Pub Date : 2026-02-05DOI: 10.1136/ejhpharm-2026-004979
Philip Wiffen
{"title":"Thirty congresses: What a journey!","authors":"Philip Wiffen","doi":"10.1136/ejhpharm-2026-004979","DOIUrl":"https://doi.org/10.1136/ejhpharm-2026-004979","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124405","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: 10.1136/ejhpharm-2025-004811
Virginie Chasseigne, Dominique Thiveaud, Sarah Ayraud-Thevenot, Christophe Lambert, Marc Laurent, Fabien Nativel
Objectives: Ecological transition has become an increasing concern among healthcare professionals, prompting interest in pro-environmental practices. This study aimed to provide evidence-based recommendations to guide healthcare professionals in selecting between single- and double-packaged sterile medical devices (SMD) based on their perceptions and practices.
Methods: A survey was co-constructed by the French Pharmaceutical Society of Medical Devices (SPFDM), the French Society for Sterilisation Sciences (SF2S), the French Society for Hospital Hygiene (SF2H), and the National Association of State-Certified Operating Room Nurses (UNAIBODE). The questionnaire was distributed electronically to healthcare professionals working in operating theatres across France.
Results: A total of 130 respondents completed the survey, including 72 operating room and registered nurses (55.5%), 30 pharmacists (23%), 20 managers (15.5%) and eight others (6%). Most participants worked in public health establishments (80.8%) with established waste sorting systems (83.1%), mainly for paper/cardboard, metal and plastic. Daily use of single-pack SMD was reported by 61.5% of respondents, although only 11.3% applied this to implantable MD. Packaging was considered an environmental criterion by 71.5% of participants, mainly based on the number of packages. Safety concerns were prevalent, with 66.9% indicating that single packaging alone was insufficient for SMD. A majority (70.8%) supported transitioning to single-pack MD where appropriate, whereas the trend reversed for implantable SMD, with 60.0% opposing single packaging. Most respondents (75.4%) favoured wider availability of dematerialised records, and 97% supported a pictogram indicating recyclability of SMD packaging.
Conclusion: This national survey provides valuable insights into SMD packaging practices in French operating theatres. While safety remains the primary concern-particularly for implantable SMD-there is strong environmental awareness and willingness to adapt practices when clinical safety is not compromised. Based on these findings, professional societies plan to develop recommendations promoting single-pack SMD where clinically appropriate, while maintaining double packaging for high-risk implantable SMD.
{"title":"Reducing packaging waste in care units: a national survey.","authors":"Virginie Chasseigne, Dominique Thiveaud, Sarah Ayraud-Thevenot, Christophe Lambert, Marc Laurent, Fabien Nativel","doi":"10.1136/ejhpharm-2025-004811","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004811","url":null,"abstract":"<p><strong>Objectives: </strong>Ecological transition has become an increasing concern among healthcare professionals, prompting interest in pro-environmental practices. This study aimed to provide evidence-based recommendations to guide healthcare professionals in selecting between single- and double-packaged sterile medical devices (SMD) based on their perceptions and practices.</p><p><strong>Methods: </strong>A survey was co-constructed by the French Pharmaceutical Society of Medical Devices (SPFDM), the French Society for Sterilisation Sciences (SF2S), the French Society for Hospital Hygiene (SF2H), and the National Association of State-Certified Operating Room Nurses (UNAIBODE). The questionnaire was distributed electronically to healthcare professionals working in operating theatres across France.</p><p><strong>Results: </strong>A total of 130 respondents completed the survey, including 72 operating room and registered nurses (55.5%), 30 pharmacists (23%), 20 managers (15.5%) and eight others (6%). Most participants worked in public health establishments (80.8%) with established waste sorting systems (83.1%), mainly for paper/cardboard, metal and plastic. Daily use of single-pack SMD was reported by 61.5% of respondents, although only 11.3% applied this to implantable MD. Packaging was considered an environmental criterion by 71.5% of participants, mainly based on the number of packages. Safety concerns were prevalent, with 66.9% indicating that single packaging alone was insufficient for SMD. A majority (70.8%) supported transitioning to single-pack MD where appropriate, whereas the trend reversed for implantable SMD, with 60.0% opposing single packaging. Most respondents (75.4%) favoured wider availability of dematerialised records, and 97% supported a pictogram indicating recyclability of SMD packaging.</p><p><strong>Conclusion: </strong>This national survey provides valuable insights into SMD packaging practices in French operating theatres. While safety remains the primary concern-particularly for implantable SMD-there is strong environmental awareness and willingness to adapt practices when clinical safety is not compromised. Based on these findings, professional societies plan to develop recommendations promoting single-pack SMD where clinically appropriate, while maintaining double packaging for high-risk implantable SMD.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146104252","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 : 2026-01-30DOI: 10.1136/ejhpharm-2025-004739
Yves Guillaume, Claire André, Lydie Lethier
Objectives: To develop a fully validated high-performance liquid chromatography (HPLC) stability-indicating assay for measuring the concentration and physical stability of 5-fluorouracil (5-FU) at standardised rounded doses in polyolefin (POF) infusion.
