Pub Date : 2026-02-06DOI: 10.1007/s11096-026-02102-6
Anita E Weidmann, Cathal Cadogan, Daniela Fialová, Ankie Hazen, Martin C Henman, Betul Okuyan, Francesca Wirth, Abdikarim Abdi, Silvana A M Urru, Lotte Stig Nørgaard
{"title":"Correction: Behavioural theories, models and frameworks to underpin clinical pharmacy and pharmacy practice research: guidance from the European Society of Clinical Pharmacy.","authors":"Anita E Weidmann, Cathal Cadogan, Daniela Fialová, Ankie Hazen, Martin C Henman, Betul Okuyan, Francesca Wirth, Abdikarim Abdi, Silvana A M Urru, Lotte Stig Nørgaard","doi":"10.1007/s11096-026-02102-6","DOIUrl":"https://doi.org/10.1007/s11096-026-02102-6","url":null,"abstract":"","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146131754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-02DOI: 10.1007/s11096-026-02100-8
J Maathuis, A Veldhuis, J B Egbers, J Geerdink, F Karapinar-Çarkit, P M L A van den Bemt, E C Hulshof, J S Kingma
{"title":"Correction: Impact of an AI-powered hospital admission prediction dashboard to guide medication reconciliation in the emergency department: a retrospective before-after study.","authors":"J Maathuis, A Veldhuis, J B Egbers, J Geerdink, F Karapinar-Çarkit, P M L A van den Bemt, E C Hulshof, J S Kingma","doi":"10.1007/s11096-026-02100-8","DOIUrl":"https://doi.org/10.1007/s11096-026-02100-8","url":null,"abstract":"","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146104784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-12DOI: 10.1007/s11096-025-02040-9
B Bullock, R Allen, Gary Grant, H Laetitia Hattingh
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.
{"title":"Managing emergency department patients with potential medication-related harm: a qualitative study.","authors":"B Bullock, R Allen, Gary Grant, H Laetitia Hattingh","doi":"10.1007/s11096-025-02040-9","DOIUrl":"10.1007/s11096-025-02040-9","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Aim: </strong>The aim of this study was to explore the perspectives of ED clinicians on prioritising ED patients admitted due to potential medication-related harm.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"236-245"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-25DOI: 10.1007/s11096-025-02051-6
Gowri Kalyani, Cynthia Ma, Phillip Shayne Pruneda, Bilqees Fatima, Rheena Sheriff, Susan Abughosh, Ronnie Ozuna, Meghana V Trivedi
Introduction: The standard treatment for Hormone Receptor-Positive breast cancer (BC) is Oral Endocrine Therapy (OET). OET reduces BC recurrence rates by ~ 50%, and non-adherence to OET leads to worse outcomes. However, OET adherence remains suboptimal, particularly among low socioeconomic status populations.
Aim: This study assessed 12-month OET adherence and identified factors associated with non-adherence among BC patients at a multispecialty hospital in Edinburg, Texas in the Rio Grande Valley region.
Method: A 12-month single-center retrospective study of BC patients taking OET was conducted. Information on patient demographics, tumor characteristics, and prescription details was gathered from electronic medical records. Inclusion criteria included patients 18 years or older who filled at least one OET prescription. OET adherence was assessed using the proportion of Days Covered. Differences between the adherent and non-adherent groups were analyzed using chi-square and Student's t-tests, while multivariable logistic regression was employed to identify factors associated with non-adherence.
Results: Of the total 346 adult female patients, 322 (93%) were Hispanic/Latino. The mean age was 60.8 years, and the mean body mass index was 30.7. Only 122 (35.3%) patients were adherent at 12 months. Patients with diabetes were less likely to be adherent (odds ratio, 0.44; 95% confidence interval: 0.25-0.80). Longer duration of therapy was associated with higher OET adherence, which was estimated to increase 1.84-fold with each additional year of therapy.
