medication error in hospital
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High Alert Medications:
Reliable Methods to EnsureSafer Use
Christian Hartman, PharmDMedication Safety Officer
Assistant Professor of Medicine
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Organization Profile
UMass Memorial Medical Center - Worcester, MA
834 bed academic medical center
Multi-campus system
Level 1 trauma center
Level 3 NICU
2008 Winner ISMP CHEERS Award
2008 Winner ASHP Affiliate Pharmacy of the YearAward
Last Joint Commission Survey - Nov 2008 No Medication Management RFIs
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Objectives
Define high-alert medications according to
TJC, IHI, and ISMP
Discuss accreditation and regulatoryrequirements for high-alert medications
Outline error prevention, identification, and
mitigation strategies and best practices
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Everybody gets so much information all
day long that they lose their common
sense.- Gertrude Stein
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Statistics
1.5 million preventable adverse drug events (ADEs) occur each yearin the United States.
Of 221,000 medication errors reported via MEDMARX 1998-2005 inthe perioperative setting:
80% of the medication errors that result in patient harm are caused by20% of medications administered by practitioners.
The leading medications involved: Insulin 11.3% Morphine 2.3%
Heparin 3.5% Fentanyl 2.9% Hydromorphone 2.7%
Committee on Identifying and Preventing Medication Errors. Aspden P, Wolcott J, Bootman JL, Cronenwett LR, Editors.
Preventing Medication Errors: Quality Chasm Series. Washington, DC: National Academies Press; July 2006.
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Alphabet Soup
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Definitions
IHI - medications that are most likely to causesignificant harm to the patient, even when usedas intended
TJC - medications that have the highest risk ofcausing injury when misused
ISMP - mistakes may not be more common inthe use of these medications; when errors occur
the impact on the patient can be significant
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Standards: Institute for Safe
Medication Practices (ISMP) limit access to high-
alert medications auxiliary labels and
automated alerts
standardize ordering,storage, preparation,and administrationemploying
redundancies such asautomated orindependent double-checks
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Standards: The Institute for
Healthcare Improvement (IHI) 5 Million Lives Campaign
Goal: reduce harm from high-alert
medications by 50% by December 2008
Aim: Anticoagulants, Narcotics and
Opiates, Insulin, Sedatives
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Standards: The Joint
Commission (TJC) National Patient Safety Goals
NPSG 3
Medication Management MM 01.01.03
MM 03.01.01
MM 08.01.01
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TJC Requirements: NPSG
03.03.01 The hospital identifies and, at a minimum, annually
reviews a list of look-alike/sound-alike medications usedby the hospital and takes action to prevent errorsinvolving the interchange of these medications
EP1: The hospital identifies a list of look-alike/sound-alikemedications used by the hospital. The list includes a minimum of10 look-alike/sound-alike medication
EP2: The hospital reviews the list of look-alike/sound-alikemedications at least annually
EP3: The hospital takes action to prevent errors involving theinterchange of the medications on the list of look-alike/sound-alike medications
Joint Commission: 2009 Hospital Accreditation Manual.
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TJC Requirements:
MM 01.01.03 The hospital safety manages high-alert and
hazardous medication EP1 - The hospital identifies, in writing, its high-alert
medications
EP2 - The hospital has a process for managinghigh-alert medications
EP3 - The hospital implements its process formanaging high-alert medications
EP4 - The hospital minimizes risks associated withmanaging hazardous medications
Joint Commission: 2009 Hospital Accreditation Manual.
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TJC Requirements:
MM 03.01.01 The hospital safety stores medications
EP9 - The hospital keeps concentrated electrolytes
present in patient care areas only when patientsafety necessitates their immediate use and
precautions are used to prevent inadvertent
administration
Joint Commission: 2009 Hospital Accreditation Manual.
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TJC Requirements:
MM 08.01.01 The hospital evaluates the effectiveness
of its medication management system. EP5 - Based on analysis of its data, as well as review of the
literature for new technologies and best practices, the hospitalidentifies opportunities for improvement in its medication
management system
EP8 - The hospital takes action when planned improvements
for its medication management processes are either not
achieved or not sustained
Joint Commission: 2009 Hospital Accreditation Manual.
