Tracking Patient Outcomes and Adverse Events: Considerations for Pharmacovigilance

Detection and response to reported safety events is one of a stool bank's most important roles. A robust material tracking and pharmacovigilance program enables timely responses to suspected adverse events including safety measures to mitigate risk to patients receiving FMT at centers being supplied by the stool bank. This paper presents OpenBiome's material tracking and pharmacovigilance program as an example for surveilling patient responses to FMT.