1. Željana Margan Koletić, HALMED
SCOPE Joint Action Stakeholder Event
Medication errors
Coding of medication errors
Željana Margan Koletić, HALMED
March 2017
London

2. Contents
Introduction
Workshop/Discussion
Conclusion

3. Introduction

4. Topic 1a Medication errors
Among 16 questions, there was one asking NCAs when they code ME(s)
Possible answers* were:
If specified in ADR report
When the ADR is reviewed/assessed
We do not code ME(s)
Other, please specify
Our institution is not responsible for this activity (if applicable).
*multiple choice possible
20/28 MSs

5. Workshop – what to expect
”ICSR assessor”
Case narratives
SmPC extract
Answer the question (voting tool sli.do):
What would you code in the ‘reaction’ field?

6. Workshop - what not to expect
MedDRA training (e.g. choosing the right MedDRA term (LLT))
Training on EMA’s Good practice guide on recording, coding, reporting and assessment of medication errors (and other relevant guidance)

7. Workshop objectives
Raise awareness about coding practice across the EU
Start root cause analysis
Ensure correct data is submitted
Ensure practice is aligned across MSs

8. Workshop
Go to
Enter code:

9. Case no. 1 Case narrative:
After 10 minute infusion, patient experienced severe infusion reaction. He received 20/56 mg/m2 dose instead of 20/27 mg/m2 dose.
SmPC - Section 4.2 Method of administration
Drug is to be administered by intravenous infusion. The 20/27 mg/m2 dose is administered over 10 minutes. The 20/56 mg/m2 dose must be administered over 30 minutes.
What would you code in ‘reaction’ field of the report?
Infusion related reaction
Infusion related reaction, wrong dose administered
Infusion related reaction, incorrect drug administration duration
Infusion related reaction, wrong dose administered, incorrect drug administration duration

10. Case no. 2 Case narrative:
After 10 minute infusion, patient experienced severe infusion reaction. He received 20/56 mg/m2 dose instead of 20/27 mg/m2 dose. The reporter stated that the nurse was not aware of the need for longer duration of the infusion.
SmPC - Section 4.2 Method of administration
Drug is to be administered by intravenous infusion. The 20/27 mg/m2 dose is administered over 10 minutes. The 20/56 mg/m2 dose must be administered over 30 minutes.
What would you code in ‘reaction’ field of the report?
Infusion related reaction
Infusion related reaction, wrong dose administered
Infusion related reaction, incorrect drug administration duration
Infusion related reaction, wrong dose administered, incorrect drug administration duration

11. Case no. 3 Case narrative:
Patient was hospitalized due to GI bleeding. He was taking warfarin for AF. At the discharge, the he was prescribed fluconazole for urinary infection and treatment with warfarin was continued. The patient was hospitalized again due to macrohaematuria and INR > 30. At the discharge it was recommended to continue warfarin therapy. Within 7 days from discharge, the patient died.
The reporter stated that it is unknown to him if fluconazole was taken and that the patient was overdosed with warfarin.
SmPC – Section 4.3
(…) Clinically significant bleeding
SmPC – Section 4.5
Drugs which are known to interact with warfarin in a clinically significant way - drugs which potentiate the effect of warfarin: (…) azole antifungals (ketoconazole, fluconazole, etc.)
What would you code in ‘reaction’ field of the report besides GI bleeding, macrohaematuria and INR increased?
Drug prescribing error (because fluconazole was prescribed)
Drug prescribing error (because warfarin was continued)
Labelled drug - drug interaction
Drug overdose
Patient died

12. Discussion SCOPE results
Out of 20* MSs that code ME when ADR report is review/assessed
11 code even if it is not specified in the report
5 code only if it is specified in the report
2 code into section “Sender’s comment”
*1 MS did not provide response; 1 MS was not full involved in SCOPE

13. Difference among MSs in number of MEs
”Unreal” picture of routine clinical practice
Impact signal detection process
Unnecessary development of minimisation measures
Impact risk communication
Additional workload for PV staff

14. Existing guidance MedDRA Term Selection: Points to Consider (MTS:PTC)
“Do not infer that a medication error has occurred unless specific information is provided. This includes inferring that extra dosing, overdose, or underdose has occurred“.
EMA Guide (2015)

15. Off label use, misuse, etc.
Take home messages
ICSR
Unintended ME
Intended
Off label use, misuse, etc.
Follow-up
Do not infer!
Sender’s
comment/diagnosis
Flag

17. Contact: zeljana.margan@halmed.hr
Questions?
Contact: