Introduction to

Pharmacovigilance
 Outlines of the presentation

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 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

Unacceptabl
e
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
 Detection
Assessment
&Understand
ing

preventio
n of
adverse
effects

Pharmacovigilanc
e
 Learning from History
•Thalidomide Disaster:
•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•Withdrawn shortly afterward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:

Humanitarian concern

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:

Medicines are supposed

to
save lives
Dying from a disease is
sometimes
unavoidable; dying
from a medicine is
unacceptable.
Lepakhin V. Geneva 2005
US • ADRs were 4th-6th
commonest cause of

A death in the US in 1994

Lazarou et al, 1998

• It has been suggested

U that ADRs may cause
5700 deaths per year in
UK.
K Pirmohamed et al, 2004
Reason 3:
ADRs are expensive !!
• 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.
Reason 4:
Promoting rational use of
medicines and adherence

Reason 5:
Ensuring public confidence

Reason 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
Response to a drug which is unintended and which occurs at
doses normally used in man for prophylaxis, diagnosis or
therapy of disease.

A
EAny untoward medical occurrence in a patient or clinical
investigation subject administered a medicinal product and
which does not necessarily have to have a causal relationship
with this
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 more
common than
adverse events,
They could occur but result in
during prescribing, harm less than
transcribing, 1% of the time.
dispensing, About 25% of Not all
administering a drug. adverse events are medication
due to
Examples of
medication
errors lead
medication errors to adverse
include, misreading errors.
or miswriting a outcomes.
prescription.
Adverse Drug Reactions (ADR) vs Adverse
Events (AE) vs Medication Errors (ME)
Seriousness of Adverse drug reactions
Serious ADR
• Life-Threatening
• Hospitalization (initial or prolonged)
• Disability
• Death
• Congenital Anomaly
• Medically important event or
reaction
• Cause Cancer

OTHER WISE ADR IS NON-SERIOUS

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 Email 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

Reporte QPP Data R

r V entry A
Thank you