Anticoagulant Safety and National Patient Safety Goal 3E

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					Anticoagulant Safety and
National Patient Safety Goal 3E

Reduce the Likelihood of Patient Harm Associated With the Use of
Anticoagulant Therapy
  Objectives
• Discuss National Patient Safety Goal 3E.
• Identify important information relating to Heparin
  usage.
• Recognize important information relating to LMWH
  and fondaparinux usage.
• Describe important aspects of warfarin usage.
• Discuss the role of patient/family education relating to
  NPSG 3E.
• Identify key actions relating to deep vein thrombosis
  prevention.



                     Company Confidential – For internal use only   2
Authors/Editors
•   The content of the course was provided by Carl Peterson,
    Pharm. D. He has been affiliated with Cardinal Health
    since 1995 and is currently Clinical Director of Cardiovascular
    Diseases for the Center for Safety and Clinical
    Excellence. Dr. Peterson has also served as a consultant on
    advisory panels for Sanofi-AventisTM, which is the
    manufacturer of Lovenox®. Dr. Peterson does not have any
    actual conflicts of interest in relation to this program.
•   The course was edited by Curt W. Quap, M.S., R.Ph, Director
    of Clinical Affairs and Angela Gomez, Ph.D., Manager of
    Clinical Education and Training.




                        Company Confidential – For internal use only   3
  Outline
• NPSG 3E
• Heparin essentials
• LMWH and fondaparinux essentials
• Warfarin essentials
• Patient/family education
• DVT prevention




                       Company Confidential – For internal use only   4
  Improving Anticoagulant Safety
National Patient Safety Goals
• Purpose—promote specific improvements in patient
  safety.
• Goals, requirements, implementation expectations
  recommended to Joint Commission Board by expert
  Advisory Group.
• Compliance assessed via on-site surveys and
  Periodic Performance Review.
• Failure to comply can lead to loss of accreditation



                     Company Confidential – For internal use only   5
    Improving Anticoagulant Safety
National Patient Safety Goal 3E
•   Reduce the likelihood of patient harm associated with the use of
    anticoagulation therapy
•   Anticoagulation is a high risk treatment, which commonly leads
    to adverse drug events due to the complexity of dosing these
    medications, monitoring their effects, and ensuring patient
    compliance with outpatient therapy.
•   The use of standardized practices that include patient
    involvement can reduce the risk of adverse drug events
    associated with the use of heparin (unfractionated), low
    molecular weight heparin (LMWH), warfarin, and other
    anticoagulants.




                          Company Confidential – For internal use only   6
    NPSG 3E Implementation Timeline
•   4/1/08 Organization leadership assigns responsibility for
    oversight and coordination of:
     – Development
     – Testing
     – Implementation
•   7/1/08 Implementation work plan in place that identifies:
     – Adequate resources
     – Assigned accountabilities
     – Time line for full implementation
•   10/1/08 Pilot testing in at least one clinical unit is underway
•   1/1/09 Process fully implemented across the organization



                           Company Confidential – For internal use only   7
    NPSG 3E Implementation Expectations

•   A 1. The organization implements a defined anticoagulant
    management program to individualize the care provided to each
    patient receiving anticoagulant therapy.

•   A 2. To reduce compounding and labeling errors, the
    organization uses ONLY oral unit dose products and pre-mixed
    infusions, when these products are available.

•   C 3. When pharmacy services are provided by the organization,
    warfarin is dispensed to each patient in accordance with
    established monitoring procedures.




                         Company Confidential – For internal use only   8
    NPSG 3E Implementation Expectations
•   C 4. The organization uses approved protocols for the initiation
    and maintenance of anticoagulation therapy appropriate to the
    medication used, to the condition being treated, and to the
    potential for drug interactions.

•   C 5. For patients being started on warfarin, a baseline
    International Normalized Ratio (INR) is available, and for all
    patients receiving warfarin therapy, a current INR is available
    and is used to monitor and adjust therapy.

•   C 6. When dietary services are provided by the organization,
    the service is notified of all patients receiving warfarin and
    responds according to its established food/drug interaction
    program.



                           Company Confidential – For internal use only   9
    NPSG 3E Implementation Expectations
•   A 7. When heparin is administered intravenously and
    continuously, the organization uses programmable infusion
    pumps.

•   C 8. The organization has a policy that addresses baseline and
    ongoing laboratory tests that are required for heparin and low
    molecular weight heparin therapies.

•   C 9. The organization provides education regarding
    anticoagulation therapy to staff, patients, and families.




