Transcript
Page 1: 13496270 Medication Error in Hospital

High Alert Medications: Reliable Methods to Ensure

Safer 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 Year

Award• 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 regulatory requirements 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 year

in the United States.

Of 221,000 medication errors reported via MEDMARX 1998-2005 in the perioperative setting: 80% of the medication errors that result in patient harm are caused by

20% 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 cause significant harm to the patient, even when used as intended

• TJC - medications that have the highest risk of causing injury when misused

• ISMP - mistakes may not be more common in the 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 administration employing

• redundancies such as automated or independent 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 used by the hospital and takes action to prevent errors involving the interchange of these medications

– EP1: The hospital identifies a list of look-alike/sound-alike medications used by the hospital. The list includes a minimum of 10 look-alike/sound-alike medication

– EP2: The hospital reviews the list of look-alike/sound-alike medications at least annually

– EP3: The hospital takes action to prevent errors involving the interchange 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 managing

high-alert medications – EP3 - The hospital implements its process for

managing high-alert medications– EP4 - The hospital minimizes risks associated with

managing 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 patient safety 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 hospital identifies 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) by

proxy

• 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 perioperative setting; 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 for the Advancement of Patient Safety.

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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 (Heparin

vs. 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 to predict patient response; types (1) minimal, (2) moderate, (3) deep, (4) anesthesia

• Problem-– Dosing confusion (ie midazolam onset of

action)– Inappropriate monitoring– Expertise, qualification, and credentialing of

staff

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 more than 50 reports of significant misuse of NMB

• 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 with cancer each year; 48,000 experience some 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 but…three times the potential to cause harm

• Over 50% of new approved medications have not had sufficient 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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Strategies for Success

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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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General Recommendations

• Design processes to prevent errors and harm.

• Design methods to identify errors and harm when they occur.

• Design methods to mitigate the harm that may result from the error.

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 Process to Prevent Errors and Harm• Standardize order sets, preprinted order forms,

clinical pathways • Standardize concentrations and dose strengths• Reminders about appropriate monitoring

parameters• Consider protocols for vulnerable populations

such 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

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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" in

inpatient and outpatient settings• Use ONLY oral unit-dose products and pre-mixed

infusions 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/IIIa

inhibitors• 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 and

opiates• 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; reversal

protocols

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 medication

supplies• 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.http://www.ismp-canada.org/download/caccn/CACCN-Spring07.pdf

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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 to

ensure 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.

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Specific Recommendations: Pediatric• Segregate medications from adult storage areas• Standardize concentrations • Compounding and dilutions should occur within the

pharmacy• 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: 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.

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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: Patient Education• Engage patient involvement

– Pain management– Anticoagulation

• Simple, visual information– Example: warfarin education

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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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• Design is not just what it looks like and feels like. Design is how it works.”

- Steve Jobs

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Contact Information

[email protected]

The American Society of Medication Safety Officerswww.asmso.org

www.twitter.com/ChrisHartman


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