P026: Pilot-testing an adverse drug event documentation form prior to its implementation in an electronic health record

Abstract

Introduction: Adverse drug events (ADEs), harmful and unintended consequences of medications, account for 1.7M emergency department (ED) visits in Canada each year. Up to 30% are due to unintentional re-prescribing of culprit drugs, partly due to lack of accessible, succinct, and comprehensible ADE information at the time of prescribing. Through a systematic review and workshops with physicians and pharmacists, we designed new ADE documentation fields. Our objective was to pilot-test the fields to anticipate and address problems prior to their integration into an electronic medical record (EMR). Methods: We seek to introduce structured ADE documentation into an EMR and PharmaNet, BC’s medication-dispensing database, to generate patient-level alerts when attempts to re-prescribe culprit drugs are made. We conducted this qualitative study in the EDs and on the wards of two BC hospitals. The ADE fields collect information about the culprit drug, its effect on the patient, treatment and outcome. We recruited a convenience sample of pharmacists, and distributed paper forms with the ADE fields to them before data collection shifts. We recorded how pharmacists evaluated patients for ADEs and completed the forms. We collected completed forms, and conducted semi-structured interviews for feedback. We analyzed data for common themes using inductive reasoning and constant comparison methods. Results: We observed 6 pharmacists documenting 24 ADEs. The field design was perceived as simple, clear, with sufficient detail to capture ADE information. Users identified fields to be omitted (e.g., excess details of culprit drug), modified (e.g., reporting options), or needing clarification (e.g., treatment details). Users were uncertain about what to report when the differential diagnosis included an ADE, but diagnostic uncertainty remained. Thus, ADE fields should enable communication about suspected events and potential alternative diagnoses. Pharmacists required follow-up in some cases to complete their determination (e.g., C. difficile toxin assay), emphasizing the need to be able to modify an ADE report. Conclusion: Paper-based pilot testing uncovered barriers to ADE documentation, and allowed us to plan for modifications and required linkages between electronic systems. In order to be functional, electronic ADE documentation must be dynamic, representing a departure from previous reporting platforms.