International Journal of Clinical Pharmacy最新文献

Background: Glucagon-like peptide 1 (GLP-1) analogues are a class of medications that stimulate glucose-dependent insulin release and slow gastric emptying. With the increasing use of GLP-1 analogues, concerns about potential psychiatric adverse events (AEs) remain under-explored.

Aim: This pharmacovigilance study aimed to investigate the prevalence of psychiatric AEs associated with currently available GLP-1 analogues by analysing publicly available national datasets from the US (FAERS), Canada (CVAROD) and Australia (DAEN).

Method: Psychiatric AE reports were extracted from all three databases for all approved GLP-1 analogues. A disproportionality analysis was conducted to calculate reporting odds ratios (RORs) and 95% confidence intervals (CIs) for psychiatric AEs of interest.

Results: Significant associations were identified when multiple databases reported elevated RORs. Semaglutide was associated with depressive symptoms (FAERS, ROR = 6.24 CI 4.49-8.69), panic attacks (FAERS, ROR = 1.46 CI 1.16-1.82) and suicidal ideation (FAERS, ROR = 2.58 CI 2.31-2.88). Liraglutide was linked to depression (CVAROD, ROR = 1.68 CI 1.12-2.51), while dulaglutide showed positive associations with eating disorders (FAERS, ROR = 1.47 CI 1.26-1.71) and insomnia (FAERS, ROR = 2.93 CI 2.35-3.66).

Conclusion: GLP-1 analogues, particularly semaglutide and liraglutide, are associated with significant psychiatric AEs, especially depression and suicidal ideation. Further studies are required to understand the mechanisms underlying these associations, particularly in patients with pre-existing psychiatric conditions.

Introduction: To improve access to innovative medications, the Chinese government introduced a dual-channel policy, allowing community pharmacies to dispense innovative drugs listed in the National Reimbursement Drug List of the national healthcare security system. However, research on how community pharmacies interpret and respond to these policies remains limited.

Aim: To investigate community pharmacy manager/ pharmacist perceptions of and responses to the dual-channel policy, with a focus on improving accessibility and the rational use of innovative drugs for patients in China.

Method: A qualitative research design, involving semi-structured interviews, was conducted in Jiangsu Province, China. The interview guide was developed to address key domains relevant to community and licensed pharmacists. The participants were recruited through purposive and snowball sampling to ensure diverse perspectives. The interviews were audio-recorded, transcribed, and analyzed using the framework method. NVivo software was used for coding and theme development, until theoretical saturation was achieved.

Results: The participants viewed the dual-channel policy as an opportunity to expand business operations and enhance market competitiveness. However, they also identified several challenges, including space and storage constraints, regional inconsistencies in electronic prescription systems, limited influence on hospital prescription flows, selective partnerships with pharmaceutical companies, and elevated service expectations from patients. In response, pharmacies have implemented a range of hardware-focused strategies, such as upgrading service areas, integrating insurance billing systems, and developing patient management platforms, as well as soft competence strategies, including pharmacist training on innovative drugs and disease knowledge, interpretation of reimbursement policies, and emergency response preparedness.

Conclusion: This study demonstrates that participation in a dual-channel policy is widely perceived by community pharmacies as a strategic opportunity, despite the associated operational and systemic challenges. Proactive engagement with the policy not only strengthened their competitive positioning but also contributed to improved pharmaceutical services and patient care outcomes.

Introduction: Mitomycin, a cytotoxic antitumor antibiotic, has been approved for the treatment of low-grade upper tract urothelial carcinoma (UTUC) and non-muscle invasive bladder cancer (NMIBC). It is also used off-label in ophthalmic procedures and gastrointestinal malignancies. Although the efficacy of mitomycin is well recognized, its safety profile, particularly regarding rare or serious adverse events (AEs), remains insufficiently characterized in large real-world populations.

Aim: This study aimed to evaluate mitomycin-associated AEs through comprehensive analysis of two major global pharmacovigilance databases, with the goal of identifying high-risk organ systems and specific AE signals requiring increased clinical awareness.