Conclusion: Approximately two-thirds of BC patients were non-adherent to OET. Diabetes and shorter time on therapy predicted poorer adherence. These results present the urgent need to address barriers to OET adherence among BC patients in the underserved area of South Texas.
{"title":"Identification of factors associated with non-adherence to oral endocrine therapy in breast cancer patients of low socioeconomic status: a single centre retrospective study.","authors":"Gowri Kalyani, Cynthia Ma, Phillip Shayne Pruneda, Bilqees Fatima, Rheena Sheriff, Susan Abughosh, Ronnie Ozuna, Meghana V Trivedi","doi":"10.1007/s11096-025-02051-6","DOIUrl":"10.1007/s11096-025-02051-6","url":null,"abstract":"<p><strong>Introduction: </strong>The standard treatment for Hormone Receptor-Positive breast cancer (BC) is Oral Endocrine Therapy (OET). OET reduces BC recurrence rates by ~ 50%, and non-adherence to OET leads to worse outcomes. However, OET adherence remains suboptimal, particularly among low socioeconomic status populations.</p><p><strong>Aim: </strong>This study assessed 12-month OET adherence and identified factors associated with non-adherence among BC patients at a multispecialty hospital in Edinburg, Texas in the Rio Grande Valley region.</p><p><strong>Method: </strong>A 12-month single-center retrospective study of BC patients taking OET was conducted. Information on patient demographics, tumor characteristics, and prescription details was gathered from electronic medical records. Inclusion criteria included patients 18 years or older who filled at least one OET prescription. OET adherence was assessed using the proportion of Days Covered. Differences between the adherent and non-adherent groups were analyzed using chi-square and Student's t-tests, while multivariable logistic regression was employed to identify factors associated with non-adherence.</p><p><strong>Results: </strong>Of the total 346 adult female patients, 322 (93%) were Hispanic/Latino. The mean age was 60.8 years, and the mean body mass index was 30.7. Only 122 (35.3%) patients were adherent at 12 months. Patients with diabetes were less likely to be adherent (odds ratio, 0.44; 95% confidence interval: 0.25-0.80). Longer duration of therapy was associated with higher OET adherence, which was estimated to increase 1.84-fold with each additional year of therapy.</p><p><strong>Conclusion: </strong>Approximately two-thirds of BC patients were non-adherent to OET. Diabetes and shorter time on therapy predicted poorer adherence. These results present the urgent need to address barriers to OET adherence among BC patients in the underserved area of South Texas.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"266-273"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145603968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-08-29DOI: 10.1007/s11096-025-01986-0
Cathy Balsom, Shawn Bugden, Lois A Jackson, Deborah Kelly
Background: People who inject drugs (PWID) are at high risk of acquiring hepatitis C virus (HCV) infection, yet many remain undiagnosed due to testing barriers. Pharmacy-based point-of-care testing could improve access; however, little is known about its acceptability among PWID.
Aim: To explore the experiences of PWID with HCV testing and their perceptions of a pharmacy-based HCV testing option.
Method: A qualitative study involving interviews with eleven PWID between June and August 2022. Participants were asked about their perceptions and experiences about HCV testing as well as their views on a proposed pharmacy-based HCV testing model which was being proposed for a separate research study. Data were analyzed using reflexive thematic analysis.
Results: Regarding their experiences with HCV testing, participants recognized the importance of testing to know their status both for their health and that of others. Several challenges to testing were described, and participants described the impact of the primary care provider on testing. It was suggested that opioid agonist therapy programs were a missed opportunity for testing, and many potential advantages to pharmacy testing were described. Privacy and confidentiality within the pharmacy, as well as the impact of the relationship with pharmacists and staff were key factors influencing uptake.
Conclusion: Pharmacy-based HCV testing is viewed by participants as a convenient and acceptable testing option. Addressing stigma, ensuring privacy, and building trust with pharmacy staff appear to be critical for uptake. This approach may help to engage PWID in HCV testing as part of HCV elimination efforts.
