The International journal of risk & safety in medicine最新文献_第2页

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。

IF 0.8

The International journal of risk & safety in medicine Pub 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":"https://doi.org/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":"9246479261432846"},"PeriodicalIF":0.8,"publicationDate":"2026-03-05","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

Strengthening pharmacovigilance for herbal medicines in Nigeria: An urgent health systems challenge. 加强尼日利亚草药药物警戒：卫生系统面临的紧迫挑战。

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The International journal of risk & safety in medicine Pub Date : 2026-03-04 DOI: 10.1177/09246479261432851

David Ololade Atanda, Oluwabukunmi Deborah Ayoola, Esther Oluwasemipe Adegunloye, Oluwatoyosi Moyinoluwa Aladelo

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。

IF 0.8

The International journal of risk & safety in medicine Pub 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":"https://doi.org/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":"9246479261432738"},"PeriodicalIF":0.8,"publicationDate":"2026-03-04","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

Adverse reactions to Rubia peregrina L.: Two case reports from Morocco. 摩洛哥对苦参的不良反应报告2例。

IF 0.8

The International journal of risk & safety in medicine Pub Date : 2026-03-02 DOI: 10.1177/09246479261427137

Khadija Dabra, Souad Skalli

{"title":"Adverse reactions to Rubia peregrina L.: Two case reports from Morocco.","authors":"Khadija Dabra, Souad Skalli","doi":"10.1177/09246479261427137","DOIUrl":"https://doi.org/10.1177/09246479261427137","url":null,"abstract":"BackgroundMedicinal plants (MPs) can cause adverse reactions (ARs) particularly affecting major detoxification organs, the kidneys. This study aims to document two cases of nephrotoxicity associated with Rubia peregrina L. (R. peregrina), a plant recognized for its medicinal properties but also potential toxicity.MethodsAn ethnobotanical study was conducted at Ibn Sina Hospital in Rabat, Morocco, involving two female patients aged 59 and 75, both presenting with anemia and no prior history of renal disease. Data were collected using a semi-structured questionnaire, and plant samples were identified. The study received ethical approval (n°05/23).Case presentationCase 1: A 59-year-old woman developed chronic renal failure requiring hemodialysis after ingesting madder root powder. Causality assessment indicated a possible link to the use of the plant. Case 2: A 75-year-old woman experienced renal failure following the consumption of a madder root decoction. Causality assessment also suggested a possible association.Neither patient had reported ARs prior to hospitalization.ConclusionsThis study is the first to document ARs linked to R. peregrina in humans, highlighting the avant nephrotoxic risks associated with its anthraquinone compounds. Despite its traditional use, the potential for serious renal damage calls for caution, further research, and regulatory measures for MPs.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261427137"},"PeriodicalIF":0.8,"publicationDate":"2026-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147346246","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

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

IF 0.8

The International journal of risk & safety in medicine Pub 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":"https://doi.org/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":"9246479261430590"},"PeriodicalIF":0.8,"publicationDate":"2026-02-27","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

A case of delayed-onset Stevens-Johnson syndrome following co-amoxiclav administration in a 98-year-old female. 一名98岁女性在阿莫昔拉夫联合用药后出现迟发性史蒂文斯-约翰逊综合征。

IF 0.8

The International journal of risk & safety in medicine Pub Date : 2026-02-17 DOI: 10.1177/09246479261426749