Method: AE data were retrieved from the FDA Adverse Event Reporting System (FAERS) covering Q1 2004 to Q3 2024. Data were deduplicated and standardized according to MedDRA terminology. Complementary data were collected from the World Health Organization VigiAccess database. Disproportionality analysis was performed using four signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The time-to-onset of adverse events was analyzed using non-parametric statistical methods.

Results: A total of 1461 mitomycin-related reports, comprising 3652 AEs, were identified in the FAERS database. Notably, strong safety signals have emerged at the system organ class (SOC) level for eye, renal and urinary, blood and lymphatic system, and skin and subcutaneous tissue disorders. At the preferred term (PT) level, high disproportionality values were observed for serious events, such as scleral thinning (OR = 7129.60, 95% CI 4576.64-11,106.7) and bladder perforation (OR = 1585.69, 95% CI 1111.91-2261.33). Over two-thirds of AEs occurred within 30 days of drug administration, although 68.93% of the reports lacked valid onset-time data. The VigiAccess findings corroborated the SOC trends observed in FAERS.

Conclusion: Mitomycin is associated with a broad range of organ-specific toxicities, many of which occur early in the treatment course and may have serious clinical consequences. This study highlights the need for early risk identification, individualized monitoring strategies, and greater pharmacovigilance in populations treated with mitomycin. These findings provide an important foundation for optimizing the safe and effective use of mitomycin in oncology and in other therapeutic settings.

Introduction: Proton pump inhibitors (PPIs) are widely prescribed as acid-suppressive agents; however, their use during pregnancy remains controversial. Although generally considered safe, omeprazole is classified as Food and Drug Administration (FDA) pregnancy category C, whereas other PPIs are classified as category B, raising concerns regarding potential maternal and fetal risks. Clarifying the safety profile during pregnancy is critical to inform clinical decision making.

Aim: This study aimed to evaluate pregnancy-related adverse event (AE) signals associated with omeprazole, esomeprazole, lansoprazole, rabeprazole, and pantoprazole using data from the US FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q1 2025.

Method: A total of 625,127 AE reports listing PPIs as primary suspect drugs were retrieved, among which 1,099 pregnancy-related reports were identified. Signal detection employs two disproportionality algorithms: the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN). Each PPI was compared with all other drugs in the database, all other PPIs, and ranitidine, a comparator that is considered relatively safe during pregnancy.

Results: Disproportionality signals for pregnancy-related AEs associated with PPIs included premature labor, low birth weight, fetal growth restriction (FGR), abortion, fetal macrosomia, pregnancy on contraception, morning sickness, pre-eclampsia, and hemorrhagic complications. Compared with all the other drugs, omeprazole showed notable signals of postpartum hemorrhage (ROR: 3.14, 95% CI 1.63-6.04; E(IC): 1.36, IC025:0.45), FGR (ROR: 2.14, 95% CI 1.52-3.01; E(IC): 1.046, IC025:0.55), and pre-eclampsia (ROR: 1.95, 95% CI 1.27-3; E(IC): 0.9, IC025:0.28). These associations persisted when compared with other PPIs or ranitidine. Pantoprazole showed consistent risk signal trends, such as premature labor (ROR: 1.48, 95% CI 1.26-1.74; E(IC): 0.56, IC025:0.32), low birth weight babies (ROR: 2.08, 95% CI 1.56-2.76; E(IC): 1.02, IC025:0.6), and morning sickness (ROR: 3.9, 95% CI 1.75-8.7; E(IC): 1.46, IC025:0.36).

Conclusion: This study detected potential disproportionality signals, suggesting an association between PPIs use during pregnancy and reported AEs. Certain signals appeared to be drug-specific rather than class-specific, such as omeprazole for postpartum hemorrhage and preeclampsia, lansoprazole for pregnancy on contraceptives, and pantoprazole for morning sickness. However, these findings should be regarded as exploratory and hypothesis generating, warranting cautious interpretation and confirmation through rigorously designed epidemiological and clinical studies.

