Therapeutic Advances in Drug Safety最新文献

{"title":"Beyond pain relief: the thrombosis threat of celecoxib.","authors":"Jingkai Di, Yujia Xi, Likun Qi, Yicong Zhao, Zijian Guo, Nan Yang, Chuan Xiang","doi":"10.1177/20420986251347354","DOIUrl":"10.1177/20420986251347354","url":null,"abstract":"<p><strong>Background: </strong>There are still some points of controversy regarding the adverse events associated with celecoxib use, particularly in terms of thrombosis.</p><p><strong>Objectives: </strong>To explore the relationship between celecoxib and thrombosis in the real world and to investigate the causality that exists.</p><p><strong>Design: </strong>We conducted pharmacovigilance analysis on spontaneously reported adverse events to evaluate the association between celecoxib and thrombotic events. In addition, Mendelian randomization studies of drug targets were used to explore the causal relationship between them.</p><p><strong>Methods: </strong>This study used the data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report database, and the Canada Vigilance Adverse Reaction (CVAR) for pharmacovigilance analysis. Among these, the Report Odds Ratio, Proportional Reporting Ratio, Information Component, and Empirical Bayesian Geometric Mean were used to determine the strength of adverse event signals. In addition, the Weibull shape parameter test was used in this study to investigate the trend of adverse events. Mendelian randomization was used to explore the causal link between celecoxib and deep vein thrombosis.</p><p><strong>Results: </strong>Pharmacovigilance signals indicated that celecoxib was associated with an increased risk of thrombosis, with deep vein thrombosis demonstrating positive signals in all three populations. In addition, Mendelian randomization analyses provided evidence to support a causal relationship between celecoxib and deep vein thrombosis and clarified that carbonic anhydrase 2, a target protein of celecoxib, is causally linked to deep vein thrombosis.</p><p><strong>Conclusion: </strong>The use of celecoxib leads to an increased risk of thrombosis and suggests a causal relationship.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251347354"},"PeriodicalIF":3.4,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144476777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abuse liability for esketamine in a cohort of patients undergoing an acute treatment course to manage treatment-resistant depression: a secondary analysis of an observational study in real-world clinical practicee.","authors":"Gilmar Gutierrez, Gustavo Vazquez, Nisha Ravindran, Raymond W Lam, Peter Giacobbe, Karthikeyan Ganapathy, Annette Kowara, André Do, Anusha Baskaran, Sean Michael Nestor, Jennifer Swainson","doi":"10.1177/20420986251347360","DOIUrl":"10.1177/20420986251347360","url":null,"abstract":"<p><strong>Background: </strong>Intranasal (IN) esketamine has become an effective and well-tolerated therapeutic option for the management of treatment-resistant depression within major depressive disorder (MDD-TRD). Despite these promising benefits, given the prevalence of ketamine abuse, concerns remain over the addiction liability that may be associated with esketamine treatment.</p><p><strong>Objectives: </strong>The objective of this study is to assess the real-world abuse liability of this substance by tracking changes in likeability and cravings through an acute treatment course.</p><p><strong>Design: </strong>This is a secondary analysis of a previously published multicenter observational study.</p><p><strong>Methods: </strong>Likeability and craving for esketamine were assessed using the Likeability and Cravings Questionnaire (LCQ) in MDD-TRD patients receiving an acute course of IN esketamine treatment (eight dosing sessions). The data were analyzed using descriptive statistics, multivariate analysis of variance (MANOVA), and pre-post effect size (Cohen's <i>d</i>).</p><p><strong>Results: </strong>Twenty-three patients (52.2% female, 43.5 ± 11.9 years old) were assessed. Most patients reported a neutral liking and no cravings for esketamine after their first dosing session. These metrics did not increase significantly by treatment endpoint. MANOVA showed that neither age, sex, baseline depression scores, the presence of side effects, or the study site had a statistically significant impact on LCQ scores either alone or in combination.</p><p><strong>Conclusion: </strong>These results agree with the available literature, showing that an acute course of IN esketamine treatment was not associated with high levels of drug liking or cravings, and this did not increase through the course of eight treatments. Though larger studies are needed, esketamine does not appear to be associated with significant abuse liability when used in an acute course of treatment for patients with MDD-TRD. These are important results for this patient population and for clinical practice.