The latest medical research on Clinical Pharmacology

The research magnet gathers the latest research from around the web, based on your specialty area. Below you will find a sample of some of the most recent articles from reputable medical journals about clinical pharmacology gathered by our medical AI research bot.

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Adverse events of nivolumab plus ipilimumab versus nivolumab plus cabozantinib: a real-world pharmacovigilance study.

International Journal of Epidemiology

No head-to-head clinical trials have compared the differences in adverse events (AEs) between nivolumab plus ipilimumab (NIVO-IPI) and nivolumab plus cabozantinib (NIVO-CABO) in the treatment of metastatic renal cell carcinoma (mRCC).

We analysed the two largest real-world databases, the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the World Health Organization's VigiBase, to elucidate the differences in AEs between NIVO-IPI and NIVO-CABO.

In total, 40,376 and 38,022 records were extracted from FAERS and VigiBase, and 193 AEs were analysed. The reporting odds ratios (ROR) with 95% confidence interval were calculated using a disproportionality analysis (NIVO-CABO/NIVO-IPI).

The reported numbers of immune-related AEs, including myocarditis, colitis, and hepatitis, were significantly higher with NIVO-IPI (ROR = 0.18 for FAERS and 0.13 for VigiBase). Contrarily, the reported numbers of other AEs, including gastrointestinal disorders (ROR = 2.68 and 2.92) and skin and subcutaneous tissue disorders (ROR = 2.94 and 3.55), considered to be potentiated by the combination of NIVO and CABO, were higher with NIVO-CABO.

Our findings contribute to the selection and clinical management of NIVO-IPI and NIVO-CABO, which minimizes the risk of AEs for individual patients with mRCC by considering distinctive differences in the AE profiles.

A systematic review of the impact of simulation on students' confidence in performing clinical pharmacy activities.

International Journal of Epidemiology

Although confidence does not automatically imply competence, it does provide pharmacy students with a sense of empowerment to manage a pharmacotherapeutic problem independently. Among the methods used in higher education, there is growing interest in simulation.

To evaluate the impact of simulation on pharmacy students' confidence in performing clinical pharmacy activities.

Articles that reported the use of simulation among pharmacy students with fully described outcomes about confidence were included. Studies for which it was impossible to extract data specific to pharmacy students or simulation were excluded. The search was carried out in Medline, Embase, Lissa and PsycInfo from inception to August the 31th, 2022. The results were synthesized into 4 parts: confidence in collecting information, being an expert in a procedure/pathology, counselling and communicating, and other results. The quality assessment of included studies was conducted using the Mixed Methods Appraisal Tool "MMAT" tool.

Among the 39 included articles, the majority were published in the last 5 years and conducted in the United States. The majority included pharmacy students in years 1 through 3 (69.2%). The most common study design was the pre-post uncontrolled design (66.7%). Studies measuring the effects of human and/or virtual simulation were mainly focused on confidence to counsel and/or communicate with patients and colleagues (n = 20). Evaluations of the effects of these types of simulation on confidence in information gathering by health professionals were also well represented (n = 16).

Simulation-based training generally yielded positive impact on improving pharmacy students' confidence in performing clinical pharmacy activities. Rigorous assessment methods and validated confidence questionnaires should be developed for future studies.

Venous Thromboembolism Prophylaxis in Obstetric Patients.

Journal of Pharmacy and Pharmacology

Venous thromboembolism (VTE), including both pulmonary embolism (PE) and deep vein thrombosis (DVT), is the leading cause of maternal death in deve...

Comparison Evaluation of Automated Nucleated Red Blood Cell Enumeration by Sysmex XN 1000 in Comparison With Microscopic Reference in Children Under 1 Year.

Clinical Laboratory

In newborns, elevated nucleated red blood cell (NRBC) levels can be associated with enhanced erythropoietic stress and might be predictive for adverse outcome. Also, the presence of NRBC in peripheral blood might lead to erroneous enumeration results of white blood cells in automated hematology analyzers. We aimed to assess the comparability of the Sysmex XN 1000 to manual slide reviews and correlation of NRBC with inflammation markers.

Specimens of 3397 children under 1 year were compared by automated and microscopic NRBC enumeration. Additionally, potential correlations between NRBC and age and inflammation markers were examined.

