Practical Rules Research Articles

New Edition of the EAEU Good Pharmacovigilance Practice: What Has Changed?

In late 2016, the Council of the Eurasian Economic Commission adopted the first version of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline) based on a similar pharmacovigilance guidance published in the EU in 2014. By Decision No.81 of 19.06.2022, the Council of the Eurasian Economic Commission has amended the EAEU GVP Guideline, and the new version has been effective since 06.12.2022. The amendment has introduced a major revision to the terminology and significant changes to the sections on the risk management system and on organisation of safety information and signal management. The current EAEU GVP Guideline includes new subsections and a reviewed procedure for submitting pharmacovigilance documents to the regulatory authorities. In this interview, we have discussed the importance of the newly introduced pharmacovigilance changes in EAEU member states for the pharmaceutical industry with Dmitriy A. Rozhdestvensky, Candidate of Medical Sciences, Head of the Section of Coordination of Activities in the Sphere of Circulation of Medicines and Medical Products of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission.

Prognosis of abnormal uterine bleeding in women of reproductive age with extragenital disorders

The purpose of the study was to elaborate on a prognostic model for predicting the development of abnormal uterine bleeding in women of reproductive age with accompanying extragenital disorders based on mathematical methods.
 Materials and methods. The study, which was in 2019-2022, involved 100 women of reproductive age with AUB and accompanying extragenital disorders under observation, who made up the main group. The control group comprised 50 women of reproductive age undergoing medical checkups. On the basis of 23 diagnostic indicators, the most informative ones were mathematically selected for the prognosis of AUB in women with extragenital abnormalities.
 Results and their discussion. The prognosis of the risk of developing AUB in women of reproductive age with extragenital disorders was carried out on a double scale (0 – low probability, 1 – high probability). The search for diagnostically informative factors involved a set of 23 working indicators that were investigated in the examined patients using four levels of the risk scale. In order to solve this issue, the factors that have the greatest importance in the formation of the prognosis were selected using discriminant analysis methods, and a corresponding mathematical model was created. The classification functions made it possible to enter the practical plane and form rules for assessing the presence/absence of the risk of developing AUB in patients of reproductive age with extragenital disorders. The corresponding expressions are the following equations:
 NP = BAS ART*75.57+FSH*2.96+prolac*0.02+estrad*0.02-40.78
 PP = BAS ART*105.35+FSH*0.79+prolac*0.1+estrad*0.08-114.49,
 where NP is a negative prognosis, PP is a positive prognosis.
 If NP > PP, then the most likely prognosis is the absence of AUB in the patient; otherwise, if PP > NP – there is an increased risk of AUB.
 Conclusion. Pulsation index in the basal arteries of the uterus, FSH, prolactin and estrogens are prognostically significant indicators for predicting the risk of abnormal uterine bleeding in patients of reproductive age with extragenital disorders. The above formula, obtained from the conducted discriminant analysis, makes it possible to predict bleeding in a specific patient

Mortality of Russian Railways employees from cardio-vascular diseases during the COVID-19 pandemic

Introduction. Diseases of cardiovascular system are the leading causes of morbidity and mortality among the able-bodied population. There have been no studies of the impact of the COVID-19 epidemic on cardiovascular mortality in Russian Railways. The study aims to analyze the mortality of Russian Railways employees from diseases of the circulatory system during the COVID-19 pandemic with the working-age population of the Russian Federation. Materials and methods. The study was carried out on the basis of data obtained during the COVID-19 pandemic (2019-2021). Information on the mortality of employees of JSC "Russian Railways" is formed on the basis of the data of the CHUZ of JSC "Russian Railways". Information about the natural movement of the working-age population was formed on the basis of data from the Unified State Register of Civil Status Records. Results. During the pandemic, the mortality rate in JSC "Russian Railways" was 2.2 times lower compared to the working-age population of the country. Excess mortality by road polygons was different. The maximum mortality rate (3.4 per 1000 employees) was among employees of enterprises of central subordination, the minimum (2.1) was on the Northern Railway. 82.5% of deaths occurred in men, while the mortality rate among men is 2 times higher compared to women. The main cause of death of workers were diseases of the circulatory system (BSC) - 28.7%. The mortality rate from BSK in JSC "Russian Railways" was 0.656, which is 2.9 times lower than for the working-age population of Russia. Conclusion. The study showed that under the conditions of a new coronavirus infection, the mortality rate from circulatory system diseases in Russian Railways employees is lower than in working-age population of Russia. Ethics. We have carried out this study in accordance with the rules of good clinical practice and the Helsinki Declaration. The study did not require the conclusion of the Ethics committee.

