Pharmacovigilance: Importance and History
Introduction
to
Pharmacovigilance
Outlines
of
the
presentation
Smooth
orientation
to
p
h
arma
c
ov
i
gilance
Why
do
we
need
p
h
arma
c
ov
i
gilance?
WHO
progra
m
m
e
for
drug
monitoring
Pharmac
ovi
gilance
in
Egypt
Important
ter
m
in
olo
g
ie
s
in
pharmacovi
gilance
Yellow
Card
&
Blue
Card
Workshop
Medicine
Safety
To
undergo
treatment
you
have
to
be
very
healthy,
because,
apart
from
your
sickness
you
have
to
withstand
the
medicine
Molière
Risk/Benefit
Balance
of
medications
Medicines
are
safe!
(X)
Approved
medicines
are
safe!
(
X
)
No
medicine
is
safe!
(X)
No
medicine
is
without
risk
(
√
)
Risk/Benefit
Balance
of
medications
Acceptable
Unacce
p
t
able
What
is
Pharmacovigilance?
WHO
definition of
pharmacovigilance
Pharmacovigilance
is
the
science
and
activities
relating
to
the
detection,
assessment,
understanding
and
prevention
of
adverse
effects
or
any
other
medicine-related
problem
P
h
a
r
m
a
c
o
v
i
g
i
l
a
n
c
e
p
r
e
v
e
n
ti
o
n
of
adverse
effects
Assessment
&Un
der
s
ta
n
d
ing
Detection
Learning
from
History
•
T
h
a
l
i
d
o
m
i
d
e
D
i
s
a
s
t
e
r
:
•
Tranquilizer launched
-
1957
•
First
reports
of
birth
defects
-
1959
•
13
reports
of
birth
defects
-
1961
•Withdrawn
shortly
afterward
•
10000
infants
affected
by
Phocomelia.
•
No
teratogenicity
detected
in
testis
during
clinical
trials
and
prior
to
launch.
Why
do
we
need
Pharmacovigilance?
Reason
1:
H
u
m
a
n
i
t
a
r
i
a
n
c
o
n
c
e
r
n
Insufficient
evidence
of
safety
from
clinical
trials,
Animal
experiments
&
Phase
1
–
3
studies
prior
to
marketing
authorization
Limitations
of
clinical
trials
•Small
number
of
patients
studied
•Restricted
populations
(age,
sex,
ethnicity)
•Narrow
indications
•Short
duration
of
drug
exposure
Reason
2:
M
e
d
i
c
i
n
e
s
a
r
e
s
u
p
p
o
s
e
d
t
o
s
a
v
e
l
i
v
e
s
Dying
from
a
disease
is
sometimes
unavoidable;
dying
from
a
medicine
is
unacceptable.
Lepakhin
V.
Geneva
2005
•
ADRs
were
4th-6th
commonest
cause
of
death
in the
US
in
1994
Lazarou
et
al,
1998
U
S
A
•
It
has
been
suggested
that
ADRs
may
cause
5700
deaths
per
year
in
UK.
Pirmohamed
et
al,
2004
UK
Reason
3:
A
D
R
s
a
r
e
e
x
p
e
n
s
i
v
e
!
!
•
Cost
of
drug
related
morbidity
and
mortality
exceeded
$177.4
billion
in
2000
(Ernst
FR
&
Grizzle
AJ,
2001:
J
American
Pharm.
Assoc).
•
ADR
related
cost
to
the
country
exceeds
the
cost
of
the
medications
themselves.
R
e
a
s
o
n
4
:
P
r
o
m
o
t
i
n
g
r
a
t
i
o
n
a
l
u
s
e
o
f
m
e
d
i
c
i
n
e
s
a
n
d
a
d
h
e
r
e
n
c
e
R
e
a
s
o
n
5
:
Ensuring
public
confidence
R
e
a
s
o
n
6
:
Ethics
To
know
of
something
that
is
harmful
to
another
person
who
does
not
know,
and
not
telling,
is
unethical
Pharmacovigilance
is
needed
in
every
country
because
of
differences
in:
•
Drug
production
•
Distribution
and
use
(
e.g.
indications,
dose,
availability)
•
Genetics,
diet,
traditions
of
the
people
(e.g.
use
of
herbal
remedies,
etc.)
