The International journal of risk & safety in medicine最新文献_第3页

Impact of proton pump inhibitors on clinical outcomes and adverse drug reactions in antiplatelet therapy: A prospective study from an Indian hospital. 质子泵抑制剂对抗血小板治疗临床结果和药物不良反应的影响：一项来自印度医院的前瞻性研究

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-02-27 DOI: 10.1177/09246479261430590

Mandati Santhosh Reddy, M S Ganachari, Pratiksha Kini

{"title":"Impact of proton pump inhibitors on clinical outcomes and adverse drug reactions in antiplatelet therapy: A prospective study from an Indian hospital.","authors":"Mandati Santhosh Reddy, M S Ganachari, Pratiksha Kini","doi":"10.1177/09246479261430590","DOIUrl":"10.1177/09246479261430590","url":null,"abstract":"BackgroundCoronary artery disease (CAD) management relies on antiplatelet therapy to prevent atherothrombotic events but increases gastrointestinal (GI) bleeding risk. Proton pump inhibitors (PPIs) are recommended for gastroprotection, though their effect on cardiovascular outcomes remains debated.ObjectivesTo evaluate the impact of PPI co-therapy on GI bleeding, cardiovascular events, adverse drug reactions (ADRs), and drug-drug interactions (DDIs) in patients on mono or dual antiplatelet therapy.MethodsA prospective observational study was conducted over 4 months in a tertiary care hospital. Patients on mono (MAPT) or dual antiplatelet therapy (DAPT), with or without PPIs, were included. Data on demographics, clinical outcomes, ADRs, and DDIs were analyzed.ResultsOf 174 patients, 48 received DAPT + PPI, 62 DAPT only, 34 MAPT + PPI, and 30 MAPT only. GI bleeding incidence was lower in PPI groups (DAPT + PPI: 6.25%, MAPT + PPI: 2.9%) versus non-PPI groups (DAPT only: 21%, MAPT only: 13.3%). Cardiovascular outcomes were unaffected (Myocardial Infarction: 27.1% vs 38.7% in DAPT + PPI vs DAPT only). 91 ADRs were reported, mainly GI bleeding (23.1%) and dyspnea (16.5%). Major DDIs included aspirin + clopidogrel (24.8%) and aspirin + ticagrelor (17.3%).ConclusionPPI co-prescription significantly reduced GI bleeding without compromising cardiovascular outcomes, supporting guideline-based prophylaxis in CAD patients receiving antiplatelet therapy.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"352-360"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147314816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Role of pathological autopsy in determining the cause of death in cases of unexpected clinical deterioration or medical incidents. 病理解剖在确定意外临床恶化或医疗事故中死亡原因的作用。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-03-07 DOI: 10.1177/09246479261432855

Sachi Miyashita, Tadashi Kamio, Hiroshi Koyama, Shingo Ohki, Yumiko Tsunano, Mizuki Sato, Kiyomitsu Fukaguchi, Hiroki Hadano

{"title":"Role of pathological autopsy in determining the cause of death in cases of unexpected clinical deterioration or medical incidents.","authors":"Sachi Miyashita, Tadashi Kamio, Hiroshi Koyama, Shingo Ohki, Yumiko Tsunano, Mizuki Sato, Kiyomitsu Fukaguchi, Hiroki Hadano","doi":"10.1177/09246479261432855","DOIUrl":"10.1177/09246479261432855","url":null,"abstract":"BackgroundThe extent to which autopsies are conducted and their role in determining the cause of death has not been sufficiently examined. We aimed to evaluate the contribution of autopsy in determining the cause of death in cases of unexpected clinical deterioration or medical accidents, using data from the Japan Center for Quality Health Care database.MethodsWe analysed data from patients with unexpected clinical deterioration who required pathological autopsy between January 2010 and November 2024. Cases were categorised based on whether autopsies were performed, and the reasons for not performing autopsies were examined.ResultsIn total, 682 reports were identified. Pathological autopsies were performed in 341 patients, and the cause of death was determined in 64.2% of cases (219 patients). The cause of death remained undetermined in 25.2% of cases (86 patients) despite autopsy. Among the 341 patients in whom autopsies were not performed, the primary reason was the family refusal (81.5%, 278 patients).ConclusionsPathological autopsies are essential for determining the cause of death in cases of unexpected clinical deterioration. Family refusal was identified as the principal barrier to autopsy, whereas lack of autopsy proposal accounted for only a small proportion of cases.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"418-424"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147372713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Flurbiprofen-induced upper respiratory and ocular adverse effects in a patient having non-cardiac chest pain. 氟比洛芬引起的非心源性胸痛患者的上呼吸道和眼部不良反应。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2025-12-24 DOI: 10.1177/09246479251411123

