Managing the Managing the

Anticoagulation ClinicAnticoagulation Clinic

IJN ExperienceIJN Experience

Dr Emily Tan Lay KoonDr Emily Tan Lay KoonCardiologistCardiologistIJNIJN

The Perils of Oral The Perils of Oral Anticoagulation ManagementAnticoagulation Management

Adverse Event Rate

Incidence per 100 patient-years

INR

Adapted from Jacobson, AK, modification of Cannegeiter SC, N Eng J Med 1995

Impact on Health Care Delivery Impact on Health Care Delivery Cost EffectivenessCost Effectiveness

Adapted from Eckman, MH et al. Chest 1998

3 Basic Models of Oral 3 Basic Models of Oral Anticoagulation ManagementAnticoagulation Management

Usual Medical Care (UMC)

Anticoagulation Clinic (AC)

Patient Self Testing (PST)

Care provided by a physician or physician group as part of routine care of the patient

Family Physician (GP), Physician, Physician Specialist (Cardiologist, Hematologist)

Care provided by a team of physician, pharmacist, nursing and healthcare staff in a specialized comprehensive care facility

Provides comprehensive anticoagulation care

Patients are trained to perform own INR testing using approved coagulation monitoring devices

Results reported to healthcare provider who gives specific instructions for follow up care

Ansell J et al. Chest 2001;119(suppl):22s-38s

Summary of trials involving Summary of trials involving Anticoagulation Clinic (AMS) and Anticoagulation Clinic (AMS) and

Usual Medical Care (UC)Usual Medical Care (UC)

Ansell et al. Chest 2008;133;160s-198s

Cohort comparison between AC and UMCCohort comparison between AC and UMC328 newly anticoagulated patients, 4 years follow up328 newly anticoagulated patients, 4 years follow up

$132,086 per 100 $132,086 per 100

patientspatientsAnnual health care Annual health care

cost reductioncost reduction

6%6%22%22%ED visitsED visits

5%5%19%19%Annual warfarin Annual warfarin

related hospitalizationrelated hospitalization

0%0%2.9%2.9%Mortality rateMortality rate

3.3%3.3%11.8%11.8%Thromboembolic Thromboembolic

eventsevents

8.1%8.1%35%35%BleedingBleeding

50.4%50.4%35%35%INR in range (2.5INR in range (2.5--4.5)4.5)

40%40%37%37%INR in range (2INR in range (2--3)3)

ACACUMCUMC

E Chiquette et al. Arch Intern Med 1998;158:1641-1647

Randomized controlled trial Randomized controlled trial comparing management by AC and comparing management by AC and

by Family Physicianby Family Physician221 patients, follow up 3 months, 2 centres (Ontario, 221 patients, follow up 3 months, 2 centres (Ontario,

London)London)

NS6%4%Deaths

0.00184%96%Patient satisfaction

NS2%1%Thromboembolic events

NS1%2%Major bleeding events

0.0011311Mean number of INR measurements

0.00540%30%Percentage or patients with INR <1.5 or >5.0 (high risk values)

0.03476%82%Percentage of time INR within range

P valueFPAC

S Wilson et al. CMAJ 2003;169(4):293-8

Cohort Comparison of Clinical Cohort Comparison of Clinical Pharmacy AC and UMCPharmacy AC and UMC6645 patients, follow up 6 months6645 patients, follow up 6 months

0

5

10

15

20

25

30

0-20 21-40 41-60 61-80 81-100

AC

UMC

% time spent in therapeutic INR range

% of patients

63.5% of AC group in target range; 55.2% of UMC group in target range; P<0.001

M Witt et al. Chest 2005;127;1515-1522

Cohort Comparison of Clinical Cohort Comparison of Clinical Pharmacy AC and UMCPharmacy AC and UMC6645 patients, follow up 6 months6645 patients, follow up 6 months

1.000

0.970

Proportion experiencing

complications

Time (days)1 181

Kaplan-Meyer survival analysis of anticoagulation therapy-related complications

UMC

AC

AC group 39% less likely to experience any anticoagulation therapy-related

complication

M Witt et al. Chest 2005;127;1515-1522

American College of Chest American College of Chest Physicians EvidencePhysicians Evidence--Based Clinical Based Clinical Practice Guidelines (8Practice Guidelines (8thth Edition) Edition)

RecommendationsRecommendations

4.1.1 For health-care providers who manage oral anticoagulation therapy, we recommend

that they do so in a systematic and coordinated fashion, incorporating patient

education, systematic INR testing, tracking, follow-up care and good patient communication of results and dosing decisions as occurs in an anticoagulation

clinic service.

