Safety in our System:Safety in our System:High Alert MedicationsHigh Alert Medications

Lynn Eschenbacher, Pharm.D.Lynn Eschenbacher, Pharm.D.Medication Safety OfficerMedication Safety Officer

Duke University Hospital Duke University Hospital

Case Study Case Study

Physician ordered Norcuron (Vercuronium) Physician ordered Norcuron (Vercuronium) for a patient via Computerized Physician for a patient via Computerized Physician Order Entry (CPOE)Order Entry (CPOE)

Ordered via remote location- not at the Ordered via remote location- not at the bedsidebedside

Accidentally prescribed for a patient on a Accidentally prescribed for a patient on a medical unit, meant for a patient in the ICUmedical unit, meant for a patient in the ICU

Case StudyCase Study

Pharmacist processed and prepared the Pharmacist processed and prepared the infusion, failing to recognize that a infusion, failing to recognize that a neuromuscular blocking agent should neuromuscular blocking agent should never be sent to a medical unitnever be sent to a medical unit

Auxiliary labels placed on bagAuxiliary labels placed on bag High Alert medicationHigh Alert medication Paralyzing agentParalyzing agent

Pharmacy technician delivered to medical Pharmacy technician delivered to medical unit and didn’t question why not an ICUunit and didn’t question why not an ICU

Case StudyCase StudyIndependent double check performed by Independent double check performed by the nurses to verifythe nurses to verify DrugDrug Pump settingsPump settings PatientPatient

Infusion started and patient walked to the Infusion started and patient walked to the bathroombathroomPatient fell to the floor once paralysis Patient fell to the floor once paralysis began to set inbegan to set in

Case StudyCase StudyPatient called for helpPatient called for help

Rapid response team respondedRapid response team responded

Nurse questioned if new drug hung could Nurse questioned if new drug hung could have done thishave done this

Physician immediately stopped the Physician immediately stopped the infusioninfusion

Patient treated and no long-term effectsPatient treated and no long-term effects

ISMP Medication Safety Alert! May 31, 2007 Volume 12 Issue 11

What Happened?What Happened?Entered on wrong patient in CPOEEntered on wrong patient in CPOENo confirmation of correct patient or hardstop in No confirmation of correct patient or hardstop in CPOE for NMB outside of the ICUCPOE for NMB outside of the ICUUnfamiliarity with the medicationUnfamiliarity with the medicationDidn’t ask for clarification or information about Didn’t ask for clarification or information about the medicationthe medicationAuxiliary labels not readAuxiliary labels not readMultiple providers involvedMultiple providers involved6 Rights6 Rights Patient, drug, dose, route, time, responsePatient, drug, dose, route, time, response

Others?Others?

How Do Errors Occur?How Do Errors Occur?

The Swiss Cheese Model

Medication Safety DefinedMedication Safety Defined

Adverse drug event (ADE)Adverse drug event (ADE) Any incident in which the use of a medication (drug Any incident in which the use of a medication (drug

or biologic) at any dose, may have resulted in an or biologic) at any dose, may have resulted in an adverse outcome in a patient adverse outcome in a patient (JCAHO 2001)(JCAHO 2001)

Adverse Drug Reaction (ADR) A response to a drug that is noxious and unintended,

and that occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function (WHO 1972)

Near Miss/Close CallNear Miss/Close Call Errors that have the capacity to cause injury, but fail

to do so, either by chance or because they are intercepted (Leape 1995)

High Alert MedicationsHigh Alert Medications

How does a medication get tagged high How does a medication get tagged high alert?alert?

1.1. A medication that is notorious for causing a lot of A medication that is notorious for causing a lot of medication errors.medication errors.

2.2. A medication that requires an intern who has worked A medication that requires an intern who has worked for less than 10 hours in a row to write for it.for less than 10 hours in a row to write for it.

3.3. A medication that requires special care because if an A medication that requires special care because if an error occurs it has the potential to result in significant error occurs it has the potential to result in significant patient harm.patient harm.

4.4. I have no idea.I have no idea.

AnswerAnswer

1.1. A medication that is notorious for causing a lot A medication that is notorious for causing a lot of medication errors.of medication errors.

2.2. A medication that requires an intern who has A medication that requires an intern who has worked for less than 10 hours in a row to write worked for less than 10 hours in a row to write for it.for it.

3.3. A medication that requires special care A medication that requires special care because if an error occurs it has the potential because if an error occurs it has the potential to result in significant patient harm.to result in significant patient harm.

