Chapter 28 - Individual Case Safety Reports

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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. Reports of overdose, abuse, off-label use, misuse, medication error, or occupational exposure without any adverse reactions form part of periodic safety update reports and not as part of ICSRs. 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 15days 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. Follow-ups are required if information is not complete. Both initial and follow-up serious and unexpected cases are reported within 15 calendar days.