Ansell et al. Chest 2008;133;160s-198s

Role of Anticoagulation Role of Anticoagulation ClinicClinic

�� Coordinate and optimize delivery of Coordinate and optimize delivery of oral anticoagulant therapyoral anticoagulant therapy–– Determining appropriateness of therapyDetermining appropriateness of therapy

–– Managing warfarin dosingManaging warfarin dosing

–– Continuous monitoring of patientContinuous monitoring of patient’’s INR s INR results, dietary factors, concomitant results, dietary factors, concomitant medications and interfering disease statemedications and interfering disease state

�� Comprehensive education and good Comprehensive education and good communication links communication links

Planning an Anticoagulation Planning an Anticoagulation Clinic ServiceClinic Service

�� Identify a needIdentify a need

�� Set up a multiSet up a multi--disciplinary steering groupdisciplinary steering group–– Planning a safe and effective service clinically Planning a safe and effective service clinically and financiallyand financially

–– Minimal disruption to organizationMinimal disruption to organization

–– Estimate impact on workload and staffingEstimate impact on workload and staffing

�� Estimate Cost Estimate Cost –– Space/roomSpace/room

–– Staff, trainingStaff, training

–– Equipment (furniture, computers/software, Equipment (furniture, computers/software, laboratory machines etc)laboratory machines etc)

Setting up an Anticoagulation Setting up an Anticoagulation ClinicClinic

�� Location and operating hoursLocation and operating hours

�� Identify all patients on warfarin and with Identify all patients on warfarin and with indications for anticoagulationindications for anticoagulation

�� Designate a clinical lead Designate a clinical lead ––Doctor/Pharmacist/NurseDoctor/Pharmacist/Nurse

�� Develop protocols and standard operating Develop protocols and standard operating proceduresprocedures

�� Staff trainingStaff training

�� Procurement of equipmentProcurement of equipment

�� Quality Assurance Quality Assurance –– parameters for parameters for evaluationevaluation

Staff Nurses

DieticianLaboratory Technician

Phlebotomist

Pharmacist

Cardiologist

AnticoagulationClinic

MultidisciplinaryTeam

Monitoring of patients Counseling

Coordinate patient’s care Monitoring of patients Counseling

Titration and dispensing of warfarin Monitoring of patients Counseling

Diet counseling INR check

LaboratoryBlood Testing

For INRLab Technician

INR within range?

Pharmacist/Nurse prescribe warfarin dosagePhysician standing order

Medication collectionFollow up appointment

Ascertain possible/probable reasonCounseling and EducationPharmacist/Nurse

Compliance Medications Supplements Diet changes Exercise Recent illness Alcohol Bleeding

Dosage adjustmentAccording to

Established protocolPharmacist/Doctor

Dietician counseling

Work Flow at INR Clinic

No

Yes

Personnel TrainingPersonnel Training

�� TrainingTraining–– Work environmentWork environment

–– Formal didactic or experiential training Formal didactic or experiential training programmeprogramme

–– SelfSelf--studystudy

�� Formal anticoagulant therapy Formal anticoagulant therapy management training programmemanagement training programme–– Singapore General HospitalSingapore General Hospital

Garcia et al. Ann Pharmacother 2008;42:979-88

Anticoagulation Therapy Anticoagulation Therapy Training ProgrammesTraining Programmes

�� Certified Anticoagulation ProviderCertified Anticoagulation Provider–– The National Certification Board for Anticoagulation Providers tThe National Certification Board for Anticoagulation Providers to formally o formally

recognise anticoagulation providers meeting educational and patirecognise anticoagulation providers meeting educational and patientent--care care experiential requirementsexperiential requirements

