The International journal of risk & safety in medicine最新文献

{"title":"Detection of cyclophosphamide residues on community pharmacy counters: An exploratory survey.","authors":"Masato Komuro, Hisanaga Nomura, Takahito Furuya, Akio Murakami, Yoshimasa Nagao, Chiaki Ogawa, Takuma Matsumoto, Syuji Horita, Shinya Takada, Ryoko Udagawa, Hisashi Tagashira, Kazuki Fukuda, Fumitaka Shinkai, Daisuke Hisamatsu, Yasuyuki Sakamoto, Seiichi Osaki, Yurina Yasuda, Yusuke Okura, Tsuneo Maki, Takahiro Nishimura","doi":"10.1177/09246479251409552","DOIUrl":"10.1177/09246479251409552","url":null,"abstract":"<p><p>ObjectiveThis study aimed to evaluate cyclophosphamide contamination in community pharmacies, investigate patient-mediated transfer and indirect risks to the public, and examine the association between the use of hospital closed system transfer devices (CSTDs) and this contamination.MethodsWipe samples from patient counselling counters at 24 community pharmacies near 10 hospitals were analysed for cyclophosphamide contamination using liquid chromatography-mass spectrometry. A questionnaire survey was conducted to assess CSTD use and cleaning practices.ResultsContamination was detected in 5/24 pharmacies (20.8%; median level: 0.7 ng/625 cm²). The overall median across the 24 pharmacies was below the limit of quantification, which does not necessarily indicate absence of contamination. Moreover, four of the five pharmacies with contamination did not have cyclophosphamide in stock during the sampling period. Contamination was observed irrespective of hospital CSTD use or the pharmacy's handling of cyclophosphamide.ConclusionsCyclophosphamide contamination detection on patient counselling counters in community pharmacies may be a result of patient-mediated transfer. However, alternative sources within pharmacies, such as inventory, packaging, and local handling, cannot be ruled out. Contamination was detected in settings with and without hospital CSTD use, indicating that CSTDs address handling-related contamination but do not mitigate patient-mediated pathways.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"300-308"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145835944","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}

{"title":"Adverse reactions to <i>Rubia peregrina</i> L.: Two case reports from Morocco.","authors":"Khadija Dabra, Souad Skalli","doi":"10.1177/09246479261427137","DOIUrl":"10.1177/09246479261427137","url":null,"abstract":"<p><p>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 <i>Rubia peregrina</i> L. (<i>R. peregrina)</i>, 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 <i>R. peregrina</i> 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.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"476-480"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","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}

{"title":"Feeding tube safety: National guidance is unsafe and must change.","authors":"Stephen J Taylor","doi":"10.1177/09246479261442065","DOIUrl":"10.1177/09246479261442065","url":null,"abstract":"<p><p>National guidance advises post-procedure pH or X-ray checks to prevent use of tubes misplaced in the respiratory tract; this occurs in 0.017% of placements. However, post-procedure checks cannot prevent the in-procedure pneumothorax in 0.43% or pneumonia from contamination in 0.20%. Extrapolated for annual Europe + USA tube placements there would be ∼ 71,500 complications.Mid-procedure CO2 checks or guided tube placement can prevent 96-100% of these complications whilst pre-emptive bridle securement reduces risk by 40% by obviating the need for most tube replacements. Together these methods would radically reduce holistic risk and cost.National guidance is obsolete and disincentivises improvements in patient safety. In-procedure tube position checks, pre-emptive bridling and evidence-based training should be recommended.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"449-454"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680278","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}

{"title":"The science of understanding risk and safety in medicine-A multilevel perspective.","authors":"Liliya E Ziganshina","doi":"10.1177/09246479261467400","DOIUrl":"10.1177/09246479261467400","url":null,"abstract":"","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"287-289"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148407855","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}

{"title":"How healthcare professionals see occupational safety.","authors":"Bayram Goktas, Deniz Tugay Arslan, Yasemin Hancioglu Baskoy, Gozde Yesilaydin, Ece Ugurluoglu Aldogan","doi":"10.1177/09246479251411127","DOIUrl":"10.1177/09246479251411127","url":null,"abstract":"<p><p>BackgroundOccupational safety is the set of measures and practices taken to ensure that employees are protected from the dangers they may be exposed to in the workplace. Its measures prevent occupational accidents and occupational diseases, allowing employees to perform their duties continuously and effectively.ObjectiveThe aim of the study is to evaluate the opinions of healthcare professionals about the activities carried out for occupational safety in the institution where they work and to determine whether occupational safety is provided for healthcare professionals in the institution.MethodThe study population consists of 195 healthcare professionals working in a public hospital operating in Ankara, Türkiye. Simple random sampling method was used in the study, and the opinions of 138 healthcare professionals who volunteered to participate in the study were evaluated.ResultsThe mean of the Occupational Safety Scale of the participants was 3.43 ± 0.87 and the value obtained was found around the average. The average occupational safety score of other healthcare professionals was higher than that of physicians and nurses/midwives.ConclusionIn line with the results, we recommend the institution to start improvement activities for occupational safety practices and to plan in-service trainings related with occupational safety.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"290-299"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145822659","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}

