Background: There are four pillars in the treatment of heart failure. During treatment, heart failure patients generally require therapy adjustment, which was deprescribing practice. Aim: This review aimed to study outcomes from deprescribing of beta blockers and renin-angiotensin aldosterone system inhibitors (RAASIs) in heart failure patients. Methods: A narrative review was carried out. The search was conducted in May 2025, using Pubmed, Cochrane Library, and Scopus. Eligible studies included randomized controlled trials (RCTs), observational studies, and retrospective studies. Interventions included deprescribing of guideline-directed medical therapy (GDMT), or beta blocker, or RAASIs. Only articles published in English between 2015 and 2025 were included in the search. Results: The search and screening resulted in seven evaluable articles. Conclusion: The current review shows that negative outcomes from deprescribing of beta blockers or RAASIs were dominant. Other measures were, therefore, needed to be taken into consideration for a better benefit/risk balance.
BackgroundPrimary care accounts for more than half of all adverse events leading to patient harm. Unique patient safety and risk management (PSRM) units have been operating in health maintenance organizations (HMOs) in Israel.ObjectiveTo explore healthcare providers' perspectives regarding the tasks, accomplishments, and recommendations concerning these PSRM units.MethodsIn-depth qualitative interviews were conducted with 40 healthcare community providers: 10 family physicians, 10 specialist physicians, 10 nurses, and 10 pharmacists.FindingsInterviewees identified two of the unit's main benefits and roles: learning from adverse events and providing backing in litigation cases. They emphasized four of the unit's accomplishments: sharing lessons learned from adverse event reports; addressing inquiries regarding clinic practice; instructing physicians on how to improve the accuracy of medical record documentation; and providing a user-friendly reporting procedure. They proposed several practices for promoting the reporting of adverse events.ConclusionsThe study suggests that embedded PSRM units promote the principles of Just Culture and encourage the reporting and discussion of adverse events. It outlines recommendations for practice and policy to support the optimization of PSRM units in primary care. The Israeli PSRM unit may offer an internationally relevant model for strengthening patient safety culture.
BackgroundAI-enabled medical devices introduce dynamic, data-dependent risks that challenge traditional safety-risk management frameworks. While ISO 14971, AAMI CR34971, and the EU Artificial Intelligence Act each address elements of device safety and algorithmic governance, they remain fragmented when applied. This review examines conceptual and operational gaps in current approaches and proposes an integrated governance model for AI-specific safety-risk management.MethodsA structured narrative review was conducted using PubMed, IEEE Xplore, Google Scholar, and regulatory repositories. Eligibility criteria focused on addressing AI-specific safety-risk management, regulatory obligations, or risk-analysis methodologies. A total of 19 academic studies and regulatory sources met inclusion criteria. Data were charted using JBI, AACODS, and normative appraisal categories, and synthesized to identify cross-cutting themes and gaps.ResultsThe review identified persistent challenges in linking AI-specific hazards to safety-risk evaluation, determining adequacy of risk controls, integrating algorithmic-risk obligations with ISO 14971 processes, and operationalizing lifecycle monitoring under the EU AI Act. Existing frameworks address components of AI risk but lack a unified operational pathway.ConclusionsAn integrated governance model is proposed to align AI-specific risk identification with established medical-device safety frameworks. This synthesis provides regulators, manufacturers, and professionals with a clearer, more actionable approach to managing AI-related safety risks.
BackgroundAcute Inflammatory Demyelinating Polyradiculoneuropathy (AIDP), the most common form of Guillain-Barré Syndrome (GBS), may rarely be complicated by myocarditis, which results from an inflammatory or autoimmune response. Conversely, acute kidney injury (AKI), caused by osmotic nephrosis, is an uncommon adverse effect associated with maltose-based intravenous immunoglobulin (IVIG) therapy, a common treatment for GBS.Case presentationA 41-year-old diabetic male diagnosed with AIDP received maltose-based IVIG. After 75 g administration, he developed flu-like symptoms and AKI, followed by signs of myocarditis, including elevated troponin, reduced ejection fraction, and ECG changes. IVIG was discontinued early due to these adverse effects. The patient required ICU care and hemofiltration but recovered with supportive treatment.ConclusionThis case highlights myocarditis as a rare complication of GBS and demonstrates that IVIG, while essential in treatment, even though maltose based, can lead to serious adverse effects including AKI, particularly in high-risk patients.