�� Research Institute of the American College of Clinical Research Institute of the American College of Clinical Pharmacy Anticoagulation Training ProgramPharmacy Anticoagulation Training Program–– 4 to 6 weeks intensive training program provided through the Uni4 to 6 weeks intensive training program provided through the University versity

of Texas and the Anticoagulation Clinics of North Americaof Texas and the Anticoagulation Clinics of North America

�� American Society of HealthAmerican Society of Health--System Pharmacists Foundation System Pharmacists Foundation Antithrombotic Pharmacotherapy TraineeshipAntithrombotic Pharmacotherapy Traineeship–– Curriculum consists of self study program and a 5Curriculum consists of self study program and a 5--day experiential day experiential

programprogram

�� University of Southern Indiana College of Nursing and Allied University of Southern Indiana College of Nursing and Allied Health Professionals Anticoagulant Therapy Management Health Professionals Anticoagulant Therapy Management Certificate ProgramCertificate Program–– Interactive 6 week, 40 hour internet certificate program for nurInteractive 6 week, 40 hour internet certificate program for nurses, ses,

pharmacist and physicianspharmacist and physicians

www.clotcare.comwww.clotcare.com; ; www.acforum.orgwww.acforum.org

Garcia et al. Ann Pharmacother 2008;42:979-88

Personnel Responsibility Personnel Responsibility

�� Collaborative practice agreementCollaborative practice agreement

–– Assigning dayAssigning day--toto--day responsibility for day responsibility for

anticoagulation managementanticoagulation management

–– Responsibilities, accountability and job Responsibilities, accountability and job

descriptionsdescriptions

–– In IJN, nurses and pharmacist manage In IJN, nurses and pharmacist manage

warfarin dosingwarfarin dosing

Garcia et al. Ann Pharmacother 2008;42:979-88

Policies, Protocol and ProceduresPolicies, Protocol and Procedures

�� Policies and procedures serve as clinical tool and Policies and procedures serve as clinical tool and quality assurance mechanism to reduce variability quality assurance mechanism to reduce variability in delivery of carein delivery of care

�� Address common and/or controversial issues that Address common and/or controversial issues that may arisemay arise

�� Reviewed, updated as evidence becomes available Reviewed, updated as evidence becomes available and approved regularly by appropriate committeesand approved regularly by appropriate committees

�� Widely disseminated throughout the organizationWidely disseminated throughout the organization

�� Available for review within the clinic at all timesAvailable for review within the clinic at all times

�� Reduce fragmentation of care by facilitating Reduce fragmentation of care by facilitating communication and transitions between healthcare communication and transitions between healthcare team membersteam members

Garcia et al. Ann Pharmacother 2008;42:979-88

Anticoagulation Management Anticoagulation Management Issues for which established Issues for which established

policies and procedures may be policies and procedures may be usefuluseful

�� Assessing risks and benefits of therapyAssessing risks and benefits of therapy

�� Documenting patientDocumenting patient’’s understanding s understanding

�� Indications and specific target INRIndications and specific target INR

�� Planned duration of therapyPlanned duration of therapy

�� Initiating therapyInitiating therapy

�� Managing therapeutic and non therapeutic INRManaging therapeutic and non therapeutic INR

�� Monitoring intervals and other lab parametersMonitoring intervals and other lab parameters

�� Defining and documenting adverse eventsDefining and documenting adverse events

�� Mechanism by which missed appointments be flaggedMechanism by which missed appointments be flagged

�� Managing nonadherence to blood tests or clinic visitsManaging nonadherence to blood tests or clinic visits

�� Managing transitions between care settingsManaging transitions between care settings

�� Defining criteria for discharging patients from dedicated ACDefining criteria for discharging patients from dedicated AC

�� Defining quality measuresDefining quality measures

�� Interrupting anticoagulation for invasive proceduresInterrupting anticoagulation for invasive procedures

�� Managing anticoagulation therapy during pregnancyManaging anticoagulation therapy during pregnancy

�� Coordination of anticoagulation therapy during travelCoordination of anticoagulation therapy during travel

�� Defining eligibility criteria and follow up requirements for patDefining eligibility criteria and follow up requirements for patient self testingient self testing

