The state policy for the safety of medicinal products involves analysis of specialists' competence in identifying adverse drug reactions (ADRs) during the use of medicinal products. It is of particular importance for the group of essential medicines, including those used in cardiology.The aim of the study was to assess ADR-reporting skills of doctors managing cardiology patients, with anti-arrhythmics as a case study.Materials and methods: from October 2019 to June 2021, the authors surveyed a sample of 223 practitioners that treated cardiology patients in Moscow and the Moscow region (36 of the respondents took the survey in person, and 187 participated on-line). The questionnaire inquired about selection criteria for the medicinal products, their assessment in terms of efficacy and safety in real-life clinical practice, and the competence and active involvement of the doctors in reporting identified ADRs.Results: most of the survey participants were high-level professionals (60.99% had 10 and more years of experience). Most of the doctors (90.13%) admitted having encountered ADRs in their practice, placing substandard quality of cardiovascular medicinal products among the causes. Moreover, 1.79% of the respondents faced such quality problems on a regular basis. Only 52.91% were familiar with the current documents regulating pharmacovigilance. A total of 61.88% applied information from Russian and foreign ADR databases in their practice. In 2021, 80.72% of the surveyed did not report data on the identified ADRs. According to the respondents, the main reasons for low reporting activity were high workload and lack of evidence for causality between a product and an ADR.Conclusion: the study demonstrated the need to intensify the work with practitioners on the safety of medicinal products and ADR identification, particularly, to train them in pharmacovigilance. According to the study results, it is feasible to develop and implement simple and user-friendly risk-oriented information systems for analysis and systematisation of ADR case reports.
A high level of morbidity and mortality from cardiovascular diseases remains prevalent in the Russian Federation, despite a decreasing trend that emerged in recent years. Rhythm and conduction disorders play an essential role in the thanatogenesis of cardiovascular pathology, which determines the medical and social significance of their pharmacotherapy. This is indicated by the stable demand for antidysrhythmic drugs from both the state and the population. This is evidenced by high levels of public procurements and retail sales of drugs for the treatment of cardiovascular diseases, since patients take this drug group for a long time and often permanently. Our marketing analysis of the antidysrhythmic drugs market used current open data from the State Register of Medicines and the State Register of Maximum Selling Prices and available analytical data. It showed that from 54.5% (metoprolol drugs) to 100% (procainamide drugs) of the market share is occupied by generic drugs made in Russia. The presented analysis confirms the assumption of a significant increase in the share of generic drugs in public procurements. This is associated with the implementation of the drug safety program for vital and essential drugs and the optimization of costs by the state. A priority of the state drug policy in Russia is to monitor the effectiveness and safety throughout its entire life cycle. Moreover, particular importance should be given to the issue of interchangeability, which is regulated by Federal Law No. 1360 dated September 5, 2020, On the Procedure for Determining the Interchangeability of Medicines for Medical Use. The annual increase in the share of generic domestic antidysrhythmic drugs on the market poses the problem of selecting the most efficient and safe approach to pharmacotherapy for practicing specialists. The solution may be to develop and implement open automated information systems for the safety profiles of the original and generic antidysrhythmic drugs.
Epilepsy is a fairly common disease which challenges social life, therefore the use of information systems and software to support patients with epilepsy is a promising trend in electronic and mobile medicine. The aim of the study was to analyse data on the existing information systems, devices, and mobile applications used to support patients with epilepsy and control risks associated with pharmacotherapy, and to assess the prospects for the development of information systems to support patients with epilepsy. The results of an advanced search and systematisation of literature and Internet data suggest a high demand for mobile and e-health. Mobile applications for patients with epilepsy have a large share of e-health tools. The applications help to monitor seizures, record the frequency of taking medications, receive advice on emergency treatment of seizures, adjust the dosage regimen, and, in general, help to reduce the risks of anticonvulsant therapy, increase patient compliance and the competence of the participants in the treatment process. The analysis of the convenience and functionality of the foreign-produced mobile applications: Epilepsy Journal, Seizure Tracker, Helpilepsy, Seizure First Aide, did not reveal any significant differences between them. The following shortcomings of the mobile applications were identified: lack of Russian language support (except Epilepsy Journal), lack of advertisement blocking options in free applications, incomplete use of video recording capabilities and location-based systems. Global trends in the development of mobile medicine suggest the need for Russian-produced software that would address the identified shortcomings of the existing foreign applications and help support patients with epilepsy.
Microcirculation dysfunction plays a significant role in the development of post-COVID syndrome caused by SARS-CoV-2. However, there have been no studies on changes in microcirculation parameters during pharmacotherapy in patients with post-COVID syndrome. To date, there are no consensus recommendations for the treatment of post-COVID syndrome in the Russian Federation.The aim of the study was to analyse the pattern of clinical manifestations of post-COVID syndrome and bulbar conjunctival angioscopy (BCA) results in a young patient undergoing treatment after mild COVID-19.Materials and methods: analysis of the clinical case of a patient who was followed up at the Therapeutic Ophthalmology Centre between February and September 2021. BCA was performed in a patient with post-COVID syndrome to compare quantitative and qualitative microcirculation parameters before and after the treatment.Results: the paper summarises clinical observation data on a 23-year-old female patient with post-COVID syndrome with mainly neuropsychiatric manifestations and a microcirculation dysfunction as determined by BCA. The patient received pharmacotherapy with meldonium, ethylmethylhydroxypyridine succinate, and meglumine sodium succinate.Conclusions: the prescribed pharmacotherapy led to a significant improvement in the patient’s condition (regression in neuropsychiatric symptoms) with simultaneous improvement of morphological and functional parameters assessed by BCA, which indicates an improvement in microcirculation processes and supports their role in post-COVID syndrome development. The obtained data suggest that the clinical picture of post-COVID syndrome is directly related to the severity of microcirculation dysfunction in various organs and tissues, and that BCA can be used for diagnosis and assessment of the syndrome’s severity, as well as for assessment of the treatment’s efficacy and safety.
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