Drug, Healthcare and Patient Safety最新文献

{"title":"Regulatory and Accreditation Systems and Their Association With Health Workforce and Healthcare Quality in Low- and Middle-Income Countries: A Systematic Review and Policy Analysis.","authors":"Thadee Vuguziga, Abdallah Ziraba","doi":"10.2147/DHPS.S629712","DOIUrl":"10.2147/DHPS.S629712","url":null,"abstract":"<p><strong>Purpose: </strong>To synthesize evidence on the association between regulatory and accreditation systems and health workforce and healthcare quality in low- and middle-income countries (LMICs), and to analyze the policy factors that shape their implementation.</p><p><strong>Methods: </strong>A systematic review reported according to PRISMA 2020. PubMed, Scopus, Web of Science and Google Scholar were searched for English-language literature published between January 2010 and March 2026. Eligible sources examined regulatory or accreditation mechanisms in at least one LMIC and were analyzed as three separate evidence streams: primary empirical studies, evidence syntheses, and policy or programme analyses. Quality was appraised with design-specific tools (CASP, Newcastle-Ottawa Scale, QuADS, AMSTAR 2 and AACODS). Evidence was synthesized narratively using thematic synthesis, and a literature-based policy analysis applied Walt and Gilson's Policy Triangle. Responsive Regulation Theory and Institutional Theory were used as interpretive lenses.</p><p><strong>Results: </strong>Of 1,243 records, 35 sources met the inclusion criteria (21 primary studies, 7 evidence syntheses and 7 policy or programme analyses). Sources came from the Middle East and North Africa (n = 12, of which 7 were from Iran), sub-Saharan Africa (n = 6), East and South Asia (n = 4) and Latin America (n = 1), with 12 multi-country sources. Thirty-two sources concerned accreditation of health facilities; only two addressed medical education accreditation and one addressed regulation of individual health professionals. Evidence was concentrated at the level of institutional processes (24 sources), where accreditation was associated with standardized procedures, documentation, internal quality assurance and governance structures. Few sources measured workforce-level outcomes (n = 3), and associations with clinical quality were mixed: the two primary impact evaluations reported divergent results. Recurrent barriers included inadequate financing, assessor shortages, fragmented governance, weak enforcement and documentation burden.</p><p><strong>Conclusion: </strong>The available evidence suggests that regulatory and accreditation systems in LMICs are associated with improvements in institutional quality processes, particularly when supportive follow-up accompanies graduated requirements. Evidence that they improve health workforce competence or patient outcomes remains limited. Controlled evaluations of licensing, continuing professional development and education accreditation in LMICs are needed.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"629712"},"PeriodicalIF":4.3,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13676289/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149215166","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potentially Clinically Relevant Drug-Drug Interactions with Direct Oral Anticoagulants: Prevalence and Contributing Factors.","authors":"Marwan Sheikh-Taha","doi":"10.2147/DHPS.S646907","DOIUrl":"10.2147/DHPS.S646907","url":null,"abstract":"<p><strong>Background: </strong>Direct oral anticoagulants (DOACs) are widely prescribed but remain susceptible to drug-drug interactions (DDIs) that increase bleeding or thrombotic risk. The real-world prevalence and factors associated with potentially clinically relevant DDIs in patients on chronic DOAC therapy require further study.</p><p><strong>Objective: </strong>To determine the prevalence of clinically relevant DDIs involving DOACs and identify patient- and treatment-related factors associated with their occurrence.</p><p><strong>Methods: </strong>A retrospective cross-sectional study was conducted among hospitalized adults receiving a DOAC as a home medication. Potentially clinically relevant DDIs were identified from documented home medications using the Lexicomp Online 2025 Drug Interactions database and classified as category C (monitor therapy), D (consider modification), and X (avoid combination). Clinical bleeding, thromboembolic, or other adverse outcomes were not assessed. Descriptive statistics and multivariable logistic regression analyzed patient characteristics and factors associated with DDIs.