{"title":"Experiences of people who inject drugs with hepatitis C testing and their perceptions of a pharmacy-based testing option: a qualitative study.","authors":"Cathy Balsom, Shawn Bugden, Lois A Jackson, Deborah Kelly","doi":"10.1007/s11096-025-01986-0","DOIUrl":"10.1007/s11096-025-01986-0","url":null,"abstract":"<p><strong>Background: </strong>People who inject drugs (PWID) are at high risk of acquiring hepatitis C virus (HCV) infection, yet many remain undiagnosed due to testing barriers. Pharmacy-based point-of-care testing could improve access; however, little is known about its acceptability among PWID.</p><p><strong>Aim: </strong>To explore the experiences of PWID with HCV testing and their perceptions of a pharmacy-based HCV testing option.</p><p><strong>Method: </strong>A qualitative study involving interviews with eleven PWID between June and August 2022. Participants were asked about their perceptions and experiences about HCV testing as well as their views on a proposed pharmacy-based HCV testing model which was being proposed for a separate research study. Data were analyzed using reflexive thematic analysis.</p><p><strong>Results: </strong>Regarding their experiences with HCV testing, participants recognized the importance of testing to know their status both for their health and that of others. Several challenges to testing were described, and participants described the impact of the primary care provider on testing. It was suggested that opioid agonist therapy programs were a missed opportunity for testing, and many potential advantages to pharmacy testing were described. Privacy and confidentiality within the pharmacy, as well as the impact of the relationship with pharmacists and staff were key factors influencing uptake.</p><p><strong>Conclusion: </strong>Pharmacy-based HCV testing is viewed by participants as a convenient and acceptable testing option. Addressing stigma, ensuring privacy, and building trust with pharmacy staff appear to be critical for uptake. This approach may help to engage PWID in HCV testing as part of HCV elimination efforts.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"139-147"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Introduction: </strong>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<sub>ss,24h</sub>) 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.</p><p><strong>Aim: </strong>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<sub>ss,24h</sub> thresholds predictive of acute kidney injury (AKI) using parametric TTE modeling.</p><p><strong>Method: </strong>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<sub>ss,24h</sub>, C<sub>ss,max</sub>, and C<sub>ss,min</sub>) 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.</p><p><strong>Results: </strong>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<sub>ss,24h</sub>, 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<sub>ss,24h</sub> 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<sub>ss,24h</sub> from 50 to 125 μg·h/mL raised 14-day AKI risk from 25 to 75%, while for CS, increasing AUC<sub>ss,24h</sub> from 25 to 50 μg·h/mL elevated risk from 20 to 60%.</p><p><strong>Conclusion: </strong>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<sub>ss,24h</sub> ≥ 101 μg·h/mL for PMB an
{"title":"Nephrotoxicity of polymyxin B and colistin sulfate in patients with multidrug-resistant gram-negative bacteria infections: a parametric time-to-event analysis.","authors":"Yuanfang Qin, Qin Ding, Shuqi Huang, Ruwei Yang, Shengnan Zhang, Tingting Wu, Jingjing Liu, Qi Pei","doi":"10.1007/s11096-025-02036-5","DOIUrl":"10.1007/s11096-025-02036-5","url":null,"abstract":"<p><strong>Introduction: </strong>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<sub>ss,24h</sub>) 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.</p><p><strong>Aim: </strong>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<sub>ss,24h</sub> thresholds predictive of acute kidney injury (AKI) using parametric TTE modeling.</p><p><strong>Method: </strong>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<sub>ss,24h</sub>, C<sub>ss,max</sub>, and C<sub>ss,min</sub>) 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.</p><p><strong>Results: </strong>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<sub>ss,24h</sub>, 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<sub>ss,24h</sub> 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<sub>ss,24h</sub> from 50 to 125 μg·h/mL raised 14-day AKI risk from 25 to 75%, while for CS, increasing AUC<sub>ss,24h</sub> from 25 to 50 μg·h/mL elevated risk from 20 to 60%.</p><p><strong>Conclusion: </strong>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<sub>ss,24h</sub> ≥ 101 μg·h/mL for PMB an","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"207-217"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145458305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-15DOI: 10.1007/s11096-025-02043-6
Rocío Guzmán-Laiz, Carles Iniesta-Navalón, Manuel Ríos-Saorín, Lorena Rentero-Redondo, Irene Garcia-Masegosa, Rebeca Añez-Castaño, Elena Urbieta-Sanz
Introduction: The development of anti-drug antibodies against tumor necrosis factor inhibitors, such as infliximab and adalimumab, is a major cause of therapeutic failure in patients with immune-mediated inflammatory diseases (IMIDs). However, immunogenicity responses are heterogeneous, and drug exposure can be restored in selected cases through individualized management.