Introduction: Off-label prescribing, use of medications outside approved indications, dosages, administration routes, or age groups is common in pediatric clinical practice, largely because of the lack of high-quality clinical trials in children. Although such prescriptions can meet urgent therapeutic needs, particularly in complex or rare pediatric conditions, they also raise significant concerns regarding safety, effectiveness, and medicolegal liability. Limited research has examined the behavioral factors that influence pediatricians' decisions to prescribe off-label drugs.

Aim: This study aimed to identify the behavioral determinants of pediatricians' off-label drug use in Chinese hospitals by applying the Theory of Planned Behavior (TPB) to assess how behavior attitudes, subjective norms, and perceived behavioral control influence prescribing intentions and behaviors.

Method: A cross-sectional survey was conducted among pediatricians from 40 hospitals across seven provinces and municipalities in China. A TPB-based questionnaire was developed and refined through expert panel review and pilot testing. Structural equation modeling (SEM) was used to test the hypothesized relationships among the TPB constructs.

Results: A total of 350 questionnaires were distributed, of which 320 were returned (response rate: 91.4%). Most pediatricians acknowledged the necessity (82.4%) and risks (78.9%) of off-label use. Attitudes reflecting perceived benefits, safety concerns, and cost implications significantly predicted behavioral intention (β = 0.51, P < 0.01). Perceived behavioral control, including barriers such as outdated labeling, lack of pediatric formulations, and limited data, also predicted intention (β = 0.26, P < 0.01), but not behavior directly (β = 0.00, P = 0.12). Subjective norms such as institutional expectations and peer influence were positively associated with intention (β = 0.07, P < 0.01). Behavioral intention was the strongest predictor of actual off-label prescription behaviors (β = 0.16, P < 0.001). Most pediatricians (85.2%) supported pharmacists' involvement in evidence reviews, documentation, and prescription oversight.

Conclusion: Pediatric off-label prescribing in China is largely intention-driven and shaped by behavior attitudes, perceived control, and professional norms. Interventions targeting these behavioral domains, along with institutional policies and pharmacist collaboration, may enhance the safety, consistency, and regulatory oversight of off-label drug use in pediatric care.

Introduction: Adherence to newly prescribed cardiometabolic medications is low. It is crucial to develop personalized behavioural interventions to address patients' specific medication adherence barriers.

Aim: The aim of this study was to develop a behavioural theory-based New Medicine Service (NMS) toolkit for use by community pharmacists in Türkiye to identify and address reasons for nonadherence in patients newly started on medications for hypertension, diabetes, or dyslipidemia.

Method: This multistage study used a literature search, expert panel, cognitive interviews, and survey with patients to identify reasons for nonadherence to include in the Turkish DOSE Nonadherence Scale. A short form of the toolkit was generated by asking the patients to select the most challenging reasons for nonadherence. To identify relevant pharmacist interventions, the theoretical domains framework (TDF-14) (v2) domains related to reasons for nonadherence were identified and matched with behavioural change techniques (BCTs). To assess the applicability of the proposed pharmacist interventions in daily practice, an online survey of community pharmacists was conducted using a modified Delphi study.

Results: The final list of reasons for nonadherence consisted of 31 items, of which 14 identified as most challenging by patients were selected for inclusion in the short form of the NMS toolkit. For the full 31 reasons, ten domains of TDF-14 and 18 BCTs were selected. In the Delphi study (response rate: 83.3%), 68 of the 81 (84.0%) pharmacist interventions were found to be applicable, corresponding to 15 BCTs.

Conclusion: The behavioural theory-based NMS toolkit was developed for use by community pharmacists to identify and address reasons for nonadherence in patients newly started on medications to manage hypertension, diabetes, or dyslipidemia. This toolkit will assist community pharmacists in developing personalized interventions to overcome nonadherence problems in patients who are newly starting medications. Future studies should be conducted to assess the impact of this new toolkit on patients' medication adherence levels and clinical outcomes.