</p><p><strong>Results: </strong>Among 870 patients (mean age 71.4 ± 13.0 years), 72.8% had at least one potentially clinically relevant DDI. Among patients with at least one potentially clinically relevant DDI, 47.4% had multiple interactions. Most were Category C (97.6%), primarily involving antidepressants with antiplatelet activity (30.4%), antiplatelet agents (30.0%), amiodarone (8.5%), and NSAIDs (7.9%). Category D and X interactions (2.4%) mainly involved CYP3A4/P-gp inhibitors or inducers such as dronedarone, erythromycin, and phenytoin. Independent predictors of DDI occurrence included the number of medications (OR 1.14; 95% CI 1.09-1.19; p < 0.0001), coronary artery disease (OR 1.55; p = 0.039), anxiety (OR 2.02; p = 0.016), dementia (OR 2.99; p = 0.006), and depression (OR 3.27; p = 0.001).</p><p><strong>Conclusion: </strong>Potentially clinically relevant DDIs involving DOACs were common in this hospitalized cohort, although most identified interactions were Category C and therefore primarily warranted monitoring. Higher medication burden and several comorbidities, including coronary artery disease, depression, anxiety and dementia were associated with the presence of potentially clinically relevant DDIs. Vigilant medication review is essential to enhance safety.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"646907"},"PeriodicalIF":4.3,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13674634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149215245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Knowledge, Attitudes And Disposal Practices For Unused Medicines Amongst Adult Residents Of Bloemfontein, South Africa.","authors":"Johannes Francois Rudolph Neuhoff, Corné Coetzee, Rajesh Vagiri","doi":"10.2147/DHPS.S594472","DOIUrl":"10.2147/DHPS.S594472","url":null,"abstract":"<p><strong>Background: </strong>In South Africa, medicine disposal is regulated by the Medicines and Related Substances Act 101 of 1965. Despite regulatory provisions, the presence of pharmaceuticals in the environment is a growing concern. This study aims to assess the knowledge, attitudes, and practices toward the disposal of unused and expired medicines among residents in Bloemfontein, Free State.</p><p><strong>Methods: </strong>This was a descriptive, quantitative, and cross-sectional study involving 394 Bloemfontein residents. During 2024 a self-administered questionnaire was distributed to adult participants. Multiple linear regression was used to identify sociodemographic determinants of knowledge, attitudes and practices. The Spearman correlation test was employed to determine correlations between KAP among residents.</p><p><strong>Results: </strong>Multiple linear regression analysis revealed gender (<i>β</i> = 0.25, R² = 0.01), employment status (<i>β</i> = 0.48, R² = 0.04), usage of private health-care systems (<i>β</i> = 0.16, R² = 0.04), and health-care worker status (<i>β</i> = -0.89, R² = 0.02) were significantly associated (<i>p ≤</i> 0.05) with a higher knowledge score. Health-care workers (<i>β</i> = -0.01, R² = 0.01) were associated with a higher attitude score. Gender (<i>β</i> = 0.15, R² = 0.02), level of education (<i>β</i> = 0.09, R² = 0.01), and being a health-care worker (<i>β</i> = -0.47, R² = 0.05) were predictors of residents' medicine disposal practices. The Spearman correlation test revealed a positive relationship (r = 0.14, n = 394, p < 0.05) between residents' knowledge and attitudes towards appropriate disposal practices.</p><p><strong>Conclusion: </strong>Significant differences in the KAP across sociodemographic variables among residents were found. Health-care workers distinguished themselves above non-health-care workers in all factors. The results of this study indicate poor knowledge, positive attitudes and inappropriate medication disposal practices amongst Bloemfontein residents. These findings and the potential effects of resident's actions require action, through the creation of awareness, holding pharmacists more accountable and additional policy changes.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"594472"},"PeriodicalIF":4.3,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615796/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149058862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Knowledge, Attitude and Practice Regarding Self-Medication Among Medical and Pharmacy Students at Damascus University: A Cross-Sectional Study.","authors":"Ahmad Alhaffar, Zain Eddin Alhawari, Reda Sandouk, Mohammad Alhanash, Wesam Ez Ragal, Youssef Latifeh","doi":"10.2147/DHPS.S632079","DOIUrl":"10.2147/DHPS.S632079","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to evaluate and compare the knowledge, attitudes, and practices regarding self-medication (SM) among medical and pharmacy students at Damascus University, Syria.