2. Pharmacovigilance is the science and
activities relating to the detection,
assessment, understanding and prevention of
adverse effects or any other drug related
problems.
Importance:
Thalidomide tragedy----This is a lesson for
Drug Safety and Regulation.
3. Improve patient care and safety
Pharmacovigilance keeps track of any drastic
effects of drugs.
Improve public health and safety
Promoting education and training in
Pharmacovigilance.
4. Timely collection of data, recording and
notification
Appropriate assessments (data completeness,
seriousness)
Expedited and periodic reporting
Creates appropriate structures for
communication
PV use tools such as data mining and
investigation of case reports to identify the
relationship’s between drugs and ADR’s
5. Adverse event: according to ICH an AE is any
untoward medical occurance in a patient or
clinical investigation of a pharmaceutical
product and which does not necessarily have
a causal relationship between the drug and
adverse event.
Adverse reaction: A response to a drug which
is noxious and unintended and which occurs
at doses normally used in humans for the
prophylaxis diagnosis or therapy of disease
or for the modification of physiological
function.
6. Non immunological
1) Type A or predictable
2) Type B or Unpredictable
Immunological
1) Type I (Ig E mediated)
2) Type II (cytotoxic)
3) Type III (immune complex)
4) Type IV (cell mediated)
8. SAE: An SAE is defined by ICH as any
untoward medical occurrence at any dose
that need any of the following criteria.
Results in death
Life threatening
Requires patient in hospitalization or
prolongation of existing hospitalization
Results in persistent or significant disability
(permanent disability)
Ex: pancreas gland fail
congenital enamely or birth defects
9. Reported information on a possible causal
relationship which is being unknown or
incompletely documented previously.
Usually more than one report is required to
generate a signal.
Before signals are published they are first
clinically assessed by PV experts at UMC
10. There are 3 types of signals
1) Cinfirmed signals –-- causal relationship
between the drug and adverse event.
2) Refuted (false) signals---no causal
relationship
3) Unconfirmed signals---require further
investigation.
11. 1) Identifying Adverse drug reactions
2) Assessing the causality
3) Documentation of ADR
4) Reporting serious ADR to PV centers/ ADR
regulatory authorities
14. 1) Case receipt
2) Data verification and validity check
3) Duplicate search
4) Complete data entry
5) Coding the adverse events and drugs
6) Causality assessment
7) Expected assessment
8) Case narration
9) Quality Control
10) Report submission
15. ARIS global:
Leading pharmacovigilance and clinical safety
system
Manage adverse event reporting and adverse
reaction
Applicable for vaccines, biologics, devices.
Flexible and scalable
Can be used by small companies and large
organizations.
16. PvNET:
Supports to segregate data entry, scientific
assessment.
Extensive data validation and cross validation
checks.
MedDRA version management
Covers full spectrum of developing good
safety report.
ARGUS:
Manage data from multiple sources.
Access flexible drug safety databases.