How many times we need pills?

• I have got a headache-

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?

Pharmacovigilance(PV)-

Overview

• Importance of PV in clinical research life cycle.

• Application of common terminologies in PV if required

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.

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

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

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.

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

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

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

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

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.

Listed/Unlisted

• Using medical judgment in doing listed and unlistedness to report any possible drug

reactions to health authorities.

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

Pharmacovigilance –Start to end

PV-Changes that were bought in India?

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

Thank you

Have a Safe medications….

• Dr.shraddha M Bhange

• Senior Medical Reviewer