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted among medical and pharmacy students using convenience sampling with snowball dissemination via online channels. Bivariate analysis using Chi-square (χ²) test was performed to examine associations between demographic variables and KAP levels, followed by multivariate binary logistic regression to identify independent predictors, reporting adjusted odds ratios (aOR) with 95% confidence intervals (CI).</p><p><strong>Results: </strong>A total of 607 participants participated (47.6% pharmacy, 52.4% medicine). Good knowledge was demonstrated by 68.4% of participants, and all participants (100%) held a positive attitude. However, optimal responsible practice was observed in only 2.1%. Multivariate analysis identified male gender as an independent predictor of fair/good practice (aOR = 2.424, 95% CI: 1.422-4.129, p = 0.001), while medical specialty showed a marginal trend relative to knowledge (aOR = 0.694, p = 0.051). Cold/cough (84.2%) and headache (82.5%) were the main managed conditions, driven primarily by the perception of illness non-seriousness (89.5%).</p><p><strong>Conclusion: </strong>A substantial knowledge-practice gap exists among healthcare students at Damascus University. While academic knowledge and positive attitudes are high, safe practices remain alarmingly low. These findings suggest that overreliance on academic knowledge and underestimation of illness severity are associated with unsafe practices, highlighting an urgent need for competency-based training in rational self-medication.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"632079"},"PeriodicalIF":4.3,"publicationDate":"2026-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13585430/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148988775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Computerized Physician Order Entry and Pediatric Prescribing Errors: A Multicenter Database Study.","authors":"Rinat Komargodski, Ilan Youngster, Inbal Ticho, Majdi Masarwi, Rotem Yeruham, Inbal Lasman Shaharabani, Arriel Benis, Inna Moldaver, Danna Krupik, Adi Klein, Yafit Hachmo, Eran Kozer","doi":"10.2147/DHPS.S618381","DOIUrl":"10.2147/DHPS.S618381","url":null,"abstract":"<p><strong>Purpose: </strong>To compare dosing error rates between computerized physician order entry (CPOE) and free-text electronic prescribing in hospitalized children during the same time period, given inconsistent evidence regarding the effectiveness of CPOE in pediatric settings.</p><p><strong>Patients and methods: </strong>We conducted a retrospective multicenter cohort study across four Israeli general hospitals between July 1, 2022, and December 31, 2023. A computerized algorithm analyzed the ten most frequently administered systemic medications and flagged potential dosing errors defined as a ≥20% deviation from weight-based recommendations. All flagged prescriptions underwent blinded independent review by a senior pediatrician with toxicology expertise and a pediatric clinical pharmacist to confirm clinical significance. Multivariable logistic regression was used to estimate adjusted odds ratios (aORs).</p><p><strong>Results: </strong>Of 122,869 medication orders for 63,081 children, the confirmed error rate was 3.6%. In unadjusted analyses, dosing errors were more frequent with CPOE than with manual prescribing (3.8% vs 2.8%; p<0.001). After adjustment, CPOE was not associated with a significant overall difference in error risk (aOR 0.98; 95% confidence interval [CI] 0.88-1.09). In the enteral-only analysis, CPOE was associated with a 33% higher risk of errors in enteral medications (aOR 1.33; 95% CI 1.18-1.51; p<0.001). Error risk also varied by hospital site, patient weight, care setting, and administration route.</p><p><strong>Conclusion: </strong>In real-world pediatric settings, CPOE was not associated with a lower overall incidence of dosing errors, and higher error rates were observed among enteral medications. These results suggest that CPOE may introduce route-specific vulnerabilities, highlighting the need for system-specific optimization rather than assuming electronic ordering is inherently safer.