The document is a presentation by Mohit Pandey on adverse drug reactions (ADRs) in the context of pharmacovigilance for his Master of Pharmacy degree. It discusses definitions of ADRs, the importance of adverse event reporting, and methodologies for post-marketing surveillance including cohort and control studies. It also outlines the assessment of seriousness and terminologies related to ADRs, providing guidelines for reporting and evaluation of adverse events.

1. MOHIT PANDEY
TEERTHANKER MAHAVEER COLLEGE OF PHARMACY
TMU, MORADABAD
ADVERSE DRUG REACTION
A
PRESENTATION
CLINICAL RESEARCH AND PHARMACOVIGILANCE
COURSE CODE :- MPL204T
FOR PARTIAL
FULLFILMENT OF
MASTER OF PHARMACY
(PHARMACOLOGY)
PRESENTED BY:-
MOHIT PANDEY
M.PHARM 2 SEM
(PHARMACOLOGY)
PRESENTED TO:-
Dr. MAYUR PORWAL
ASSOCIATE PROFESSOR
PHARMACOLOGY

2. According to WHO “A response to a drug that is
noxious and unintended and occurs at doses normally
used in man for the prophylaxis, diagnosis or therapy
of disease, or for modification of physiological
function”.
Noxious means :- injurious or harmful
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Pre-Marketing surveillance Post-Marketing surveillance
Phase-1
Phase-2
Phase-3
Spontaneous ADR Reporting
Epidemiological methods
Case Control Cohort Studies
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Post-Marketing surveillance
 Pharmacovigilance methodologies are used for detection of risk and for the collection of risk information.
 Two epidemiological methods are most commonly used which are:
COHORT STUDIES :- Patient exposed to a particular drug and are followed up actively and
systematically then the ADR frequencies are compared to an unexposed control population.
CONTROL STUDIES :- Individual affected by the adverse event being studied are identified. Each
case is matched with several disease ,both cases and controls are investigated their exposure to
possible causative agents prior to occurrence of the event. The odd ratio calculated on the basis of
exposure data.
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 Any undesirable adverse event suspected
to be associated with use of drug,
biological product, herbal
drugs,cosmetics,medical devices, should
be reported.
 All ADRs as a result of prescription or non
prescription.
 All suspected ADR regardless of whether
or not the product was used in accordance
with the product information provided by
the company marketing the product.
 Patient information.(confidential manner)
 Description of adverse reactions
(laboratory results, if available are to be
included).
 Information related to the suspected
drug(s).
 Information about how the adverse
reaction had been managed.
 Information about the reporter.

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WHO-UMC (Uppsala Monitoring Centre)
National Coordination centre (NCC)
IPC,Ghaziabad
ADR Monitoring Centre (AMC)
Healthcare professionals, patients and other
FIG.- ADR REPORTING PROCESS
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Source:- Pharmacovigilance Programme of India (ipc.gov.in)

9. Seriousness
Seriousness of an ADR is refers to its life threatening nature and is defined as
“Any untoward reaction to the medicinal product that may result in death, requires
inpatient hospitalization or results in prolongation of existing hospitalization,
results in persistent or significant disability/incapacity, is a congenital
anomaly/birth defect, or is a medically important event or reaction.”
untoward :- unexpected
Severity
The term “Severe or severity” is often used to describe the intensity of a specific
medical event ( graded as in mild,moderate,severe or lethal).
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Seriousness Assessment
Seriousness of reaction is categorized according to FDA criteria on the basis of their life
threatening nature.
• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability or permanent Damage
• Congenital Anomaly/Birth defect
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TERMINOLOGIES IN ADR
ADVERSE DRUG
REACTION:- Any noxious
change which is
suspected to be due to a
drug, occurs at doses
normally used in man,
requires treatment or
decrease in dose or
indicates caution in future
use of the same drug.
ADVERSE DRUG EVENT:-
Any untoward medical
occurrence that may
present during treatment
with a pharmaceutical
product but which does not
necessarily have a causal
relationship with this
treatment.
SIDE EFFECT:- This
refers to any known
effect of a
pharmaceutical
product occurring at
normal dosage which
is related to the
pharmacological
properties of the drug.
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1. Petrova G, Stoimenova A, Dimitrova M, Kamusheva M, Petrova D, Georgiev O.
Assessment of the expectancy, seriousness and severity of adverse drug reactions reported
for chronic obstructive pulmonary disease therapy. SAGE open medicine. 2017 Jan
31;5:2050312117690404.
2. Pharmacovigilance Programme of India (ipc.gov.in)

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