Sensitivity of computed tomography performed within six hours of onset of headache for diagnosis of subarachnoid haemorrhage: prospective cohort study

Objective To measure the sensitivity of modern third generation computed tomography in emergency patients being evaluated for possible subarachnoid haemorrhage, especially when carried out within six hours of headache onset

Characterizing and Comparing Adverse Drug Events Documented in 2 Spontaneous Reporting Systems in the Lower Mainland of British Columbia, Canada: Retrospective Observational Study

BackgroundRobust adverse drug event (ADE) reporting systems are crucial to monitor and identify drug safety signals, but the quantity and type of ADEs captured may vary by system characteristics. ObjectiveWe compared ADEs reported in 2 different reporting systems in the same jurisdictions, the Patient Safety and Learning System–Adverse Drug Reaction (PSLS-ADR) and ActionADE, to understand report variation. MethodsThis retrospective observational study analyzed reports entered into PSLS-ADR and ActionADE systems between December 1, 2019, and December 31, 2022. We conducted a comprehensive analysis including all events from both reporting systems to examine coverage and usage and understand the types of events captured in both systems. We calculated descriptive statistics for reporting facility type, patient demographics, serious events, and most reported drugs. We conducted a subanalysis focused on adverse drug reactions to enable direct comparisons between systems in terms of the volume and events reported. We stratified results by reporting system. ResultsWe performed the comprehensive analysis on 3248 ADE reports, of which 12.4% (375/3035) were reported in PSLS-ADR and 87.6% (2660/3035) were reported in ActionADE. Distribution of all events and serious events varied slightly between the 2 systems. Iohexol, gadobutrol, and empagliflozin were the most common culprit drugs (173/375, 46.2%) in PSLS-ADR, while hydrochlorothiazide, apixaban, and ramipril (308/2660, 11.6%) were common in ActionADE. We included 2728 reports in the subanalysis of adverse drug reactions, of which 12.9% (353/2728) were reported in PSLS-ADR and 86.4% (2357/2728) were reported in ActionADE. ActionADE captured 4- to 6-fold more comparable events than PSLS-ADR over this study’s period. ConclusionsUser-friendly and robust reporting systems are vital for pharmacovigilance and patient safety. This study highlights substantial differences in ADE data that were generated by different reporting systems. Understanding system factors that lead to varying reporting patterns can enhance ADE monitoring and should be taken into account when evaluating drug safety signals

Pilot-testing an adverse drug event reporting form prior to its implementation in an electronic health record

Adverse drug events (ADEs), harmful unintended consequences of medication use, are a leading cause of hospital admissions, yet are rarely documented in a structured format between care providers. We describe pilot-testing structured ADE documentation fields prior to integration into an electronic medical record (EMR). Methods We completed a qualitative study at two Canadian hospitals. Using data derived from a systematic review of the literature, we developed screen mock-ups for an ADE reporting platform, iteratively revised in participatory workshops with diverse end-user groups. We designed a paper-based form reflecting the data elements contained in the mock-ups. We distributed them to a convenience sample of clinical pharmacists, and completed ethnographic workplace observations while the forms were used. We reviewed completed forms, collected feedback from pharmacists using semi-structured interviews, and coded the data in NVivo for themes related to the ADE form. Results We completed 25 h of clinical observations, and 24 ADEs were documented. Pharmacists perceived the form as simple and clear, with sufficient detail to capture ADEs. They identified fields for omission, and others requiring more detail. Pharmacists encountered barriers to documenting ADEs including uncertainty about what constituted a reportable ADE, inability to complete patient follow-up, the need for inter-professional communication to rule out alternative diagnoses, and concern about creating a permanent record. Conclusion Paper-based pilot-testing allowed planning for important modifications in an ADE documentation form prior to implementation in an EMR. While paper-based piloting is rarely reported prior to EMR implementations, it can inform design and enhance functionality. Piloting with other groups of care providers and in different healthcare settings will likely lead to further revisions prior to broader implementations.Medicine, Faculty ofNon UBCEmergency Medicine, Department ofReviewedFacult

Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study

Background: Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data. Methods We linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data. Results Among 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0–11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%). Conclusions Adverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care.Emergency Medicine, Department ofPopulation and Public Health (SPPH), School ofScience, Faculty ofStatistics, Department ofNon UBCMedicine, Faculty ofReviewedFacult

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

BackgroundExisting 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. ObjectiveThis study aims to compare the utility, strengths, and weaknesses of different data standards for documenting adverse drug event symptoms and diagnoses. MethodsWe 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. ResultsWe 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. ConclusionsUsability, 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

Emergency department-based medication review on outpatient health services utilization: interrupted time series

Background: One in nine emergency department (ED) visits in Canada are caused by adverse drug events, the unintended and harmful effects of medication use. Medication reviews by clinical pharmacists are interventions designed to optimize medications and address adverse drug events to impact patient outcomes. However, the effect of medication reviews on long-term outpatient health services utilization is not well understood. This research studied the effect of medication review performed by clinical pharmacists on long-term outpatient health services utilization. Methods: Data included information from 10,783 patients who were part of a prospective, multi-centre quality improvement evaluation from 2011 to 2013. Outpatient health services utilization was defined as total ED visits and physician contacts, aggregated to four physician specialty groups: general and family practitioners (GP); medical specialists; surgical specialists; and imaging and laboratory specialists. During triage, patients deemed high-risk based on their medical history, were systematically allocated to receive either a medication review (n = 6403) or the standard of care (n = 4380). Medication review involved a critical examination of a patient’s medications to identify and resolve medication-related problems and communicate these results to community care providers. Interrupted time series analysis compared the effect of the intervention on health services utilization relative to the standard of care controlling for pre-intervention differences in utilization. Results: ED-based pharmacist-led medication review did not result in a significant level or trend change in the primary outcome of total outpatient health services utilization. There were also no differences in the secondary outcomes of primary care physician visits or ED visits relative to the standard of care in the 12 months following the intervention. Our findings were consistent when stratified by age, hospital site, and whether patients were discharged on their index visit. Conclusion: This was the first study to measure long-term trends of physician visits following an ED-based medication review. The lack of differences in level and trend of GP and ED visits suggest that pharmacist recommendations may not have been adequately communicated to community-based providers, and/or recommendations may not have affected health care delivery. Future studies should evaluate physician acceptance of pharmacist recommendations and should encourage patient follow-up to community providers.Medicine, Faculty ofOther UBCEmergency Medicine, Department ofPopulation and Public Health (SPPH), School ofReviewedFacult

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

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.Medicine, Faculty ofOther UBCNon UBCEmergency Medicine, Department ofPopulation and Public Health (SPPH), School ofReviewedFacult