Adverse Drug Event Reporting Essay Example | Topics and Well Written Essays - 2500 words

Adverse Drug Event Reporting - Essay Example Adverse events on a product must be communicated amongst the investigators, the sponsors and the institutional review board (IRB). This case study is about a pharmaceutical product called Product X, which is marketed, in many countries globally including US, EU, and Japan. A patient was admitted to hospital following an adverse event he experienced while taking Product X as part of a clinical trial. The Investigator sends a detailed adverse event report to the clinical trial sponsor (U.S. Department of Health and Human Services, et al., 2009) A number of steps were followed to report this adverse event from the moment it was experienced by the patient to its eventual inclusion in regulatory reports. Their different step took varying periods to be accomplished. The amount of time taken before reporting is often determined by the seriousness of the adverse event. In case of a life-threatening adverse event, which put the patient at the immediate risk of death, all the reporting should be done promptly in not more than 7 calendar days (U.S. Department of Health and Human Services, et al., 2009) In case of a serious adverse event, which results in hospitalization like in case of Product X the reporting, should be prompt since the adverse event may develop into a life-threatening one. Suspected adverse events or reactions are treated with less seriousness since they are considered less serious. In case the adverse event is unexpected, which is an effect that the investigators or the sponsors had not anticipated, the reporting should be prompt since the level of seriousness is not certain. Therefore, the investigators and sponsor reviewed the safety information for product X to enable them to decide the seriousness of the adverse event. This was crucial in determining the urgency of reporting. In this case study, the assumption made is that the adverse event of Product X was serious since it resulted in hospitalization.