Date post: | 15-Dec-2015 |
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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 - 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
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?