Safety of Lipid-Lowering Therapy with Statins according to a Regional Pharmacovigilance Centre

Scientific relevance. Since statins are widely used to prevent cardiovascular diseases, the control of statin-related complications is essential from both medical and social perspectives.Aim. The study aimed to analyse unsolicited reports on adverse drug reactions (ADRs) to control the safety of statin therapy.Materials and methods. The study analysed information on ADRs observed during statin treatment from the reporting forms submitted by medical organisations in Irkutsk to the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2022. The causal relationship between ADRs and statin therapy was assessed using the Naranjo scale.Results. The database contained 1068 ADR reporting forms; 12 (1.1%) were spontaneous reports of statin-related complications, including 4 cases (33.4%) of myalgia, 7 cases (58.3%) of myalgia with moderately elevated transaminase levels (3–5 times the upper limit of normal), and 1 case of rhabdomyolysis that required statin discontinuation. In all cases, a reduction in the statin dose resulted in a regression in the clinical symptoms of ADRs. Most ADRs were observed in women with comorbidities (diabetes mellitus, obesity, and hypothyroidism), but the small sample size prevented the authors from testing the identified differences for statistical significance.Conclusions. According to the study results, statins have a reliable safety profile. Adequate and patient-specific selection of statin doses and ADR prevention are important responsibilities of clinical practitioners

Our experience of monitoring of drugs safety in gerontological practice

The analysis of work on identification and registration of complications of medicinal therapy in medical institutions of the Irkutsk region showed that the frequency of undesirable medicinal reactions at inpatients is more senior than 60 years makes from 10 % to 25 %. At advanced age the special place is taken by dysfunction of a digestive tract and allergic reactions at purpose of cardiovascular medicines, and also antibacterial and the antiglaucomous medicines. The number of cases of absence of therapeutic effect of PM in this age group made 18,9 %, reactions from the digestive tract - 15,5 % of cases, thus in 6,5 % pseudomembranous colitis was registered. It is established that risk factors of emergency of such reaction were the background pain or depressive syndrome, accompanying application of more than three drugs and absence of the scheme of a titration of dosages

All-in-one: Multi-task Learning for Rumour Verification

Automatic resolution of rumours is a challenging task that can be broken down into smaller components that make up a pipeline, including rumour detection, rumour tracking and stance classification, leading to the final outcome of determining the veracity of a rumour. In previous work, these steps in the process of rumour verification have been developed as separate components where the output of one feeds into the next. We propose a multi-task learning approach that allows joint training of the main and auxiliary tasks, improving the performance of rumour verification. We examine the connection between the dataset properties and the outcomes of the multi-task learning models used

Analysis of Data on Adverse Drug Reactions and Functional Flaws of the Pharmacovigilance System Associated with Self-Treatment with Antibiotics

In the Russian Federation, a substantial proportion of the population (39.3–75.7%) opts for self-treatment. Self-administration of prescription medicinal products, particularly antibiotics, can lead to serious adverse drug reactions (ADRs). The safety of medicines in circulation relies upon the proper functioning of the pharmacovigilance system, both in general and in the case of self-medication ADRs.The aim of the study was to analyse data on the serious ADRs attributed to self-treatment with antibiotics and reported to the Regional Centre for Drug Safety Monitoring of the Irkutsk Region, as well as on the pharmacovigilance problems associated with self-treatment.Materials and methods: the study analysed the suspected ADR reporting forms from the database accumulated by the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2019. The inclusion criteria for the reporting forms were full completion and a Naranjo probability score categorising antibiotic–ADR causality at least as “possible”.Results: of the total 2325 reports in the database, 790 (34%) were on the ADRs associated with the use of antibiotics. Of these, 222 reported serious ADRs caused by self-medication. The largest number of ADRs (126) was recorded in patients aged 40–70 years; the proportion of women (60.32%) was significantly higher than the proportion of men (39.68%). Hospitalisation was required for 23 patients with serious adverse events. In 80% of the studied cases, patients justified the need for self-prescription of antibiotics with cough (which they regarded as acute bronchitis), but their presumptive diagnosis coincided with that established in the hospital only in 47.83% of the cases. The reports of ADRs during self-treatment with antibiotics were mainly received from hospitals (205 cases), and much less often from outpatient clinics and directly from patients (9 and 8 cases, respectively). There were no reports from pharmacy organisations; and it may be assumed that their employees did not take active part in reporting.Conclusions: the use of antibiotics for self-medication can lead to serious ADRs; therefore, the medicinal products of this class should be used only as directed by a doctor. To reduce the incidence of ADRs, it is necessary to raise awareness of the population and medical specialists conducting antibiotic therapy. The quality of medical care will benefit from proper performance of pharmacovigilance activities by all parties to the circulation of medicines, active involvement of patients in treatment safety monitoring, inclusion of specific sections on practical functioning of the pharmacovigilance system into the training curricula of pharmaceutical professionals, and creation of a feedback system connecting pharmacovigilance organisations to medical ones and other subjects of the circulation of medicines