Erkan Gencer

引用次数: 0

Ocular adverse reactions associated with intraocular pressure-reducing drugs: An analysis of the FDA adverse event reporting system (FAERS). 与眼压降低药物相关的眼部不良反应：FDA不良事件报告系统（FAERS）的分析

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-01-02 DOI: 10.1177/09246479251414278

Chengzhi Liu, Shuaihao Zhang, Xinyu Wang, Jiaoyue Dong, Jiaqi Shen, Mingyue Liu, Xusheng Cao

{"title":"Ocular adverse reactions associated with intraocular pressure-reducing drugs: An analysis of the FDA adverse event reporting system (FAERS).","authors":"Chengzhi Liu, Shuaihao Zhang, Xinyu Wang, Jiaoyue Dong, Jiaqi Shen, Mingyue Liu, Xusheng Cao","doi":"10.1177/09246479251414278","DOIUrl":"10.1177/09246479251414278","url":null,"abstract":"BackgroundIntraocular pressure (IOP)-lowering drugs are essential for glaucoma treatment but can cause ocular and systemic adverse events (AEs). This study utilizes the FDA Adverse Event Reporting System (FAERS) database to investigate the AE signals associated with these drugs.MethodsA retrospective analysis of FAERS data from Q1 2004 to Q4 2023 was conducted. A total of 107,604 AE reports related to IOP-lowering drugs were analyzed using four signal detection methods: ROR, PRR, BCPNN, and MGPS.ResultsSignificant AE signals were identified, including ocular surface damage linked to preservatives, cardiovascular disorders associated with β-blockers, and ear-related issues with carbonic anhydrase inhibitors and prostaglandin analogs. Carteolol showed a new signal for hepatobiliary disorders.ConclusionsThe study highlights key safety concerns with IOP-lowering drugs, including ocular, cardiovascular, and ear-related AEs. These findings emphasize the need for careful monitoring and further research to confirm these associations and mitigate risks.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"315-327"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145890968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety of prescribed drug use among pregnant women attending antenatal care in Midwestern Brazil: A cross-sectional study. 在巴西中西部参加产前保健的孕妇中处方药使用的安全性：一项横断面研究。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-03-04 DOI: 10.1177/09246479261432738

Kethleen S D Oliveira, Bruna T Ruy, Carine F Correa, Paulo M A Lima

{"title":"Safety of prescribed drug use among pregnant women attending antenatal care in Midwestern Brazil: A cross-sectional study.","authors":"Kethleen S D Oliveira, Bruna T Ruy, Carine F Correa, Paulo M A Lima","doi":"10.1177/09246479261432738","DOIUrl":"10.1177/09246479261432738","url":null,"abstract":"BackgroundMedication use during pregnancy is common but safety data remain limited. The FDA previously categorized drugs from A-X, later replaced by the Pregnancy and Lactation Labeling Rule (PLLR), which provides narrative risk summaries, clinical considerations, and supporting data.ObjectiveTo assess the safety of medications prescribed to pregnant women in Midwestern Brazil using both FDA categories and the PLLR.MethodsThis cross-sectional study reviewed medical records of women receiving prenatal care at a university outpatient clinic in Goiânia, Brazil. Patient characteristics, prescribed medications, and trimester of use were recorded. Each drug was classified by FDA categories and evaluated for PLLR structure.ResultsOf 93 women, 76 (81.7%) received at least one prescription (41 drugs; 241 prescriptions), most during the first trimester (61.8%). Supplements were the most frequent (38.6%), followed by analgesics/anti-inflammatory (26.6%) and gastrointestinal agents (17.0%). FDA categories were: 14.6% A, 41.5% B, 29.3% C, and 7.3% D. Under PLLR, 17 drugs (41.5%) had complete information; among 24 incomplete labels, the Data section was most often missing (46.3%), followed by Clinical Considerations (14.6%).ConclusionsMost women received medications, mainly supplements and analgesics. Although FDA categories suggested low apparent risk, PLLR assessment revealed information gaps that limit evidence-based prescribing.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"361-371"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147350170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Association between obesity/overweight in adolescents and low food safety knowledge and practice. 青少年肥胖/超重与食品安全知识和实践不足之间的关系

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-05-22 DOI: 10.1177/09246479261452519

