Clinical Pharmacy[JOURNAL]
Sun
200 papers
Responsiveness and minimum important change of the Pharmacotherapeutic Symptom Evaluation-20-Australian version: a tool for measuring changes in medicine-related symptoms over time.
Mekuria AB, Andrade AQ, Lim R … +3 more , Rowett D, Hedström M, Roughead EE
Int J Clin Pharm · 2026 Apr · PMID 41222603 · Full text
INTRODUCTION: Monitoring patient-reported symptoms over time may support early detection of medicine-related harms. The Pharmacotherapeutic Symptom Evaluation-20-Australian version (PHASE-20-Australian version) is an 11-...
INTRODUCTION: Monitoring patient-reported symptoms over time may support early detection of medicine-related harms. The Pharmacotherapeutic Symptom Evaluation-20-Australian version (PHASE-20-Australian version) is an 11-point rating scale designed for longitudinal monitoring of medicine-related symptoms; however, its responsiveness and minimum important change (MIC) have not been established. AIM: To evaluate the responsiveness and MIC of the PHASE-20-Australian version for monitoring changes in medicine-related symptoms over time. METHOD: A prospective cohort study was conducted among Australian adults (≥ 18 years) taking medications. Participants completed the PHASE-20-Australian version at baseline and follow-up and reported perceived symptom changes using the Global Rating Scale (GRS) at follow-up. Responsiveness was assessed by correlating score changes with the GRS and calculating the area under the receiver operating characteristic (ROC) curve (AUC). MIC was estimated using ROC anchor-based and 0.5 standard deviation (SD) distribution-based methods and then compared with the Smallest Detectable Change (SDC). RESULTS: Among 102 participants, 52% were aged ≥ 60 years and 65.7% were female. Strong correlations were observed for overall score changes (rho = 0.815) with the GRS as well as for 84.2% of individual symptoms (rho = 0.701-0.897). The tool demonstrated good to strong discriminative ability (AUC = 0.739-0.975 for improvement; 0.764-0.977 for deterioration), with sensitivity and specificity ≥ 0.75 for 16 symptoms. The MIC values ranged from 0.5 to 1.5 using the ROC method and 0.9-1.8 using the 0.5 SD approach. The estimated MIC values exceeded the SDC for 84.2% of symptoms. Limited responsiveness (rho < 0.7, AUC < 0.7) and MIC values below the SDC were noted for forgetful, swollen legs/ankles and frequent urination/incontinent of urine. CONCLUSION: The PHASE-20-Australian version is responsive for most symptoms, with a clinically meaningful change of approximately 2.0 points on a 0-10 scale. The estimated MIC is applicable at the individual level, although caution is needed for symptoms with an MIC below the SDC.
Managing emergency department patients with potential medication-related harm: a qualitative study.
Bullock B, Allen R, Grant G … +1 more , Hattingh HL
Int J Clin Pharm · 2026 Feb · PMID 41222602 · Publisher ↗
INTRODUCTION: Medication-related harm (is a challenge globally and contributes to emergency department (ED) presentations. Accurate medication histories are essential to identify whether medication-related harm contribut...
INTRODUCTION: Medication-related harm (is a challenge globally and contributes to emergency department (ED) presentations. Accurate medication histories are essential to identify whether medication-related harm contributed to an ED presentation. AIM: The aim of this study was to explore the perspectives of ED clinicians on prioritising ED patients admitted due to potential medication-related harm. METHOD: We conducted semi-structured qualitative interviews with purposively selected ED doctors, pharmacists, and nurses from a hospital and health service in Southeast Queensland, which includes both a tertiary and secondary ED. Participants were interviewed face-to-face May-July 2023. Interviews were guided by a piloted interview guide with seven open-ended questions focusing on clinicians' views of medication management and prioritisation in suspected medication-related harm cases. RESULTS: Fifteen clinicians with varying ED experience levels were interviewed: five doctors, five pharmacists, five nurses. Average interview time was 19 min (9-44 min). Thematic analysis of the interview data identified two key themes and six subthemes related to the prioritisation of patients with suspected medication-related harm and the role of ED clinicians in medication management. ED clinicians used varied and inconsistent processes to identify and flag patients who were either admitted with or suffered potential medication-related harm during admission and identified a need for a strategic structured process. The value of ED pharmacists was highlighted by all non-pharmacist participants. CONCLUSION: Findings indicate that, in the absence of standardised prioritisation processes, ED clinicians rely heavily on individual clinical judgement. This underscores the need for the development of a tool specifically designed for the ED context to guide patient prioritisation.
Islamic reasoning and the use of prohibited medicines among Muslim patients: a qualitative study.
Nazar Z, Ali B, Rutter P … +1 more , Barnes N
Int J Clin Pharm · 2025 Dec · PMID 41219623 · Full text
INTRODUCTION: Muslim patients may avoid medicines containing ingredients prohibited by their faith (haram), such as alcohol, gelatine, or porcine derivatives. While Islamic law permits exceptions based on necessity (daru...
