Scribd
Upload
43 views16 pages

Definitions: - Pharmacovigilance - Adverse Event - Adverse Reaction

This document defines key terms related to pharmacovigilance including adverse events, adverse reactions, side effects, and signals. It discusses organizations involved in pharmacovigilance like WHO, CIOMS, and ICH. Pharmacovigilance is defined as the science relating to detection, assessment, understanding and prevention of adverse effects from drugs. Serious adverse events that require hospitalization or lead to disability or death must be reported. Causality is assessed as certain, probable, possible, unlikely or unclassified/unassessable depending on the available information.

Uploaded by

Ramaiyan Dhanapal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
43 views16 pages

Definitions: - Pharmacovigilance - Adverse Event - Adverse Reaction

This document defines key terms related to pharmacovigilance including adverse events, adverse reactions, side effects, and signals. It discusses organizations involved in pharmacovigilance like WHO, CIOMS, and ICH. Pharmacovigilance is defined as the science relating to detection, assessment, understanding and prevention of adverse effects from drugs. Serious adverse events that require hospitalization or lead to disability or death must be reported. Causality is assessed as certain, probable, possible, unlikely or unclassified/unassessable depending on the available information.

Uploaded by

Ramaiyan Dhanapal
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 16

1

Definitions
Pharmacovigilance
Adverse event
Adverse reaction
Unexpected adverse reaction
Serious adverse reaction
Side effect
Signal
Causality
2
Definitions
Organisations involved:
WHO - World Health Organization
CIOMS - Council of International
Organizations of Medical Sciences
ICH - International Conference on
Harmonisation
3
Pharmacovigilance
WHO, 2002
The science and activities relating to
the detection, assessment,
understanding and prevention of
adverse effects or any other drug-
related problem
4
Adverse event
Medical occurrence temporally
associated with the use of a medicinal
product, but not necessarily causally
related
5
Adverse reaction
WHO, (1972)
'A response to a drug which is noxious
and unintended, and which occurs at
doses normally used in man for the
prophylaxis, diagnosis, or therapy of
disease, or for the modifications of
physiological function'.
6
Unexpected adverse reaction
Not consistent with applicable product
information or characteristics of drug.
7
Side effect
Unintended effect occurring at normal
dose related to the pharmacological
properties
8
Signal
Possible causal relationship adverse
event and drug
Previously unknown or incompletely
documented
More than one report is needed.
Depending on:
Quality of the information
Seriousness of the event
9
Serious adverse event or
reaction
Any untoward medical occurrence that
at any dose;
Results in death
Life threatening
Requires inpatient hospitalization or
prolongation of existing hospitalization
Results in persistent of significant disability
or incapacity
10
Frequency of adverse drug reactions
(CIOMS)
Very common
Common (frequent)
Uncommon (infrequent)
Rare
Very rare
>= 1/10
> = 1/100 and < 1/10
>= 1/1000 and < 1/100
>= 1/10000 and <
1/1000
< 1/10000
11
Certain
Event or laboratory test abnormality, with plausible
time relationship to drug intake
Cannot be explained by disease or other drugs
Response to withdrawal plausible (pharmaco-
logically, pathologically)
Event definitive pharmacologically or
phenomenologically (An objective and specific
medical disorder or a recognised pharmacological
phenomenon)
Rechallenge (if necessary)
Drug Safety 1994;10:93-102
12
Probable
Event or laboratory test abnormality, with
reasonable time relationship to drug intake
Unlikely to be attributed to disease or other
drugs
Response to withdrawal clinically
reasonable
Rechallenge not necessary
13
Possible
Event or laboratory test abnormality, with
reasonable time relationship to drug intake
Could also be explained by disease or other
drugs
Information on drug withdrawal lacking or
unclear
14
Unlikely
Event or laboratory test abnormality, with
a time to drug that makes a relationship
improbable (but not impossible)
Diseases or other drugs provide plausible
explanations
15
Conditional / Unclassified
Event or laboratory test abnormality
More data for proper assessment needed
Or additional data under examination
16
Unassessable / Unclassifiable
A report suggesting an adverse reaction
Cannot be judged because of insufficient or
contradictory information
Report cannot be supplemented or verified

You might also like