Ghada Mahmoud Khafagy, Raghda Selet, Mai D Sarhan

{"title":"Association between obesity/overweight in adolescents and low food safety knowledge and practice.","authors":"Ghada Mahmoud Khafagy, Raghda Selet, Mai D Sarhan","doi":"10.1177/09246479261452519","DOIUrl":"10.1177/09246479261452519","url":null,"abstract":"BackgroundObesity among adolescents is one of the most prevalent noncommunicable disorders. Currently, around 17% of teenagers are obese and are vulnerable to long-term consequences. Obesity pathophysiology is complicated, varied, and not fully understood. Multiple studies have found altered gut flora in obese people. Dietary choices are one of the key variables influencing the diversity of the human gut microbiota.ObjectiveWe conducted this study to assess whether there is a possible relationship between food safety knowledge and practice and obesity.MethodsThis cross-sectional study was carried out on 127 subjects (adolescent patients). BMI was assessed by taking anthropometric measurements, and the resulting data were interpreted using WHO BMI-for-age charts (14-19 years). Food habits were assessed in all subjects using a food frequency questionnaire, while food safety knowledge and practice were assessed in all subjects using the Byrd-Bred Benner questionnaire.ResultsOverweight and obese adolescents had a significantly lower knowledge score (6.39 ± 2.41) than normal-weight participants (11.30 ± 2.2), p < 0.001. Overweight and obese adolescents had significantly lower practice scores (6.32 ± 2.3) than normal-weight participants (13.48 ± 1.8), p < 0.001.ConclusionObesity and overweight seem to be associated with lower food safety knowledge and practice.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"408-417"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147990849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Prevalence and predictors of self-medication among adults in Mbeya Urban, Tanzania. 坦桑尼亚姆贝亚市成年人自我药疗的流行率和预测因素。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-05-16 DOI: 10.1177/09246479261452515

Salum Manguja, Theresia Estomih Nkya

{"title":"Prevalence and predictors of self-medication among adults in Mbeya Urban, Tanzania.","authors":"Salum Manguja, Theresia Estomih Nkya","doi":"10.1177/09246479261452515","DOIUrl":"10.1177/09246479261452515","url":null,"abstract":"BackgroundSelf-medication is a common health-seeking behavior in low- and middle-income countries, influenced by easy drug access and limited health insurance. In Tanzania, particularly in urban areas such as Mbeya, empirical evidence remains scarce.Materials and methodsA cross-sectional study was conducted from February to March 2025 among 381 adults in Mbeya Urban, selected via simple random sampling. Data were collected using a structured questionnaire on socio-demographics, self-medication practices, drugs used, sources, and reasons for self-medication. Data were analyzed using descriptive statistics, and associations were assessed using Chi-square tests (p < 0.05).ResultsThe prevalence of self-medication was 45.1%. Antibiotics (27.9%), analgesics (25.6%), and antimalarials (15.7%) were commonly used, primarily obtained from pharmacies and drug shops (67.4%). Main reasons included perceived mild illness (43.0%) and lack of time to visit health facilities (26.7%). Self-medication was significantly associated with education (χ2 = 57.41, p < 0.001), occupation (χ2 = 45.03, p < 0.001), religion (χ2 = 55.36, p < 0.001), and health-insurance status (χ2 = 55.76, p < 0.001).ConclusionSelf-medication is widespread in Mbeya Urban, driven by access to medicines and limited healthcare utilization. Targeted community education, pharmacist regulation, and expanded health insurance coverage are needed to promote rational drug use and curb antimicrobial resistance.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"399-407"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147960409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Proactive risk analysis in chemotherapy nursing processes: A systematic review of FMEA/FMECA applications. 化疗护理过程中的主动风险分析：FMEA/FMECA应用的系统回顾。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2026-03-05 DOI: 10.1177/09246479261432846

Gennaro Laus, Giuseppe Bertozzi, Aldo Di Fazio, Federico Ruta, Tommaso Cassano, Sipontina Rita Zerulo

