Safe oral anticoagulation in underserved clinics Krishna Bhaskarabhatla, MD and Sandra Natareno, RN, BSN NHCAC Health Center, 25 East Salem Street, Hackensack,

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 bleeding1944 - Link – synthesis of Warfarin1952 - Rodenticide1954 - 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

Narrow therapeutic window

Source: British J of Cardiol

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 under-anticoagulated) 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.

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.

• Just 3 drugs (Warfarin [6.2%], 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 out-patient 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 Yes 9No 32Under-insured 7

Language English 24Spanish 17Others 8

Race/Ethinicity White 14other 7Black 8Hispanic 19

Indication for Warfarin Atrial Fibrillation 15Deep Venous Thrombosis/Pulmonary Embolism 21Prosthetic Valve 4Prior TIA/Stroke 2Other 6

The medications the patients carry provides some insight into the disease burden. And

on-board Warfarin added to the complexity!

1 2 3 40

5

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25

30

Series1

Number of medications

The clinical management chain is as strong as its weakest link

Patient

Provider

Prothrombin time

Pharmacy

Policy Phone

©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

INR < 1.5 1.5 to 1.9 2.0 to 3.0 3.1 to 3.9 4.0 to 4.9 >5.0

Adjustment Increase dose 10 to 20 %; consider extra dose

Increase dose

5 to 10% †No change Decrease dose

5 to 10%†Hold for 0 to 1 day then decrease dose

10%βSeek emergency room evaluation Next INR 4 to 8 days 7 to 14 days No. of consecutive in-

range INRs x 1 wk(max:

4 wks) ‡

7 to 14 days 4 to 8 days

DOSE ADJUSTMENT ALGORITHMSFor target INR of 2.0 to 3.0, no bleeding:*

INR < 1.5 1.5 to 2.4 2.5 to 3.5 3.6 to 4.5 4.5 to 6.0 >6.0Adjustment Increase dose 10 to 20

%; consider extra doseIncrease dose

5 to 10%†No change Decrease dose

5 to 10%; consider holding one dose

Hold for 1 to 2 days then decrease dose

5 to 15% β Seek emergency room evaluation

Next INR 4 to 8 days 7 to 14 days No. of consecutive in-range INRs x 1 wk(max:

4 wks) ‡

7 to 14 days 2 to 8 days

For target INR of 2.5 to 3.5, no bleeding:*

† 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 ‡ 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

NORTH HUDSON COMMUNITY ACTION CORPORATION HEALTH CENTERS25 East Salem Street, Hackensack, NJ 07601 Telephone: 201.996.2121 Facsimile: 201.996.4432

Out Patient Anti-coagulation Flow SheetStart date: ____ / ____ / _______ Target INR:[ ] 2.0 – 3.0 [ ] 2.5 – 3.5 other: _______

Name: Date of Birth: Medical Record #:: Nationality: Language:Education: 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 Done on Received on Pt informed on INR Result Complications Current dose New dose Next INR test Initials

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

Out Patient Anti-coagulation Flow SheetStart date: ____ / ____ / _______ Target INR:[ ] 2.0 – 3.0 [ ] 2.5 – 3.5 other: _______

Name: Date of Birth: Medical Record #:: Nationality: Language:Education: 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 Done on

Received on

Pt informed on

INR Result

Complications Current dose

New dose

Next INR test

Initials

INR < 1.5 1.5 to 1.9 2.0 to 3.0 3.1 to 3.9 4.0 to 4.9 >5.0Adjustment

Increase dose 10 to 20 %; consider extra dose

Increase dose 5 to 10% †

No change Decrease dose 5 to 10%†

Hold for 0 to 1 day then decrease dose 10%β

Seek emergency room evaluation

Next INR 4 to 8 days

7 to 14 days

No. of consecutive in-range INRs x 1 wk(max: 4 wks) ‡

7 to 14 days

4 to 8 days

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 OpinionDay 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

surgery)

No LMWH - Assess hemostasis - Start regular warfarin dosage in evening

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

OutcomesMonths of follow up 12 months follow up 18 months follow

up

Total patients months 243 468Average follow up duration 8.3 9Average time in therapeutic range 4.9 (58.8%) 5.86 (65%)Total INR results 258 505INR 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 7Patients requiring emergency care 2 2Adherence 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

2008/sep

2008/oct

2008/nov

2008/dec

2009/jan

2009/feb

2009/mar

2009/apr

2009/may

2009/jun

2009/jul

2009/aug

2009/sep

2009/oct

2009/nov

2009/dec

2010/jan

2010/feb

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Over-therapeuticTherapeuticSub-therapeutic

education initiative

Analysis of INR results

First 12 months 18 months follow up so far

14479

35

Therapeutic

Sub-therapeutic

334

125

46

Therapeutic

Over therapeutic

Sub-therapeutic

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Quarterly outcomes

Education initiative

Quarterly outcomesN

umbe

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Test result communication times(days)

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August 2008 January 2008

Patients’ needs assessment Dedicated telephone line

Progress of safe initiativeSeptember 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]