INTRODUCTION: Muslim patients may avoid medicines containing ingredients prohibited by their faith (haram), such as alcohol, gelatine, or porcine derivatives. While Islamic law permits exceptions based on necessity (darura) or biotransformation (istihala), the way these principles influence medication adherence and shape patient-healthcare provider (HCP) interaction is underexplored. AIM: To explore how Muslims apply Islamic reasoning to medication adherence decisions involving medicines containing haram ingredients. METHOD: Thirteen ethnically diverse Muslim adults were purposively sampled for semi-structured interviews. A prior scoping review and mosque-based public and patient involvement (PPI) informed the interview guide. Interview data were analysed using Braun and Clarke's Reflexive Thematic Analysis (RTA), with themes constructed inductively. Data interpretation was guided by the Necessity-Concerns Framework (NCF) and locus of control (LOC) theory. Rigour was supported through member checking, peer debriefing and reflexive journalling. RESULTS: Four themes emerged: (1) Halal as worldview: the halal-haram spectrum functioned as a moral lens for daily behaviour and intake, extending to medication use. (2) Motivations for consumption: halal was linked to perceived health and spiritual benefit, while haram signalled impurity and harm. (3) Minor illness or major disease: darura and istihala were applied flexibly in chronic or life-threatening illness, whereas participants avoided prohibited medicines for minor conditions, favouring complementary remedies. Practical workarounds included switching dosage forms or opening gelatine capsules and discarding the shell to minimise religious harm. Decisions were shaped by perceived severity, symptom burden, financial considerations, and the extent to which HCPs were perceived as trustworthy, culturally competent, and responsive to religious disclosure, all of which influenced adherence. (4) Personalised care: participants valued shared decision-making, transparent disclosure of religiously relevant excipients, and a reasonable degree of religious literacy among HCPs; scepticism about halal certification underscored the need for clearer labelling and guidance. CONCLUSION: Islamic reasoning influenced how participants engaged with medicines deemed haram. Supporting adherence requires pharmacy practice that incorporates religious literacy and responds to concerns about transparent labelling and faith-sensitive communication. These steps will strengthen patient-centred care by aligning religious and ethical reasoning with treatment decisions, fostering trust, enhancing adherence, and supporting more equitable care for Muslim patients.
Risk prediction models for adverse drug reactions in pediatrics: a scoping review.
Gao R, Liu J, Huang L … +9 more , Zeng L, Zhu YZ, Yu Q, Gao Y, Xu Z, Peng Q, Xu Y, Li H, Zhang L
Int J Clin Pharm · 2026 Feb · PMID 41217606 · Publisher ↗
INTRODUCTION: Predictive models play a critical role in enhancing medication safety in clinical practice. While multiple models for adverse drug reactions (ADRs) in adults have demonstrated potential clinical utility, pe...
INTRODUCTION: Predictive models play a critical role in enhancing medication safety in clinical practice. While multiple models for adverse drug reactions (ADRs) in adults have demonstrated potential clinical utility, pediatric-specific predictive models remain understudied, with limited comprehensive evaluation of their methodological quality and reporting standards. AIM: To map the landscape of existing risk prediction models for ADRs specifically developed or validated for pediatric patients, and to describe their characteristics, methodological quality, and reporting completeness. METHOD: A systematic search was conducted in Embase, PubMed, CNKI, Wanfang, VIP, and SinoMed for studies on pediatric ADR prediction models. The information from included studies was evaluated using the Systematic Reviews of Prediction Modelling Studies (CHARMS) checklist, the risk of bias was assessed with the Prediction Model Risk of Bias Assessment Tool (PROBAST), and adherence to Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) guidelines was reviewed. Predictive ability of the included model, including the area under the receiver operating characteristic curve (AuROC), sensitivity, and specificity, was also reported. RESULTS: Out of 12,667 screened studies, 7 articles (describing 10 models) met the inclusion criteria. Study designs included case-control, nested case-control, prospective cohort, and cross-sectional studies. Logistic regression was the primary modeling method, with one study using machine learning. Common methodological limitations included unreported handling of missing data and univariable predictor screening. Model discrimination (AuROC) ranged from 0.63-0.97, with sensitivity and specificity between 52.02-98.50% and 33.33-98.79%, respectively. TRIPOD adherence varied (62.16-86.49%), with notable reporting deficiencies in blinding, sample size justification, intervention details, model usage instructions, and supplementary materials. No models underwent external validation. CONCLUSION: Existing pediatric ADR prediction models are limited by methodological and reporting shortcomings. Future research should focus on rigorous model development and external validation to ensure generalizability across diverse clinical settings.
Nephrotoxicity of polymyxin B and colistin sulfate in patients with multidrug-resistant gram-negative bacteria infections: a parametric time-to-event analysis.
Qin Y, Ding Q, Huang S … +5 more , Yang R, Zhang S, Wu T, Liu J, Pei Q
Int J Clin Pharm · 2026 Feb · PMID 41201487 · Publisher ↗
INTRODUCTION: Multidrug-resistant Gram-negative bacteria (MDR-GNB), especially carbapenem-resistant strains, pose a major therapeutic challenge in intensive care units and are associated with high morbidity and mortality...
