Pharmacovigilance involves monitoring the safety of drugs on the market. It is important for improving patient care and safety, as shown by the thalidomide tragedy. Key aspects of pharmacovigilance include timely reporting and assessment of adverse drug reactions and signals to identify relationships between drugs and side effects. Causality assessment tools are used to evaluate reported adverse events and determine if the drug likely caused the reaction. Pharmacovigilance systems help manage this process from case intake to reporting.

1. D.DIVYA
M. Pharmacy

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)

7.  Miscellaneous
1) Jarisch – herxheimer reaction
2) Infectious mononucleosis

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

12.  Identifiable patient
 Suspected drug
 Suspected event
 Report information

13. 1) Naranjo scale
2) WHO-UMC scale
3) Hartwig and Seigels scale

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.