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High Alert Medications: Reliable Methods to Ensure Safer Use Christian Hartman, PharmD Medication Safety Officer Assistant Professor of Medicine

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  • High Alert Medications: Reliable Methods to Ensure

    Safer Use

    Christian Hartman, PharmDMedication Safety Officer

    Assistant Professor of Medicine

  • 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

  • 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

  • Everybody gets so much information all day long that they lose their common sense.

    - Gertrude Stein

  • 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.

  • Alphabet Soup

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • Where do we begin?

    Specific medications General drug classes Specific processes Specific patient populations

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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

  • High Risk Processes: Pediatrics Similar medication error rates as adults butthree 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

  • 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.

  • Strategies for Success

  • "Anyone can make the simple complicated. Creativity is making the complicated simple."

    - Charles Mingus

  • Strategies for Success

    General recommendations for all medications and processes

    Specific recommendations for select medications

    Additional recommendations

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.php

  • Changing Practice/Behavior

    Forced Functions Constraints Check lists/pathways Policy Guidelines Education

  • 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.

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

  • Patient Information Drug Information Communication of Orders Storage Device Use Staff Competency Patient Education Risk Assessment

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • 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: 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.

  • 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.

  • 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: Dedicated Teams Anticoagulation management team Interdisciplinary pain management team Dedicated pediatric and oncology

    coverage Annual risk assessment team - Failure

    Mode and Effect Analysis

  • Additional Recommendations: Patient Education Engage patient involvement

    Pain management Anticoagulation

    Simple, visual information Example: warfarin education

  • 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

  • Clinical Surveillance

  • 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

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

    - Steve Jobs

  • Contact Information

    [email protected]

    The American Society of Medication Safety Officerswww.asmso.org

    www.twitter.com/ChrisHartman

    mailto:[email protected]://www.asmso.orghttp://www.twitter.com/ChrisHartman