The influence of violations in the work of mechanized milking operators on the quality of milk and the occurrence of mastitis

Mastitis is the most common disease on livestock farms. The reasons leading to the occurrence of mastitis and a decrease in the quality of milk are diverse. Violation of milking technology, maintenance, principles of mastitis prevention, untimely diagnosis and its defective treatment causes significant economic damage to dairy farms. The object of research was cattle milk. In the milk samples, the number of somatic cells and the number of mesophilic aerobic and facultive atianaerobic microorganisms were taken into account using standard techniques [1, 3]. The analysis of the organization of milking was carried out in the hall of the rotary type "Carousel". The purpose of the work: to improve the quality of milk and reduce the amount of mastitis by eliminating shortcomings in the work of machine milking operators. During the study, it was found that at the time of milking on the platform "Carousel" there were animals with contamination of the limbs and mammary gland. We have identified the following shortcomings in the analysis of the milking routine: a small amount of milking of the first trickles of milk, poor-quality cleaning and drying of nipples with a scrubber, connection of animals to the milking machine with an incomplete milk ejection reflex, violation of animal milking hygiene, repeated connections to the milking machine, non-compliance with the rules of nipple treatment after milking. The available data obtained during the study make it possible to better understand the etiology of mastitis, the problem of increased numbers of bacteria and somatic cells in milk due to violations of the work of machine milking operators. The results obtained allow us to state the need for the use of informative diagnostic methods in the practical activities of specialists at dairy enterprises in the Russian Federation. We have developed practical recommendations and rules for the prevention of mastitis and improving the quality of milk. As a result of the introduction of the created recommendations and rules into practice, it was possible to reduce the number of animals with mastitis, reduce bacterial contamination and the number of somatic cells in milk.

The Marginal Abatement Cost of Antimicrobials for Dairy Cow Mastitis: A Bioeconomic Optimization Perspective

Maintaining udder health is the primary indication for antimicrobial use (AMU) in dairy production, and modulating this application is a key factor in decreasing AMU. Defining the optimal AMU and the associated practical rules is challenging since AMU interacts with many parameters. To define the trade-offs between decreased AMU, labor and economic performance, the bioeconomic stochastic simulation model DairyHealthSim (DHS)© was applied to dairy cow mastitis management and coupled to a mean variance optimization model and marginal abatement cost curve (MACC) analysis. The scenarios included three antimicrobial (AM) treatment strategies at dry-off, five types of general barn hygiene practices, five milking practices focused on parlor hygiene levels and three milk withdrawal strategies. The first part of economic results showed similar economic performances for the blanked dry-off strategy and selective strategy but demonstrated the trade-off between AMU reduction and farmers' workload. The second part of the results demonstrated the optimal value of the animal level of exposure to AM (ALEA). The MACC analysis showed that reducing ALEA below 1.5 was associated with a EUR 10,000 loss per unit of ALEA on average for the farmer. The results call for more integrative farm decision processes and bioeconomic reasoning to prompt efficient public interventions.

Toward end-to-end latency management of 5G network slicing and fronthaul traffic (Invited paper)

5G network slicing allows operators to deploy virtual connectivity services tailored for specific purposes on top of the same underlying physical infrastructure. For some 5G services, the telecommunication operator needs to provide the customer with real-time information of the end-to-end Quality of Service for a particular slice. This paper focuses on the challenges behind this target, how per-layer per-segment monitoring can be performed based on common open interfaces to standard OAM protocols, and provides practical rules to plan end-to-end latency for slices. Then it reviews a few latency engineering approaches for fronthaul traffic from work carried out in this research area.