Garcia et al. Ann Pharmacother 2008;42:979-88

DocumentationDocumentation

�� Accurate and easily Accurate and easily

accessible accessible

documentation documentation

systemsystem

�� Computer software Computer software

programs or paper programs or paper

formsforms

TreatmentIndications for anticoagulation therapy

Target INR

Start date

Anticipated duration of therapy

Tablet strength(s) of vitamin K antagonist

Risk factors for bleeding and clotting

Demographics

MiscellaneousComplications

Missed appointments

Plans for interrupting anticoagulation therapy

CommunicationDocumentation of patient education processes

Garcia et al. Ann Pharmacother 2008;42:979-88

Computer Software Computer Software ProgrammesProgrammes

�� DocumentationDocumentation

�� Dosage adjustment and managementDosage adjustment and management

�� Statistical analysisStatistical analysis

�� Randomized controlled trial evaluating Randomized controlled trial evaluating

software showing at least comparable software showing at least comparable

if not superior outcome compared with if not superior outcome compared with

manual dose titrationmanual dose titration

Computer Software ProgrammeComputer Software Programme

info@RxFiles.net248-321-0971Intelligent Dosing System

www.clinpharmacologist.bigstep.com

Therapeutics TechnologiesDrugCalc

www.doseresponse.com

mhudson@doseresponse.com

Keystone Therapeutics Inc, Pittsburg, 800-633-8642

DoseResponse

www.4s-dawn.com4S Information Systems Ltd, UK, 011-44-15395-63091

DAWN AC Anticoagulation Therapy Software v.6.03

www.coumacare.comBristol-Myers Squibb Pharmaceuticals, 800-328-7709

CoumaCare Patient Management System (v5.1a)

www.standingstoneinc.comStanding Stone Inc, 800-648-9877

CoagClinic

www.zycare.comZyCare Inc, 919-419-7228CoagCare Management System

www.clevclog.freeserve.co.ukClever Clog, EnglandClever Clog

Groesener-telehealth@worldnet.att.net

www.telehlthsys.com

Telehealth Systems Inc, 877-490-6161

Anticoagulation Management Program(AMP)

www.e-medicalmonitor.come-MedicalMonitor, SpainANTHEMA

Web address/emailVendor/Contact infoSoftware Product

Adapted from Ansell et al. Managing Oral Anticoagulation Therapy:Clinical and Operational Guidelines 2003

Patient Education and Patient Education and CounselingCounseling

�� Patient safety is enhanced when Patient safety is enhanced when

patients are actively involved in, patients are actively involved in,

understand and take responsibility for understand and take responsibility for

their caretheir care

�� Verbal, written, internetVerbal, written, internet

�� DiscussionDiscussion

�� Allow time for questionsAllow time for questions

�� All team membersAll team members

Evaluation and Quality Evaluation and Quality Assurance (QA)Assurance (QA)

�� Time in therapeutic range (TTR)Time in therapeutic range (TTR)–– Fraction of INR within therapeutic range (Fraction of INR within therapeutic range (egeg. No . No of of INRsINRs in range divided by total no of INR in range divided by total no of INR tests).tests).

–– ‘‘CrossCross--section of the filessection of the files’’ –– assessing fraction of assessing fraction of patients with INR in range at one point in time patients with INR in range at one point in time compared to the total no of patients tested.compared to the total no of patients tested.

–– ‘‘Linear interpolationLinear interpolation’’ –– linear relationship exists linear relationship exists between 2 INR values and allocates a specific between 2 INR values and allocates a specific INR value to each day between tests for each INR value to each day between tests for each patient.patient.

�� Number of adverse outcomes Number of adverse outcomes –– hemorrhage hemorrhage (major, minor), thromboembolic event(major, minor), thromboembolic event

Patient Self Testing and Patient Self Testing and MonitoringMonitoring

�� Self monitoringSelf monitoring –– self test and self adjust self test and self adjust treatment according to a predetermined treatment according to a predetermined dose schedule dose schedule

�� Self testSelf test –– self test and call a clinic to self test and call a clinic to receive the appropriate dose adjustmentreceive the appropriate dose adjustment

�� Convenience, better treatment compliance, Convenience, better treatment compliance, more frequent monitoring, fewer more frequent monitoring, fewer thromboembolic and hemorrhagic thromboembolic and hemorrhagic complications, improving quality of lifecomplications, improving quality of life