Methods: Diluted 5-FU infusion solutions were aseptically prepared by further dilution of a 5-FU stock solution with 0.9% sodium chloride in POF bags, at banded doses between 500 mg and 800 mg. The POF bags were stored under refrigeration (4°C) in the dark (long-term stability conditions) or at room temperature (25°C) in daylight for a short period of 24 hours (simulated in-use conditions).
Results: The long-term stability of 5-FU at selected standardised rounded doses (500-800 mg) in NaCl 0.9% in POF bags was confirmed for 3 months at 4°C in the dark. Additionally, during the simulated in-use study, no signs of chemical instability were observed.
Conclusions: A stability-indicating HPLC method was developed to determine 5-FU concentrations in dose-banding conditions associated with colour variation investigations. This study supports a centralised production of 5-FU at standardised dose banding.
{"title":"Fully validated HPLC-UV detection method associated with colour variation control for evaluation of the stability of 5-fluorouracil chemotherapy polyolefin infusion bags at dose banding.","authors":"Yves Guillaume, Claire André, Lydie Lethier","doi":"10.1136/ejhpharm-2025-004739","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004739","url":null,"abstract":"<p><strong>Objectives: </strong>To develop a fully validated high-performance liquid chromatography (HPLC) stability-indicating assay for measuring the concentration and physical stability of 5-fluorouracil (5-FU) at standardised rounded doses in polyolefin (POF) infusion.</p><p><strong>Methods: </strong>Diluted 5-FU infusion solutions were aseptically prepared by further dilution of a 5-FU stock solution with 0.9% sodium chloride in POF bags, at banded doses between 500 mg and 800 mg. The POF bags were stored under refrigeration (4°C) in the dark (long-term stability conditions) or at room temperature (25°C) in daylight for a short period of 24 hours (simulated in-use conditions).</p><p><strong>Results: </strong>The long-term stability of 5-FU at selected standardised rounded doses (500-800 mg) in NaCl 0.9% in POF bags was confirmed for 3 months at 4°C in the dark. Additionally, during the simulated in-use study, no signs of chemical instability were observed.</p><p><strong>Conclusions: </strong>A stability-indicating HPLC method was developed to determine 5-FU concentrations in dose-banding conditions associated with colour variation investigations. This study supports a centralised production of 5-FU at standardised dose banding.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146092448","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 : 2026-01-27DOI: 10.1136/ejhpharm-2025-004915
Eduardo Tejedor-Tejada, Seira Climent Ballester, Iván Cores-Rodríguez, Daniel Ortiz Del Olmo
{"title":"Evolution of clinical trials and regulatory challenges in Europe: a data-driven perspective.","authors":"Eduardo Tejedor-Tejada, Seira Climent Ballester, Iván Cores-Rodríguez, Daniel Ortiz Del Olmo","doi":"10.1136/ejhpharm-2025-004915","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004915","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146061179","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}
A 68-year-old male with severe burns was admitted for treatment. During the prolonged hospitalisation, discrepancies were observed between estimated glomerular filtration rate (eGFR) based on serum creatinine (eGFRcre) and actual renal function, as indicated by vancomycin therapeutic drug monitoring. Serum cystatin C measurement revealed a difference between eGFR based on serum cystatin C (eGFRcys) and eGFRcre. The patient experienced drug-induced liver injury, likely due to an inaccurate renal function assessment using serum creatinine. Adjusting drug doses based on eGFRcys improved clinical outcomes. Therefore, eGFRcre may overestimate renal function in patients with decreased muscle mass from prolonged hospitalisation and reduced physical activity. In emergency medicine, especially for patients with conditions affecting muscle mass, eGFRcys may be a more reliable marker for renal function evaluation than eGFRcre. Hence, alternative methods should be considered for assessing renal function in special populations to ensure appropriate drug dosing and prevent adverse effects.