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TJC Sentinel Event Alerts
Issue 41 September 24, 2008: Preventing errors relating to commonly
used anticoagulants
Issue 39 - April 11, 2008: Preventing pediatric medication errors
Issue 34 - July 14, 2005: Preventing vincristine administration errors
Issue 33 - December 20, 2004: Patient controlled analgesia (PCA) byproxy
Issue 23 - September 1, 2001: Medication errors related to potentially
dangerous abbreviations
Issue 19 May 1, 2001: Look-alike, sound-alike drug names
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Where do we begin?
Specific medications
General drug classes
Specific processes Specific patient populations
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Specific Medications: Insulin
MEDMARX - 9,135 errors in perioperativesetting; 4.2 % causing harm
Problem-
Multiple products available Look alike sound alike names and products
Abbreviations (Lantus 15Units)
Difficult dosing regimens
Hicks RW, Becker SC, Cousins DD. MEDMARX Data Report: A Chartbook of Medication
Error Findings from the Perioperative Setting from 1998-2005. Rockville, MD: USP Center forthe Advancement of Patient Safet .
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Specific Medications: Opiates
Largest category of drugs associated with
error related deaths
Problem-
Name confusion (oxycodone vs oxycontin)
Dose conversion (morphine vs. dilaudid)
Overlapping regimens
Multiple dosage forms (PO, IV, TD, etc)
Koczmara C, Hyland S.. Preventing narcotic associated adverse events in critical care units.
Dynamics 15:7-10, Fall 2004.
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Specific Medications:
Anticoagulants Bates and colleagues report that anticoagulants
accounted for 4% of preventable ADEs and 10%of potential ADEs.
Problem- Multiple products (Heparin) Difficult dosing regimens
Abbreviations (Heparin 5000Units)
Look alike sound alike names and products (Heparinvs. Hespan)
Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse
drug events: Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274:29-34.
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Specific Medications:
Concentrated Electrolytes 5 to 10 patients die annually due to
concentrated KCl in the United States
Reversal is difficult
Problem-
Access and storage
Procurement
Joint Commission Resources: Reducing the risk of errors associated with concentrated
electrolyte solutions. Joint Commission: The Source 6:1-2, Mar. 2008.
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Specific Medications: Sedation
Sedation is a continuum and often difficult topredict patient response; types (1) minimal, (2)moderate, (3) deep, (4) anesthesia
Problem- Dosing confusion (ie midazolam onset ofaction)
Inappropriate monitoring
Expertise, qualification, and credentialing ofstaff
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
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Specific Medications: NMB
According to USP, there have been morethan 50 reports of significant misuse ofNMB
Problem- Improper storage (ICU vs floor)
Look alike sound alike (Vanco vs Vec)
Inappropriate monitoring Medication use process
Smetzer JL. Preventing errors with neuromuscular blocking agents. Jt Comm J Qual Patient
Saf 32: 56-59, Jan. 2006.
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Specific Medications:
Adrenergic Agents Ben Kolb - syringe that was supposed to
contain lidocaine actually contained
epinephrine
Problem-
Look alike sound alike names and packaging
Multiple manufacturers
Large vial sizes
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High Risk Processes: Oncology
In the US, 1.2 million are diagnosed withcancer each year; 48,000 experiencesome type of adverse event
Problem- Selection/procurement/storage
Ordering and monitoring
Transcribing Preparation and administration
Joint Commission Resources: Medication safety with the use of chemotherapy agents. Joint
Commission Perspectives on Patient Safety. 8:1-5, Mar. 2008
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High Risk Processes: Pediatrics
Similar medication error rates as adults butthree timesthe potential to cause harm
Over 50% of new approved medications have not hadsufficient pedi research
Problem- Complex regimens and dosing
Medication preparation
Immature ability to metabolize
Lack of communication
Joint Commission Resources: Preventing pediatric medication errors. Joint Commission
Perspectives on Patient Safety. 7:5-6, Sept. 2007
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High Risk Processes: Elderly
Insulin, warfarin, and digoxin were implicated in one in
every three estimated ADEs treated in ED and 41.5% of
estimated hospitalizations
Problem-
Altered metabolism
Decreased renal function
Polypharmacy
Communication and technology
Budnitz DS, Pollock DA, Weidenbach KN, et al. National surveillance of emergency
department visits for outpatient adverse drug events. JAMA. 2006;296:1858-1866.