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"618381"},"PeriodicalIF":4.3,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13505762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148817873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Qualitative Exploratory Study of Families' Experiences and Recommended Strategies to Improve the Medication Management of Older Adults During Transitions of Care.","authors":"Caitlin Deery, Kerry Hwang, Grace Marconi, Maneesh Prasad, Kelly Ottosen, Stephanie M Garratt, Pauline Wong, Elizabeth Manias","doi":"10.2147/DHPS.S610521","DOIUrl":"10.2147/DHPS.S610521","url":null,"abstract":"<p><strong>Background: </strong>Amid healthcare workforce shortages and an aging population, families are increasingly performing informal caregiving tasks, equipping them with skills unique to their older relative's medications. Yet, despite high rates of medication errors during transitions of care, family members' expertise is rarely solicited by healthcare professionals in hospital.</p><p><strong>Purpose: </strong>To understand how families are engaged in older adults' medication management, and to explore strategies for improving medication management during transitions of care.</p><p><strong>Methods: </strong>A qualitative exploratory study was conducted between October 2024 and January 2025. Semi-structured interviews were audio-recorded, transcribed verbatim, and analyzed using the Framework Method. Inductive themes were conceptualized from the data and deductively mapped to the Patient and Family Engagement Framework.</p><p><strong>Results: </strong>In total, 66 semi-structured interviews were conducted. Eight inductive themes were generated from the data and deductively mapped to three levels of engagement comprising consultation, involvement, and partnership and shared leadership. Four themes mapped onto consultation, with family members mainly receiving and transferring medication information between healthcare professionals. Three themes reflected involvement, where healthcare professionals considered family members' preferences when determining the treatment options. At this level of engagement, responsibility for managing medications was delegated between families and healthcare professionals. The last theme aligned with partnership and shared leadership, where families initiated medication changes and negotiated treatment plans with healthcare professionals. An application or QR code was proposed as a strategy to improve medication information transfer. Family members also believed that being offered alternative treatments and a list of possible medication questions to ask would enhance collaborative decision-making.</p><p><strong>Conclusion: </strong>Families rarely received an invitation to participate in medication decision-making, highlighting how preferences for active engagement are difficult to address under current practices. Policymakers should consider strategies that promote shared decision-making, such as mandating that alternative treatment options are provided where clinically appropriate.</p><p><strong>Registration: </strong>Registered in ANZCTR (ACTRN12624000901505) on the 24^th of July 2024.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"610521"},"PeriodicalIF":4.3,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13460087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148711519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of a CCB-Related Pharmacogenomics-Guided Strategy with Blood Pressure Outcomes and Short-Term Safety in Chinese Patients with Hypertension: A Secondary Exploratory Analysis of Two Randomized Cohorts.","authors":"Kunhong Deng, Yan Guo, Yaxin Zhang, Hui Qiu, Yun Kuang, Yu Wang, Di Meng, Meng Zhang, Chengxian Guo","doi":"10.2147/DHPS.S637282","DOIUrl":"10.2147/DHPS.S637282","url":null,"abstract":"<p><strong>Introduction: </strong>Calcium channel blockers (CCBs) show notable interindividual variability in antihypertensive response. This study evaluated the association of a pharmacogenomics (PGx)-guided antihypertensive strategy incorporating <i>CACNA1C</i> rs2238032 and <i>CYP3A5</i> rs776746 with short-term blood pressure (BP) outcomes among Chinese patients with hypertension receiving CCB-containing regimens.</p><p><strong>Methods: </strong>This secondary exploratory analysis included patients receiving CCB-containing regimens from two previously completed multicenter randomized cohorts conducted in Hunan and Fujian provinces, China. The Hunan cohort assessed a 4-week PGx-guided strategy combined with structured management, while the Fujian cohort evaluated genotype-guided treatment during 4-8 weeks after an initial standardized management phase. The primary endpoint was BP control at the last follow-up; secondary endpoints included changes in systolic BP (SBP) and diastolic BP (DBP), medication use, and short-term safety outcomes. Multivariable regression models were used to adjust for prespecified clinical covariates.