medication errors: we're looking down the tunnel and ... · – major medication error; –...
TRANSCRIPT
Medication ErrorsWe're Looking Down the Tunnel and
Seeing Light
(10+ years since IOM)Michael R. Cohen, RPh, MS, ScD
Institute for Safe Medication Practices
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Disclosure Information
Michael R. Cohen, RPh, MS, ScD has no financial relationships to disclose
and will not discuss off label use and/or investigational use in this presentation.
Medication Safety Issues
Culture of safety (blame and shame)Error reporting programsQuality issuesPatient safety technologyProduct related issues
Heparin issuesRecent high-profile reports of injury
Error Reporting Programs and Resulting Improvement Efforts
B+
Patient Safety Act and Quality Improvement Act of 2005
Patient Safety Organizations
ISMP Medication Errors Reporting Program
Pennsylvania Patient Safety Reporting Program
Operated by theInstitute for Safe Medication Practices
www.ismp.org
ISMP is a federally certified patient safety organization (PSO)
Other reporting programs
Maryland Patient Safety Center PSOPennsylvania Patient Safety AuthorityVHA Center for Patient Safety/NASANew York Patient Occurrence and Tracking System (NYPORTS) Oregon Patient Safety CenterMedMARx (medication errors)
Other government funded programs
FDA MedWatch
Web M and M(allows sharing of cases via Internet)
Medication Error Reporting System
Early warning system– Issue nationwide hazard alerts and press
releasesLearning– Dissemination of information and tools
Change– Product nomenclature, labeling, and packaging
changes, device design, practice issuesStandards and Guidelines– Advocates for national standards and guidelines
National Quality Forum Serious Reportable Events (SREs)
Errors in medical care that are clearly identifiable, preventable, and serious in their consequences Examples:– surgery on the wrong body part; – foreign body left in a patient after surgery;– mismatched blood transfusion; – major medication error; – severe “pressure ulcer” acquired in the hospital
National Quality Forum Serious Reportable Events (SREs)
Errors in medical care that are clearly identifiable, preventable, and serious in their consequences Problem in the safety and credibility of a health care facilityExamples:– surgery on the wrong body part; – foreign body left in a patient after surgery;– mismatched blood transfusion; – major medication error; – severe “pressure ulcer” acquired in the hospital
National Patient Safety Goals
The Joint Commission (TJC)Sentinel Event Reporting Program
“You can get much further with a kind word and a gun than you can with a kind word alone.”
Al Capone
JCAHO
NQF Safe Practices
Culture of safety
C+
The single greatest impediment to error prevention in the medical industry is “that we punish people for making mistakes.”
Lucian Leape
Safety Culture “sins”Focus on individualsHindsight biasReacting to emotional component of patient harmFailure to move beyond proximate causesBelieving there is a single root causeResponse confused with proactive risk management when actually reactiveTunnel vision (both causes and actions)Weak error reduction strategies
Culture of Safety
Errors not a measure of competencyManagement style– promote safety and “Just Culture”Value complainersReward patient safety and reportingEncourage story tellingVisible leadership (walk arounds) – medication safety officer
ISMP top things to do to improve safety
Be proactive, not reactive. Learn from experience of other organizations. Medication safety officer/team.Focus on unsafe practices/at risk behaviors (e.g., unlabelled containers, sharing insulin pens, abbreviating drug names, patient weight conversions, etc.)Implement technologies (smart pumps, bedside bar code scanning, follow automated dispensing cabinet guidelines, e-Rx, etc.)Standardize drug concentrations, units of measure, etc.Encourage error reporting – internal and external (see “ISMP Med Safety Alert! Pump up the volume – tips for increasing reporting. Feb 9, 2006 -http://www.ismp.org/Newsletters/acutecare/articles/20060209.asp
Just Culture - The Three Behaviors
Human Error
Product of our current system design
Manage through changes in:
• Processes• Procedures• Training• Design• Environment
Console
At-Risk Behavior
Unintentional Risk-Taking
Manage through:
• Removing incentives for At-Risk Behaviors• Creating incentives for healthy behaviors• Increasing situational awareness
Coach
RecklessBehavior
Intentional Risk-Taking
Manage through:
• Remedial action• Disciplinary action
Punish
Two Disconnected Conversations
No Blame Accountability
Criminal Charges for Medication Errors
ISMP top things to do to improve safety
Be proactive, not reactive. Learn from experience of other organizations. Medication safety officer/team.Focus on unsafe practices/at risk behaviors (e.g., unlabelled containers, sharing insulin pens, abbreviating drug names, patient weight conversions, etc.)Implement technologies (smart pumps, bedside bar code scanning, follow automated dispensing cabinet guidelines, e-Rx, etc.)Standardize drug concentrations, units of measure, etc.Encourage error reporting – internal and external (see “ISMP Med Safety Alert! Pump up the volume – tips for increasing reporting. Feb 9, 2006 -http://www.ismp.org/Newsletters/acutecare/articles/20060209.asp
Quality Issues
B+
Hand WashingTypical hand hygiene rates circa 1999: 20-30%Public reporting of / “no pay” for/?lawsuits for HAIs: tremendous push to improveMany organizations now at 40-70%, and stuck “It’s a Systems Problem”: Education, dispensers every 3 feetA systems problem? Really?