INTRODUCTION: Multidrug-resistant Gram-negative bacteria (MDR-GNB), especially carbapenem-resistant strains, pose a major therapeutic challenge in intensive care units and are associated with high morbidity and mortality. Polymyxin B (PMB) and colistin sulfate (CS) are the last-line agents for MDR-GNB infections; however, their clinical use is limited by nephrotoxicity. Although the steady-state 24-h area under the curve (AUC) has been suggested as a predictor of nephrotoxicity, prior studies have mainly applied semiparametric approaches that cannot fully describe the risk across exposure levels. Parametric time-to-event (TTE) analysis offers a more robust framework but has not been applied to polymyxin-induced nephrotoxicity. AIM: This study aimed to identify clinical and pharmacological factors influencing PMB- and CS-associated nephrotoxicity in critically ill patients with MDR-GNB infections and to establish AUC thresholds predictive of acute kidney injury (AKI) using parametric TTE modeling. METHOD: We retrospectively analyzed real-world data from 562 patients with MDR-GNB infections treated with PMB (n = 354) or CS (n = 208) at Xiangya Third Hospital, Central South University, between July 2018 and July 2023. Pharmacokinetic profiles were simulated using published models, and drug exposure parameters (AUC, C, and C) were estimated. Propensity score matching was used to balance the baseline covariates. Kaplan-Meier curves and log-rank tests were used to compare the AKI incidence between the groups. Parametric TTE models were developed using NONMEM (version 7.5), incorporating exposure parameters and covariates. The model performance was validated using bootstrap and visual predictive checks. Classification and regression tree (CART) analyses were used to determine the exposure thresholds. RESULTS: Overall, 39.4% of patients developed AKI, with a significantly higher incidence in the PMB group than in the CS group (51.7% vs. 18.4%). The final PMB model identified AUC, sepsis, transplant history, and vancomycin co-administration as independent risk factors, with an EC50 of 80.4 μg·h/mL for PMB. For CS, AUC and multisite infections predicted AKI with an EC50 of 57.5 μg·h/mL. CART analysis revealed nephrotoxicity thresholds of 101 μg·h/mL for PMB and 44 μg·h/mL for CS administration. Simulation showed that increasing PMB AUC from 50 to 125 μg·h/mL raised 14-day AKI risk from 25 to 75%, while for CS, increasing AUC from 25 to 50 μg·h/mL elevated risk from 20 to 60%. CONCLUSION: In critically ill patients with MDR-GNB infections, higher plasma exposure to PMB and CS was strongly associated with increased nephrotoxicity. Exposure thresholds of AUC ≥ 101 μg·h/mL for PMB and ≥ 44 μg·h/mL for CS significantly elevated the AKI risk. Therapeutic drug monitoring should be integrated into clinical practice to optimize polymyxin dosing, reduce toxicity, and improve patient outcomes.
Comparative effectiveness and safety of fluticasone-based versus beclometasone-based single-inhaler triple therapies in patients with chronic obstructive pulmonary disease: a population-based cohort study.
Dong YH, Pan SW, Chen MC … +3 more , Chen CY, Tsai NH, Kumamaru H
Int J Clin Pharm · 2026 Apr · PMID 41201486 · Full text
INTRODUCTION: There is a paucity of comparative real-world evidence for fluticasone-based and beclometasone-based single-inhaler triple therapies in patients with chronic obstructive pulmonary disease (COPD). AIM: To com...
INTRODUCTION: There is a paucity of comparative real-world evidence for fluticasone-based and beclometasone-based single-inhaler triple therapies in patients with chronic obstructive pulmonary disease (COPD). AIM: To compare clinical outcomes of fluticasone/umeclidinium/vilanterol (a once-daily dry powder inhaler) and beclometasone/glycopyrrolate/formoterol (a twice-daily metered dose inhaler) in patients with COPD. METHOD: This population-based cohort study enrolled patients with COPD who initiated fluticasone/umeclidinium/vilanterol or beclometasone/glycopyrrolate/formoterol from a nationwide Taiwanese database between 2019 and 2022. The effectiveness outcomes included severe and moderate exacerbations and the safety outcomes were pneumonia and composite cardiovascular events. Patients were followed from the first day after cohort entry to the earliest of each outcome occurrence, study treatment discontinuation or change, death, end of data (2022/12/31), or the 365th day after cohort entry. Cox regression models were employed to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for each outcome comparing fluticasone/umeclidinium/vilanterol versus beclometasone/glycopyrrolate/formoterol after high-dimensional propensity score matching. RESULTS: There were 12,971 initiators included in the high-dimensional propensity score matched cohort. The HR suggested a lower risk of severe and moderate exacerbations (0.80 [95% CI 0.69-0.93] and 0.80 [95% CI 0.74-0.87], respectively) and a marginally non-significant decreased risk of pneumonia (0.85 [95% CI 0.70-1.02]) associated with fluticasone/umeclidinium/vilanterol. However, both treatments showed a similar risk of composite cardiovascular events (0.96 [95% CI 0.69-1.35]). The results were generally consistent across several pre-specified sensitivity and subgroup analyses. Of note, among patients treated for ≥ 90 days (nearly 73% of the initiators), the differences in clinical outcomes of both treatments tended to be minimal, with an HR of 0.98 (95% CI 0.78-1.23) for severe exacerbations, 0.93 (95% CI 0.72-1.20) for pneumonia, and 1.07 (95% CI 0.64-1.77) for composite cardiovascular events. Nevertheless, fluticasone/umeclidinium/vilanterol remained having a lower risk of moderate exacerbations (0.86 [95% CI 0.74-0.98]). CONCLUSION: This cohort study conducted in an Asian COPD population suggests that fluticasone/umeclidinium/vilanterol may be a preferred initial treatment option over beclometasone/glycopyrrolate/formoterol. While among patients who are able to maintain their therapies for ≥ 90 days, both treatments may demonstrate more comparable effectiveness and safety profiles.
Correction: European Society of Clinical Pharmacy: 5 steps of medication safety-medication without harm, where are we now?
Weidmann AE, Lutters M
Int J Clin Pharm · 2025 Dec · PMID 41196548 · Publisher ↗
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Perspectives of patients with rheumatoid arthritis towards the use of parenteral methotrexate: a qualitative study.
Tan JM, Desforges K, Chai WC … +3 more , Proudman SM, Wiese MD, Reeve E
Int J Clin Pharm · 2026 Apr · PMID 41196547 · Full text
INTRODUCTION: Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease. Disease-modifying antirheumatic drugs (DMARDs) are the cornerstone of management and methotrexate is broadly considered as first-line...
