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Serious Adverse Events

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Presentation on theme: "Serious Adverse Events"— Presentation transcript:

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


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