CONTENTS

 Introduction
 Scope
 Objective
 Requirements for ICSRs
 15 days Alert report
 Source of ICSR
 Reporting procedure
 Conclusion
 Reference
 Introduction

Individual Case Safety Reports (ICSR) play a key role in assessing the
risk-benefit profile of a given medicinal product. An ICSR is considered
to be valid for reporting to a regulatory authority if it has at least one
single identifiable patient, one identifiable reporter, one or more
suspect adverse drug reaction, and one or more suspect identifiable
product. If one or more of these four elements is missing, the case is not
a valid AE report. Adverse events are coded using standardized
terminology from a medical dictionary. Seriousness assessment is done
separately for every reported adverse event within a case. A spontaneous
report is an unsolicited communication by healthcare professionals or
consumers to a company or regulatory authority. Solicited reports are
reports derived from organized data collection systems such as a registry
or patient support programs. Special situations such as cases of exposure
of fetus or embryo to a medicinal product through maternal or paternal
exposure need to be followed to know pregnancy outcome. However, if
they are associated with adverse reactions, they are reported in
accordance with the criteria outlined. Reports of lack of efficacy (LOE)
are discussed in periodic safety update reports.
However, if the case is deemed serious and LOE is unexpected, the
ICSR would qualify for 15 days submission. Also, LOE associated with
medicinal products used in critical conditions or for the treatment of life-
threatening diseases, vaccines, and contraceptives are reported within a
15-day time frame.
 Scope

1. Patient Information: Basic demographic details of the patient

such as age, gender, and medical history.
2. Drug Information: Details about the drug involved, including its
name, dose, route of administration, batch number, and indication
for use.
3. Concomitant Medications: Any other medications the patient was
taking at the time of the adverse event, as they could potentially
interact with the suspect drugs.
4. Reporter Information: Details about the person or entity
reporting the adverse event, such as their name, contact
information, and affiliation (e.g., healthcare professional, patient,
or pharmaceutical company).
5. Regulatory Reporting: Compliance with regulatory requirements
for reporting adverse events to relevant health authorities, such as
the FDA (U.S. Food and Drug Administration) or the EMA
(European Medicines Agency).
6. Post-Marketing Surveillance: ICSRs contribute to post-
marketing surveillance efforts, which involve monitoring the safety
of drugs after they have been approved and marketed. This
ongoing surveillance helps identify rare or long-term adverse
effects that may not have been detected during pre-market.
 Objective

1. Detection of Adverse Events: ICSRs serve as the primary means

of detecting adverse events associated with pharmaceutical
products.

2. Signal Detection: ICSRs contribute to signal detection, which

involves the identification of new or changing patterns of adverse
events that may indicate a previously unrecognized safety issue.

3. Risk Management: ICSRs play a crucial role in risk management

strategies for pharmaceutical products.

4. Contribution to Post-Marketing Surveillance: ICSRs contribute

to post-marketing surveillance efforts, which involve monitoring
the safety of drugs once they are approved and available.

5. Support for Regulatory Decision-Making: ICSRs provide

valuable data to agencies make evidence-based decisions regarding
the approval, labeling, and post-marketing regulation of
pharmaceutical products.

6. Support for Healthcare Professionals and Patients: ICSRs serve

as a mechanism for healthcare professional and patients to report
suspected adverse reactions associated with drugs.
 Requirements of ICSRs

1. Timeliness: ICSRs must be submitted to regulatory authorities in a

timely manner according to regulatory requirements. This ensures
that potential safety concerns are identified and addressed
promptly.
2. Completeness: ICSRs should contain all relevant information
about the adverse event, including the patient's demographic data,
medical history, concomitant medications, details of the adverse
event, and outcome. Complete and accurate information is
essential for proper evaluation and analysis.
3. Quality: The quality of ICSRs is crucial for effective
pharmacovigilance. Reports should be clear, concise, and free from
errors or inconsistencies. Healthcare professionals and
pharmaceutical companies must ensure that ICSRs are of high
quality to facilitate accurate assessment and decision-making.
4. Standardization: Standardized formats and terminology, such as
those defined by the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use
(ICH), are often used for reporting ICSRs. This facilitates data
exchange and analysis across different stakeholders and ensures
consistency in reporting practices.
5. Follow-up: In cases where additional information is required to
fully assess an adverse event, follow-up with the reporter or patient
may be necessary. Timely and thorough follow-up is essential for
obtaining complete and accurate information and resolving any
discrepancies or uncertainties. In cases where additional
information is required to fully assess an adverse event, follow-up
with the reporter or patient may be necessary.
 15 Days Alert report