                           Company Confidential – For internal use only   10
    NPSG 3E Implementation Expectations
•   C 10. Patient/family education includes the importance of
    follow-up monitoring, compliance issues, dietary restrictions,
    and potential for adverse drug reactions and interactions.

•   A11. The organization evaluates anticoagulation safety
    practices.




                           Company Confidential – For internal use only   11
  Outline
• NPSG 3E
Heparin essentials
• LMWH and fondaparinux essentials
• Warfarin essentials
• Patient/family education
• DVT prevention




                      Company Confidential – For internal use only   12
                Sites of Action
12        12a                                               tissue
                                                            thromboplastin
     11         11a

                       9a                                    7a          7
           9

                10                10a                     10

           prothrombin                         thrombin

                             fibrinogen                              fibrin
      = heparin



                      Company Confidential – For internal use only            13
 Heparin aPTT Therapeutic Range
               aPTT Variation by Reagent Manufacturer

 Biotrak
                                                                             Solid = 1.5-2.5 x control
 Biotrak                                                                     Hatched = 0.2-0.4 u/ml

      IL

      IL

Organon

Organon

  Ortho

  Ortho

           0      20   40          60          80          100          120         140       160
                            Company Confidential – For internal useal. Ann
                                          Brill-Edwards et only              Int Med 1993;119:104-9.
                                                                                                   14
             Example Heparin Curve
       200


       150
aPTT




       100


       50


        0
             0   0.1   0.2     0.3         0.4           0.5           0.6     0.7   0.8   0.9
                             Heparin anti-10a activity u/ml

                                Company Confidential – For internal use only               15
  Starting Heparin
• Patient information
   – Indication for treatment
   – Goals of therapy
   – Target aPTT
   – Bleeding risk
• Baseline lab values
   – aPTT or anti-10a activity
   – CBC, platelets
   – Basic chemistries



                                                       IE 8--… policy addresses baseline
                                                                  and ongoing lab tests 16
                         Company Confidential – For internal use only
   Weight-Based Heparin Dosing
      Sample DVT Nomogram                         Sample ACS Nomogram
APTT (sec)     Dose                       APTT (sec)             Dose

Initial dose   80 Units/kg bolus          Initial dose           60 Units/kg bolus
               18 Units/kg/hr                                    12 Units/kg/hr
aPTT <40       80 Units/kg bolus          aPTT  35              60 Units/kg bolus
                4 Units/kg/hr                                    4 Units/kg/hr
APTT 40-70     40 Units/kg bolus          APTT 35-50             30 Units/kg bolus
                2 Units/kg/hr                                    2 Units/kg/hr
APTT 70-110    NC                         APTT 50-70             NC

APTT 111-135  2 Units/kg/hr              APTT 70-100             2 Units/kg/hr

APTT >135      Hold 60 min                APTT >100              Hold 60 min
                3 Units/kg/hr                                    3 Units/kg/hr

                                                                     IE 4--… organization uses
                         Company Confidential – For internal use only   approved protocols 17
    Monitoring Heparin
•   aPTT
     – Q6 hrs until stable therapeutic aPTT
     – aPTT at least daily
     – Resume 6 hourly monitoring after dose adjustments
•   Platelet count
     – Treatment—at least every other day
     – Prophylaxis—every 2-3 days
     – Continue until at least day 14
•   CBC every 2-4 days as indicated
•   Serum chemistry as indicated
     – Hyperkalemia infrequently in diabetics
•   Signs and symptoms of thromboembolic events
•   Signs and symptoms of bleeding


                                                           IE 8--… policy addresses baseline
                                                                      and ongoing lab tests 18
                             Company Confidential – For internal use only
    Heparin-Induced Thrombocytopenia
•   Immune response
    – Heparin-dependent anti-platelet factor 4 antibodies
    – React with PF4/heparin complex
    – Induce platelet aggregation
•   Incidence and onset
     – Varies with disease and dose, approx. 1-5%%
     – Very rare <5 days onset
     – Rare delayed onset (> 2 weeks)
•   LMWH
    – Less likely to form antibodies
    – Lower incidence of clinical HIT
    – Significant cross reactivity with formed antibodies




                          Company Confidential – For internal use only   19
    Heparin-Induced Thrombocytopenia
•   Clinical suspicion
     – Sudden heparin resistance
     – Disease recurrence in the presence of adequate
       anticoagulation
     – Timing > 5-7 days into therapy
•   Laboratory suspicion
     – Platelet count decrease to < 150,000/mm3
     – Decrease > 50% from baseline regardless of absolute
       count
•   Laboratory confirmation (should not delay treatment)
•   HIT is a thrombotic disorder
    – Venous and/or arterial thromboembolism
    – Not associated with bleeding despite low platelet counts




                         Company Confidential – For internal use only   20
                  HIT Management
•                Discontinue ALL heparin
•                Is stopping heparin enough?


