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ASSESSMENT OF
SUSPECTED ADVERSE
DRUG REACTION
INTRODUCTION
Spontaneous reporting system data
acquisition, assessment, presentation and
interpretation.
Causality assessment part of the 1st step
in case assessment and is based on a
general system that is intended for all
reactions and all drug.
Causality
2.Timing
The time from when the drug was started until the
reaction develops may be a characteristic of the reaction.
For example ,anaphylaxis usually develops with in a few
minutes of parenteral drug admini.
Alternatively some reactions develop months or years
later and may be related to a cumulative effect of the
traditional drug.In very rare cases the effect may be
observed in the next generation for example
diethylstilbestrol and vaginal cancer.
3. Relationship to dose
Adverse reactions are often dose related and may be
minimized by reducing the dose of the drug being taken.
If the symptoms resolve when the medicine stopped, this
suggests that the symptoms were associated with the
medicine although it could be coincidental. The process
of recovery after stopping a suspected medicinal product
is classified as positive dechallenge.
In contrast ,if a medicine is reintroduced and the
symtoms recur,this strongly suggests that the medicine is
responsible. This process is classified as positive
rechallenge.However
following
serious
ADR,
rechallenge is seldom justifiable.
Probability calculation
(Bayes Theorem)
The Formula
Pr(DCE I AC) = Pr (AC I DCE) x Pr (DCE)
Pr(OCE I AC)
Pr Probability
AC Additional character
DCE Drug Cause Event
OCE Other Cause Event
a)
b)
c)
d)
Yes
No
Dont
Know
+1
+2
-1
+1
+2
-1
-1
+2
-1
+1
+1
+1
+1
+1
CAUSALITY ASSESSMENT
C3: Reasonable time, may be due to
concurrent disease, other drugs, no
information on dechallenge
C4: Improbable temporal relationship, other
confounding factors such as drugs, chemicals,
underlying disease
C5: Insufficient information to analyse the
report
Case causality
assessment
How close is the relationship
between drug and event?
Did the drug cause the event?
Definitions
Dechallenge withdrawing the drug(s) and
recording the outcome improved or not
improved
Rechallenge giving one drug again under
the same conditions as before and
recording the outcome recurrence or no
recurrence.
Medscape
(http://www.medscape.com)
Medical News Today
(http://www.medicalnewstoday.com)
Medsafe, New Zealand
(http://www.medsafe.govt.nz)
Lareb - Netherland Pharmacovigilance
(www.lareb.com)
WHO Vigisearch, Vigibase, Vigimed
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