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Anticoagulation Outpatient Service

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					Outpatient
Anticoagulation
Services:
Providers’ Section

  High Alert Medication Working Group
          26-28 February 2008
Outpatient Service

   Addresses 2008 NPSG requirement 3E
    – C 4: Initiation and maintenance of
      anticoagulation therapy
    – A 5: Baseline INR availability
    – C 6: Dietary involvement/notification
    – C 8: Monitoring for UFH/LMWH
Warfarin (Coumadin )          ®



Initiation
Provider Responsibilities:
 Identify patients requiring
  anticoagulation
 Prescribe an appropriate initial dose of
  anticoagulant medication
 Order baseline labs, to include INR,
  CBC, Renal Panel, Urinalysis (U/A),
  Fecal Occult Blood Test (FOBT) and
  bHCG (when appropriate)
Warfarin (Coumadin)
Initiation
Provider Responsibilities, cont'd:
 Referral includes minimum of:
  – Diagnosis for which Warfarin (Coumadin)
    is being initiated
  – Target INR range*
  – Anticipated duration of therapy
Warfarin (Coumadin)
Initiation
Provider Responsibilities, Cont'd:
 Referral for dietary counseling, as
  available.
 Referring provider is responsible for
  anticoagulation management until the
  patient has been established with the
  anticoagulation service.
Provider Monitoring

Provider Responsibilities, Cont'd:
 Short-term anticoagulation:
    – Clinical assessment at end of treatment
      period
    – Provider must order discontinuance of
      anticoagulation as indicated
   Chronic anticoagulation:
    – Yearly clinical assessment
    – Yearly CBC, BUN/Cr, U/A, FOBT
Low Molecular Weight
Heparin (LMWH) Initiation
Provider Responsibilities:
 Identify patients requiring LMWH
  anticoagulation
 Prescribe an initial dose of LMWH

 Order baseline labs, to include baseline
  INR, CBC, UA, FOBT, BUN/Cr
LMWH Initiation

   Referral:
    – Diagnosis for which LMWH is being
      initiated
    – Patient weight (in kg)‫‏‬
    – Anticipated duration of therapy
   Monitoring:
    – Platelet Count: Days 5 and 10 to assess
      for Heparin Induced Thrombocytopenia
      (HIT)
Bridging onto Warfarin (Coumadin)
  Therapy (Initiating Treatment)‫‏‬

   LMWH and Warfarin (Coumadin)
    should be initiated concurrently
   The combination should be continued
    for at least 5 days, then discontinue
    once INR has been within target range
    for two consecutive days.
   Follow-up accordingly in Warfarin
    (Coumadin) program
Bridging with LMWH for
Invasive Procedures

   Risk stratification
   Determine level of bridging therapy
    needed
   Initiate bridging process up to 7-10
    days prior to procedure, as indicated
                         Bridging with LMWH:
                          Risk Stratification
            Low                             Medium                              High


Acute VTE > 3 months ago       Acute VTE within past 2-3          Acute VTE within past month
                                   months


Uncomplicated nonvalvular      Recurrent venous VTE disease       Acute arterial thromboembolic
   atrial fibrillation            (last acute episode at least        event in past month
                                  3 months ago)‫‏‬



Uncomplicated bileaflet        Non-valvular atrial fibrillation   Nonvalvular atrial fibrillation
   mechanical heart valve in      with one additional risk           with > one risk factor*,
   the aortic position, NSR.      factor*, mechanical heart          mechanical heart in the
                                  valve with one additional          mitral position or valve with
                                  risk factor.**                     > one additional risk
                                                                     factor**
           Bridging with LMWH:
            Risk Stratification

   *Risk factors in atrial fibrillation:
    – Age>65
    – Hx of HTN
    – Previous TIA or stroke
    – Diabetes
    – LV dysfunction
    – Large left atrium
             Bridging with LMWH:
              Risk Stratification

