4. Why do you need Pharmacovigilance
Humanitarian concern
ADR May cause sudden death
Promoting rational use of
medicine & adherence
Ethics
To know something that is harmful to another
person who does not know.
PHARMACOVIGILANCE
6. ADVERSE DRUG
REACTION (ADR)
• A response to a medicine which is noxious and unintended, and which occurs at doses
normally used in man.
ADVERSE DRUG
EVENT (ADE)
• Any unwanted medical occurrence that may present during treatment with a medicine but
which dose not necessarily have a causal relationship with this treatment.
UNEXPECTED
ADVERSE DRUG
REACTION
• An adverse reaction, the nature or severity of which is not consistent with domestic labelling
or market authorization, or expected from characteristics of the drug.
SERIOUS
ADVERSE DRUG
EVENT/ REACTION
• Results in death
• Require inpatient hospitalization or prolongation of existing hospitalization
• Result in persistent or significant disability
• Is life-threatening
Common terminologies of Pharmacovigilance
7. Detecting and reporting
ADR’s
Other methods for
collecting ADR
Spontaneous
reporting
Mandatory
reporting
Comparable observational studies Active surveillance
18. References
Global Pharmacovigilance
- UMC & WHO programs for international drug monitoring
ICH E2E Guideline
Pharmacovigilance Wikipedia
pharmacovigilance program in Bangladesh