{"title":"Patient with severe burns for whom serum cystatin C-based assessment was performed due to suspected errors in serum creatinine-based renal function evaluation: a case report.","authors":"Hidehiko Koreeda, Naoki Yoshikawa, Akira Sasaki, Kazuyuki Tasaki, Hiroki Itoh, Hidenobu Ochiai, Ryuji Ikeda","doi":"10.1136/ejhpharm-2025-004703","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004703","url":null,"abstract":"<p><p>A 68-year-old male with severe burns was admitted for treatment. During the prolonged hospitalisation, discrepancies were observed between estimated glomerular filtration rate (eGFR) based on serum creatinine (eGFRcre) and actual renal function, as indicated by vancomycin therapeutic drug monitoring. Serum cystatin C measurement revealed a difference between eGFR based on serum cystatin C (eGFRcys) and eGFRcre. The patient experienced drug-induced liver injury, likely due to an inaccurate renal function assessment using serum creatinine. Adjusting drug doses based on eGFRcys improved clinical outcomes. Therefore, eGFRcre may overestimate renal function in patients with decreased muscle mass from prolonged hospitalisation and reduced physical activity. In emergency medicine, especially for patients with conditions affecting muscle mass, eGFRcys may be a more reliable marker for renal function evaluation than eGFRcre. Hence, alternative methods should be considered for assessing renal function in special populations to ensure appropriate drug dosing and prevent adverse effects.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028732","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 : 2026-01-22DOI: 10.1136/ejhpharm-2025-004858
Eleonora Castellana, Maria Rachele Chiappetta
Objectives: Drug rash with eosinophilia and systemic symptoms (DRESS) is a rare but potentially fatal adverse drug reaction characterised by cutaneous and systemic involvement. This study aimed to analyse patients with DRESS reported through the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Methods: All DRESS reports submitted to FAERS between 1 January 2003 and 13 October 2025 were extracted. Patient characteristics were analysed descriptively according to severity, sex, age group and suspected drugs.
Results: A total of 26 831 patients with DRESS were identified, of which 99.67% were classified as having a serious adverse reaction. Overall mortality was 6.9% (1846 deaths). Female patients were more frequently affected than male patients. Adults aged 18-64 years represented the largest group. Allopurinol, lamotrigine and vancomycin were the most frequently suspected drugs, accounting for over 30% of reports.
Conclusions: DRESS remains a severe adverse drug reaction. Early recognition and continuous pharmacovigilance are essential to reduce associated morbidity and mortality.
{"title":"Drug rash with eosinophilia and systemic symptoms: descriptive analysis of pharmacovigilance.","authors":"Eleonora Castellana, Maria Rachele Chiappetta","doi":"10.1136/ejhpharm-2025-004858","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004858","url":null,"abstract":"<p><strong>Objectives: </strong>Drug rash with eosinophilia and systemic symptoms (DRESS) is a rare but potentially fatal adverse drug reaction characterised by cutaneous and systemic involvement. This study aimed to analyse patients with DRESS reported through the US Food and Drug Administration Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>All DRESS reports submitted to FAERS between 1 January 2003 and 13 October 2025 were extracted. Patient characteristics were analysed descriptively according to severity, sex, age group and suspected drugs.</p><p><strong>Results: </strong>A total of 26 831 patients with DRESS were identified, of which 99.67% were classified as having a serious adverse reaction. Overall mortality was 6.9% (1846 deaths). Female patients were more frequently affected than male patients. Adults aged 18-64 years represented the largest group. Allopurinol, lamotrigine and vancomycin were the most frequently suspected drugs, accounting for over 30% of reports.</p><p><strong>Conclusions: </strong>DRESS remains a severe adverse drug reaction. Early recognition and continuous pharmacovigilance are essential to reduce associated morbidity and mortality.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028745","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}
Background: The term stratification is increasingly used in pharmaceutical care to guide the allocation of interventions and optimise patient follow-up. However, its conceptual boundaries remain ambiguous and are frequently conflated with related constructs such as triage, clinical scoring or prioritisation, thereby compromising consistency in implementation. This lack of conceptual clarity hinders the development of standardised tools and limits the comparability and transferability of stratified care models in clinical pharmacy practice.