Aim: To evaluate the clinical management and pharmacokinetic (PK) outcomes of immunogenicity in IMIDs treated with infliximab or adalimumab, by assessing its prevalence and phenotypes, associated factors, and the effectiveness of therapeutic interventions in reversing its PK impact.
Method: This retrospective cohort study included 997 patients treated with infliximab (n = 278) or adalimumab (n = 719). Immunogenicity was defined by detectable anti-drug antibodies and/or undetectable serum drug levels. Patients were stratified into three phenotypes based on anti-drug antibody titers and serum concentrations. Therapeutic drug monitoring guided clinical decision-making in cases of suspected treatment failure, immunogenicity, or subtherapeutic exposure, in accordance with institutional protocols. PK reversal was defined as the reappearance of detectable drug levels after intervention without switching therapy.
Results: Immunogenicity was identified in 240 patients (24.1%), more frequently among those treated with infliximab (28.4%) than with adalimumab (22.4%; p = 0.064). Multivariable analysis confirmed treatment with infliximab (OR: 1.43; 95% CI: 1.04-1.97) and prior immunogenicity (OR: 3.69; 95% CI: 1.50-9.11) as risk factors, while concomitant immunosuppressants were protective (OR: 0.62; 95% CI: 0.45-0.84). Among 77 patients managed actively, PK reversal was achieved in 76.7%. The rate of reversal was higher with adalimumab (80.0%) than with infliximab (62.5%; p = 0.039), and in patients with undetectable antibodies and low drug concentrations (Group 3) than in those with low-level antibodies (77.5% vs 50.0%; p = 0.024). Dose intensification and supervised administration were effective in achieving PK reversal (79.2% and 70.8%, respectively). Median serum drug concentrations increased significantly after intervention in both groups (p < 0.001).
Conclusion: Therapeutic drug monitoring-guided interventions tailored to immunogenicity phenotype can restore drug exposure in a substantial proportion of patients treated with tumor necrosis factor inhibitors. Recognition of reversible immunogenicity is essential for optimizing long-term therapeutic success and avoiding premature drug discontinuation.
