Preventing Venous Thromboembolism and
Improving the Safety of Anticoagulation Therapy
Dale Bratzler, DO, MPH
Michael Gulseth, PharmD, BCPS
Dan Ford
Hayley Burgess, PharmD, BCPP
Charles Denham, MD
March 5, 2008
© 2008 TMIT
1
NQF Safe Practices for Better Healthcare:
A Consensus Report
• 30 Safe Practices
Criteria for Inclusion
• Specificity
• Benefit
• Evidence of
Effectiveness
• Generalization
• Readiness
© 2008 TMIT
2
NQF Safe Practices Maintenance Committee
Safe Practice Update Process
• SWOT analysis of each practice
 Comprehensive literature search
 Expert technical advisory support from more than 250
experts
 Participation by The Joint Commission, CMS, and AHRQ
 Input from hospitals and facility involved in 100,000 and
5M Lives Campaign
 “Feedback from the Field” - Hospitals that reported
publicly through The Leapfrog Group and TMIT National
Research Test Bed
© 2008 TMIT
3
Harmonization – The Quality Choir
© 2008 TMIT
4
Culture SP 1
2007 NQF Report
Culture
Consent & Disclosure
Consent & Disclosure
Workforce
Information Management &
Continuity of Care
Medication Management
Healthcare-Assoc. Infections
Condition- &
Site-Specific Practices
© 2008 TMIT
5
Culture
2007 NQF Report
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
ID Mitigation
Risk & Hazards
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Labeling
Studies
Order
Read-back
Discharge
System
CPOE
Abbreviations
Medication Management
Med. Recon.
Pharmacist
Central Role
High-Alert
Meds.
Std. Med.
Labeling & Pkg.
Unit-Dose
Medications
Healthcare-Associated Infections
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath.
BSI Prevention
Sx-Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2008 TMIT
CHAPTER 2: Creating and Sustaining a Culture of
Patient Safety
• Leadership Structures & Systems
• Culture Measurement, Feedback, and Interventions
• Teamwork Training and Team Interventions
• Identification and Mitigation of Risks and Hazards
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
6
DVT/VTE
Prevention
Contrast
Media Use
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
CHAPTER 5: Information Management & Continuity of
Care
• Critical Care Information
• Order Read-back
• Labeling Studies
• Discharge Systems
• Safe Adoption of Integrated Clinical Systems
including CPOE
• Abbreviations
CHAPTER 6: Medication Management
• Medication Reconciliation
• Pharmacist Role
• Standardized Medication Labeling & Packaging
• High-Alert Medications
• Unit-Dose Medications
CHAPTER 7: Healthcare-Associated Infections
• Prevention of Aspiration and VentilatorAssociated Pneumonia
• Central Venous Catheter-Related Blood Stream
Infection Prevention
• Surgical Site Infection Prevention
• Hand Hygiene
• Influenza Prevention
CHAPTER 8: Condition- & Site-Specific Practices
• Evidence-Based Referrals
• Wrong-Site, Wrong-Procedure, Wrong-Person
Surgery Prevention
• Perioperative Myocardial Infarct/Ischemia
Prevention
• Pressure Ulcer Prevention
• DVT/VTE Prevention
• Anticoagulation Therapy
• Contrast Media-Induced Renal Failure Prevention
New Safe Practice Considerations
•
•
•
•
•
© 2008 TMIT
Methicillin-resistant Staph aureus (MRSA)
Urinary Tract Infections (UTI)
Handover/Hand-off
Second Patient
Organ Donorship
7
Preventing Venous Thromboembolism and
Improving the Safety of Anticoagulation Therapy
Objectives:
• Describe the impact of Venous Thromboembolism (Safe
Practice 28) complications as it relates to the nation's
healthcare patient population.
• Prepare for pay for performance requirements and review
national measures.
• Describe the requirements for the Joint Commission
National Patient Safety Goal 3E and Anticoagulation
Therapy (Safe Practice 29).
• Discuss strategy and stepwise process for planning,
design, and implementation of an inpatient anticoagulant
service.
© 2008 TMIT
8
Safe Practice 28: Reduce the occurrence of venous
thromboembolism
Safe Practice
• Evaluate each patient upon admission, and regularly
thereafter, for the risk of developing VTE/DVT. Utilize
clinically appropriate, evidence-based methods of
thromboprophylaxis.
Additional Specifications
• Document the VTE risk assessment and prevention plan in
the patient’s record.