Overall, there was good correlation (r = 0.97) between automated (range: 0%-3883%) and microscopic enumeration (range: 0%-3694%) of NRBC with high comparability up to a NRBC value of 200% and an increase in the variation between the two methods with increasing NRBC numbers. When 94 samples with ≤ 200% NRBC and ≥ 30% divergence between methods were separately reanalyzed with respect to overlapping cell populations in their scattergrams, Sysmex would have generated unrecognized incorrect automated results in 47 samples, corresponding to 1.4% of total study samples. NRBC counts were negatively correlated to age, but not to inflammation markers.

Sysmex XN 1000 is highly precise in the enumeration of NRBC in children under 1 year up to counts of 200% and might replace time-intense manual counting in routine diagnostics. In the setting of neonatal and intensive care diagnostics, microscopic control and supervision of scattergrams are highly recommended for any automated NRBC enumeration processes.

Reliability of a Screening Method Using Antibiotic Disks to Detect Carbapenemases in Glucose-Nonfermenting Gram-Negative Microorganisms From Clinical Samples of a Regional Hospital in Southeastern Spain.

Clinical Laboratory

Infections by glucose-nonfermenting gram-negative bacilli (NFGNB) pose a major public health problem due to multiresistance to beta-lactam antibiotics, especially plasmid-borne carbapenemases. Their detection by microbiology laboratories is challenging, and there is a need for easy-to-use and reliable diagnostic techniques. Our objective was to evaluate an in-house screening method to presumptively detect carbapenemases in NFGNB in a simple and clinically useful manner.

The study included 175 NFGNB isolates from urinary, respiratory, and rectal samples. In a triple assay, isolates were incubated at 37°C for 24 h on three solid-culture media: MacConkey II Agar, 5% Sheep Blood Columbia Agar and Mueller Hinton II Agar; meropenem (MEM) and cefepime (FEP) disks were employed for screening. Studies were then performed on the inhibition halo diameter, scanning effects, and the appearance of mutant colonies, which were compared with those observed using the colorimetric Neo-Rapid CARB Kit and immunochromatography (NG5-Test Carba and K-Set for OXA-23). Receiver operating characteristic curves were constructed for these data.

Carbapenemases were expressed by 79/175 (45.1%): 19 Pseudomonas aeruginosa and 60 Acinetobacter baumannii. Optimal inhibition halo diameter cutoffs to detect this resistance on 5% sheep blood agar were as follows: 6 mm (MEM) and 6.5 mm (FEP) for P. aeruginosa (in the absence of scanning effects and mutations) and 10.5 mm (MEM) and 16 mm (FEP) for A. baumannii (even in the presence of scanning effects).

The combined utilization of MEM and FEP antibiotic disks in 5% sheep blood agar, measuring their inhibition haloes, offers an effective method to predict the presence of carbapenemases as resistance mechanism in P. aeruginosa and A. baumannii.

Pregabalin-Induced Parkinsonism: Case Report and Review of the Literature.

Journal of Pharmacy and Pharmacology

Pregabalin is an anti-epileptic drug approved for the treatment of neuropathic pain and focal-onset seizures. In a few cases, pregabalin was associ...

Characterization of the Benefits and Risks of Therapeutic Anticoagulation in Patients Admitted with Severe COVID-19 (CRITAC).

Canadian Journal of Psychiatry

Severe COVID-19 is associated with increased rates of thrombotic complications. Recent provincial recommendations in British Columbia have suggested providing thromboprophylaxis with therapeutic anticoagulation for hospital inpatients with severe COVID-19 who do not have a high risk of bleeding.

To characterize the rates of major bleeding, thrombotic events, complications from COVID-19, and adverse effects among patients with severe COVID-19 treated with therapeutic anticoagulation.

This retrospective chart review involved patients with laboratory-confirmed COVID-19 who were admitted to 3 sites within a local health authority between April 1 and December 31, 2021, and received therapeutic anticoagulation for thromboprophylaxis.

After screening of 1036 patients, 72 patients were included in the study. The mean age of participants was 54 years, 63% (n = 45) were male, and 92% (n = 66) were receiving supplemental oxygen by nasal prongs on admission. The primary outcome, major bleeding, was experienced by 1 patient (1%). Increasing oxygen requirements resulting in progression to high-flow nasal cannula occurred in 11 patients (15%), and 5 patients (7%) required admission to the intensive care unit. One patient (1%) experienced a thrombotic event, and 1 patient (1%) had a minor bleed. The mean duration of hospitalization was 10 (standard deviation 10.8) days. One death occurred during the study period, and no cases of heparin-induced thrombocytopenia were observed.