{"title":"Immunogenicity phenotypes and reversal of pharmacokinetic impact in anti-TNF-treated immune-mediated diseases: a real-world study.","authors":"Rocío Guzmán-Laiz, Carles Iniesta-Navalón, Manuel Ríos-Saorín, Lorena Rentero-Redondo, Irene Garcia-Masegosa, Rebeca Añez-Castaño, Elena Urbieta-Sanz","doi":"10.1007/s11096-025-02043-6","DOIUrl":"10.1007/s11096-025-02043-6","url":null,"abstract":"<p><strong>Introduction: </strong>The development of anti-drug antibodies against tumor necrosis factor inhibitors, such as infliximab and adalimumab, is a major cause of therapeutic failure in patients with immune-mediated inflammatory diseases (IMIDs). However, immunogenicity responses are heterogeneous, and drug exposure can be restored in selected cases through individualized management.</p><p><strong>Aim: </strong>To evaluate the clinical management and pharmacokinetic (PK) outcomes of immunogenicity in IMIDs treated with infliximab or adalimumab, by assessing its prevalence and phenotypes, associated factors, and the effectiveness of therapeutic interventions in reversing its PK impact.</p><p><strong>Method: </strong>This retrospective cohort study included 997 patients treated with infliximab (n = 278) or adalimumab (n = 719). Immunogenicity was defined by detectable anti-drug antibodies and/or undetectable serum drug levels. Patients were stratified into three phenotypes based on anti-drug antibody titers and serum concentrations. Therapeutic drug monitoring guided clinical decision-making in cases of suspected treatment failure, immunogenicity, or subtherapeutic exposure, in accordance with institutional protocols. PK reversal was defined as the reappearance of detectable drug levels after intervention without switching therapy.</p><p><strong>Results: </strong>Immunogenicity was identified in 240 patients (24.1%), more frequently among those treated with infliximab (28.4%) than with adalimumab (22.4%; p = 0.064). Multivariable analysis confirmed treatment with infliximab (OR: 1.43; 95% CI: 1.04-1.97) and prior immunogenicity (OR: 3.69; 95% CI: 1.50-9.11) as risk factors, while concomitant immunosuppressants were protective (OR: 0.62; 95% CI: 0.45-0.84). Among 77 patients managed actively, PK reversal was achieved in 76.7%. The rate of reversal was higher with adalimumab (80.0%) than with infliximab (62.5%; p = 0.039), and in patients with undetectable antibodies and low drug concentrations (Group 3) than in those with low-level antibodies (77.5% vs 50.0%; p = 0.024). Dose intensification and supervised administration were effective in achieving PK reversal (79.2% and 70.8%, respectively). Median serum drug concentrations increased significantly after intervention in both groups (p < 0.001).</p><p><strong>Conclusion: </strong>Therapeutic drug monitoring-guided interventions tailored to immunogenicity phenotype can restore drug exposure in a substantial proportion of patients treated with tumor necrosis factor inhibitors. Recognition of reversible immunogenicity is essential for optimizing long-term therapeutic success and avoiding premature drug discontinuation.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"246-256"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145523423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-11DOI: 10.1007/s11096-025-02069-w
E Sterling Feininger, Casey C May, Archana Hinduja, Eric McLaughlin, Jacob P Counts
Introduction: First line treatment of cerebral edema or elevated intracranial pressure involves hyperosmolar therapy.
Aim: The purpose of this study was to identify risk factors associated with hypertonic saline solutions (HTS) non-responders post HTS bolus for treatment of cerebral edema.
Method: This single center, retrospective cohort study included neurocritical care patients who received one bolus dose of 3% NaCl (> 100 mL) or 23.4% NaCl (30 mL) and obtained one serum sodium level between one and eight hours after administration. The primary outcome was to determine the incidence of HTS non-responders, defined as a serum sodium response of < 5 mEq/L on repeat lab draw, and to identify risk factors associated with HTS non-response (sodium < 5 mEq/L) within 8 h after a HTS bolus dose.
Results: A total of 200 patients were included. The primary neurologic injuries included were acute ischemic stroke (41.5%) and intracerebral hemorrhage (35.5%). For the primary outcome, 127 (63.5%) patients were HTS non-responders. Risk factors associated with HTS non-response, included patients who did not receive mannitol prior to HTS (OR 3.31, 95% CI 1.34-8.17; p = 0.009), male sex (OR 2.43; 95% CI 1.27-4.63; p = 0.007), and patients without intraventricular hemorrhage (IVH) (OR 2.12; 95% CI 1.11-4.06; p = 0.024).
Conclusion: Overall, 63.5% patients were non-responders to HTS. Risk factors for non-response to HTS included no prior mannitol therapy, male sex, and patients without IVH. Further studies are warranted to assess the impact these risk factors have on HTS dosing and the treatment of cerebral edema.