</p><p><strong>Results: </strong>A total of 4608 patients in Hunan and 418 patients in Fujian were included. In the Hunan cohort, the genotype-guided group had higher 4‑week BP control (81.83% vs 25.07%; adjusted OR = 14.56, P < 0.001) and greater SBP/DBP decreases. In the Fujian cohort, genotype-guided therapy was associated with higher 8‑week BP control (81.74% vs 77.39%; adjusted OR = 2.43, P = 0.003) and greater DBP decrease. Associations were stronger among patients whose BP remained uncontrolled after standardized management. No short-term safety concerns were identified.</p><p><strong>Conclusion: </strong>A genotype-guided antihypertensive strategy incorporating CCB-related PGx information, including <i>CACNA1C</i> rs2238032 and <i>CYP3A5</i> rs776746, was associated with improved short-term BP control among Chinese patients with hypertension receiving CCB-containing regimens, without an apparent short-term safety disadvantage. However, these findings should be interpreted as exploratory associations rather than proof of causal benefit. Further prospective randomized studies are needed to confirm these findings.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"637282"},"PeriodicalIF":4.3,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13435354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148673234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and Evaluation of a Gamification-Based Mobile Application for Reporting Adverse Drug Reactions by Patients and Healthcare Professionals: A Pilot Usability Study in Diabetes Care.","authors":"Kimia Mahini, Rezvan Rahimi, Zohreh Vanaki","doi":"10.2147/DHPS.S618861","DOIUrl":"10.2147/DHPS.S618861","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) represent a significant challenge in pharmacovigilance, particularly for patients with chronic conditions like diabetes. Traditional reporting methods are often cumbersome and suffer from substantial underreporting. Mobile health applications with gamification elements offer a promising approach to enhance ADR reporting engagement.</p><p><strong>Objective: </strong>This study aimed to design, develop, and evaluate a gamified mobile application (RxFeedback) for ADR reporting among diabetic patients and healthcare professionals in Iran, with gamification mechanics (points, leaderboards, challenges) as the core engagement strategy.</p><p><strong>Methods: </strong>This analytical cross-sectional pilot study employed a user-centered design methodology in three phases: 1) Requirements gathering through literature review and stakeholder surveys (5 patients, 4 professionals); 2) Application development using Flutter framework with Dart programming language for Android platform; 3) Evaluation using Mobile Application Rating Scale (MARS) by 5 experts and Questionnaire for User Interaction Satisfaction (QUIS) by 20 patients.</p><p><strong>Results: </strong>The RxFeedback application incorporated comprehensive ADR reporting features, medication management, and gamification elements (points system, leaderboards, challenges). Expert evaluation yielded a mean MARS score of 3.65/5, with highest scores in functionality (4.05) and lowest in aesthetics (3.40). Patient satisfaction assessment showed an overall QUIS score of 6.14/10, with highest satisfaction in application features (6.8) and lowest in terminology (5.7), though the limited sample size (n=20 patients, n=5 experts) and focus on usability should be noted as preliminary study constraints.</p><p><strong>Conclusion: </strong>RxFeedback demonstrated acceptable usability and quality (MARS: 3.65/5; QUIS: 6.14/10) in this pilot study. However, effectiveness in improving actual ADR reporting rates was not assessed. These findings establish preliminary acceptability as a foundation for future experimental studies.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"618861"},"PeriodicalIF":4.3,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13429119/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148663663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Seasonal Variation in Reporting of Venous Thromboembolism in a Spontaneous Adverse Event Reporting System: Analysis of the Japanese Adverse Drug Event Report Database.","authors":"Hiroyuki Tanaka, Toshihiro Ishii","doi":"10.2147/DHPS.S615764","DOIUrl":"10.2147/DHPS.S615764","url":null,"abstract":"<p><strong>Background: </strong>Venous thromboembolism (VTE) is a major cardiovascular disorder associated with high morbidity and mortality. Several epidemiological studies have reported seasonal variations in VTE, with higher rates during winter. However, it remains unclear whether reports of VTE adverse events in spontaneous reporting systems exhibit similar seasonal patterns.