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.

    http://www.ismp.org/selfassessments/asa2006/Intro.asp
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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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    S f

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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.

    G l R d i

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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.

    S ifi R d ti

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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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    S ifi R d ti

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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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    S ifi R d ti

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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.

    S ifi R d ti

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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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    S ifi R d ti

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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.

    S ifi R d ti

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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.

    S ifi R d ti

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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

    [email protected]

    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]