4.4. I have no idea.I have no idea.

Warfarin and insulins caused: Warfarin and insulins caused: One in every sevenOne in every seven estimated adverse drug events estimated adverse drug events

treated in emergency departments treated in emergency departments More than a quarterMore than a quarter of all estimated hospitalizations of all estimated hospitalizations

In the In the elderlyelderly, insulin, warfarin, and digoxin were , insulin, warfarin, and digoxin were implicated in:implicated in: One in every threeOne in every three estimated adverse drug events estimated adverse drug events

treated in emergency departmentstreated in emergency departments 41.5%41.5% of estimated hospitalizations of estimated hospitalizations

Budnitz DS, Pollock DA, Weidenbach KN, et al. Budnitz DS, Pollock DA, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug eventsNational surveillance of emergency department visits for outpatient adverse drug events . . JAMAJAMA. 2006;296:1858-1866.. 2006;296:1858-1866.

What Does the Evidence Tell Us?What Does the Evidence Tell Us?

IHI 5 Million Lives CampaignIHI 5 Million Lives Campaign

Reducing Harm from High-Alert Medications

The Goal: Reduce harm from high-alert medications by

50% by December 2008

IHI 5 Million Lives FocusIHI 5 Million Lives Focus

AnticoagulantsAnticoagulants Heparin and WarfarinHeparin and Warfarin

Narcotics/OpiatesNarcotics/Opiates Patient-Controlled AnalgesiaPatient-Controlled Analgesia

InsulinInsulin

SedativesSedatives e.g., Midazolame.g., Midazolam

IHI Recommended MeasuresIHI Recommended MeasuresADEs:ADEs:

Related to Anticoagulant per 100 Admissions with Anticoagulant Administered

Related to Insulin per 100 Admissions with Insulin Administered Related to Narcotic per 100 Admissions with Narcotic Administered Related to Sedative per 100 Admissions with Sedative Administered

Percent of Patients Receiving:Percent of Patients Receiving: Anticoagulant with Treatment Appropriately Managed According to Protocol Heparin with aPPT Outside Protocol Limits Insulin with Blood Glucose Level Outside Protocol Limits Insulin with Treatment Appropriately Managed According to Protocol Narcotic Who Receive Subsequent Treatment with Naloxone Narcotic with Treatment Appropriately Managed According to Protocol Sedative Who Receive Subsequent Treatment with Flumazenil Sedative with Treatment Appropriately Managed According to Protocol Warfarin with INR Outside Protocol Limits

IHI Measure ExamplesIHI Measure Examples

The number of adverse drug events (ADEs) The number of adverse drug events (ADEs) associated with an anticoagulant per 100 associated with an anticoagulant per 100 admissions in which the patient was admissions in which the patient was administered at least one dose of an administered at least one dose of an anticoagulant, as detected using the anticoagulant, as detected using the IHI Global Trigger ToolIHI Global Trigger Tool (using only the (using only the Medication Module and Care Module triggers).Medication Module and Care Module triggers).

The percentage of patients receiving insulin with The percentage of patients receiving insulin with blood glucose levels outside the safety limits set blood glucose levels outside the safety limits set by the hospital’s insulin protocol during insulin by the hospital’s insulin protocol during insulin administration administration

Duke University Hospital ApproachDuke University Hospital Approach

Identify High Alert MedicationsIdentify High Alert Medications

Understand what causes harm at DUHUnderstand what causes harm at DUH Data analysisData analysis

Decrease variation and standardizeDecrease variation and standardize

Develop long lasting solutionsDevelop long lasting solutions

Involvement with front line staff up to Involvement with front line staff up to senior leadershipsenior leadership

Demonstrate improvement with dataDemonstrate improvement with data

Duke High Alert MedicationsDuke High Alert Medications Direct Thrombin InhibitorsDirect Thrombin Inhibitors Neuromuscular Blocking Neuromuscular Blocking

AgentsAgents IT administered medicationsIT administered medications Total Parenteral Nutrition Total Parenteral Nutrition

(TPN)(TPN) Antiarrhythmics (amiodarone Antiarrhythmics (amiodarone

IV, lidocaine IV, dofetilide)IV, lidocaine IV, dofetilide) Vasopressors (dopamine, Vasopressors (dopamine,

dobutamine, epinephrine, dobutamine, epinephrine, norepinephrine, phenylephrine)norepinephrine, phenylephrine)

Potassium IVPotassium IV Heparin IVHeparin IV OpiatesOpiates Chemotherapy IV and ITChemotherapy IV and IT BenzodiazepinesBenzodiazepines WarfarinWarfarin Insulin IVInsulin IV

Selection of High Alert MedicationsSelection of High Alert Medications

Based on:Based on: Previous medication errorsPrevious medication errors Sentinel EventsSentinel Events ISMP, USP and other national dataISMP, USP and other national data

Increased risk of causing significant patient harm Increased risk of causing significant patient harm when they are involved in medication errors. when they are involved in medication errors.