In this study of hospital inpatients with severe COVID-19 who were deemed to be at low risk of bleeding and who received therapeutic anticoagulation, there were low rates of both major bleeding and thrombotic events.

Two for One: Merging Continuing Professional Development and Faculty Development in the CATE Curriculum for Pharmacy Preceptors.

Canadian Journal of Psychiatry

Continuing professional development (CPD) and faculty development (FD) are not traditionally combined, although there is evidence that integrating them enhances knowledge acquisition.

To explore preceptors' perceptions and the effectiveness of CATE (Clinical And Teaching Education), an education model that blends clinical content with the application of that clinical knowledge through a specified teaching technique.

Thirty-five hospital and community pharmacy preceptors from the Leslie Dan Faculty of Pharmacy, University of Toronto, participated in CATE, which consisted of a 2-hour synchronous, online workshop integrating clinical content about depression with the "One-Minute Preceptor" (OMP) teaching skill. Qualitative and quantitative data were collected longitudinally using surveys and semistructured interviews. Participant and process outcomes were explored through descriptive and thematic analysis using a modified Kirkpatrick framework.

Participants valued the incorporation of educational theory and opportunities to practise the OMP using scripted role plays based on the depression-related content. The combination of FD and CPD was appealing, although participants wanted more clarity about their integration. The CATE model positively influenced their approaches to serving as preceptors, and using the OMP helped to reveal learners' knowledge gaps. There was a desire to share the teaching technique with colleagues to provide a more cohesive approach to teaching.

Integrating CPD and FD in a synchronous, online environment was feasible and well received, and it helped to solidify preceptors' roles as educators. Combining CPD and FD represents an effective strategy to build the clinical and educational expertise of preceptors, which in turn has the potential to improve the quality of experiential learning for pharmacy students. This novel method of fostering the pedagogical growth of preceptors could be a model for other health professions.

[Not Available].

Canadian Journal of Psychiatry

Since 2022, it has been mandatory in Québec to report all incidents and accidents (I&As) occurring in health-care facilities. Since 2011, a summary report of these I&As has been published each year. However, it is difficult to compare health facilities given that no denominator is specified and ratios are not calculated.

The primary objective was to calculate the ratios of total I&As and medication-related I&As per 1000 inpatient-days per type of facility for all health-care facilities in Québec.

This retrospective descriptive study was based on data from the period of April 1, 2016, to March 31, 2021. Data were extracted from the National Register of Incidents and Accidents Occurring during the Provision of Health Care and Social Services in Québec (Registre national des incidents et accidents survenus lors de la prestation des soins et services de santé au Québec) and financial reports. The ratios of total I&As/1000 inpatient-days and medication-related I&As/1000 inpatient-days, expressed as the mean ± standard deviation and median [minimum; maximum], were calculated.

A total of 85 health-care facilities had usable data, specifically 33 acute-care facilities, 45 long-term care facilities, and 7 rehabilitation facilities. The mean ratio for total I&As/1000 inpatient-days varied from 33 ± 19 to 38 ± 22 in acute-care facilities, from 14 ± 5 to 16 ± 7 in long-term care facilities, and from 99 ± 39 to 147 ± 55 in rehabilitation facilities. The mean ratio for medication-related I&As/1000 inpatient-days varied from 11 ± 7 to 12 ± 7 in acute care facilities, from 3 ± 2 to 4 ± 3 in long-term care facilities, and from 24 ± 10 to 40 ± 21 in rehabilitation facilities.

This exploratory study demonstrated the feasibility of calculating I&A ratios from the National Register of Incidents and Accidents Occurring during the Provision of Health Care and Social Services in Québec. These ratios facilitate discussion of the reporting culture of I&As within the health-care system. It is hoped that these ratios will be added to future annual reports from the Québec I&A register.

Assessing Hospital Pharmacists' Scope of Clinical Practice in Ontario.

Canadian Journal of Psychiatry

Expansion of the scope of pharmacists' activities in hospital is associated with reductions in adverse events and drug-related readmissions. However, the breadth of hospital pharmacists' clinical activities varies widely across Ontario due to provisions in the provincial Public Hospitals Act. Few data exist defining expanded scope in institutions across Ontario.

The primary objective was to describe the scope of practice of hospital pharmacists in Ontario who were undertaking expanded clinical activities based on policies or medical directives. The secondary objectives included determining benefits, limitations, facilitators, and barriers associated with implementing these activities.

A survey was sent to the pharmacy leadership of Groups A and B public hospitals across Ontario. The survey contained quantitative and qualitative questions focused on 3 domains of expanded-scope activities: adaptation, discontinuation, and renewal of medication orders; prescriptive authority; and drug monitoring.

