Serious Adverse Events & Reporting Victoria Wilde Drug Safety Assistant

1. Serious Adverse Events & Reporting Victoria Wilde Drug Safety Assistant

2. 1. What is a serious adverse event? (SAE) 2. Where does our event information come from? 3. How do we process an SAE? 4. MedDRA coding 5. Final points Overview

3. An event is serious if it results in... • Death • Hospitalisation/prolonging an existing hospitalisation • Significant loss of function or disability • Congenital malformation • Life threatening in any way • IV antibiotics/anti-fungals/anti-virals

4. Where does adverse event data come from? • From data which has been entered at follow-up onto the live system (including patient diaries) • From the NHS IC (deaths and malignancies)

5. Pharmacovigilance inbox - screenshot

6. Pharmacovigilance - process • All events checked by the PV team • Reporting • Events coded using MedDRA • Further information requests • Further information forwarded

7. Reporting The following information must be present in order to report an event: • Legible & recognised disorder/signs/symptoms (bad examples: ‘thyroid’, ‘pt hospitalised’) • Date of event • Biologic therapy details at time of event This is to ensure that the event is reported to the correct company.

8. Examples “Attended GP (15/03/2011) with chest pain referred to Cardiac clinic. Diagnosis 1. Coronary Artery Disease. 2. Typical angina type II, referred for angiogram.” “Intrepid carcinoma left wrist lesion, ongoing from ?patch impetigo left thenar eminence and wrist” “Ovarian cyst requiring hospitalisation and IV antibiotics” • “Menia” “Histology shows an area of invasive squamous cell carcinomna (left lower leg) which is well differentiated. SCC Excised and skin grafted” “SCC/Yca”

9. Reporting • Biologic therapy at time of event decides which company an SAE is reported to • SAEs are reported whether they are considered to be related to the drug or not • If an event occurs after the patient has stopped a biologic we follow the 90 day guidelines

10. Exceptions to the 90 Day Rule • Pregnancy • Send to all applicable companies • Malignancy - Send to all applicable companies • Death - Send to last company

11. Requests for further information • Email to clinician • Diagnosis • Outcome • Confirm date/biologic if unknown • Causality • Events of Special Interest (ESI) forms • gather event specific information

12. Events of Special Interest (ESI) forms • Aplastic anaemia • Demyelination • Lymphoproliferative disease • Malignancy • Myocardial infarction • Pregnancy (Outcome) • Hepatic dysfunction • Congestive Heart Failure • Serious Infection • Tuberculosis (TB) • Surgery • ESIs without forms • Cerebrovascular accident • Pulmonary embolism • Misuse, abuse, overdose and medication error • Progressive Multifocal Leucoencephalopathy • Hypersensitivity

13. Follow Up Reporting • If/when we receive more information on an event, a follow-up report is sent • ESI received after initial report – sent along with a follow up report

14. MedDRA • Medical Dictionary for Regulatory Activities • Computer programme which allows individual adverse outcomes to be coded and stored on database in specific groups • These groups can be pulled out, cross referenced, counted and compared

15. Structural Hierarchy of the MedDRA Terminology System Order Class (SOC) (HLGT) High Level Group Term High Level Term (HLT) (PT) Preferred Term Lowest Level Term (LLT)

16. Structural Hierarchy of the MedDRA Terminology Myocardial infarction System Order Class Cardiac Disorders Coronary artery disorders High Level Group Term Ischaemic coronary artery disorders High Level Term Preferred Term Heart attack Lowest Level Term

17. MedDRA coding issues Example: Chest Pain Lowest Level Term Chest Pain Ischaemic coronary artery disorders High Level Group Term Pain and discomfort NEC Respiratory signs and symptoms NEC

18. Final Points • Receipts/ Monthly reconciliation lists • Monthly pharmacovigilance meeting

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