Time constraints, confusion about the definition, and a litany of other factors all played a role in the collection of vital drug AE data.
Corrine M. Hohl, MD, MHSc, FRCPC
The existing systems for clinicians to report the adverse events (AEs) related to drugs do not allow physicians to properly record these complex events, according to new study data.
After observing 238 hours of clinical investigation of 65 suspected AEs, investigators determined that due to physician time constraints and the complexity of AEs, better systems—including electronic medical record systems—must be utilized to properly generate the drug event data needed to provide safer care to patients.
“The reporting systems need to be designed around the clinical needs of patients and health care providers, rather than the data needs of agencies engaged with pharmacologic surveillance and research,” Corrine M. Hohl, MD, MHSc, FRCPC, a senior author of the study, told MD Magazine. “This will likely yield more robust and more complete data as a byproduct of safer clinical care. This requires adverse drug event reporting systems to be redesigned and integrated into clinical documentation platforms.”
The investigators developed 5 recommendations intended on mitigating the issues in drug AE reporting:
Hohl, an associate professor of emergency medicine and scientist at the Center for Clinical Epidemiology and Evaluation at the University of British Columbia in Vancouver, Canada, and colleagues used ethnographic workplace observation and focus groups from a group of 4 locations in British Columbia. Trained research assistants shadowed clinical pharmacists and physicians during 4- to 8-hour data collection shifts at varying times of the day.
Of the 238 hours of compiled data, 197 hours (82.7%) were with clinical pharmacists in emergency departments (EDs), 27 hours (11.3%) with physicians in EDs, and 14 hours (0.5%) with clinical pharmacists in hospital wards. All told, 7 focus groups were held with 85 providers—4 with hospital pharmacists, and 1 each with ED physicians, general practitioners, and hospitalists.
In total, 41 AEs were observed to be reported in clinical charts—with “time pressures” impacting the extent to which these events were documented. “One emergency physician commented: ‘I want to give [the patient] to someone who has more time than me,’ and ‘I’m still waiting on phone calls, so I’ll be interrupted again—it’s killing me,’” the authors wrote.
Hohl and colleagues noted that they found that providers were regularly documenting these AEs—and were interested in doing so, despite the myriad of challenges and uncertainties regarding the reporting of these events. “The implication of this study is that we need to rethink the framework for adverse drug event reporting,” Hohl said.
Variability in terminology was observed, with drug AEs often diagnosed as “dosing problems, noncompliance, treatment failures, ineffective drugs, drug interactions, untreated indications, and drug use without an indication,” Hohl and colleagues wrote. In addition, the severity of the event, whether the AE had been mentioned in previous literature, and whether it was preventable, among other factors, all played a role in the clinician’s decision to report the event to external agencies.
As a result of multiple sources resulting in complexity, the decision to report AEs tended to be made on a case- and context-dependent basis.
“I don’t believe our findings will be a surprise to physicians and pharmacists,” Hohl said. “Our work attempts to understand the barriers that they encounter when reporting and attempts to explain why they don’t report. I hope that reporting agencies will pay close attention to our work when attempting to redesign their electronic systems.”
The study, “Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study,” was published in JMIR.
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