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251347360"},"PeriodicalIF":3.4,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144476776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors related to dosing frequency and route of administration in methotrexate intolerance among patients with rheumatoid arthritis: a cross-sectional study.","authors":"Haya M Almalag, Jawza F Alsabhan, Abdurhman S Alarfaj, Eman Alfi, Shorouq Albalawi, Asma A Al-Shadaawi, Sahar A Alshehri, Ghadah Asaad Assiri, Ibrahim Almaghlouth, Mohammed A Omair","doi":"10.1177/20420986251349449","DOIUrl":"10.1177/20420986251349449","url":null,"abstract":"<p><strong>Background: </strong>Methotrexate is central to the management of rheumatoid arthritis (RA). However, its use is often limited by methotrexate intolerance.</p><p><strong>Objectives: </strong>This study aims to explore the association between alternative methotrexate dosing methods and methotrexate intolerance.</p><p><strong>Design: </strong>A cross-sectional study.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted on patients with RA receiving methotrexate for at least 3 months at the outpatient clinic of King Saud University Medical City, Riyadh, Saudi Arabia. The electronic survey collected data on demographics, marital and educational status, methotrexate use, Methotrexate Intolerance Severity Score (MISS), and Health Assessment Questionnaire. Statistical analyses (univariate and linear or logistic regression) were conducted to evaluate the associations between the administration methods and methotrexate intolerance (MISS ⩾6).</p><p><strong>Results: </strong>The study included 154 patients, predominantly female (89%; mean age (standard deviation, ±SD): 50 (±12) years). Methotrexate tolerance was observed in 64% of the participants, while 36% had a MISS above the cutoff point of 6, indicating intolerance. Methotrexate-intolerant patients were younger (mean age (±SD): 47 (±12) years) than tolerant patients (mean age (±SD): 54 (±12) years; <i>p</i> = 0.005). No significant differences were found between methotrexate-tolerant and methotrexate-intolerant patients regarding dose, frequency, relation to meals, and time of day.</p><p><strong>Conclusion: </strong>Methotrexate tolerance was not associated with different administration methods: split-dose versus single weekly dose, or subcutaneous versus oral administration.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251349449"},"PeriodicalIF":3.4,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12171254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144317905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance processes in low- and middle-income countries: moving from data collection to data analysis and interpretation.","authors":"Olga Menang, Peter van Eeuwijk, Karen Maigetter, Andy Stergachis, Christian Burri","doi":"10.1177/20420986241300006","DOIUrl":"10.1177/20420986241300006","url":null,"abstract":"<p><strong>Background: </strong>The analysis and interpretation of pharmacovigilance data is an essential component of the continuous benefit-risk assessment of authorised medicinal products. Effective pharmacovigilance data analysis starts with data collection and involves critical activities, such as signal detection, that enable the generation of new information on marketed products, and inform safety-related regulatory actions. This real-time pharmacovigilance data analysis, which requires efficient collaboration and exchange of information between the key pharmacovigilance stakeholders, represents a challenge for many low- and middle-income countries (LMIC).<b>Objectives::</b> To assess the capacity for analysis of pharmacovigilance data in LMIC and to identify mechanisms to strengthen data analysis, interpretation and evidence-based pharmacovigilance decision-making.</p><p><strong>Design: </strong>We used a convergent parallel mixed-methods study design consisting of qualitative and quantitative methods.</p><p><strong>Methods: </strong>Qualitative and quantitative methods consisted of semi-structured interviews and an online survey, respectively. Quantitative research was complemented by cross-sectional analyses of the number of adverse event reports from LMIC in VigiBase^® from 2019 to 2023.</p><p><strong>Results: </strong>Nine key informants from eight countries were interviewed and 50 respondents from 34 countries completed the online survey. Four major themes emerged from the data and are proposed as transformative actions to strengthen pharmacovigilance data analysis and interpretation in LMIC: build on existing pharmacovigilance data analysis capacity rather than create new or parallel mechanisms; implement standardised procedures to enable efficient data analysis; augment the work of the safety committees by assigning pharmacovigilance staff to data analysis; and implement mechanisms that allow benefit-risk evaluation and decision-making.