Room‐Temperature‐Processable Highly Reliable Resistive Switching Memory with Reconfigurability for Neuromorphic Computing and Ultrasonic Tissue Classification

AbstractReversible metal‐filamentary mechanism has been widely investigated to design an analog resistive switching memory (RSM) for neuromorphic hardware‐implementation. However, uncontrollable filament‐formation, inducing its reliability issues, has been a fundamental challenge. Here, an analog RSM with 3D ion transport channels that can provide unprecedentedly high reliability and robustness is demonstrated. This architecture is realized by a laser‐assisted photo‐thermochemical process, compatible with the back‐end‐of‐line process and even applicable to a flexible format. These superior characteristics also lead to the proposal of a practical adaptive learning rule for hardware neural networks that can significantly simplify the voltage pulse application methodology even with high computing accuracy. A neural network, which can perform the biological tissue classification task using the ultrasound signals, is designed, and the simulation results confirm that this practical adaptive learning rule is efficient enough to classify these weak and complicated signals with high accuracy (97%). Furthermore, the proposed RSM can work as a diffusive‐memristor at the opposite voltage polarity, exhibiting extremely stable threshold switching characteristics. In this mode, several crucial operations in biological nervous systems, such as Ca2+ dynamics and nonlinear integrate‐and‐fire functions of neurons, are successfully emulated. This reconfigurability is also exceedingly beneficial for decreasing the complexity of systems—requiring both drift‐ and diffusive‐memristors.

Changes to the EAEU Guideline on Good Pharmacovigilance Practices

By Decision No. 81 of 19.06.2022, the Council of the Eurasian Economic Commission amended the Guideline on Good Pharmacovigilance Practices of the Eurasian Economic Union (EAEU GVP Guideline), the core regulatory document on pharmacovigilance requirements for the EAEU Member States. The amendment involved all critical pharmacovigilance processes, and its consequences are yet to be assessed.The aim of the study was to analyse the changes to the EAEU GVP Guideline effective since 06.12.2022. The author summarised information on the changes made to the EAEU GVP Guideline by Decision No. 81 of the Council of the Eurasian Economic Commission of 19.06.2022 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union”. He described the differences between the old and the new versions of the EAEU GVP Guideline. Having critically reviewed the updated regulatory document, the author commented on its positive and negative aspects. The review created a starting point for further analysis of the changes to the EAEU GVP Guideline. At the time of writing, there were no other published works assessing the significance of most of the changes for the pharmaceutical industry and designated pharmacovigilance organisations in the EAEU Member States. The author assessed their significance through the prism of the recent years’ events in Russia and the world, including the COVID-19 pandemic. In connection with the amended guideline coming into force in 2022, the author suggested a transitional standstill period for both the pharmaceutical industry and designated pharmacovigilance organisations. He offered further improvements for the guideline. The article may be of practical interest to pharmacovigilance specialists, heads of pharmaceutical organisations, and employees of regulatory authorities.

Adoption of patient communication rules in clinical practice and the role of faith-based communities in shaping them: the palliative aspect of spiritual support

ABSTRACT The goal is to analyse patient communication rules and explore the role of specific faith-based communities in shaping them. The study was based on data collected from four groups of patients of different psychological types. About 77% of all patients in need of palliative care in Russia have diseases related to non-malignant diseases, among which there are also those requiring psychological medical care and spiritual support. Psychospiritual work, divided between psychotherapists and workers of faith-based organisations, was carried out over a period of eight months. The work was divided into four phases. The mental status of the patients was analysed in each phase. The analysis of the mental status showed improvement of the patients' mental state in the second and fourth phases, after interacting with the workers of a faith-based organisation. During the experiment, communication problems between patients and representatives of faith-based communities were identified in the study groups.

Data breaches in the age of surveillance capitalism: Do disclosures have a new role to play?

