Drug Safety最新文献

{"title":"Anticholinergic Drug Use in Elderly Patients: Compliance with STOPP-START and BEERS Criteria in Spain-A Descriptive Study.","authors":"Javier Santandreu, Francisco Félix Caballero, Elena González-Burgos","doi":"10.1007/s40264-025-01622-w","DOIUrl":"https://doi.org/10.1007/s40264-025-01622-w","url":null,"abstract":"<p><strong>Introduction: </strong>Dementia is the most prevalent neurodegenerative disorder. Several studies have demonstrated an association between anticholinergic drug use and an increased risk of cognitive and physical impairment. However, anticholinergic drugs are commonly prescribed for various clinical conditions, and their cumulative effects, referred to as anticholinergic burden, can contribute to cognitive decline and dementia. Although the causal relationship remains inconclusive, a higher anticholinergic burden is linked to a greater risk of cognitive deterioration.</p><p><strong>Objective: </strong>This study aims to assess the compliance of patients aged ≥ 65 years with the STOPP-START and Beers criteria concerning the concurrent use of medications with high anticholinergic potency in situations where their use is not clinically justified.</p><p><strong>Methods: </strong>This observational descriptive study was conducted using data from the Spanish Database for Pharmacoepidemiological Research (BIFAP). The study population comprised male and female patients aged ≥ 65 years.</p><p><strong>Results: </strong>Of the 81,405 patients who developed dementia during the study period, 46.7% had been exposed to multiple anticholinergic drugs. Among them, 81.1% used these drugs sequentially, while 18.9% used two or more simultaneously. The absolute risk of developing dementia was 6.5% in patients who met the STOPP-START and BEERS criteria, compared to 13.4% in those who did not.</p><p><strong>Conclusion: </strong>Although a high anticholinergic burden is a risk factor for cognitive decline, the unjustified concurrent use of multiple anticholinergic drugs remains uncommon among the elderly population in Spain.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145312605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions.","authors":"Jami Peters, Ayad K Ali, Maria Moitinho de Almeida, Keiko Asao, Tarek A Hammad, Xintong He, Alexander Michel, Annalisa Rubino, Sono Sawada, Rachel E Sobel, Stefan de Vogel","doi":"10.1007/s40264-025-01621-x","DOIUrl":"https://doi.org/10.1007/s40264-025-01621-x","url":null,"abstract":"<p><p>Post-authorization studies (PAS) are often mandated by regulatory authorities as a condition of marketing authorization of pharmaceutical products. This article explores specific regulations and trends in China, Japan, and South Korea, highlighting the scientific and operational limitations that such PAS pose to the stakeholders in these regions including significant variations in regulatory requirements. Pharmacovigilance guidelines and publications on regional regulatory trends were reviewed. Active surveillance studies are widely adopted to fulfill post-authorization requirements in East Asia countries. These are primary data collection studies, i.e., traditional site-based studies that monitor the frequency of all adverse events (and clinical outcomes when requested) of the newly approved pharmaceutical product during a predefined treatment period. Such studies generally present limitations regarding the product's safety profile characterization, including the absence of a comparator group, selection bias, limited sample size, and considerable resources needed to conduct the studies. These limitations explain the trend toward hypothesis testing studies, conducted with secondary data (e.g., large electronic database studies) as preferred over traditional active surveillance studies. Harmonizing regulatory approaches and enhancing access to comprehensive data sources are critical for generating fit-for-purpose evidence to support regulatory decision making in these regions. Therefore, we propose a decision tool to assist with the planning of PAS in China, Japan, and South Korea. This article is endorsed by the International Society for Pharmacoepidemiology (ISPE).