Therapeutic Advances in Drug Safety最新文献

{"title":"A post-marketing disproportionality analysis of the safety of ribociclib based on the FDA Adverse Event Reporting System.","authors":"Jiayan Xu, Ruo Wang, Kunwei Shen","doi":"10.1177/20420986251324633","DOIUrl":"https://doi.org/10.1177/20420986251324633","url":null,"abstract":"<p><strong>Background: </strong>Although there are reports of adverse events (AEs) of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors, the safety of ribociclib alone has not yet been comprehensively evaluated in real-world clinical practice.</p><p><strong>Objectives: </strong>To investigate the overall real-world safety profile of ribociclib by mining data from the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Design: </strong>A retrospective disproportionality analysis was conducted based on the FAERS database.</p><p><strong>Methods: </strong>We processed reports from the first quarter of 2017 to the second quarter of 2023 and applied disproportionality analysis using four different methods: reporting odds ratio, Medicines and Healthcare Products Regulatory Agency, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.</p><p><strong>Results: </strong>A total of 12,885 AE reports of ribociclib as the primary suspect were enrolled. 48.81% of AEs occur within 60 days of ribociclib administration. Blood and lymphatic system disorders and abnormalities in investigation at the system organ class level showed statistically significant signals in all four methods. Nausea (<i>n</i> = 1426), neutropenia (<i>n</i> = 940), vomiting (<i>n</i> = 863), white blood cell count decreased (<i>n</i> = 812), and alopecia (<i>n</i> = 536) turned out to be the five most frequent AEs at the preferred term level. Twenty-eight AEs undiscovered in the label were newly identified. Neutropenia, as a widely recognized AE, was observed to potentially result in more serious outcomes than previously anticipated (<i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>This study utilized the FAERS database to analyze real-world AE signals associated with ribociclib following its market approval. We characterized the clinical profiles of reported AEs and found some significant signals consistent with previous clinical trials. In addition, several AEs not included in the drug label or exhibiting unexpected severity were detected. These findings provide valuable insights for clinicians and highlight directions for further causality-focused research to validate the observed results.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251324633"},"PeriodicalIF":3.4,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869255/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143543543","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":"Artificial intelligence in drug development: reshaping the therapeutic landscape.","authors":"Sarfaraz K Niazi, Zamara Mariam","doi":"10.1177/20420986251321704","DOIUrl":"10.1177/20420986251321704","url":null,"abstract":"<p><p>Artificial intelligence (AI) is transforming medication research and development, giving clinicians new treatment options. Over the past 30 years, machine learning, deep learning, and neural networks have revolutionized drug design, target identification, and clinical trial predictions. AI has boosted pharmaceutical R&D (research and development) by identifying new therapeutic targets, improving chemical designs, and predicting complicated protein structures. Furthermore, generative AI is accelerating the development and re-engineering of medicinal molecules to cater to both common and rare diseases. Although, to date, no AI-generated medicinal drug has been FDA-approved, HLX-0201 for fragile X syndrome and new molecules for idiopathic pulmonary fibrosis have entered clinical trials. However, AI models are generally considered \"black boxes,\" making their conclusions challenging to understand and limiting the potential due to a lack of model transparency and algorithmic bias. Despite these obstacles, AI-driven drug discovery has substantially reduced development times and costs, expediting the process and financial risks of bringing new medicines to market. In the future, AI is expected to continue to impact pharmaceutical innovation positively, making life-saving drug discoveries faster, more efficient, and more widespread.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251321704"},"PeriodicalIF":3.4,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11851753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504226","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":"Impact of dipeptidyl peptidase-4 inhibitors on incidence of colorectal cancer in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.","authors":"Rongrong Fu, Jingqi Chen, Yingying Fang, Qingping Wu, Xiaoming Zhang, Zhiyan Wang","doi":"10.1177/20420986251318842","DOIUrl":"10.1177/20420986251318842","url":null,"abstract":"<p><strong>Background: </strong>The association between dipeptidyl peptidase-4 inhibitors (DPP-4i) exposure and the risk of colorectal cancer (CRC) in patients with type 2 diabetes mellitus (T2DM) is unclear.