   **Risk factors for arterial thromboembolism
    in mechanical heart valve:
    –   Prior thromboembolism
    –   Atrial fib
    –   Caged ball or caged disk valve
    –   More than one mechanical heart valve
    –   Valve in mitral position
    –   Severe LV dysfunction
    –   Age>65
            Low                     Intermediate                    High
  *Discontinue warfarin       *Discontinue warfarin        *Discontinue warfarin
therapy 3 – 5 days before    therapy 3 – 5 days before   therapy approximately 3-5
   procedure, and allow      procedure, and allow INR    days before procedure and
     INR to return near      to return to near normal.     allow INR to return to
          normal.                  *Start LMWH                   near normal.
*Consider PO Vitamin K         prophylactic dose (see     *Start LMWH treatment
  if INR > 1.7 day before              below).                dose (see below).
   procedure if bleeding    *Stop LMWH 12-24 hours       *Stop LMWH 12-24 hours
         risk high.              before procedure.            before procedure.
    *Restart warfarin as    *Consider PO Vitamin K if    *Consider PO Vitamin K if
      soon as possible         INR > 1.7 day before         INR > 1.7 day before
 following the procedure.      procedure and risk of        procedure and risk of
  *If procedure increases         bleeding is high.            bleeding is high.
 risk of thrombosis begin    *After procedure: resume     *After procedure: resume
 LMWH at prophylactic          LMWH 24 hours post         LMWH in 12-24 hours or
           doses.*             procedure and restart       when patient achieves
                                warfarin as soon as        hemostasis, and restart
                             possible. Treatment doses       warfarin as soon as
                                 of LMWH may be                    possible.
                                     considered.


*LMWH Prophylaxis: enoxaparin 30 mg SQ q12 hr or 40 mg SQ daily
**LMWH Treatment: enoxaparin 1 mg/kg SQ q12 hr
           Days relative to surgery                    Anticoagulation Management

-10 to -7                             Assess thrombosis and bleeding risk. Determine appropriate
                                      bridging plan. Evaluate aspirin or other antiplatelet therapy.
                                      Obtain baseline CBC, and serum creatinine. Screen for
                                      heparin induced thrombocytopenia (HIT)‫‏‬



-7                                    Stop aspirin or other antiplatelet therapy. INR testing


-5 or -3                              Stop warfarin
-2 to -3                              Start LMWH. Obtain labs if not already performed.


-24 hours to -1                       Last dose LMWH. Obtain INR. Consider PO Vit K if INR >
                                      1.7 and bleeding risk high


0 procedure                           Resume warfarin at usual maintenance dose evening of
                                      procedure
+1                                    If hemostasis is achieved, resume LMWH. Continue
                                      warfarin.
+2 to +3                              INR testing. Hematology to check platelets.


≥‫‏‬day‫‏4‏‬                              INR test. Continue warfarin. Stop LMWH if INR > 2.
         Bridging with LMWH:
             Bleeding Risk

   High risk of bleeding:
    – CNS surgery
    – Major thoracic
    – Major abdominal
    – Major pelvic surgery
    – Polypectomy via colonoscopy
    – Other closed procedures
QUESTIONS?
Outpatient
Anticoagulation
Service:
Dosing Subcommittee

High Alert Medication Working Group
        26-28 February 2008
JCAHO Expectations for
3E
   A2
    – To reduce compounding and labeling
      errors, the organization uses ONLY oral
      unit dose products and pre-mixed
      infusions, when these products are
      available.
A2

   Recommended:
    – Brand name Coumadin
         If not available
            –   Pharmacy to notify Coumadin program
            –   Pharmacy to notify patient
            –   INR rechecked in 1-2 weeks
            –   Recommend specific generic??? TRICARE???
         Recommend restricting strengths of Coumadin
          dispensed
            – 2 mg, 5 mg
            – 1 mg as needed
JCAHO Expectations for 3E

   C3
    – When pharmacy services are provided by
      the organization, warfarin is dispensed for
      each patient in accordance with
      established monitoring procedures.
C3
   Coumadin program will monitor patient
    records at a minimum of every 4 weeks to
    identify non-adherent patients
    – Attempt to contact patient by phone 3x’s and
      document by TCon
    – Utilize program “tool kit” to contact non-
      adherent patients and potentially disenroll
      patient
    – Limit quantity and refills for non-adherent
      patients; pt. should be instructed to contact PCM
      or anticoagulation service
   Patient should contact anticoagulation
    service when initiated on new medications
    or altered medication doses
JCAHO Expectations for 3E

   C8
    – The organization has a policy that
      addresses baseline and ongoing
      laboratory tests that are required for
      heparin and LMWH therapies.
C8

   Initializing LMWH
    – Baseline-CBC, BUN/SCr, FOBT, UA,
      weight
    – Days 3 and 5, repeat CBC (HIT)
   Long term treatment with LMWH
    – Routine CBC, SCr
C8 Continued…

   Recommend monitoring anti-factor Xa
    – Obesity (TBW > 150 kg)
    – Severe renal impairment (CrCl <30 ml/min)
    – Pediatric
    – Bleed
    – Pregnancy
Disclaimer