BackgroundDrug-Induced Multisystem Syndromes (DIMS) represent a clinically significant yet under-recognized group of delayed immune-mediated adverse drug reactions characterized by heterogeneous clinical presentations, diagnostic uncertainty, and substantial morbidity. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Drug-Induced Hypersensitivity Syndrome (DIHS) are prototypical conditions within this spectrum.MethodsThis narrative review synthesizes current evidence on the immunopathogenesis, pharmacogenomic susceptibility, clinical manifestations, diagnostic challenges, and pharmacovigilance strategies associated with delayed multisystem drug hypersensitivity reactions. The DIMS framework is proposed as a mechanistic, hypothesis-driven construct intended to enhance pharmacovigilance signal recognition rather than replace existing diagnostic classifications.ResultsDIMS typically develop weeks after drug exposure and involve multisystem inflammatory injury affecting organs such as the liver, kidney, lungs, and heart. T-cell-mediated immune activation, cytokine amplification, and viral reactivation are central pathogenic mechanisms. Mortality varies by syndrome subtype, ranging from approximately 5-10% in DRESS/DIHS to 25-35% in Toxic Epidermal Necrolysis (TEN). Pharmacogenomic factors, including HLA alleles and cytochrome P450 polymorphisms, contribute to susceptibility.ConclusionThe DIMS framework may support improved early recognition, pharmacovigilance signal detection, and prevention strategies. Integration of pharmacogenomics and artificial intelligence-based analytics may facilitate risk stratification and safer, personalized therapeutic decision-making.
Individual autonomy is fragile.We must ask whether we have been swept up with ' a crowd '; perhaps trapped within a ' thought window ', carried by mass narrative, or entranced by the certainty of the totalitarised mind.Loss of the individual to the group can occur on any scale, from ' group-think ' cognitive bias, through the eager madness of a literal crowd, to the modern global reach of propaganda and technocratic totalitarianism.Milgram electrocution experiments show potential for the mind to be rapidly totalitarised - the hypnotic, focal enthusiasm of ' engaged followers '.This work was performed at the time Hannah Arendt coined the term ' banality of evil ' and described a new form of criminal, the bureaucrat.Totalitarianism is an ever present under current in society and the scientific community is not exempt from the dangers. Strictly enforced bed rest for patients is one of the best known medical mass narratives, responsible for the loss of many lives.Responses to the COVID pandemic years echo the ideologies of history.Healthy curiosity, dissent from the main stream and open debate are essential to progress in science and must be welcome at all times.
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.
Background: Preliminary reports have suggested a batch-dependent safety signal for COVID-19 vaccines. It is important to establish if these findings can be replicated. Methods: We used publicly available nationwide data from Germany spanning the first 3.5 years of the vaccination campaign to calculate weekly rates of spontaneously reported suspected adverse events (SAEs) per 1000 administered vaccine doses. Results: SAE rates ranged between 2.2 and 22.8 per 1000 doses and women accounted for 72% of all SAEs. Crucially, SAE rates for Comirnaty (Pfizer-BioNTech), Spikevax (Moderna), and Vaxzevria (AstraZeneca) were very high in the initial phase of vaccination rollout and hereafter declined precipitously. For example, SAE rates in weeks 1-4 of 2021 were 8.2, 50.8, and 620.9 per 1000 doses of Comirnaty, Spikevax, and Vaxzevria, respectively, but fell to 4.4, 11.6, and 7.4 per 1000 doses in weeks 12-16 of 2021. Conclusions: SAE rates in Germany were highly elevated in the initial phase of COVID-19 vaccination rollout and then fell precipitously, a pattern compatible with a batch-dependent safety signal. Furthermore, there was a considerable overrepresentation of women with SAEs. These preliminary results call for more definitive studies of batch-dependent COVID-19 vaccine safety.
Background Self-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 methods A 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). Results The 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 (χ 2 = 57.41, p < 0.001), occupation (χ 2 = 45.03, p < 0.001), religion (χ 2 = 55.36, p < 0.001), and health-insurance status (χ 2 = 55.76, p < 0.001). Conclusion Self-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.
Many thanks to the editors of the International Journal of Risk & Safety in Medicine 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.