</p><p><strong>Objectives: </strong>This meta-analysis aims to investigate the relationship between DPP-4i exposure and the incidence of CRC in patients with T2DM.</p><p><strong>Design: </strong>A systematic review and meta-analysis.</p><p><strong>Methods: </strong>A comprehensive search of electronic databases, including PubMed, Web of Science, EMBASE, and ScienceDirect, was conducted up to March 2024. The studies including randomized clinical trials (RCTs), cohort studies, and case-control studies were retrieved. The odds ratio (OR) was calculated using Stata 12.0 statistical software. The primary outcome assessed was the incidence of CRC.</p><p><strong>Results: </strong>This meta-analysis incorporated six retrospective cohort studies and two case-control studies. The findings indicate that the incidence of CRC in the DPP-4i exposure group was significantly higher than that in the control group (OR = 1.11, 95% CI: 1.02-1.21, <i>p</i> = 0.013). Subgroup analysis revealed that both male (OR = 2.07, <i>p</i> < 0.001) and female participants (OR = 1.49, <i>p</i> = 0.05) in the DPP-4i exposure group exhibited a significantly higher incidence of CRC compared to the control group. Among participants younger than 65 years, the incidence of CRC was markedly elevated in the exposure group (OR = 2.81, <i>p</i> < 0.001). Furthermore, when the exposure duration was less than 1 year, the CRC incidence in the exposure group surpassed that of the control group (OR = 1.24, <i>p</i> = 0.005). When sulfonylureas (SU) were used as control drugs, the incidence of CRC was higher in the exposure group (OR = 1.10, <i>p</i> = 0.017).</p><p><strong>Conclusion: </strong>There is a potential correlation between DPP-4i exposure and increased incidence of CRC in T2DM patients. This association appears to be influenced by gender, age, duration of exposure, and the choice of control medications. Therefore, attention should be paid to colorectal diseases when DPP-4i is employed in the clinic.</p><p><strong>Trial registration: </strong>The meta-analysis has been registered with the International Prospective Register of Systematic Reviews (PROSPERO). The registration number is CRD42024535292.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251318842"},"PeriodicalIF":3.4,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837066/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143459529","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":"Navigating pharmacokinetic and pharmacodynamics challenges of β-lactam antibiotics in patients with low body weight: efficacy, toxicity, and dosage optimization.","authors":"Yu-Ju Tseng, Chih-Hsun Tai, Guan-Yuan Chen, Yen-Lin Chen, Shih-Chi Ku, Tsung-Yu Pai, Chien-Chih Wu","doi":"10.1177/20420986251320414","DOIUrl":"10.1177/20420986251320414","url":null,"abstract":"<p><strong>Background: </strong>Patients with low body weight (LBW) often exhibit altered pharmacokinetics (PK) in renal clearance and total body water. These changes complicate β-lactam antibiotic dosing, potentially resulting in suboptimal efficacy or increased toxicity.</p><p><strong>Objectives: </strong>To evaluate the attainment of PK/pharmacodynamic (PD) targets, the prevalence of subtherapeutic and supratherapeutic concentrations, and the incidence of neurotoxicity among LBW patients treated with piperacillin/tazobactam (TZP), cefepime (FEP), and meropenem (MEM).</p><p><strong>Design: </strong>A prospective observational study conducted at a tertiary hospital from January 2020 to December 2022.</p><p><strong>Methods: </strong>Adult patients with a body mass index ⩽18.5 kg/m² who received TZP, FEP, or MEM were included. Trough serum concentrations were analyzed for PK/PD targets: 100% time above minimum inhibitory concentration (100% fT > MIC) and 100% time above four times MIC (100% fT > 4MIC). Neurotoxicity was assessed using standardized criteria. Statistical analyses identified factors associated with concentration variability and adverse outcomes.</p><p><strong>Results: </strong>Seventy-two patients were included: 29 received TZP, 23 FEP, and 20 MEM. Achievement of the 100% fT > MIC target was comparable across all antibiotics (~70%), but 100% fT > 4 MIC attainment was significantly higher for FEP (47.8%) than for TZP (10.3%) and MEM (30%) (<i>p</i> = 0.01). Supratherapeutic concentrations were observed in 34.8% of FEP users compared to 3.4% and 5% for TZP and MEM, respectively (<i>p</i> = 0.002). Neurotoxicity occurred in 13% of FEP patients but was not reported in TZP or MEM groups (<i>p</i> = 0.04). Subtherapeutic concentrations were noted in approximately 30% of patients across all groups.</p><p><strong>Conclusion: </strong>PK changes complicate β-lactam antibiotic dosing, resulting in frequent failure to achieve PK/PD targets. FEP demonstrated a particularly high risk of supratherapeutic concentrations and neurotoxicity. Therapeutic drug monitoring is crucial to optimize dosing and improve safety in this population.