Adverse Drug Reaction Management

Adverse
Drug Reaction Management

Content

       Identifying
adverse events

       Assessing
adverse events

       Reporting
adverse reactions

Objective

After completion of this lecture, student will be able
to:

       Identify
adverse events

       Assess
adverse events

       Report
adverse reactions

INTRODUCTION

Ø  It
describes the procedure  for identifying,
recording and reporting of Adverse 
Reactions(AE) and Serious Adverse Reactions (SARs)

Ø  It
also describes the procedure for reporting 
Suspected Unexpected Serious Adverse Reactions(SUSARs)

ABBREVATIONS

Ø  AE/AR      Adverse Event/Reaction

Ø  SAE/SAR   Serious Adverse Event/Reaction

Ø  SUSAR        Suspected Unexpected Serious Adverse
Reactions

Ø  CTIMP       Clinical Trail of an Investigational Manufacturing
Product

Ø  NIMP        Non Investigational Medicinal Product

DEFINITIONS

ADVERSE EVENTS

Any Untowarded medical occurance in a patient or a clinical trial
participant administered an investigational product, and which does not
necessarily have a causal relationship with the drug

ADVERSE REACTIONS

All untowarded and unintended responses to the IMP related
to any dose administered to that participant.

SERIOUS ADVERSE REACTIONS

    Any untowarded
medical occurance that at any dose

Ø  Results
in death

Ø  Is
life-threatening

Ø  Requires
hospitalisation,or prolongation of existing hospitalisation

Ø  Results
in persistent or significant disability or incapacity

Ø  Is
a congenital anomaly.

    SUSPECTED
UNEXPECTED SERIOUS ADVERSE REACTIONS

       The
trail protocol or IB should include a list of known side effects for each drug
in the study.

        This should be consulted when a SAR occurs, to
determine expectedness. If the event is not listed, or has occurred in a more
serious form,or more frequently than expected, it should be considered to be a
SUSAR

Identifying of Adverse Events

       The
protocol should state whether any NIMPs are to be supplied to participants in
the trail.

       The
procedure for notifying such adverse events to the Principal Investigator must
be clearly documented in the trail protocol.

       The
trial protocol should define how AEs will be recorded, and states that all SAEs
will be reported to the Sponsor.

       AEs
may also be identified by support documents, for example clinical biochemistry,
hematology, and radiology.

Assessment of Adverse
Event

       AEs
must be assessed for  seriousness, causality,
expectedness, and severity

       It
is the responsibility of the PI to assess each AE for  seriousness, causality, expectedness, and
severity

       The
sponsor should review if a SAR reported to them is expected or not. If the
event is not expected it will be considered as a SUSAR.

Assessment of
Severity

Ø  The
CI or PI or delegated medically qualified research team member should make an
assessment of severity for each AR.

Ø  The
assessment should be recorded on the SAE form and reported to the sponsor
according to the following categories:

        Mild: A reaction that is easily tolerated by
the subject.

        Moderate: A reaction that is sufficiently
discomforting to interfere with normal everyday activities.

       Severe:
A reaction that prevents normal everyday activities

Reporting of Adverse reactions

Ø  Patient
details

              Initials

              Gender

              Age and
date of birth

              Weight

              Height

Ø  Suspected
drugs

              Generic
name of the drug *

              Indication(s)
for which suspect drug was prescribed or tested.

              Dosage
form and strength

              Daily
dose and regimen (specify units – e.g., mg, ml, mg/kg) ..

              Route of
administration.

              Starting
date and time of day.

              Stopping date and time, or duration of
treatment

Ø  Other
Treatment(s)

                  Provide the same information for
concomitant drugs

Ø  Details
of Suspected Adverse Drug Reaction(s) Full description of reaction(s) including
body site and severity, as well as the criteria for regarding the report as
serious,whenever possible, describe a specific diagnosis for the reaction

       Start
date (and time) of onset of reaction

       Stop
date (and time) or duration of reaction

Ø  Outcome

              Information
on recovery; results of specific tests and/or treatment.

              For a
fatal outcome, cause of death and its possible relationship to the suspected
reaction; any post-mortem findings.

              Any
Other information relevant to facilitate assessment of the case, such as
medical history of allergy, drug or alcohol abuse; family history; findings
from special investigations etc

Ø  Details
about the Investigator*

              Name

              Address

              Telephone
number

              Profession
(speciality)

              Date of
reporting the event to Licensing Authority:

              Date of
reporting the event to Ethics Committee overseeing the site:

              Signature
of the Investigator

Responsibilities

Responsibilities of
Sponsor

       SAE
should be reported to the licensing authority within 14 calendar days

       Submit
status report to the licensing authority 
periodically

 Responsibilities of Investigator

  • Ensure
    adequate medical care is provided to the subject

       SAE
and unexpected  AE should be reported to
the sponsor within 24 hrs

        To the EC within 7 working days

       Regular
reporting of adverse events is done through data collection in case report
forms

       Adverse
events are already known as potential risks when participating in a research
study with a specific investigational product

       It
is important to have a documented baseline assessment that is detailed with
health history and current health issues prior to exposure to the
investigational product

       As
the participant is exposed to the investigational product, the research team
must document any changes in health that may be due to the research study
product and report these adverse events through normal data collection tools
provided by the sponsor

       Most
reports require a brief history of the event

       Key
information that is helpful to the reviewers of the reports are:

       participant
demographic information, when the participant started the research study, what
research intervention the participant was receiving,

       previous
medical history, concomitant medications

       last
exposure to investigational product,

        abnormal labs or diagnostic tests,

        when the study team was notified of the event,
description of the actual event, relationship of the AE to the investigational
product,

        whether the participant was hospitalized,

        the event has resolved or not,

       whether
the participant will be removed from the research study or continue to receive
the research product

IDENTIFYING
OF ADVERSE REACTIONS

Summary

       Adverse event – Any Untowarded medical
occurance in a patient or a clinical trial participant administered an
investigational product  , and which does
not necessarily have a causal relationship with the drug

       Adverse reactions- All untowarded and
unintended responses to the IMP related to any dose administered to that
participant

 

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