</p><p><strong>Conclusions: </strong>Findings from this research revealed that many LMIC have implemented procedures for reporting and collecting suspected adverse events, but a considerable proportion of the data collected is not analysed in-country due to a lack of requisite knowledge, processes and structures to support such analysis. Establishing the four essential elements proposed by this research will equip LMIC for efficient data analysis, thereby supporting consistent decision-making through pharmacovigilance.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986241300006"},"PeriodicalIF":3.4,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12159475/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144286575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Building functional and sustainable pharmacovigilance systems: an analysis of pharmacovigilance development across high-, middle- and low-income countries.","authors":"Olga Menang, Peter van Eeuwijk, Karen Maigetter, Andrea de Soyres-Kuemmerle, Edinam Agbenu, Christian Burri","doi":"10.1177/20420986251342941","DOIUrl":"10.1177/20420986251342941","url":null,"abstract":"<p><strong>Background: </strong>There has been notable progress in pharmacovigilance (PV) in low- and middle-income countries (LMIC) in the last decade. However, only a few of these PV systems are fully functional, unlike in high-income countries where stringent legislation, regulations and operational guidelines have enabled the establishment of effective PV systems. The key challenges faced in LMIC include organisational inefficiencies; weak infrastructure; inconsistent and poorly enforced regulations; and inadequate financing and shortage of trained personnel. Furthermore, low adverse event volume and poor data quality hinder the capacity for safety data generation and utilisation. With the increasing availability of essential and innovative medicines in LMIC, establishing robust PV systems is crucial for effective safety surveillance.</p><p><strong>Objectives: </strong>This research aims to analyse the development of PV systems across high-, middle- and low-income countries and to carve out essential elements for functionality and sustainability of PV systems in LMIC.</p><p><strong>Design: </strong>A convergent parallel mixed-methods design, combining qualitative and quantitative methods.</p><p><strong>Methods: </strong>Qualitative and quantitative research consisted of semi-structured interviews and an online survey, respectively.</p><p><strong>Results: </strong>Twelve key informants from 10 countries were interviewed and 52 respondents from 36 countries completed the online survey. From the qualitative and quantitative data, we identified nine essential elements for sustainable PV development in LMIC: understanding the drivers of PV development; adequately resolving core system challenges; implementing an efficient organisational structure and good governance; establishing procedures for PV activities; ensuring availability of qualified and trained staff; identifying alternate sources of financing; having a strategic development plan; adequately leveraging the health system; and effectively integrating the pharmaceutical sector in the national PV system.</p><p><strong>Conclusion: </strong>Findings from this research indicate that significant efforts are still needed to upgrade PV systems in LMIC to meet global standards despite the progress achieved in recent years. Developing the different areas emerging from this research, within the framework of a holistic, fit-for-purpose PV system strengthening, would enable a comprehensive progression from basic to functional and thus sustainable PV systems in LMIC.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251342941"},"PeriodicalIF":3.4,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144485847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adherence to WHO/INRUD prescription indicators in public hospitals: evidence from the Ashanti Region, Ghana.","authors":"Richard Delali Agbeko Djochie, Rita Owusu-Donkor, Elizabeth Modupe d'Almeida, Francis Kwadwo Gyamfi Akwah, Emmanuel Kyeremateng, Samuel Opoku-Afriyie, Cecilia Akosua Tabiri, Francis Kyei-Frimpong, Samuel Dwomoh, Francis Fordjour, Jonathan Boakye-Yiadom","doi":"10.1177/20420986251346321","DOIUrl":"10.1177/20420986251346321","url":null,"abstract":"<p><strong>Background: </strong>Rational prescribing optimizes medicine use, reduces costs, and improves patient outcomes. However, adherence to rational prescribing practices varies, particularly in low- and middle-income countries like Ghana, where healthcare systems differ across urban, peri-urban, and rural settings.