                              60
                                   Thromboembolic Events After Stopping Heparin
    Cumulative percent with




                              50
         thrombosis




                              40
                              30                              Management (n = 62)
                              20                              D/C heparin only    58%
                                                              Start warfarin      34%
                              10
                                                              Unspecified          8%
                              0
                                                     10

                                                          12

                                                                 14

                                                                       16

                                                                              18

                                                                                     20

                                                                                           22

                                                                                                  24

                                                                                                       26

                                                                                                            28

                                                                                                                 30
                               0

                                     2

                                         4

                                             6

                                                 8




                                                     Days after stopping heparin
                                                                  Warkentin TE et al. Am J Med 1996;101:502-7.
                                                       Company Confidential – For internal use only                   21
 HIT Management
• Discontinue ALL heparin
• Treatment options
  – Direct thrombin inhibitor
     • Lepirudin—first line
     • Argatroban—first line
     • Bivalirudin—second line (first line in cardiac cath lab)
  – Discontinue warfarin, start or resume:
     • With platelet count recovery
     • Full overlap with parenteral agent
  – LMWH contraindicated
  – Fondaparinux--no data


                       Company Confidential – For internal use only   22
  Outline
• NPSG 3E
• Heparin essentials
LMWH and fondaparinux essentials
• Warfarin essentials
• Patient/family education
• DVT prevention




                       Company Confidential – For internal use only   23
                Sites of Action
12        12a                                               tissue
                         Fondaparinux                       thromboplastin
     11         11a

                       9a                LMWH                7a          7
           9

                10               10a                      10

           prothrombin                         thrombin               Direct thrombin
                                                                         inhibitors
                             fibrinogen                              fibrin




                      Company Confidential – For internal use only                 24
    LMWH/Fondaparinux Monitoring

• Same baseline labs
   – SCr important for dosing
• Same regular testing/clinical monitoring except
   – No routine anticoagulation testing
   – Examine for significant injection site hematoma
• Platelet counts
   – LMWH--every 2-3 days
   – Fondaparinux—specific need or frequency not established




                                                      IE 8--… policy addresses baseline
                                                                 and ongoing lab tests 25
                        Company Confidential – For internal use only
    Enoxaparin/Fondaparinux Dosing

Enoxaparin
•   Treatment--1 mg/kg Q12h (DVT only 1.5 mg/kg QD)
    – ClCr < 30 ml/min 1 mg/kg daily
•   DVT prevention--40 mg daily or 30 mg BID
    – ClCr < 30 ml/min 30 mg daily
Fondaparinux
•   Treatment
    – DVT/PE 5 mg, 7.5 mg or 10 mg daily by body weight
    – ACS 2.5 mg daily (unapproved use)
•   DVT prevention—2.5 mg daily
•   Not recommended for ClCr < 30 ml/min


                       Company Confidential – For internal use only   26
    LMWH Anti-10a Activity Monitoring
•   Special populations (e.g., renal dysfunction with ClCr < 30
    ml/min, extreme obesity, pregnancy)
•   When
     – 2nd or 3rd dose
     – Peak level 4 hours post SC dose
     – If indicated, at the time of a clinical event
•   Target range
     – Every 12h dosing                    0.6-1.0 Units/ml
     – Every day dosing                    1.0-2.0 Units/ml
•   Dose adjustment
     – Rough proportion

•   Fondaparinux monitoring—no data, not recommended


                         Company Confidential – For internal use only   27
  Outline
• NPSG 3E
• Heparin essentials
• LMWH and fondaparinux essentials
Warfarin essentials
• Patient/family education
• DVT prevention




                       Company Confidential – For internal use only   28
                         Sites of Action
         12        12a                                               tissue
                                                                     thromboplastin
              11         11a

                               9a                                     7a           7   t 1/2 = 6 hrs
                    9

                         10                10a                     10         t 1/2 = 40-60 hrs


t 1/2 = 60-96 hrs   prothrombin                         thrombin

                                      fibrinogen                              fibrin

               = warfarin                                            Protein C t 1/2 = 6 hrs


                               Company Confidential – For internal use only                       29
  Starting warfarin
• Patient information
   – Indication for treatment
   – Goals of therapy
   – Target INR
   – Concurrent drugs
   – Bleeding risk
• Baseline lab values
   – INR
   – CBC, platelets
   – Basic chemistries


