Medical Ethics

ISSN Print 2713-0894 ISSN Online 2713-0908

BIOMEDICAL JOURNAL OF ERMC EASTERN EUROPEAN

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Fitilev SB, Vozzhaev AV, Shkrebniova II, Kliuev DA, Saakova LN

Early phase clinical research is an essential step in the development of novel medicinal products. Its main subjects are healthy volunteers. The research quality and outcomes directly depend on how and among whom healthy volunteers are selected and how well the volunteers follow the requirements. Selection of healthy volunteers for participation in early phase clinical research can be influenced by a number of various factors and ethical problems. Better comprehension of volunteer’s expectations, potential fears, limiting factors and motives will promote adherence to respective ethical standards and, as a rule, result in qualitative research practice. In this article, authors have tried to analyze the attitude of healthy volunteers towards various aspects of participation in clinical research using own research experience and available literature data. Surveys of healthy volunteers, individual observations and interviews of researchers with participants represented data to be analyzed. Basic variables of interest included the social and demographic portrait of a healthy volunteer, motivation and barriers to research participation, perception of risks by volunteers and their attitude to adverse events, and financial aspects.

Received: 2023-02-02

Published online: 2023-03-06

DOI: 10.24075/medet.2023.006

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VIEWS 1182

Butranova OI, Zyryanov SK

Considering patients of elderly and senile age, pronounced discrimination continues to be observed, expressed in their insufficient inclusion or non-inclusion in randomized clinical trials. As a result, the clinical recommendations based on the results of such studies cannot be fully applicable to this category of patients. The problems of inclusion/non-inclusion of older people in clinical trials are numerous. The reasons for their occurrence and solutions affect, among other things, the ethical sphere. Compliance with basic ethical principles such as respect for persons, beneficence and justice should underlie the decision to include a patient in a study. In general, when evaluating these ethical principles from the point of view of the well-being of the entire population of elderly and senile patients, it is necessary to rethink the principles according to which this category of patients was excluded from clinical trials.

Received: 2023-01-30

Published online: 2023-03-06

DOI: 10.24075/medet.2023.005

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VIEWS 1264

Butranova OI, Ushkalova EA, Zyryanov SK

Increased life expectancy along with an increasing share of elderly and senile patients in the structure of the population make the tasks of longer healthy life expectancy pressing. A set of activities aimed at optimization of management of patients within the framework of gerontological practice should include elimination and prevention of diagnostic and therapeutic errors. The basic risk factors of medical errors include high heterogeneity of elderly and senile patients, overburdened healthcare system, polypharmacy, including due to parallel prescription of drugs to the same patient by multiple medical professionals, concomitant diseases, and high comorbidity, measured by the Charlson Comorbidity Index. Mismanagement of elderly patients can result both from underestimated severity of the patient’s conditions, and from hyperdiagnostics. Typical errors of pharmacotherapy include use of potentially inappropriate medications, potential prescribing omissions, simultaneous prescription of drugs with high risk of clinically significant interactions, incorrect selection of dosage without taking into account the renal failure, which is associated with high risk of toxic effects. Affordability of medical aid for an elderly patient is another important social aspect influencing the patient’s quality of life. As far as basic ethical principles of management of elderly and senile patients go, it is necessary to respect independence, well-being and justice for the patients regarding possible obtaining of qualitative medical aid as compared with other age groups.

Received: 2023-01-30

Published online: 2023-02-28

DOI: 10.24075/medet.2023.004

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VIEWS 1404

Fokina DS, Zhukova OV, Grekhov AV, Khokholov AL

A lack of the single criterion for classifying rare diseases as a group of orphan diseases is the main current problem. First, it is associated with rare detection of symptoms among patients, especially children. Second, specialists have a limited number of methods of detecting orphan diseases. As the disease is considered rare, it is not profitable for pharmaceutical companies to produce the preparations which are purchased not in large numbers, but in single packages, because expenses on clinical trials and marketing advertising exceed return of investment. The market of orphan drugs in Russia is at the stage of development and formation. Medical organizations that carry out medicinal therapy of patients with orphan diseases require a clear set of regulatory documents ensuring provision of medical and pharmaceutical aid. Special attention should be paid to drawing up the lists of medicinal preparations to treat the patients. Personified accounting of patients with detected orphan diseases is an important stage for medical and pharmaceutical organizations. Modern diagnostics of orphan diseases at early stages, especially in children, exploration of specialized genetic methods of research and making them accessible for the population constitute an essential problem.

