Transcript Slide 1

Safe oral anticoagulation in
underserved clinics
Krishna Bhaskarabhatla, MD and Sandra Natareno, RN, BSN
NHCAC Health Center, 25 East Salem Street, Hackensack, NJ 07601
North Hudson Community Action Program which has been in existence since 1965 added health services in 1994 and became a FQHC in 1997
Learning Objectives
• Participants will understand the process to develop and incorporate a
patient safety facilitating documentation form with ready to use built-in
guideline to monitor INR and adjust Warfarin dose
• Participants will demonstrate the knowledge to develop standardized
clinical management teams, orientation sessions, care processes and
quality audits to promote safety amongst patients receiving Warfarin
therapy
• Participants will demonstrate the knowledge to develop multicultural
education and literacy programs to promote safety amongst patients
receiving Warfarin therapy
“Knowing is not enough; we must apply.
Willing is not enough; we must do”
- Goethe 1749-1832
Sweet Clover – Warfarin WARF (Wisconsin
Alumni Research Foundation) and –arin from
coumarin.
Coumarin in damaged or spoilt
moldy “Sweet clover” is converted to
Dicoumarin. This interferes with
Vitamin K dependent clotting factors
II, VII, IX, X resulting in bleeding
1920 - Cattle – fatal bleeding
1944 - Link – synthesis of Warfarin
1952 - Rodenticide
1954 - Human use
Warfarin is an oral anticoagulant used to
prevent and treat thromboembolism
• Warfarin’s use has increased over time largely because of its
indication “atrial fibrillation” in an aging population
• Why does Warfarin requires frequent monitoring?
– Narrow therapeutic index
– Potential for numerous drug and dietary interactions
• Monitoring the International Normalized Ratio (INR) a measure of
Warfarin’s effect on clotting factors and the blood’s propensity to
clot, is essential for maintaining the drug within its narrow
therapeutic window
-Long et al. Thrombosis Journal 2010. 8:5
While warfarin therapy can markedly reduce the rate of thromboembolic
events, among treated patients, nearly one-half have international
normalized ratios (INRs) outside the therapeutic range, placing them at
risk for serious, preventable complications such as stroke (if underanticoagulated) and bleeding (if over-anticoagulated).
Samsa G P et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review
of medical records from 2 communities. Arch Intern Med. 2000; 160(7): 967–73.
Narrow therapeutic window
Source: British J of Cardiol
Are adverse drug reactions associated
with Warfarin– a major public health
problem?
National Surveillance of Emergency Department
Visits for Outpatient Adverse Drug Events (ADEs)
• More than 700 000 patients were treated for ADEs in US EDs
annually in 2004 and 2005, and 1 of every 6 required subsequent
hospital admission, transfer to another health care facility, or ED
observation admission.
Warfarin [6.2%]
• Just 3 drugs (
, insulin, and digoxin),
with narrow therapeutic index and high risk of overdose or toxicity,
caused nearly one third of ED-treated ADEs in patients aged 65
years or older
-JAMA 2006 Oct 18; 296:1858-66
National Surveillance of Emergency Department
Visits for Outpatient Adverse Drug Events (ADEs)
• 16 of the 18 drugs most commonly causing ADEs have been in
clinical use for more than 20 years.
• These statistics underscore the need for intensified prevention
efforts, and identify areas in which to focus interventions for the
greatest public health impact
-JAMA 2006 Oct 18; 296:1858-66
• Ambulatory Warfarin-related ADEs have significant effects on both
patient outcomes and healthcare costs
-Long et al. Thrombosis Journal 2010. 8:5
Joint Commission’s new anticoagulation National Patient Safety
Goal 3E requires
Action to “ reduce the likelihood of patient
harm associated with the use of anticoagulant
therapy”
Joint commission: 2008 National Patient Safety Goals –
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/08_npsgs.htm
Our unique situation
When we started our new Hackensack health center in August
2008, several patients were transferred to our health center from a
regional hospital’s closed ambulatory care center. The Warfarin
care was fragmented. There was no ownership for either the
patients or the providers.
We had an immediate need to develop a safety initiative to
standardize accountable patient-centered management of warfarin
therapy in our community health centers (which provide outpatient health care for underserved populations in New Jersey) and
reduce warfarin associated adverse events
Our challenges
•
•
•
•
•
?