                                                                        IE 5--… baseline INR
                         Company Confidential – For internal use only
                                                                             Is available 30
       Typical Warfarin Dosing Nomogram
   Day       INR           Dose (mg)                 Day              INR               Dose
   1                       5                         4                <1.5              10
   2         <1.5          5                                          1.5-1.9           5-7.5
             1.5-1.9       2.5                                        2.0-3.0           0-5
             2.0-2.5       1-2.5                                      > 3.0             0
             >2.5          0                         5                <1.5              10
   3         <1.5          5-10                                       1.5-1.9           7.5-10
             1.5-1.9       2.5-5                                      2.0-3.0           0-5
             2.0-2.5       0-2.5                                      >3.0              0
             2.5-3.0       0-2.5                     6                <1.5              7.5-12.5
             >3.0          0                                          1.5-1.9           5-10
                                                                      2.0-3.0           0-7.5
Crowther M et al. Ann Int Med 1997;127:333.                           >3.0              0

                                                                               IE 4--… organization uses
                                Company Confidential – For internal use only      approved protocols 31
  Transitioning to Warfarin

• aPTT may increase as warfarin kicks in
• Do not discontinue parenteral agent until:
   – Minimum 4-5 day overlap regardless of INR response
   – Two consecutive therapeutic INRs
   – No strong direction of INR change




                      Company Confidential – For internal use only   32
    Secrets to Warfarin Success
• Start early
• Avoid starting doses > 5 mg unless dose
  requirement is already known
    – < 4 mg for elderly, frail, liver disease
• PM drug, AM INR
• Maximum single dose INR effect approx. 36 hrs
• INR is algebraic sum of 2-3 previous doses
• Patience is a virtue—big dose changes = big
  problems
• Dose requirement often changes after discharge


                         Company Confidential – For internal use only   33
    Warfarin Drug/Drug and Food/Drug
    Interactions

Drug/Drug                                 Food/Drug
•   Metabolism                            •    Drug-like interactions
     –  Enzyme induction                       – Herbal remedies
     –  Enzyme competition               •    Increased vitamin K intake
•   Protein binding                             – Rapid 
     –  Displacement                     •    Decreased vitamin K intake
•   Absorption                                  – Delayed 
     –  Short gut
•   Vitamin K
     –  Broad spectrum
       antibiotics           Arrows indicate direction
                                  of INR change

                                                                    IE 6--… established food/drug
                            Company Confidential – For internal use only  Interaction program 34
  Outline
• NPSG 3E
• Heparin essentials
• LMWH and fondaparinux essentials
• Warfarin essentials
Patient/family education
• DVT prevention




                       Company Confidential – For internal use only   35
     Warfarin Patient Education
•   Why you are taking warfarin
•   How warfarin works and how it will benefit you
•   How and when to take warfarin
•   Monitoring, dose-adjusting, and the INR
•   Your role in your therapy including medication and blood testing
    compliance
•   Communicating with all health care providers
•   Diet
•   Lifestyle considerations
•   Potential for drug interactions including OTC and herbal products
     – Address aspirin
•   Signs and symptoms of thromboembolism and what to do
•   Signs and symptoms of bleeding and what to do



                                                        IE 9, 10--… organization provides
                            Company Confidential – Foreducation to staff, patients, families
                                                      internal use only                  36
     LMWH/Fondaparinux Patient Education
•   Why you are taking this drug
•   How the drug works and how it will benefit you
•   How and when to administer doses including aseptic technique
•   Storage
•   Monitoring
•   Your role in your therapy including medication and blood testing
    compliance
•   Communicating with all health care providers
•   Lifestyle considerations
•   Signs and symptoms of thromboembolism and what to do
•   Signs and symptoms of bleeding and what to do




                                                        IE 9, 10--… organization provides
                            Company Confidential – Foreducation to staff, patients, families
                                                      internal use only                  37
  Outline
• NPSG 3E
• Heparin essentials
• LMWH and fondaparinux essentials
• Warfarin essentials
• Patient/family education
DVT prevention




                       Company Confidential – For internal use only   38
DVT Incidence by Surgery
              DVT Incidence Without Prophylaxis
Trauma

 LE Fx

 Hip Fx

   THR

   TKR

 Spine

 Neuro

  Gyne

General

          0        20           40                   60                80          100
                                   Any DVT (%)