• Explicit organizational policies and procedures should be in
place for the prevention of VTE.
Applicable Clinical Care Settings
• Short and long-term acute care hospitals, long-term care
facilities, and nursing homes.
© 2008 TMIT
9
Safe Practice 29: Ensure that long-term antithrombotic
(anticoagulation) therapy is effective and safe
Safe Practice
Every patient on long-term oral anticoagulants should be monitored
by a qualified health professional using a careful strategy to
ensure an appropriate intensity of supervision.
Additional Specifications
• Explicit organizational policies and procedures should be in
place regarding antithrombotic services that include at least
documentation of:
• indication for long-term anticoagulation;
• target INR range;
• duration of long-term anticoagulation and/or a review date;
• a longitudinal record of INR values and warfarin doses; and
• timing of the next INR appointment.
Applicable Clinical Care Settings
• This practice is applicable in all care settings
© 2008 TMIT
10
Prevention and Treatment of
Venous Thromboembolism
Development of National Performance
Measures
Dale W. Bratzler, DO, MPH
QIOSC
Medical DO,
Director
Dale
W. Bratzler,
MPH
Oklahoma
Foundation
Medical Quality
QIOSC
Medicalfor
Director
11
Prevention of Venous Thromboembolism
• Recent estimates show that
– more than 900,000 Americans suffer VTE
each year
• about 400,000 of these being DVT
• About 500,000 being manifest as PE
– In about 300,000 cases, PE proves fatal; it is
the third most common cause of hospitalrelated deaths in the United States.
Is pulmonary embolism the most common
cause of death in the US?
Heit JA, Cohen AT, Anderson FA on behalf of the VTE Impact Assessment Group. [Abstract] American Society
of Hematology Annual Meeting, 2005.
12
Prevention of Venous Thromboembolism
Introduction
• VTE Remains a major health problem
– In addition to the risk of sudden death
• 30% of survivors develop recurrent VTE
within 10 years
• 28% of survivors develop venous stasis
syndrome within 20 years
– Incidence increases with age
Goldhaber SZ. N Engl J Med. 1998;339:93-104.
Silverstein MD, et al. Arch Intern Med. 1998;158:585-593.
Heit JA, et al. Thromb Haemost. 2001;86:452-463.
Heit JA. Clin Geriatr Med. 2001;17:71-92.
Heit JA, et al. Mayo Clin Proc. 2001;76:1102-1110.
13
Prevention of Venous Thromboembolism
• The majority (93%) of estimated VTErelated deaths in the US were due to
sudden, fatal PE (34%) or followed
undiagnosed VTE (59%)
For many patients, the first symptom of VTE is
sudden death!
How many of those patients with sudden death in the
hospital or after discharge attributed to an acute coronary
event actually died of acute pulmonary embolism?
Heit JA, Cohen AT, Anderson FA on behalf of the VTE Impact Assessment Group. [Abstract] American Society
of Hematology Annual Meeting, 2005.
14
National Body Position Statements
• Leapfrog1:
PE is “the most common preventable cause of hospital death in
the United States”
• Agency for Healthcare Research and Quality (AHRQ)2:
Thromboprophylaxis is the number 1 patient safety practice
• American Public Health Association (APHA)3:
“The disconnect between evidence and execution as it relates
to DVT prevention amounts to a public health crisis.”
1.
2.
3.
The Leapfrog Group Hospital Quality and Safety Survey. Available at: www.leapfrog.medstat.com/pdf/Final/doc
Shojania KG, et al. Making Healthcare Safer: A Critical Analysis of Patient Safety Practices. AHRQ, 2001. Available at:
www.ahrq.gov/clinic/ptsafety/
White Paper. Deep-vein thrombosis: Advancing awareness to protect patient lives. 2003. Available at:
www.alpha.org/ppp/DVT_White_Paper.pdf
15
Medical “Injuries” During
Hospitalization
Postoperative DVT or PE:
• 2nd commonest medical “injury” overall
• 2nd commonest cause of excess length of stay
• 3rd commonest cause of excess mortality
• 3rd commonest cause of excess charges
Zhan et a. JAMA 2003;290:1868
16
Annual cost to treat VTE
• $11,000 per DVT episode per patient
• $17,000 per PE episode per patient
• Recurrence increases hospitalization costs
by 20%
• Complications of anticoagulation
• Time lost from work
– Quality of life: venous stasis and pulmonary
HTN
17
Consequences of Surgical Complications
• Dimick and colleagues demonstrated increased
costs of care:
–
–
–
–
infectious complications was $1,398
cardiovascular complications $7,789
respiratory complications $52,466
thromboembolic complications $18,310
Dimick JB, et al. J Am Coll Surg 2004;199:531-7.
