ICSR refers to the format and content for the submission of an individual report of suspected adverse reactions in relation to a medicinal product that occurs in a single patient at a specific point of time.

An ICSR is said to be valid when it meets the below criteria:

At least one identifiable reporter;

One single identifiable patient;

Atleast one suspect adverse reaction and

At least one suspect medicinal product.

Collection of ICSRs:

Health authorities and marketing authorisation holders (MAH) should take appropriate measures to collect and collate all reports of suspected adverse reactions from medicinal products for human use originating from various sources.

Sources of adverse events (AE) include spontaneous reports, literature, product/patient support programs, registries, pharmacoepidemiologic studies, market research programs, medical information, health authorities, post-marketing commitment studies, social media etc.

Adverse events are collected/ received by various means; self reported by patients (sometimes relatives, caregivers), Healthcare professionals (HCP) (physicians, pharmacist, nurse). This reporting is largely voluntary and done by the  following ways:

  • Reporting to Health authorities, some examples as below:

AE can be directly reported to the Health authorities such as

European Medicines Agency (EMA) (https://www.adrreports.eu/en/report_side_effect.html);

The United States Food and Drug Administration (US FDA) (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda);

Medicines and Healthcare products Regulatory Agency (MHRA) (https://www.gov.uk/guidance/send-and-receive-information-on-adverse-drug-reactions-adrs)

  • Reporting to Pharmaceutical company: Patients/ HCPs can report AE by emails/ telephone on company site. AE can also be received by sales teams, company employees, call centers specifically engaged for the activity by pharma companies.
  • Reporting through Social media: Information of AEs experienced after intake of a drug could be reported on social media sites. Pharmaceutical companies and health authorities can no longer afford to neglect social media and the internet.

ICSR collection can be done by means of a pharmacovigilance system to allow for acquiring sufficient information and validation for the scientific evaluation of the reports.

The system should be such that the collected reports are authentic, legible, accurate, consistent, verifiable and as complete as possible for their clinical evaluations (usually true for solicited reports).

All the pharmacovigilance data is recorded, processed, analysed, submitted and archived in the pharmacovigilance databases taking into consideration the regional data protection requirements.

Also the system should allow for timely exchange of pharmacovigilance data between regulatory bodies and the MAH, business partners within the legal submission time frame.

Reference: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf