The Canadian journal of hospital pharmacy最新文献

Background: Clinical studies in critical care sometimes require very short time frames for study inclusion and drug administration, which may occur at any time. To optimize patient management, experimental drugs can be made directly available within the study unit.

Objective: To determine key areas of focus for controlling the non-patient-specific drug dispensing process for experimental drugs used in clinical trials.

Methods: After a preliminary survey, 3 pilot units were selected: the surgical intensive care unit, the post-intervention surveillance unit (PISU), and the cardiology unit. The failure modes, effects, and criticality analysis (FMECA) risk assessment method was applied.

Results: A total of 281 risks were identified. The majority were "acceptable" - 123 (44%), 110 (39%), and 147 (52%) - or "tolerable" - 139 (49%), 148 (53%), and 130 (46%) - in surgical intensive care, the PISU, and cardiology, respectively. The number of "unacceptable" risks was 19 (7%), 23 (8%), and 4 (1%) in the 3 units, respectively. Communication was identified as the most critical process across all 3 units. Following risk prioritization, 17 corrective measures were proposed.

Conclusions: This study helped identify potential areas for intervention to control the non-patient-specific drug dispensing process. Once the proposed actions are implemented, a reduction in overall risk criticality is expected, with all remaining risks falling within acceptable or tolerable levels. In the long term, this project aims to improve the management of patients enrolled in critical care clinical trials and promote research within the units involved.

Background: Drug-induced liver injury (DILI) is an important but underdiagnosed adverse drug reaction in hospitalized patients. The complexity of diagnosis, under-reporting, and a lack of standardized assessment tools contribute to underestimation of its prevalence.

Objectives: To estimate the prevalence of DILI in a tertiary care hospital and to discuss the role of clinical pharmacists in using the Roussel Uclaf Causality Assessment Method (RUCAM) to detect, assess, and manage DILI.

Methods: This cross-sectional study included patients who were admitted between January and June 2022 to a tertiary care hospital in Porto Alegre, Brazil. All hospitalized patients with alanine aminotransferase (ALT) levels at least 3 times the upper limit of normal at any point during the hospital stay were screened. Suspected cases of DILI were evaluated by trained pharmacists using the RUCAM. Data were collected retrospectively from electronic medical records and analyzed using descriptive and inferential statistics.

Results: Of 56 014 patients admitted to the hospital during the study period, 1274 had elevated ALT, of whom 38 were classified by the RUCAM as having DILI. Among these, 33 (87%) experienced development of DILI during the hospital stay. Most of the patients (n = 29, 76%) were in general hospital wards, and this factor showed a significant association with occurrence of DILI. Anti-infectives were the most commonly implicated drugs (69%), specifically the combination of rifampicin, isoniazid, pyrazinamide, and ethambutol and various β-lactams. Simvastatin was also commonly implicated. None of the DILI cases were reported to the institutional pharmacovigilance system.

Conclusions: DILI remains under-recognized and under-reported in hospital settings. This study reinforces the potential role of clinical pharmacists in active surveillance using RUCAM and highlights the need for institutional strategies prioritizing the monitoring of liver function in high-risk patients, particularly on general wards.

Background: National consensus-based clinical pharmacy key performance indicators (cpKPIs) are health quality indicators representing processes of care associated with an impact on meaningful patient outcomes. Canadian hospitals are measuring cpKPIs at the local level. However, variations exist regarding which cpKPIs are measured and the associated cpKPI practice profiles. At the time this study was undertaken, a national registry did not exist to capture real-world cpKPI patient data and to track pooled national progress.

Objectives: To develop a national cpKPI patient registry, to characterize cpKPI-related care delivered, and to generate pooled national summary cpKPI reports to inform the advancement of pharmacy practice and improve patient outcomes.

Methods: In this national, retrospective, observational quality improvement study, hospitals measuring at least one cpKPI in at least one inpatient area were enrolled and submitted aggregated, de-identified cpKPI patient data for the calendar year 2018 (January to December). Patient-proportion cpKPI data for individual hospitals were summarized, and pooled national reports were generated.

Results: Overall, 32 Canadian health care organizations were enrolled, capturing 275 896 patient visits. The core analysis focused on 25 acute care institutions that were continuously measuring cpKPIs. The most commonly delivered cpKPI processes of care were development of a pharmaceutical care plan (59% of patients), resolution of drug therapy problems (37% of patients), and participation in interprofessional patient care rounds (36% of patients). The least commonly delivered cpKPI care services were patient medication education during the hospital stay (7% of patients), medication reconciliation at discharge (15% of patients), and patient medication education at discharge (17% of patients).

Conclusions: The first national registry for capturing clinical pharmacy health quality indicators was established and used to characterize real-world cpKPI-related patient care delivery. The findings from this registry could facilitate hospital-level cpKPI benchmarking and could support national sharing of best practices to advance pharmacy practice and improve patient outcomes.

Background: Following a restructuring of its pharmacy practices and activities, the pharmacy department of the Institut universitaire de cardiologie et de pneumologie de Québec developed a patient prioritization tool to optimize its delivery of pharmaceutical care. This tool assigns a vulnerability score to patients according to their medications and certain vulnerability factors established in the literature. The tool identifies vulnerable patients who need pharmaceutical care on a mandatory basis (within 1 day) or a priority basis (between 1 and 3 days).

Objective: To describe pharmacist interventions carried out for patients admitted to the study institution, in terms of pharmaceutical care provided in relation to scoring with the prioritization tool.

Methods: This prospective study involved patients admitted to the study institution for at least 48 hours between May 10 and May 19, 2023. The prioritization tool was applied for all included patients, who were followed prospectively throughout their stay. The pharmacists recorded their interventions on a data collection form. Data were analyzed using frequency analysis, and relationships between variables were expressed using the Pearson correlation coefficients and percentages.

Results: Of the 393 patients seen during the study period, 304 were included in the study. Of these, 186 had a priority designation and 64 had a mandatory designation, according to the prioritization tool. The pharmacists performed a total of 1023 interventions, with 194 of the 304 included patients receiving at least 1 pharmacist intervention. The number of interventions for each patient increased with the person's vulnerability score. The most frequent activities were chart review (n = 453, 44.3%), followed by the prescription (n = 115, 11.2%), dose adjustment (n = 64, 6.3%), and discontinuation (n = 64, 6.3%) of a medication. The mean response time was 1.25 days for patients deemed to need pharmaceutical care on a mandatory basis and 1.57 days for patients deemed to need care on a priority basis.

Conclusion: In this study, the number of interventions per patient increased with the person's vulnerability score. Although pharmacists responded faster than the recommended time for patients deemed to need care on a priority basis, the response time for patients needing care on a mandatory basis could be improved.

Background: Gene therapy using adeno-associated viruses (AAVs) has emerged as a promising approach for the treatment of genetic disorders, including hemophilia, a rare bleeding disorder. Recently approved AAV-based treatments for hemophilia, such as etranacogene dezaparvovec and fidanacogene elaparvovec, could provide long-term benefits by targeting the genetic basis of the condition. Nonetheless, the application of gene therapies presents several challenges that necessitate a multidisciplinary approach.

Objectives: To explore the challenges associated with AAV-based gene therapy and the role of pharmacy professionals in ensuring its safe and effective application, using treatment of hemophilia as a care model.

Data sources: Relevant literature was identified through searches in the PubMed, Embase, and Google Scholar databases, with a focus on publications related to AAV-based gene therapy, hemophilia, and the involvement of pharmacy professionals.

Study selection and data extraction: Peer-reviewed articles, clinical guidelines, and regulatory documents were selected based on their relevance to the clinical, logistical, and ethical dimensions of AAV-based gene therapy.

Data synthesis: Pharmacy professionals are integral to the continuum of care for AAV-based gene therapy. Their responsibilities include product handling and preparation, patient education, medication management, and long-term safety monitoring. Furthermore, pharmacy professionals can help address challenges such as financial obstacles, regulatory adherence, and ethical issues.

Conclusions: Using their expertise in medication management, patient education, and health system processes, pharmacy professionals can enhance the safety, effectiveness, and accessibility of AAV-based gene therapies for hemophilia, ultimately leading to better patient outcomes.

Background: Most hospitals in British Columbia have fewer than 200 beds, yet the clinical pharmacy services provided and factors influencing their delivery in this context are unknown.

Objectives: To describe on-site clinical pharmacy services and associated contextual barriers and enablers in small BC hospitals.

Methods: Between January and April 2022, an internet-based survey questionnaire was deployed to all pharmacy licence holders at BC hospitals with fewer than 200 beds (n = 23 licence holders representing 58 hospitals). Site characteristics, clinical activities, and barriers to and enablers of clinical pharmacy services (according to the Consolidated Framework for Implementation Research [CFIR]), as well as free-text responses, were captured.

Results: Of the 23 licence holders invited to participate, 18 (78%) responded, representing 37 (64%) of the small hospitals. Provision of clinical pharmacy services was reported at 27 (73%) of the 37 hospitals. Resolution of drug therapy problems and patient education were delivered at all of these hospitals. Conversely, the comprehensive patient care bundle and discharge medication reconciliation were never performed at 15 (56%) and 11 (41%), respectively, of these 27 hospitals. Of the 9 CFIR barriers, insufficient external networking and insufficient resources were reported by 17 (94%) and 16 (89%), respectively, of the 18 respondents. Funding and staffing barriers were reported, using free text, by 14 (78%) and 13 (72%), respectively, of the 18 respondents. Of the 21 CFIR enablers, the following 5 were reported by all respondents: agreement that clinical services are supported by adequate evidence, that such services will improve quality, that they will meet patient needs, that they will satisfy patients, and that a strong need exists for these services.

Conclusions: On-site clinical pharmacy services were delivered at most small BC hospitals; however, opportunities exist to expand clinical services. Pharmacy leaders should implement change strategies that overcome contextual barriers and enhance enablers.

Background: The antibiotic cefazolin is commonly used in pregnancy, as first-line prophylaxis for cesarean section wounds or as an alternative to penicillin for prophylaxis against group B Streptococcus. About 10% of people report a penicillin allergy, and clinicians have historically avoided the use of β-lactams (including cefazolin) in these individuals. Instead, they have used non-β-lactams, which can lead to poorer maternal outcomes.

Objective: To evaluate the safety of cefazolin in pregnant patients with a documented history of penicillin allergy.

Methods: This retrospective cohort study included all pregnant patients with a documented penicillin allergy at the time of receiving their first dose of cefazolin at a large tertiary care hospital (January 2016 to August 2021). Descriptive statistics were calculated.

Results: A total of 179 patients were included in the analysis. Most (175 [97.8%]) had no allergic adverse event after receiving cefazolin. Two patients (1.1%) experienced immunoglobulin E (IgE)-mediated hives, and 2 patients (1.1%) experienced non-IgE-mediated rashes. No patients experienced anaphylaxis, and no patients with a documented history of anaphylaxis to penicillins experienced an allergic adverse event related to cefazolin. All 4 patients who experienced an allergic adverse event were discharged with no readmission to the study institution associated with the allergic adverse event.

Conclusion: No patients with a documented history of anaphylaxis to penicillin experienced an allergic adverse event upon receiving cefazolin. Cefazolin was safely given to pregnant people with a history of penicillin allergy.

Background: The potential toxicity of excipients is a recurrent issue in pediatrics, particularly for neonates. The first IV formulation of acetaminophen approved in Canada (Avir Pharma Inc) contains the excipient povidone K-12, which lacks safety data for individuals with immature renal function, specifically, neonates, infants, and those with anuria. Povidone is eliminated by the kidneys and may accumulate in these populations.

Objective: To assess the safety of IV povidone K-12 in pediatrics.

Methods: The safety of IV povidone K-12 was assessed by first reviewing the available data and then measuring the amount of povidone K-12 exceeding the molecular weight threshold for glomerular filtration (25 000 g/mol). Size exclusion chromatography was used to assess the molecular weight of povidone K-12 to allow estimation of the proportions of povidone K-12 below various molecular weight thresholds.

Results: Case reports of povidone accumulation causing organ failure and death in adults were found in the literature. However, the published data were insufficient to assess the risk of accumulation, as no reliable molecular weight determinations could be found. Measurements by chromatography showed that the amount of povidone exceeding the molecular weight threshold of 25 000 g/mol was less than 2 ppm (0.0002%), which suggests a low risk of accumulation despite immature renal function.

Conclusions: Povidone K-12 is unlikely to accumulate in neonates, infants, or patients with impaired renal function, with the possible exception of patients with anuria.