Ensuring Safety of Ensuring Safety of Anticoagulation TherapyAnticoagulation Therapy

AbhaAbha Agrawal, MD, FACPAgrawal, MD, FACP

Chief Medical OfficerChief Medical OfficerKings County HospitalKings County Hospital

Clinical Associate DeanClinical Associate DeanSUNY Downstate College of MedicineSUNY Downstate College of Medicine

Brooklyn, NYBrooklyn, NY

NYACP Webinar | April 29 2011

CME DisclosureCME Disclosure

AbhaAbha AgrawalAgrawal hhas no relationships with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

Kings County Hospital CenterKings County Hospital Center

650650--bed academic bed academic tertiary hospitaltertiary hospitalLevelLevel--1 Trauma 1 Trauma CenterCenter26,000 discharges26,000 discharges750,000 clinic visits750,000 clinic visits130,000 ED visits130,000 ED visits

NYC HHCNYC HHC

Largest municipal health system in the Largest municipal health system in the countrycountry11 acute care hospitals11 acute care hospitals>100 diagnostic and treatment centers>100 diagnostic and treatment centers7,700 beds7,700 beds23,000 deliveries23,000 deliveries227,000 admissions227,000 admissions

AgendaAgenda

Risks of anticoagulantsRisks of anticoagulantsSafety strategiesSafety strategiesUsing health IT to improve anticoagulation Using health IT to improve anticoagulation safetysafety–– Case study 1: Electronic anticoagulation Case study 1: Electronic anticoagulation

protocolprotocol–– Case study 2: Root cause analysis of a Case study 2: Root cause analysis of a

medication errormedication error

Balancing the RiskBalancing the Risk

ThromboembolismBleeding

ProblemProblem

PE remains the commonest PE remains the commonest preventablepreventable cause cause of hospital deaths.of hospital deaths.Many Many ““atat--riskrisk”” patients donpatients don’’t receive VTE t receive VTE prophylaxis prophylaxis (Lancet Jun 2008 ENDORSE study)(Lancet Jun 2008 ENDORSE study)::–– TOTAL: >68,000 patientsTOTAL: >68,000 patients

Surgical Surgical –– 65% 65% ““atat--riskrisk””, medical , medical –– 42% 42% ““atat--riskrisk””

–– Of Of ““atat--riskrisk”” patientspatientsSurgical Surgical –– 59% received recommended prophylaxis59% received recommended prophylaxisMedical Medical –– 40% received recommended prophylaxis40% received recommended prophylaxis

VTE Occurs Despite ProphylaxisVTE Occurs Despite Prophylaxis

NEJM PROTECT Apr 7 2011 studyNEJM PROTECT Apr 7 2011 study–– Critically ill patientsCritically ill patients–– 3764 patients3764 patients–– 1873 in 1873 in dalteparindalteparin armarm

5.1% had DVT despite prophylaxis5.1% had DVT despite prophylaxis1.3% had PE1.3% had PE

–– 1873 in UFH arm1873 in UFH arm5.8% had DVT despite prophylaxis5.8% had DVT despite prophylaxis2.3% had PE2.3% had PE

Disturbing Numbers Ahead!!

Risk of AnticoagulantsRisk of Anticoagulants

Medicare OIG study Nov 2010Medicare OIG study Nov 2010

780 Medicare beneficiaries discharged in 780 Medicare beneficiaries discharged in Oct 2008Oct 2008–– 13.5 %: adverse events13.5 %: adverse events–– Additional 13.5% Additional 13.5% -- temporary harmtemporary harm–– 44% preventable44% preventable–– 1.5% 1.5% -- contributed to their deaths = 15,000 contributed to their deaths = 15,000

Medicare beneficiaries in a month (based on Medicare beneficiaries in a month (based on ~ 1 million in a month)~ 1 million in a month)

OIG Medicare StudyOIG Medicare Study

Medications31%

Ongoing Pt Care28%

Surgery / Procedures

26%

Infections15%

Medicare OIG Study (Contd.)Medicare OIG Study (Contd.)

Medication events Medication events –– 31% = 4031% = 40–– Excessive bleeding Excessive bleeding -- 1212–– Delirium or change in mental status Delirium or change in mental status -- 77–– Hypoglycemic event Hypoglycemic event –– 66–– Acute renal insufficiency Acute renal insufficiency –– 44–– Severe hypotension Severe hypotension –– 44–– Respiratory complications Respiratory complications –– 44–– Severe allergic reactions Severe allergic reactions -- 33

OIG Medicare StudyOIG Medicare Study

12 deaths 7 Meds Related 5 ACs

Other 5

• 2 blood stream infection

• 2 aspiration

• 1 VAP

Other 2

• Hypoglycemic episodes

DriversDrivers

DriversDrivers

ISMP: 3 of 14 high alert meds are ISMP: 3 of 14 high alert meds are anticoagulantsanticoagulantsAHRQ 2011: AC safety as 1 of 11 high AHRQ 2011: AC safety as 1 of 11 high impact interventionsimpact interventionsLeapfrog safety objective #18: march 2006Leapfrog safety objective #18: march 2006NPSG: 2011: goal: #3NPSG: 2011: goal: #3AC included in IHI 5 million lives AC included in IHI 5 million lives campaigncampaign