INTRODUCTION: Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease. Disease-modifying antirheumatic drugs (DMARDs) are the cornerstone of management and methotrexate is broadly considered as first-line treatment. Gastrointestinal side effects and variable bioavailability however limit adherence to and effectiveness of oral methotrexate, while parenteral methotrexate remains underutilized. AIM: To explore RA patients' perspective and their level of acceptance towards parenteral methotrexate and to investigate the barriers and enablers to its use. METHOD: A qualitative study was conducted using semi-structured interviews between May and August 2022. Participants were recruited using convenience and purposive sampling strategy. The Theoretical Framework of Acceptability (TFA) was used to guide the development of the interview guide and data analysis (directed content analysis). RESULTS: Twenty-five participants (68% female, 76% with experience using parenteral methotrexate) were interviewed. All seven TFA constructs were found to influence participants' acceptance of parenteral methotrexate. High acceptance was related to the TFA constructs "perceived effectiveness", "intervention coherence", "self-efficacy" and "ethicality". Experience with disease improvement and gastrointestinal tolerance with parenteral methotrexate was valued by the participants, and understanding these benefits was linked with high acceptability (perceived effectiveness). Participants reported a high level of confidence in using methotrexate injections and adapting to the injection-taking routine (self-efficacy). The user-friendly design of the methotrexate pre-filled syringe, along with the support from healthcare professionals, served as enablers (intervention coherence and ethicality). Minimal opportunity costs (e.g., no major lifestyle sacrifices) further supported acceptability, though some reported initial injection anxiety (affective attitude). Barriers were frequently identified in the "burden" construct, including travel inconvenience and injection-associated cost. Participants without the experience with methotrexate injections expressed the need for further information, particularly regarding the logistical and safety aspects of parenteral methotrexate (intervention coherence). CONCLUSION: Our findings highlighted that patients' comprehension of the benefits of using parenteral methotrexate, confidence in self-administration, healthcare professionals' support, and the ease of using injections may help optimize treatment acceptability, underscoring the importance of patient's education from healthcare professionals and the availability of patient-friendly devices.
Economics, efficacy and safety of five traditional Chinese medicine injections plus chemotherapy as adjuvant therapy for non-small cell lung cancer: A network meta-analysis.
Xu K, Li H, Zhu Y … +7 more , Jing Z, Gao L, Sun Y, Ding B, Yao H, Wang H, Li X
Int J Clin Pharm · 2025 Dec · PMID 41166056 · Publisher ↗
INTRODUCTION: Lung cancer remains a leading cause of cancer-related morbidity and mortality worldwide, with non-small cell lung cancer (NSCLC) accounting for > 85% of cases. Traditional Chinese Medicine (TCM) has played...
INTRODUCTION: Lung cancer remains a leading cause of cancer-related morbidity and mortality worldwide, with non-small cell lung cancer (NSCLC) accounting for > 85% of cases. Traditional Chinese Medicine (TCM) has played an integral role in NSCLC management, particularly in combination with chemotherapy. Although the safety and efficacy of TCM injections have been widely studied, comprehensive pharmacoeconomic evaluations remain limited. AIM: This review aimed to evaluate the safety, efficacy, and cost-effectiveness of five TCM injections, Marsdenia tenacissima, Aidi, Kanglaite, Kangai, and Shenqi Fuzheng, in combination with chemotherapy for the treatment of advanced NSCLC. METHOD: A systematic literature review identified 165 randomized controlled trials (RCTs) published between 2000 and 2024. A Bayesian network meta-analysis (NMA) was performed to compare the objective response rates (ORR) and adverse events (AEs) among the five TCM injections plus chemotherapy versus chemotherapy alone. A decision tree model with a 6-month time horizon was constructed from the healthcare system perspective, incorporating direct medical costs, including drug administration, monitoring, and AE management. The incremental cost-effectiveness ratios (ICERs) were calculated based on incremental ORR improvements. One-way and probabilistic sensitivity analyses were performed to test the robustness of the model. RESULTS: All five TCM injections combined with chemotherapy demonstrated superior ORR compared with chemotherapy alone. Kanglaite injection showed the highest ORR improvement (12.5%) and lowest incidence of leukopenia and hepatic dysfunction. However, Kangai injection exhibited the lowest ICER of $19.56 per 1% ORR gain, indicating the highest cost-effectiveness. The ICERs for the remaining regimens were $43.38 (Marsdenia tenacissima), $29.68 (Aidi), $56.94 (Kanglaite), and $28.08 (Shenqi Fuzheng) per 1% ORR. Sensitivity analyses confirmed the robustness of these findings, with ORR and injection costs identified as the key drivers. CONCLUSION: Among the five TCM injections evaluated, Kangai injection combined with chemotherapy has emerged as the most cost-effective regimen for advanced NSCLC. These findings support the integration of TCM into evidence-based cancer care, and highlight the need for further pharmacoeconomic research, particularly in real-world clinical settings.
Medication safety in patients with hepatic disease: proof of concept of a new approach to screen for patients at risk-a retrospective evaluation utilizing electronic prescribing systems.
Strobach D, Grebe A, Steinbrech J … +2 more , Günther M, Hug MJ
Int J Clin Pharm · 2025 Dec · PMID 41166055 · Publisher ↗
INTRODUCTION: Hepatic impairment (HI) leads to pharmacokinetic and pharmacodynamic changes demanding adjustment of drug therapy. To increase medication safety, hospital pharmacists need to quickly identify patients at ri...