Diverse populations
Illiteracy issues
Uninsured populations
Access to laboratory tests
Lack of coordinated
system to monitor the
patients on warfarin
• Patient and staff
Education
• Patient Adherence and
concordance to
anticoagulation
Demographics
Insurance
Language
Race/Ethinicity
Indication for Warfarin
Yes
9
No
32
Under-insured
7
English
24
Spanish
17
Others
8
White
14
other
7
Black
8
Hispanic
19
Atrial Fibrillation
15
Deep Venous Thrombosis/Pulmonary Embolism
21
Prosthetic Valve
4
Prior TIA/Stroke
2
Other
6
The medications the patients carry provides
some insight into the disease burden. And
on-board Warfarin added to the complexity!
30
25
20
1
2
15
3
4
10
5
0
1
2
Number of medications
3
4
The clinical management chain is as strong as its
weakest link
Patient
Policy
Phone
Provider
Pharmacy
Prothrombin
time
©Krishna Bhaskarabhatla 2010
Strengthening the clinical
management of chain
We strengthened this chain for better
monitoring, education and communication
of clinical management of blood thinner
Warfarin - especially timely relay of “Blood
test results and dosage adjustment of
medications”
Of Monitoring
• A recent study found that high proportions of ambulatory patients taking
drugs with a narrow therapeutic range had no serum concentration
monitoring during 1 year of use
Raebel MA et al. Am J Manag Care. 2006;12:268-274
• Careful monitoring and enhancing patient self-management for warfarin
(Coumadin) to achieve appropriate outpatient anticoagulation and
prevent complications is one of the 11 safety practices were rated most
highly in terms of strength of the evidence supporting more widespread
implementation.
Shojania KG et al. Making health care safer: a critical
analysis of patient safety practices. Evid Rep Technol
Assess (Summ). 2001;43:87-99
Communication, adherence and concordance
• Effective communication regarding medications has been shown to
promote medication adherence in the treatment of chronic diseases7 and
can help prevent medication-related errors.
Piette J D, Schillinger D, Potter M B. et al. Dimensions of patient-provider communication and
diabetes self-care in an ethnically diverse population. J Gen Intern Med. 2003; 18(8): 624–33.
• In a sample of diverse, older patients undergoing chronic anticoagulation,
clinician-patient discordance in warfarin regimen was common and
unrelated to patients reports of adherence. To promote safe and effective
care, clinicians should sequentially determine adherence (missed doses)
and regimen concordance during routine medication assessment.
Dean Schillinger et al. Preventing Medication Errors in Ambulatory Care: The Importance of
Establishing Regimen Concordance. Advances in Patient safety. Volume 1.From research to
implementation. http://www.ncbi.nlm.nih.gov
We quickly realized the need to streamline and develop
a model for the delivery of care for patients on
Warfarin
Strong institutionalized
program for education,
monitoring and
communication of
management decisions within
the team and with the
patients
Development of a clinical care team:
• We formed a dedicated team consisting of a physician leader, two
nurses and two medical assistants who underwent orientation
• We designed a warfarin dose and INR documentation form with
built-in warfarin dosing guideline
NORTH HUDSON COMMUNITY ACTION CORPORATION HEALTH CENTERS
25 East Salem Street, Hackensack, NJ 07601 Telephone: 201.996.2121 Facsimile: 201.996.4432
Out Patient Anti-coagulation Flow Sheet
Start date: ____ / ____ / _______
Target INR:[ ] 2.0 – 3.0 [ ] 2.5 – 3.5 other: _______
Name:
Date of Birth:
Medical Record #::
Nationality:
Education:
Telephone:
Pharmacy & Telephone:
Language:
Occupation:
Indication for anticoagulation:[ ] A.Fib [ ] DVT [ ] Pulmonary embolism [ ] CVA [ ] Mechanical valve
Entry Warfarin dose:
Test Done on
Received on
[ ] other:
Therapy duration: [ ] 3 months [ ] 6 months [ ] 1 year [ ] Indefinite [ ] other: _________
INR Result
Current dose
New dose
Next INR test
Initials
Complications
Pt informed on
The Algorithm below is adapted from that of the anticoagulation service at the University of Michigan5 and is consistent with
recommendations from the American College of Chest Physicians guideline, Umich Antocoagulation management service, Mark H. Ebell.
