International Journal of Risk & Safety in Medicine

Modern medical education faces the challenges of digitalization, the implementation of evidence-based medicine, the development of research skills, and interdisciplinarity. In response, Sechenov University has developed a curriculum based on Cochrane methodology aimed at training professionals capable of making clinical decisions under uncertainty and data deficit, while taking into account both scientific validity and ethical standards.

A cross-sectional online survey was conducted among 3rd- to 6th-year medical students to assess their knowledge in evidence-based medicine methodology, research skills, and satisfaction with the program.

A total of 359 students were surveyed. Study year significantly affected knowledge level, with systematic knowledge accumulation occurring over time (p < 0.001). Senior students demonstrated higher proficiency with evidence-based medicine tools and research skills, although even in years 5–6, a considerable proportion of students were initially unsure of specific topics. Overall, 87.5% of all respondents reported increased knowledge, and 95.8% were fully satisfied with the course.

To develop clinical and critical thinking in medical students—enabling them to act reasonably in complex and changing clinical situations with incomplete or conflicting data and strict adherence to bioethical norms—it is necessary to expand practical training based on Cochrane methodology.

Due to the rising prevalence of resistant bacteria, there is a growing tendency to prescribe fluoroquinolones (FQs) to pediatric patients. Real world safety parameters of FQs in children may be studied using data of national pharmacovigilance databases. The aim of our study was to estimate the structure of adverse drug reactions (ADR) associated with FQs in pediatric patients.

retrospective study of spontaneous reports registered in Russian National Pharmacovigilance database–Automatized Information System “Pharmacovigilance” for the period: 1 April 2019–31 January 2024.

Total number of pediatric SRs was 280 (19.2%). Mean age was 12.1 ± 5.9 years (min – 1 day, max – 18 years), and adolescents were the most involved age group (n = 176, 62.9%). Mean time to ADR onset was 13.9 + 41.0 (min = 0, max = 303) days. Leading FQs were levofloxacin (49.6%, n = 139), ciprofloxacin (31.1%, n = 87), and moxifloxacin (15%, n = 42). Top-5 SOCs included “Immune disorders” (18.9%), “Gastrointestinal disorders” (15.0%), “Skin and subcutaneous tissue disorders” (14.7%), “General disorders and administration site conditions” (11.7%), and “Investigations” (7.6%). Top-5 PTs were urticaria, diarrhea, rash, arthralgia, and pruritus.

Levofloxacin, ciprofloxacin, and moxifloxacin were the primary FQs linked to ADRs in the pediatric population. Most prevalent were allergic reactions. Children receiving FQs should be closely monitored from the start of treatment throughout their entire hospital stay and for an extended period following discharge.

Artificial intelligence (AI) is increasingly integral to healthcare’s digital transformation, enhancing areas such as disease prevention and control. Traditional AI models focus on patient-centered data from electronic medical records (EMRs). This study aims to improve drug prescription recommendation systems by developing a physician’s digital profile (DP), incorporating physician characteristics into machine learning models.

Visit-level EMR clinical data (2018-2023) of Moscow’s children’s polyclinics was collected and contained information on 174,806 appointments with 30 physicians and 53,453 patients. We developed multi-output regression models (LGBMRegressor) using gradient boosting algorithms. Models were trained with and without the physician’s DP, which included personal, drug, and nosological features adapted for machine learning.

Incorporating the physician’s digital profile significantly improved model performance. The LGBMRegressor with DP reduced the average RMSE from 4.20 to 0.74. Models utilizing the DP more accurately predicted drug prescriptions and better captured individual physician behaviors.

Developing a physician’s digital profile has been shown to enhance the predictive performance of machine learning models in drug prescribing. This approach supports the optimization of clinical decision support systems, fostering more safe and personalized care and potentially reducing prescribing errors. Moreover, aggregated model outputs may inform drug demand forecasting and assist in optimizing pharmaceutical inventory planning at the population level.

People with dementia (PwDs) are particularly vulnerable to adverse events (AEs). Recognising and understanding AEs is essential to improve patient safety.

