Transcript Adverse Drug Events July 2005

Adverse Drug Event Reporting
Pharmacy Department
Dale Tucker, RPh, BCPS
Detroit Medical Center
Last Updated July 2005 by Julie Berman (DRH), Albert Bajjoka (HVSH), May
Saba (CHM), Kim Tsilimingras (SGH), & Dale Tucker (HUH)
Goals and Objectives
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Goal: To orient the pharmacist to the
importance of reporting adverse drug events
(ADEs) in order to improve patient safety
through greater sharing of information via a
non-punitive reporting system.
Goals and Objectives
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Objective: To
familiarize the
pharmacist with the
process of reporting
adverse drug events into
Dr Quality, the DMC’s
on-line reporting
database, aka, the Risk
Prevention &
Management System
Adverse Drug Events (ADEs)
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These are any adverse outcome caused by
medication use
They can occur because of an action by a
physician, pharmacist, or nurse
Near-miss errors can happen. They are
considered adverse drug events even though
the medication did not reach the patient
Examples of Adverse Drug Events
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U for units read as an extra 0 for a dose of
insulin, i.e., 10 units misread as 100 units
Patient receives roommate’s medications
Drug prescribed as 1.0 mg is interpreted,
dispensed, and given as 10 mg
Patient develops ARF secondary to overdose
of aminoglycoside
Medication orders are labeled with the wrong
patient’s name
Reasons to Report Drug ADEs
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To improve patient safety
To improve processes to prevent future errors
To alert manufacturers in the case of previously
unknown or infrequent adverse events
To prevent or decrease the number of errors by
improving processes in medication ordering,
dispensing, administration, and monitoring
Reporting Follow-up
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Reports are evaluated by unit managers and
department supervisors
They record what follow-up measures were
undertaken and make suggestions to prevent
future incidents
Reviewed for consideration to send to the FDA
Risk Management follows trends closely
Important to Remember
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Reports are meant to be a non-punitive method
to look at systems and processes
Do report near-miss errors in order to increase
understanding as to the scope of the issue
Near-miss errors are ones that are identified
before the drug is sent or given to the patient
either in the pharmacy or on the hospital units
Adverse Drug Reactions
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Report unusual
reactions
Report usual
reactions when
serious
Report all reactions
to drugs new to the
market
Examples of Adverse Drug Reactions
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Patient develops HIT on LMWH
Patient develops a rash while on antibiotics
Patient on TMP/SMX develops increasing
serum creatinine
Patient on lisinopril develops angioedema
Patient on warfarin has to stop therapy
because of excessive bleeding
Accessing Dr Quality
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Choose “Dr Quality” icon from desktop
computer screen anywhere in the hospital, OR
From intranet web page, click on “Links”
Click on “Doctor Quality”
Enter email code and password
Click on “Enter DoctorQuality”
Use of Dr Quality
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Click on “Event
Entry”
Enter information in
prompt boxes and
click “Next” to go to
the next page
Starred items are
mandatory entries
Click on
Event
Entry
Choose the site
of the event
from drop
down menu,
then click on
next.
Enter the location of
the event from
the drop down
menu and the
date and time it
occurred. If not a
recent event,
leave the default
date and time;
click on next.
Indicate the type of
event from the
drop down menu,
then click on next.
Events may
involve patients,
employees or
visitors.
Indicate the medical record
number, the patient’s last
and first name, gender,
date of birth, room
number, and diagnosis.
From the drop down
menu choose the patient
care setting, then click
on next.
Choose your role and
the role of the
person who told
you about the
event from the
drop down menus,
then click on next.
Under the
Medication/
Infusion drop
down menu
indicate your
choice. If an
ADR, indicate
monitoring/drug
reaction, then
click on next.
In the second drop
down box, indicate
the most
appropriate
descriptor. For
example, if an
increase in INR
because of
Monistat, indicate
drug-drug
interaction, then
click on next.
Search for the name
of the drug
involved by
entering the first
three letters of the
generic name, then
click on next.
Choose the correct
drug from the drop
down menu, then
click on next.
Describe the details
of the event and
indicate a level of
impact, then click
on next.
Indicate physician
and witness
involvement if
known, then click
on next.
Indicate possible
contributing
factors from the
drop down menu
then click on next
Indicate any
recommendations
for improvement
and check the
verify accuracy
box then click on
next
Click on submit event
report to complete
the process
You can then do
another entry or
close Dr Quality
Use of Dr Quality
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A “Virtual Classroom”
may be accessed for
more complete
information on
entries into the Risk
Prevention and
Management System
which is Dr Quality
Conclusion
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Reporting of adverse drug events is the
responsibility of all health care personnel
Reporting of adverse drug events is to help
improve processes to prevent future errors and
improve patient safety
Reporting of adverse drug events is meant to
be non-punitive