18
Inherited risk factors for DVT
Group 1 disorders
Group 2 disorders
• Protein C deficiency (2.5-6%) • Factor V leiden (6%)
• Protein S deficiency (1.3-5%) • Prothrombin (G20210A)
(5-10%)
• Antithrombin deficiency (0.57.5%)
• Elevated VIII, IX, XI
• Hyperhomocysteinemia
• Arteriosclerosis
19
Acquired Risk Factors
Risk Factor
Attributable Risk
Hospitalization/Nursing home
61.2
Active malignant neoplasm
19.8
Trauma
12.5
CHF
11.8
CV catheter
10.5
Neurologic disease with paresis
8.2
Superficial vein thrombosis
4.3
Varicose veins/stripping
6
Many others….
Being in the hospital is the greatest risk
factor for VTE!
20
Risk Factors for VTE
• Previous venous thromboembolism
• Increased age
• Surgery
• Trauma - major, local leg
• Immobilization - ? bedrest, stroke, paralysis
•
•
•
•
Malignancy & its Rx (CTX, RTX, hormonal)
Heart or respiratory failure
Estrogen use, pregnancy, postpartum
Central venous lines
• Thrombophilic abnormalities
Therefore, most patients in the hospital need VTE prophylaxis!
21
Cases per 10,000 person-years
VTE is a Disease of Hospitalized and
Recently Hospitalized Patients
1000
VTE 100X more common in
hospitalized patients!
100
Recently
hospitalized
10
1
Hospitalized patients
Heit JA. Mayo Clin Proc. 2001;76:1102
22
Community residents
Risk of DVT in Hospitalized Patients
No prophylaxis + routine objective screening for DVT
Patient group
DVT incidence
Medical patients
10 - 20 %
Major gyne/urol/gen surgery
15 - 40 %
Neurosurgery
15 - 40 %
Stroke
20 - 50 %
Hip/knee surgery
40 - 60 %
Major trauma
40 - 80 %
Spinal cord injury
60 - 80 %
Critical care patients
15 - 80 %
23
Prevention of Venous Thromboembolism
• Despite the well known risk of VTE and
the publication of evidence-based
guidelines for prevention, multiple medical
record audits have demonstrated
underuse of prophylaxis
Anderson FA Jr, et al. Ann Intern Med. 1991;115:591-595.
Anderson FA Jr, et al. J Thromb Thrombolysis. 1998; 5 (1 Suppl):7S-11S.
Bratzler DW, et al. Arch Intern Med. 1998;158:1909-1912.
Stratton MA, et al. Arch Intern Med. 2000;160:334-340.
24
Thromboprophylaxis Use in Practice
1992-2002
Patient Group
Studies
Patients
Prophylaxis
Use (any)
Orthopedic surgery
4
20,216
90 % (57-98)
General surgery
7
2,473
73 % (38-98)
Critical care
14
3,654
69 % (33-100)
Gynecology
1
456
Medical patients
5
1,010
66 %
23 % (14-62)
How many patients with COPD, CVA, heart failure, pneumonia, etc
do you have in your hospital that are not on DVT prophylaxis?
25
Prevention of
Venous
Thromboembolism
W. Geerts, chair
G. Pineo
J. Heit
D. Bergqvist
M. Lassen
C. Colwell
J. Ray
Seventh ACCP
Consensus
Conference on
Antithrombotic
Therapy
Chest 2004;126:338S-400S
26
Prevention of Venous Thromboembolism
Low-, moderate-, or high-risk
Benefit: risk favors
routine prophylaxis
Benefit: risk uncertainlocal practice or
individual prophyl.
Benefit: risk favors
no prophylaxis
Focus of New Measures
• Major orthopedic
surgery
(THR, TKR, HFS)
• Major trauma
• Laparoscopic surgery
• Vascular surgery
• Cardiac surgery
• Spinal cord injury
• Elective spine
surgery
• Major general, gyne,
urologic surgery
• Arthroscopic surgery
• Major neurosurgery
• Medical patients with
additional risk factors
• Burns
• Isolated lower
extremity fracture
• Most ICU patients
27
• Surgical patients:
- brief duration
- fully mobile
- no additional RFs
• Medical patients:
- fully mobile
- no additional RFs
• Long distance travel
How many of these
patients do we actually
admit to the hospital
anymore?
