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

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

ABBREVATIONS
AE/AR Adverse Event/Reaction

SAE/SAR Serious Adverse Event/Reaction

SUSAR Suspected Unexpected Serious Adverse Reactions

CTIMP Clinical Trail of an Investigational Manufacturing Product

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

Results in death

Is life-threatening

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Requires hospitalisation,or prolongation of existing hospitalisation

Results in persistent or significant disability or incapacity

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

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

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

Patient details

Initials

Gender

Age and date of birth

Weight

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Height

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

Other Treatment(s)

Provide the same information for concomitant drugs

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

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

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

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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

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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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