Off-Label Prescribing in Paediatric Cardiology: Regulatory Aspects and Safety Assessment by Spontaneous Reporting

In paediatrics, it is a common practice to use pharmaceuticals outside the approved Summary of Product Characteristics (i.e. off-label). According to the literature, up to 45% of inpatient paediatric prescriptions and 10–20% of outpatient ones are for off-label uses. It is essential to analyse such uses, as it helps medical practitioners act reasonably and professionally.The aim of the study was to explore the possibility of using spontaneous reports to assess the risks of the off-label use of cardiac medicinal products in children in the Irkutsk region.Materials and methods. The authors analysed 25 reporting forms on adverse drug reactions (ADRs) in paediatric cardiac patients from the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region and regional data from the Automated Information System (AIS) of the Federal Service for Surveillance in Healthcare of the Russian Federation (Roszdravnadzor) submitted in 2009–2020. The inclusion criterion for reporting forms was a causal relationship between the off-label use of a medicinal product and the ADR that was scored as “possible” or higher on the Naranjo probability scale.Results. According to the reporting forms, the off-label use of cardiac medicinal products in children was associated with ADRs, such as angiooedema, cutaneous symptoms, and bronchospasm. The majority of ADRs (84%) were considered severe. The medicinal products were prescribed for heart failure, arterial hypertension, and cardiac arrhythmias. The majority of ADR reports (75%) were submitted by inpatient medical organisations.Conclusions. The analysis of spontaneous ADR reporting databases is a simple and informative method for studying the safety of medicinal products. It is necessary to raise awareness of ADRs associated with off-label prescribing amongst paediatric cardiologists in order to reduce the incidence of ADRs. The following contributions will improve the quality of medical care: all parties involved with pharmaceuticals should adhere to good pharmacovigilance practices, medical practitioners should be actively involved in treatment safety monitoring, and the professional training curricula of paediatric cardiologists and paediatricians should include specific units on the practical functioning of pharmacovigilance