简介:脑水肿或颅内压升高的一线治疗包括高渗治疗。目的:本研究的目的是确定高渗盐水(HTS)治疗脑水肿后无反应的危险因素。方法:本研究为单中心、回顾性队列研究,纳入了神经危重症患者,这些患者在给药后1 ~ 8小时内分别给予3% NaCl (> 100ml)或23.4% NaCl (30ml),并获得1个血清钠水平。主要结局是确定HTS无反应的发生率,定义为血清钠反应。结果:共纳入200例患者。原发性神经损伤包括急性缺血性脑卒中(41.5%)和脑出血(35.5%)。对于主要结局,127例(63.5%)患者为HTS无反应。与HTS无反应相关的危险因素包括HTS前未接受甘露醇治疗的患者(OR 3.31, 95% CI 1.34-8.17; p = 0.009)、男性(OR 2.43; 95% CI 1.27-4.63; p = 0.007)和无脑室内出血(IVH)的患者(OR 2.12; 95% CI 1.11-4.06; p = 0.024)。结论:总体而言,63.5%的患者对HTS无反应。对HTS无反应的危险因素包括没有接受过甘露醇治疗、男性和没有IVH的患者。需要进一步的研究来评估这些危险因素对HTS剂量和脑水肿治疗的影响。
{"title":"Risk factor analysis of hypertonic saline non-responders for the treatment of cerebral edema: a retrospective cohort study.","authors":"E Sterling Feininger, Casey C May, Archana Hinduja, Eric McLaughlin, Jacob P Counts","doi":"10.1007/s11096-025-02069-w","DOIUrl":"10.1007/s11096-025-02069-w","url":null,"abstract":"<p><strong>Introduction: </strong>First line treatment of cerebral edema or elevated intracranial pressure involves hyperosmolar therapy.</p><p><strong>Aim: </strong>The purpose of this study was to identify risk factors associated with hypertonic saline solutions (HTS) non-responders post HTS bolus for treatment of cerebral edema.</p><p><strong>Method: </strong>This single center, retrospective cohort study included neurocritical care patients who received one bolus dose of 3% NaCl (> 100 mL) or 23.4% NaCl (30 mL) and obtained one serum sodium level between one and eight hours after administration. The primary outcome was to determine the incidence of HTS non-responders, defined as a serum sodium response of < 5 mEq/L on repeat lab draw, and to identify risk factors associated with HTS non-response (sodium < 5 mEq/L) within 8 h after a HTS bolus dose.</p><p><strong>Results: </strong>A total of 200 patients were included. The primary neurologic injuries included were acute ischemic stroke (41.5%) and intracerebral hemorrhage (35.5%). For the primary outcome, 127 (63.5%) patients were HTS non-responders. Risk factors associated with HTS non-response, included patients who did not receive mannitol prior to HTS (OR 3.31, 95% CI 1.34-8.17; p = 0.009), male sex (OR 2.43; 95% CI 1.27-4.63; p = 0.007), and patients without intraventricular hemorrhage (IVH) (OR 2.12; 95% CI 1.11-4.06; p = 0.024).</p><p><strong>Conclusion: </strong>Overall, 63.5% patients were non-responders to HTS. Risk factors for non-response to HTS included no prior mannitol therapy, male sex, and patients without IVH. Further studies are warranted to assess the impact these risk factors have on HTS dosing and the treatment of cerebral edema.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"307-314"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145722607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-08-26DOI: 10.1007/s11096-025-01991-3
Sara Javanparast, Daria S Gutteridge, Peter D Hibbert, Elizabeth Manias, Andrew C Stafford, Gregory M Peterson, Gillian E Caughey, Janet K Sluggett
Introduction: The Aged Care Onsite Pharmacist (ACOP) program was recently launched in Australia to enable pharmacists to deliver clinical governance, clinical pharmacy and education services on the ground in residential aged care homes (RACHs). As the program is now being scaled up nationally, it is crucial to understand the complex interactions between various factors at the individual and organisational levels to ensure the program is successfully implemented and achieves its ultimate goal of improving the quality use of medicines in RACHs.
Aim: This qualitative study aimed to explore stakeholders' perspectives on medication management, perceived value of onsite pharmacists, and key considerations for successful program implementation in RACHs.
