International Journal of Clinical Pharmacy最新文献

Background: The second victim phenomenon, denoting the harmful effects of patient safety incidents on healthcare practitioners, remains insufficiently examined within the pharmacy workforce.

Aim: This study aimed to investigate the second victim phenomenon in community pharmacies, focusing on its triggers, impacts on pharmacists' well-being, and effects on pharmaceutical care and safety.

Method: This consensus study with the Nominal Group Technique involved 27 community pharmacists in three equal groups. The final ranks of the statements scored by participants from 5 to 1 were recalculated using the Van Breda method, combining three distinct data sets with higher values for a higher impact on the output evaluated. Statistics were applied to ascertain event distribution and investigate the potential relationships between event categories and outcomes for patients and pharmacists.

Results: "Patient-centric anxiety" (6.8) was the top mental health issue, followed by "Personal responsibility and resilience" and "Future concerns and career aspirations" (6.0 each). The dominant support was "Colleague/Peer support" (5.3). The most frequent patient safety incidents were "Inadequate pharmaceutical service" (8.0) and "Wrong drug dispensed" (7.8). Most errors (63%) were dispensing failures, primarily wrong drug dispensed (44.4%). Of these, 50% were near misses, 25.0% caused no harm, and 16.7% had serious consequences. Field notes suggest contributing factors like inadequate supervision, crowding, and storage issues.

Conclusion: This study revealed the second victim phenomenon among pharmacists, which potentially stems from breaches in practice standards. The impact on the quality and safety of pharmaceutical care and its influence on pharmacists' well-being should be studied in further studies.

Background: Drug-induced hypofibrinogenemia has received increasing scrutiny; however, the specific drugs involved remain poorly characterized. Hypofibrinogenemia can have significant clinical implications, including increased bleeding risks.

Aim: This study aimed to utilize the FDA Adverse Event Reporting System (FAERS) to identify and analyze drugs frequently implicated in drug-induced hypofibrinogenemia.

Method: A disproportionality analysis was conducted using FAERS data from January 2004 to March 2024. Various statistical tools were used, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio, Medicines and Healthcare Products Regulatory Agency metrics, and Bayesian confidence propagation neural network.

Results: The analysis included 17,627,340 cases involving 52,373,206 adverse events, with 1,661 cases identified as hypofibrinogenemia. The top five drugs associated with hypofibrinogenemia by case number were methotrexate (124 cases), tigecycline (119 cases), tocilizumab (100 cases), pegaspargase (83 cases), and alteplase (57 cases). The drugs ranked by signal strength based on ROR included eravacycline (ROR 2173.84, 95% CI 1208.80-3909.30), tigecycline (ROR 747.34, 95% CI 619.03-902.24), crotalidae polyvalent immune Fab (ROR 407.67, 95% CI 291.07-570.99), pegaspargase (ROR 216.06, 95% CI 173.15-269.61), and asparaginase (ROR 184.93, 95% CI 132.18-258.72).

Conclusion: This analysis of FAERS data identified 52 drugs associated with hypofibrinogenemia, most (88.5%) of which do not mention this risk in their prescribing information. These findings demonstrate the need for the monitoring of blood fibrinogen and may serve as a reference for the explore of the characteristics and underlying mechanism of drug-induced hypofibrinogenemia in the real world.

Background: Deprescribing inappropriate cardiovascular and antidiabetic medication has been shown to be feasible and safe. Healthcare providers often perceive the deprescribing of cardiovascular and antidiabetic medication as a challenge and therefore it is still not widely implemented in daily practice.

Aim: The aim was to assess whether training focused on conducting a deprescribing-oriented clinical medication review (CMR) results in a reduction of the inappropriate use of cardiovascular and antidiabetic medicines.

Method: A cluster randomized controlled trial involving 20 community pharmacists, who conducted a clinical medication review in 10 patients. The intervention group received training on deprescribing. Patients 70 years or older with polypharmacy having a systolic blood pressure below 140 mmHg and using antihypertensive medication and/or an HbA1c level below 54 mmol/mol and using antidiabetic medication, were included. Follow-up took place within 4 weeks (T1) and after 3 months (T2). The primary outcome measure was the proportion of patients with one or more cardiovascular and antidiabetic medicine deprescribed within 3 months after the CMR (T2).

Results: A total of 71 patients in the intervention group and 69 patients in the control group were included. At T2, 32% of patients in the intervention group and 26% in the control group (OR 1.4, CI 0.65-2.82, p = 0.413) had one or more cardiovascular or antidiabetic medicines discontinued. Regarding any medication, these percentages were 51% and 36%, (OR 1.8, CI 0.92-3.56, p = 0.085) respectively.

