PRESENTED BY :

DR.T.TULASI PRIYANKA
CLINICAL PHARMACOLOGIST
ADVERSE DRUG REACTION :

• An adverse drug reaction is a “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 or for the
modification of physiologic function.”
ADVERSE DRUG EVENT :

• Adverse drug event is “an injury resulting from the

use of a drug. Under this definition, the term ADE
includes harm caused by the drug (adverse drug
reactions and overdoses) and harm from the use of
the drug (including dose reductions and
discontinuations of drug therapy.
SIDE EFFECT :

• Unintended — but predictable — symptoms that can

develop while taking a medication. They can happen
at normal, recommended doses, and they’re unrelated
to the intended purpose of the medication.
IS AN ADVERSE DRUG REACTION THE SAME
AS AN ADVERSE DRUG EVENT?
• No, they’re not the same. ADRs are a type of
adverse drug event (ADE).

• ADEs are very general. They encompass any type of harm

that’s caused by a medication. They can be preventable or
non-preventable. And ADEs can happen at normal doses or
at non-recommended doses. They may also happen when a
medication is used as directed, or when it’s used
inappropriately.
ADR vs SIDE EFFECT :
ADR DIFFER FROM A SIDE EFFECT OR
ALLERGY:

• Adverse drug reactions (ADRs) and side effects are both

unintended responses to a medication. But ADRs are
harmful and more unexpected than side effects. Side effects
are more predictable than ADRs. Plus, side effects can be
beneficial or harmful
PVPI :

• Pharmacovigilance Programme of India (PvPI) . It is an

Indian Government Organisation which identifies and
responds to Drug safety problems.
WHERE DO WE REPORT ADR?

SUSPECTED
ADVERSE DRUG
REACTION
REPORTING FORM
WHERE ADVERSE DRUG REACTIONS
SHOULD BE MONITORED ?

• It should be monitored in Adverse Drug Reaction

Monitoring Centre (AMCs)
NEAREST ADR MONITORING CENTRE?

• GSL MEDICAL COLLEGE, RAJAHMUNDRY

COMMITTEE MONITORS THE ADVERSE
DRUG REACTIONS?
• Pharmacovigilance Committee (PvC) monitors
adverse drug reactions