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"Anyone can make the simple
complicated. Creativity is making the
complicated simple."- Charles Mingus
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Strategies for Success
General recommendations for all
medications and processes
Specific recommendations for select
medications
Additional recommendations
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Design Process to Prevent
Errors and Harm Standardize order sets, preprinted order forms,
clinical pathways
Standardize concentrations and dose strengths
Reminders about appropriate monitoringparameters
Consider protocols for vulnerable populationssuch as the elderly, pediatric, and obese
patients
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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Design Methods to Identify
Errors and Harm Ensure that critical lab information is available to those
who need the information and can take action
Implement independent double-checks where
appropriate
Instruct patients on symptoms to monitor and when to
contact a health care provider for assistance
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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Methods to Mitigate Harm
Develop protocols allowing for the
administration of reversal agents without
having to contact the physician
Ensure that antidotes and reversal agents
are readily available
Have rescue protocols available
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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How do we make mistakes?
-Exercise
Two teams
Team 1 count bounce passes for
players in WHITE shirts
Team 2 count chest passes for players
in WHITE shirts
http://viscog.beckman.uiuc.edu/flashmovie/15.php
http://viscog.beckman.uiuc.edu/flashmovie/15.phphttp://viscog.beckman.uiuc.edu/flashmovie/15.php -
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Changing Practice/Behavior
Forced Functions
Constraints
Check lists/pathways Policy
Guidelines
Education
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General Recommendations:
Anticoagulants Format anticoagulation orders to follow the patient
through transitions of care
Use an anticoagulant dosing service or "clinic" ininpatient and outpatient settings
Use ONLY oral unit-dose products and pre-mixedinfusions as available
Staff training and competency assessment
Conduct an Antithrombotic Therapy Self-assessment or
FMEA http://www.ismp.org/selfassessments/asa2006/Intro.asp
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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Patient Information
Drug Information
Communication of Orders
Storage
Device Use Staff Competency
Patient Education
Risk Assessment
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Specific Recommendations:
Heparin Weight-based heparin protocol/nomogram
Preprinted order forms or ordering protocols
Account for the use of thrombolytics and GIIg/IIIainhibitors
LMWH and Heparin conversion standards Standard concentrations
Separate like products
Hep-flush ordered and available in syringe
Monitoring parameters are implemented
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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Specific Recommendations:
Warfarin Narrow therapeutic index - centralized dosing
and monitoring service
Standardize dosing, monitoring, reversal
Minimize available strengths; no tablet splitting Nutrition consult for patients on warfarin to avoid
drug/food interactions
Patient education and follow-up
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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General Recommendations:
Opiate and Narcotics Standardize protocols
Monitoring for adverse effects of narcotics andopiates
Protocols for reversal agents Centralized pain services
Independent double-checks
Minimize multiple drug strengths and
concentrations where possible Mutual pain assessment and toileting
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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Specific Recommendations:
Insulin Eliminate or standardize sliding scales
Independent double-check
Pre-printed insulin infusion orders and flowsheets
Separate LASA; standardize manufacturer
Prepare all infusions in the pharmacy
Standardize to a single concentration for IV
Safeguards on high-dose insulin concentration; reversalprotocols
5 Million Lives Campaign. Getting Started Kit: Preventing Harm from High-Alert Medications.
Cambridge, MA: Institute for Healthcare Improvement; 2008.
