A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment
. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subjects study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs.
This is an unanticipated problem, which resulted in an adverse event.
Explanation:
It is important that a study drug be thoroughly evaluated before being applied to a patient, because an error can cause very harmful reactions. However, sometimes errors go unnoticed, even if the study coordinator is cautious and tries not to make any mistakes as it may harm the patient, as happened in the case shown in the question. These errors that go unnoticed refer to a situation where an unforeseen problem has resulted in an adverse event.