</p><p><strong>Objectives: </strong>This study assessed adherence to WHO/INRUD prescribing indicators in public hospitals and determined each hospital's Index of Rational Drug Prescribing (IRDP).</p><p><strong>Design: </strong>A retrospective descriptive study was conducted in 25 public hospitals across rural, peri-urban, and urban settings in the Ashanti Region of Ghana.</p><p><strong>Methods: </strong>Data from 5091 patient encounters were analyzed to assess prescribing indicators, including the average number of medicines per encounter, generic prescribing, adherence to the Essential Medicines List (EML), antibiotic use, and injection prescribing. IRDP scores were calculated, and geographic comparisons were performed using analysis of variance (ANOVA), with <i>p</i> < 0.05 considered statistically significant.</p><p><strong>Results: </strong>No hospital met the WHO target of <2 medicines per encounter (regional average: 3.63 ± 0.62). Generic prescribing averaged 72.26%, and EML adherence was 91.85%, with no hospital achieving 100%. Antibiotic prescribing exceeded the <30% target, averaging 60.84%. Injection use aligned best with WHO standards (average: 13.42%), with 22 of 25 hospitals meeting the <20% threshold. The regional IRDP was 3.67, with rural hospitals scoring lowest (3.63), followed by peri-urban (3.64) and urban hospitals (3.81). No significant geographic differences in IRDP scores were observed (<i>p</i> > 0.05).</p><p><strong>Conclusion: </strong>While injection use aligns with WHO standards, gaps remain in generic prescribing, antibiotic use, and EML adherence. Strengthening prescriber training, antimicrobial stewardship programs, and policy enforcement is essential to improving prescribing practices and patient outcomes in public hospitals in the Ashanti Region.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251346321"},"PeriodicalIF":3.4,"publicationDate":"2025-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12146595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance analysis of secondary primary malignancies and antibiotic interactions in CAR-T cell therapies.","authors":"Yun Peng, Yuxuan Song, Jiaxing Lin, Caipeng Qin, Yiqing Du, Tao Xu","doi":"10.1177/20420986251340866","DOIUrl":"10.1177/20420986251340866","url":null,"abstract":"<p><strong>Background: </strong>Chimeric antigen receptor T-cell (CAR-T) cell therapy represents a significant advancement in cancer treatment, offering remarkable responses in certain hematologic malignancies. However, the risk of secondary primary malignancies (SPMs) associated with CAR-T therapy is a growing concern. Recent studies suggest that antibiotics, which are frequently used in CAR-T patients, may influence this risk, yet their effects remain poorly understood.</p><p><strong>Objective: </strong>This study aims to systematically evaluate the association between antibiotics and the incidence and timing of SPMs in patients receiving CAR-T cell therapy, using data from the FDA's Adverse Event Reporting System (FAERS) database.</p><p><strong>Design: </strong>We analyzed reports from FAERS spanning from Q2 2017 to Q1 2024, focusing on SPMs associated with various CAR-T therapies.</p><p><strong>Methods: </strong>A comprehensive signal analysis was conducted to explore the associations between antibiotic usage and specific SPMs for different CAR-T products. In addition, we employed cumulative hazard curves to evaluate the time to onset of SPMs in patients receiving antibiotics versus those who did not.</p><p><strong>Results: </strong>We have provided a comprehensive summary of all signals for CAR-T-associated SPMs. In addition, our analysis identified significant variations in the association between antibiotics and SPM incidence depending on the CAR-T therapy administered. Antibiotics were associated with a decreased risk of SPMs in patients treated with anti-CD19 CAR-T therapies, particularly brexucabtagene autoleucel. Conversely, a higher risk of SPMs was observed in association with antibiotics for anti-BCMA therapies, with idecabtagene vicleucel showing a notably elevated risk. Notably, antibiotics were associated with an earlier onset of SPMs across CAR-T therapies, suggesting a possible relationship between antibiotics and the timing of these malignancies. Finally, we explored the underlying biological pathways that may be associated with these observations.</p><p><strong>Conclusion: </strong>Antibiotics were associated with both the risk and timing of SPMs in patients undergoing CAR-T cell therapy. This study highlights the need for further research to better understand the complex interactions between antibiotics and CAR-T therapies, as well as the potential implications for clinical management and patient care.