СПОСОБ ЛЕЧЕНИЯ ГЕНЕРАЛИЗОВАННОЙ ЦИТОМЕГАЛОВИРУСНОЙ ИНФЕКЦИИ У ДЕТЕЙ ГРУДНОГО ВОЗРАСТА

Purpose of the study. Evaluation of the effectiveness of treatment of generalized cytomegalovirus infection (CMVI) in infants with a combination of ganciclovir and VIFERON®.Materials and methods. 52 children of the first months of life were treated with generalized CMV. Patients are divided into 3 groups: the first included 25 children who received ganciclovir for 14—21 days, then — IFN-α-2b in combination with antioxidants vitamins E and C (VIFERON®); The second group consisted of 17 patients receiving only ganciclovir; in the third group included 10 children who had only symptomatic treatment of CMVI: hepatoprotectors, broad-spectrum antibiotics (ceftriaxone, ampicillins) at age dosages. Therapy was carried out under the control of viral load in the blood serum on the 14th and 21st day from the start of treatment. Patients of the 1st group with a decrease in the clinical manifestations of CMV and a decrease in the viral load to 104—103 copies/ml on the 14—21 day were prescribed rectal suppositories of IFN-α-2b (VIFERON®) 150 000 IU according to the original scheme.Results. In the 1st group, all children during 3—6 months had an elimination of the virus from the blood and liquor. Relapse of CMV was not observed. Children of the second group had a decrease in the viral load was observed, but the elimination of the virus from the blood, the cerebrospinal fluid did not occur. Patients of the 3rd group had the viral load remained at the same level, it increased by 102 copies/ml at one patient.The conclusion. Using of combined antiviral therapy with ganciclovir and IFN-α-2b in combination with antioxidants vitamins E and C (VIFERON®) promotes elimination of the virus from blood and liquor, transferring and keeping it in an inactive state, which prevents the development of complications. The proposed method for treatment of CMV can be successfully used in inpatient and outpatient settings.Цель исследования — оценка эффективности лечения генерализованной цитомегаловирусной инфекции (ЦМВИ) у детей грудного возраста комбинацией ганцикловира и препарата ВИФЕРОН®.Материалы и методы. Пролечено 52 ребенка первых месяцев жизни с генерализованной ЦМВИ. Пациенты распределены на 3группы: в 1-ю вошли 25 детей, получавших ганцикловир в течение 14—21 дня, затем — ИФН-α-2b в комплексе с антиоксидантами витаминами Е и С (ВИФЕРОН®); 2-ю группу составили 17 пациентов, получавших только ганцикловир; в 3-ю группу включили 10 детей, у которых применяли только симптоматическое лечение ЦМВИ: гепатопротекторы, антибиотики широкого спектра действия (цефтриаксон, ампициллины) в возрастных дозировках. Терапию проводили под контролем вирусной нагрузки в сыворотке крови на 14-й и 21-й день от начала лечения. Пациентам 1-й группы при уменьшении клинических проявлений ЦМВИ и снижении вирусной нагрузки до 10 4—103 копий/мл на 14—21-й день назначали ректальные суппозитории ИФН-α-2b (ВИФЕРОН®) 150 000 МЕ по оригинальной схеме.Результаты. В 1-й группе у всех детей в течение 3—6 мес. происходила элиминация вируса из крови и ликвора. Рецидива ЦМВИ не отмечалось. У детей 2-й группы наблюдалось снижение вирусной нагрузки, но элиминации вируса из крови, ликвора не происходило. У больных 3-й группы вирусная нагрузка оставалась на том же уровне, а у 1 пациента увеличилась на 102 копий/мл.Заключение. Сочетанное использование комбинированной противовирусной терапии ганцикловиром и ИФН-α-2b в комплексе с антиоксидантами витаминами Е и С (ВИФЕРОН®) способствует элиминации вируса из крови и ликвора, переводу и удержанию его в неактивном состоянии, что предотвращает развитие осложнений. Предлагаемый способ лечения ЦМВИ может успешно использоваться в стационарных и в амбулаторных условиях.

Цитомегаловирусная инфекция у детей

The article is devoted to the actual problem of childhood — cytomegalovirus (CMV). The urgency of CMV research is caused by its wide spreading among children. Many scientists used to consider CMV relatively low-hazard, opportunistic. The authors prove its exceptional dangerousness, emphasizing that it imperceptibly suppresses and exhausts immunity, in this respect ranking second after the human immunodeficiency virus. Currently, there is a growth of infection spreading worldwide and a high death rate caused by this infectijn. The article presents a contemporary view of CMV, its various clinical manifestations related to late diagnosis. Experts attention to this problem is caused not only by the possibility of the progress of severe forms with newborns and infants, but also the potential risk of formation of prognostically unfavorable consequences.Статья посвящена актуальной проблеме детского возраста — цитомегаловирусной инфекции (ЦМВИ). Многие специалисты долгое время считали ее относительно опасной и оппортунистической. В настоящее время отмечается рост заболеваемости и смертности от этой инфекции во всех странах мира. В статье представлен современный взгляд на ЦМВИ, ее разнообразные клинические проявления. Авторы показывают ее исключительную роль в подавлении и истощении иммунитета. Интерес к данной проблеме специалистов обусловлен не только возможностью развития тяжелых форм этого заболевания у новорожденных и детей первого года жизни, но и потенциальным риском формирования прогностически неблагоприятных последствий

MONITORING OF DRUG SAFETY IN CLINICAL PRACTICE

The results of work on identification and registration of complications of medicinal therapy in medical institutions of the Irkutsk region showed that that the frequency of undesirable medicinal reactions in patients made from 10 to 30 %. The standard scheme of antibacterial therapy results in resistance of pathogenetic flora. Hospital patients have great possibility of being infected with microorganisms, the so-called hospital strains (bacteria). The drug safety monitoring showed the necessity of the policing of prescribing of cardiovascular, antibacterial and antiglaucoma drugs

RumourEval 2019: Determining rumour veracity and support for rumours

This is the proposal for RumourEval-2019, which will run in early 2019 as part of that year's SemEval event. Since the first RumourEval shared task in 2017, interest in automated claim validation has greatly increased, as the dangers of "fake news" have become a mainstream concern. Yet automated support for rumour checking remains in its infancy. For this reason, it is important that a shared task in this area continues to provide a focus for effort, which is likely to increase. We therefore propose a continuation in which the veracity of further rumours is determined, and as previously, supportive of this goal, tweets discussing them are classified according to the stance they take regarding the rumour. Scope is extended compared with the first RumourEval, in that the dataset is substantially expanded to include Reddit as well as Twitter data, and additional languages are also included