Method: We employed a qualitative approach and conducted semi-structured interviews (n = 61) with residents/families, pharmacists, medical practitioners, RACH staff, and individuals involved in policy and planning. Participants with experience working in both metropolitan and rural areas were included. The interviews were audio-recorded, transcribed, and thematically analysed, both inductively and deductively. The Consolidated Framework for Implementation Research informed the design of the study, developing interview schedules and data analysis.
Results: Factors influencing the program implementation were grouped into five themes: (1) Individuals: factors concerning individuals involved in the program; (2) Innovation: factors related to the program design; (3) Process: implementation process actions; (4) Inner setting: factors relating to the organisational context; and (5) Outer setting: factors pertaining to the policy context. Most participants valued the potential contribution of onsite pharmacists. Program flexibility was noted as essential to increase its acceptability, uptake and adoptability. A desire for implementation strategies was evident. Workforce, organisational leadership, infrastructure and resources, and broader policy support were noted as critical for the program's success.
Conclusion: The ACOP program represents a promising strategy to enhance medication management in RACHs. However, implementation on a large scale necessitates a thoughtful consideration of various interconnected factors at the individual, organisation and policy levels that may affect its uptake, adoptability, and long-term sustainability. This has implications for policymakers and providers at the scale up phase to ensure the program achieves its ultimate goal of enhancing residents' health outcomes.
{"title":"The Aged Care Onsite Pharmacist (ACOP) program in Australia: a qualitative study to examine key considerations for successful implementation in residential aged care homes.","authors":"Sara Javanparast, Daria S Gutteridge, Peter D Hibbert, Elizabeth Manias, Andrew C Stafford, Gregory M Peterson, Gillian E Caughey, Janet K Sluggett","doi":"10.1007/s11096-025-01991-3","DOIUrl":"10.1007/s11096-025-01991-3","url":null,"abstract":"<p><strong>Introduction: </strong>The Aged Care Onsite Pharmacist (ACOP) program was recently launched in Australia to enable pharmacists to deliver clinical governance, clinical pharmacy and education services on the ground in residential aged care homes (RACHs). As the program is now being scaled up nationally, it is crucial to understand the complex interactions between various factors at the individual and organisational levels to ensure the program is successfully implemented and achieves its ultimate goal of improving the quality use of medicines in RACHs.</p><p><strong>Aim: </strong>This qualitative study aimed to explore stakeholders' perspectives on medication management, perceived value of onsite pharmacists, and key considerations for successful program implementation in RACHs.</p><p><strong>Method: </strong>We employed a qualitative approach and conducted semi-structured interviews (n = 61) with residents/families, pharmacists, medical practitioners, RACH staff, and individuals involved in policy and planning. Participants with experience working in both metropolitan and rural areas were included. The interviews were audio-recorded, transcribed, and thematically analysed, both inductively and deductively. The Consolidated Framework for Implementation Research informed the design of the study, developing interview schedules and data analysis.</p><p><strong>Results: </strong>Factors influencing the program implementation were grouped into five themes: (1) Individuals: factors concerning individuals involved in the program; (2) Innovation: factors related to the program design; (3) Process: implementation process actions; (4) Inner setting: factors relating to the organisational context; and (5) Outer setting: factors pertaining to the policy context. Most participants valued the potential contribution of onsite pharmacists. Program flexibility was noted as essential to increase its acceptability, uptake and adoptability. A desire for implementation strategies was evident. Workforce, organisational leadership, infrastructure and resources, and broader policy support were noted as critical for the program's success.</p><p><strong>Conclusion: </strong>The ACOP program represents a promising strategy to enhance medication management in RACHs. However, implementation on a large scale necessitates a thoughtful consideration of various interconnected factors at the individual, organisation and policy levels that may affect its uptake, adoptability, and long-term sustainability. This has implications for policymakers and providers at the scale up phase to ensure the program achieves its ultimate goal of enhancing residents' health outcomes.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"169-181"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823688/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-08-26DOI: 10.1007/s11096-025-01978-0
Léa Solh Dost, Bertrand Guignard, Giacomo Gastaldi, Aveen Hasan Hamzo, Mathieu Nendaz, Marie-Claude Audétat, Marie P Schneider
Background: The roles of community pharmacists have evolved from dispensing medications to clinical decision makers. This shift requires a clearer understanding of pharmacists' clinical reasoning. Managing hospital discharge prescriptions requires analytical reasoning to ensure patient safety through medication reconciliation and patient education.