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251340866"},"PeriodicalIF":3.4,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12144370/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144249735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world insights into safety, tolerability, and predictive factors of adverse drug reactions in treating idiopathic pulmonary fibrosis with pirfenidone and nintedanib.","authors":"Alessio Provenzani, Daniele Leonardi Vinci, Miriam Alaimo, Salvatore Di Maria, Fabio Tuzzolino, Gaetano Floridia, Roberta Di Stefano, Anna Carollo, Adriana Callari, Piera Polidori, Patrizio Vitulo","doi":"10.1177/20420986251341645","DOIUrl":"10.1177/20420986251341645","url":null,"abstract":"<p><strong>Background: </strong>Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, life-threatening lung disease with a global incidence of 0.09-1.30 per 10,000 individuals. Pirfenidone and nintedanib are the approved treatments for IPF.</p><p><strong>Objectives: </strong>This study evaluated the real-world safety and tolerability profiles of pirfenidone and nintedanib in IPF patients treated at the Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS ISMETT). A comparative analysis was conducted based on the number, types, and severity of adverse drug reactions (ADRs) and to identify potential predictors of treatment discontinuation or ADR onset based on patient characteristics.</p><p><strong>Design: </strong>A retrospective observational study was conducted on 531 IPF patients treated at IRCCS ISMETT with either pirfenidone or nintedanib.</p><p><strong>Methods: </strong>Eligible patients were selected based on the logged monthly dispensations provided by the pharmacy service for both therapies. Covariates were extracted from electronic medical records (age, sex, body mass index, smoking history, comorbidities, forced vital capacity (FVC) %, diffusing capacity of the lung for carbon monoxide (DLCO) %, 6-minute walk test (6-MWT), polytherapy, oxygen therapy, drug switch, etc.). ADRs were categorized by severity and follow-up status, and further classified according to the Medical Dictionary for Regulatory Activities, specifying the Preferred Terms and the related System Organ Classes. Chi-square or Fisher's exact test was used for categorical variables, and univariate and multiple logistic regression identified potential risk factors for ADR onset. Backward Stepwise logistic regression (BSLR) was used to determine independent variables associated with ADR occurrence.</p><p><strong>Results: </strong>The nintedanib group had more frequent ADRs related to gastrointestinal and hepatobiliary disorders, with nausea, diarrhea, anorexia, and weight loss as the most common. The pirfenidone group had more ADRs related to skin, nervous system, and vascular disorders, such as rash, nausea, dizziness, and blood pressure imbalances. Significant baseline differences between groups included age, smoking status, FVC (%), DLCO (%), and 6-MWT, with the nintedanib cohort showing worse baseline characteristics. A total of 450 ADRs were reported: 59.6% for nintedanib and 40.4% for pirfenidone. Independent variables that significantly increased the likelihood of experiencing ADR were drug change, treatment type, gender, and age.</p><p><strong>Conclusion: </strong>Identifying ADR predictors is essential for personalizing treatment strategies. Both pirfenidone and nintedanib are crucial in managing IPF, highlighting the need for further research to optimize personalized therapies and patient outcomes.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251341645"},"PeriodicalIF":3.4,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12117236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144174923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacist support in the entry of blood drug concentration test order avoids vancomycin-induced kidney injury.","authors":"Naoki Yoshikawa, Chiaki Miyata, Hidehiko Koreeda, Shuichi Nakahara, Yuki Matsusaki, Yusei Yamada, Takehiko Nagano, Hidenobu Ochiai, Ryuji Ikeda","doi":"10.1177/20420986251339580","DOIUrl":"10.1177/20420986251339580","url":null,"abstract":"<p><strong>Background: </strong>Task shifting and sharing have been proposed as strategies to address healthcare staffing shortages and improve patient outcomes. In emergency and intensive care medicine, pharmacist interventions have shown potential to reduce medication errors and improve care quality. However, the precise benefits of pharmacist support in therapeutic drug monitoring (TDM) for emergency center inpatients require further verification.