Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset.

Background: Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized.

Objective: The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety.

Methods: We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format.

Results: We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations.

Conclusions: By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.