Of 56 hospitals invited, 46 (82%) submitted a survey response, with 1 exclusion (due to no response on some mandatory questions). The most common expanded-scope activity was independent performance of therapeutic drug monitoring (71%, 32/45). Pharmacists had the authority to independently adapt, discontinue, or renew inpatient medication orders in 60% (27/45) of hospitals, and could independently initiate medication orders in 20% (9/45). Barriers to implementing expanded-scope activities included limited time and staffing. Facilitators included proactive leadership, demonstrated clinical value, and strong rapport with other health care providers.

Many institutions in Ontario have established polices to expand pharmacists' clinical activities, but there is a great deal of variability in scope of practice. Advocacy at the provincial level to unify scope of practice will help to optimize patient outcomes.

[Not Available].

Canadian Journal of Psychiatry

The safety of care provided is based on an analysis of medication incidents and accidents.

The primary objective was to describe medication-related incidents and accidents (I&A) within a university-affiliated hospital.

This retrospective descriptive study was based on data from a 500-bed mother-child university-affiliated hospital. All I&As declared between April 1, 2018, and March 31, 2022, were considered. The analysis included all medication-related I&As that occurred during an admission or in an outpatient setting. Some variables were recoded manually. Descriptive statistical analyses were performed.

A total of 23 284 I&As were considered, including 7578 medication-related I&As. Daily averages of 15.9 ± 14.0 I&As and 5.2 ± 0.3 medication-related I&As were reported. There were 22.4 medication-related I&As/1000 inpatient days. The majority of medication-related I&As occurred in surgery (20%, 1530/7578), oncology (19%, 1405/7578), and pediatrics (16%, 1200/7578). Most were associated with incorrect dosing (21%, 1575/7578); infiltration, extravasation, or removed lines (19%, 1405/7578); and omissions (16%, 1205/7578). Physical consequences were reported in 15% (1158/7578) of the medication-related I&As. Conversely, psychological consequences were reported in less than 1% (44/7578) of medication-related I&As.

This study provides a comprehensive descriptive profile over a 4-year period. Most of the reported I&As did not lead to consequences for patients. The sharing of ratios promotes comparative analysis with other facilities and can contribute to discussions about risk reduction. A culture of reporting events is present within this health care facility.

Characteristics of Drug Poisonings Seen in the Emergency Department of an Urban Hospital.

Canadian Journal of Psychiatry

Drug poisoning, either intentional or non-intentional, is a frequent diagnosis in the emergency department (ED), necessitating patient management from multiple services.

To describe the drug poisonings seen in the ED of a large academic urban hospital.

This retrospective descriptive study used 3 years of data (2018-2020) abstracted from the hospital's electronic medical record system and linked to validated, coded extracts from the Canadian Institute for Health Information Discharge Abstract Database. Patients with a diagnosis of acute drug poisoning who presented to the ED were identified on the basis of International Statistical Classification of Diseases and Related Health Problems, 10th revision, Canada (ICD-10-CA) codes, and data were collected for demographic characteristics, the drugs involved, in-hospital management, and inpatient outcomes. Patients with diagnosis of an acute drug reaction, inebriation, or nondrug or in-hospital poisoning were excluded. Data were stratified and analyzed in relation to the intent of drug poisoning.

A total of 2983 visits for drug poisoning, involving 2211 unique patients (mean age 38.3 [standard deviation 16.2] years, 54.7% female), were included, yielding an overall incidence rate of 15.7 drug poisonings per 1000 ED visits (8.1 intentional, 6.4 non-intentional, and 1.3 unknown intent). Among the 1505 intentional drug poisonings, the most prevalent drug sources were antidepressants (n = 405, 26.9%), benzodiazepines (n = 375, 24.9%), and acetaminophen (n = 329, 21.9%); in contrast, opioids (n = 594, 48.1%) were most prevalent for the 1236 non-intentional poisonings. For 716 (24.0%) of the poisoning visits, the patient was admitted to acute care services, and the in-hospital mortality rate was 1.0% (n = 31). In addition, 111 patients (9.0%) with non-intentional drug poisoning left against medical advice. Finally, for 772 (25.9%) of the poisoning visits, the patient returned to the ED after discharge with a subsequent drug poisoning.

Drug poisonings are a common cause of visits to urban EDs. They are rarely fatal but are associated with substantial utilization of hospital resources and considerable recidivism.