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

2. Overview 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

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
In this example, this has not been ticked as being an ESI. However it is a Psoriasis flare so we would ask for an ESI form for this.

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”
“Menia”
“Ovarian cyst requiring hospitalisation and IV antibiotics”
“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
to clinician
Diagnosis
Outcome
Confirm date/biologic if unknown
Causality
Events of Special Interest (ESI) forms
gather event specific information
E.g. – clinician twice, one month apart. Then call. ESI forms come from the website. Specific events which are relevant to biologics

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
MedDRA is now the internationally accepted coding dictionary for use by all international regulatory authorities and drug companies It was devised to increase consistency in adverse event reporting between different countries

15. Structural Hierarchy of the MedDRA Terminology
System Order Class
(SOC)
High Level Group Term
(HLGT)
High Level Term
(HLT)
MedDRA provides a hierarchy of 5 levels of groups of medical terms into which an Adverse Event can be classified. Each level is linked to the one above and below. The medical terms in the groups at the lower end of the hierarchy are very specific descriptors of the adverse event. The ones at the top include the adverse event in groups of medical terms which are very general.
Every Adverse Event is entered at the LLT. This represents the event as reported by the patient or nurse eg heart attack
Each LLT is linked by MedDRA to ONE PT. This represents the medical term for the event. Eg myocardial infarction
Preferred Term
(PT)
Lowest Level Term
(LLT)

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

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

19. SAFETY MONITORING IN BADBIR