The rise of big data has led to profound changes to the dynamics of accumulation and profiteering. Today, data is captured, produced, and reproduced with such regularity that its collection, utility, and value can go largely unnoticed, giving rise to “surveillance capitalism” (Zuboff, 2019a). This paper explores emerging forms of exploitation within the data economy, including the rise of “instrumentarian power” (Zuboff, 2019a), opacity surrounding data collection and use, and the impact of data breaches on our capacity to function within the information economy. We consider whether new forms of extended responsibility reporting may help to disrupt the trajectory of surveillance capitalism and democratise participation in the digital economy (Crawford, 2021). We draw on the accounting literature on organisational disclosures to consider whether the disclosure of data breaches might enhance accountability by making aspects of the surveillance economy knowable to us. Empirically, our analysis considers the various rules currently governing the disclosure of data breaches in Australia, the US, the EU, and Canada, and the application of these rules in practice. While regulation of the digital economy is developing, laws governing the disclosure of data breaches are highly dependent on an organisation’s judgement. As a consequence, the nature, scale, and timeliness of these disclosures vary significantly, and the lack of clear routines makes it difficult for stakeholders to assess data risks. In response, we consider whether a mandatory disclosure framework might contribute usefully to the public “naming and taming” of surveillance capitalism (Zuboff, 2019a) and the democratisation of our digital future.

Die juristische Argumentation in den böhmischen Robotpatenten 1680–1738

The article discusses the legal reasoning in the “Robotpatente”, which were issued for serfs in Bohemia between 1680 and 1738. Of special interest is the position of ‘natural equity’ (natürliche Billigkeit) in the hierarchy of legal norms within the text and the position of the whole “Robotpatente” within the hierarchy of norms in Habsburg Bohemia. Reflections on natural equity were based on Roman law, rather than on secular natural law theories. I argue that the “Robotpatente” were not aimed at changing present customary law and practical rules, their aim was to step in when laws and customs were silent. In the hierarchy of legal norms in the “Robotpatente” of 1680, 1717 and 1738 itself, ‘natural equity’ always came last. Its role was not to change or exclude the current rules, but to fill in the gaps between them. It is only in the great “Restored Robotpatent” of 1738 that the role of natural equity is differentiated. It is divided into four sections – while natural equity is used in the traditional way in the sections one and two, which regulate the relations between peasants and their landlords, it is almost missing in the section three, which is on the relations to the sovereign. Moreover, it is differentiated in section four, which discusses the implementation. Here, the role of ʺnatural equity” is foreseen only in chaotic accidental cases which defy all known rules. All written laws, urbaria and customary rules took precedence over natural equity. Even though the “Robotpatente” adjudicated all “ancient privileges” to be cancelled, it put forward “legal urbaria”’ as the best safeguard of justice for the peasants.

Modern technologies in digital communicative adaptation of bachelor degree students

The development of foreign language speech through communication is an axiom according to which those who master a foreign language must master sociolinguistic and practical rules. Modern technologies make it possible to form, develop and improve competencies in the field of speaking foreign languages. Digitalization of the educational environment is one of the most relevant topics in the research of Russian and foreign scientists today. The novelty and purpose of our work is to create an innovative adaptive-integrative approach and technologies in the field of digital communicative adaptation of undergraduate students of the language pedagogical direction. We have introduced and considered the concepts of digital communicative adaptation, adaptive-integrative approach, oral digital portfolio. The algorithm of the work of Pskov State University students in classes on the basic course of a foreign language in the conditions of digitalization of the educational environment is also shown and conclusions are drawn about the benefits and effectiveness of these technologies. The research methods were the study and referencing of scientific literature, analysis of the products of students' activities, questionnaires and pedagogical experiment. Practical significance is the possibility of teaching foreign languages online, as well as in mixed and hybrid formats at the level of higher education.