Fam Pract Manag. 2005; 12(5)77-83. and Ansell J, Hirsh J, Poller L, et al. The pharmacology and management of the vitamin K
antagonists. Chest. 2004;126:204S–233S
DOSE ADJUSTMENT ALGORITHMS
For target INR of 2.0 to 3.0, no bleeding:*
INR
Adjustment
Next INR
< 1.5
1.5 to 1.9
2.0 to 3.0
Increase dose 10 to 20
%; consider extra dose
Increase dose
5 to 10% †
No change
4 to 8 days
7 to 14 days
3.1 to 3.9
4.0 to 4.9
Decrease dose
5 to 10%†
Hold for 0 to 1 day
then decrease dose
10%β
No. of consecutive inrange INRs x 1
wk(max: 4 wks) ‡
7 to 14 days
4 to 8 days
3.6 to 4.5
Decrease dose
5 to 10%; consider
holding one dose
4.5 to 6.0
Hold for 1 to 2 days
then decrease dose
5 to 15% β
7 to 14 days
2 to 8 days
>5.0
Seek emergency
room evaluation
For target INR of 2.5 to 3.5, no bleeding:*
INR
Adjustment
Next INR
< 1.5
Increase dose 10 to 20
%; consider extra dose
1.5 to 2.4
Increase dose
5 to 10%†
2.5 to 3.5
No change
4 to 8 days
7 to 14 days
No. of consecutive inrange INRs x 1
wk(max: 4 wks) ‡
† If INR is 1.8 to 1.9 or 3.1 to 3.2, consider no change with repeat INR in 7 to 14 days
>6.0
Seek emergency
room evaluation
‡ for example, if a patient has had three consecutive in-
range INR values, recheck in 3 weeks * If INR is 2.3 to 2.4 or 3.6 to 3.7, consider no change with repeat INR in seven to 14 days
Name:
Date of Birth:
Out Patient Anti-coagulation Flow Medical Record #::
Sheet
Nationality:
Start date: ____ / ____ / _______ Language:
Target INR:[ ] 2.0 – 3.0 [ ] 2.5 –
Education:
3.5 other: _______
Occupation:
Telephone:
Pharmacy & Telephone:
Indication for anticoagulation:[ ] A.Fib [ ] DVT [ ] Pulmonary embolism [ ] CVA
[ ] Mechanical valve [ ] other:
Entry Warfarin dose: Therapy duration: [ ] 3 months [ ] 6 months [ ] 1 year [ ]
Indefinite [ ] other: _________
Test
Received Pt
INR
Complications Current New Next
Done on on
informed Result
Initials
dose
dose INR
on
test
INR
< 1.5
Adjustme Increase
nt
dose 10
to 20 %;
consider
extra
dose
Next INR 4 to 8
days
1.5 to 1.9 2.0 to 3.0
Increase No change
dose
5 to 10% †
3.1 to 3.9 4.0 to 4.9
Decrease
Hold for 0
dose
to 1 day
5 to 10%† then
decrease
dose 10%β
7 to 14
days
7 to 14
days
No. of
consecutive
in-range
INRs x 1
wk(max: 4
wks) ‡
4 to 8 days
>5.0
Seek
emergency
room
evaluation
A focused patient centered medical home for
Longitudinal care
• Registry-now paper based - soon EHR
• Daily our team sort out and record the INR results
• Physician makes a decision on the Warfarin dose regimen and the
when to do the next INR testing and follow up plans are
communicated and arrangements made
• In one study 40% of those with ADEs did not have a follow up plan
• Patient empowerment: preventable ADEs – avoid warfarin-drug
interactions. Patient non-adherence is associated with ADE
associated hospitalizations
-Long et al. Thrombosis Journal 2010. 8:5
Bridge Therapy Protocol for patients on Warfarin
who have to undergo surgery
Recommendations for Bridge Therapy Protocol* Based on Expert Opinion
Recommendations for Bridge Therapy Protocol* Based on Expert Opinion
Day Recommendation
-5 to -4 Stop warfarin (Coumadin) therapy and check INR
−3 or -2 Start LMWH once or twice daily
-1 Last dose of LMWH 12 to 24 hours before procedureCheck INR; if 1.5 or higher, give vitamin K (1 mg
orally) 0 (day of surgery)
0 (day of No LMWH - Assess hemostasis - Start regular warfarin dosage in evening
surgery)
1 Continue regular warfarin dosage - Restart LMWH therapeutic dosage (procedures with low risk
of bleeding and/or patients or procedures with high risk of thrombosis) or LMWH prophylactic
dosage (procedures with high risk of bleeding)
2 Check INR
4 to 10 Check INR - Stop LMWH when INR is 2.0 or higher
References
Ansell J et al. Chest. 2004;126(3 suppl):204S–33S.
Jafri SM. Am Heart J. 2004;147:3–15.
Dunn A. 2006;21:85–9.
Launch: September 2008 and there after
In September 2008, after initial piloting, we incorporated the
documentation form (patient identification, patient and pharmacy
telephone numbers, indication for and current dose of warfarin
therapy, target and current INR, length of therapy) into our care
process
• Every enrolled patient receives education on warfarin therapy, INR
monitoring, dietary and drug interactions.
