Adverse Drug Events
(ADEs)
Holli Temple, PharmD
Chief Pharmacy Advisor for the Partnership for
Patients Initiative through CMS
Clinical Assistant Professor
University of Texas at Austin College of Pharmacy
Definition of an ADE
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World Health Organization (WHO) definition
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An ADE is “noxious and unintended and occurs at
doses used in man for prophylaxis, diagnosis,
therapy, or modification of physiologic functions.”
WHO definition includes ADEs from medication
errors
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Med errors occur at any stage from ordering to
administering
Some ADEs are harmless, cause injury, or are “near
misses”
Definition of an ADE
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IHI Global Trigger Tool definition
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Harm is defined as “unintended physical injury
resulting from or contributed to by medical care
that requires additional monitoring, treatment or
hospitalization, or that results in death.”
IHI focuses on errors of commission (active
delivery of care) and excludes errors of omission
Includes all adverse events – whether
preventable or not
IHI tool measures harm over time
Measuring Harm from
Medications
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ADEs – single greatest risk of harm to
patients in hospitals
Voluntary reporting and tracking of med
errors
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Low yield – only 10-20% of errors are reported
Of those reported, 90-95% did not cause harm
Conventional method of sifting through the
medical record to uncover errors costly and
largely ineffective
Measuring Harm from
Medications
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National Coordinating Council for Medication
Error Reporting and Prevention (NCC MERP)
Error Categorization
Categories below do NOT cause harm
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Category A: capacity to cause error
Category B: error did not reach the patient
Category C: error reached the patient, no harm
Category D: error reached patient and required
monitoring or intervention to confirm that it resulted in
no harm to the patient
Measuring Harm from
Medications
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Categories below DO cause harm:
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Category E: temporary harm to patient;
intervention required
Category F: temporary harm to patient and
required initial or prolonged hospitalization
Category G: permanent patient harm
Category H: intervention require to sustain life
Category I: patient death
ADE Triggers
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Before starting chart review, team to agree
on list of medication related triggers to review
at your hospital.
Example triggers:
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M1: C. Diff positive stool
M2: PTT greater than 100 seconds
M3: INR greater than 6
M4: Glucose less than 50 mg/dl
ADE Triggers
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M5: Rising BUN or serum creatinine 2x over
baseline
M6: vitamin K administration (Aqua-mephyton®,
Mephyton®, phytonadione)
M7: diphenhydramine (Benadryl®) administration
M8: flumazenil (Romazicon®) administration
M9: naloxone (Narcan®) administration
M10: anti-emetic administration ondansetron
(Zofran®), promethazine (Phenergan®)
ADE Triggers
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M11: over-sedation/hypotension
M12: abrupt medication stop
M13: Other
Trigger yield (from Rozich study):
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anti-emetic use most numerous -- ~ 7% of ADEs
abrupt medication stop accounted for ~ 35% of
ADEs
most common: anticoagulants, sedatives, pain
medications, antibiotics, insulin
Identifying and Measuring
ADEs
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Form multi-disciplinary team – at least 3
people
Decide on list of triggers for your facility
Review trigger tool; each chart review
requires its own form whether or not an ADE
is identified
Identifying and Measuring
ADEs
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Random sample of 10 patient charts every 2
weeks
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Obtain a few extra in case those selected do not
match criteria for evaluation
Records need to be:
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Closed and complete
Inpatients with LOS at least 24 hours
Patient age 18 years or older
Exclude inpatient psych and rehab patients
Identifying and Measuring
ADEs
Where to look?
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Discharge summary – may include
adverse events
Medication Administration Record (MAR)
Laboratory results
Prescriber orders
Nursing notes
Physician progress notes
Identifying and Measuring
ADEs
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If time permits, review other areas of record
(e.g. H&P, ED report)
Set a 20 minute limit for each chart reviewed
(after training completed)
An ADE is defined as unintended harm to a
patient (from the patient’s viewpoint)
Would you be happy if event happened to
you? If not, likely an ADE
Identifying and Measuring
ADEs
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Systematically/selectively review portions of
the chart where the triggers are most likely
found
If trigger found, review portion of chart that
will reveal whether or not an ADE occurred
If harmful event found, determine level of
harm (E – I) and briefly describe ADE
Use professional judgment to make
determination
Identifying and Measuring
ADEs
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Complete ADE Patient Record Review Sheet
for the sampled charts
Summarize findings in the ADE Monthly
Summary Sheet
For each chart reviewed, document
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Whether or not an ADE occurred
Number of ADEs
Total number of medication doses received
(optional)
Outcome
Measures/Calculations
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Percent of Admissions with an ADE
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Total N# with ADE from sample/total N# of
records in sample
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If a patient experienced more than one ADE, only count
that patient once in the numerator.
ADEs per 1000 doses
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Total N# of ADE from sample/total N# of
medication doses administered to the patients in
the sample
Outcome ADE Measures
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We will track your measures (Percent of
Admissions with an ADE and ADEs per 1000
doses) over time in a run chart
http://www.ihi.org/knowledge/Pages/Tools/RunChart.aspx
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Are changes to processes making medication
use safer in the hospital? Graph results to see if
improving
Tools available on IHI.org
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Trigger Tool for Measuring ADEs –
http://app.ihi.org/Workspace/tools/trigger/Cre
ateTool.aspx
Improvement Tracker available for use -http://app.ihi.org/Workspace/tracker/CreateTracker.a
spx?MeasureId=606
Tools available on IHI.org
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Other trigger tools available
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ICU Adverse Event Trigger Tool
Pediatric Trigger Toolkit: Measuring ADEs in the
Children’s Hospital
Trigger Tools for Measuring ADEs in the Nursing
Home
Questions?