This study analysed FAERS data from the past decade to identify AE symptom characteristics in PwDs.

The FAERS data (2014–2024) was reviewed, extracting reports with dementia as an indication. The reports’ features were described and analysed, including k-means clustering to identify patterns.

From 2014 to 2024, 20,913 reports related to PwDs were extracted. Consumers and health care professionals were the most common reporters. Regarding patient outcomes, 38.7% of records reported hospitalisation and 10.6% reported death. The most frequently reported AEs were death, aggression, and bradycardia. Cholinesterase inhibitors (ChEIs), antipsychotics, and anticonvulsants were frequently associated with nervous system and psychiatric disorders. K-means clustering identified four groups, with older PwDs on ChEIs experiencing cardiovascular issues, while younger PwDs on antipsychotics faced higher mortality, drug ineffectiveness, and fall risks.

Many symptoms observed in PwDs are often attributed to ageing or disease progression, potentially obscuring their link to drug-related causes. Enhancing AE reporting across healthcare roles, promoting public awareness, conducting regular medication reviews, and providing training in early detection are vital for the safe management of dementia.

Linezolid is one of the most used antibacterials to treat resistant gram-positive infections, though its use may result in a number of toxic effects, especially in the older adults. There is lack of data derived from the real-world studies regarding safety of linezolid in the elderly.

To disclose the structure of adverse drug reactions (ADRs) associated with linezolid in patients ≥60 years.

Retrospective analysis of spontaneous reports (SRs) from the Russian Pharmacovigilance database (April 2019–December 2024).

SRs of patients ≥60 years accounted up to 19.9% in the total structure of SRs. Top-5 system-organ classes (SOCs) were blood and lymphatic system disorders (24.4%, n = 68), gastrointestinal disorders (17.6%, n = 49), investigations (11.1%, n = 31), skin and subcutaneous tissue disorders (9.7%, n = 27), and general disorders and administration site conditions (6.1%, n = 17). Top-5 preferred terms (PTs) were thrombocytopenia (7.9%, n = 22), anemia (7.2%, n = 20), nausea 4.3% (n = 12), diarrhea (3.6%, n = 10), vomiting (3.6%, n = 10), and leukopenia (3.6%, n = 10).

Linezolid-induced myelosuppression was identified as the most significant safety concern in patients ≥60 years, underscoring the necessity for careful laboratory and clinical monitoring in this population.

In real-world clinical practice, the effectiveness of medications for secondary prevention of acute myocardial infarction (AMI) is limited by low patient adherence. The lack of systematic adherence analysis inevitably distorts the evidence base for the effectiveness of these medications.

To investigate 1-year adherence to post-AMI therapies (statins, dual antiplatelet therapy (DAPT), and neurohormonal antagonists) using the Proportion of Days Covered (PDC) metric and evaluate its impact on treatment effectiveness through data from the Electronic Medical Information and Analytical System (EMIAS).

The study included 276 patients who had undergone AMI. The follow-up period was 12 months after discharge from the hospital. Adherence was considered acceptable at PDC ≥80%. Efficacy was assessed based on endpoints for DAPT, low-density lipoprotein cholesterol (LDL-C) reduction>50% for statin therapy and left ventricular ejection fraction (LVEF) for heart failure (HF) therapy.

Annual adherence rates were critically low: 38.8% for DAPT, 37.6% for statin therapy, and 24.2% for neurohormonal therapy of HF. High adherence versus non-adherence was associated with a significant reduction in the risk of composite cardiovascular events for DAPT (p = 0.047); for statins, a reduction in LDL-C ≥50% was achieved significantly more often (31.6% vs 13.2%); and for HF patients, a significantly greater increase in LVEF was observed (55.6% vs 50.12%).

The evidence base for the effectiveness of long-term pharmacotherapy in real-world clinical practice should be derived from the analysis of variables of interest exclusively within the treatment-adherent patient cohort.

Irrational use and improper disposal of medicines lead to environmental pollution. There is compelling evidence of the negative impact of medications on biological systems. In Russia, there is no legislation regarding the disposal of expired medications at home. Expired medications generated at home are considered household waste.