</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"24th ISoP Annual Meeting \"Pharmacovigilance: Back to the Future\" 24-27 October 2025 Cairo, Egypt.","authors":"","doi":"10.1007/s40264-025-01605-x","DOIUrl":"https://doi.org/10.1007/s40264-025-01605-x","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145299240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Charting and Sidestepping the Pitfalls of Disproportionality Analysis.","authors":"Michele Fusaroli, Daniele Sartori, Eugène P van Puijenbroek, G Niklas Norén","doi":"10.1007/s40264-025-01624-8","DOIUrl":"10.1007/s40264-025-01624-8","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systematic Review Examining the Effectiveness of Professional, Organisational and Structural Interventions in Primary Care to Reduce Medication-Related Hospitalisations and Deaths.","authors":"Hanan Khalil, Brian G Bell, Richard N Keers, Penny J Lewis, Megan Foreman, Amelia Taylor, Barbara Iyen, Aziz Sheikh, Darren M Ashcroft, Anthony J Avery","doi":"10.1007/s40264-025-01619-5","DOIUrl":"https://doi.org/10.1007/s40264-025-01619-5","url":null,"abstract":"<p><strong>Background: </strong>Medication-related adverse events in primary care are a leading cause of hospital admissions and mortality, commonly resulting from medication errors. Previous reviews have assessed interventions broadly across healthcare settings, but few have focused specifically on interventions targeting medication errors in primary care.</p><p><strong>Objective: </strong>To evaluate the effectiveness of professional, organisational, and structural interventions in primary care settings in reducing medication-related hospital admissions, emergency department (ED) visits, and mortality.</p><p><strong>Methods: </strong>We conducted a systematic review using the Cochrane methodology of systematic reviews and PRISMA guidelines for reporting. A comprehensive search of CENTRAL, MEDLINE, Embase, CINAHL, and trial registries up to October 2024 was undertaken. Randomised controlled trials conducted in primary care that assessed the impact of interventions on hospital admissions, ED visits, and mortality were included. Cochrane Risk of bias assessments and random-effects meta-analyses were performed.</p><p><strong>Results: </strong>Interventions were classified according to the Cochrane Effective Practice and Organisation of Care criteria into Professional, Organisational and Structural. Sixty-two studies met the inclusion criteria. Professional interventions, including educational training and clinical decision tools, showed little to no effect on primary outcomes (risk ratio [RR] 1.01, 95% confidence interval [CI] 0.94-7.00 for hospital admissions; RR 1.00, 95% CI 0.98-1.02 for mortality; very-low to low certainty evidence). Organisational interventions, such as pharmacist-led medication reviews and multidisciplinary care models reduced the number of hospital admissions (RR 0.81, 95% CI 0.70-0.95; low-certainty evidence), but had uncertain effects on ED visits and mortality. Structural interventions, such as system-level support and quality monitoring, showed a reduction in hospital admissions (RR 0.90, 95% CI 0.83-0.97; moderate-certainty evidence), but evidence for other outcomes showed limited or very-low certainty.</p><p><strong>Conclusion: </strong>Organisational and structural interventions in primary care may reduce medication-related hospital admissions and may help inform clinical practice through implementation of multidisciplinary care models and system-level quality monitoring approaches. However, the overall certainty of evidence is low to very low, highlighting the need for high-quality trials to better inform clinical practice and policy.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Harm to Children from Prescribing and Administration Errors in Acute Care: A Multidisciplinary Panel Assessment.","authors":"Virginia Mumford, Magdalena R Raban, Erin Fitzpatrick, Amanda Woods, Alison Merchant, Tim Badgery-Parker, Ling Li, Peter Gates, Richard O Day, Geoffrey Ambler, Luciano Dalla-Pozza, Madlen Gazarian, Alan Gardo, Peter Barclay, Les White, Johanna I Westbrook","doi":"10.1007/s40264-025-01618-6","DOIUrl":"https://doi.org/10.1007/s40264-025-01618-6","url":null,"abstract":"<p><strong>Introduction: </strong>Medication errors continue to cause inpatient harm in children and can be difficult to both identify and classify. Medication error studies often focus on assessing potential harm and there is little published data on actual harm from medication errors in children.</p><p><strong>Objective: </strong>Our aim was to use multidisciplinary panels to identify and describe the actual harm resulting from prescribing and administration medication errors occurring at a major paediatric hospital.</p><p><strong>Methods: </strong>We reviewed medication error data collected from retrospective medication record reviews to identify prescribing errors (26,369 orders, 19,692 errors and 3782 patients) and prospective direct observations (5137 dose administrations, 3663 errors and 1530 patients) to identify administration errors. Errors with the potential to cause serious harm and with evidence that the error reached the patient formed the dataset for our study. Case studies (n = 566) describing the prescribing and administration errors and a brief clinical summary were reviewed by multidisciplinary panels to determine whether there was evidence in patients' records of actual harm and to rate the severity of the harm identified.