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

Impact of early in-hospital medication review by clinical pharmacists on health services utilization.

BACKGROUND:Adverse drug events are a leading cause of emergency department visits and unplanned admissions, and prolong hospital stays. Medication review interventions aim to identify adverse drug events and optimize medication use. Previous evaluations of in-hospital medication reviews have focused on interventions at discharge, with an unclear effect on health outcomes. We assessed the effect of early in-hospital pharmacist-led medication review on the health outcomes of high-risk patients. METHODS:We used a quasi-randomized design to evaluate a quality improvement project in three hospitals in British Columbia, Canada. We incorporated a clinical decision rule into emergency department triage pathways, allowing nurses to identify patients at high-risk for adverse drug events. After randomly selecting the first eligible patient for participation, clinical pharmacists systematically allocated subsequent high-risk patients to medication review or usual care. Medication review included obtaining a best possible medication history and reviewing the patient's medications for appropriateness and adverse drug events. The primary outcome was the number of days spent in-hospital over 30 days, and was ascertained using administrative data. We used median and inverse propensity score weighted logistic regression modeling to determine the effect of pharmacist-led medication review on downstream health services use. RESULTS:Of 10,807 high-risk patients, 6,416 received early pharmacist-led medication review and 4,391 usual care. Their baseline characteristics were balanced. The median number of hospital days was reduced by 0.48 days (95% confidence intervals [CI] = 0.00 to 0.96; p = 0.058) in the medication review group compared to usual care, representing an 8% reduction in the median length of stay. Among patients under 80 years of age, the median number of hospital days was reduced by 0.60 days (95% CI = 0.06 to 1.17; p = 0.03), representing 11% reduction in the median length of stay. There was no significant effect on emergency department revisits, admissions, readmissions, or mortality. LIMITATIONS:We were limited by our inability to conduct a randomized controlled trial, but used quasi-random patient allocation methods and propensity score modeling to ensure balance between treatment groups, and administrative data to ensure blinded outcomes ascertainment. We were unable to account for alternate level of care days, and therefore, may have underestimated the treatment effect in frail elderly patients who are likely to remain in hospital while awaiting long-term care. CONCLUSIONS:Early pharmacist-led medication review was associated with reduced hospital-bed utilization compared to usual care among high-risk patients under 80 years of age, but not among those who were older. The results of our evaluation suggest that medication review by pharmacists in the emergency department may impact the length of hospital stay in select patient populations

Methods for evaluating adverse drug event preventability in emergency department patients

Background: There is a high degree of variability in assessing the preventability of adverse drug events, limiting the ability to compare rates of preventable adverse drug events across different studies. We compared three methods for determining preventability of adverse drug events in emergency department patients and explored their strengths and weaknesses. Methods: This mixed-methods study enrolled emergency department patients diagnosed with at least one adverse drug event from three prior prospective studies. A clinical pharmacist and physician reviewed the medical and research records of all patients, and independently rated each event’s preventability using a “best practice-based” approach, an “error-based” approach, and an “algorithm-based” approach. Raters discussed discordant ratings until reaching consensus. We assessed the inter-rater agreement between clinicians using the same assessment method, and between different assessment methods using Cohen’s kappa with 95% confidence intervals (95% CI). Qualitative researchers observed discussions, took field notes, and reviewed free text comments made by clinicians in a “comment” box in the data collection form. We developed a coding structure and iteratively analyzed qualitative data for emerging themes regarding the application of each preventability assessment method using NVivo. Results: Among 1356 adverse drug events, a best practice-based approach rated 64.1% (95% CI: 61.5–66.6%) of events as preventable, an error-based approach rated 64.3% (95% CI: 61.8–66.9%) of events as preventable, and an algorithm-based approach rated 68.8% (95% CI: 66.1–71.1%) of events as preventable. When applying the same method, the inter-rater agreement between clinicians was 0.53 (95% CI: 0.48–0.59), 0.55 (95%CI: 0.50–0.60) and 0.55 (95% CI: 0.49–0.55) for the best practice-, error-, and algorithm-based approaches, respectively. The inter-rater agreement between different assessment methods using consensus ratings for each ranged between 0.88 (95% CI 0.85–0.91) and 0.99 (95% CI 0.98–1.00). Compared to a best practice-based assessment, clinicians believed the algorithm-based assessment was too rigid. It did not account for the complexities of and variations in clinical practice, and frequently was too definitive when assigning preventability ratings. Conclusion: There was good agreement between all three methods of determining the preventability of adverse drug events. However, clinicians found the algorithmic approach constraining, and preferred a best practice-based assessment method.Medicine, Faculty ofNon UBCEmergency Medicine, Department ofPopulation and Public Health (SPPH), School ofOther UBCReviewedFacult

Primary and Secondary Outcomes, and Treatment Effects.

<p>Primary and Secondary Outcomes, and Treatment Effects.</p

The modified Adverse Drug Event clinical decision rule used to identify patients at high-risk for adverse drug events in the emergency department.

<p><b>[<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0170495#pone.0170495.ref017" target="_blank">17</a>]</b> PCIS = patient care information system.</p

Baseline characteristics of enrolled patients, by group assignment.

<p>Baseline characteristics of enrolled patients, by group assignment.</p