Objective: To clarify the concept of stratification in pharmaceutical care by identifying its defining attributes, antecedents, consequences and empirical referents.
Methods: A structured concept analysis was conducted using the Walker and Avant framework. A comprehensive literature search was performed across major biomedical databases covering the period from January 2000 to May 2025. Empirical studies, theoretical articles, conceptual frameworks and models addressing stratification or patient prioritisation in pharmaceutical care and related health services were included. Relevant publications were screened independently by both authors and analysed thematically.
Results: Eleven publications were included in the concept analysis. Four defining attributes of stratification in pharmaceutical care were identified: patient-centred segmentation, prioritisation of care intensity, resource-sensitive allocation and structured re-stratification over time. Key antecedents included increasing clinical complexity, limited pharmacist availability and the need for value-based care. Consequences and empirical referents were also identified, allowing stratification to be distinguished from related constructs such as triage or risk scoring.
Conclusion: This concept analysis establishes a theory-based conceptual foundation for stratification in pharmaceutical care. Clarifying its meaning may support greater conceptual consistency and inform the development, implementation and evaluation of structured patient prioritisation models across healthcare settings.
{"title":"Stratification in pharmaceutical care: a concept analysis.","authors":"Ramón Morillo-Verdugo, Fiona McIntyre, Enrique Contreras Macías","doi":"10.1136/ejhpharm-2025-004767","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004767","url":null,"abstract":"<p><strong>Background: </strong>The term stratification is increasingly used in pharmaceutical care to guide the allocation of interventions and optimise patient follow-up. However, its conceptual boundaries remain ambiguous and are frequently conflated with related constructs such as triage, clinical scoring or prioritisation, thereby compromising consistency in implementation. This lack of conceptual clarity hinders the development of standardised tools and limits the comparability and transferability of stratified care models in clinical pharmacy practice.</p><p><strong>Objective: </strong>To clarify the concept of stratification in pharmaceutical care by identifying its defining attributes, antecedents, consequences and empirical referents.</p><p><strong>Methods: </strong>A structured concept analysis was conducted using the Walker and Avant framework. A comprehensive literature search was performed across major biomedical databases covering the period from January 2000 to May 2025. Empirical studies, theoretical articles, conceptual frameworks and models addressing stratification or patient prioritisation in pharmaceutical care and related health services were included. Relevant publications were screened independently by both authors and analysed thematically.</p><p><strong>Results: </strong>Eleven publications were included in the concept analysis. Four defining attributes of stratification in pharmaceutical care were identified: patient-centred segmentation, prioritisation of care intensity, resource-sensitive allocation and structured re-stratification over time. Key antecedents included increasing clinical complexity, limited pharmacist availability and the need for value-based care. Consequences and empirical referents were also identified, allowing stratification to be distinguished from related constructs such as triage or risk scoring.</p><p><strong>Conclusion: </strong>This concept analysis establishes a theory-based conceptual foundation for stratification in pharmaceutical care. Clarifying its meaning may support greater conceptual consistency and inform the development, implementation and evaluation of structured patient prioritisation models across healthcare settings.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145988656","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 : 2026-01-14DOI: 10.1136/ejhpharm-2025-004730
Radhwan M Hussein, Zahraa Alaa Alrufaei, Muntadher Zmezim, Mohammed Qasim Rasheed, Huda Jassim Muhammad, Hamid Alghurabi, Mustafa Ridha Shihan, Zahraa Sabbar Omran
Objectives: Transfusion-dependent β-thalassaemia (TDT) requires lifelong blood transfusions, resulting in progressive iron overload and liver injury. Serum ferritin is a practical surrogate for iron burden, while liver function tests (LFTs) may reflect hepatic damage. However, the influence of gender and the chelation regimen on the ferritin-LFT relationship remains underexplored. This study evaluated these associations in a large Iraqi TDT cohort.
