Željana Margan Koletić, HALMED SCOPE Joint Action Stakeholder Event Medication errors Coding of medication errors Željana Margan Koletić, HALMED 20 - 21 March 2017 London

Contents Introduction Workshop/Discussion Conclusion

Introduction

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

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?

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)

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

Workshop Go to http://sli.do Enter code:

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

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

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

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

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

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)

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

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