Gabriella Baldacchino, Francesca Farrugia, Godfrey Baldacchino

{"title":"A case of delayed-onset Stevens-Johnson syndrome following co-amoxiclav administration in a 98-year-old female.","authors":"Gabriella Baldacchino, Francesca Farrugia, Godfrey Baldacchino","doi":"10.1177/09246479261426749","DOIUrl":"https://doi.org/10.1177/09246479261426749","url":null,"abstract":"BackgroundStevens-Johnson Syndrome is a type IV hypersensitivity mucocutaneous reaction characterised by a widespread desquamating rash, and is considered to be an emergency due to its potentially fatal complications. Drugs account for 50-80% of Stevens-Jonson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) cases, with anticonvulsants, antibiotics, analgesics and allopurinol being the most common causative agents. Co-amoxiclav contains amoxicillin (a penicillin) and clavulanic acid (a beta-lactamase inhibitor) and is widely used in healthcare settings for treatment of common infections due to its relatively broad spectrum and good safety profile. However, few publications have attributed SJS/TEN to co-amoxiclav administration.CaseWe describe the insidious development of Stevens-Johnson Syndrome in a 98-year-old female after receiving intravenous and oral co-amoxiclav (amoxicillin/clavulanic acid). The patient had received co-amoxiclav in prior hospital admissions with no reported complications.OutcomeThis was successfully treated with immunosuppressive therapies. The patient's frailty, as well as the exposed areas of skin and immunosuppression made her susceptible to a serious urinary tract infection and fall, which complicated her hospital stay.ConclusionCo-amoxiclav, while generally a well-tolerated antibiotic, should be a recognised cause of Stevens-Johnson syndrome, and care should be taken to prevent complications, especially in the elderly population.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261426749"},"PeriodicalIF":0.8,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146215516","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

The causes of Australian excess deaths in 2021, and beyond: An ecological study considering COVID-19, the lockdowns, and the vaccines. 2021年及以后澳大利亚超额死亡的原因：一项考虑COVID-19、封锁和疫苗的生态学研究。

IF 0.8

The International journal of risk & safety in medicine Pub Date : 2026-02-14 DOI: 10.1177/09246479261426743

Raphael Lataster

{"title":"The causes of Australian excess deaths in 2021, and beyond: An ecological study considering COVID-19, the lockdowns, and the vaccines.","authors":"Raphael Lataster","doi":"10.1177/09246479261426743","DOIUrl":"https://doi.org/10.1177/09246479261426743","url":null,"abstract":"BackgroundNumerous concerns have been raised about excess mortality persisting beyond the COVID-19 pandemic. COVID-19 and the lockdowns are typically offered as explanantia, with some suggesting that COVID-19 vaccines could be contributing. With its relative isolation it is prudent to pay attention to Australia, which provides a unique opportunity to consider what effectively became a large-scale vaccine safety trial.ObjectiveThe purpose of this study is to determine the plausibility of COVID-19 vaccination contributing to Australia's excess mortality.MethodsVarious regions of Australia displaying excess mortality were identified, and then the plausibility of three explanantia were considered in turn: COVID-19, the lockdowns, and COVID-19 vaccines.FindingsI found that in 4 of Australia's 8 major regions excess mortality was present, correlating with rapid and thorough COVID-19 vaccination programs, before mass exposure to COVID-19, and in the absence of lengthy and highly restrictive lockdowns.ConclusionsCombined with increasing evidence that the efficacy/effectiveness and safety of COVID-19 vaccines have been greatly exaggerated, including acknowledgements from the Australian and American governments that several deaths have been caused by the vaccines, these findings make it a near-certainty that COVID-19 vaccines have been - and continue to be - contributing to excess mortality.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261426743"},"PeriodicalIF":0.8,"publicationDate":"2026-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146195718","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

Publication notice. 发布通知。

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The International journal of risk & safety in medicine Pub Date : 2026-02-07 DOI: 10.1177/09246479261423804

引用次数: 0

Dimensions of medical errors - The three victims and defensive medicine. 医疗差错的维度——三个受害者和防御性医学。

IF 0.8

The International journal of risk & safety in medicine Pub Date : 2026-02-01 Epub Date: 2025-09-30 DOI: 10.1177/09246479251372341

