Pharmacovilgilance
Pharmacovilgilance
Pharmacovilgilance
Mohanad AlBayati
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World Health Organization
Medicine Safety
• To undergo
treatment you
have to be very
healthy, because
apart from your
sickness you
have to stand
the medicine.
Molière
3
World Health Organization
Pharmacovigilance
What IS this?
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World Health Organization
Vigilance
Vigilare = to watch
alert watchfulness
forbearance of sleep; wakefulness
watchfulness in respect of danger;
care; caution; circumspection
the process of paying close and
continuous attention
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World Health Organization
Pharmacovigilance
• The science and activities relating
to the detection, evaluation,
understanding and prevention of
adverse drug reactions or any other
drug-related problems
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World Health Organization
Pharmacovigilance
Major Aims
• early detection of unknown safety
problems
• detection of increases in frequency
• identification of risk factors
• quantifying risks
• preventing patients from being affected
unnecessarily
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World Health Organization
Why Pharmacovigilance?
• Post-marketing Topics
Unexpected adverse reactions
Interactions
Dependence
Long-term efficacy, Resistance
Risk factors
Quality (Counterfeit)
Cost assessment
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World Health Organization
Why Pharmacovigilance?
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World Health Organization
WHO Programme for International
Drug Monitoring
WHO
WHO
Collaborating
HQ Centre, Uppsala
National
Centres
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World Health Organization
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
Frequency of occurrence
Vigilance (Latin):
– to keep awake or alert
– to keep watch
– the process of paying close and
continuous attention
Definition of Pharmacovigilance
Analysis &
Evaluation of data
Acting to protect
public health
Actions taken from the PV findings
include
1. Restriction in use
2. Changes in the specified dose of the medicine
3. Introduction of specific warnings in the
product information
4. Changing the legal status of a medicine, e.g.,
from over-the-counter to prescription only
5. Product recall: In rare cases, removal of the
medicine from the market, if the risks of a
medicine are found to outweigh the benefits
International collaboration
in the field of pharmacovigilance
• WHO runs the Uppsala Monitoring
Centre( started in 1968, moved to
Uppsala Sweden in 1978)
• European Union runs the European
Medicines Evaluation Agency (EMEA)
• United States, the FDA is responsible
for monitoring post-marketing studies.
• Egyptian PV center
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.
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EU-Pharmacovigilance scope
Animal safety
• serious and non-serious adverse reactions
Lack of expected efficacy
Off-label use / misuse
Humans reacting after exposure
Violations of residue levels
Potential environmental problems
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Minimal requirements of an AE report
• Identifiable reporter
• Animal (species)
• Suspected product
• Adverse event
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Thank you for patient