Prophylaxis Modalities
• Mechanical
– Graduated compression stockings (GCS) (e.g., “white
hose”)
– Sequential compression devices
• Venous foot pumps (currently recommended only for
orthopedic surgery in patients with bleeding risk)
In most studies, less effective than
pharmacologic prophylaxis and patient
compliance rates are generally low.
Rates of compliance with mechanical forms of prophylaxis
in many studies is less than 50% - has become a new target
of malpractice litigation.
28
Pharmacologic Prophylaxis
•
•
•
•
Low-dose unfractionated heparin (LDUH)
Low-molecular weight heparin (LMWH)
Fondaparinux
Warfarin
29
Development of National Performance
Measures
to Prevent and Treat VTE
30
Why the need for performance
measures?
• Despite widespread publication and
dissemination of guidelines, practices
have not changed at an acceptable pace
– There are still far too many needless deaths
from VTE in the US
• Reasonably good evidence that using
performance measures for accountability
can accelerate the rate of change
31
32
Venous Thromboembolism
Statement of Organization Policy
“Every healthcare facility shall have a written policy
appropriate for its scope, that is evidence-based
and that drives continuous quality improvement
related to VTE risk assessment, prophylaxis,
diagnosis, and treatment.”
33
Venous Thromboembolism
Characteristics of Preferred Practices
General
• Protocol selection by multidisciplinary teams
• System for ongoing QI
• Provision for RA/stratification, prophylaxis,
diagnosis, treatment
• QI activity for all phases of care
• Provider education
34
Venous Thromboembolism
Characteristics of Preferred Practices
(cont.)
Risk Assessment/Stratification
• RA on all patients using evidence-based policy
• Documentation in patient record that done
Prophylaxis
• Based on assessment & risk/benefit, efficacy/safety
• Based on formal RA, consistent with accepted,
evidence-based guidelines
35
Venous Thromboembolism
Characteristics of Preferred Practices
(cont.)
Diagnosis
• Objective testing to justify continued initial therapy
Treatment and Monitoring
• Ensure safe anticoagulation, consider setting
• Incorporate Safe Practice 29
• Patient education; consider setting and reading
levels
• Guideline-directed therapy
• Address care setting transitions in therapy
36
Surgical Care Improvement Project
First Two VTE Measures Endorsed by NQF
• Prevention of venous thromboembolism
• Proportion who have recommended VTE
prophylaxis ordered
• Proportion who receive appropriate form of
VTE prophylaxis (based on ACCP
Consensus Recommendations) within 24
hours before or after surgery
Limited to surgical patients – NQF endorsed, required
reporting to Medicare for Annual Payment Update, and will be
posted to Hospital Compare soon.
These measures are NQF-endorsed
37
Surgical Care Improvement Project
Hospital Voluntary Self-Reporting, Qtr. 2, 2007
National Average*
Benchmark
98.6
100
97.2
84.8
80.5
Percent
80
60
40
20
0
Recommended VTE Prophylaxis
Timely VTE Prophylaxis
Benchmark rates were calculated for all HQA reporting hospitals in the US based on discharges using the Achievable Benchmarks of
CareTM methodology (http://main.uab.edu/show.asp?durki=14527).
38
Ongoing Gaps in Performance
Hospital Voluntary Self-Reporting, Qtr. 2, 2007
Low performers
Benchmark
98.6
100
97.2
Percent
80
60
54.6
48.6
40
20
0
Recommended VTE Prophylaxis
Timely VTE Prophylaxis
Benchmark rates were calculated for all HQA reporting hospitals in the US based on discharges using the Achievable Benchmarks of
CareTM methodology (http://main.uab.edu/show.asp?durki=14527).
39
7 Refined Measures Recommended for
Endorsement by Steering Committee
• Risk Assessment/Prophylaxis domain
• Prophylaxis w/in 24 hours of admission or
surgery, OR a documented risk assessment
showing that the patient does not need
prophylaxis
• Prophylaxis/documentation w/in 24 hours
after ICU admission or surgery
Discards any “requirement” for a documented risk
assessment – allows programs of default prophylaxis.