Проблемы допроса потерпевших и свидетелей по делам о ятрогенных преступлениях

The investigation of iatrogenic crimes is markedly complex due to the ambiguity of the rules governing medical treatment. The specific nature of victims and medical witnesses necessitates a systematic review of numerous tactical provisions. The personal characteristics of victims and witnesses are examined, the subject of their interrogation is determined, and the documents presented during the interrogation are also considered. The difficulty of assessing the investigative situation prior to and during the interrogation is highlighted. It is suggested that the question of the victim's condition prior to the relevant medical treatment be included in the content of the interrogation of the persons concerned. Existing classifications of witnesses are assessed and necessary clarification is made as regards their division into stable and unstable. The problem of the language style of communication between the investigator and the interrogated persons, first and foremost the witnesses with medical knowledge, is examined. Its essence is that besides an aspect of an establishment and maintenance of the psychological contact with the interrogator, reached by the understandable for the named person terminological content of dialogue, there is an searching-cognitive aspect of the special terminology, which is objectively difficult to avoid due to the character of clear circumstances, mediating the sphere of the medical aid. From the point of view of the predictive function of this study, a way of solving this problem is outlined. In the authors' opinion, it consists in conjunction of functional manifestation of identity of an investigator with the subject-terminological discourse, defined in the most general form of a criminological characteristic of the investigated crime (groups of crimes), each element of which more or less has its own terminological description. When preparing to question witnesses and victims, it is suggested that so-called duplicate questions be formulated which would preserve the specifics of the subject matter of the case as reflected in the interrogation report and at the same time contain the necessary clarifications of the relevant testimony. The views on the types of criminal violations of medical treatment activity are evaluated. The conclusion is made that deontological violations, manifested in the deviation from medical ethics, cannot be considered a criminal violation of medical treatment activities, as they are not included in the mechanism of crime as an element of the criminological characteristics of the crimes under consideration. For the same reason, omissions in the completion of medical records, manifested in obscure, inaccurate entries should not be included in the number of criminal violations of the rules of medical and therapeutic activity. The possibility of building algorithms for the investigation of iatrogenic crimes depending on the type of criminal violation of the rules of medical practice is pointed out. The authors declare no conflicts of interests.

Abuse of procedural rights by participants in civil proceedings

The article is devoted to the abuse of procedural rights by participants in civil proceedings, which is a full-fledged offense, resulting in complicated access to justice and delaying the process. The article is devoted to the abuse of procedural rights by participants in civil proceedings, which is a full-fledged offense, resulting in complicated access to justice and delaying the process. The problem of abuse of procedural rights has been and remains quite relevant for the national science and practice, because the correct and timely consideration and resolution of civil cases in conditions of procedural bad faith becomes an extremely difficult task. The Civil Procedure Code of Ukraine in the new edition for the first time among the basic principles of civil proceedings enshrined the provision on the inadmissibility of abuse of procedural rights, defined the actions of persons that can be qualified as abuse, and also provided a mechanism for combating such a negative phenomenon. Abuse of procedural rights is a rather subjective and evaluative concept. At the same time, it should be emphasized that the abuse of the right should be considered as a procedural offense only if a causal link between the abuse and the harm caused (establishment of certain risks) to another party to the case is established. The introduced innovations are quite appropriate, but they are not free from shortcomings, given the inclusion of the most common situations of abuse of civil procedural rights and at the same time ignoring more complex ways of abuse (implicit abuse (for example, abuse of judge's recusal or filing several different in content/subject claims regarding the same legal relationship), as well as the fact that judges currently do not apply the articles sufficiently. The author concludes that enshrining the prohibition of abuse of procedural rights in the civil procedural legislation is a significant step towards improving the efficiency of civil procedure. At the same time, attention should be paid to the certainty and characterization of actions which may be qualified as abuse of procedural rights, with a view to their compliance with national and international legislation, as well as to the uniform interpretation of the rules in law enforcement practice.

Lesson of the Week: In the Nick of Time!

Management of diabetes lends itself very well to several classical rules of good clinical practice, an elaboration of which is out of the scope of this short story. However, a couple of these are noteworthy. “Diagnosis should precede treatment as much as possible except for measures of resuscitation” applies to diabetes as to all other conditions. In diabetes, diagnosis and classification are the same. Hence, a serious attempt to classify diabetes at the time of diagnosis or as soon as possible after that is mandatory.[1] In particular, when the patient's characteristics are atypical, or events do not follow the expected course, making assumptions under these circumstances can be very dangerous.[2] In this vignette, an unusual case of diabetes in a young woman is presented and discussed with an analysis of lessons to be learned. The present case report exemplifies several themes of “not expecting the expected,” “not making unfounded assumptions,” and “ignoring several alert signals.”

