Serious Adverse Events& Reporting

Victoria WildeDrug Safety Assistant

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

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

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)

Pharmacovigilance inbox - screenshot

Pharmacovigilance - process

• All events checked by the PV team

• Reporting

• Events coded using MedDRA

• Further information requests

• Further information forwarded

ReportingThe 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.

“Intrepid carcinoma left wrist lesion, ongoing from ?patch impetigo left thenar eminence and wrist”

“Menia”

“SCC/Yca” “Histology shows an area of invasive squamous cell carcinomna (left lower leg) which is well differentiated. SCC Excised and skin grafted”

“Ovarian cyst requiring hospitalisation and IV antibiotics”

“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.”

Examples

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

Exceptions to the 90 Day Rule

• Pregnancy - Send to all applicable companies

• Malignancy - Send to all applicable companies

• Death - Send to last company

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

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

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

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

Structural Hierarchy of the MedDRA Terminology

System Order Class

High Level Group Term

High Level Term

Preferred Term

Lowest Level Term (LLT)

(PT)

(HLT)

(HLGT)

(SOC)

Structural Hierarchy of the MedDRA Terminology

System Order Class

High Level Group Term

High Level Term

Preferred Term

Lowest Level Term

Myocardial infarction

Heart attack

Ischaemic coronary

artery disorders

Coronary artery disorders

Cardiac Disorders

MedDRA coding issuesExample: Chest Pain

Lowest Level Term Chest Pain

High Level Group Term

Ischaemic coronary artery disorders

Pain and discomfort NEC

Respiratory signs and symptoms NEC

Final Points

• Receipts/ Monthly reconciliation lists• Monthly pharmacovigilance meeting

SAFETY MONITORING IN BADBIR

BADBIR database

Clinical data

NHS IC register

•Coded to MedDRA•SAEs reported as

required to appropriate company

Serious adverse events

•Coded to MedDRAAdverse events

BADBIR safety monitoring

team

Safety signal?

DMC

BADBIR analysis comparing rates

Convey findings to

dermatology community

Safety signal?