Background: This study compared the effects of anti-seizure medication (ASM) monotherapy and polytherapy on hematological parameters in patients with epilepsy (PWE).Objective To compare hematological parameters and derived inflammatory indices in patients with epilepsy receiving ASM monotherapy versus polytherapy and determine independent predictors and discriminatory performance of these parameters. Methods: A hospital-based cross-sectional study was conducted between January and June 2024 at the Neurology Clinic of Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria. Two hundred adult PWE were enrolled and classified into monotherapy or polytherapy groups. Sociodemographic and clinical data were collected. Venous blood samples were analyzed using the Sysmex XN-1000 hematology analyzer. Statistical analyses included independent t-tests, chi-square tests, logistic regression, and receiver operating characteristic (ROC) analysis (p < 0.05). Results: Males predominated in the monotherapy group (58.8%), while females predominated in the polytherapy group (84.1%; p < 0.001). Monotherapy showed significantly higher neutrophils, hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin concentration, and neutrophil-lymphocyte ratio, but lower mean platelet volume. Neutrophils, hemoglobin, MCV, MCHC, and MPV independently predicted treatment pattern. ROC analysis showed moderate discrimination for MPV, while others performed poorly. Conclusion: ASM polytherapy is associated with greater hematological alterations. Monotherapy should be prioritized when feasible, with routine hematological monitoring recommended.
Background: The article describes a case of methemoglobinemia in a 4-year-old child with nephrotic syndrome with simultaneous use of therapeutic doses of three drugs that cause methemoglobinemia: lidocaine (topically), benzocaine (topically), and co-trimoxazole (systemically). An increase in the level of methemoglobin in the blood to 47.6% led to the development of respiratory failure. To correct the child's condition, high-flow oxygen therapy was performed and ascorbic acid was administered. During the day, there was a positive trend, the level of methemoglobin decreased to 1.5%. Toxicological examination of urine showed the presence of lidocaine, benzocaine, and trimethoprim. Thus, in conditions of polypragmasia in a child with comorbidity, the simultaneous use of three drugs with the potential of methemoglobinemia caused a significant increase in the level of methemoglobin and the development of respiratory failure, which required hospitalization in the intensive care unit. After 2 days, the patient's condition stabilized and he was transferred to a specialized department. As far as we know, this is the first documented case of methemoglobinemia in a child with polypragmasia.
Background Lorlatinib, 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.Objective To characterize neuropsychiatric adverse events (AEs) of lorlatinib using FAERS post-marketing data.Methods FAERS 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).Results Among 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).Conclusions Lorlatinib 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.
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.
Background Medication-induced oral hyperpigmentation represents an adverse drug reaction characterized by variable latency and unclear mechanism. Diagnosis is particularly challenging in older adults due to non-specific symptoms, multiple comorbidities and polypharmacy.Case report We present the first documented case of a woman in her 80s experiencing patchy, bluish hyperpigmentation of dorsum of tongue and buccal mucosa with altered taste sensation and swallowing difficulty, in association with chronic venlafaxine ingestion that remained undiagnosed for many years. To establish the current diagnosis, a comprehensive history taking, clinical examination, blood investigations and imaging studies were utilized to rule out the endogenous causes. Following discontinuation of venlafaxine, at 1 month follow-up, there was complete resolution of oral hyperpigmentation together with significant improvement in dysphagia and dysgeusia indicating a probable association with the drug.Conclusion This report highlights the need for the healthcare professionals to be aware of the medications linked to oral hyperpigmentation to facilitate timely diagnosis, patient reassurance and optimize management.
Robust evidence depends on disciplined methods rather than slogans. This commentary draws on my experience with Cochrane Crowd to show how brief, well-structured micro-tasks can strengthen the evidence pipeline. Two features are central: the platform logs every screening decision for audit, and hidden calibration items help maintain contributor accuracy. In routine queues, volunteers identify randomised controlled trials and tag Population, Intervention, Comparison and Outcome (PICO) elements, reducing noise and prioritising relevant records. When publication volume surges, this volunteer triage preserves high recall without sacrificing precision, giving review teams a cleaner starting point. Regular exposure to trial anatomy also sharpens bias detection in peer review and teaching. Individually, each task is modest; collectively, these tasks provide a practical defence against distortions in the research record. I encourage colleagues to devote a brief, focused session each week to Cochrane Crowd and help make trustworthy evidence more visible.
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 (p = 0.046) and among HCEs aged 18-25 years (p = 0.033). Females were more prone to exposure while handling/discarding BMWs (p = 0.0001).ConclusionTraining, particularly among junior HCEs, is needed to prevent NSSIs and exposure to infectious body fluids.
Background: The 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. Methods: We 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. Results: In 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). Conclusions: Pathological 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.
Background Chemotherapy 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. Aim To systematically review the effectiveness of FMEA/FMECA methodologies in identifying and mitigating risks within nursing processes related to chemotherapy preparation, administration, and management. Methods A 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. Results Thirteen 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. Conclusion FMEA/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.