</p><p><strong>Results: </strong>Actual harm was identified in 89 case studies and rated as minor in 43% (n = 38), moderate in 48% (n = 43) and serious in 9% (n = 8). There were no cases of harm rated as severe resulting in death. Antibacterials were the most common medications in cases with harm (n = 38/89 cases), and dosing errors (n = 32/89) the most common error type associated with harm. Younger patients had a significantly (t = 2.4, df = 198, p = 0.017) greater risk of actual harm from medication errors, and children aged under 12 months formed a higher proportion of those with actual harm (χ² (1, N = 566) = 10.5, p = 0.001). The most frequent type of administration errors leading to harm were wrong infusion rates of intravenous antibiotics (19/67 cases); 12 of these instances occurred in children under 12 months. Administration errors were more likely to result in actual harm (1.83%; 67 /3663 errors) compared with prescribing errors (0.21%; 42/19,692).</p><p><strong>Conclusions: </strong>We found higher rates of actual harm associated with medication errors in younger patients, wrong dose prescribing errors and intravenous antibiotic administration errors. These important findings provide opportunities for developing tailored interventions targeting identified high-risk areas to enable the successful reduction of preventable harms in paediatric patients.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of New-Onset Atrial Fibrillation in Opioid Users: A Systematic Review and Meta-Analysis on 24,006,367 Participants.","authors":"Danilo Menichelli, Gianluca Gazzaniga, Arianna Pannunzio, Ilaria Maria Palumbo, Arianna Pani, Pasquale Pignatelli, Emanuele Valeriani, Daniele Pastori","doi":"10.1007/s40264-025-01555-4","DOIUrl":"10.1007/s40264-025-01555-4","url":null,"abstract":"<p><strong>Background: </strong>Despite ongoing efforts, the prescription of opioids is still common. Long-term opioid use has been associated with an increased risk of adverse cardiovascular outcomes.</p><p><strong>Objective: </strong>We aimed to evaluate the association between opioid use and the risk of new-onset atrial fibrillation.</p><p><strong>Methods: </strong>We performed a systematic review and meta-analysis of studies retrieved from MEDLINE and EMBASE databases according to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines from inception to 29 January, 2024. The protocol was registered at PROSPERO (CRD42024512500). Two authors independently screened and extracted data from included studies. The quantitative analysis included only observational studies and results were synthesised by a pooled hazard ratio. Risk of bias was performed according to the ROBINS-I Cochrane tool, and the summary of evidence according to GRADE (Grading of Recommendations, Assessment, Development and Evaluations).</p><p><strong>Results: </strong>Four out of 782 studies met the inclusion criteria for a quantitative analysis with 24,006,367 participants. Overall, 153,734 were opioid users. The proportion of women ranged from 13.2 to 100% and the median age ranged from 34 to 65 years. Studies reported 991,263 cases of new-onset atrial fibrillation. The pooled analysis showed a significant association between use of opioids and new-onset atrial fibrillation (hazard ratio 1.96, 95% confidence interval 1.43-2.69 with high heterogeneity). A sensitivity analysis by removing the study with the largest cohort showed similar results to the main analysis. In the summary of findings, the certainty of the evidence according to GRADE was moderate.</p><p><strong>Conclusions: </strong>We found a significant association between opioid use and the risk of new-onset atrial fibrillation. When prescribing opioids, the risk of new-onset atrial fibrillation should be considered, especially in the presence of other risk factors for atrial fibrillation.