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BACKGROUND: Take-home buprenorphine/naloxone is an effective method of initiating opioid agonist therapy in the Emergency Department (ED) that requires ED healthcare worker buy-in for large-scale implementation. We aimed to investigate healthcare workers perceptions of ED take-home buprenorphine/naloxone, as well as barriers and facilitators from an ED healthcare worker perspective. METHODS: In the context of a take-home buprenorphine/naloxone feasibility study at a tertiary care teaching hospital we conducted a descriptive qualitative study. We conducted one-on-one in person or telephone interviews and focus groups with ED healthcare workers who cared for patients given take-home buprenorphine/naloxone in the feasibility study at Vancouver General Hospital from July 2019 to March 2020. We conducted 37 healthcare worker interviews from December 2019 to July 2020. We audio recorded interviews and focus groups and transcribed them verbatim. We completed interviews until we reached thematic saturation. DATA ANALYSIS: We inductively coded a sample of transcripts to generate a provisional coding structure and to identify emerging themes, which were reviewed by our multidisciplinary team. We then used the final coding structure to analyze the transcripts. We present our findings descriptively. RESULTS: Participants identified a number of context-specific facilitators and barriers to take-home buprenorphine/naloxone provision in the ED. Participants highlighted ED conditions having either facilitative or prohibitive effects: provision of buprenorphine/naloxone was feasible when ED volume was low and space was available but became less so as ED volume increased and space decreased. Similarly, participants noted that patient-related factors could have a facilitative or prohibitive effect, such as willingness to wait (willing to stay in the ED for study-related activities and buprenorphine/naloxone initiation activities), receptiveness to buprenorphine/naloxone, and comprehension of the instructions. As for staff-related factors, time was identified as a consistent barrier. Time included time available and time required to initiate buprenorphine/naloxone (including time building rapport). Healthcare worker familiarity with buprenorphine/naloxone was noted as either a facilitating factor or a barrier, and healthcare workers indicated that ongoing training would have been advantageous. Many healthcare workers identified that the ED is an important first point of contact for the target patient population. CONCLUSION: Integrating a buprenorphine/naloxone program into ED care requires organizational supports (e.g., for managing buprenorphine/naloxone within limitations of ED volume, space, and time), and ongoing education of healthcare workers to minimize identified barriers.

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OBJECTIVES: Many emergency department (ED) patients with opioid use disorder are candidates for home buprenorphine/naloxone initiation with to-go packs. We studied patient opinions and acceptance of buprenorphine/naloxone to-go packs, and factors associated with their acceptance. METHODS: We identified patients at two urban EDs in British Columbia who met opioid use disorder criteria, were not presently on opioid agonist therapy and not in active withdrawal. We offered patients buprenorphine/naloxone to-go as standard of care and then administered a survey to record buprenorphine/naloxone to-go acceptance, the primary outcome. Survey domains included current substance use, prior experience with opioid agonist therapy, and buprenorphine/naloxone related opinions. Patient factors were examined for association with buprenorphine/naloxone to-go acceptance. RESULTS: Of the 89 patients enrolled, median age was 33 years, 27% were female, 67.4% had previously taken buprenorphine/naloxone, and 19.1% had never taken opioid agonist therapy. Overall, 78.7% believed that EDs should dispense buprenorphine/naloxone to-go packs. Thirty-eight (42.7%) patients accepted buprenorphine/naloxone to-go. Buprenorphine/naloxone to-go acceptance was associated with lack of prior opioid agonist therapy, less than 10 years of opioid use and no injection drug use. Reasons to accept included initiating treatment while in withdrawal; reasons to reject included prior unsatisfactory buprenorphine/naloxone experience and interest in other treatments. CONCLUSION: Although less than half of our study population accepted buprenorphine/naloxone to-go when offered, most thought this intervention was beneficial. In isolation, ED buprenorphine/naloxone to-go will not meet the needs of all patients with opioid use disorder. Clinicians and policy makers should consider buprenorphine/naloxone to-go as a low-barrier option for opioid use disorder treatment from the ED when integrated with robust addiction care services.

