‫نظام التيقظ الدوائي‬
Pharmacovigilence
Khalifah Abdulwahid
Products Manager
Guess ..what happened ?
‫كارثة طفل الثاليدوميد‬
 Thalidomide
 Phocomelia
 Motions sickness
 2500 - 7000
 1957 - 1961
 Germany
Objectives
i. To know Pharmacoviglence concept .
ii. To understand Adverse drug reactions.
iii. To learn how to do spontaneous reporting
of ADR.
Outline
i.
ii.
iii.
iv.
v.
vi.
vii.
Pharmacovigilance concept .
Adverse drug effects terms .
Individual case safety report (ICSR( .
Causality assessment
Role of Med. Rep
ICSR activity
Summary
Clinical trial
Drugs
Risk
Benefit
Risk-Benefit Management
Question
What relationship
between PV &
Thalidomide Disaster
Definitions
Adverse event /experience (AE)
Suspected adverse drug reaction (SUADR)
Adverse drug reactions (ADR)
Expected
Unexpected
ADR statistics
ADR statistics
Quotes
"Dying from a disease
is sometimes
unavoidable. But,
dying from an adverse
drug reaction is
unacceptable".
Dr
Vladimir LepakhinGeneva 2005
To undergo treatment
you have to be very
healthy, because
apart from your
sickness you have to
withstand the
medicine.
Molière
Pharmacovigilence
‫دواء‬
Pharmakon
‫يقظة‬
Vigilance
It ‘s science and activity for
Detection
Assessment
Understanding
and prevention of adverse drugs effects
PV Global authorities
System of Pharmacovigilance
Reporting
ADR
Assessment
Prevention
Patient&
Healthcare
professional
&Pharmacist
Physician&
PV committee
PV
authorities
ICSR
Causality
assessment
Signals
Pharmacovigilance tools
(ICRS)
Identifiable
reporter
(primary
source)
• physician,
pharmacist, other
healthcare
professional,
lawyer, consumer
Single
Identifiable
patient
• Patient
identification
number, date of
birth, age, age
group or gender.
suspected
substance/m
edicinal
product
Suspected
Adverse
Reaction
• One or more
suspected
substance/medi
cinal product
• causal
relationship
between the
medicinal
product and the
adverse event
Individual Case Safety Report (ICSR)
 An identifiable patient
A. Patient
B. Sex
C. Weight
D. Age at time of reaction or date of birth
 Suspected medicine
A.
B.
C.
D.
E.
F.
G.
H.
Name (brand name)
Strength (concentration)
Dose, Frequency
Dosage form
Route of administration
Indication for use
Duration of use, date started, date stopped
Batch number (especially for vaccines)
Individual Case Safety Report (ICSR)
 Suspected adverse reaction
A. Description of the reaction
B. Expectedness of the reaction (in accordance with the approved
product information)
C. Seriousness of the reaction
D. Date the reaction started, stopped
E. Outcomes attributed to adverse reaction
F. Relevant tests/laboratory data (if available)
 An identifiable reporter
A. Name
B. Address
C. Contact details
D. Qualification (if healthcare professional)
Serious ICSRs
death
1.life-threatening
1.inpatient hospitalisation
1.prolongation of existing
hospitalisation,
1.results in persistent or significant
disability or incapacity
1.congenital anomaly/birth
defect.
1.Medically important event
????
‫?‪How to Submit ADR report‬‬
‫• باإلمكان الحصول على التطبيق من ‪ Google play store‬بالبحث عن التيقظ الدوائي‬
How to Submit ADR report?
How to Submit ADR report?
How to Submit ADR report?
E-mail : ypc@sbd-ye.org
Fax:619171
ICSR flow chart
ICSR
Process
ICSRs
Introduction
ICSRs
collection
ICSRs
validation
ICSRs
follow-up
ICSRs
reporting
to
authority
causality
assessment
Emerging
safety
issues
ICSRs data
Quality
managem
ent
Causality
(relationship between cause and effect)
• Causality assessment is the evaluation of the likelihood that a
particular treatment is the cause of an observed adverse event.
• It assesses the relationship between a drug treatment and the
occurrence of an adverse event.
27
Methods Of Causality
• There are two widely used causality assessment scales,
1. The World Health Organization-Uppsala Monitoring Center
(WHO-UMC) criteria
2. Naranjo algorithm.
28
Causality assessment (Who scale)
Causality
Certain
Probable/
Likely
Possible
Unlikely
Conditional /
unclassified
Unassessible
/unclassifiable
Definitions
• reasonable time relationship to drug intake
• Not attributed to disease or other drugs
• Response to withdrawal clinically reasonable ( + Dechallenge )
• Rechallenge not required ( + Rechallenge )
30
Certain
Good timing
no other causes
certain
+ Dechallenge
+ Rechallenge
Probable
Probable
Good timing
other causes
unlikely
+
Dechallenge
Rechallenge
Possible
Possible
Good timing
Other causes
possible
- De challenge
- Re challenge
Unlikely
Conditional / unclassified
• More data needed for assessment
• Follow-up vital
• Can not exclude possibility
35
Unassessible
• Insufficient or contradictory information
• Data can not be supplemented or verified
36
Quality issue reports
 Physical properties Ex >>>
 form
 Color
 Taste
 Odor
Activity of ICSR
Role of Medical representative
4Cs
 Conducting
 Collecting
 Confirming
 Communicating
Summary
THANKS