Aim: This study assessed community pharmacists' practices and their clinical reasoning towards hospital discharge prescriptions.
Method: This mixed-method study consisted of two phases. First, community pharmacists participated in a simulated encounter in their pharmacy, where a patient presented a discharge prescription. Their practices and the structure of the encounter were assessed using a structured checklist of practices adapted from the MEDICODE checklist. Following the simulation, participants verbalised their thought processes in a retrospective think-aloud session. These semi-structured interviews were transcribed and analysed using both inductive and deductive qualitative methods. Charlin et al.'s model was used to assess clinical reasoning, while the Calgary-Cambridge model evaluated communication structure.
Results: Among 14 participating pharmacists, 13 performed medication reconciliation, and 10 contacted the simulated prescriber to address discrepancies. While most provided adherence aids, only seven assessed non-adherence, and five actively collaborated with the patient. Pharmacists exhibited diverse interview structures, often revisiting previous discussion points. Clinical reasoning misconceptions, such as assumptions or premature closure, were observed at multiple stages of the clinical reasoning process.
Conclusion: Community pharmacists demonstrate strong medication-related skills but face challenges in clinical reasoning for discharge prescriptions. Clinical reasoning training, semi-structured consultations, and greater patient engagement would help tailor and improve post-discharge care.
{"title":"Community pharmacists' practices and clinical reasoning towards hospital discharge prescription: a study using simulations and retrospective think-aloud methodology.","authors":"Léa Solh Dost, Bertrand Guignard, Giacomo Gastaldi, Aveen Hasan Hamzo, Mathieu Nendaz, Marie-Claude Audétat, Marie P Schneider","doi":"10.1007/s11096-025-01978-0","DOIUrl":"10.1007/s11096-025-01978-0","url":null,"abstract":"<p><strong>Background: </strong>The roles of community pharmacists have evolved from dispensing medications to clinical decision makers. This shift requires a clearer understanding of pharmacists' clinical reasoning. Managing hospital discharge prescriptions requires analytical reasoning to ensure patient safety through medication reconciliation and patient education.</p><p><strong>Aim: </strong>This study assessed community pharmacists' practices and their clinical reasoning towards hospital discharge prescriptions.</p><p><strong>Method: </strong>This mixed-method study consisted of two phases. First, community pharmacists participated in a simulated encounter in their pharmacy, where a patient presented a discharge prescription. Their practices and the structure of the encounter were assessed using a structured checklist of practices adapted from the MEDICODE checklist. Following the simulation, participants verbalised their thought processes in a retrospective think-aloud session. These semi-structured interviews were transcribed and analysed using both inductive and deductive qualitative methods. Charlin et al.'s model was used to assess clinical reasoning, while the Calgary-Cambridge model evaluated communication structure.</p><p><strong>Results: </strong>Among 14 participating pharmacists, 13 performed medication reconciliation, and 10 contacted the simulated prescriber to address discrepancies. While most provided adherence aids, only seven assessed non-adherence, and five actively collaborated with the patient. Pharmacists exhibited diverse interview structures, often revisiting previous discussion points. Clinical reasoning misconceptions, such as assumptions or premature closure, were observed at multiple stages of the clinical reasoning process.</p><p><strong>Conclusion: </strong>Community pharmacists demonstrate strong medication-related skills but face challenges in clinical reasoning for discharge prescriptions. Clinical reasoning training, semi-structured consultations, and greater patient engagement would help tailor and improve post-discharge care.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"127-138"},"PeriodicalIF":3.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144953176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}