40
7 Refined Measures Recommended for
Endorsement by Steering Committee
• Treatment and Monitoring domain
• IVC filter appropriate indication
• Documented acute VTE with a contraindication to
anticoagulation; or chronic thromboembolic pulmonary
hypertension
• Measure recommended for quality improvement only
• Patients w/overlap of anticoagulation therapy
• At least five calendar days of overlap and discharge
with INR > 2.0, or discharge on overlap therapy
• Patient receiving UFH with dosage/platelet
count monitoring by protocol/nomogram
• Nomogram/protocol incorporates routine platelet count
monitoring+
41
7 Refined Measures Recommended
(cont.)
• Treatment/Monitoring Domain (cont.)
• Discharge instructions consistent with Joint Commission
safety goals (Follow-up Monitoring, Compliance Issues,
Dietary Restrictions, Potential for Adverse Drug
Reactions/Interactions)
• Outcome
• Incidence of potentially-preventable VTE – proportion
of patients with hospital-acquired VTE who had NOT
received VTE prophylaxis prior to the event
• Incorporate the new “present on admission” codes
42
Strategies to Improve VTE Prophylaxis
• Hospital policy of risk assessment for all
admitted patients??
– Most will have risk factors for VTE and should
receive prophylaxis
– Preprinted protocols for surgical patients
– Electronic reminders (Kucher – NEJM 2005;352:969)
– Default prophylaxis (opt out)
43
1 point each
3 points each
• age 41-60
• minor surgery planned
• major surgery past month
• varicose veins
• inflamm bowel disease
• current leg swelling
• obesity (BMI > 25)
• acute MI
• CHF past month
• sepsis past month
• serious lung disease past month
• COPD
• medical patient at bedrest
• other_____________________
• age > 70
• previous DVT, PE
• family H/O VTE
• factor V Leiden
• prothrombin 20210A
• elevated homocysteine
• lupus anticoagulant
• elevated ACA
• HIT
• other thrombophilia
5 points each
• hip / knee arthroplasty
• hip/pelvis/leg fracture (< 1 month)
• stroke (< 1 month)
• multiple trauma (< 1 month)
• acute spinal cord injury (< 1 mo)
2 points each
• age 60-74
• arthroscopic surgery
• malignancy (current or previous)
• major surgery (> 45 min)
• laparoscopic surgery (> 45 min)
• confined to bed (> 72 hrs)
• plaster cast (< 1 month)
• central venous access
Caprini – Dis Mon 2005;51:70
Women only (1 point each)
• BCP or HRT
• pregnancy / postpartum (< 1 mo)
• H/O unexplained stillbirth, > 3
spontaneous abortions, premature
birth with toxemia, IUGR
44
No individual risk assessment
protocol has ever been validated in a
clinical trial. While it seems intuitive that
more points equates to greater risk of
VTE, that has never been proven in a
study, and we certainly have no idea if
you need more prophylaxis for more
points!
45
Should VTE prophylaxis
be the default
for all hospitalized patients?
46
Summary
• VTE is very common, often unrecognized,
and a common cause of hospital morbidity
and death
• The vast majority of hospitalized patients
are at risk for VTE
• New national performance measures will
focus on evidence-based prevention and
treatment of VTE
If your organization is serious about Patient Safety, you
have to address VTE prevention and treatment!
47
PATIENT ADVOCATE
Dan Ford
Vice President
Furst Group
© 2008 TMIT
48
NQF Safe Practice 29 and NPSG 3E:
How to Accomplish in the Hospital
Michael P. Gulseth, Pharm. D., BCPS
© 2008 TMIT
49
Objectives
• Compare and contrast NQF safe practice
#29 to NPSG 3E
• Describe strategies to accomplish this in
the hospital
• Identify key articles supporting inpatient
anticoagulation services
© 2008 TMIT
50
Safe Practice 29
• Every patient on long-term oral
anticoagulants should be monitored by a
qualified health professional using a
careful strategy to ensure an appropriate
intensity of supervision.
© 2008 TMIT
51
Policies and Procedures Should
Require Documentation of:
• Indication for long-term anticoagulation
• Target INR range
• Duration of long-term anticoagulation
and/or a review date
• A longitudinal record of INR values and
warfarin doses
• Timing of the next INR appointment
© 2008 TMIT
52
Joint Commission NPSG 3E
Rationale
• Anticoagulation is a high risk treatment, which
commonly leads to adverse drug event 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.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/
© 2008 TMIT
53
Expectations/Timeline
• As of April 1, 2008, the [organization]’s leadership has
assigned responsibility for oversight and coordination of
the development, testing, and implementation of NPSG
Requirement 3E.