Although mistakes may or may not be more Although mistakes may or may not be more common with these drugs, the consequences of common with these drugs, the consequences of an error are potentially more devastating to an error are potentially more devastating to patients. patients.

Data CollectionData Collection

ISMP Quarterly Action AgendaISMP Quarterly Action Agenda

IHI Trigger ToolIHI Trigger Tool

Electronic Surveillance ToolElectronic Surveillance Tool

Voluntary ReportsVoluntary Reports

Root Cause AnalysisRoot Cause Analysis

Failure Mode and Effect AnalysisFailure Mode and Effect Analysis

On-Line ReportingOn-Line ReportingSingle Portal for all events: Blood Transfusion related, Falls, Patient Visitor issues, Surgical/invasive, Treatment/testing, and Equipment

On-Line ReportingOn-Line Reporting

Areas of FocusAreas of Focus

PrescribingPrescribing

PreparationPreparation

DispensingDispensing

AdministrationAdministration

MonitoringMonitoring

Identification and Mitigation of RiskIdentification and Mitigation of Risk

AnalyzeAnalyze medication related events specific to institutionUtilize scientific methodologyscientific methodology to identify root causes and opportunities for improvementMulti-disciplinary teamsMulti-disciplinary teams to develop action items to address the root causesCulture and buy-inCulture and buy-in to adopt these improvementsMistake proofMistake proof where possible to ensure long lasting solutions

Identification and Mitigation of RiskIdentification and Mitigation of Risk

AnalyzeAnalyze RCA, FMEA

Scientific MethodologyScientific Methodology Six Sigma, PDSA, FADE

CultureCulture AHRQ Culture of Safety Survey

Mistake ProofingMistake Proofing Elimination, Replacement, Facilitation,

Detection, Mitigation

Six SigmaSix Sigma

Deployed January 2004

~32 Black Belts

~62 Green Belts

DMAIC, DMADV, GE Workout™, Lean, Change Management

Six Sigma Oversight Committee with RAIL (rolling action item list)

Multidisciplinary ParticipationMultidisciplinary Participation

Official Physician champions for each effortReport out at several physician, nursing and pharmacy forums

Clinical Peer Review Committee Clinical Practice Council Performance Improvement Oversight Committee Medication Safety Council

Knowledge experts includedAddress Issues that have been identifiedShare your institution’s data

Example: Mistake ProofingExample: Mistake Proofing

Insulin ExamplesInsulin Examples

Standardization to one IV insulin nomogramStandardization to one IV insulin nomogram

CPOE Insulin order sets (Subcutaneous and IV) CPOE Insulin order sets (Subcutaneous and IV) and can only order insulin from order setand can only order insulin from order set

Standardization of hypoglycemia treatment Standardization of hypoglycemia treatment protocol- placed in all patient chartsprotocol- placed in all patient charts

Nutrition and insulinNutrition and insulin Example: Insulin administered at MN and tube feed Example: Insulin administered at MN and tube feed

held at 3am due to residuals. What do you do?held at 3am due to residuals. What do you do?

Insulin AdvisorInsulin Advisor

Opiate ExamplesOpiate ExamplesStandardized the PCA concentrations available for the adult populationCPOE

Standardized ordering using a PCA orderset Added critical risk factor assessment Additional monitoring recommendations Lean body weight for dosing Hard stop for morphine PCA and ESRD RT consult for patients with sleep apnea

Developed a pre-op screening electronic assessment tool with the critical risk factors related to potential oversedation highlighted in red at the top of the electronic formDeveloped pre-op screening education for patients to help set realistic expectations for post-op pain management

PCA AdvisorPCA Advisor

Pre-op screening alertPre-op screening alert

Anticoagulation ExamplesAnticoagulation Examples

Standardized ordering in CPOE (10/1/07)Standardized ordering in CPOE (10/1/07) Direct Thrombin InhibitorsDirect Thrombin Inhibitors HeparinHeparin WarfarinWarfarin

Nursing protocol to alert physicians to Nursing protocol to alert physicians to returned lab results and prompts for returned lab results and prompts for change in orderschange in ordersRevised the pharmacist managed warfarin Revised the pharmacist managed warfarin monitoring formmonitoring form

Warfarin Monitoring FormWarfarin Monitoring Form

Look-Alike High Alert DrugsLook-Alike High Alert Drugs

Look-Alike DrugsLook-Alike Drugs

Look-Alike DrugsLook-Alike Drugs

Aoccdrnig to a rscheearch at Cmabrigde Uinervtisy, it deosn't mttaer in waht oredr the ltteers in a wrod are, the olny iprmoetnt tihng is taht the frist and lsat ltteer be at the rghit pclae. The rset can be a toatl mses and you can sitll raed it wouthit porbelm. Tihs is bcuseae the huamn mnid deos not raed ervey lteter by istlef, but the wrod as a wlohe.

