmed during this hospital admission. If yes, then you must enter in the date of the diagnostic test that gave the confirmationMay enter up to 2 anticoagulants that the patient is being discharged on.
48 Anticoagulation Medication Reconciliation New drop down box specific to anticoagulant drugsMay enter up to 2 anticoagulants prescribed at the time of discharge
49 Anticoagulation Medication Reconciliation Will include a question about whether the patient had a DVT or PE confirmed during this hospital admission. If yes, then you must enter in the date of the diagnostic test that gave the confirmation.QuestionDate
50 Summary #3Overlap therapy for a MINIMUM of 5 days and until a stable therapeutic INR > 2 on 2 consecutive days is required for patients with VTE treated with AC.Med reconciliation and documentation is imperative for success
52 Why do we care about Warfarin? It is the most commonly prescribed anticoagulant>31 Million prescriptions dispensed in 2004It is the medication most commonly responsible for serious & life-threatening adverse reactionsNarrow therapeutic window fine line between being helpful & harmfulAmong the top 5 drugs contributing to ER visitsAmong the top 2 drugs causing hospitalization
53 Warfarin Anticoagulant effect (VII, IX) vs. Antithrombotic effect (X, II)Anticoagulant effect can be seen within 2 daysAntithrombotic effect takes minimum of 4-5 days due to the t ½ of prothrombin (24-48 hours)
54 Dosing Variability The average warfarin dose is 5 mg. Loading doses do not help achieve a therapeutic INR more quickly given the need for a 5 day overlapFrom Mol Interventions 6:
55 Warfarin Current ACCP guidelines recommend 5-10 mg initial dosing In the elderly, patients who are debilitated, malnourished, have CHF, liver disease or recent surgery or who are taking medications which increase sensitivity to warfarin - initial dose should be ≤ 5 mgHospital patients should RARELY receive more than 5 mg initial warfarin dosing“Loading doses” do not alter the need for overlap and may increase the risk of bleedingHigher initial doses may be suitable for stable, healthy outpatientsChest 2008;133(3Suppl):
56 Warfarin Follow Up Appointment All patients discharged on Warfarin:Discharge instructions must include an appointment for Warfarin follow up monitoring.Discharging provider enters this information in the follow up section on patient profile (CMC) which has a new option specific to Warfarin follow up.Includes:The clinic or physician that will cover the follow up monitoringUH “Coumadin Clinic” is called “Anticoagulation Monitoring Service”Phone numberDate next PT/INR is due
57 Summary #4Choose warfarin initiation doses based on patient characteristicsNOT 5 mg for everyoneUsually after hospital dc warfarin dose requirements decreaseABXDiet interruptionCo-morbid/intervening illness
58 Anticoagulation Monitoring Service AKA – Coumadin Clinic
61 Anticoagulation Monitoring Service Referral Steps to schedule an initial visit to the Anticoagulation Monitoring Service:1. An appointment must be scheduled for the patient to be seen; they are not "walk-in" visits.2. Complete this form and fax to along with recent office note or discharge summary.(Concord Health Center only fax to (440) and Geauga only fax to (440) ).3. Call to notify Anticoagulation Monitoring Service of patient and confirm receipt of order form; this will ensure transition of patient and help to prevent gaps in care. An initial appointment can be made for the patient at this time or the scheduling office will contact the patient to schedule. Our goal is to see your patient within 3-5 business days.4. Orders cannot be taken from Residents, Fellows, CNP's or PA's; a managing physician MUST be listed.5. The referring physician must ensure an interim management plan is in place until the patient can be seen.6. The referring physician must ensure that there is a managing physician responsible for the ongoing needs of the patient. The managing physician will be contacted by the Anticoagulation Monitoring Service staff for any patient care related issues.7. Compliance with appointments and/or medication regimen is expected, otherwise patients will be discharged from the anticoagulation monitoring service with ample warning.
62 Anticoagulation Monitoring Service Responsibilities of the Anticoagulation Monitoring Service Staff:1. If we are unable to schedule the visit within 3-5 business days of receiving the form or being discharged from the hospital, you will be contacted by our office.2. The clinic staff cannot initiate anticoagulant therapy, nor can they bridge therapy without orders from the managing physician. Furthermore, they will not assume responsibility for the monitoring of the patient's anticoagulation until the patient has been seen for the initial visit.3. Progress notes will be sent to the managing physician's office via fax after each visit.Criteria for patient enrollment in the Anticoagulation Monitoring Service:1. Patient is ambulatory and able to come to the clinic for appointments. The clinic will not provide anticoagulation monitoring for patients receiving home health, hospice or those getting venous punctures at a laboratory.2. Patients without a managing physician will not be enrolled in the Anticoagulation Monitoring Service.3. Patients/caregiver should have no previous compliance issues documented and is a willing, active participant in their care.
63 Therefore – engage the PCP early and often Begin the referral process early
64 Anticoagulation Management Must document and “manage” all aspects of anticoagulationMinimum of 5 days overlap requiredINR max 3 days after starting therapyMin every 2 days during the transitionNeed 2 checks the week following
65 Anticoagulation Monitoring Service SUMMARY Monitor anticoagulation for a MANAGING PHYSICIANNurse driven protocol following the orders of the physicianWe ARE NOT responsible for the patient until the first visit – usually 3-5 days after dcIf the visit is delayed someone else needs to be monitoringIf the visit is missed someone else is responsibleWe do NOT dose adjust without ordersExpectations are that the orders are followed – any desirable adjustments may be made and will be followedie. shorter or longer intervals for managementIf warfarin or lovenox etc are required the managing physician must be engagedWe will facilitate referrals for the physician with the pharmacy
66 Warfarin Follow Up Appointment All patients discharged on Warfarin:Discharge instructions must include an appointment for Warfarin follow up monitoring.Discharging provider enters this information in the follow up section on patient profile (CMC) which has a new option specific to Warfarin follow up.Includes:The clinic or physician that will cover the follow up monitoringUH “Coumadin Clinic” is called “Anticoagulation Monitoring Service”Phone numberDate next PT/INR is due
68 SUMMARY #5When anticoagulation is going to be required engage the PCP early and oftenBegin the referral process early
69 ConclusionsOn admission ALL patients require DVT risk assessment and prophylaxis ordersHeparin when required - use the order setsHigh dose vs. Low doseAnti-Xa monitoring is the UHCMC standard for adult patientsOverlap therapydocumented is required AND must beDischarge on anticoagulation requires effortPCP contact for follow up/monitoringAMS referralInterim plan for delays in presenting to the AMS****LMWH or other anticoagulants may require pre-authorization so request SW/pharmacy approvals early