To study the effectiveness of separate collection of medicines and analyze unused medicines discarded by patients.

We organized separate collection of expired and unused medicines in two polyclinics in Kazan. An ATC/DDD (Anatomical Therapeutic Chemical/Defined Daily Dose) analysis was conducted to estimate how many drugs are not consumed by people and are thrown away in the general waste.

From November 2022 to April 2024, a total of 4737 trade names of medicines or 707 INNs (International Nonproprietary Names) and 195 dietary supplements were collected, totaling 243 kg of medicines and supplements that were subsequently sent for proper disposal. The ATC/DDD analysis showed that the largest number of DDDs collected were medicines for treating cardiovascular system disorders, digestive system and metabolism disorders, and blood and hematopoietic system disorders.

To assess the rationality of medicine use, it is important to conduct qualitative and quantitative evaluation of disposed medicines. Such analysis can be part of actual consumption analysis, as not all medicines dispensed to patients in pharmacies are actually consumed by them.

The treatment of multidrug-resistant (MDR) tuberculosis (TB) requires the long-term administration of multiple second-line drugs in combination therapy.

We investigated the ADRs to a 9-month all-oral regimen (i.e., pyrazinamide, ethambutol, high-dose isoniazid, levofloxacin, bedaquiline, and clofazimine) and a longer 18-months regimen (i.e., levofloxacin, bedaquiline, linezolid, clofazimine, and cycloserine) for MDR-TB during the first 4 months of treatment.

The patients in this cohort study were recruited from three referral hospitals in Indonesia. The inclusion criteria were patients aged ≥18 years diagnosed with MDR-TB who received either the 9-month all-oral or 18-months regimens. We used the causality assessment categories from the WHO–Uppsala Monitoring Center.

A total of 60 patients were included in this study. The ADRs included nausea and/or vomiting (48.3%), arthralgia (38.3%), prolonged QTcF interval (30.0%), among others. One case of prolonged QT interval in a grade 3 ADR was observed, in which the 18-month regimen was modified during the first 4 months of treatment.

In the first 4 months of treatment, the predominant ADRs were nausea and/or vomiting, arthralgia, and prolonged QT interval. This study showed that active patient monitoring is needed.

Visual snow is an abnormal visual perception, frequently occurring in the context of visual snow syndrome. Recent literature has suggested a link with serotonin reuptake inhibiting antidepressants, but there is little research on this topic.

We aimed to identify cases of visual snow and visual snow syndrome linked to serotonin reuptake inhibiting antidepressants to evaluate the possibility of an association.

Retrospective analysis of patient adverse event reports linking serotonin reuptake inhibiting antidepressants with visual snow or visual snow syndrome using data from RxISK.org, a global database of spontaneous reports of drug-linked adverse events. Each case was subject to a causality assessment: a RxISK score of 0–4 indicates more information is required, 5–8 a likely link and ≥9 a strong possibility of a link between the medication and the symptoms.

24 cases were identified; 16 male and 8 female patients, with a mean age of 30 years. All had visual snow, and 10 patients (42%) had visual snow syndrome. Reports originated from 8 countries and involved 10 different drugs. Symptoms began on the drug in 14 cases (58%), after reducing the dose in 6 cases (25%), and after discontinuation in 4 cases (17%). At the time of reporting, 22 patients (92%) had stopped the suspect drug but without resolution of symptoms. The mean RxISK score was 9.5 (range 2–17).

Serotonin reuptake inhibiting antidepressants may trigger visual snow and visual snow syndrome that fails to resolve or can even worsen or emerge after stopping the drug. With usage of these medications rising worldwide, cases are likely to increase. Further research is vital to understand potential mechanisms and risk factors.

COVID-19-associated thrombotic complications became a major problem of pandemic. Clinical practice guidelines are meant to present approaches to preventing and managing them. In our previous studies, we found that direct oral anticoagulants (DOACs) consumption and expenditure in Russia through COVID-19 pandemic was extensive, exceeding CPGs’ recommendations in 2020 and 2021, particularly in outpatient settings.