• As of July 1, 2008, an implementation work plan is in
place that identifies adequate resources, assigned
accountabilities, and a time line for full implementation of
NPSG Requirement 3E by January 1, 2009.
• As of October 1, 2008, pilot testing in at least one clinical
unit is under way.
• As of January 1, 2009, the process is fully implemented
across the organization.
• So what are the expectations by January 1, 2009?
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/
© 2008 TMIT
54
Implementation Expectations
• The organization implements a defined anticoagulant
management program to individualize the care provided
to each patient receiving anticoagulant therapy.
• To reduce compounding and labeling errors, the
organization uses ONLY oral unit dose products and premixed infusions, when these products are available.
• When pharmacy services are provided by the
organization, warfarin is dispensed for each patient in
accordance with established monitoring procedures.
• 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.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/
© 2008 TMIT
55
Implementation Expectations
• 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.
• 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.
• When heparin is administered intravenously and
continuously, the organization uses programmable
infusion pumps.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/
© 2008 TMIT
56
Implementation Expectations
• The organization has a policy that addresses baseline
and ongoing laboratories tests that are required for
heparin and low molecular weight heparin therapies.
• The organization provides education regarding
anticoagulation therapy to prescribers, staff, patients,
and families.
• Patient/family education includes the importance of
follow-up monitoring, compliance issues, dietary
restrictions, and potential for adverse drug reactions and
interactions.
• The organization evaluates anticoagulation safety
practices.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/
© 2008 TMIT
57
Roles of the Inpatient
Anticoagulation Program
• Providing anticoagulant dosing
– Dosing heparin, LMWH, warfarin, argatroban, etc.
• Assuring regular monitoring and patient evaluation
– Designing policies to assure coagulation labs are drawn when
needed; consulting on individual patients
• Provision of repeated patient education
– Assuring hospital education on warfarin, LMWH, etc.
• Communicating with other patient care providers that are
involved in the patient’s care
– Helping surgeons and hospitalists communicate regarding the
risks vs. benefits of therapy and picking the right option
• Meeting transitional care needs
© 2008 TMIT
58
Roles of the Inpatient
Anticoagulation Program
• Helping with changes from heparin to LMWH and vice
versa
• Setting up short stay/outpatient VTE treatment programs
• Assuring the systematic prophylaxis of VTE
• Evaluating available anticoagulant products for formulary
– Not just about cost
• Assuring smooth transitions in care
• Assisting in determining the appropriateness of care
– Picking the right parenteral antithrombin agent for the disease,
renal function, patient history, etc.
• Evaluating the safety of the dispensing and
administration procedures used by the facility
• And many more…..
© 2008 TMIT
59
So how do you get there?
• The organization implements a defined
anticoagulant management program to
individualize the care provided to each patient
receiving anticoagulant therapy.
– Identify a qualified professional and start an
anticoagulation program that covers both outpatients
and inpatients
– Also use that leader to evaluate and improve other
practices to assure the safety of anticoagulant use
– Where do you start?
© 2008 TMIT
60
Step 1: Review the literature and
network with others
• Take a close look at the articles already
presented
– Which hospitals seem similar to your situation?
– Which articles deal with issue that your hospital is
struggling with?
• Closely evaluate the Bond and Raehl article
– Can be used to postulate a financial benefit to the
hospital
• Talk to colleagues at other hospitals who have
services like you are contemplating
– Site visits are a very good idea to see a service first
hand
Dager WE, Gulseth MP. Implementing pharmacist anticoagulation management in the inpatient setting.
Am J Health-Syst Pharm. 2007; 64: 1071-1079.
© 2008 TMIT
61
Bond and Raehl analysis
• Bond and Raehl evaluated the potential
impact of pharmacist management of
heparin and warfarin
• 1995 Medicare and the National Clinical
Pharmacy Services Databases from 955
hospitals comparing data from hospitals
that have the service to those that don’t
Pharmacotherapy 2004; 24(8): 953-963.