</p><p><strong>Material and methods: </strong>A retrospective pharmacovigilance study was conducted using data from the Japanese Adverse Drug Event Report (JADER) database. Reports of VTE, including deep vein thrombosis and pulmonary embolism, were identified from the adverse event records of the JADER database. Monthly reporting rates were calculated by dividing the number of VTE reports by the total number of adverse event reports. Seasonal variations were evaluated using negative binomial regression models with monthly indicator variables and harmonic seasonal terms. The association between monthly VTE reporting rates and the mean monthly temperature in Tokyo was assessed using Pearson's correlation analysis.</p><p><strong>Results: </strong>VTE adverse event reports showed a clear seasonal pattern. In the harmonic seasonal model, the estimated peak occurred in December and the nadir in July, with a peak-to-nadir rate ratio of 1.29. The harmonic seasonal model showed a better fit than the monthly indicator model (Akaike information criterion: 1696.8 vs 1712.6). Monthly VTE reporting rates were inversely correlated with mean monthly temperature in Tokyo (Pearson's r = -0.769, p = 0.003).</p><p><strong>Conclusion: </strong>VTE adverse event reports in the JADER database showed a clear seasonal pattern, with higher and lower reporting rates in winter and summer, respectively. Seasonal and environmental factors may be associated with seasonal variation in VTE reporting. It should be noted, however, that spontaneous reporting data cannot be used to estimate the absolute incidence of VTE or to establish causal relationships between drugs and adverse events. Further studies using complementary data sources are required to confirm these findings.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"615764"},"PeriodicalIF":4.3,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13367476/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148445155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality and Timeliness of Pharmacovigilance Reporting in Malawi: A Cross-Sectional Analysis of Individual Case Safety Reports.","authors":"Francis Kachidza Chiumia, Frider T Chimimba, Evans Chimayi Chirambo, Ian Peter Manja, Theophilus Rolland Chadza, Wilfred Kantchilala, Peter Mchenga, Happy Magwaza Nyirongo, Wyson Mbewe Mkanda, Felix Khuluza","doi":"10.2147/DHPS.S613967","DOIUrl":"10.2147/DHPS.S613967","url":null,"abstract":"<p><strong>Background: </strong>Adverse events related to use of medicinal products are among the significant causes of morbidity and mortality. Quality of adverse event reports is essential for safety risk management. We therefore analyzed trends, timeliness and completeness of individual case safety reports (ICSRs) at a regional pharmacovigilance (PV) centre in Malawi.</p><p><strong>Methods: </strong>This was a cross-sectional study involving data extraction from ICSR reports that were submitted from 2017 to 2024. The data included patient demographics, adverse events, suspected products and reporter details. ICSR completeness was assessed using the vigiGrade^® tool.</p><p><strong>Results: </strong>The PV centre received a total of 1,057 ICSRs during the targeted period. These included 940 (88.9%) ADR and 117 (11.1%) AEFI cases. Most of the ADRs were serious (56.1%, n=527) while most of the AEFIs were not serious (58.1%, n=68), p<0.001. Highest reporting rates were recorded in 2022. Most of the ADR cases were related to Isoniazid (16.6%, n=156), followed by tenofovir/lamivudine/dolutegravir (14.5%, n=136). For the AEFIs, most cases were related to pneumococcal conjugate (22.2%, n=26), followed by pentavalent vaccine (21.4%, n=25). The median vigiGrade score for the ADRs was 0.7 (95% CI: 0.7-0.9; IQR: 0.57-1). This was significantly lower (P<0.001) as compared to the AEFIs with a median score of 1 (95% CI: 1-1; IQR: 0.7 -1). There was no significant difference in transmission time between ADR and AEFI reports, p=0.106. The median duration for transmission of ADR reports was 19.5 days (95% CI: 17-21 days; IQR: 6-56 days), while the median time AEFI report transmission was 8 days (95% CI: 3-30.9 days; IQR: 1-156 days).</p><p><strong>Conclusion: </strong>The study highlights poor quality and delayed reporting of adverse events. This may hinder safety signal detection, proper regulatory decision making and compromise patient safety. Strengthening digital reporting mechanisms would enhance quality reporting and streamline timely data flow.</p>","PeriodicalId":11377,"journal":{"name":"Drug, Healthcare and Patient Safety","volume":"18 ","pages":"613967"},"PeriodicalIF":4.3,"publicationDate":"2026-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13332787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148390286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}