Methods: A retrospective cross-sectional study was conducted on 323 patients with TDT at the Center of Hereditary Blood Diseases, Karbala, Iraq. Data on demographics, ferritin, LFTs, transfusion history and chelation regimen were collected. Mann-Whitney U test, Fisher's exact test, Spearman's correlation and multiple linear regression were used to explore predictors of ferritin, including interaction terms. Receiver operating characteristic (ROC) analysis assessed aspartate aminotransferase (AST) and alanine aminotransferase (ALT) cut-offs for predicting ferritin >2500 ng/mL.
Results: Median ferritin was 2214 ng/mL. AST (ρ=0.581) and ALT (ρ=0.516) showed strong positive correlations with ferritin (p<0.001). Gender-stratified analyses revealed consistent AST-ferritin associations, with females demonstrating additional links involving bilirubin and alkaline phosphatase (ALP). Patients on deferasirox (DFX) + deferoxamine (DFO) had higher ferritin, AST and ALT than DFX alone (p<0.001). In regression models, AST and DFX+DFO were independent predictors overall, while subgroup models identified bilirubin and interaction effects in females, and bilirubin-treatment interactions in the DFX+DFO group. ROC analysis showed AST cut-offs were lower in females and combination therapy, though predictive accuracy remained high (AUC >0.79 in all subgroups).
Discussion: Gender and the chelation regimen modify the ferritin-LFT relationship in TDT. AST is a consistent predictor of ferritin across all groups, while bilirubin and interaction terms contribute in specific subgroups. These findings highlight the need for gender- and regimen-specific interpretation of biochemical markers, especially where advanced iron assessment is unavailable.
{"title":"Impact of gender and chelation on the ferritin-liver function test relationship in transfusion-dependent β-thalassaemia.","authors":"Radhwan M Hussein, Zahraa Alaa Alrufaei, Muntadher Zmezim, Mohammed Qasim Rasheed, Huda Jassim Muhammad, Hamid Alghurabi, Mustafa Ridha Shihan, Zahraa Sabbar Omran","doi":"10.1136/ejhpharm-2025-004730","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004730","url":null,"abstract":"<p><strong>Objectives: </strong>Transfusion-dependent β-thalassaemia (TDT) requires lifelong blood transfusions, resulting in progressive iron overload and liver injury. Serum ferritin is a practical surrogate for iron burden, while liver function tests (LFTs) may reflect hepatic damage. However, the influence of gender and the chelation regimen on the ferritin-LFT relationship remains underexplored. This study evaluated these associations in a large Iraqi TDT cohort.</p><p><strong>Methods: </strong>A retrospective cross-sectional study was conducted on 323 patients with TDT at the Center of Hereditary Blood Diseases, Karbala, Iraq. Data on demographics, ferritin, LFTs, transfusion history and chelation regimen were collected. Mann-Whitney U test, Fisher's exact test, Spearman's correlation and multiple linear regression were used to explore predictors of ferritin, including interaction terms. Receiver operating characteristic (ROC) analysis assessed aspartate aminotransferase (AST) and alanine aminotransferase (ALT) cut-offs for predicting ferritin >2500 ng/mL.</p><p><strong>Results: </strong>Median ferritin was 2214 ng/mL. AST (ρ=0.581) and ALT (ρ=0.516) showed strong positive correlations with ferritin (p<0.001). Gender-stratified analyses revealed consistent AST-ferritin associations, with females demonstrating additional links involving bilirubin and alkaline phosphatase (ALP). Patients on deferasirox (DFX) + deferoxamine (DFO) had higher ferritin, AST and ALT than DFX alone (p<0.001). In regression models, AST and DFX+DFO were independent predictors overall, while subgroup models identified bilirubin and interaction effects in females, and bilirubin-treatment interactions in the DFX+DFO group. ROC analysis showed AST cut-offs were lower in females and combination therapy, though predictive accuracy remained high (AUC >0.79 in all subgroups).</p><p><strong>Discussion: </strong>Gender and the chelation regimen modify the ferritin-LFT relationship in TDT. AST is a consistent predictor of ferritin across all groups, while bilirubin and interaction terms contribute in specific subgroups. These findings highlight the need for gender- and regimen-specific interpretation of biochemical markers, especially where advanced iron assessment is unavailable.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145984812","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 : 2026-01-13DOI: 10.1136/ejhpharm-2025-004610
Dorian Protzenko, Cecile Berard, Vincent Hoang, Guillaume Hache
Objective: Atrial fibrillation in elderly patients increases the risk of thromboembolism, necessitating long-term anticoagulation. While non-vitamin K oral anticoagulants (NOACs) are generally preferred, appropriate dosing in older patients who are frail remains a challenge. This study aimed to evaluate the impact of NOAC underdosing and identify bleeding risk factors using artificial intelligence in a local elderly population.