© 2008 TMIT
64
If a hospital did not have a heparin
service:
• 11.41% higher death rates
– 6.37% vs. 7.19%
• Length of stay was 10.05% higher
– 7.79 days vs. 8.66 days
• Medicare charges were 6.6% higher
– $1145 more per patient
• Bleeding complications were 3.1% higher
– 8.84% vs. 9.12%
Pharmacotherapy 2004; 24(8): 953-963.
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If a hospital did not have a warfarin
service:
• 6.2% higher death rates
– 6.66% vs. 7.1%
• Length of stay was 5.86% higher
– 8.04 days vs. 8.54 days
• Medicare charges were 2.16% higher
– $370 more per patient
• Bleeding complications were 8.09% higher
– 8.41% vs. 9.15%
Pharmacotherapy 2004; 24(8): 953-963.
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Step 2: Plan the Anticoagulation
Service
• Successful programs will have support from:
– Pharmacy
– Medical staff
– Hospital administration
– Nursing
• Think about things from their perspective and assure
those issues are addressed
Dager WE, Gulseth MP. Implementing pharmacist anticoagulation management in the inpatient setting.
Am J Health-Syst Pharm. 2007; 64: 1071-1079.
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Step 3: Gain Formal Approval of the
Program
• The pharmacy and therapeutics committee
will likely need to approve all programs,
protocols, and guidelines
– What policies and procedures are needed?
Dager WE, Gulseth MP. Implementing pharmacist anticoagulation management in the inpatient setting.
Am J Health-Syst Pharm. 2007; 64: 1071-1079.
© 2008 TMIT
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Step 4: Launch the Program and
Address Unanticipated Issues
• Be sure to do careful planning prior to
launch, but
• Be careful not to “over plan”
– Not having the service in place could be the
bigger issue
– Piloting is an excellent way to avoid this
• Once “bugs” are worked out, expand to
other areas
Dager WE, Gulseth MP. Implementing pharmacist anticoagulation management in the inpatient setting.
Am J Health-Syst Pharm. 2007; 64: 1071-1079.
© 2008 TMIT
69
Step 5: Monitor Program Quality
and Strive for Improvement
• Don’t let quality issues go
– Address system issues that need to be
addressed
– Provide individual, one on one, feedback
when individual pharmacists do not perform
adequately and strive to improve their skills
• Be sure to credit your staff when care is
improved
Dager WE, Gulseth MP. Implementing pharmacist anticoagulation management in the inpatient setting.
Am J Health-Syst Pharm. 2007; 64: 1071-1079.
© 2008 TMIT
70
Step 6: Expand into New Arenas as
the Patient Need Arises
• Look for the next opportunity to improve
care
• What is the department’s role with rVIIa?
• How is vitamin K being utilized?
• Is an inpatient “antithrombosis” program
the next step?
Dager WE, Gulseth MP. Implementing pharmacist anticoagulation management in the inpatient setting.
Am J Health-Syst Pharm. 2007; 64: 1071-1079.
© 2008 TMIT
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• Managing
Anticoagulation
Patients in the
Hospital; the Inpatient
Anticoagulation
Service
• Published by ASHP
June, 2007
• Available at
www.ashp.org
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Managing Anticoagulation Patients
in the Hospital
• Part 1: Program Design and Implementation
– Chapter 1: Introduction to the Inpatient Anticoagulation
Service
– Chapter 2: Literature Review Supporting Inpatient Pharmacy
Management of Anticoagulation
– Chapter 3: Anticoagulant Safety: Identification of the Gaps
– Chapter 4: Planning of the Inpatient Anticoagulation Service
– Chapter 5: Winning Support for the Inpatient
Anticoagulation Service
– Chapter 6: Justifying the Program to Hospital
Administration: The Financial Perspective
– Chapter 7: Pharmacist Education and Training
– Chapter 8: Patient Education Needs
– Chapter 9: Monitoring and Maintaining Program Quality
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Managing Anticoagulation Patients
in the Hospital
• Part 2: Anticoagulant Knowledge 101
– Chapter 10: Essential Warfarin Knowledge
– Chapter 11: Heparin, Low Molecular
Weight Heparin, and Fondaparinux
– Chapter 12: Essential Direct Thrombin
Inhibitor Knowledge
– Chapter 13: Helpful References and
Preparing for the Future
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In closing…..
• Anticoagulation services will likely become
as fundamental of a service as kinetics
• Pharmacists need to be recognized as
providers
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PATIENT ADVOCATE
Dan Ford
Vice President
Furst Group
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Q&A
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