ICSR- Collection, Processing, and Reporting of ICSR

 

An Individual Case Study Report (ICSR) is a safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product. It is an important facet of adverse event reporting which is a source of data in PV (Pharmacovigilance). The ICSR is most commonly associated with PV. To build a compliant ICSR, there are four elements that must be mentioned:

• A diagnosed patient
• A reporter
• A suspect drug
• An adverse event

Adverse event reporting is a Regulatory requirement in most of countries for pharmaceutical companies. It also provides data to the companies and drug Regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The source of adverse event reports may include reports from:

• Healthcare professionals or patients
• Patient support programs
• Clinical or post-marketing studies
• Literature sources
• Media including websites
• Or, reported to drug Regulatory authorities themselves

The implementation of ICSR varies from drug to drug. The applicant must reach out to the Regulatory agency before submitting the reports to clarify the content of ICSR. More details about the content and guidance document of ICSR is available on the websites of the agencies.

An ICSR is considered to be valid for reporting to a regulatory authority if it has; 

• Atleast one single identifiable patient
• One identifiable reporter
• One or more suspect adverse drug reaction
• One or more suspect identifiable product

If one or more of these events are missing, the case is not valid AE report or said to be an invalid case.

The following steps involves in ICSR Case Processing Workflow

1. Case receipt

2. Data Verification and Validity check and Validity Assessment

3. Triage

4. Duplicate search

5. Book-in and registration 

6. Complete data entry

7. Quality review

8. Follow-up of reports

9. Medical review

Case Reporting-

The information that need to be reported;

Every single problem related to the use of a drug.

ADRs associated with contrast medium used in radiology studies, vaccines, diagnostics,

drugs used in traditional medicines, herbal remedies, cosmetics, medical devices &

equipment.

Product technical complaints (physical issues, packing issues, suspected pharmaceutical

defects, and counterfeit pharmaceuticals).

Development of resistance.

All suspected adverse reactions.

All safety-related issues.

All medical errors.

Individuals who are responsible for reporting

Healthcare professionals.

Clinical trial investigators.

Marketing authorization holders (MAH) (Pharmaceutical manufacturers).

Patients and their relatives (consumers).

Regulatory authorities (to MAH & WHO)

Authors (Literature reports)

References:

1. https://pharmacovigilancetutorials.wordpress.com/2020/04/25/my-new-chapter/

2. https://publicsafetyandvigilance.com/icsr-case-processing-activity/

Student Name: Lakshmi Prasanna Reddy

Student ID:021/022023

Qualification: Bachelor’s of Physiotherapy

e-Mail ID: prasannaputluru15@gmail.com