INTRODUCTION: Hepatic impairment (HI) leads to pharmacokinetic and pharmacodynamic changes demanding adjustment of drug therapy. To increase medication safety, hospital pharmacists need to quickly identify patients at risk. Laboratory parameters and liver scores are often available only with timely delay. Alternatively, screening for typical drugs used in severe HI in electronic prescribing systems could be an option. AIM: To test a new approach for the timely identification of patients with hepatic impairment. Drugs typically used in severe HI and its complications were evaluated as screening tools in patients with documented liver disease to identify patients who probably require drug adjustment to liver function. METHOD: Patients ≥ 18 years and hospitalized in the year 2022 with an ICD-10-GM coding for liver disease were identified retrospectively. ICD-10-GM classes of special interest, reflecting severe HI, were defined (K70 (alcoholic liver disease), K72 (hepatic failure) and K74 (liver fibrosis/cirrhosis)). Drugs typically used in severe hepatic impairment and its complications (index drugs) were defined as carvedilol, propranolol, lactulose, L-ornithin-L-aspartate, rifaximin, spironolactone and ursodeoxycholic acid. For all patients, use of index drugs according to the electronic prescribing system, laboratory liver parameters, MELD (Model of Endstage Liver Disease) and MELD 3.0 were documented. We analysed, how many patients and how many cases of hepatic ICD-10-GM-codes were identified by screening for index drugs. RESULT: Of 2319 patients with a hepatic ICD-10-GM-code in 2022, 2012 had electronic charts available. For these, 2916 main class ICD-10-GM codes were documented (4505 including main and sub-classes; median 1; IQR 1-3). Of 2012 patients, 1005 (50%) were treated with index drugs. Of the 2916 main ICD-10-GM classes, 1754 (60%) had index drugs, more often in codes of special interest (K74 82.5%, K70 79.7%, K72 68.9%). Patients in these main classes of special interest had higher MELD (median 14.8-18.2) and MELD 3.0 (18-22.9) compared to the overall patient cohort (MELD 12; MELD 3.0 15.9) and frequently laboratory liver parameters out of normal range. CONCLUSION: Screening via index drugs typically used in hepatic impairment is a promising tool to identify patients at risk probably needing drug adjustment to hepatic function. Further studies need to determine the practical use of this tool to increase drug therapy safety.
Exploring pediatricians' off-label prescribing behavior in China: A theory of planned behavior-based study.
Zhang Y, Sun X, Wang D … +3 more , Hua Y, Wang G, Ramalho N
Int J Clin Pharm · 2025 Dec · PMID 41160282 · Publisher ↗
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 cl...
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.
Hospital readmissions related to adverse drug withdrawal events in older adults: a pilot study.
Mellors D, Antonas D, Russell P … +4 more , Arunasalam H, Ailabouni N, Koeper I, Reeve E
Int J Clin Pharm · 2026 Apr · PMID 41160281 · Full text
INTRODUCTION: Drug-related hospitalisations are common and approximately 50% are preventable. They can be caused by adverse drug reactions, therapeutic failures, and Adverse Drug Withdrawal Events (ADWEs). ADWEs include...
INTRODUCTION: Drug-related hospitalisations are common and approximately 50% are preventable. They can be caused by adverse drug reactions, therapeutic failures, and Adverse Drug Withdrawal Events (ADWEs). ADWEs include any clinically significant set of symptoms caused by the cessation or dose reduction of a medication, including physiological withdrawal reactions or return of the underlying medical condition; few studies have examined the prevalence and characteristics of ADWEs. AIM: To conduct a pilot study to determine the proportion of hospital readmissions caused or contributed to by ADWEs in older adults, explore the characteristics of these events, and test the method of assessment of ADWEs. METHOD: A retrospective case note review included patients that were admitted to geriatric units with two hospital admissions within a three month period. Participants were screened for deprescribing events, defined as medication cessation, dose reduction, or substitution. Two assessors then independently reviewed the data to determine if an ADWE had occurred and assessed its contribution to a readmission. RESULTS: Ten participants experienced 33 deprescribing events during their first hospital admission, or between admissions. A total of seven out of the 33 deprescribing events (affecting six participants) were assessed to have likely led to an ADWE (21%). Of these, six were assessed as likely contributing to the readmission. Of the total 12 readmissions examined (across 10 participants), five readmissions (five participants) were assessed as likely being contributed to by an ADWE (41.6%). The most common medications that were assessed as likely to have contributed to an ADWE-related hospital admission were cardiac medications, particularly diuretics, which were implicated in four out of six ADWEs assessed as likely to have contributed to hospital readmission. CONCLUSION: ADWEs are potentially common in complex older adults and their potential contribution to hospital readmissions highlights the need for further research on how to identify and ultimately prevent them.
Comparative evaluation of pregnancy-related adverse events associated with proton pump inhibitors using the FDA adverse event reporting system database.
Dong W, Ran Y, Cai Y … +2 more , Yang Y, Liu H
Int J Clin Pharm · 2025 Dec · PMID 41128788 · Publisher ↗
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 Foo...
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.
Barriers, facilitators, and implementation strategies for pharmacogenomics in community pharmacies: a cross-sectional survey among local champions in pharmacies and key opinion leaders in pharmacogenomics.
Kiani P, Bet PM, Jessurun NT … +4 more , Hoogland P, Mentink J, Swen JJ, Borgsteede SD
Int J Clin Pharm · 2026 Apr · PMID 41128787 · Full text
INTRODUCTION: Pharmacogenomics (PGx) tailors drug treatments to an individual's genetic profile and contributes to improved efficacy and reduced adverse drug reactions. Community pharmacists have shown interest in PGx, a...
