Medication Error In Hospital
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High Alert Medications: Reliable Methods to Ensure Safer Use
Christian Hartman, PharmD Medication 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 highalert medications • auxiliary labels and automated alerts • standardize ordering, storage, preparation, and administration employing • redundancies such as automated or independent doublechecks
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/soundalike 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;274:2934.
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 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
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
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.
• • • • • • • •
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 Officers www.asmso.org www.twitter.com/ChrisHartman
Christian Hartman, PharmD Medication 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 highalert medications • auxiliary labels and automated alerts • standardize ordering, storage, preparation, and administration employing • redundancies such as automated or independent doublechecks
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/soundalike 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;274:2934.
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 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
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
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.
• • • • • • • •
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 Officers www.asmso.org www.twitter.com/ChrisHartman
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