Look-Alike/Sound-Alike DrugsLook-Alike/Sound-Alike Drugs

hydralazinehydralazine hydroxyzinehydroxyzine

cerebyxcerebyx celebrexcelebrex

vinblastinevinblastine vincristinevincristine

chlorpropamidechlorpropamide chlorpromazinechlorpromazine

glipizideglipizide glyburideglyburide

daunorubicindaunorubicin doxorubicindoxorubicin

Look-Alike/Sound-Alike Drugs Look-Alike/Sound-Alike Drugs TALL MAN LETTERINGTALL MAN LETTERING

hydrALAZINEhydrALAZINE hydrOXYzinehydrOXYzine

ceREBYXceREBYX ceLEBRexceLEBRex

vinBLASTinevinBLASTine vinCRIStinevinCRIStine

chlorproPAMIDEchlorproPAMIDE chlorproMAZINEchlorproMAZINE

glipiZIDEglipiZIDE glyBURIDEglyBURIDE

DAUNOrubicinDAUNOrubicin DOXOrubicinDOXOrubicin

DUH Look Alike/Sound Alike EffortsDUH Look Alike/Sound Alike Efforts

TallMan Lettering:TallMan Lettering: Smart Pumps, Automated Dispensing Smart Pumps, Automated Dispensing

Cabinets, Medication Administration Record, Cabinets, Medication Administration Record, bin in the central pharmacy, storeroom, IV bin in the central pharmacy, storeroom, IV room and satellitesroom and satellites

Future: CPOE, Pharmacy computer systemFuture: CPOE, Pharmacy computer system

Posters highlighting similar productsPosters highlighting similar products Example: Ephedrine and PromethazineExample: Ephedrine and Promethazine

Communication and EducationCommunication and Education

Key to SuccessKey to Success

Often an after thought, but needs to be part of Often an after thought, but needs to be part of the effortsthe efforts Staff and FaultyStaff and Faulty

Medication Safety MinutesMedication Safety Minutes

FlyersFlyers

Grand RoundsGrand Rounds PatientsPatients

BrochuresBrochures

PamphletsPamphlets

VideosVideos

Medication Safety FlyerMedication Safety Flyer

Medication Safety FlyerMedication Safety Flyer

Demonstration of ImprovementDemonstration of Improvement

CurrentCurrent Balanced Scorecard (BSC)Balanced Scorecard (BSC)

Reduction in ADEs resulting in harmReduction in ADEs resulting in harmReduction in ADEs resulting in harm specific to Reduction in ADEs resulting in harm specific to opiates and insulinopiates and insulinIncrease in overall reportingIncrease in overall reporting

FutureFuture Incorporation of ADE-Surveillance (Triggers) Incorporation of ADE-Surveillance (Triggers)

on BSCon BSC IHI Global Trigger tool IHI Global Trigger tool

Balanced ScorecardBalanced Scorecard

Critical Success FactorsCritical Success Factors

DUHS establishes priorities within each DUHS establishes priorities within each quadrant of the Balanced Scorecard.quadrant of the Balanced Scorecard. Clinical Quality, Customer, Finance, Work CultureClinical Quality, Customer, Finance, Work Culture

Critical Success Factors (CSFs) help to Critical Success Factors (CSFs) help to communicate and measure these priorities. communicate and measure these priorities.

The CSFs cascade down throughout lower level The CSFs cascade down throughout lower level scorecards within the organization and support scorecards within the organization and support the DUHS vision and strategy.the DUHS vision and strategy.

Demonstration of ImprovementDemonstration of Improvement

Individual projectsIndividual projects Process measuresProcess measures Outcome measuresOutcome measures

Unique to projectsUnique to projects

Oversight by Core Safety Team for Clinical Oversight by Core Safety Team for Clinical Service Line or by Six Sigma Oversight Service Line or by Six Sigma Oversight CommitteeCommittee

What We Know About Making What We Know About Making ErrorsErrors

All of us make errorsAll of us make errors

Errors are not made on purposeErrors are not made on purpose

No one wants to admit errors if they know No one wants to admit errors if they know punishment is the resultpunishment is the result

Error Error ≠ Bad Behavior≠ Bad Behavior

Errors happen for a reasonErrors happen for a reason

Lucian Leape, MD

Medication SafetyMedication Safety

Bottom Line: If the system is not fixed Bottom Line: If the system is not fixed the same error will happen again the same error will happen again