Joint Commission Sentinel EventsJoint Commission Sentinel Events

Sentinel Events Alert #41: 2008Sentinel Events Alert #41: 2008–– Anticoagulants: One of the 5 drugs associated Anticoagulants: One of the 5 drugs associated

with patient safety incidents.with patient safety incidents.–– MEDMARX database: 2001MEDMARX database: 2001--20062006

59,316 anticoagulants related errors reported59,316 anticoagulants related errors reported60% reached the patient60% reached the patient3% led to harm or death3% led to harm or deathPerformance error (e.g. administration is the most Performance error (e.g. administration is the most common cause of error).common cause of error).

Risk of AnticoagulantsRisk of Anticoagulants

Hemorrhagic complicationsHemorrhagic complications–– IV UFH: <3%IV UFH: <3%

Risk increases with increased dosage and age >70 Risk increases with increased dosage and age >70 yearsyears

–– LMWH: less major bleeding than UFHLMWH: less major bleeding than UFH–– Thrombolytic therapy increases the risk of Thrombolytic therapy increases the risk of

major bleeding 1.5 major bleeding 1.5 –– 3X in patients receiving 3X in patients receiving AC therapyAC therapy

Chest 2008: ACCP Guidelines

Why anticoagulants are high risk Why anticoagulants are high risk meds?meds?

Narrow therapeutic rangeNarrow therapeutic rangeInteraction with many common foods and Interaction with many common foods and medicationsmedicationsNeed frequent and timely lab monitoringNeed frequent and timely lab monitoringSpecial issues exist in the elderly, Special issues exist in the elderly, including bleeding complications including bleeding complications associated with fallsassociated with fallsSpecial risks in neonatesSpecial risks in neonates

Why anticoagulants are high risk Why anticoagulants are high risk meds? (contd.)meds? (contd.)

Lack of standardization for the naming, Lack of standardization for the naming, labeling and packaging of anticoagulants labeling and packaging of anticoagulants creates confusion. creates confusion. Potentially confusing dosing regimens, Potentially confusing dosing regimens, newer agents.newer agents.Special risk during transfers and handSpecial risk during transfers and hand--offs.offs.

Anticoagulants: Risk PointsAnticoagulants: Risk Points

Lack of critical patient informationLack of critical patient information–– Ht, wt, allergies Ht, wt, allergies –– missing or datedmissing or dated–– Lab values Lab values –– PT/PTT/INR PT/PTT/INR –– missing or didnmissing or didn’’t t

seeseeBaselineBaselinemonitoringmonitoring

–– Concomitant use of other anticoagulantsConcomitant use of other anticoagulants–– Renal impairmentRenal impairmentTransfers and handTransfers and hand--offsoffs

AgendaAgenda

Risks of anticoagulantsRisks of anticoagulantsSafety strategiesSafety strategiesUsing health IT to improve anticoagulation Using health IT to improve anticoagulation safetysafety–– Case study 1: Electronic anticoagulation Case study 1: Electronic anticoagulation

protocolprotocol–– Case study 2: Root cause analysis of a Case study 2: Root cause analysis of a

medication errormedication error

Steps in Medication ProcessSteps in Medication Process

Prescribing 39%

12%

11%

38%

CPOE / Decision Support

Robots / Pyxismachines

Bar-coded med admin

Transcription

Dispensing

Administration

Leape et al. JAMA. 1995Bates, BMJ, 2000

Error

Adverse Event

Bates DW et al. J Gen Intern Med. 1993

WhatWhat’’s in a name?s in a name?

Medication ErrorsMedication Errors

Reason, James. Human Error. Cambridge University Press, 1990

Sharp End Errors = Active Errors

Blunt End Errors = Latent Errors

ReasonReason’’s Swiss Cheese Models Swiss Cheese Model

Human versus Systems: Human versus Systems: ComplexityComplexity

I donI don’’t want to maket want to makethe wrong mistake.the wrong mistake.

Yogi BerraYogi Berra

AgendaAgenda

Risks of anticoagulantsRisks of anticoagulantsSafety strategiesSafety strategiesUsing health IT to improve anticoagulation Using health IT to improve anticoagulation safetysafety–– Case study 1: Electronic anticoagulation Case study 1: Electronic anticoagulation

protocolprotocol–– Case study 2: Root cause analysis of a Case study 2: Root cause analysis of a

medication errormedication error

Case Study 1: Electronic Acute Case Study 1: Electronic Acute Anticoagulation Therapy ProtocolAnticoagulation Therapy Protocol

Covers UFH, LMWH and Covers UFH, LMWH and WarfarinWarfarinIntegrated into hospitalIntegrated into hospital--wide EHR and wide EHR and CPOECPOEIntegrated into barIntegrated into bar--cod medication cod medication administration module for nursesadministration module for nursesUsed in ED and Inpatient Used in ED and Inpatient –– all servicesall services

Hirsh J et al. Chest June 2008. Antithrombotic and thrombolytic therapy. ACCP evidence-based clinical practice guidelines

Electronic AC Therapy ProtocolElectronic AC Therapy Protocol

MethodologyMethodology–– CorporateCorporate--wide AC Committee wide AC Committee –– Jan 2007Jan 2007–– Representation from multiple hospitalsRepresentation from multiple hospitals–– Included MD, RN, Lab, Pharmacy, IT, Project Included MD, RN, Lab, Pharmacy, IT, Project

ManagementManagement–– Reviewed literature, recommended dosing Reviewed literature, recommended dosing

guidelines, defined design specifications and guidelines, defined design specifications and workflow integration, beta testing.workflow integration, beta testing.