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251320414"},"PeriodicalIF":3.4,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11837059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143459532","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":"A critical opinion-based review of hospital pharmacy compounding with respect to the risk of leachable substances due to the off-label use of plastic primary packaging.","authors":"William Bello, Julian Pezzatti, Camille Stampfli, Laurent Carrez, Serge Rudaz, Farshid Sadeghipour","doi":"10.1177/20420986251317424","DOIUrl":"10.1177/20420986251317424","url":null,"abstract":"<p><p>Hospital pharmacies play a unique role in healthcare by regularly compounding drug products (DPs) in response to hospital demands and practices, for example, drug shortages, to cater to frail and vulnerable patients with infectious, chronic or nutrition-related conditions. Drugs are compounded in precise concentrations for extended durations, sometimes involving complex formulations. A significant challenge in this context is the off-label use of short-term plastic primary packaging for long-term storage of compounded DPs, which could be due to a lack of awareness, financial constraints and inadequate regulation. Without proper risk assessments, such packaging can release potentially harmful leachable compounds, posing a serious threat to patient safety. Evaluating hospital pharmacy compounding procedures to mitigate this risk is essential. While off-label drug use is a well-known concept in hospitals, off-label use of plastic primary packaging is an entirely different practice. In both the United States and Europe, healthcare professionals, including pharmacists, are allowed to use medical devices, including primary packaging, in ways that are not explicitly approved by regulators based on their clinical judgement and best practices, taking into account the patient's best interest. However, this off-label use could bring about unique risks and challenges, especially in the highly controlled environment of hospital pharmacy compounding, where patient safety is crucial. Therefore, the current review explores the historical context and the current landscape of hospital pharmacies, investigates the potential root causes of container closure integrity issues in pharmaceutical compounding, discusses the materials of construction as well as their physical-chemical properties influencing their roles in most popular primary packaging and finally presents expert opinions aimed at identifying long-term solutions to the existing challenges regarding their off-label uses in hospital pharmacy compounding.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251317424"},"PeriodicalIF":3.4,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11826846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143433770","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":"Flecainide use in arrhythmic patients who have structural heart disease.","authors":"Naruepat Sangpornsuk, Voravut Rungpradubvong, Tachawut Tiensantisuk, Pattranee Leelapattana, Ronpichai Chokesuwattanakul, Somchai Prechawat","doi":"10.1177/20420986251316462","DOIUrl":"10.1177/20420986251316462","url":null,"abstract":"<p><strong>Background: </strong>Current guidelines recommend the use of only on a limited basis in patients with normal or minimal structural heart disease. The CAST study, the only randomized controlled trials, showed increased mortality from long-term flecainide use in post-myocardial infarction (MI) patients with reduced left ventricular ejection fraction (LVEF). However, many later studies have revealed its safety when used in other structural heart diseases.</p><p><strong>Objectives: </strong>This study investigates the incidence of ventricular tachycardia (VT) or ventricular fibrillation (VF) VT/VF in patients with structural heart disease compared to those with a normal heart when using flecainide.</p><p><strong>Methods: </strong>We retrospectively recruited patients who had received at least one dose of flecainide in the past 5 years. Baseline characteristics, indications for flecainide use, and echocardiography results were reviewed. After 1 year, we evaluated the incidence of ventricular arrhythmias and all-cause mortality.</p><p><strong>Results: </strong>After screening, 447 patients had received at least one dose of flecainide, and 336 patients were included in the study. Forty-seven patients (14%) had structural heart disease as defined by our protocols. Left ventricular hypertrophy (LVH) and impaired LVEF accounted for 28% and 25% of cases, respectively. There were five patients with coronary artery disease (CAD). After 1 year, ventricular arrhythmias occurred in two patients (4.7%) in the structural heart group; these patients had also experienced arrhythmias before receiving flecainide. In the non-structural heart group, ventricular arrhythmias were detected in three patients (1.1%). In multivariate analysis, structural heart disease was not associated with an increased incidence of ventricular arrhythmias (OR = 4.8 (0.6-38.44), <i>p</i> = 0.139).