•
Pharmaceutical
quality
and
composition
(active/inactive
ingredients
)
Who
program
for
international
drug
monitoring
Who
program
for
international
drug
monitoring
•
Started
1968
•
Located
in
Uppsala,
Sweden
•
Collaborating
centre
for
maintaining
global
ADR
database
-
Vigibase
Roles
of
WHO
Collaborating
Centre
•
Identify
early warning
signals
of
serious
adverse
reactions
to
medicines
•
Evaluate
the
hazard
•
Undertake
research
into
the
mechanisms
of
action
to
aid
the
development
of
safer and
more
effective
medicines
Important
Terminologies
in
Pharmacovigilance
Side
Effect
(SE)
Vs
Adverse
Drug
Reaction
(ADR)
Vs
Adverse Event
(AE)
S
E
R
e
s
p
o
n
s
e
t
o
a
d
r
u
g
w
h
i
c
h
i
s
u
n
i
n
t
e
n
d
e
d
a
n
d
w
h
i
c
h
o
c
c
u
r
s
a
t
d
o
s
e
s
n
o
r
m
a
l
l
y
u
s
e
d
i
n
m
a
n
f
o
r
p
r
o
p
h
y
l
a
x
i
s
,
d
i
a
g
n
o
s
i
s
o
r
t
h
e
r
a
p
y
o
f
d
i
s
e
a
s
e
.
A
E
A
n
y
u
n
t
o
w
a
r
d
m
e
d
i
c
a
l
o
c
c
u
r
r
e
n
c
e
i
n
a
p
a
t
i
e
n
t
o
r
c
l
i
n
i
c
a
l
i
n
v
e
s
t
i
g
a
t
i
o
n
s
u
b
j
e
c
t
a
d
m
i
n
i
s
t
e
r
e
d
a
m
e
d
i
c
i
n
a
l
p
r
o
d
u
c
t
a
n
d
w
h
i
c
h
d
o
e
s
n
o
t
n
e
c
e
s
s
a
r
i
l
y
h
a
v
e
t
o
h
a
v
e
a
c
a
u
s
a
l
r
e
l
a
t
i
o
n
s
h
i
p
w
i
t
h
t
h
i
s
t
r
e
a
t
m
e
n
t
.
A
D
R
R
e
s
p
o
n
s
e
t
o
a
d
r
u
g
w
h
i
c
h
i
s
n
o
x
i
o
u
s
a
n
d
u
n
i
n
t
e
n
d
e
d
a
n
d
w
h
i
c
h
o
c
c
u
r
s
a
t
d
o
s
e
s
n
o
r
m
a
l
l
y
u
s
e
d
i
n
m
a
n
f
o
r
p
r
o
p
h
y
l
a
x
i
s
,
d
i
a
g
n
o
s
i
s
o
r
t
h
e
r
a
p
y
o
f
d
i
s
e
a
s
e
A
c
a
u
s
a
l
r
e
l
a
t
i
o
n
s
h
i
p
b
e
t
w
e
e
n
t
h
e
d
r
u
g
a
n
d
t
h
e
o
c
c
u
r
r
e
n
c
e
i
s
s
u
s
p
e
c
t
.
Adverse
Drug
Reaction
(ADR)
Vs
Adverse
Event
(AE)
Medication
Errors
(ME)
They
could
occur
during
prescribing,
transcribing,
dispensing,
administering
a
drug.
Examples
of
medication
errors
include,
misreading
or
miswriting
a
prescription.
Medication
errors
are
more
common
than
adverse
events,
but
result
in
harm
less
than
1%
of
the
time.
About
25%
of
adverse
events
are
due
to
medication
errors
.
Not
all
medication
errors
lead
to
adverse
outcomes
.
Adverse
Drug
Reactions
(ADR)
vs
Adverse
Events
(AE)
vs
Medication
Errors
(ME)
Seriousness
of
Adverse
drug
reactions
S
e
r
i
o
u
s
A
D
R
•
Life-Threatening
•
Hospitalization
(initial or
prolonged)
•
Disability
•
Death
•
Congenital
Anomaly
•
Medically
important
event
or
reaction
•
Cause
Cancer
O
T
H
E
R
W
I
S
E
A
D
R
I
S
N
O
N
-
S
E
R
I
O
U
S
Serious
reports
should
be
submitted
in
expedited
manner
i.e.
as
soon
as
possible
&
no
later
than
15
calendar
days
.
Thus
they
best
submitted
Online
or
Fax
We
are
almost
there
A
VALID
REPORT
CONSISTS
OF:-
•
Identifiable
patient
•
Identifiable
drug
(pharmaceutical
product)
•
Identifiable
reaction
•
Identifiable
reporter
Who
should
report?
•
Healthcare
Professionals
•
Marketing
authorization
holder
(MAH)
•
Patients
&
their
relatives
•
Nurses
•
Pharmacists
Reports
Journey
R
e
p
o
r
t
e
r
Q
P
P
V
D
a
t
a
e
n
t
r
y
R
A
Thank you
Delve into the world of pharmacovigilance through this insightful presentation covering topics such as the need for pharmacovigilance, risk/benefit balance of medications, WHO definition, detection of adverse effects, and learning from past disasters like the Thalidomide case. Explore why pharmacovigilance is crucial in ensuring medication safety and understanding its significant impact on public health.