�� Cost effectiveCost effective

Ansell et al. International J of Card 2005;37-45

Comparison of Anticoagulation Comparison of Anticoagulation Management ModelsManagement Models

Adapted and modified from Ansell JE, J Thrombosis and Thrombolysis, 1998

Patient Self Monitoring Patient Self Monitoring –– better better INR within target range INR within target range

Heneghan et al. Lancet 2006;367:404-11

Meta-analysis of 14 randomized trial

Patient Self Monitoring Patient Self Monitoring –– lower lower thromboembolic eventsthromboembolic events

Heneghan et al. Lancet 2006;367:404-11

Meta-analysis of 14 randomized trial

Patient Self Monitoring Patient Self Monitoring –– lower lower major haemorrhagemajor haemorrhage

Heneghan et al. Lancet 2006;367:404-11

Meta-analysis of 14 randomized trial

Patient Self Monitoring Patient Self Monitoring Selection of patientSelection of patient

�� Patients on long term anticoagulation Patients on long term anticoagulation therapytherapy

�� Most patients who are able to lead an Most patients who are able to lead an independent and self supporting lifeindependent and self supporting life

�� Intellectual ability Intellectual ability –– able to understand the able to understand the concept of oral anticoagulation therapy and concept of oral anticoagulation therapy and its potential risksits potential risks

�� Willingness to actively participate in Willingness to actively participate in treatment, sufficient manual dexterity and treatment, sufficient manual dexterity and acuity of visionacuity of vision

�� No previous experience is necessaryNo previous experience is necessary

�� Training requiredTraining requiredAnsell et al. International J of Card 2005;37-45

Patient Self Monitoring Patient Self Monitoring CoagulometersCoagulometers

Ansell et al. International J of Card 2005;37-45

Medic AlertMedic Alert

�� The MedicAlert FoundationThe MedicAlert Foundation

–– NonNon--profit company founded in 1956 in profit company founded in 1956 in

CaliforniaCalifornia

�� Maintains a database of membersMaintains a database of members’’ medical medical

information that is made available to information that is made available to

medical authorities in the event of an medical authorities in the event of an

emergencyemergency

�� Members wear a distinctive metal bracelet Members wear a distinctive metal bracelet

or necklace at all timesor necklace at all times

Medic AlertMedic Alert

�� Medical conditions and medicationsMedical conditions and medications

AnticoagulantsAnticoagulants

AsthmaAsthma

DiabetesDiabetes

EpilepsyEpilepsy

�� Blood GroupBlood Group

�� AllergiesAllergies

�� Special needs Special needs –– pacemaker, organ donorpacemaker, organ donor

Medic Alert Application Medic Alert Application

Yayasan MedicAlert Yayasan MedicAlert MalaysiaMalaysia

c/o University Malaya c/o University Malaya Medical Centre,Medical Centre,

59100 KL59100 KL

Tel/Fax : Tel/Fax : +603+603--7960135579601355

2424--hour Hotline : hour Hotline : +603+603--7957511179575111

www.ummc.edu.my

Take Home MessageTake Home Message

�� WarfarinWarfarin has a narrow therapeutic range and has a narrow therapeutic range and therefore requires effective monitoring to reduce therefore requires effective monitoring to reduce adverse outcomes.adverse outcomes.

�� Proper management of anticoagulation by a Proper management of anticoagulation by a multidisciplinary team of healthcare workers in a multidisciplinary team of healthcare workers in a dedicated anticoagulation clinic is cost effective and dedicated anticoagulation clinic is cost effective and improves patientimproves patient’’s quality of life by delivery of s quality of life by delivery of optimum anticoagulation care.optimum anticoagulation care.

�� Patient self testing and monitoring provides a Patient self testing and monitoring provides a convenient and reasonable reliable alternative to convenient and reasonable reliable alternative to attending an anticoagulation clinic.attending an anticoagulation clinic.

““The successful use of oral anticoagulation The successful use of oral anticoagulation depends on an essential triad :depends on an essential triad :

A Vigilant physicianA Vigilant physicianA Cooperative patientA Cooperative patientAA readily available, reliable readily available, reliable

laboratorylaboratory””

…………Askey and CherryAskey and CherryJAMA 1950; 144:97JAMA 1950; 144:97--100100