</p><p><strong>Conclusion: </strong>Our study showed that no patients died due to ventricular arrhythmia, and the incidence of VT/VF was not increased in patients with structural heart disease. A prospective study is needed to further evaluate the safety of flecainide in patients with structural heart disease other than ischemic heart disease.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251316462"},"PeriodicalIF":3.4,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11815794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143410843","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":"Is there a risk of esketamine misuse in clinical practice?","authors":"Carlos Roncero, Milton Merizalde-Torres, Néstor Szerman, Marta Torrens, Pablo Vega, Pilar Andres-Olivera, Francisco Javier Álvarez","doi":"10.1177/20420986241310685","DOIUrl":"https://doi.org/10.1177/20420986241310685","url":null,"abstract":"<p><p>In 2019, intranasal esketamine gained approval as a promising therapy for those individuals grappling with treatment-resistant depression. Both clinical trials and real-world studies have underscored its efficacy in alleviating and remitting depressive symptoms, with sustained benefits observed for nearly 4.5 years. As the <i>S</i>-enantiomer of ketamine, esketamine's dosing guidelines and strict medical supervision stem from prior research on ketamine's use in depression and history as a recreational drug. Despite initial concerns, long-term clinical studies have not documented instances of abuse, misuse, addiction or withdrawal, and the same was found in case reports or subsamples of high-risk populations with comorbidities such as substance use disorder or alcohol use disorder. Esketamine has proven to be safe and well tolerated without fostering new-onset substance use in vulnerable groups. Real-world studies reinforced these observations, reporting no adverse events (AEs) related to pharmacological interactions of esketamine with any other substance, and no new-onset drug or alcohol misuse, craving, misuse or diversion of use. Reports of esketamine craving remain rare, with only one case report documented in 2022. Most drug-related AEs reported in pharmacovigilance databases are those identified in the product's technical data sheet and with known reported frequency. More importantly, no register of illicit acquisition of esketamine or its tampering for obtaining ketamine or other altered products was found in our search. Overall, our review confirms esketamine's safety across diverse patient populations, reassuring its responsible use and the scarcity of reports of abuse or misuse since its introduction to the market.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986241310685"},"PeriodicalIF":3.4,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068073","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":"Overlapping of DRESS and Stevens-Johnson syndrome due to first-line antituberculosis drugs: a case report.","authors":"Cristian Morán-Mariños, Felix Llanos-Tejada, Rebeca Huamani-Llantoy, Capriny Bernal-Turpo, Kimberly López-Pilco, Alex Ventura-Leon, Renato Casanova-Mendoza","doi":"10.1177/20420986241312484","DOIUrl":"10.1177/20420986241312484","url":null,"abstract":"<p><p>The overlap of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome (SJS) caused by antituberculosis drugs represents an extremely rare event. This situation can manifest between 2 and 8 weeks after the first exposure to the medication. The overlap of these conditions can lead to atypical clinical manifestations, thus complicating the early diagnosis and the implementation of early treatment. This report describes the case of a patient who developed the DRESS/SJS overlap 35 days after starting antituberculosis treatment. The patient experienced severe skin and systemic involvement, a situation that required her admission and monitoring in the intensive care unit. From our experience with this case, we conclude the importance of an accurate and timely diagnosis using validated scoring systems such as RegiSCAR to confirm the clinical diagnosis of DRESS/SJS and ALDEN to assess the likelihood of drug causality. Timely intervention with corticosteroids plays a key role in moderating the exaggerated immune response, helping to alleviate dermatological symptoms and prevent long-term organ damage. In addition, the availability of safe therapeutic alternatives for tuberculosis treatment allows for more effective and safer management in these patients.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986241312484"},"PeriodicalIF":3.4,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11760121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047769","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":"Automatic tool for the reconciliation of serious adverse events for pharmacovigilance: design and implementation of Reconciliaid.","authors":"Sara Contu, Renaud Schiappa, Yann Chateau, Emmanuel Chamorey","doi":"10.1177/20420986241299567","DOIUrl":"10.1177/20420986241299567","url":null,"abstract":"<p><strong>Background: </strong>Reporting serious adverse events (SAEs) is crucial to reduce or avoid toxicities that can lead to major consequences for patient's health due to treatments tested in clinical trials. Its exhaustiveness is often inadequate, and we observe discrepancies between data published by pharmacovigilance organizations and clinical databases.