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Presentation Transcript
Introduction to Pharmacovigilance
Outlines of the presentation Smooth orientation to pharmacovi gilance Important terminologie s in pharmacovi gilance WHO Why dowe need pharmacovi gilance? Yellow Card & BlueCard Pharmacovi gilance in Egypt programme for drug monitoring Workshop
MedicineSafety T o undergo treatment you have to be very because, apart from your sickness you withstandthe medicine healthy, have to Moli re
Risk/Benefit Balance ofmedications Medicines aresafe! (X) Approved medicines aresafe! (X) No medicine issafe! (X) No medicine is withoutrisk ( )
Risk/Benefit Balance ofmedications Acceptable Unacceptable
WHO definition of pharmacovigilance Pharmacovigilance is the science and activities detection, understanding of adverse effects or any other medicine-relatedproblem relating to the assessment, and prevention
Detection Assessment &Understand ing prevention of adverse effects Pharmacovigilance
Learning fromHistory Thalidomide Disaster: Tranquilizer launched -1957 Firstreports of birthdefects - 1959 13reports of birthdefects - 1961 Withdrawn shortlyafterward 10000 infants affected by Phocomelia. No teratogenicity detected in testis during clinical trials and prior to launch.
Why do we need Pharmacovigilance?
Reason1: Humanitarianconcern Insufficient evidence ofsafety from clinical trials, Animal experiments & Phase 1 3 studies prior to marketing authorization
Limitations of clinicaltrials Small number ofpatients studied Restricted populations(age, sex,ethnicity) Narrow indications Short duration ofdrug exposure
Reason2: Medicines are supposedto savelives Dying from a disease is sometimesunavoidable; dying from a medicineis unacceptable. Lepakhin V . Geneva2005
USA ADRs were 4th-6th commonest cause of death in the US in1994 Lazarou et al,1998 UK It has been suggestedthat ADRs may cause 5700 deaths per year inUK. Pirmohamed et al,2004
Reason3: ADRsareexpensive!! Cost of drug related morbidity andmortality exceeded$177.4 billion in2000 (ErnstFR& GrizzleAJ,2001:JAmericanPharm. Assoc). ADR related cost to the country exceeds the cost of the medicationsthemselves.
Reason 4: Promoting rational use of medicines and adherence Reason5: Ensuringpublicconfidence Reason6: Ethics T o know of something that is harmful to another person who doesnot know,and not telling, isunethical
Pharmacovigilance is needed in every country becauseof differencesin: Drugproduction Distribution and use ( e.g. indications, dose,availability) Genetics, diet, traditions of the people (e.g. remedies,etc.) Pharmaceutical composition ingredients) use of herbal quality (active/inactive and
Who program for international drug monitoring
Who program for international drug monitoring Started1968 Located inUppsala, Sweden Collaborating centrefor maintaining global ADR database -Vigibase
Roles of WHO CollaboratingCentre Identify early warning signals of seriousadverse reactions to medicines Evaluate the hazard Undertake research into the mechanisms ofaction to aid the developmentof safer and more effective medicines
Important Terminologies in Pharmacovigilance
Side Effect (SE) Vs Adverse Drug Reaction (ADR) Vs Adverse Event(AE) SE Response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease. AE Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product andwhich does not necessarily have to have a causal relationship withthis treatment. ADR Response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease A causal relationship between the drug and the occurrence is suspect.
Adverse Drug Reaction (ADR) Vs Adverse Event(AE)
Medication Errors(ME) Medication errors are morecommon than adverse events, but result in harm less than 1% of the time. About 25%of adverse events are due to medicationerrors. They could occur during prescribing, transcribing, dispensing, administering a drug. Examples of medication errors include, misreadingor miswriting a prescription. Not all medication errors leadto adverse outcomes.
Adverse Drug Reactions (ADR) vs Adverse Events (AE) vs Medication Errors(ME)
Seriousness of Adverse drugreactions SeriousADR Life-Threatening Hospitalization (initial orprolonged) Disability Death CongenitalAnomaly Medically important event orreaction CauseCancer OTHER WISE ADR ISNON-SERIOUS
Serious reports should be submitted in manner i.e. as soonas possible & no later than 15 calendar days. Thustheybestsubmitted OnlineEmailorFax expedited
A V ALID REPOR T CONSISTSOF:- Identifiablepatient Identifiable drug (pharmaceuticalproduct) Identifiablereaction Identifiablereporter
Who shouldreport? HealthcareProfessionals Marketingauthorization holder(MAH) Patients & theirrelatives Nurses Pharmacists
Reports Journey Reporter QPPV Dataentry RA
