Pharmacovigilance-definition and importance adverse drug reaction and adverse events type of reporters valid or invalid ADR listedness/expectedness

1. How many times we need pills?
• I have got a headache-

2. Candies and drugs?
• Popping pills like candies, are they really helping you, or causing some other
unwanted reactions?
• Anything entering our human body has to be safe, effective and helpful for our
body and should cure, treat, prevent or enhance our physical or mental well being.
• How do we ensure our drugs or vaccines are safe and effective and that they will
ultimately help us?

3. Pharmacovigilance(PV)-
Overview
• Importance of PV in clinical research life cycle.
• Application of common terminologies in PV if required

4. Drugs/Pills –Do they really help?
Why do we need to know and collect information on drugs or medicines?
a) Unexpected adverse reactions
b) Drug-Drug interactions
c) Long term efficacy
d) Quantify and recognise risk factors
Pharmacovigilance-The reason we humans invented it is-
To Keep our eyes open and our medicines safe.

5. Definition of Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection,
assessment, understanding and prevention of adverse effects, particularly long term and
short term side effect, of medicines (Source: The Importance of Pharmacovigilance,
WHO 2002).
-identifying new information about hazards associated with medicines
– preventing harm to patients

6. Basic Principles of Pharmacovigilance
 What are adverse drug reactions(ADR) and adverse drug events(AE).
 Difference between ADR and AE
 Serious and Non serious ADR
 Valid and non valid ADR
 Unlisted and listed ADR
 Workflow in PV for ADR

7. ADR and AE-Difference and Definition
Adverse events-(ADR)
An adverse event is any untoward medical occurrence in a patient administered a
medicinal product and which does not necessarily have to have a causal relationship
with this treatment.
Adverse drug reaction-(AE) A reaction, in contrast to an event, is characterized by the
fact that a causal relationship between the drug and the occurrence is suspected.
Stevens Johns Syndrome-caused by many infectious cause and by many drugs
including common drugs like acetaminophen (Tylenol, others), ibuprofen that we
routinely self prescribe.

8. Difference between ADR and AE
Adverse drug reaction Adverse event
Casual relation with drug may or may not
be
Casual relation with drug is suspected or is
possible
A patient admitted for anaphylactic
reaction to bee sting noted rash after
taking cetirizine
A healthy normal patient had rash 30
minutes after taking cetirizine

9. Minimum Criteria for Reporting
• For regulatory reporting, the minimum data elements for a case are –
– An identifiable reporter
– An identifiable patient
– An adverse reaction
– A suspect drug

10. Valid and Invalid ADR
Valid ADR Invalid ADR
Identifiable patient , product, event and
reporter
Non identifiable patient, product or event
and reporter
A 35 year old subject had rash after taking
penicillin as reported by Dr. ABC
“10 patients had rash after taking some
antibiotic” reported in newspaper

11. Adverse drug reactions(ADR)-reporters
– The case can be reported, while the drug is in the clinical trial or when it is in
the market. The case can be reported by eminent researchers through their
publication.
Type of reporter Description
Spontaneous Reporting When the drug is in market
Literature Reporting
Clinical Trial Reporting
Through publication i.e by
HCP (Health Care
Professional) and Non-HCP
When the drug is in clinical
trial

12. Serious and Non serious ADR
– ADR can be non serious when it does not fulfil seriousness criteria.
– ADR is serious when it fulfills following seriousness criteria-
1. Fatal.
2. Life threatening (NOTE: The term “life-threatening”
in the definition of “serious” refers to an event/reaction
in which the patient was at risk of death at the time of
the event/reaction; it does not refer to an event/
reaction which hypothetically might have caused death
if it were more severe).
3. Leads to or prolongs hospitalisation.
4. Leads to disability.
5. All birth defects / congenital anomalies.
6. Medically important.

13. Listed/Unlisted
• Using medical judgment in doing listed and unlistedness to report any possible drug
reactions to health authorities.

14. Listed/unlisted or expected/unexpected
Listed/expected Unlisted/Unexpected
Exact Event is present in CCDS, CCSI,I
B, SmPC, Package inserts
Exact event is not present in CCDS, CCSI,
IB, SmPC, Package inserts
Event of same etiology, cause, severity
and duration is present in above
mentioned documents
Event is of different cause, duration or
severity is present .
In CCDS pneumonia is present and
reported event is pneumonia it is listed
In CCDS only bacterial pneumonia is
present and reported event is viral
pneumonia then it is unlisted

15. Pharmacovigilance –Start to end

16. PV-Changes that were bought in India?

17. Summary
• PV-To keep our medicines Safe and protect human race.
• PV steps involves collection of safety information by collecting adverse drug
reactions data and then making this data available to HCP and consumers.
• What are adverse drug reactions(ADR) and adverse drug events(AE).
• Difference between ADR and AE-done
• Serious and Non serious ADR
• Valid and non valid ADR
• Type of reporter
• Unlisted and listed ADR

18. Thank you
Have a Safe medications….
• Dr.shraddha M Bhange
• Senior Medical Reviewer