</p><p><strong>Objectives: </strong>While the process of reconciliation aims at reducing these differences, it remains a very time-consuming and imprecise task. We propose a tool to automate this process.</p><p><strong>Design: </strong>We have developed and tested Reconciliaid, an application that compares the SAEs of the databases of clinical trials collected according to a standard inspired by the Clinical Data Interchange Standards Consortium, and of pharmacovigilance collected according to the international standards ICH-E2B (R3). It generates a reconciliation file that indicates precisely what information does not coincide in the two databases to facilitate the identification of inconsistencies.</p><p><strong>Methods: </strong>Reconciliaid was tested to create 13 reconciliation files, containing 290 SAEs. We inspected these files to determine their ability in identifying the inconsistencies and compared the manual and semi-automated reconciliation time. Four users answered the System Usability Scale (SUS) to measure its usability.</p><p><strong>Results: </strong>The application identified all variables of interest in all reconciliations. Different formats and libraries were automatically harmonized, allowing a perfect identification of inconsistencies for all variables. The matching of the same SAE in the two databases was correct in 97.2% of the reconciliations. Reconciliaid is six times faster than the manual approach for senior data managers (range = 3-24 times). A novice data manager performed three reconciliations 4.8 faster with the help of Reconciliaid than manually (29 min vs 134 min) and with fewer mistakes. Mean SUS score was 92.5.</p><p><strong>Conclusion: </strong>Reconciliaid has a high level of usability, can increase the quality of reconciliation, and reduces considerably the reconciliation time, allowing to increase the frequency of reconciliation processes and to focus resources on patient safety and medical assessment.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986241299567"},"PeriodicalIF":3.4,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11742157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143011986","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":"Drug interactions in patients with alcohol use disorder: results from a real-world study on an addiction-specific ward.","authors":"Sebastian Schröder, Christina Massarou, Tabea Pfister, Stefan Bleich, Phileas Johannes Proskynitopoulos, Johannes Heck, Martin Schulze Westhoff, Alexander Glahn","doi":"10.1177/20420986241311214","DOIUrl":"10.1177/20420986241311214","url":null,"abstract":"<p><strong>Background: </strong>The majority of patients with alcohol use disorder (AUD) regularly take medication. Alcohol interacts negatively with many commonly prescribed drugs. However, little is known about the characteristics and frequency of potential alcohol-medication and drug-drug interactions in patients with AUD.</p><p><strong>Objectives: </strong>This study aimed to determine the prevalence and characteristics of drug interactions in patients with AUD during withdrawal therapy on an addiction-specific ward.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Methods: </strong>Medication charts were analyzed and screened for potential alcohol-medication and drug-drug interactions. For the screening of potential alcohol-medication interactions, the drugs.com classification was utilized and potential drug-drug interactions were identified using the mediQ electronic interaction program.</p><p><strong>Results: </strong>In our study, almost two-thirds (66.3%; 1089/1643) of all patient cases were prescribed at least one drug that could potentially interact with alcohol. Four percent of all alcohol-medication interactions were classified as severe, 91.8% as moderate, and 4.3% as mild. Drug classes commonly involved in serious interactions with alcohol were analgesics and drugs used in diabetes. A total of 811 potential drug-drug interactions were identified, of which 3.3% were classified as severe and 96.5% as moderate. Psychoanaleptics (ATC N06) and psycholeptics (ATC N05) were most frequently associated with moderate to severe interactions.</p><p><strong>Conclusion: </strong>Potential alcohol-medication and drug-drug interactions are common in hospitalized patients with AUD. Improvements in the quality of prescribing should focus on the use of psychotropic drugs.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986241311214"},"PeriodicalIF":3.4,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11742168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012005","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}