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Adverse Drug Event Reporting
Pharmacy DepartmentDale 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
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
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)
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
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
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
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
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
Report unusual reactions
Report usual reactions when serious
Report all reactions to drugs new to the market
Examples of Adverse Drug Reactions
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
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
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
A “Virtual Classroom” may be accessed for more complete information on entries into the Risk Prevention and Management System which is Dr Quality
Conclusion
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