   The following slides are general
    guidelines and should not supersede
    clinical judgment
Dosing
   Initiation
    – 5 mg for most patients
    – An increased initiation dose of up to 10 mg may
      be acceptable in some patients
    – Consider decreased dose (less than 5 mg) in the
      following patients
           Elderly > 60 yo
           Patients weighing less than IBW
           Renal/hepatic impairment
           CHF
           High risk bleed patients
           Interacting medications (Flagyl, amiodarone, Bactrim,
            etc.)
           Malnourished/NPO
           Ethnicities (Chinese-Asian, Pacific-Asian)
Dosing

   Management
    – Dosing
        Per CHEST guidelines, INRs outside the therapeutic
         range should be adjusted 5-20% of the cumulative
         weekly total dose
       OR
        Increased monitoring if the INR is expected to return
         to the therapeutic range without a dose change
        Published nomograms are available to guide dosing;
         however, note that clinical judgment supersedes the
         nomograms
Adjusted Dosing

   Drug Interactions
   Disease State Interactions
   The following slides are not all
    inclusive
   More frequent monitoring and possible
    dose adjustment may be required
Warfarin-Drug Interactions:

  Drugs that may potentially lengthen PT / increase INR

    Antibiotics                 Anti-inflammatories
     –   Carbenicillin            –   Allopurinol
     –   Erythromycin             –   Fenoprofen
     –   Fluconazole              –   Ibuprofen
     –   Fluoroquinolones         –   Indomethacin
     –   Isoniazid                –   Naproxen
     –   Ketoconazole             –   Phenylbutazone
     –   Metronidazole            –   Piroxicam
     –   Moxalactam               –   Sulfinpyrazone
     –   Cephalosporins           –   Zileuton
     –   Trimethoprim/sulfa
Warfarin-Drug Interactions
    Drugs that may potentially lengthen PT / increase INR
    Antiarrhythmics              Others
      – Amiodarone                 –   Alcohol (acute)
      – Quinidine                  –   Anabolic steroids
                                   –   Cimetidine
                                   –   Clofibrate
                                   –   Disulfiram
                                   –   Lovastatin
                                   –   Omeprazole
                                   –   Phenytoin
                                   –   SSRI’s
                                   –   Tamoxifen
                                   –   Thyroxine
                                   –   Vitamin E (large doses)
Warfarin-Drug
Interactions
Drugs that may potentially shorten PT / decrease INR

   Alcohol                     Penicillin
   Antacids                    Rifampin
   Antihistamines              Spironolactone
   Barbiturates                Sucralfate
   Carbamazepine               Trazodone
   Cholestyramine              Vitamin C (large doses)
   Griseofulvin
   Haloperidol
   Oral contraceptives
Warfarin-Disease
Interactions
May potentially lengthen PT / increase INR

   Blood dyscrasias            Hepatic disorders
   Cancer                      Fever
   Collagen vascular           Hyperthyroidism
    disease                     Poor nutritional state
   CHF                         Prolonged hot weather
   Diarrhea                    Steatorrhea
   Dietary deficiency
Warfarin-Disease
Interactions
Drugs that may potentially shorten PT / decrease INR

   Edema
   Hyperlipidemia
   Hypothyroidism
   Nephrotic syndrome
      Maintenance Goal INR 2-3
For INR < 2.0*     May  consider one-time increased dose   Recommend repeat INR in
                   Increase the weekly dose by 5-20%       no more than 7 days.
                   Assess patient for risk factors and
                   consider LMWH
For INR 3.1-3.5*   Decrease the weekly dose 5-15%.         Recommend repeat INR in
                   May consider one-time dose reduction.   no more than 2 weeks.



For INR 3.6-4.0    May consider one-time dose reduction    Recommend repeat INR in
                   Hold 0-1 doses                          no more than 2 weeks.
                   Decrease weekly dose by 5-15%


For INR 4.1-4.9    Hold1-2 doses                           Recommend repeat INR in
                   Then decrease the weekly dose by 5-     no more than 7 days.
                   15%
Maintenance Goal INR 2.5-3.5
For INR < 1.7 in mitral   Initiate   LMWH or UFH per bridging   Recheck INR frequently until
MVR Coumadin program      protocol                               patient is stable within
patients                  May consider one-time increased       therapeutic range
                          dose
                          Increase the weekly dose by 10-
                          20%
For INR < 2.5*            Increase    the weekly dose by 5-     Recheck INR within 7 days.
                          15%
                          May consider one-time increased
                          dose
                          Assess patient for risk factors and
                          consider LMWH.
For INR 3.5-4.0*          Decrease  the weekly dose 5-15%.      Recheck INR in no more
                          May consider one-time dose            than 2 weeks.
                          reduction.
Maintenance Goal INR 2.5-3.5
  For INR 4.1 to 4.9   Hold 0-1 doses                           Recheck INR
                       Decrease weekly dose by 5-15%            in no more
                       May consider one-time dose reduction.
                                                                 than 2
                                                                 weeks.




