This document provides an introduction to pharmacovigilance. It defines pharmacovigilance as the science relating to detecting, assessing, understanding, and preventing adverse drug reactions. The document outlines the need for pharmacovigilance due to limitations of clinical trials, medication errors, and adverse drug reactions being a leading cause of death. It describes Egypt's pharmacovigilance center and important terms like adverse drug reactions, adverse events, and serious reports. Healthcare professionals, patients, and marketing authorization holders should report valid adverse events containing identifiable information to the pharmacovigilance center.

1. Introduction to
Pharmacovigilance
Done By CID PV Team
QPPV :- Dr. Rania Kamel
Deputy :- Dr. Nahla Raafat

2. Outlines of the presentation
Smooth
orientation
to
pharmacovi
gilance
Why do we
need
pharmacovi
gilance?
WHO
programme
for drug
monitoring
Pharmacovi
gilance in
Egypt
Important
terminologie
s in
pharmacovi
gilance
Yellow
Card &
Blue Card
Workshop

3. Smooth orientation to
Pharmacovigilance concept.

4. Medicine Safety
To undergo treatment
you have to be very
healthy, because,
apart from your
sickness you have to
withstand the
medicine
Molière

5. Risk/Benefit Balance of medications
Medicines are safe! (X)
Approved medicines are safe! (X)
No medicine is safe! (X)
No medicine is without risk (√)

6. Risk/Benefit Balance of medications
Acceptable
Unacceptable

7. What is Pharmacovigilance?

8. 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

9. Pharmacovigilance
prevention
of adverse
effects
Assessment
&Understand
ing
Detection

10. 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•Withdrawn shortly afterward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.

11. Why do we need
Pharmacovigilance?

12. Reason 1:
Humanitarian concern
Insufficient evidence of safety
from clinical trials, Animal
experiments & Phase 1 – 3
studies prior to marketing
authorization

14. Limitations of clinical trials
•Small number of patients
studied
•Restricted populations (age,
sex, ethnicity)
•Narrow indications
•Short duration of drug
exposure

15. 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

16. • ADRs were 4th-6th
commonest cause of death
in the US in 1994
Lazarou et al, 1998
USA
• It has been suggested that
ADRs may cause 5700
deaths per year in UK.
Pirmohamed et al, 2004
UK

17. 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.

18. 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

19. 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 )

20. Who program for international
drug monitoring

21. Who program for international drug
monitoring
• Started 1968
• Located in Uppsala,
Sweden
• Collaborating centre for
maintaining global ADR
database - Vigibase

22. 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

23. Pharmacovigilance in Egypt

24. What is EPVC
(Egyptian Pharmacovigilance centre )
In accordance with the
legislation, EPVC has
established a
pharmacovigilance system for
the collection and evaluation
of information relevant to the
risk-benefit balance of
medicinal products, Medical
devices & Biocides.
(cosmetics, Vet. Products &
Herbal products )

25. Implemented levels of regulatory actions in
Egypt based on EPVC decisions
• Asking for specific data from MAH
• Modify the package insert
• Black box warning in the insert
• Boxed warning on the outer pack
• Contraindication
• Distribute “Dear Dr Letter”
• Preventing importation of specific batches
• Recall of certain batches from the market
• Suspension of the marketing authorization
• Withdrawal of the marketing authorization

26. Important Terminologies in
Pharmacovigilance

27. 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 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.

28. Adverse Drug Reaction (ADR) Vs Adverse
Event (AE)

29. 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.

30. Adverse Drug Reactions (ADR) vs Adverse
Events (AE) vs Medication Errors (ME)

31. 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

32. 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

33. We are almost there

42. A VALID REPORT CONSISTS OF:-
• Identifiable patient
• Identifiable drug (pharmaceutical product)
• Identifiable reaction
• Identifiable reporter

43. Who should report?
• Healthcare Professionals
• Marketing authorization
holder (MAH)
• Patients & their relatives
• Nurses
• Pharmacists

44. Reports Journey
Reporter QPPV Data entry RA

46. Workshop

47. Q1:- Define Pharmacovigilance:
Pharmacovigilance is
the science and activities relating to the
detection, assessment, understanding and
prevention of adverse effects or any other
medicine-related problem

48. Q2:-Why do we need Pharmacovigilance ?
• Humanitarian concern
• Medicines are supposed to save lives
• ADRs are expensive !!
• Promoting rational use of medicines and adherence
• Ensuring public confidence
• Ethics To know of something that is harmful to another
person who does not know, and not telling, is unethical

49. Q3:- What are limitations to Clinical trials:
1. Small number of patients studied
2. Restricted populations (age, sex, ethnicity)
3. Narrow indications
4. Short duration of drug exposure

50. Q4:- Define ADRs :
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

51. Q5:- Mention four examples for serious ADR:
1. Life-Threatening
2. Death
3. Congenital Anomaly
4. Disability

52. Q6:- Mention four criteria for a valid report:
1.Identfiable patient
2.Identfiable Drug
3.Identfiable reaction
4.Identfiable reporter

53. Q7:- Who should report ?
1. Healthcare professional
2. Marketing Authorization Holder
3. Nurses
4. Pharmacist
5. Patient

54. Contact information
Dr. Rania Kamel
Rania.Kamel@hotmail.com
Dr. Nahla Raafat
nahlaraafat@gmail.com