Mohamed Abosheisha, Islam Omar

{"title":"Dimensions of medical errors - The three victims and defensive medicine.","authors":"Mohamed Abosheisha, Islam Omar","doi":"10.1177/09246479251372341","DOIUrl":"10.1177/09246479251372341","url":null,"abstract":"BackgroundDespite recent advances in medical sciences, the utilisation of technology, and the spread of awareness on patient safety, medical errors still occur and impose a significant burden on healthcare facilities and society. Safety incidents have an impact on the doctor-patient relationship, leading to a defensive medical practice.ObjectiveThis narrative review aims to present an overview of the dimensions of medical errors and their consequences, with a focus on the second victim phenomenon and defensive medicine.MethodsSearch of the PubMed-indexed relevant publications in the English language. The full texts of the relevant publications have been summarised.ResultsThis review explored the dimensions of medical errors and their consequences. The second victim phenomenon describes the physical symptoms and emotional experience of the healthcare practitioners involved in safety incidents. There is a limited number of structured support programs to help the second victims. Unfair media coverage of medical errors adds pressure and directs the blame rather than contributing to solving the problem. Defensive medicine originated due to the increasing litigation claims and represents a fundamental change in the doctor-patient relationship. It takes two forms: positive and negative defensive medicine.ConclusionsThis multidimensional presentation of the topic may be helpful to readers involved in such incidents or working to mitigate their consequences. Patients should understand they are not the only victims of the harm imposed on them. The staff involved should seek help, and healthcare facilities should offer support programs for staff involved in safety incidents. The general audience should receive the published material about medical errors in a reasonably neutral manner and avoid one-sided presentations in the media.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"23-30"},"PeriodicalIF":0.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145202890","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

Nifedipine and mycophenolate mofetil-induced gingival hyperplasia in a patient with systemic sclerosis: Role of concomitant therapy and pharmacovigilance aspects. 硝苯地平和霉酚酸酯诱发的系统性硬化症患者的牙龈增生：伴随治疗和药物警戒方面的作用。

IF 0.8

The International journal of risk & safety in medicine Pub Date : 2026-02-01 Epub Date: 2025-11-05 DOI: 10.1177/09246479251389217

Shreya K Gowda, Bevan Priyadarshan, Biswanath Behera, Vishal Thakur

{"title":"Nifedipine and mycophenolate mofetil-induced gingival hyperplasia in a patient with systemic sclerosis: Role of concomitant therapy and pharmacovigilance aspects.","authors":"Shreya K Gowda, Bevan Priyadarshan, Biswanath Behera, Vishal Thakur","doi":"10.1177/09246479251389217","DOIUrl":"10.1177/09246479251389217","url":null,"abstract":"BackgroundDrug-induced gingival overgrowth (DIGO) is a common adverse effect of anticonvulsants, calcium channel blockers (CCBs), and immunosuppressants like cyclosporine, with nifedipine being the most frequently implicated CCB. In contrast, mycophenolate mofetil (MMF)-induced DIGO is rare due to its antifibrotic properties.Case reportWe report a case of a 26-year-old female with systemic sclerosis (SSc), receiving nifedipine and MMF for Raynaud's phenomenon and interstitial lung disease, who presented with grade I gingival hyperplasia confined to interdental papillae. Despite good oral hygiene, gingival inflammation, microstomia, and plaque accumulation contributed to DIGO. Nifedipine was substituted with tadalafil, and MMF was replaced with nintedanib due to worsening interstitial lung disease. The pathogenesis of DIGO involves TGF-β-mediated fibroblast proliferation and extracellular matrix deposition, mechanisms also implicated in SSc-related fibrosis. Genetic polymorphisms in TGF-β and fibroblast regulatory genes further increase susceptibility. Effective management includes drug substitution, meticulous oral hygiene, and surgical excision for persistent cases.ConclusionThis report highlights the need for vigilant pharmacovigilance in SSc patients, emphasizing early detection, genetic risk assessment, and preventive dental care to mitigate DIGO progression. Personalized risk stratification based on genetic profiling may enhance DIGO prevention and therapeutic strategies in high-risk individuals.","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"144-147"},"PeriodicalIF":0.8,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145447020","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