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

Christian.Hartman@asmso.org

The American Society of Medication Safety Officerswww.asmso.org

www.twitter.com/ChrisHartman

mailto:Christian.Hartman@asmso.orghttp://www.asmso.orghttp://www.twitter.com/ChrisHartman