Adverse Drug Event Reporting

1. 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)

2. 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.

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Adverse Drug Reactions • Report unusual reactions • Report usual reactions when serious • Report all reactions to drugs new to the market

10. 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

11. 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”

12. 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

13. Click on Event Entry

14. Choose the site of the event from drop down menu, then click on next.

15. 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.

16. Indicate the type of event from the drop down menu, then click on next. Events may involve patients, employees or visitors.

17. 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.

18. Choose your role and the role of the person who told you about the event from the drop down menus, then click on next.

19. Under the Medication/ Infusion drop down menu indicate your choice. If an ADR, indicate monitoring/drug reaction, then click on next.

20. 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.

21. Search for the name of the drug involved by entering the first three letters of the generic name, then click on next.

22. Choose the correct drug from the drop down menu, then click on next.

23. Describe the details of the event and indicate a level of impact, then click on next.

24. Indicate physician and witness involvement if known, then click on next.

25. Indicate possible contributing factors from the drop down menu then click on next

26. Indicate any recommendations for improvement and check the verify accuracy box then click on next

27. Click on submit event report to complete the process

28. You can then do another entry or close Dr Quality

29. 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

30. 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