</p><p><strong>Objective: </strong>To determine the contribution of pharmacist support in entering blood drug concentration test orders to patient safety during anti-methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) drug administration in the emergency and critical care center, and investigate the association between this support and the frequency of vancomycin-induced kidney injury.</p><p><strong>Design: </strong>Single-center retrospective cohort study comparing outcomes 2 years before and 2 years after implementing pharmacist support for blood concentration test order entry.</p><p><strong>Methods: </strong>Patients receiving intravenous vancomycin with blood concentrations measured at the emergency center were included. Propensity score matching was used to minimize confounding. The primary outcome was the change in frequency of vancomycin-induced kidney injury before and after pharmacist support implementation.</p><p><strong>Results: </strong>Pharmacist support significantly reduced the frequency of vancomycin-induced kidney injury (from 6.5% to 0.0%, <i>p</i> = 0.043) and shortened time to first TDM implementation (<i>p</i> = 0.019) in the overall cohort. Similar significant reductions were observed in the propensity score matched cohort (from 11.9% to 0.0%, <i>p</i> = 0.013).</p><p><strong>Conclusion: </strong>Pharmacist support in entering blood drug concentration test orders significantly reduced vancomycin-induced kidney injury frequency and shortened time to first TDM, enhancing patient safety during anti-MRSA medication administration in the emergency and critical care center. This task-shifting approach demonstrates clear benefits for patient care and physician workload.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251339580"},"PeriodicalIF":3.4,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12103665/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of electronic distribution of Direct Healthcare Professional Communications by the Danish Medicines Agency: a survey study of physicians' experiences and preferences.","authors":"Per Sindahl, Mathias Møllebæk, Helga Gardarsdottir, Marie Louise De Bruin, Christine Erikstrup Hallgreen, Marianne Hald Clemmensen","doi":"10.1177/20420986251333911","DOIUrl":"10.1177/20420986251333911","url":null,"abstract":"<p><strong>Background: </strong>The efficient distribution of Direct Healthcare Professional Communications (DHPCs) is crucial for ensuring healthcare providers promptly receive important new safety information.</p><p><strong>Objectives: </strong>This study aimed to evaluate the implementation of the electronic distribution of DHPCs by the Danish Medicines Agency (DKMA) and to assess how future safety communication can be improved.</p><p><strong>Design: </strong>We conducted a web-based cross-sectional survey among Danish physicians using a self-administered questionnaire.</p><p><strong>Methods: </strong>DKMA sends DHPCs to healthcare professionals via an electronic mailbox called e-Boks which is linked to the unique personal identifier. To evaluate DKMA's distribution of DHPCs, participants were asked about awareness, frequency and barriers of reading, preferred distribution channel and overall satisfaction. To further identify potential improvements, respondents were asked about general preferences regarding sender and channels of safety information in addition to which information sources they use to keep up-to-date.</p><p><strong>Results: </strong>A total of 2238 physicians completed the survey corresponding to a response rate of 26% based on the total target population. The total awareness was 81%. Compared to previous research, awareness of GPs increased from 66% to 82%, and the percentage of GPs who rarely or never read DHPCs decreased from 33% to 20%. In addition, our study revealed a preference for receiving DHPCs electronically through e-Boks as opposed to workplace-delivered postal letters, and a preference for the DKMA over pharmaceutical companies as the sender of DHPCs. One-third of the respondents were either 'dissatisfied' or 'very dissatisfied' with the current solution. A professional mailbox and point-of-care alerts when prescribing may complement the primary distribution channel to strengthen the uptake. Additionally, existing information sources already frequented by the target group may be used to communicate safety information.</p><p><strong>Conclusion: </strong>The DKMA's electronic distribution of DHPCs suggests an improvement and may serve as inspiration for other agencies. However, the considerable dissatisfaction calls for further improvements.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251333911"},"PeriodicalIF":3.4,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12103656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}