Real-world evidence of sotrovimab effectiveness for preventing severe outcomes in patients with COVID-19: A quality improvement propensity-matched retrospective cohort study of a pan-provincial program in Alberta, Canada.

OBJECTIVES: Post-marketing surveillance of sotrovimab's effect during implementation in the Canadian population is limited. METHODS: The study used a propensity score-matched retrospective cohort design. Follow-up began between the periods of December 15, 2021 and April 30 2022. The study assessed any severe outcome defined as all-cause hospital admission or mortality within 30 days of a confirmed COVID-19-positive test. Covariate-adjusted odds ratios between sotrovimab treatment and the severe outcome was conducted using logistic regression. RESULTS: There were 22,289 individuals meeting the treatment criteria for sotrovimab. There were 1603 treated and 6299 untreated individuals included in the analysis. The outcome occurrence in the study was 5.49% (treated) and 4.21% (untreated), with a median time from diagnosis to treatment of 1.00 days (interquartile range 2.00 days). In the propensity-matched cohort, sotrovimab was not associated with lower odds of a severe outcome (odds ratio 1.20, 95% confidence interval 0.91-1.58), adjusting for confounding variables. CONCLUSIONS: After adjusting for confounding variables, sotrovimab treatment was not associated with lower odds of a severe outcome within 30-days of COVID-19-positive date.

Rituximab for Pediatric Central Nervous System Inflammatory Disorders in Alberta, Canada.

BACKGROUND: Early and effective treatment of central nervous system (CNS) inflammatory disorders is vital to reduce neurologic morbidity and improve long-term outcomes in affected children. Rituximab is a B-cell-depleting monoclonal antibody whose off-label use for these disorders is funded in the province of Alberta, Canada, by the Short-Term Exceptional Drug Therapy (STEDT) program. This study describes the use of rituximab for pediatric CNS inflammatory disorders in Alberta. METHODS: Rituximab applications for CNS inflammatory indications in patients <18 years of age were identified from the STEDT database between January 1, 2012, and December 31, 2019. Patient information was linked to other provincial datasets including the Discharge Abstract Database, Pharmaceutical Information Network, and Provincial Laboratory data. Analysis was descriptive. RESULTS: Fifty-one unique rituximab applications were identified, of which 50 were approved. New applications increased from one in 2012 to a high of 12 in 2018. The most common indication was autoimmune encephalitis without a specified antibody (n = 16, 31%). Most children were approved for a two-dose (n = 33, 66%) or four-dose (n = 16, 32%) induction regimen. Physician-reported outcomes were available for 24 patients, of whom 14 (58%) were felt to have fully met outcome targets. CONCLUSION: The use of rituximab for pediatric CNS inflammatory disorders has increased, particularly for the indication of autoimmune encephalitis. This study identified significant heterogeneity in dosing practices and laboratory monitoring. Standardized protocols for the use of rituximab in these disorders and more robust outcome reporting will help better define the safety and efficacy of rituximab in this population.

Patient Factors Associated with Prescribing of Iron for IV Administration: A Descriptive Study.

BACKGROUND: IV administration of iron is appropriate for the treatment of iron deficiency anemia (IDA) when orally administered iron has not been effective, tolerated, or clinically appropriate. In Calgary, Alberta, high levels of IV iron utilization required review, because of significant health care resource utilization, high cost, and reduced accessibility. OBJECTIVES: The primary objective was to describe the population of adult patients in Calgary with estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 for whom IV iron was dispensed from acute care facilities, in terms of pretreatment laboratory data, previous use of oral iron, and treatment location, as well as to characterize dose and product selection for IV iron. The secondary objective was to determine the proportion of inpatients whose treatment was in alignment with the Toward Optimized Practice clinical practice guideline for IDA. METHODS: A retrospective review of electronic charts was used to obtain data about patients with a first dose of IV iron dispensed in Calgary hospitals between March 1 and December 31, 2018. The data were analyzed descriptively. RESULTS: A total of 1352 patients met the inclusion criteria. These patients received a total of 3532 doses of IV iron, 97.1% of which were iron sucrose, at a median of 300 mg per infusion. Laboratory indices assessed before the first infusion were hemoglobin (mean 92, standard deviation [SD] 19.6 g/L), mean corpuscular volume (mean 81 [SD 10.3] fL), and ferritin (median 18 [interquartile range 9-48] µg/L). Among the included patients, 233 (17.2%) had oral iron dispensed within 90 days before their first IV dose of iron. Only 146 (20.1%) of the 726 inpatients had treatment that was in alignment with the Toward Optimized Practice IDA guideline. CONCLUSIONS: There was substantial variation in baseline hemoglobin, mean corpuscular volume, and ferritin, and in the use of oral iron before initiation of IV iron treatment. Provision of educational tools and stewardship initiatives may help in ensuring alignment of iron prescribing with current guidelines.