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Specific Recommendations:
Concentrated Electrolytes Eliminate storage on patient care units when
possible
Segregate bulk supplies within the pharmacy
Secure after hours access to medicationsupplies
Utilize premix/pre-packaged where feasible
Auxiliary labeling and packaging
Pop-up warnings/alerts in ADM
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
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Specific Recommendations:
Sedation Stock only one concentration of moderate sedation
agents
Preprinted order forms/sets
Monitor all children on chloral hydrate
Age/size appropriate resuscitation equipment
Adequately trained personnel
Fall prevention program
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
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Specific Recommendations:
NMB Secure/segregate storage
Restrict access to ICU, ED, OR only
Auxiliary labeling and packaging
Alerts and pop-up warnings Do not store on unit dose cart/ADM matrix
drawer; ADM single item only
Standardize formulary and prescribing
Prompt removal of product after D/C
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.htt ://www.ism -canada.or /download/caccn/CACCN-S rin 07. df
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Specific Recommendations:
Adrenergic Agents Premixed solutions and prefilled syringes when
feasible
Standardize concentrations
Apply LASA standards Standardize ordering (ie do not use titrate to
effect)
Extravasation policy and kit
Utilize different manufacturers when feasible toensure packaging looks different
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
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Specific Recommendations:
Oncology Procurement/Dispensing - standardize
Storage - physical separation, negative pressure room,
LASA
Ordering - standard order sets, CPOE, ordering policy,
dose limits, pair with protocols, forced - weight, blood
counts
Transcribing - prohibit verbals if possible, transcription
policy, independent verification
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
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Specific Recommendations:
Oncology Preparation/Dispensing - independent verification, check offs, staff
protection (USP 797, closed systems, etc), labeling
Administration - independent verification of new starts/rate
changes/etc, smart pumps, clearly marked catheters
Monitoring - interdisciplinary monitoring, standard orders for
laboratory monitoring, cumulative dose
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
Specific Recommendations
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Specific Recommendations:
Pediatric Segregate medications from adult storage areas
Standardize concentrations
Compounding and dilutions should occur within thepharmacy
Oral syringes for oral liquids Patient specific unit dosing provided by pharmacy
Mandatory weights and ongoing assessment
Pediatric P&T Committee and formulary
Ordered using weight based formula (mg/kg) Visual cues for pediatric orders and records
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
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Specific Recommendations:
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Specific Recommendations:
Elderly Polypharmacy assessment
Concurrent renal dosing monitoring
program
Comprehensive falls risk assessment
Adoption of Beers criteria and mitigation
strategies
High-Alert Medications: Strategies for Improving Safety. Joint Commission Joint Commission
Resources.
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Beers List
Donna M. Fick, James W. Cooper, William E. Wade, Jennifer L. Waller, J. Ross Maclean, and Mark H. Beers. Updating the Beers
Criteria for Potentially Inappropriate Medication Use in Older Adults: Results of a US Consensus Panel of Experts. Arch Intern Med,
Dec 2003; 163: 2716 - 2724.
Additional Recommendations:
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Additional Recommendations:
Dedicated Teams Anticoagulation management team
Interdisciplinary pain management team
Dedicated pediatric and oncology
coverage
Annual risk assessment team - Failure
Mode and Effect Analysis
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Additional Recommendations:
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Additional Recommendations:
Technology Computerized Practioner Order Entry/ePrecribing Bar Coded Medication Administration (BCMA)
Dispensing verification
RFID
Smart Pumps
Medication carousel
Electronic, real-time surveillance of trigger drugs, labs,etc
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Clinical Surveillance
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A Robust Program
Analyzes medications and processes
Applies standards and regulations
Develops strategies to prevent, Identify,
and mitigate errors and harm
Utilizes technology when feasible
Engages the patient and family
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Contact Information
The American Society of Medication Safety Officers
www.asmso.org
www.twitter.com/ChrisHartman
mailto:[email protected]://www.asmso.org/http://www.twitter.com/ChrisHartmanhttp://www.twitter.com/ChrisHartmanhttp://www.asmso.org/mailto:[email protected]