RéSUMé: OBJECTIFS: De nombreux patients des services d'urgence (SU) atteints d'un trouble lié à la consommation d'opioïdes sont des candidats à l'initiation à la buprénorphine/naloxone à domicile avec des trousses à emporter. Nous avons étudié les opinions des patients et l'acceptation des paquets de buprénorphine/naloxone à emporter, ainsi que les facteurs associés à leur acceptation. MéTHODES: Nous avons identifié des patients à deux urgences urbaines de la Colombie-Britannique qui répondaient aux critères relatifs aux troubles liés à l'utilisation d'opioïdes, qui ne suivaient pas actuellement un traitement aux agonistes des opioïdes et qui n'étaient pas en sevrage actif. Nous avons offert aux patients la buprénorphine/naloxone à emporter comme norme de soins, puis nous avons administré une enquête pour enregistrer l'acceptation de la buprénorphine/naloxone à emporter, le critère de jugement principal. Les domaines d'enquête comprenaient la consommation actuelle de substances, l'expérience antérieure avec le traitement aux agonistes opioïdes et les opinions liées à la buprénorphine/naloxone. Les facteurs du patient ont été examinés pour déterminer l'association avec l'acceptation de la buprénorphine/naloxone à emporter. RéSULTATS: Sur 89 patients inscrits, l'âge médian était de 33 ans, 27,0% étaient des femmes, 67,4% avaient déjà pris de la buprénorphine/naloxone et 19,1% n'avaient jamais pris de traitement aux agonistes opioïdes. Dans l'ensemble, 78,7% des répondants étaient d'avis que les SU devraient distribuer des paquets de buprénorphine/naloxone à emporter. Trente-huit (42,7%) patients ont accepté la buprénorphine/naloxone à emporter. L'acceptation de la buprénorphine/naloxone à emporter était associée à l'absence de traitement antérieur par agonistes opioïdes, à moins de 10 ans d'utilisation d'opioïdes et à l'absence de consommation de drogues injectables. Les raisons d'accepter comprenaient le fait de commencer un traitement pendant le sevrage; les raisons de rejeter comprenaient une expérience antérieure insatisfaisante de buprénorphine/naloxone et un intérêt pour d'autres traitements. CONCLUSION: Bien que moins de la moitié de notre population à l'étude ait accepté la buprénorphine/naloxone à emporter lorsqu'elle lui était offerte, la plupart ont pensé que cette intervention était bénéfique. Isolément, la buprénorphine/naloxone à emporter à l'urgence ne répondra pas aux besoins de tous les patients atteints de troubles liés à l'utilisation d'opioïdes. Les cliniciens et les décideurs devraient considérer la buprénorphine/naloxone à emporter comme une option à faible barrière pour le traitement des troubles liés à la consommation d'opioïdes par l'urgence lorsqu'elle est intégrée à de solides services de soins de la toxicomanie.

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OBJECTIVE: Emergency department (ED)-initiated buprenorphine may prevent overdose. Microdosing is a novel approach that does not require withdrawal, which can be a barrier to standard inductions. We aimed to evaluate the feasibility of an ED-initiated buprenorphine/naloxone program providing standard-dosing and microdosing take-home packages and of randomizing patients to either intervention. METHODS: We broadly screened patients ≥18 years old for opioid use disorder at a large, urban ED. In a first phase, we provided consecutive patients with 3-day standard-dosing packages, and then we provided a subsequent group with 6-day microdosing packages. In a second phase, we randomized patients to standard dosing or microdosing. We attempted 7-day telephone follow-ups and 30-day in-person community follow-ups. The primary feasibility outcome was number of patients enrolled and accepting randomization. Secondary outcomes were numbers screened, follow-up rates, and 30-day opioid agonist therapy retention. RESULTS: We screened 3954 ED patients and identified 94 with opioid use disorders. Of the patients, 26 (27.7%) declined participation: 10 identified a negative prior experience with buprenorphine/naloxone as the reason, 5 specifically cited precipitated withdrawal, and none cited randomization. We enrolled 68 patients. A total of 14 left the ED against medical advice, 8 were excluded post-enrollment, 21 received standard dosing, and 25 received microdosing. The 7-day and 30-day follow-up rates were 9/46 (19.6%) and 15/46 (32.6%), respectively. At least 5/21 (23.8%) provided standard dosing and 8/25 (32.0%) provided microdosing remained on opioid agonist therapy at 30 days. CONCLUSIONS: ED-initiated take-home standard-dosing and microdosing buprenorphine/naloxone programs are feasible, and a randomized controlled trial would be acceptable to our target population.

