TY  - JOUR
AU  - Hohl, Corinne M
AU  - Small, Serena S
AU  - Peddie, David
AU  - Badke, Katherin
AU  - Bailey, Chantelle
AU  - Balka, Ellen
PY  - 2018
DA  - 2018/02/27
TI  - Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study
JO  - JMIR Public Health Surveill
SP  - e21
VL  - 4
IS  - 1
KW  - adverse events
KW  - pharmacovigilance
KW  - drug safety
KW  - adverse drug reaction
KW  - adverse drug event
KW  - electronic health records
KW  - information and technology
KW  - medication reconciliation
KW  - qualitative research
AB  - Background: Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. Objective: Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. Methods: This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. Results: We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. Conclusions: Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care. 
SN  - 2369-2960
UR  - http://publichealth.jmir.org/2018/1/e21/
UR  - https://doi.org/10.2196/publichealth.9282
UR  - http://www.ncbi.nlm.nih.gov/pubmed/29487041
DO  - 10.2196/publichealth.9282
ID  - info:doi/10.2196/publichealth.9282
ER  -