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