Introduction: Drug-induced movement disorders (DIMDs) are often underrecognized and challenging to diagnose and manage in clinical practice. Sodium valproate (VPA), a widely prescribed antiepileptic drug, causes DIMDs. Predictive modeling based on electronic medical records and machine learning algorithms offers a promising approach to improve early identification of adverse drug reactions (ADRs) and enhance clinical safety.

Aim: This study aimed to conduct real-world active surveillance of VPA-associated DIMDs using hospital information system data, to identify independent risk factors, and to develop a clinically applicable prediction model for early warning and intervention.

Method: In this retrospective case-control study, data were collected from hospitalized patients prescribed sodium valproate between 2018 and 2022. DIMD cases were identified through automated alerts generated by the ADE Active Surveillance and Assessment System II, and subsequently confirmed using the Naranjo scale for manual causality assessment. A clinical prediction model was developed using LASSO logistic regression and was presented as a nomogram. Model performance was evaluated using area under the receiver operating characteristic (ROC) curve, calibration curve, decision curve analysis (DCA), and clinical impact curve (CIC).

Results: Of the 6692 patients screened, 98 were confirmed to have DIMDs, yielding an incidence rate of 1.46%. Four independent protective factors were identified: higher lymphocyte count, red blood cell count, serum sodium concentration, and co-administration of levetiracetam. The nomogram demonstrated good discrimination (AUC = 0.774), acceptable calibration (Brier score = 0.194), and strong clinical utility across a threshold probability range of 10-70%.The results of the external validation suggest that the efficiency of the model remained stable and showed no significant decline. It had better predictive ability in high- and medium-risk groups and had significant potential for clinical application. The incidence of DIMDs was significantly higher among patients receiving VPA for therapeutic purposes than among those receiving VPA prophylactically.

Conclusion: VPA-associated DIMDs are common in hospitalized patients. The prediction model based on routine clinical indicators enabled the identification of high- and middle-risk individuals, thereby facilitating timely monitoring and targeted interventions to reduce the burden of movement-related ADRs.

Introduction: Venous thromboembolism (VTE) is a common and preventable complication in orthopedic surgery, yet adherence to prophylaxis guidelines remains suboptimal. A pharmacist-led anticoagulation care model based on the Pharmacist Early Active Consultation (PEAC) framework may enhance the quality and safety of VTE prevention in surgical patients.

Aim: This study aimed to evaluate the impact of a pharmacist-led Venous Thromboembolism Clinical Pharmaceutical Care (VTE-CPC) model, derived from the PEAC framework, on VTE prevention and anticoagulation quality in orthopedic surgery patients.

Method: A retrospective cohort study was conducted at a tertiary hospital in China. Patients admitted between December 2023 and May 2024 received routine care (no VTE-CPC group), while those admitted between June and November 2024 received additional pharmacist-led interventions (VTE-CPC group). Multivariate logistic regression was used to identify independent risk factors for VTE. Propensity score matching (PSM) was performed to control baseline differences, resulting in a balanced cohort of 812 patients. Outcomes included VTE incidence, pharmacological prophylaxis practices, and safety endpoints.

Results: A total of 959 patients were included (no VTE-CPC: n = 531; VTE-CPC: n = 428). The incidence of VTE was significantly lower in the VTE-CPC group (3.74%) compared to the no VTE-CPC group (7.53%, p = 0.020). VTE-CPC remained an independent protective factor in multivariate analysis (OR = 0.45; 95% CI 0.23-0.84; p = 0.015). In the PSM matched cohort, patients in the VTE-CPC group had higher rates of postoperative pharmacological prophylaxis (22.66% vs. 16.26%, p = 0.027) and improved dosage appropriateness across all perioperative phases (p < 0.05). No significant differences were observed between groups in rates of bleeding events, thrombocytopenia, or hepatic/renal dysfunction.

Conclusion: A pharmacist-led anticoagulation management model based on the PEAC framework significantly reduced perioperative VTE incidence without increasing adverse events. These findings support broader implementation of proactive, pharmacist-driven strategies to improve thromboprophylaxis quality in orthopedic surgery.