INTRODUCTION: Pharmacogenomics (PGx) tailors drug treatments to an individual's genetic profile and contributes to improved efficacy and reduced adverse drug reactions. Community pharmacists have shown interest in PGx, and Dutch pharmacists have been early adopters in applying PGx guidelines, particularly through integration of the Dutch Pharmacogenetics Working Group recommendations. Despite growing evidence of its benefits, large-scale implementation in community pharmacies remains limited. This raises an important question for global stakeholders: if PGx adoption is constrained even in a system with robust infrastructure and guidelines, what lessons can be drawn for broader implementation? AIM: To examine current PGx practices in leading Dutch community pharmacies and to identify key barriers, facilitators, and implementation strategies for integrating PGx into routine pharmacy care. METHOD: A cross-sectional survey was conducted among Dutch pharmacy professionals with experience in PGx implementation. Participants were categorized as key opinion leaders (KOLs), involved in national PGx policymaking, research, or representing academia or professional organizations, or local champions (LCs), defined as practicing pharmacists directly involved in local PGx implementation in hospital or community pharmacies. The questionnaire was retrospectively mapped to Consolidated Framework for Implementation Research domains. Quantitative data were analyzed descriptively and qualitative responses were inductively thematically grouped to contextualize findings. RESULTS: Of the 67 invited professionals, 46 completed the questionnaire (response rate: 69%). Among respondents, 70% were LCs and 30% KOLs. Among KOLs (n = 14), the most frequently cited barriers included costs (79%, n = 11/14), inadequate Information and Communication Technology (ICT) support (29%, n = 4/14), and legal or regulatory uncertainty (29%, n = 4/14). A positive view on the clinical value of PGx was reported by 81% of LCs (n = 26/32) and 93% of KOLs (n = 13/14). Suggested facilitators by LCs included improved ICT infrastructure (56%, n = 18/32), enhanced education and training (44%, n = 14/32), and stronger interdisciplinary collaboration (25%, n = 8/32). CONCLUSION: PGx implementation in Dutch pharmacies is hindered by structural barriers such as fragmented ICT and lack of reimbursement, despite strong professional support. Embedding PGx into pharmacy workflows and aligning policy, infrastructure, and education are essential. These findings may inform broader efforts to integrate PGx into pharmacies across diverse systems.
The effect of empagliflozin on renal outcomes compared to sitagliptin with type 2 diabetes: target trial emulation using electronic medical records.
Kang MJ, Lee HK, Ko M … +3 more , Jang HY, Kim IW, Oh JM
Int J Clin Pharm · 2026 Apr · PMID 41128786 · Full text
INTRODUCTION: The renal effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors in diverse populations remain under investigation. While randomized controlled trials have shown renoprotective effects of SGLT2 inhibi...
INTRODUCTION: The renal effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors in diverse populations remain under investigation. While randomized controlled trials have shown renoprotective effects of SGLT2 inhibitors, their impact in routine clinical settings and specific populations such as Koreans requires further evaluation. AIM: This study aimed to evaluate the impact of empagliflozin compared to sitagliptin on renal function and related clinical outcomes in patients with type 2 diabetes (T2D) using a target trial emulation approach. METHOD: We conducted a retrospective cohort study using electronic medical records from a Korean tertiary care hospital between 2018 and 2019. New users of empagliflozin or sitagliptin were identified and matched using propensity scores to control for confounding factors. Primary outcomes included changes in estimated glomerular filtration rate (eGFR) and other renal function markers over time. Secondary outcomes included acute kidney injury, albuminuria, and composite renal events, as well as other clinical parameters. A modified intention-to-treat analysis was performed, with follow-up up to 13 months. RESULTS: After matching, 219 T2D patients were identified in each group. Empagliflozin was associated with a slower decline in eGFR compared to sitagliptin (p < 0.05). Serum phosphorus levels increased more with empagliflozin (p < 0.05). Empagliflozin showed a non-significant trend toward lower risk of composite renal outcomes (hazard ratio [HR] 0.78; 95% confidence interval [CI], 0.50-1.22). Significant increases in weight loss (HR 2.95; 95% CI, 2.01-4.33) and urination frequency (HR 4.05; 95% CI, 1.14-14.34) were observed with empagliflozin. Serum uric acid levels decreased more in the empagliflozin group (p < 0.05). CONCLUSION: This real-world study suggests that empagliflozin may offer renoprotective benefits compared to sitagliptin in T2D patients. However, the increased serum phosphorus levels warrant careful monitoring. These findings provide valuable insights for clinical decision-making in managing T2D patients at risk of renal complications.
Addressing potentially inappropriate prescribing in care homes: regional evaluation of a pharmacist-led model in Northern Ireland.
Doherty AS, Adamson G, Mallett J … +5 more , Darcy C, McKee H, Friel A, Scott MG, Miller EFR
Int J Clin Pharm · 2025 Dec · PMID 41118061 · Publisher ↗
INTRODUCTION: Potentially inappropriate prescribing (PIP) increases the risk for medication-related harm amongst older adults, with those in long-term care at particular risk. AIM: This study sought to evaluate a medicin...