{"title":"Proactive risk analysis in chemotherapy nursing processes: A systematic review of FMEA/FMECA applications.","authors":"Gennaro Laus, Giuseppe Bertozzi, Aldo Di Fazio, Federico Ruta, Tommaso Cassano, Sipontina Rita Zerulo","doi":"10.1177/09246479261432846","DOIUrl":"10.1177/09246479261432846","url":null,"abstract":"BackgroundChemotherapy management is a high-risk process, especially in oncology nursing, where errors can have serious consequences. Proactive risk analysis tools such as Failure Mode and Effects Analysis (FMEA) and its variant with Criticality Analysis (FMECA) are increasingly used to enhance safety.AimTo systematically review the effectiveness of FMEA/FMECA methodologies in identifying and mitigating risks within nursing processes related to chemotherapy preparation, administration, and management.MethodsA systematic review was conducted following PRISMA 2020 guidelines. Literature was searched in PubMed and the Cochrane Library (as of February 9, 2025), including studies published from 2016 onwards in English, Italian, or Spanish. The quality of included studies was assessed using the Newcastle-Ottawa Scale, and a qualitative synthesis was performed.ResultsThirteen studies met the inclusion criteria. FMEA/FMECA proved effective in identifying vulnerabilities in chemotherapy workflows, leading to the implementation of preventive and corrective actions. Improvements were observed in patient and staff safety, error reduction, process standardization, and integration of technological solutions.ConclusionFMEA/FMECA are valuable tools in proactively managing risks in oncology nursing. Their success depends on the active involvement of nursing staff and continuous training. Routine use is recommended to improve care quality and occupational safety.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"432-442"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147358752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Risk management plans and drug safety in Canada: A cross-sectional study. 加拿大的风险管理计划和药物安全：一项横断面研究。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2025-12-28 DOI: 10.1177/09246479251414280

Joel Lexchin

{"title":"Risk management plans and drug safety in Canada: A cross-sectional study.","authors":"Joel Lexchin","doi":"10.1177/09246479251414280","DOIUrl":"10.1177/09246479251414280","url":null,"abstract":"BackgroundHealth Canada uses risk management plans (RMPs) to identify and monitor risks associated with drugs in the postmarket phase but does not make the contents of these RMPs public.ObjectiveTo identify information about RMPs that is available in other Health Canada documents and to analyze extent of the information.MethodsA list of new active substances (NAS) approved by Health Canada between July 1, 2015 and May 5, 2025 was generated. These drugs were searched on the Summary Basis of Decision website and any information about the contents of the RMPs was copied verbatim. The information was read iteratively and grouped into themes.ResultsThere were 385 NAS approved and 381 had RMPs. For 301 the only information was that they had been reviewed by Health Canada and found to be acceptable. The information about the other 80 was typically vague and revealed little about how the information that they generated would be used to enhance safety.ConclusionHealth Canada needs to make RMPs publicly available, should explain how their implementation will be monitored and evaluated, how the information they generate will be used to enhance drug safety and should publish updates to them as necessary.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"309-314"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13428812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145852208","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}

引用次数: 0

The importance of nutrivigilance in Middle East countries and the necessity for incorporation into pharmacovigilance health authorities' regulations. 中东国家营养警戒的重要性以及将药物警戒纳入卫生当局条例的必要性。

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The International journal of risk & safety in medicine Pub Date : 2026-08-01 Epub Date: 2025-12-26 DOI: 10.1177/09246479251412662

Samer Shukur Mohammed

{"title":"The importance of nutrivigilance in Middle East countries and the necessity for incorporation into pharmacovigilance health authorities' regulations.","authors":"Samer Shukur Mohammed","doi":"10.1177/09246479251412662","DOIUrl":"10.1177/09246479251412662","url":null,"abstract":"BackgroundNutrivigilance has become increasingly vital as global supplement consumption rises. However, in many Middle Eastern countries, these products are marketed with limited oversight and minimal integration within existing pharmacovigilance systems.ObjectiveTo highlight the public health importance of nutrivigilance, review international models, and propose the incorporation of nutrivigilance practices into pharmacovigilance regulations within Middle Eastern health authorities.MethodsThis perspective synthesizes findings from global regulatory frameworks, including the U.S. FDA, European Food Safety Authority (EFSA), and national nutrivigilance programs and evaluates their applicability in Middle Eastern contexts.ResultsSignificant variability exists between countries regarding nutrivigilance implementation. Developed nations employ structured post-marketing surveillance systems, whereas Middle Eastern countries lack harmonized approaches. The absence of specialized nutrivigilance units and public awareness campaigns contributes to underreporting and potential adverse health outcomes. Integrating nutrivigilance into national pharmacovigilance programs could enhance consumer safety, regulatory decision-making, and data sharing.ConclusionEstablishing nutrivigilance within Middle Eastern pharmacovigilance regulations is an urgent public health priority. Creating dedicated departments, harmonizing standards, fostering regional collaboration, and enhancing reporting culture will strengthen safety monitoring and consumer protection.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"455-457"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145835952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0