• The physician reviews the INR results daily and provides action plan
on warfarin dosing and follow up INR testing that is promptly
communicated to the patient. We encourage the patients to have
monthly INR testing if results are therapeutic.
• Every month, our team discusses the monthly quality committee
audit findings and make necessary changes. In March 2009, our
administration developed a policy to recruit our other eight
community health centers in the project.
Patients receiving group education through video and
verbal presentation on oral anticoagulation
BEST approach: Be careful Eat Right Stick to Routine Test Regularly
Staying Active and Healthy
with Blood Thinners Video
English Version: http://www.healthcare411.ahrq.gov/videocast.aspx?id=555
Spanish Version: http://www.healthcare411.ahrq.gov/videocast.aspx?id=556
Outcomes
Months of follow up
12 months follow up
18 months follow
up
Total patients months
243
468
Average follow up duration
8.3
9
Average time in therapeutic range
4.9 (58.8%)
5.86 (65%)
Total INR results
258
505
INR results in therapeutic range
144 (56%)
334 (66%)
INR results in sub-therapeutic range
79 (30.5%)
125 (24%)
INR results in over the therapeutic range
35 (13.5%)
46 (9%)
INR results >5
5
7
Patients requiring emergency care
2
2
Adherence to therapy: number of
patients (total no. of patients)
25 (29)
51 (52)
Concordance to regimen (total no. of
patients)
23 (29)
47 (52)
Number of patients in or outside therapeutic range
education
initiative
30
25
20
15
10
5
0
Over-therapeutic
Therapeutic
Sub-therapeutic
Analysis of INR results
First 12 months
18 months follow up so far
Over therapeutic
46
35
Therapeutic
79
Sub-therapeutic
144
125
Sub-therapeutic
Therapeutic
334
Quarterly outcomes
100
Education initiative
90
Therapeutic
Number of INR results
80
70
60
50
40
Sub-therapeutic
30
20
10
Over-therapeutic
0
1
2
3
Quarterly outcomes
4
Test result communication times(days)
40
35
Patients’ needs
assessment Dedicated
telephone line
30
25
20
15
10
5
0
August 2008
January 2008
Progress of safe initiative
September 2008
Brainstorming of the needs and challenges
October 2008
Design of documentation tool and piloting
Formation of clinical care team, protocols
Development of Registry
Standardization of the initiative
March 2009
Spread of this initiative to other 8 health centers
October 2009
New education tool AHRQ booklet for patients: BEST approach:
Be careful Eat Right Stick to Routine Test Regularly
January 2010
Dedicated telephone line for patient access
February 2010
Patient education video incorporated into the project. Group
education sessions
Moving forward
• We learnt that we can further increase the time in the therapeutic
range of INR (a good predictor for reducing adverse events) and
have better adherence rates.
• We started a simple registry populating with patients receiving
warfarin therapy.
• The challenges remain access to laboratory work up, timely
communication to patients
• So where are we heading with warfarin prescribing?
• Warfarin will continue to be the oral anticoagulant of choice,
possibly for the next decade, while we await an oral thrombin
inhibitor that is both effective and safe.
Joint Commission’s new anticoagulation National Patient Safety
Goal 3E requires
Action to “ reduce the likelihood of patient
harm associated with the use of anticoagulant
therapy”
Joint commission: 2008 National Patient Safety Goals –
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/08_npsgs.htm
Joint Commission’s
2008 National Patient Safety Goals
Ambulatory Care – Anticoagulation Therapy Requirement 3E:
A 1. The organization implements a defined anticoagulant management
program to individualize the care provided to each patient receiving
anticoagulant 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
2008 National Patient Safety Goals
• (M) C 3. When pharmacy services are provided by the organization,
warfarin is dispensed for each patient in accordance with established
monitoring procedures.
• (M) 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.
• (M) A 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.
• (M) 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.
2008 National Patient Safety Goals
• A 7. When heparin is administered intravenously and continuously, the
organization uses programmable infusion pumps.
• (M) C 8. The organization has a policy that addresses baseline and ongoing
laboratories tests that are required for heparin and low molecular weight
heparin therapies.
• (M) C 9. The organization provides education regarding anticoagulation
therapy to staff, patients, and families.
• (M) C 10. Patient/family education includes the importance of follow-up
monitoring, compliance issues, dietary restrictions, and potential for
adverse drug reactions and interactions.
• A 11. The organization evaluates anticoagulation safety practices (see
MM.8.10).
Through this on-going project we streamlined the warfarin
therapy management through timely evaluation of results
and prompt communication with our patients.
Questions?
Email: Krishna Bhaskarabhatla, MD
[email protected]