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1079-1088"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Value of Sensitivity Analyses in Assessing the Risk of Two Rare Neurological Adverse Events and Pseudoephedrine Use.","authors":"G Caleb Alexander, Francine Chingcuanco, Abhilok Garg, Daniel Budnitz","doi":"10.1007/s40264-025-01575-0","DOIUrl":"10.1007/s40264-025-01575-0","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1073-1077"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12423255/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144590656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of GLP1-Receptor Agonists with Risk of Hepatocellular Carcinoma: A Retrospective Cohort Study.","authors":"Joane Titus, Vinay Katukuri, Moheb Boktor, Ishak A Mansi","doi":"10.1007/s40264-025-01558-1","DOIUrl":"10.1007/s40264-025-01558-1","url":null,"abstract":"<p><strong>Background: </strong>The use of glucagon-like peptide-1 receptor agonists (GLP-1RA) has exponentially increased owing to their favorable cardio-renal-metabolic effects. Some studies have raised concerns about a potential association between GLP-1RA use and malignancy. This study aimed to examine the association between GLP-1RA use and risk of hepatocellular carcinoma (HCC).</p><p><strong>Methods: </strong>This retrospective propensity score (PS)-matched cohort study used data from the Veterans Health Administration (years 2006-2021). Using a new-user active comparator design, the study included adults who initiated a GLP-1RA or dipeptidyl peptidase-4 inhibitor (DPP4i) as an active comparator and had no prior history of HCC or liver transplantation. The primary outcome was incident HCC. We developed a PS that included 133 variables encompassing diabetes severity, hepatic conditions, liver disease scores, vital signs, laboratory investigations, comorbidity scores, and use of other medication classes.</p><p><strong>Results: </strong>Of 147,969 GLP-1RA and 263,664 DPP4i users, 100,248 pairs of GLP-1RA and DPP4i users were PS-matched. Hepatocellular carcinoma occurred in 302 (0.30%) GLP-1RA users and in 230 (0.23%) DPP4i users (odds ratio [OR]: 1.31, 95% confidence interval [95% CI]: 1.11-1.56). Secondary analysis, which stratified patients by duration of medication use, showed an increased risk of HCC in association with GLP-1RA use > 6 months, but similar HCC risk if medication use was < 6 months (OR: 0.96; 95% CI 0.68-1.35).</p><p><strong>Conclusions: </strong>Glucagon-like peptide-1 receptor agonists use was associated with a modest but statistically significant increase in HCC risk versus DPP4i use. Although the reported benefits of GLP-1RA seem to far exceed this modest increased risk, further studies are warranted due to exponentially increasing GLP-1RA use and their broadening indications.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1089-1101"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex Differences in Electrolyte Disturbances Among Diuretic Users According to Renal Function and Age.","authors":"Narumi Maida, Shingo Kondo, Naoko Hayashi, Hiroki Iwata, Noriko Kobayashi, Katsunori Yamaura","doi":"10.1007/s40264-025-01564-3","DOIUrl":"10.1007/s40264-025-01564-3","url":null,"abstract":"<p><strong>Introduction: </strong>Diuretics are widely used in Japan for the treatment of hypertension and heart failure. Electrolyte disturbance is a common adverse reaction to diuretics and may be life-threatening. Previous studies have shown that diuretic-induced electrolyte disturbance is more common in women. Electrolyte balance is regulated by the kidneys, and renal function tends to decline with advancing age.</p><p><strong>Objective: </strong>The aim of this study was to identify patients at high risk of adverse reactions to diuretics, considering the effects of sex, renal function, and age on susceptibility to diuretic-induced electrolyte disturbance.</p><p><strong>Methods: </strong>Claims data for 67,135 patients on diuretics in Japan were sourced from DeSC Healthcare, Inc. The data covered the period from April 2020 to March 2021.</p><p><strong>Results: </strong>Analysis of patient numbers using the chi-squared test showed that hyperkalemia was more common in men than in women (326 vs. 271; p = 0.003) and that hypokalemia was more common in women than in men (413 vs. 285; p < 0.001). Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for women considering age and renal function (estimated glomerular filtration rate [eGFR]). In elderly patients aged ≥ 75 years, the odds of developing hypokalemia in women compared to men were 1.47 (95% CI 1.13-1.91) for eGFR 60-30 mL/min/1.73 m² and 2.05 (95% CI 1.08-4.10) for eGFR < 30 mL/min/1.73 m².</p><p><strong>Conclusion: </strong>Among women aged ≥ 75 years, those in lower eGFR groups (60-30 and < 30) had higher odds of hypokalemia compared to men. These data highlight the importance of monitoring for adverse reactions to diuretics, particularly hypokalemia, in elderly women with low eGFR.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"1149-1159"},"PeriodicalIF":3.8,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12422990/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144483632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}