CONTEXTE: L'administration de fer par intraveineuse (IV) convient au traitement de l'anémie ferriprive lorsque son administration par voie orale n'a pas été efficace, tolérée ou appropriée d'un point de vue clinique. À Calgary (Alberta), il a fallu réviser les quantités de fer administrées par IV en raison de la mobilisation importante des ressources de soins de santé et des coûts élevés que cela exigeait ainsi que de l'accessibilité réduite au produit. OBJECTIFS: L'objectif principal consistait à décrire la population de patients adultes, dont le taux estimé de filtration glomérulaire était supérieur ou égal à 30 mL/min/1,73 m2 et à qui on administrait du fer par IV dans des installations de soins intensifs de Calgary. La description devait se faire en termes de données de laboratoire préalables au traitement, d'administration antérieure de fer par voie orale et de lieu du traitement; il s'agissait aussi de décrire la dose et la sélection du produit pour l'administration de fer par IV. L'objectif secondaire consistait à déterminer la proportion de patients hospitalisés, dont le traitement s'alignait sur les directives de pratique clinique Toward Optimized Practice relatives à l'anémie ferriprive. MÉTHODES: Un examen rétrospectif des tableaux électroniques a permis d'obtenir des données sur les patients, ayant reçu une première dose de fer par IV dans les hôpitaux de Calgary, entre le 1er mars et le 31 décembre 2018. Les données ont fait l'objet d'une analyse descriptive. RÉSULTATS: Au total, 1352 patients répondaient au critère d'inclusion. Ils ont reçu 3532 doses de fer par IV, dont 97,1 % de saccharose de fer à raison d'une médiane de 300 mg par perfusion. Les indices de laboratoire évalués avant la première perfusion concernaient l'hémoglobine (moyenne 92, écart-type [ET] 19,6 g/L), le volume corpusculaire moyen (moyenne 81 [ET 10,3] fL) et la ferritine (moyenne 18 [écart interquartile 9­48] µg/L). Parmi les patients de l'étude, 233 (17,2 %) avaient reçu du fer par voie orale 90 jours avant la première dose de fer administrée par IV. Seuls 146 (20,1 %) des 726 patients hospitalisés avaient reçu un traitement conforme aux directives de pratique clinique Toward Optimized Practice relatives à l'anémie ferriprive. CONCLUSIONS: On a constaté une variation importante de l'hémoglobine de base, du volume corpusculaire moyen et de la ferritine, ainsi que de l'utilisation du fer par voie orale avant le début du traitement par IV. Des outils pédagogiques et des initiatives de gestion pourraient aider à assurer l'alignement de la prescription de fer sur les directives actuelles.

Clinical practice guidelines for creating an acute care hospital-based antimicrobial stewardship program: A systematic review.

BACKGROUND: Antimicrobial stewardship programs (ASPs) are dedicated to improving antimicrobial use. Although clinical practice guidelines (CPGs) are available for the development of ASPs, it is unclear what the quality of these guidelines are. We therefore systematically reviewed published CPGs for the development of acute care hospital-based ASPs. METHODS: Primary literature, CPG and health technology assessment databases, and infectious diseases society websites were searched. Abstract and full-text review of the search results for inclusion were performed independently by 2 assessors. Overall quality of included CPGs was assessed using the Appraisal of Guidelines for Research and Evaluation II instrument. RESULTS: We identified 1,064 unique publications; 18 warranted full-text review. Five publications were included in the final review. The National Institute for Care and Excellence from the United Kingdom, the Dutch Working Party on Antibiotic Policy, and the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America from the United States all had high quality guidelines on the Appraisal of Guidelines for Research and Evaluation II scale. DISCUSSION: We identified 5 CPGs for creating a hospital-based ASP. Prior authorization and/or restriction policies that appeared in all 5 guidelines should be considered essential for the development of an effective hospital-based ASP. CONCLUSIONS: High quality CPGs are available for implementation of ASPs in acute care hospitals.

Antimicrobial stewardship in rural nursing homes: Impact of interprofessional education and clinical decision tool implementation on urinary tract infection treatment in a cluster randomized trial.

OBJECTIVES: To measure the impact of an antimicrobial stewardship initiative on the rate of urine culture testing and antimicrobial prescribing for urinary tract infections (UTIs) between control and intervention sites. Secondary objectives included evaluation of potential harms of the intervention and identifying characteristics of the population prescribed antimicrobials for UTI. DESIGN: Cluster randomized controlled trial. SETTING: Nursing homes in rural Alberta, Canada. PARTICIPANTS: The study included 42 nursing homes ranging from 8 to 112 beds.Methods/interventions:Intervention sites received on-site staff education, physician academic detailing, and integrated clinical decision-making tools. Control sites provided standard care. Data were collected for 6 months prior to and 12 months after the intervention. RESULTS: Resident age (83.0 vs 83.8 years) and sex distribution (female, 62.5% vs 64.5%) were similar between the groups. Statistically significant decreases in the rate of urine culture testing (-2.1 tests per 1,000 resident days [RD]; 95% confidence interval [CI], -2.5 to -1.7; P < .001) and antimicrobial prescribing for UTIs (-0.7 prescriptions per 1,000 RD; 95% CI, -1.0 to -0.4; P < .001) were observed in the intervention group. There was no difference in hospital admissions (0.00 admissions per 1,000 RD; 95% CI, -0.4 to 0.3; P = .76), and the mortality rate decreased by 0.2 per 1,000 RD in the intervention group (95% CI, -0.5 to -0.1; P = .002). Chart reviews indicated that UTI symptoms were charted in 16% of cases and that urine culture testing occurred in 64.5% of cases. CONCLUSION: A multimodal antimicrobial stewardship intervention in rural nursing homes significantly decreased the rate of urine culture testing and antimicrobial prescriptions for UTI, with no increase in hospital admissions or mortality.