Conclusion: Increased awareness and ability of community pharmacists to deprescribe medication and use of general practitioners' data, led community pharmacists and general practitioners to successfully conduct a more deprescribing-focused CMR in daily practice. Further research is needed to assess the necessity of additional training to optimize the deprescribing of cardiovascular and antidiabetic medication. The study was registered at The Netherlands Trial Register (registration no: NL8082).

Background: Few studies have examined the use of self-screening tools and patient alert cards (PAC) for screening adverse drug reactions (ADRs).

Aim: To evaluate the benefits of self-screening tools and PAC for screening ADRs.

Method: A prospective study of outpatients was conducted at a tertiary care teaching hospital. The sample included patients over 18 years of age who were currently taking one of four prescription medicines-methotrexate, sulfasalazine, cyclosporine, or prednisolone. A self-screening tool was distributed to patients in either hard copy or on-line format depending on patient preference. Simple random sampling was used to assign patients to either receive a PAC or not.

Results: A total of 922 self-screening tools were distributed with 709 returned (71.5%). Over half (n = 388) of the respondents reported a total of 3437 symptoms that they credited to their medication. The most commonly reported symptom was angioedema (15.8%). The majority of patients (76.7%) used the temporal relationship between the onset of symptoms and the administration of the drug to decide if their ADR was associated with the drug and this proportion was higher in respondents who selected the online self-screening tool (70.7% and 83.2%, p = 0.040). Half of the patients reported high satisfaction with their PACs.

Conclusion: Providing patients with a self-screening tool and a PAC supported patients to report more ADRs compared to rates for spontaneous reporting alone. We propose that they should be provided to all patients to increase ADR reporting and to encourage HCPs to provide drug information, thereby improving patient medication safety.

Background: Pancreatic cancer (PC) is a malignant tumor with a low survival rate. Lipid modifiers show potential for PC therapy, but evidence is lacking.

Aim: This Mendelian randomization (MR) study aimed to explore the relationship between lipid traits, and lipid-lowering drug target genes with PC risk.

Method: Genetic instrumental variables associated with lipid traits and lipid-lowering drug target genes were used to perform MR analyses of PC risk. MR estimation was based on genome-wide association study data from two large sample sets, and the MR results were meta-analyzed to assess their impact on PC risk. To ensure the reliability of lipid-modifying drug targets, we conducted a Summary Data-based Mendelian Randomization (SMR) analysis. Additionally, a two-step MR analysis was employed to explore potential mediating effects.

Results: In two independent datasets, HMG-CoA reductase (HMGCR) inhibition was statistically associated with a lower risk of PC (OR 0.50, [95% CI 0.25-1.00]; p = 0.0453). The results were further supported by SMR analysis, which showed a similar association (OR 0.51, [95% CI 0.28-0.96]; p = 0.0369). Mediation analysis revealed that 11.69% of the protective effect of HMGCR inhibitors on PC is mediated through lower BMI levels. No significant effect of lipid traits and the other eight lipid-lowering drug targets on PC risk was found.

Conclusion: This study suggests that HMGCR may be a potential drug target for the treatment or prevention of PC, providing important insights into the use of lipid-targeted drugs in PC therapy.

Background: Maribavir is a novel antiviral agent targeting cytomegalovirus through inhibition of the UL97 protein kinase, exhibiting a distinct mechanism of action. However, limited data are available on its safety profile post-marketing.

Aim: This study aimed to evaluate the adverse events (AEs) associated with maribavir using the Food and Drug Administration's Adverse Event Reporting System (FAERS), providing insights to inform clinical practice.

Method: We conducted a retrospective analysis of maribavir-related adverse event reports from the FAERS database, spanning the fourth quarter of 2021 to the second quarter of 2024. Signal detection was performed using four statistical methods: the proportional reporting ratio, reporting odds ratio, Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker.

Results: A total of 1372 reports associated with maribavir were identified. Seven significant signals emerged at the system organ class level. At the preferred term level, 76 adverse events (AEs) demonstrated positive signals, including novel events such as pleural effusion, hypersomnia, and anosmia, alongside signals related to ear disorders. The majority of AEs were reported within the first month of maribavir use.

Conclusion: This study identified several new adverse event signals for maribavir, offering healthcare professionals a deeper understanding of its safety profile, which may guide safer clinical usage.

Background: Recent studies suggest that duloxetine administration before non-laparoscopic surgery may reduce postoperative pain and analgesic requirement without increasing adverse event occurrence.

Aim: To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) on preoperative administration of duloxetine versus placebo for postoperative pain relief in adults undergoing laparoscopic surgery, assessing efficacy- and safety-related outcomes.

