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

Hohl, Corinne M.; Woo, Stephanie A.; Cragg, Amber; Wickham, Maeve E.; Ackerley, Christine Rose; Scheuermeyer, Frank; Villanyi, Diane

doi:10.9778/cmajo.20180190

Cited by 16 publications

(21 citation statements)

References 26 publications

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“…It was often difficult to assess the preventability of an event without knowing the exact circumstances of the care that had been provided, or the patient's perspective. Individual and professional biases may have affected how reviewers perceived the preventability of an event . Not all contributing factors were explicitly documented in the research or medical records, and therefore, undoubtedly, our clinical judgement, the patient's prior history, and documentation of the event's resolution informed our assessments.…”

Section: Discussionmentioning

confidence: 99%

Preventable adverse drug events: Descriptive epidemiology

Woo

Cragg

Wickham

et al. 2020

Brit J Clinical Pharma

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Aim Our objective was to identify preventable adverse drug events and factors contributing to their development. Methods We performed a retrospective chart review combining data from three prospective multicentre observational studies that assessed emergency department patients for adverse drug events. A clinical pharmacist and physician independently reviewed the charts, extracted data and rated the preventability of each adverse drug event. A third reviewer adjudicated all discordant or uncertain cases. We calculated the proportion of adverse drug events that were deemed preventable, performed multivariable logistic regression to explore the characteristics of patients with preventable events, and identified contributing factors. Results We reviewed the records of 1 356 adverse drug events in 1 234 patients. Raters considered 869 (64.1%) of adverse drug events probably or definitely preventable. Patients with mental health diagnoses (OR 1.8; 95% CI 1.3–2.5) and diabetes (OR 1.7; 95% CI 1.2–2.4) were more likely to present with preventable events. The medications most commonly implicated in preventable events were warfarin (9.4%), hydrochlorothiazide (4.5%), furosemide (4.0%), insulin (3.9%) and acetylsalicylic acid (2.7%). Common contributing factors included inadequate patient instructions, monitoring and follow‐up, and reassessments after medication changes had been made. Conclusions Our study suggests that patients with mental health conditions and diabetes require close monitoring. Efforts to address the identified contributing factors are needed.

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Section: Discussionmentioning

confidence: 99%

Preventable adverse drug events: Descriptive epidemiology

Woo

Cragg

Wickham

et al. 2020

Brit J Clinical Pharma

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“…An Ontario database study estimated that 54% of elderly patients were re-exposed to a high-risk medication within 6 months of a presentation related to an adverse drug reaction [ 31 ]. From our prior work, we anticipate that over one third of our patients will be seniors ≥ 80 years of age [ 13 ]. Assuming a re-exposure proportion of 30% in patients ≥ 80, and 15% in younger patients, we anticipate 20% of patients being re-exposed to culprit medications over a 12-month period in the control arm.…”

Section: Methodsmentioning

confidence: 99%

“…Robust prospective data help explain why: only 0.3% of clinically significant adverse drug events to outpatient medications were caused by errors in multi-center studies [ 3 , 4 , 11 , 12 ]. In contrast, 33% of patients presenting to hospital with an adverse drug event due to outpatient medications were suffering an event caused by re-exposure to culprit medication—a medication that had previously caused harm [ 13 ]. In a Dutch study of seniors admitted to hospital because of an adverse drug reaction, a subset of adverse drug events defined as undesirable effects due to medication use within the therapeutic dosing range, 27% were restarted on the culprit drug within 180 days [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Hau

Brasher

Cragg

et al. 2021

Trials

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Background Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE’s implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. Methods We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial’s primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial’s primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. Discussion These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. Trial registration ClinicalTrials.gov NCT04568668, NCT04574648. Registered on 1 October 2020.

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“…Adverse drug events comprise various types of medication-related problems, including adverse drug reactions (ie, noxious effects that occur within a standard dosing range of a prescription drug). Adverse drug events frequently recur without documentation and communication, which compromises patient safety [ 5 ]. The incidence, severity, and recurrence of adverse drug events suggest a need for greater documentation and communication of such events to avoid patients being re-exposed to harmful medications [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

“…Adverse drug events frequently recur without documentation and communication, which compromises patient safety [ 5 ]. The incidence, severity, and recurrence of adverse drug events suggest a need for greater documentation and communication of such events to avoid patients being re-exposed to harmful medications [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study

Chan¹,

Small²,

Wickham³

et al. 2021

J Med Internet Res

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Background Existing systems to document adverse drug events often use free text data entry, which produces nonstandardized and unstructured data that are prone to misinterpretation. Standardized terminology may improve data quality; however, it is unclear which data standard is most appropriate for documenting adverse drug event symptoms and diagnoses. Objective This study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. Methods We performed a mixed methods substudy of a multicenter retrospective chart review. We reviewed the research records of prospectively diagnosed adverse drug events at 5 Canadian hospitals. A total of 2 pharmacy research assistants independently entered the symptoms and diagnoses for the adverse drug events using four standards: Medical Dictionary for Regulatory Activities (MedDRA), Systematized Nomenclature of Medicine (SNOMED) Clinical Terms, SNOMED Adverse Reaction (SNOMED ADR), and International Classification of Diseases (ICD) 11th Revision. Disagreements between research assistants regarding the case-specific utility of data standards were discussed until a consensus was reached. We used consensus ratings to determine the proportion of adverse drug events covered by a data standard and coded and analyzed field notes from the consensus sessions. Results We reviewed 573 adverse drug events and found that MedDRA and ICD-11 had excellent coverage of adverse drug event symptoms and diagnoses. MedDRA had the highest number of matches between the research assistants, whereas ICD-11 had the fewest. SNOMED ADR had the lowest proportion of adverse drug event coverage. The research assistants were most likely to encounter terminological challenges with SNOMED ADR and usability challenges with ICD-11, whereas least likely to encounter challenges with MedDRA. Conclusions Usability, comprehensiveness, and accuracy are important features of data standards for documenting adverse drug event symptoms and diagnoses. On the basis of our results, we recommend the use of MedDRA.

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

Cited by 16 publications

References 26 publications

Preventable adverse drug events: Descriptive epidemiology

Preventable adverse drug events: Descriptive epidemiology

Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

The Utility of Different Data Standards to Document Adverse Drug Event Symptoms and Diagnoses: Mixed Methods Study

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