FDA regulation require manufacturers packers, distributors and an

applicants to submit an ICSR on FDA From 3500A, or its
equivalent for each post marketing adverse drug experience that is
both serious and unexpected to the agency within 15 calendar days
of initial receipt of information about the adverse drug experience.

In addition to the ICSR 15-day Alert reports frequently include

related documents. Such as medical records, hospital discharge
summaries, or other documentation related to the event (ICSR
attachments).
 Sources of ICSR

The two main categories of ICSR sources are:

1. Unsolicited sources: Unsolicited sources of ICSRs pertain to
reports of adverse events or suspected adverse reactions that are
spontaneously submitted by individuals or entities without any
specific request or prompting from regulatory authorities or
product manufacturers. It is consist of:
a. Spontaneous reports
b. Information from literature
c. Information from internet/digital media
d. Information from other sources

2. Solicited sources: Solicited sources of ICSRs refer to reports of

adverse events or suspected adverse reactions that are actively
 sought or requested by regulatory authorities, manufacturers, or
research investigators. It is consist of:
a. Contractual agreements
b. Regulatory authority source

Reporting procedure

1. Identification: Healthcare professionals, patients, consumers,

or clinical trial investigators identify and recognize adverse
events associated with drugs or medical products.
2. Collection: Once an adverse event is identified, it needs to be
collected and documented. This can occur through various
channels, such as spontaneous reporting systems, clinical trial
protocols, literature review, or post-marketing surveillance
activities.
3. Documentation: The adverse event details are documented in
a standardized format, typically using an ICSR form. This
form captures essential information about the event, including
the patient's demographics, medical history, details of the
drug or product involved.
4. Assessment: After documentation, the adverse event is
assessed to determine its causality relationship with the drug
or product. This assessment involves evaluating factors such
as temporal relationship, known pharmacological effects,
patient factors, and other potential causes.
5. Reporting: Once the adverse event is documented and
assessed, it needs to be reported to the relevant regulatory
authorities and/or pharmaceutical companies.
 6. Follow up: In some cases, additional information may be
required to fully evaluate the adverse event. Follow up with
the reporter or healthcare provider may be necessary.

Conclusion

The conclusion for an ICSR (Individual Case Safety Report) should

summarize the key finding and implication of reports.
In conclusion, Individual Case Safety Reports (ICSRs) represent critical
instruments in pharmacovigilance, facilitating the identification,
evaluation, and mitigation of adverse drug reactions. By systematically
documenting and analyzing adverse events associated with medicinal
products, ICSRs provide invaluable insights into the safety profiles of
drugs, aiding healthcare professionals and regulatory agencies in making
informed decisions to protect patient health. The collaborative efforts of
healthcare providers, regulatory authorities, pharmaceutical companies,
and patients are essential in ensuring the thorough and timely reporting
of adverse events. As technology advances, leveraging automation and
data analytics will further enhance the efficiency and accuracy of ICSR
processes, enabling proactive risk management strategies. However,
ongoing commitment to vigilance, transparency, and continuous
improvement is paramount to address emerging challenges and ensure
the effectiveness of pharmacovigilance systems in safeguarding public
health. Through sustained collaboration and innovation, stakeholders can
strive towards a safer and more resilient healthcare landscape, where
patient safety remains the foremost priority.
 Reference

 https://www.sciencedirect.com/science/article/abs/pii/
B9780128021033000298
 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9870831/
#:~:text=ICSRs%20are%20replicated%20between
%20different,resulting%20from%20the%20replication
%20process.
 An Introduction to Pharmaciviligilance : Patrick Waller, Wiley
Publisher.
 Pharmacovigilance by Dr. Snehalatha, Vaishnavi S. Nirali
Prakashan, First Edition.