Method: We systematically searched MEDLINE, Embase, and Cochrane Library, covering all records up to July 19, 2024. Inclusion criteria consisted of RCTs comparing preoperative administration of duloxetine versus placebo in adults undergoing laparoscopic surgery and reporting at least one outcome of interest. The random-effects model was used to estimate the mean difference (MD) and risk ratio (RR), along with their respective 95% confidence intervals (95%CIs).

Results: We included four RCTs (227 patients). Compared with placebo, duloxetine provided a statistically lower pain scores at 2 (MD - 1.04; 95%CI - 1.75, - 0.33), 4 (MD - 1.28; 95%CI - 1.77, - 0.79), 8 (MD - 1.22; 95%CI - 1.72, - 0.72), 12 (MD - 1.64; 95%CI - 2.88, - 0.41), and 24 h (MD - 1.05; 95%CI - 1.72, - 0.39) after surgery. Duloxetine also granted a statistically longer time to first analgesic requirement (MD 128.38 min; 95%CI 41.31, 215.46), compared with placebo. Additionally, the duloxetine group had a significantly lower risk of nausea/vomiting (RR 0.48; 95%CI 0.25, 0.90), while there were no significant differences between both groups for the risk of dizziness, headache, and somnolence.

Conclusion: Compared with placebo, duloxetine administration before laparoscopic surgery significantly minimized postoperative pain intensity, delayed analgesic requirement, and reduced nausea/vomiting risk.

Background: Lung cancer is the leading cause of cancer-related deaths in China, and pembrolizumab shows differential efficacy in advanced non-small cell lung cancer (NSCLC) with different PD-L1 expression levels.

Aim: To assess the cost-effectiveness of PD-L1 testing associated with pembrolizumab for first-line treatment of NSCLC from the perspective of Chinese healthcare system.

Method: Over a lifetime horizon, a three-state partitioned survival model was developed to assess the cost-effectiveness of PD-L1 testing and no PD-L1 testing. In the PD-L1 testing group, patients were stratified by PD-L1 tumor proportion score ≥ 50%, 1-49%, or < 1% and received pembrolizumab monotherapy, pembrolizumab plus chemotherapy, or chemotherapy alone, respectively. In the non-PD-L1 testing group, all patients received pembrolizumab plus chemotherapy. Model inputs were obtained from published literature and a healthcare price database, and clinical outcomes from two randomized clinical trials were used. The net monetary benefit (NMB) was estimated for the PD-L1 testing group versus the non-PD-L1 testing group. Deterministic and probabilistic sensitivity analyses, and scenario analyses were conducted to assess robustness of results.

Results: Using PD-L1 testing to guide treatment led to cost savings of $49,392.7 and a reduction in quality-adjusted life years (QALYs) of 0.234, resulting in a positive NMB of $46,421.7 at a willingness-to-pay (WTP) threshold of $12,680.8/QALY (GDP per capita in China, 2023). Findings were robust across sensitivity and scenario analyses.

Conclusion: Using PD-L1 testing to guide first-line pembrolizumab treatment in patients with advanced NSCLC is a cost-effective strategy at a WTP threshold of $12,680.8/QALY for China.

Background: Drug-related problems (DRPs) are significant issues in healthcare contributing to adverse health outcomes and increased healthcare costs. While community pharmacists play a pivotal role in identifying, classifying, and documenting DRPs, there is a need to map approaches undertaken.

Aim: The aim of this scoping review was to examine the approaches to identifying, classifying, and documenting DRPs in community pharmacies in Europe, and their associated barriers and facilitators.

Method: The scoping review was conducted according to the Joanna Briggs Institute guidelines and reported according to the PRISMA-ScR guidelines. The search was conducted across 11 databases from inception until March 2023. Studies of all designs reporting DRPs in European community pharmacies were included. Titles, abstracts, and full texts were screened independently by two researchers, followed by data extraction and synthesis.

Results: The search yielded 67 relevant studies. Forty-eight studies described approaches to DRP identification as predominantly relying on professional knowledge and computer software. The classification methods, described in 41 studies, varied with reports of predefined systems and computer-generated classifications. Documentation approaches were described in 53 studies and were primarily computer-based. Facilitators included electronic support systems, pharmacist experience, while barriers encompassed the complexity of classification as well as variations in training, IT solutions, operational structures, and implementation.

Conclusion: There is a lack of a standardized approach to identifying, classifying, and documenting DRPs in European community pharmacies. A framework for pharmacist education and a time-saving approach to documenting DRPs consistently could serve to overcome the barriers to their identification and documentation. Furthermore, the implementation of a standardised approach to classifying DRPs could facilitate comparison of the management of DRPs across Europe.