Received: 2023-01-10

Published online: 2023-02-27

DOI: 10.24075/medet.2023.003

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VIEWS 1247

Palyutin ShH, Zilber IE, Pozdnyakov NO, Sinitsina OA, Speshilova SA, Sirotkina AM

During the long history of antibiotics, resistance of causative agents of main infectious diseases was estimated as a very serious threat to effective treatment of patients and as a social and economic problem faced by the entire mankind. The activities performed by the medical society provided no significant effect resulting in growing antibiotic resistance. The pandemic of novel coronavirus infection only made things worse. It became a new challenge for the medical community regarding searching solutions which are clinical, organizational and methodological by nature in the global struggle with resistance to antibiotics. The reviews of several studies of coronaviral infections have shown that treatment with antibiotics failed to correlate with the decreased all-cause mortality. In this work, we have reviewed some aspects of therapy with antibiotics, including ethical ones. Ethical aspects of antibiotic therapy concern decisions of physicians about administration of commonly unnecessary antimicrobial agents.

Received: 2022-12-21

Published online: 2023-02-25

DOI: 10.24075/medet.2023.002

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VIEWS 1065

Strakhov VV, Korsakov MK, Fedorov VN, Vdovichenko VP, Shetnev AA, Popova AA, Volkhin NN

Glaucoma is the leading cause of irreversible blindness. Its leading symptom and the most important initial link of the disease pathogenesis is represented by an increase of intraocular pressure (IOP). Decrease of IOP is a basic notion in the therapy of glaucoma. Drug-induced therapy is currently the most widely spread initial intervention to decrease IOP. Prostaglandin analogues are referred to the basic group of pharmacotherapeutic agents, because they are the most effective and well tolerated. Beta-blocking agents are selected as an alternative. Other medicinal products to treat glaucoma include inhibitors of carbonic anhydrase for systemic (acetazolamide and methazolamide) and local (dorzolamide and brinzolamide) use. Systemic inhibitors of carbonic anhydrase are, on the one hand, more active than non-systemic medicinal preparations, and, on the other hand, have numerous side effects which are not safe for humans. Thus, medicinal preparations for local use are most frequently applied in the therapy of glaucoma. If necessary, they are combined with beta-blocking agents or alpha-adrenergic agonists.

Received: 2023-01-16

Published online: 2023-02-16

DOI: 10.24075/medet.2023.001

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VIEWS 1334

Drigo AE, Zheltkevich OV, Bazanova TA

No properly formed and subsequent regulation concept has been presented until now by a number of the issues, which are essential for the pharmaceutical branch. Development and a complex structure of the state regional retail market of medicines, including the activity objects as part of organizations with various organizational and legal forms managed or coordinated by representatives of public entities, have been reviewed in complex within the trial. The model of the structure of the state segment considering organizational and legal interactions used during examination of the regional pharmaceutical market in the Kostroma region has been suggested. Distribution of objects within the state segment structure was analyzed. The differences in the strategies of functioning and development of the state and private segments of the regional retail market of medicines have been identified. Legal preconditions and social and economic conditions of the growing role of healthcare institutions in the system of drug supply of population have been designated. It has been established that the tendencies intensifying participation of the state in the system of drug supply to ensure proper management of budgetary resources and risk prevention were accompanied by previously adopted extra-branch changes of legislation. This could result in reduction of the state segment in economics that would inevitably lead to serious changes in the structure of the pharmaceutical market and redistribution of social load among its participants [2]. A serious understanding of prospects of functioning of the state segment of retail trade of medicines is required both at the level of regulatory agencies and within the professional community considering the preservation of social services of medicinal aid and decreased risks of negative phenomena on the pharmaceutical market.

Received: 2022-10-20

Published online: 2023-02-01

DOI: 10.24075/medet.2022.066

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VIEWS 1047

Galeev RR, Lileeva EG, Ryzhkova EA, Galeeva EV, Lezhnina NA

State control over the drug quality is a key component of the healthcare system aimed at provision of patients with safe and effective medicinal products [1]. Stable development of this direction was closely associated with update of testing laboratories, which performed the function, and was characterized as a stable growth of laboratory competencies in the field of not just implementation of new analytical methods, but also in the systemic approach to improvement of skills and knowledge of personnel directly involved in laboratory research. A common approach reflected in accreditation criteria for compliance with GOST ISO 17025 means that the testing laboratory has a plan for internal and external education. However, conventional attitude to this issue does not lead to the desired practical effect. Then the laboratory is urged to find additional ways of development. Formation of competence centers by a certain vector of knowledge on the basis of testing centers can be a perspective option of the systemic approach to updating skills of the personnel. The Yaroslavl branch of the Information Center for Expertise, Accounting and Analysis of Circulation of Human Medicinal Products of the Federal Supervisory Agency for Healthcare and basic department of innovative pharmacy of the Yaroslavl State Medical University that successfully uses the basis can serve as examples of such an approach.

Received: 2022-10-20

Published online: 2023-02-01

DOI: 10.24075/medet.2022.065

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VIEWS 1030