Can reporting of adverse drug reactions create safer systems while improving health data?

Hohl, Corinne M.; Lexchin, Joel; Balka, Ellen

doi:10.1503/cmaj.150057

Cited by 15 publications

(19 citation statements)

References 6 publications

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“…Without an understanding of adverse drug event reporting barriers, newly designed reporting software risks being ineffective [ 22 ]. To date, studies investigating underreporting have focused on provider knowledge and attitudes and advocated for interventions targeting provider behaviors [ 23 , 24 ].…”

Section: Introductionmentioning

confidence: 99%

Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study

Hohl

Small

Peddie

et al. 2018

JMIR Public Health Surveill

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BackgroundAdverse 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.ObjectiveOur objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting.MethodsThis 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.ResultsWe 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.ConclusionsExisting 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.

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Section: Introductionmentioning

confidence: 99%

Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study

Hohl

Small

Peddie

et al. 2018

JMIR Public Health Surveill

Self Cite

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“…This is because the current process of documentation is unwieldy and inefficient (Hohl, Lexchin, Balka 2015). The comprehensive reporting of adverse effects as mandated by the Act may thus require the development of a new framework for the documentation of such occurrences.…”

Section: Discussionmentioning

confidence: 99%

Reforming the Regulation of Therapeutic Products in Canada: The Protecting of Canadians from Unsafe Drugs Act (Vanessa’s Law)

Fierlbeck¹

2016

HRO-ORS

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“…However, no clinically useful reporting platform exists at present to achieve this aim, and the platforms that exist are not used to communicate clinically meaningful information between care providers. 32 Previous medication safety and health information technology implementation evaluations have focused on single sectors of health (e.g., hospitals) and therefore have had limited ability to measure inappropriate re-exposures to harmful medications across health sectors. 10,13,[28][29][30][31] To date, to our knowledge there has been only 1 randomized trial evaluating the impact of an electronic decision support system on the represcription of contraindicated drugs.…”

Section: Chart Review By a Pharmacist And Physicianmentioning

confidence: 99%

Repeat adverse drug events associated with outpatient medications: a descriptive analysis of 3 observational studies in British Columbia, Canada

Hohl

Woo

Cragg

et al. 2019

cmajo

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A dverse drug events are a leading cause of emergency department visits and unplanned hospital admissions in Canada 1-3 and a key focus of patient safety initiatives. 4 In 2017, the World Health Organization called for a commitment to reduce severe, avoidable medication-related harms by 50% over the next 5 years. 5 In the United States, the National Action Plan for Adverse Drug Event Prevention called for coordinated efforts in surveillance, oversight and research to develop effective evidence-based strategies to reduce adverse drug events. 6 Identifying system-level weaknesses that contribute to adverse drug events may allow us to target a broader range of events, develop and evaluate innovative system-level interventions, understand why previous prevention efforts have had limited success, and develop new metrics for evaluation. 5 Preliminary studies suggest that unintentional re-exposures to culprit or high-risk medications represent a safety risk. 7-9 However, this evidence is limited, and repeat adverse drug events are poorly understood. If repeat adverse drug events are common, they are likely to warrant new systems-level approaches for prevention. To date, health information technologies have focused on improving clinician adherence to treatment and monitoring guidelines,

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Can reporting of adverse drug reactions create safer systems while improving health data?

Cited by 15 publications

References 6 publications

Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study

Why Clinicians Don’t Report Adverse Drug Events: Qualitative Study

Reforming the Regulation of Therapeutic Products in Canada: The Protecting of Canadians from Unsafe Drugs Act (Vanessa’s Law)

Repeat adverse drug events associated with outpatient medications: a descriptive analysis of 3 observational studies in British Columbia, Canada

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