Association of Dissemination of an Educational Communication Tool With Docusate Administration.

Importance: A clear message and call to action can affect the use of a medication with limited efficacy. Objectives: To assess the association of the dissemination of an educational document about the lack of efficacy of docusate with docusate administration and whether changing docusate administration was associated with a change in administration of comparable laxatives. Design, Setting, and Participants: In this quasi-experimental, pre-post study of all acute care and continuing care facilities serviced by Alberta Health Services in Alberta, Canada, an interrupted time series analysis was performed to examine the association of an educational communication tool with docusate administration from June 1, 2014, through May 31, 2016. Interventions: A Drugs & Therapeutics Backgrounder was disseminated to all pharmacists in December 2014. Backgrounders are academic detailing tools to assist pharmacists in supporting drug stewardship and are supplemented by online, interactive webinars. Main Outcomes and Measures: This study examined whether a decrease in docusate administration across the organization occurred after release of the backgrounder. Messaging in the backgrounder stated that, unless clinically necessary, docusate should not be replaced by another medication. This study assessed whether that message was accepted by measuring administration of comparable laxatives. Study medication administration is reported as defined daily doses (DDDs) per 1000 inpatient-days (PDs). Rates were compared for the 6 months before the intervention and 3, 6, 12, and 18 months after intervention. Results: Among the 111 acute care facilities (8500 beds) and 24 000 long-term care beds of the Alberta Health Services, predicted docusate administration decreased from preintervention (474 DDDs/1000 PDs) to 3 months (321 DDDs/1000 PDs; 95% CI, 304-465 DDDs/1000 PDs), 6 months (296 DDDs/1000 PDs; 95% CI, 277-456 DDDs/1000 PDs), 12 months (251 DDDs/1000 PDs; 95% CI, 207-499 DDDs/1000 PDs), and 18 months (214 DDDs/1000 PDs; 95% CI, 148-536 DDDs/1000 PDs). Administration of the comparable laxatives did not statistically significantly change (preintervention: 627 DDDs/1000 PDs; 18 months after intervention: 702 DDDs/1000 PDs; 95% CI, 295-694 DDDs/1000 PDs; P = .13). Conclusions and Relevance: A communication document supported by live presentations was associated with decreased administration of docusate up to 6 months, with a leveling of the association after 1 year. Significant systemic change can be achieved without extensive and complex interventions if the evidence and messaging are aligned.

Development of clinical pharmacy key performance indicators for hospital pharmacists using a modified Delphi approach.

BACKGROUND: Key performance indicators (KPIs) are quantifiable measures of quality. There are no published, systematically derived clinical pharmacy KPIs (cpKPIs). OBJECTIVE: A group of hospital pharmacists aimed to develop national cpKPIs to advance clinical pharmacy practice and improve patient care. METHODS: A cpKPI working group established a cpKPI definition, 8 evidence-derived cpKPI critical activity areas, 26 candidate cpKPIs, and 11 cpKPI ideal attributes in addition to 1 overall consensus criterion. Twenty-six clinical pharmacists and hospital pharmacy leaders participated in an internet-based 3-round modified Delphi survey. Panelists rated 26 candidate cpKPIs using 11 cpKPI ideal attributes and 1 overall consensus criterion on a 9-point Likert scale. A meeting was facilitated between rounds 2 and 3 to debate the merits and wording of candidate cpKPIs. Consensus was reached if 75% or more of panelists assigned a score of 7 to 9 on the consensus criterion during the third Delphi round. RESULTS: All panelists completed the 3 Delphi rounds, and 25/26 (96%) attended the meeting. Eight candidate cpKPIs met the consensus definition: (1) performing admission medication reconciliation (including best-possible medication history), (2) participating in interprofessional patient care rounds, (3) completing pharmaceutical care plans, (4) resolving drug therapy problems, (5) providing in-person disease and medication education to patients, (6) providing discharge patient medication education, (7) performing discharge medication reconciliation, and (8) providing bundled, proactive direct patient care activities. CONCLUSIONS: A Delphi panel of hospital pharmacists was successful in determining 8 consensus cpKPIs. Measurement and assessment of these cpKPIs will serve to advance clinical pharmacy practice and improve patient care.