{"title":"Neuropsychiatric adverse events associated with lorlatinib in ALK-positive NSCLC.","authors":"Eleonora Castellana, Maria Rachele Chiappetta","doi":"10.1177/09246479261442221","DOIUrl":"10.1177/09246479261442221","url":null,"abstract":"<p><p>BackgroundLorlatinib, a third-generation ALK/ROS1 inhibitor, is highly effective in ALK-positive non-small-cell lung cancer (NSCLC), particularly for intracranial disease. It is associated with a distinctive neuropsychiatric toxicity profile.ObjectiveTo characterize neuropsychiatric adverse events (AEs) of lorlatinib using FAERS post-marketing data.MethodsFAERS reports listing lorlatinib as the primary suspect (November 2018-December 2024) were analyzed via OpenVigil 2.1. Neuropsychiatric AEs were grouped into four domains: cognitive, mood, speech, and psychotic. Disproportionality was assessed using Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR).ResultsAmong 3452 reports, cognitive effects predominated: cognitive disorder (2.95%, ROR: 16.68, PRR: 16.22), memory impairment (2.35%, ROR: 4.07, PRR: 3.99), and confusional state (1.77%, ROR: 3.22, PRR: 3.18). Mood alterations included affective disorder (0.43%, ROR: 13.13, PRR: 13.08) and personality change (0.32%, ROR: 10.32, PRR: 10.29). Speech disturbances included slow speech (0.2%, ROR: 18.49, PRR: 18.45) and speech disorder (1.22%, ROR: 6.47, PRR: 6.40). Psychiatric manifestations were most pronounced: olfactory hallucinations (0.14%, ROR: 91.44, PRR: 91.31), auditory hallucinations (1.3%, ROR: 22.0, PRR: 21.7), and acute psychosis (0.2%, ROR: 22.12, PRR: 22.07).ConclusionsLorlatinib exhibits a multidimensional neuropsychiatric profile with rare but highly specific events. Proactive monitoring of cognitive, mood, speech, and psychotic domains is recommended in clinical practice.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"382-389"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147680296","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}

{"title":"Excess mortality, statistical significance, and causation: Analyzing controversies in COVID-19 vaccine research.","authors":"Raphael Lataster","doi":"10.1177/09246479261446501","DOIUrl":"10.1177/09246479261446501","url":null,"abstract":"<p><p>Many thanks to the editors of the <i>International Journal of Risk & Safety in Medicine</i> for inviting me to provide commentary and context on the academic discourses around 4 articles published herein that provide a more balanced view of COVID-19 vaccines, including research on the potential harms of the vaccines and their possibly contributing to excess mortality. I conclude that the criticisms highlighted here are unsuccessful in allaying the concerns raised in these studies, and that ongoing scrutiny on COVID-19 vaccines is warranted and necessary.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"446-448"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147795761","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}

{"title":"Clinical profile of healthcare employees with needlestick and sharps injuries and infectious body fluid exposure in tertiary care hospitals in southern India.","authors":"Nitin Joseph, Jithin Surendran, Ayandeep Baruah, Sunny Dev, Aditi Raj Gupta, Aastha Shukla, Priyanka Roy, Nadia Ozair, Pranshi Agarwal","doi":"10.1177/09246479261432856","DOIUrl":"10.1177/09246479261432856","url":null,"abstract":"<p><p>BackgroundNeedle-stick and sharps injuries (NSSIs) are major occupational hazards faced by healthcare employees (HCEs) worldwide.ObjectivesThis study aimed to assess trends of NSSIs among HCEs and their exposure to other infected body fluids, as well as to determine their risk factors.MethodsThis retrospective observational study involved secondary data of NSSIs collected from January 2016 to June 2023.ResultsThere was a constant decline in the number of NSSI incidents over the time, except in 2021. Among the 334 HCEs with a history of exposure, 129 (38.6%) were staff nurses. Most HCEs [274 (82.0%)] developed a prick from the injector needle, and the majority (39.4%) received a prick on the fingers of the left hand. The majority (24.1%) were exposed to NSSIs and infectious body fluids while handling/discarding biomedical wastes (BMWs). Delays in screening and initiation of postexposure prophylaxis (>24 h) were observed among 10.3% and 15.1% of HCEs, respectively. There were significantly more NSSIs than other forms of occupational exposure during the COVID-19 period (<i>p</i> = 0.046) and among HCEs aged 18-25 years (<i>p</i> = 0.033). Females were more prone to exposure while handling/discarding BMWs (<i>p</i> = 0.0001).ConclusionTraining, particularly among junior HCEs, is needed to prevent NSSIs and exposure to infectious body fluids.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"372-381"},"PeriodicalIF":0.8,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147392044","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}