  For INR > 4.9        See CHEST guidelines for management of
                       patients with high INR values
Managing Elevated INRs

   INR ≥ 5.0 but < 9.0; no significant
    bleeding
    – Omit next 1-2 doses
    – Monitor more frequently
    – Resume at lower dose when INR in
      therapeutic range
    OR
      alternatively, may omit dose and give vit
      K (≤5 mg PO)
Continued…

   INR ≥ 9.0; no significant bleeding
    – Contact patient’s PCM
    – Hold warfarin therapy and give 5-10 mg
      orally vit K
    – Monitor INR more frequently (in 24-48
      hours)
    – May repeat vit K dose if needed
    – Resume lower dose when INR
      therapeutic; repeat INR as necessary
Continued…

   Serious bleeding at any elevation of
    INR or life-threatening bleed
    – Instruct patient to hold Coumadin
    – Send patient to ER or other appropriate
      facility
    – Contact patient’s PCM
    – Instruct patient to contact Coumadin
      clinic upon discharge from hospital/ED
QUESTIONS?
Outpatient
Anticoagulation
Services:

Outpatient Program Group
 High Alert Medication Working Group
         26-28 February 2008
    Maintenance
    Protocol/Guidelines (C4)
   All AMEDD/MEDCOM anticoagulant programs will
    have a physician medical director. (Requirement)
   Dosing adjustments will be performed by a
    Physician, Midlevel provider, Clinical Pharmacist, or
    specially trained RN only. (Requirement)
   All AMEDD/MEDCOM facilities will use ACC/ACCP
    guidelines for a basis in initiation and maintenance
    therapy. (Requirement)
INR Availability and
Monitoring (A5)
   Intervals between INR evaluation will
    not exceed 4 weeks. (Requirement)
   INR’s will be obtained and resulted within
    24 hours. (Requirement)
   Anticoagulation programs will conduct an
    in-person initial enrollment.
    (Requirement)
   PCM’s will conduct an annual in-person
    reassessment (Requirement)
INR Availability and
Monitoring (A5)

   PCM’s will re-order participation in the
    anticoagulation program annually

   Recommend a common database
    documentation system (i.e.
    Standingstone, DoseResponse, etc.)
INR Availability and
Monitoring (A5)
   Require a flag in AHLTA for patients
    on an anticoagulant therapy.

   Require a section in AHLTA for
    anticoagulation therapy.
    – Section for POC testing data input
    – Graphic capability for in/out of range
    – Current Dose
    – Target Range
     Patient/Family Education
     (C10)

   Follow up INR monitoring maximum every 4
    weeks or less (Requirement)

   Patients deemed noncompliant with local
    program compliance SOP’s will be referred
    back to their PCM for management.
    Documentation of compliance issues will be
    completed using Tool Kit resources
Tool Kit

   Creation of Tool Kit to encompass
    standardized patient education to address:
   Intake form
   Patient contract
   Compliance notification letter
   Diet education
   PCM annual re-evaluation guideline
   Education materials
   Civilian Provider referral form
   High Risk/Low Risk form for dental and invasive
    procedures
Tool Kit

   AHLTA AIM/Template form
   Alternate laboratory testing site letter
   Guideline and establishment of SOP’s
Tool Kit

   Components will be re-evaluated every
    4 years
   Outpatient team will divide up to
    develop Tool Kit.
   Time line will be in conjunction with
    the April – October time line
   Need to develop mechanism to
    distribute tool kit items to participants.
Safety Evaluation (A11)

   Creation of a Bundle database to track
    unexpected events for outpatient
    anticoagulation patients using the
    AMEDD patient safety program
    (Requirement)
Safety Evaluation (A11)

   Triggers
    – Blood products
    – Admission for bleeding related events
    – Vitamin K use
    – Bleeding required intervention
    – Clot formation
    – Mechanical heart valve patients with INR
      <1.7
    – Any INR > 6.0

				
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