The Role of Medication Safety Research in Evidence-Informed Practice Development,...
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The Role of Medication Safety Research in Evidence-Informed
Practice Development
Matthew Grissinger, FISMP, FASCP
Director, Error Reporting Programs
Institute for Safe Medication Practices
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Pidetty Potilasturvallisuuspäivillä Helsingissä 18.3.2013
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ISMP Medication Errors
Reporting Programs
Pennsylvania Patient Safety Reporting Program
Operated by
The Institute for Safe Medication Practices A federally-certified Patient Safety Organization
(PSO)
www.ismp.org
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MERP Process
• Report sent to ISMP
– Follow-up with reporters for causality
and validation for select cases
– Receive supporting material
• Scanned orders
• Pictures of products
– Entered into database
– Forward to FDA and manufacturer
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http://patientsafetyauthority.org/ PA-PSRS (Pennsylvania Patient Safety Reporting System)
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Patient Safety Provisions
• Establishment of Patient Safety Authority
– Non-regulatory
• Mandates medical facility patient safety
plans
• Provides for confidentiality of information
• Identifies procedures for reporting medical
errors and written notification to patients
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© ISMP 2012
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www.patientsafetyauthority.org
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Recent Advisory Topics
• Adverse Drug Events with HYDROmorphone:
How Preventable are They?
• Medication Errors with the Dosing of Insulin:
Problems across the Continuum
• Medication Errors in Labor and Delivery:
Reducing Maternal and Fetal Harm
• Neuromuscular Blocking Agents: Reducing
Associated Wrong-Drug Errors
• Medication Monitoring Errors: Inappropriate
Levofloxacin Doses
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High Alert Medications
• 25% of all medication error reports
involved a high-alert drug
– 44% involved pain management medications
including morphine, hydromorphone,
meperidine and fentanyl.
– 16.3% involved insulin products.
– 14.2% involved heparin.
– 9.4% involved warfarin (COUMADIN®).
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32% of all wrong drug errors did not list
the second drug in the report
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9.7% of Medication Error reports
are classified as “other”
Other?
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What else we’ve seen….
• Of the 15,511 reports submitted in December
2006,
– 72.4% of the reports had no contributing factor
selected
– The event detail in 24% reports contained 20 or
fewer characters
• Of the 6,937 serious event reports in 2006, 13%
contained 116 characters or less in the event
detail (this bullet contains 117 characters)
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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx
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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx
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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx
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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Mar6(1)/Pages/10.aspx
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Using Adverse Drug Reaction (ADR)
Reports to Identify Medication Errors
• PSA analysts reviewed ADR reports submitted to
the Authority to determine if there were cases
that may have been preventable
• Greater than a 1 mg dose for the general adult
population for an opioid-naïve patient
• 1 mg or greater for an elderly patient who was opioid-
naïve
• Multiple opioids
• There were 937 ADR reports submitted to the
Authority between June 2004 and October 2009
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www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/69.aspx
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Adverse Drug Reaction (ADR) Reports
Mentioning HYDROmorphone
• Of the reported CNS and respiratory adverse
reactions, (65%, n=292) appear to have been
preventable events, in which
– Opiate naive patients received a dose in excess of what
would be needed to resolve pain symptoms
– HYDROmorphone was prescribed and administered
with other medications that would lead to additive
sedative effects
www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/69.aspx
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• Nurses reported more ADEs through voluntary
IRs than pharmacists, parents/patients, medical
staff combined.
Kunac DL, Reith DM. Preventable medication-related events in hospitalized children in New
Zealand. N Z Med J. 2008; 121:17-32.
Figure 1 from Kunac et al.6
Who Reports Medication Errors?
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Voluntary Reporting
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© ISMP 2012
Studies of medical services suggest that only
1.5% of all adverse events result in an
incident report.
O'Neil A,. Ann Intern Med 1993;119:370-376
“We found that less than 4% of all adverse
drug events involving use of rescue drugs
were reported.”
