Adverse Drug Event Reporting Pharmacy Department Dale Tucker, RPh, BCPS Detroit Medical Center Last...

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