To analyze Russian clinical practice guidelines on the use of DOACs for COVID-19.

We conducted thematic content analysis of Russian guidelines using qualitative research methods. Purposive sampling allowed including all existing guidelines on the use of DOACs in COVID-19 pandemic. The sample size was limited to the results of our previous searches of the Russian guideline and bibliographic databases. We focused on indications, contraindications, dosing regimens, monitoring, and drug interactions and compared with international recommendations.

Only one guideline advised against outpatient DOAC use for COVID-19, aligning with international standards. The guidelines lacked clarity on indications, dosing, and treatment duration. Only two of six guidelines included safety monitoring recommendations, while four provided precautions.

We conclude that the found textual problems could potentially cause the established excessive consumption of direct oral anticoagulants in outpatients with COVID-19 on the rise the pandemic.

To analyse regulatory positions and drug policies of the Commonwealth of Independent States (CIS), compared to those of the EU, UK, USA i of the nootropics, used in Russia for Alzheimer’s disease.

We searched E-library to reveal the list of nootropics used and studied in Russia for Alzheimer’s disease. We assessed official pharmaceutical registries of nine countries for registration status of identified nootropics, 7 National Essential Medicines Lists (EML), and four clinical practice guidelines (CPG) on Alzheimer’s disease. We compared the results of Russia with other countries regulatory and policy positions.

E-Library searches identified 11 nootropicspiracetam, citicoline, idebenone, vinpocetine, choline alfoscerate, Cerebrolysin®, Kortexin®, ethylmethylhydroxypyridine succinate, glycine, nicergoline, nimodipine. Eight nootropic have registration for use in all CIS countries (excluding idebenone, nimodipine), four (piracetam, nimodipine, nicergoline, idebenone) – in UK, nimodipine – in the USA, and idebenone – in EU. National EMLs included: nine nootropics (Russia), 8 – Belarus and Kazakhstan, 4 – Uzbekistan, 2 – Armenia. The studied nootropic agents are not included on the WHO Model EML and on the National EML of the Kyrgyz Republic. They are not listed in the CPG for Treatment of dementia and Alzheimer’s disease in the USA, the EU, and the UK. Russian CPGs for Alzheimer’s disease recommend Cerebrolysin® and choline alfoscerate.

The studied nootropics are registered for use and listed on National EMLs of Russia, Armenia, Belarus, Kazakhstan, Uzbekistan. None is included on the WHO Model EML and the National EML of Kyrgyzstan, Only CPG of the RF recommend using two nootropics as adjuvant therapy of Alzheimer’s disease, Cerebrolysin® and choline alfoscerate. CPG of the European Union, the United Kingdom, and the USA do not mention nootropics as potential treatment options for Alzheimer’s disease.

Acute coronary syndrome remains a leading cause of mortality, making antiplatelet therapy crucial for the treatment and secondary prevention of this condition.

We aimed to analyze consumption of antiplatelet drugs in the outpatient segment of the pharmaceutical market in the Republic of Tatarstan in 2018 and 2023.

We conducted a descriptive study based on sales data for antiplatelet drugs from two major suppliers.

Consumption was calculated in milligrams and defined daily doses. To assess therapy coverage, we calculated standard course doses for dual antiplatelet therapy and monotherapy based on clinical guidelines.

During the study period, we identified a significant increase in the consumption of all antiplatelet drugs. Acetylsalicylic acid consumption doubled. Among P2Y₁₂-receptor inhibitors, clopidogrel showed the highest absolute increase (2.5 times), while ticagrelor (3.2 times) and prasugrel (4 times) showed the highest relative growth rates. The estimated number of patients who could have been treated with the sold volumes of antiplatelet drugs in 2018 was 15.4 times, and in 2023 was 35.2 times higher than the official number of registered ACS patients.

We observe a significant increase in outpatient antiplatelet drug consumption, reflecting current trends toward expanding indications and increasing therapy duration.