INTRODUCTION: Potentially inappropriate prescribing (PIP) increases the risk for medication-related harm amongst older adults, with those in long-term care at particular risk. AIM: This study sought to evaluate a medicines optimisation pharmacist case management model for older adults in care homes in Northern Ireland (NI). METHOD: Secondary analysis of prospective data collected during the case management model delivered to older adults (≥ 65 years) across 32 care homes in NI (N = 1,095). Medication Appropriateness Index (MAI) scores were compared at baseline and post-intervention. Variability in MAI per medication score change (ΔMAI) was examined using multiple linear regression. Multiple logistic and Poisson regressions examined potential associations between ΔMAI and secondary outcomes, including unplanned hospital admissions (all-cause); general practitioner (GP) call-outs; out-of-hours (OOH) GP call-outs; and emergency department (ED) visits. RESULTS: PIP was highly prevalent at baseline (83.5%; n = 914). A significant reduction in MAI (per medication) score was observed from pre to post-intervention; 82% (n = 898) of participants experienced some MAI score improvement. Overall, 3,044 clinical interventions were delivered; 2,062 medications were stopped, 141 medications were started, and 438 dosages were changed. Several unexpected significant associations were observed between ΔMAI and GP call-outs during follow-up; sensitivity analyses suggested these findings were likely due to confounding. No association was observed between ΔMAI (per medication) and likelihood for unplanned hospital admission. CONCLUSION: PIP is highly prevalent in NI care homes and was significantly reduced by a medicine optimisation pharmacist case management model. Clinical pharmacist input in long-term care is warranted to lessen medication-related harm for older adults.
Comparative risks of inflammatory bowel disease in patients with type 2 diabetes mellitus treated with SGLT-2 inhibitors versus DPP-4 inhibitors: a real-world nationwide cohort study.
Yu YJ, Chien WC
Int J Clin Pharm · 2025 Dec · PMID 41118060 · Publisher ↗
INTRODUCTION: Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) have been suggested to exert anti-inflammatory effects in the gastrointestinal tract based on preclinical and observational studies. Whether these effects...
INTRODUCTION: Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) have been suggested to exert anti-inflammatory effects in the gastrointestinal tract based on preclinical and observational studies. Whether these effects translate into a reduced risk of inflammatory bowel disease (IBD), compared with other antidiabetic agents of similar therapeutic rank, remains unclear. AIM: This study aims to evaluate the association between SGLT-2i use and the risk of IBD in patients with type 2 diabetes mellitus (T2DM), using dipeptidyl peptidase-4 inhibitors (DPP-4i) as an active comparator. METHOD: A retrospective cohort study was conducted using Taiwan's National Health Insurance Research Database from 2016 to 2022. Patients with T2DM who initiated SGLT-2i or DPP-4i therapy were included. Propensity score matching (1:4) was performed based on key covariates. Adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) were calculated for incident IBD, including its subtypes ulcerative colitis (UC) and Crohn's disease (CD), using Cox proportional hazards models and Fine and Gray competing risk models (considering death as a competing event), with further adjustment for residual confounding. Sensitivity analyses were conducted using alternative induction periods and several on-treatment approaches that accounted for treatment discontinuation. RESULTS: Among 258,355 patients (51,671 SGLT-2i users and 206,684 DPP-4i users), the incidence of IBD was lower in the SGLT-2i group (12.51 vs. 35.83 per 100,000 person-years). SGLT-2i use was associated with a significantly reduced risk of IBD (aHR: 0.391; 95% CI 0.237-0.645; p < 0.001), with consistent results across multiple sensitivity analyses. CONCLUSION: In this nationwide real-world cohort, SGLT-2i use was associated with a lower risk of IBD compared with DPP-4i among patients with T2DM. These findings suggest potential gut-protective effects of SGLT-2i and support their consideration in clinical decision-making for patients at elevated risk of IBD. Further prospective studies are warranted to validate these observations and elucidate the underlying mechanisms.
Effectiveness and safety of different antiplatelet therapies for minor ischemic stroke or high-risk transient ischemic attack: a systematic review and network meta-analysis.
Jin T, Jiang H, Chen G … +6 more , Chen M, Hu Y, Yu L, Chen J, Hu W, Dai H
Int J Clin Pharm · 2025 Dec · PMID 41118059 · Publisher ↗
INTRODUCTION: Approximately one-third of patients with minor ischemic stroke (MIS) and transient ischemic attack (TIA) fail to achieve functional independence due to stroke progression or recurrent stroke. Identifying ef...
INTRODUCTION: Approximately one-third of patients with minor ischemic stroke (MIS) and transient ischemic attack (TIA) fail to achieve functional independence due to stroke progression or recurrent stroke. Identifying effective secondary prevention strategies is crucial to reduce morbidity, mortality, and disability. AIM: This systematic review and network meta-analysis aimed to evaluate the effectiveness and safety of various antiplatelet therapies using network meta-analysis and to identify the optimal treatment option for patients with MIS or high-risk TIA. METHOD: Studies were retrieved from PubMed, Embase, Web of Science, and Cochrane Library from inception to August 29, 2024. Randomized controlled trials (RCTs) and observational studies comparing antiplatelet treatments for MIS or high-risk TIA were included through consensus. The primary outcome was recurrent strokes. The secondary outcomes included recurrent ischemic strokes and a composite outcome combining ischemic stroke, myocardial infarction, and vascular death. The safety outcomes included intracerebral hemorrhage (ICH), any bleeding events, and all-cause mortality. Treatments were ranked based on the surface under the cumulative rank curve (SUCRA). RESULTS: Nineteen studies, including 12 RCTs and seven observational studies with 90,483 patients, were analyzed. Compared with aspirin or other mono antiplatelet therapies, both dual antiplatelet therapies of clopidogrel plus aspirin and ticagrelor plus aspirin reduced the risk of recurrent strokes, recurrent ischemic strokes, and the composite outcome without increasing the risk of ICH or all-cause mortality. However, ticagrelor plus aspirin significantly increased the risk of any bleeding. This treatment had the highest SUCRA score (0.97) for the primary outcome and the lowest (0.01) for any bleeding. CONCLUSION: Based on the combined results of effectiveness and safety, clopidogrel plus aspirin may be the optimal choice. However, for patients with a low bleeding risk, ticagrelor plus aspirin serves as an appropriate alternative.