Engineering as “Technology of Technology” and the Subjugated Technical Practice

This article calls into question the simplistic identification of modern technology with quantitative efficiency in order to develop three main themes. First, I establish that technology, broadly construed, is the use of knowledge and resources to meet specific human needs. Accordingly, dominant technical practice that favors efficiency and numerical criteria and discriminates against other technologies should more appropriately be called “technology of technology.” Second, I delineate how dominant practice in engineering is an exemplar of technology of technology, when it becomes socially ambitious while remaining technically provincial and bears upon our personal and institutional life. Third, I illustrate what I call the “subjugated technical practice,” which exists under the rule of the dominant technical practice. Recognizing the importance of subjugated technical practices to engineering, I propose the concept of “critical technology of technology,” which is intended to advance technological alternatives and make critique an essential part of our technological world.

Research on the Design of Industry and Education Integration Capability Maturity Model

This article introduces the design and evaluation method of the capability Maturity Model for the Integration of Industry and Education. Based on the interpretation of the industry-education integration documents issued by the country and major provinces and cities, the capability model architecture is designed into four levels: Dimension, Process Area Group, Process Area, and Capability Practice. Each maturity level and its objectives are defined, and a capability dictionary is established according to different requirements for the different maturity levels. The evaluation method sets weights for Dimensions and Process Areas based on their importance, and designs scoring rules for Capability Practice to determine the current capability maturity level of the organization.

From the Traditional Rule of Law to the Intelligent Rule of Law: The Approach to the Rule of Law from the New Technology Revolution Perspective

Nowadays, we are at the junction of the information revolution and the intelligence revolution; China’s society is also in the transition from an information society to an innovative society. Under such a backdrop, it has also become an important and challenging task to make the rule of law follow the footsteps of the times so as to realize the triple modernization of the rule of law in terms of its concept, system, and technology. Based on the defects of traditional theory and practice, under the background of the new technological revolution, this paper will explore the development direction of the rule of law under the background of the new technological revolution around such topics as rule of law thinking, rule of law construction, rule of law practice, and discuss the problems that may be encountered in specific practice.

AN OBSERVATIONAL CLINICAL STUDY OF RELEVANCE OF GOODSALL'S RULE IN 50 CASES OF FISTULA IN ANO AT TERTIARY CARE HOSPITAL IN SOUTH GUJARAT

Despite being one of the oldest reported medical conditions, the management and treatment of stula in ano are still in the evolving phase. The management of stula-in-ano requires conrmation of the diagnosis, identifying the stulous tract and inner opening. In majority of patients a single primary stula tract exists and the anatomy can be determined adhering to the principles described by Goodsall. A thorough clinical examination of the patient is essential in the assessment of stula-in-ano, sometimes helped by imaging such as magnetic resonance imaging and Fistulogram. Although Goodsall's rule was accepted in the past, as a method to determine the course of the stula, recent studies showed poor conicting results. This study is an attempt to review the relevance of Goodsall's rule in clinical practice at a tertiary care hospital in South Gujarat.

Knowledge of surgeons and practical stances of healthcare institutions in the Ile-de-France region toward sustainable development: A cross-sectional study.

Climate change represents one of the gravest threats to health. Surgical activities mobilize a large number of resources which contribute to increased emission of CO2 and anesthetic gases in the environment. The objective of this study was to assess the level of knowledge of surgeons and the practical stances of healthcare establishments toward sustainable development. This was a descriptive cross-sectional study, lasting 2 months. From 1 May 2021 to 30 June 2021, surgeons were asked via an online questionnaire to participate. A total of 131 out of the 457 contacted surgeons responded. A majority practiced in the private sector, 48.9% knew little about the rules of sustainable development in operating theaters, and 43.5% had an average level. The sustainable development charter was available in only 23% of establishments, while 19% had a sustainable development committee, and specific sustainable development actions were carried out in 27%. The level of knowledge of surgeons in Île-de-France on sustainable development was low. In general, surgical units were not complying with the rules of good practice on CO2 reduction. It is necessary to find strategies to reduce the impact of operating theaters on the environment.