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Adverse Drug Event Reporting From Clinical Care: Mixed-Methods Analysis for a Minimum Required Dataset
David Peddie1,2, Serena S Small1,2, Katherin Badke3
1Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada.
JMIR Medical Informatics
|June 30, 2018
Summary
Standardizing adverse drug event (ADE) reporting is crucial for patient safety. A new 26-field dataset was developed to improve communication and clinical decision-making among healthcare providers.
Area of Science:
- Pharmacovigilance and Patient Safety
- Health Informatics
- Clinical Decision Support
Background:
- Healthcare transitions necessitate medication information transfer.
- Non-standardized adverse drug event (ADE) reporting hinders patient safety.
Purpose of the Study:
- To define a minimum dataset for documenting and communicating ADEs.
- To support clinical decision-making and enhance patient safety through standardized ADE information.
Main Methods:
- Mixed-methods analysis including systematic review of ADE reporting systems.
- Fieldwork and clinician end-user group consultations to inform dataset design.
- Pilot testing and refinement of a preliminary reporting form.
Main Results:
- Evaluated 1782 data fields; clinicians recommended 26 for the standardized dataset.
- Prioritized data fields based on electronic availability, prospective causality, and clinical relevance.
- Developed a dataset focusing on reporter, patient, ADE, and drug information.
Conclusions:
- A standardized ADE reporting dataset was created, addressing clinician information needs.
- The dataset can improve inter-provider communication and be integrated into electronic systems.
- Anonymized data holds potential for pharmacovigilance and research enhancement.
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