                                                              Chest 2001;119 Suppl 1:132S-75S
                        Company Confidential – For internal use only                      39
  DVT Incidence in Medical Patients
• Incidence by condition
   – Ischemic stroke with paralysis 55%
   – MI 24%
   – General 16%
      • Mostly CHF, COPD, infectious diseases
      • Proximal/symptomatic DVT approx. 5%
• Why so little information?
   – Wide range of medical conditions
   – Wide variation in level of ―sickness‖
   – Few trials compared to surgery




                        Company Confidential – For internal use only   40
  DVT Risk Factors
Major Risk Factors                         Other risk factors
• Age >40 > 60                             • Obesity
• Surgery--minor vs major                  • Pregnancy
• Anesthesia--type, duration               • Estrogen use
• Prior VTE                                • Venous insufficiency
• Hypercoagulable state,                   • General immobility
  inherited or acquired                    • Nephrotic syndrome
• Hip/knee arthroplasty                    • Indwelling venous catheter
• Hip fracture                             • Medical conditions--e.g., CHF,
• Major trauma                                respiratory, inflammatory
                                              bowel disease, pneumonia
• Spinal cord injury
                                           • *Cancer
• Stroke with paralysis
• *Cancer



                        Company Confidential – For internal use only          41
  Selecting a DVT Prevention Regimen

           Lowest                        DVT Risk                          Highest

  Age          < 40                        40-60                       > 60

Surgery        Minor                  Nonmajor                        Major

 Risk          none                        some                       many
Factors
 Major         No Major Risk Factors                                  Major
 Risk                                                                 Risk Factors

1st Line    Aggressive Heparin Q12 Heparin Q8 LMWH
            ambulation LMWH        LMWH       Fondaparinux
  Tx
                       ES or IPC   IPC        Warfarin

                       Company Confidential – For internal use only                  42
DVT Risk Factor Assessment
      Each Risk Factor Represents 1 Point                 Each Risk Factor Represents 2 Points
 Age 41-60 years                                    Age 60-74 years
 Minor surgery planned                              Arthroscopic surgery
 History of prior major surgery (< 1 month)         Malignancy (present or previous)
 Varicose veins                                     Major surgery (> 45 minutes)
 History of inflammatory bowel disease              Laparoscopic surgery (> 45 minutes)
 Swollen legs (current)                             Patient confined to bed (> 72 hours)
 Obesity                                            Immobilizing plaster cast (< 1 month)
 Acute myocardial infarction                        Central venous access
 Congestive heart failure (< 1 month)
 Sepsis (< 1 month)
                                                          Each Risk Factor Represents 5 Points
 Serious lung disease incl. pneumonia (< 1 month)
 Abnormal pulmonary function (COPD)                 Elective major lower extremity arthroplasty
 Medical patient currently at bed rest              Hip, pelvis or leg fracture (< 1 month)
 Other risk factors__________________________       Stroke (< 1 month)
 ___________________________________________         Multiple trauma (< 1 month)
                                                     Acute spinal cord injury (paralysis)(< 1 month)
      Each Risk Factor Represents 3 Points
 Age over 75 years                                    For Women Only (Each Represents 1 Point)
 History of DVT/PE
 Family history of thrombosis*                      Oral contraceptives or hormone replacement therapy
 Positive Factor V Leiden                           Pregnancy or postpartum (<1 month)
 Positive Prothrombin 20210A                        History of unexplained stillborn infant, recurrent
 Elevated serum homocysteine                        spontaneous abortion (> 3), premature birth with
 Positive Lupus anticoagulant                       toxemia or growth-restricted infant
 Elevated anticardiolipin antibodies
 Heparin-induced thrombocytopenia (HIT)
 Other congenital or acquired thrombophilia
 If yes: Type_______________________________
 *most frequently missed risk factor
                                                     Total Risk Factor Score
Selecting a DVT Prevention Regimen

Risk Score   Risk Level            Regimen

0-1          Low                   Early ambulation

2            Moderate              ES or SCD
                                   UFH 5000 U BID-TID
                                   Enox 40 mg QD or Fonda 2.5 mg QD
3-4          High                  UFH 5000 U TID
                                   Enox 40 mg QD or Fonda 2.5 mg QD
                                   +/- SCD
5 or more    Very High             ES or SCD + drug
                                   UFH 5000 U TID
                                   Enox 40 mg QD or 30 mg BID
                                   Fonda 2.5 mg QD
                                   Warfarin (ortho only)


                    Company Confidential – For internal use only      44
Q&A

Company Confidential – For internal use only   45

				
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