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BACKGROUND: Patients commonly transition between health care settings, requiring care providers to transfer medication utilization information. Yet, information sharing about adverse drug events (ADEs) remains nonstandardized. OBJECTIVE: The objective of our study was to describe a minimum required dataset for clinicians to document and communicate ADEs to support clinical decision making and improve patient safety. METHODS: We used mixed-methods analysis to design a minimum required dataset for ADE documentation and communication. First, we completed a systematic review of the existing ADE reporting systems. After synthesizing reporting concepts and data fields, we conducted fieldwork to inform the design of a preliminary reporting form. We presented this information to clinician end-user groups to establish a recommended dataset. Finally, we pilot-tested and refined the dataset in a paper-based format. RESULTS: We evaluated a total of 1782 unique data fields identified in our systematic review that describe the reporter, patient, ADE, and suspect and concomitant drugs. Of these, clinicians requested that 26 data fields be integrated into the dataset. Avoiding the need to report information already available electronically, reliance on prospective rather than retrospective causality assessments, and omitting fields deemed irrelevant to clinical care were key considerations. CONCLUSIONS: By attending to the information needs of clinicians, we developed a standardized dataset for adverse drug event reporting. This dataset can be used to support communication between care providers and integrated into electronic systems to improve patient safety. If anonymized, these standardized data may be used for enhanced pharmacovigilance and research activities.

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BACKGROUND: 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. OBJECTIVE: Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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OBJECTIVES: Adverse drug events (ADEs) cause or contribute to one in nine emergency department (ED) presentations in North America and are often misdiagnosed. EDs have insufficient clinical pharmacists to complete medication reviews in all incoming patients, even though pharmacist-led medications reviews have been associated with improved health outcomes. Our objective was to validate clinical decision rules to identify patients presenting with ADEs so they could be prioritized for pharmacist-led medication review. METHODS: This multicenter, prospective study was conducted in two tertiary and one community hospital in Canada. We enrolled 1,529 adults presenting to EDs over 12 months. We applied two clinical decision rules and collected baseline variables prior to assessments by clinical pharmacists and physicians. We compared the physician and pharmacist diagnoses with the decision rule results. The primary outcome was a moderate or severe ADE, defined as an unintended and harmful event related to medication use or misuse, which required a change in medical therapy, diagnostic testing, consultation, or admission. An independent committee adjudicated uncertain and discordant cases. We calculated the diagnostic accuracy of both rules. RESULTS: Among 1,529 patients, 184 (12.0%) were diagnosed with an ADE. Rule 1 contained the variables 1) having a preexisting medical condition or having taken antibiotics within 1 week and 2) age > 80 years or having a medication change within 28 days. They had a sensitivity of 91.3% (95% confidence interval [CI] = 86.3%-95.0%) and a specificity of 37.9% (95% CI = 35.3%-40.6%) for ADEs. CONCLUSIONS: Our study validated clinical decision rules that can be applied by clinical pharmacists to limit the number of patients requiring medication review, while identifying the majority of patients presenting with clinically significant ADEs.

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BACKGROUND: To reduce medication discrepancies (unintended differences between a patient's outpatient and inpatient medication regimens), Canadian institutions have implemented medication reconciliation forms that are prepopulated with outpatient medication dispensing data. These may prompt prescribers to reorder discontinued medications or continue newly contraindicated medications. Our objective was to evaluate the incidence of medication discrepancies and errors of commission after the implementation of such forms. METHODS: This retrospective chart review included patients previously enrolled in an observational study in which a research pharmacist prospectively collected best-possible medication histories in the emergency department. Research assistants uninvolved with the parent study compared medication orders written in the first 48 hours after admission with the research pharmacist's best-possible medication history to identify medication discrepancies and errors of commission, defined as inappropriate medication continuations and reordering of previously stopped medications. An independent panel adjudicated the clinical significance of the errors. RESULTS: Of 151 patients, 71 (47.0% [95% confidence interval (CI) 39.2-54.9]) were exposed to 112 medication errors on admission. Of the 112 errors, 24 (21.4% [95% CI 14.9-29.9]) were clinically significant. Errors of commission accounted for 24.1% (27/112 [95% CI 17.3-32.8]) of all errors; 10 (37.0% [95% CI 18.8-55.2]) of the errors of commission were clinically significant. INTERPRETATION: Medication errors were common after the implementation of electronically prepopulated medication reconciliation forms. Prospective research is required to examine the impact of prepopulated medication reconciliation forms and ensure they do not facilitate errors of commission.

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BACKGROUND: 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.

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BACKGROUND: Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs. OBJECTIVE: We aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada. METHODS: To develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting. RESULTS: This is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation and communication of ADEs. CONCLUSIONS: We take this approach with the recognition that information technology-based solutions in health care often fall short of expectations as a result of designers' failure to account for organizational and work practice considerations, and the needs of end-users. We describe how integrating qualitative methods into an iterative participatory design process (planned in partnership with end-users) will allow us to address specific clinical needs, conceptualize linkages between systems, integrate the reporting system into clinicians' workflow, and design the system to optimize its uptake into practice.

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AIM: Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. METHODS: We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. RESULTS: We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). CONCLUSION: We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance.

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