Schade, Am J Med Qual. 2006 Sep-Oct;21(5):335-41
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Problems with Quantitative Reporting
• Quality of reports
• Competing programs
• Fear of punitive action
• Follow-up
• A reporting program alone does not
improve patient safety
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Factors that Inhibit Reporting
• Lack of a clear definition of a medication
error
• Insufficient information collected
• Failure to improve the medication system
or address reported issues
• Lack of feedback to staff
• Complex reporting process
• Fear of punishment or ridicule
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Medication Error Reporting Forms
• Too much emphasis on front line staff to
fill out the entire form
• Unrealistic expectations of what staff will
know
• Who is going to follow-up?
• Which reports do we put time into further
investigation?
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Ineffective Error Measurement
• Total reliance only on spontaneous reporting
• Analysis
– Lack of identifying root causes of errors
• Internal aggregate data – Focus on error rates
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0
5
10
15
20
25
30
35
January February March April May June
Wrong Drug Wrong Dose Wrong Patient
“Trending” of Error Reports
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Aggregated Data
• Shows interesting trends
• Better for global evaluation
• No detail to work with
• Cause unclear at the macro level
• Potential false conclusions
• What really happened?
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Risk Identification in Healthcare
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© ISMP 2012
The detection of a potential or actual
problem associated with patient care
Recognizing variations in process or
expected outcomes which may or may not
involve patient harm
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Methods of Data Collection • Proactive Risk Assessment
– Self Assessments
– Failure Mode and Effects Analysis (FMEA)
– External Sources of Data
– Walkrounds™
– Staff Meetings, Safety Briefs
• Concurrent Risk Assessment
– Pharmacy Interventions (clinical or dispensing staff)
– Nursing Interventions
– Triggers and Markers
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Methods of Data Collection
• Retrospective Risk Assessment
– Observational methodology
– Data from technology
– Chart reviews
– Internal, voluntary reporting
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© ISMP 2012
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PA HEN Opioid
Knowledge Assessment
• Types of questions
– Opioid-naïve vs. opioid-tolerant patients
– Long-acting opioids
– Equianalgesic dosing
• HYDROmorphone dosing
– Patient-specific conditions requiring a lower
starting dose of opioids
– Concomitant medications
– Monitoring the effects of opioids
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Opioid Tolerant
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0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Overall
Doctors
Residents
PA/NP
Nurses
Pharmacists
% Answering Correctly
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Pharmacist Interventions
• Order interventions
– Dose adjustment for antibiotic therapy
based on current laboratory values
• Computer screening and alerts
– Patient information
– Lab information
– Drug database
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Process Measures
• Are you hospitals performing processes
as expected?
• Measuring the rate of compliance
• Does not tell you “why” they didn’t follow
process
– “Didn’t follow policy and procedure”
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Process Measures
• Phone calls to obtain weights / Patients
on IV heparin/enoxaparin
• Phone calls to clarify aminoglycoside
dosing / New orders for
aminoglycosides
• Patients assessed for opioid status /
Patients prescribed opioids
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Triggers • An easily identifiable, focused item
representing an opportunity (or clue)
that may lead to an adverse event
• Medications, laboratory tests, patient
conditions
• “Something went wrong”
• Effective method for measuring the
overall level of harm
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Medication “Triggers”
Triggers
• Antihistamines
• Epinephrine
• Dextrose 50%
• Glucagon
• Naloxone
• Vitamin K
• Protamine
Possible ADE
• Allergic reactions
• Allergic reactions
• Hypoglycemia
• Hypoglycemia
• Narcotic overdose
• Warfarin misuse
• Heparin misuse
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Triggers
• INR more than 6
• PTT greater than 100 seconds
• Blood glucose more than 300 or
less than 50
• STAT medications or labs
• Oversedation events (RST calls)
• Patient falls
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Outcome Measures
• Measuring the rate of harm
– Naloxone use / Patients administered
opioids
– Patients with BG <70 / Patients on insulin
– Patients with INR >6 / Patients on warfarin
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Alternatives to Error Reporting for
Research Purposes
• Triggers
• Tracking of pharmacist interventions
• Focused audits/checks
• Errors detected and averted by automation
• Preparation variances
• Direct observational methods
• Must be a consistent process over time to be
useful as a measure
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Questions?