Real-world safety assessment of ublituximab: a pharmacovigilance analysis based on the FDA adverse event reporting system.
Luo S, Feng Y, Huang Z … +7 more , Zhang D, Gao X, Liu C, Liu Z, Zhao K, Tian R, Huang X
Int J Clin Pharm · 2025 Dec · PMID 41118058 · Publisher ↗
INTRODUCTION: Ublituximab, a novel glycoengineered murine/human type Ⅰ chimeric IgG1-class monoclonal antibody targeting a unique CD20 epitope, is approved for the management of relapsing forms of multiple sclerosis in a...
INTRODUCTION: Ublituximab, a novel glycoengineered murine/human type Ⅰ chimeric IgG1-class monoclonal antibody targeting a unique CD20 epitope, is approved for the management of relapsing forms of multiple sclerosis in adults. While the safety and efficacy of ublituximab have been evaluated in several randomized clinical trials, real-world pharmacovigilance data remain limited. AIM: This study aimed to evaluate the post-marketing adverse events (AEs) associated with ublituximab utilizing the FDA Adverse Event Reporting System (FAERS) database, thereby delineating the safety profile of ublituximab in the post-approval setting. METHOD: The AE reports of ublituximab as the primary suspected drug from Q4 2022 to Q4 2024 were collected from the FAERS database. Disproportionality analysis, including the Reporting Odds Ratio, the Proportional Reporting Ratio, the Bayesian Confidence Propagation Neural Network, and the Multi-Item Gamma Poisson Shrinker, was performed to identify potential safety signals associated with ublituximab. Complementary analyses, comprising subgroup analysis, Weibull distribution, and sensitivity assessment, were conducted to characterize the ublituximab-associated AEs. RESULTS: A total of 1,190 reports encompassing 448 distinct AEs were collected. Known AEs that are consistent with the FDA label, such as infusion-related reactions (n = 591, ROR = 271.35, 95% CI 246.57-298.61) and infections (urinary tract infection: n = 28, ROR = 4.31, 95% CI 2.97-6.27; Respiratory tract infection: n = 8, ROR = 7.39, 95% CI 3.69-14.8), were reaffirmed, along with unexpected AEs like alopecia (n = 12, ROR = 2.06, 95% CI 1.17-3.64) and headache (n = 50, ROR = 2.55, 95% CI 1.93-3.38). The Weibull distribution characteristic of AEs is an early failure type, which indicates that vigilant monitoring in the initial treatment cycle is critical. Subgroup analyses revealed variations in the distribution across age and gender subgroups. Sensitivity analysis confirmed the consistency and robustness of the data. CONCLUSION: This study provided preliminary insights into the post-marketing safety profile of ublituximab by confirming its known AEs and investigating unexpected AEs. These findings contribute to evidence-based risk minimization strategies and pharmacovigilance activities for ublituximab in clinical practice.
Implementing a clinical pharmacy intervention for older adult inpatients with chronic non-cancer pain: a feasibility study.
Abderhalden J, Lang C, Meyer-Massetti C … +4 more , Müller D, Cadisch P, Bertschi D, Goetschi AN
Int J Clin Pharm · 2026 Apr · PMID 41108444 · Full text
INTRODUCTION: Chronic non-cancer pain (CNCP) affects 22-88% of older adults and is associated with a lower quality of life and polypharmacy. It thus puts these already very vulnerable patients at a greater risk of medica...
INTRODUCTION: Chronic non-cancer pain (CNCP) affects 22-88% of older adults and is associated with a lower quality of life and polypharmacy. It thus puts these already very vulnerable patients at a greater risk of medication-related harm. AIM: This feasibility study aimed to implement a multimodal clinical pharmacy intervention to improve CNCP-related care for older adult inpatients on hospital geriatrics wards. METHOD: We conducted a single-arm feasibility study from January to May 2025, including patients aged 65 or older, hospitalised on the geriatrics ward of a tertiary hospital in Switzerland and previously diagnosed with CNCP. Feasibility was defined as the ability to perform the intervention as planned and approximated by recruitment and dropout rates. The intervention included semi-structured interviews about patients' pain histories, collected patient-reported outcome measures (PROMs) and recorded therapy goals. Pharmacists then conducted medication reviews using a previously developed and validated trigger tool. The trigger tool was used as a standardised approach for identifying medication-related issues, comprising a set of previously validated quality indicators. Findings were discussed during interprofessional ward rounds. Final treatment decisions were made jointly with patients. We followed up with patients by telephone one month after hospital discharge. RESULTS: Of 253 screened patients, we included 48 patients: 28 (58%) were interviewed, and 18 (38%) had a follow-up telephone call. Pharmacists suggested 56 therapy changes, with 29 identified by the trigger tool and 27 identified by regular medication review. Therapy change acceptance rates by the care team were 78% and 41%, respectively. Pain frequency and the highest and lowest pain levels over the last seven days all decreased after hospital discharge, although these changes cannot be causally attributed to the intervention. Other pain-related PROMs showed no change or just a slight improvement or deterioration. CONCLUSION: The present feasibility study showed that implementing a clinical pharmacy intervention for older adult inpatients was indeed feasible. However, the recruitment rates were relatively low, and dropout rates were relatively high. Using a standardised approach involving a trigger tool showed promising results for detecting medication-related problems. These are important first indicators that including pharmacists more closely in standard care could be beneficial to CNCP patients.
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