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Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

ABSTRACT: 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.Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting.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.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.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.

SUBMITTER: Hohl CM

PROVIDER: S-EPMC5849794 | biostudies-other | 2018 Feb

REPOSITORIES: biostudies-other

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Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

Hohl Corinne M CM Small Serena S SS Peddie David D Badke Katherin K Bailey Chantelle C Balka Ellen E

JMIR public health and surveillance 20180227 1

<h4>Background</h4>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.<h4>Objective</h4>Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting.<h4>Methods</h4>This qualitative study was conducted in 1 ambulatory center, and the emergency departmen ...[more]

PMID: 29487041

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Project description:Objectives:Platinum compounds cause several adverse events, such as nephrotoxicity, gastrointestinal toxicity, myelosuppression, ototoxicity, and neurotoxicity. We evaluated the incidence of renal impairment as adverse events are related to the administration of platinum compounds using the Japanese Adverse Drug Event Report database. Methods:We analyzed adverse events associated with the use of platinum compounds reported from April 2004 to November 2016. The reporting odds ratio at 95% confidence interval was used to detect the signal for each renal impairment incidence. We evaluated the time-to-onset profile of renal impairment and assessed the hazard type using Weibull shape parameter and used the applied association rule mining technique to discover undetected relationships such as possible risk factor. Results:In total, 430,587 reports in the Japanese Adverse Drug Event Report database were analyzed. The reporting odds ratios (95% confidence interval) for renal impairment resulting from the use of cisplatin, oxaliplatin, carboplatin, and nedaplatin were 2.7 (2.5-3.0), 0.6 (0.5-0.7), 0.8 (0.7-1.0), and 1.3 (0.8-2.1), respectively. The lower limit of the reporting odds ratio (95% confidence interval) for cisplatin was >1. The median (lower-upper quartile) onset time of renal impairment following the use of platinum-based compounds was 6.0-8.0?days. The Weibull shape parameter ? and 95% confidence interval upper limit of oxaliplatin were <1. In the association rule mining, the score of lift for patients who were treated with cisplatin and co-administered furosemide, loxoprofen, or pemetrexed was high. Similarly, the scores for patients with hypertension or diabetes mellitus were high. Conclusion:Our findings suggest a potential risk of renal impairment during cisplatin use in real-world setting. The present findings demonstrate that the incidence of renal impairment following cisplatin use should be closely monitored when patients are hypertensive or diabetic, or when they are co-administered furosemide, loxoprofen, or pemetrexed. In addition, healthcare professionals should closely assess a patient's background prior to treatment.

Project description:BackgroundWith increasing survival rates, a growing population of patients with cancer have received or will receive adjuvant therapy to prevent cancer recurrences. Patients and caregivers will confront the complexities of balancing the preventative benefits of adjuvant therapy with possible near-term or long-term adverse events (AEs). Adjuvant treatment-related AEs (from minimal to severe) can impact therapeutic adherence, quality of life, emotional and physical health, and survival. However, to the authors' knowledge, limited information is available regarding how stakeholders use or desire to use adjuvant-related AE information to inform the care of patients with cancer.MethodsA qualitative, purposeful sampling approach was used to elicit stakeholder feedback via semistructured interviews (24 interviews). Drug development, drug regulatory, clinical, payer, and patient/patient advocacy stakeholders were questioned about the generation, dissemination, and use of adjuvant treatment-related AE information to inform the care of patients with cancer. Transcripts were coded independently by 2 senior health care researchers and reconciled to identify key themes.ResultsAll stakeholder groups in the current study identified needed improvements in each of the following 4 areas: 1) improving the accessibility and relevance of AE-related information; 2) better integrating and implementing available information regarding AEs for decisions; 3) connecting contemporary cultural and economic value systems to the generation and use of information regarding adjuvant treatment-related AEs; and 4) addressing a lack of alignment and ownership of stakeholder efforts to improve the use of AE information in the adjuvant setting.ConclusionsDespite commonalities in the overall needs identified by the diverse stakeholders in the current study, broad systemic change has been stymied. The current study identified the lack of alignment and the absence of a central "owner" of these diffuse efforts as a previously unrecognized hurdle to realizing the desired systemic improvements. Future initiatives aimed at improving quality of life and outcomes for patients receiving adjuvant therapy through the improved use of AE information must address this challenge through innovative collectives and novel leadership strategies.

Project description:BackgroundIt is estimated that 237 million medication errors occur in England each year with a significant number occurring in the community. Our understanding of the causes of preventable medication errors and adverse drug events (ADE) affecting patients with mental illness is limited in this setting. Better understanding of the factors that contribute to errors can support the development of theory-driven improvement interventions.MethodsRemote qualitative semi-structured interviews with 26 community-based healthcare professionals in England and Wales were undertaken between June-November 2022. Recruitment was undertaken using purposive sampling via professional networks. Interviews were guided by the critical incident technique and analysed using the framework method. Any data that involved speculation was not included in the analysis. Independent analysis was carried out by the research team to extract themes guided by the London Protocol.ResultsA total of 43 medication errors and 12 preventable ADEs were discussed, with two ADEs having an unknown error origin. Prescribing errors were discussed most commonly (n = 24), followed by monitoring errors (n = 8). Six contributory factor themes were identified: the individual (staff); the work environment; the teams/interfaces; the organisation and management; the patient; and the task and technology. The individual (staff) factors were involved in just over 80% of all errors discussed. Participants reported a lack of knowledge regarding psychotropic medication and mental illnesses which accompanied diffusion of responsibility. There were difficulties with team communication, particularly across care interfaces, such as ambiguity/brevity of information being communicated and uncertainty concerning roles which created confusion amongst staff. Unique patient social/behavioural contributory factors were identified such as presenting with challenging behaviour and complex lifestyles, which caused difficulties attending appointments as well as affecting overall clinical management.ConclusionThese findings highlight that the causes of errors are multifactorial with some unique to this patient group. Key areas to target for improvement include the education/training of healthcare professionals regarding neuropharmacology/mental illnesses and enhancing communication across care interfaces. Future research should explore patient perspectives regarding this topic to help develop a holistic picture. These findings can be used to guide future intervention research to ameliorate medication safety challenges for this patient group.

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Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

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Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

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