Methods: A retrospective study was conducted that included 119 patients with atrial fibrillation who were treated with apixaban or rivaroxaban between October 2020 and May 2022. Patients were categorised based on whether NOAC prescriptions were in accordance with dosing recommendations. Bivariate analyses and univariable logistic regression were performed to assess associations with clinical outcomes. To identify bleeding risk factors, a combination of stepwise logistic regression, learning vector quantisation and variable permutation was used. These risk factors were then used to develop supervised machine learning models to predict bleeding risk, for interpretation purposes.
Results: Significant differences in bleeding and thrombotic events were observed between patients with guideline-concordant and underdosed prescriptions. Using univariable logistic regression, underdosing NOACs was associated with a lower risk of bleeding (OR 0.3) but a higher risk of thrombosis (OR 6.7). In the multivariable analysis, guideline adherence, sex and NOAC choice were identified as key predictors of bleeding events. Guideline-concordant prescriptions were independently associated with an increased bleeding risk.
Conclusions: Underdosing NOAC was associated with a reduced bleeding risk but at the cost of a markedly increased thrombosis risk. Guideline-concordant dosing was also associated with higher bleeding risk in the multivariable model. Overall, the results do not support systematic underdosing of NOACs in elderly patients. These findings were shared with local prescribers to reinforce appropriate dosing practices and to improve follow-up for patients identified as being at increased bleeding risk.
{"title":"Evaluation of the impact of NOAC underdosing and exploration of bleeding risk factors in elderly patients with atrial fibrillation: artificial intelligence-based approach.","authors":"Dorian Protzenko, Cecile Berard, Vincent Hoang, Guillaume Hache","doi":"10.1136/ejhpharm-2025-004610","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004610","url":null,"abstract":"<p><strong>Objective: </strong>Atrial fibrillation in elderly patients increases the risk of thromboembolism, necessitating long-term anticoagulation. While non-vitamin K oral anticoagulants (NOACs) are generally preferred, appropriate dosing in older patients who are frail remains a challenge. This study aimed to evaluate the impact of NOAC underdosing and identify bleeding risk factors using artificial intelligence in a local elderly population.</p><p><strong>Methods: </strong>A retrospective study was conducted that included 119 patients with atrial fibrillation who were treated with apixaban or rivaroxaban between October 2020 and May 2022. Patients were categorised based on whether NOAC prescriptions were in accordance with dosing recommendations. Bivariate analyses and univariable logistic regression were performed to assess associations with clinical outcomes. To identify bleeding risk factors, a combination of stepwise logistic regression, learning vector quantisation and variable permutation was used. These risk factors were then used to develop supervised machine learning models to predict bleeding risk, for interpretation purposes.</p><p><strong>Results: </strong>Significant differences in bleeding and thrombotic events were observed between patients with guideline-concordant and underdosed prescriptions. Using univariable logistic regression, underdosing NOACs was associated with a lower risk of bleeding (OR 0.3) but a higher risk of thrombosis (OR 6.7). In the multivariable analysis, guideline adherence, sex and NOAC choice were identified as key predictors of bleeding events. Guideline-concordant prescriptions were independently associated with an increased bleeding risk.</p><p><strong>Conclusions: </strong>Underdosing NOAC was associated with a reduced bleeding risk but at the cost of a markedly increased thrombosis risk. Guideline-concordant dosing was also associated with higher bleeding risk in the multivariable model. Overall, the results do not support systematic underdosing of NOACs in elderly patients. These findings were shared with local prescribers to reinforce appropriate dosing practices and to improve follow-up for patients identified as being at increased bleeding risk.</p>","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145965749","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 : 2026-01-12DOI: 10.1136/ejhpharm-2025-004906
Xiaohua Zhou, Hong Jian Ji, Hongbao Yang
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