–– Nov 2007: pilot at Bellevue HospitalNov 2007: pilot at Bellevue Hospital–– Next ~ 18 months: corporateNext ~ 18 months: corporate--wide rolloutwide rollout

Electronic AC Therapy ProtocolElectronic AC Therapy Protocol

ObjectivesObjectives–– Improving adherence to evidenceImproving adherence to evidence--based AC based AC

guidelinesguidelines–– Reducing variations in dosing protocols Reducing variations in dosing protocols

across HHCacross HHC–– Improving safety by providing pointImproving safety by providing point--ofof--care care

decision support during ordering processdecision support during ordering process–– Improving communication between Improving communication between

physicians, nurses, and pharmacistsphysicians, nurses, and pharmacists

FeaturesFeatures

Dosing recommendations for UFH, LMWH, Dosing recommendations for UFH, LMWH, WarfarinWarfarin based on evidencebased on evidence--based guidelinesbased guidelinesAutomated ordering of corollary lab orders such Automated ordering of corollary lab orders such as CBC, as CBC, aPTTaPTT and platelet count with and platelet count with medication orderingmedication orderingTrend report, built in the order set, summarizing Trend report, built in the order set, summarizing historic anticoagulation medication and pertinent historic anticoagulation medication and pertinent lab ordering from the last 10 calendar days lab ordering from the last 10 calendar days available from the order entry screenavailable from the order entry screen

PointPoint--ofof--care Decision Supportcare Decision Support

““No weightNo weight”” alertalert““Weight considerationWeight consideration”” alert if >72 hr oldalert if >72 hr oldBaseline lab warningBaseline lab warningPlatelet warningPlatelet warning–– <100 k or >50% drop<100 k or >50% dropCreatinineCreatinine clearance calculation and clearance calculation and warningwarningEmbedded mandatory HIT questionEmbedded mandatory HIT question

Anticoagulation Order SetAnticoagulation Order Set

UFH Order SetUFH Order Set

Heparin bolus orderHeparin bolus order

Rx / Lab ReportRx / Lab Report

Corollary Orders with HeparinCorollary Orders with Heparin

UFH Adjustment DoseUFH Adjustment Dose

Decision Support FeaturesDecision Support Features

EnoxaparinEnoxaparin

EnoxaparinEnoxaparin

FondaparinuxFondaparinux order setorder set

FondaparinuxFondaparinux

FondaparinuxFondaparinuxTo order fondaparinux, patient must have a cr clearance of >= 30 ml/min, determined from the most recent weight and serum creatinine results. If any of these three are missing or not recent, enter or order the appropriate values.

CoumadinCoumadin

WarfarinWarfarin NomogramNomogram

WarfarinWarfarin NomogramNomogram: Patient: Patient’’s INR s INR is 1.2is 1.2

Select therapy daySelect therapy day

Day 5 of the Day 5 of the NomogramNomogram

Day 6 of the Day 6 of the NomogramNomogram

Case Study 2: Medication ErrorCase Study 2: Medication Error74 year old man with multisystem illness in 74 year old man with multisystem illness in MICU develops PE.MICU develops PE.Started on heparin infusion Started on heparin infusion –– develops Heparindevelops Heparin--induced thrombocytopeniainduced thrombocytopeniaPrescribed Prescribed correctcorrect weightweight--based dose of based dose of ArgatrobanArgatroban..Pharmacist dispenses Pharmacist dispenses correct correct IV mixed bagIV mixed bagNurse mistakenly infuses 20X greater dose of Nurse mistakenly infuses 20X greater dose of the medication.the medication.Patient dies of bleeding complications within 12 Patient dies of bleeding complications within 12 hours.hours.

ArgatrobanArgatroban OrderOrder

Label on the IV bagLabel on the IV bag

‘‘KKǘǘblerbler--RossRoss’’ Stages: Stages: Medication SafetyMedication Safety

Adapted from Donald Berwick, MD, IHI 2004 Frontiers of Healthcare conference

I - Denial

II - Anger

III - Bargaining

IV - Depression

V - Acceptance

“The data are wrong”

“The data are right, but it’s not a problem”

“The data are right; it’s a problem, but it’s not my problem”

“It’s my problem, but there is nothing I can do about it”

“I accept the burden of improvement”

KnowingKnowing is not enough; we must is not enough; we must applyapply..WillingWilling is not enough; we must is not enough; we must dodo..

Johann Wolfgang von Goethe.