Pharmacovigilance involves monitoring medical substances to watch for adverse effects. It aims to understand drug safety risks and effectiveness based on evidence beyond clinical trials. Pharmacovigilance classifies adverse drug reactions and assesses causality between drugs and adverse events to enhance public health. Adverse drug reactions are unintended harmful responses to drugs, while adverse drug events may lack identified causality. Multiple sources can report adverse events to further pharmacovigilance activities.
4. Basic Terminologies
for
Pharmacovigilance
Co-Suspect Drug
Drug taken along with suspected drug and results in an adverse event.
Concomitant Drug Drug taken along with suspected drug.
Past Drug Drug stopped before starting of the suspected drug.
Suspect Drug
A drug which is associated with adverse drug reaction
5. What is Pharmacovigilance ?
As per the WHO, Pharmacovigilance is
defined as the “ Science and activities
relating to the assessment, detection,
understanding and prevention of adverse
effects or any other possible drug-related
problem”.
6. Needs & Aim of Pharmacovigilance
Lack of Evidence for
safety from Clinical
Trials
To understand the risk
and effectiveness of
drug
To enhance public
health and safety
Assist the rational
use of medicines
To enhance patient
care and Safety
7. Adverse Drug
Reaction
Any unintended and noxious response to a
active pharmaceutical ingredient or a drug at
any particular or a specified dose is termed
as Adverse Drug Reaction.
8. Severe Adverse Drug
Reaction
Severe Adverse Drug Reactions (ADRs) are a
huge wellbeing trouble as characterized as
responses to any portion of a medication that
outcome in death, are dangerous, require
hospitalization or prolongation of existing
hospitalization and may lead to death
9. Classification of ADRs
Type A - Augmented
Type B - Bizzare
Type C - Chemical
Type D - Delayed
Type E – Exit/End of
Treatment
Type F - Familial
Type G -
Genotoxicity
Type H -
Hypersensitivity
Type U -
Unclassified
10. Adverse Drug
Event
Any untoward medical occurrence which
happens to either a patient or subject in a
clinical investigation when an active
pharmaceutical ingredient is been
administered by a patient.
11. What is Causality ?
It can be termed as a relationship
between suspected drug and its
adverse drug event.
12. ADR vs ADE
One who finds the
causality for adverse
occurrence is adverse
drug reaction.
One who fails to find
the causality for
adverse occurrence is
adverse drug event.
13. Sources of Adverse
Event Reports
Solicited
Reports
Market
Surveys
Medical Chart
Reviews
Continuous
Reporting
Patient
Registries