{"title":"Real-world drug safety surveillance in south India: Experience from an ADR monitoring center.","authors":"Pratiksha Kini, Mandati Santhosh Reddy, M S Ganachari","doi":"10.1177/09246479261472658","DOIUrl":"https://doi.org/10.1177/09246479261472658","url":null,"abstract":"<p><p>BackgroundAdverse drug reactions (ADRs) are a major cause of medication-related morbidity and contribute significantly to healthcare burden. Systematic evaluation of ADRs is essential for strengthening pharmacovigilance and improving patient safety.ObjectiveTo assess the severity, predictability, preventability, causality, management, and outcomes of ADRs reported to an Adverse Drug Reaction Monitoring Centre (AMC) in a tertiary care teaching hospital.MethodsAn observational study was conducted using ADR reports submitted to the AMC between January and December 2025. Eligible reports were extracted from the VigiFlow database and analyzed using standardized pharmacovigilance assessment tools. Descriptive statistics were used to summarize the data.ResultsA total of 1,994 ADR reports were analyzed. Adults (59.0%) and elderly patients (28.0%) accounted for most reports. Mild ADRs predominated (64.3%), while 77.2% were classified as predictable Type A reactions. Preventability assessment showed that 72.9% of ADRs were either definitely or probably preventable. Most ADRs were non-serious (81.6%) and categorized as probable (65.1%) on causality assessment. Gastrointestinal disorders were the most commonly affected organ class, and anti-invectives were the most frequently implicated drug class.ConclusionMost ADRs were mild, predictable, and potentially preventable, highlighting opportunities to enhance medication safety through rational prescribing, therapeutic monitoring, and strengthened pharmacovigilance practices.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261472658"},"PeriodicalIF":0.8,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148612363","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}

{"title":"Heavy metal contamination in pharmaceuticals: A narrative review of prevalence, health risks, and regulatory gaps in Nigeria.","authors":"Blessing Abraham Ogungbe, David Ololade Atanda, Janet Adedoyin Bepo, Adedamola Akin Akinyemi","doi":"10.1177/09246479261471793","DOIUrl":"https://doi.org/10.1177/09246479261471793","url":null,"abstract":"<p><p>Pharmaceutical quality and safety are critical to public health, yet low- and middle-income countries such as Nigeria remain vulnerable to medicine safety challenges due to weak regulatory enforcement and limited market surveillance. A major concern is contamination of pharmaceutical products with toxic heavy metals, including lead, cadmium, mercury, arsenic, nickel, and chromium. These metals can bioaccumulate and cause adverse health effects even at low concentrations, such as neurodevelopmental impairment, renal and hepatic dysfunction, reproductive toxicity, and cardiovascular complications. This narrative review synthesised evidence on the prevalence of heavy metal contamination in pharmaceuticals marketed in Nigeria, associated health risks, and the adequacy of existing regulatory frameworks.Relevant literature published between 2005 and 2025 was identified through a comprehensive literature search of major databases such as PubMed, Google Scholar, African Journals Online, and Scopus, supplemented with reports from the National Agency for Food and Drug Administration and Control, the World Health Organisation, and grey literature. Studies assessing industrially manufactured or over-the-counter medicines for heavy metal contamination in Nigeria were included.The findings reveal recurrent contamination across several pharmaceutical categories, particularly syrups, locally manufactured analgesics, and herbal preparations. Lead and cadmium were the most frequently reported contaminants, with some products containing multiple metals and exceeding pharmacopeial limits. Heavy metal exposure induces oxidative stress and cellular damage, contributing to kidney injury, neurotoxicity, haematological effects, and endocrine disruption. Children, pregnant women, individuals with renal impairment, and frequent users of herbal medicines were identified as particularly vulnerable. Overall, heavy metal contamination remains a significant medicine safety concern in Nigeria, highlighting the need for stronger regulation, improved analytical capacity, and risk-based surveillance.</p>","PeriodicalId":520800,"journal":{"name":"The International journal of risk & safety in medicine","volume":" ","pages":"9246479261471793"},"PeriodicalIF":0.8,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148586660","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}