Professional Documents
Culture Documents
Pharmacovigilance
Pharmacovigilance
Outline
Theme
Ensure safer drugs to the healthcare community
Pharmacovigilance
Why do we need pharmacovigilance
The study of ADRs is the
concern of the field of
pharmacovigilance
Adverse drug reactions
• ADR is defined as any harm associated with the
use of given drugs at a normal dosage during
normal use.
Vigilance (Latin):
– to keep awake or alert
– to keep watch
– the process of paying close and
continuous attention
Definition of Pharmacovigilance
1. Patient details
2. Suspected drug
3. Suspected reaction
4. Reporter details
What should be reported?
1. All suspected reactions including minor
ones
2. All serious, unexpected, unusual ADRs
3. Change in frequency of a given reaction
4. All suspected drug-drug, drug-food, drug
food supplements interactions
5. ADRs associated with drug withdrawal
6. ADRs due to medication errors
7. ADRs due to lack of efficacy or suspected
pharmaceutical defect
Why is the yellow card scheme
?important
1. The scheme acts as an early warning
system for the identification of
previously unrecognized reactions
Doubtful ADR 0
Take home message
• Pharmacovigilance is a dynamic clinical and
scientific discipline
• ADR reporting is the cornerstone
pharmacovigilance activity
• The majority of global information related to
ADRs arises from Western countries
• Countries have to support their own national
pharmacovigilance.
• Each country should support its own PV
program
A successfully implemented
pharmacovigilance centre can
minimize, prevent and improve the use
of drugs by discovering ADRs at the
level of general public use.