INDIVIDUAL CASE SAFETY REPORT (ICSR)
Introduction
(ICSR) is a report of a specific patient's adverse event and is the source of information for pharmacovigilance. An Individual Case Safety Report (ICSR) must be created and delivered to the Competent Authority (CA) of the Member State for every case of a suspected or confirmed adverse event.
This refers to the structure and content for disclosing one or more possible adverse reactions to a medication that manifest in a single patient at a particular period.
The ICSR (Individual Case Study Report) is where pharmacovigilance gets its information. VigiBase, a global database for individual case safety reports, was created by WHO and is kept up to date by UMC on its behalf.
An ICSR (Individual Case Study Report) helps provide an understanding about risks related to drugs/medical devices approved for usage.
Types of ICSR’s reports
Based on the sources and types of data collection ICSR’s are classified into two categories:
Solicited ICSR’s
Non Solicited ICSR’s
Collection of ISCR's
Sources for ICSR collections:
The pharmaceutical organization is required by law to gather the safety information pertaining to its product. The sources listed below will be used to gather safety data:
Spontaneous sources
Clinical sources
Literature sources
Health Authority
The staff of the corporate affiliates gathers all of these adverse events and sends them to the ICSR processing facilities.
Processing of ISCR
The company affiliates send all of these major adverse events or adverse events gathered from multiple sources to the processing centers by uploading the SAE forms into software such as ARISg or ARGUS. The drug safety associates at the processing centers conduct the following measures.
1. ICSR’s Initiation Team
Initiations/ Case booking: The drug safety associates check for duplicate ICSRs after receiving the SAE forms.
Validity of ICSR: The case is forwarded for deletion if the received ICSR does not meet any of the following requirements. If the ICSR received meets the 4 validity conditions, the following will happen.
Reporter
Patient
Adverse event
Suspect drug
Duplicate searches: Due to the large number of instances in the pharmacovigilance database (such as ARGUS or ARISg), it is possible that duplicate ICSRs will be generated. Duplicate searches will be conducted based on the following standards:
• Patient identification information, including name, initials, gender, and study number
• Reporter identification, such as the nation and contact information.
• Study identifiers, such as the protocol, subject, and site numbers.
• Source identifiers, such as instances from the health authority.
These duplicated searches assist in determining if it is necessary to open a new case or follow up on an already-opened case.
2. Case Coding / Case processing: Following case initiation, these cases enters the pipeline for data entry and coding. The ICSR needs to include the following details.
AE source and Reporter details:
Patient details:
Suspected Medicinal Product(s)
3. Quality Review: Before submitting the ICSR to the regulatory body, the quality assessment team evaluates its quality. Before transferring this to the next workflow, the quality review team corrects any mistakes that happened during data input and makes sure all of the questions are answered.
4. Medical Review: Before sending the ICSR for regulatory submission, a medical reviewer will make sure that all medical considerations have been adequately handled. The following aspects will be focused during a medical examination:
1. Appropriateness of the AE terminology used for adverse event (AE) capture
2. The sequence of the AEs
3. Coding verification
4. Verification of the AE Terms' Seriousness categorization
5. Confirming the categorization of AE Terms as Listedness/Expectedness
6. Examines related illnesses and medical history
7. Identifying any particular supplementary information required for a medical evaluation
8. When necessary, company causality assessment
9. Recognizing potential warning signs
Reporting of ISCR
After the medical review, the case has been forwarded to several stakeholders for submission following medical examination. These include:
The licensing partner
The researchers
The regulatory authority
The Ethics committee/Institutional review boards.
CONCLUSION:
ICSRs are significant because they offer an alternative viewpoint to adverse event reports, which may be gathered from a variety of patients. The ICSR contains information on people who have used the medical interventions or goods we are interested in learning about.
REFERENCES
Harshitha Nagothu
M Pharmacy
Email: nagothuharshitha49@gmail.com
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