Wachter, Pronovost. NEJM 10/1/09
Patient safety technology
B
Do First Investment
Don’t Bother
Low
High
Impact
HighCost
CPOEBar-coding
Smart pumps
Automated ADE monitoring
Dedicated ICUPharmacist
Pocket drug reference
Preprinted order forms
Medication training
Limiting abbreviations
Drug-food interactions
Constraintson high alert drugs
Intervention database
Unit dose dispensing
(Courtesy David Bates)
Automated dispensing cabinets
Med Safety Officer
Robotic dispensing
Product safety
B
Examples of the Impact Medication Error Reporting
http://www.ismp.org/about/merpimpact.asp
US Food and Drug Administration
PDUFA IV –– Nomenclature testing– Package label requirements– Device safety– Patient safety news– FDA-ISMP Fellowship– Etc.
Division of Medication Error Prevention and Analysis (DMEPA)
Look-alike and Sound-alike Drug Names
Generic Name n %
Insulin* 386 11.3
Morphine* 164 4.8
Heparin* 120 3.5
Fentanyl* 98 2.9
Hydromorphone* 91 2.7
Warfarin* 88 2.6
Potassium Chloride* 69 2.0
Vancomycin 69 2.0
Enoxaparin* 60 1.8
Metoprolol Tartrate 42 1.2
Furosemide 41 1.2
Methylprednisolone 35 1.0
Meperidine* 33 1.0
Leading Products in Harmful Medication Errors
From MedMarx 2007 * = high alert
Problems associated with PCA
Patient selection, assessment and monitoringDrug product mix-upsHuman factors/design flawsStaff training, and competency assessmentOrder communication errorsPCA by proxyDevice-related issues
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Risk Evaluation and Mitigation Strategies (REMS)
Look-alike product labeling
Slide 43
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Current labeling
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TALLman LETTering
Considerations with color on labels
Potential for mix-ups within the class must be considered
Availability of medicines
D-
Drug Shortages
Clinical effects –Adversely affect drug therapy–Compromise or delay medical
treatment/procedures–Result in failure to treat and
progression of disease–Result in medication errors and
adverse patient outcomes
Drug ShortagesFinancial effects of shortages– Costly alternative medications for
provider and patient– Significant time spent on addressing
shortages– Additional costs associated with
treatment of adverse outcomes Emotional effects of shortages– Frustration, anger, mistrust– Strain professional relationships
Adverse patient effects due to drug shortage
Tubing Misconnections
Forthcoming ISO standards for “small bore” connectors
• ISO 80369-1 General Requirements• ISO 80369-2 Breathing Gas Systems• ISO 80369-3 Enteral Feeding• ISO 80369-4 Urological• ISO 80369-5 Limb Cuffs• ISO 80369-6 Neuraxial• ISO 80369-7 Vascular/Luer fittings
(formerly ISO 594)
This is not the end. It is not even the beginning of the end. But it is perhaps, the end of the beginning.