Introduction: Medications with anticholinergic effects are widely used despite the mounting evidence of physical and cognitive impairment associated with their use among older adults.

Aim: A systematic review was conducted to describe the prevalence of anticholinergic medication use in community-dwelling older adults, document the factors associated with their use and describe the most frequently used medication classes.

Method: MEDLINE, Embase and CINAHL were searched from inception to May 2024. All study designs except case reports and case studies were eligible if they included community-dwelling older adults aged 65 and older and assessed the factors associated with anticholinergic medication use. An open-source artificial intelligence screening tool was used to optimise title and abstract screening. The subsequent review of the full texts of potentially eligible studies and data extraction were conducted in the Covidence systematic review tool using standardised data collection forms. Study quality was assessed with the Newcastle-Ottawa scale. The study selection, data extraction and quality assessment were conducted independently by two reviewers.

Results: From 4139 records of interest, the seven selected studies included five cross-sectional and two retrospective studies, published between 2014 and 2021. The risk of bias was assessed to be low in five studies and high in two studies. Greater anticholinergic burden was associated with female sex, lower socioeconomic status, higher co-morbidity score, higher frailty probability, specific diseases, polypharmacy and greater use of healthcare, while increasing age was associated with both increased and decreased anticholinergic burden. Anticholinergic exposure, varied from a low of 6.2% of medical visits in the United States between 2006 and 2015, assessed with the 2015 Beers Criteria and the Anticholinergic Risk Scale, to a high of 72.8% of medication claims (dispensed medications) in South Korea, over the year 2012, assessed with the 2015 Beers Criteria and the Anticholinergic Burden Scale. The use of six different anticholinergic scales and different evaluation periods did not allow a meaningful comparison of the prevalence of anticholinergic exposure across studies. Antidepressants, antihistamines and antimuscarinics were the most common medication classes in the two studies using this classification.

Conclusion: This systematic review documented key socioeconomic and health status factors to be targeted by interventions aimed at limiting the use of anticholinergic medications in community-dwelling older adults.

Introduction: Medication adherence is essential for the effective management of chronic diseases; however, adherence among patients remains suboptimal in China. Understanding the multidimensional determinants of adherence is critical in designing interventions to improve treatment outcomes. The health ecology model (HEM) provides a comprehensive framework that integrates individual, behavioral, social, and environmental influences on health behaviors.

Aim: This study aimed to identify the multilevel determinants of medication adherence among Chinese patients with chronic diseases using an ecological framework based on the HEM and to provide evidence to inform pharmacist- and policy-driven strategies to enhance adherence.

Method: Data were derived from the 2021 Psychology and Behavior Investigation of Chinese Residents, a nationally representative survey of 1162 adults with chronic diseases. Medication adherence was assessed using the Medication Adherence Rating Scale. Independent variables were categorized into five hierarchical levels according to the HEM: personal traits, behavioral characteristics, interpersonal networks, working and living conditions, and policy environment. Binary logistic regression analyses were performed sequentially to identify factors associated with good medication adherence.

Results: Among the participants, 23.8% demonstrated good adherence to medication. In the final regression model (AUC = 0.721; Hosmer-Lemeshow p = 0.790; R² = 0.168), higher adherence was significantly associated with older age (OR 1.616, p < 0.01), lower depression levels (OR 0.663-0.869, p < 0.05), absence of alcohol use (OR 1.485, p < 0.05), being married OR 1.829, p < 0.01), higher education (OR 1.784, p < 0.05), higher income (OR 1.679, p < 0.01), and eligibility for medical subsidies (OR 1.763, p < 0.01).

Conclusion: This nationwide study demonstrated that medication adherence among Chinese patients with chronic diseases is influenced by interconnected personal, psychosocial, and socioeconomic factors. Multifaceted interventions, including pharmacist involvement in adherence monitoring, family-based support, mental health screening, and the expansion of subsidy programs, may improve medication adherence and optimize chronic disease management.