Vol 3, No 1S (2021): Supplement
- Year: 2021
- Articles: 23
- URL: https://journals.eco-vector.com/PharmForm/issue/view/3384
- DOI: https://doi.org/10.17816/phf_31S
-
Description:
Материалы Научно-практической Конференции: «Охрана окружающей среды. Оценка экологических рисков при обращении отходов радиофармацевтических лекарственных препаратов»
From the editor
From the editor
Abstract
Научно-практическая конференция «Охрана окружающей среды. Оценка экологических рисков при обращении отходов радиофармацевтических лекарственных препаратов» прошла в Санкт-Петербургском химико-фармацевтическом университете в очном формате. Организаторами ее выступили: кафедра промышленной экологии Санкт-Петербургского государственного химико-фармацевтического университета, Российская экологическая академия и Северо-Западный институт медико-биологических проблем и охраны окружающей среды.



Приветствие
Greeting



Greeting



Greeting



Greeting



Вступительное слово
Opening remarks



Opening remarks



Пленарное заседание
Radiation Medicine: Past and Present
Abstract
The article presents a brief history of the emergence and development of Radiation Medicine. This branch of medicine, being at the junction of medicine, physics and chemistry, goes back to the days when the major scientific discoveries were made. Targeted Radionuclide Therapy, known as ‘Magic Bullet’, has been intensively developed. The list of β-emitting radionuclides used for the treatment of various diseases is expanding. New α-emitting radionuclides have also been involved in the therapy. Russian medicine, albeit with a delay, is following the same path. Targeted radionuclide therapy and the drugs used for it are becoming more and more relevant.



Prospective directions and problems of ensuring Radiation Safety in Radiation Medicine
Abstract
The development of Radiation Medicine in the Russian Federation has resulted in the necessity to improve the regulatory and methodological support for ensuring Radiation Safety. Following the introduction of new diagnostics and therapy methods into practice, as well as the use of new radiopharmaceuticals, the actualization of radiation monitoring methods and the provision of radiological protection for patients, personnel and the public have become the most urgent tasks.
Radionuclide therapy with new radiopharmaceuticals, which can be used in the day patient departments, is one of the promising directions in the development of Russian Radiation Medicine. The main tasks of ensuring Radiation Safety in the departments of radionuclide therapy are the regulation of radioactive waste management, the development of discharge criteria after the administration of radiopharmaceuticals and methods for Internal Dosimetry.



Methods of biological waste management generated by patients
Abstract
The development of radiation medicine in the Russian Federation has resulted in the improvement of the regulatory and methodological framework for radiation safety regulation. The main obstacle for the development of radionuclide therapy in the Russian Federation is the liquid radioactive waste management (mainly urine and faeces of patients) generated during radionuclide therapy on an ambulatory basis (day patient department). The paper presents a brief analysis of the current domestic and international regulatory liquid radionuclide waste management documents. It has been shown that there is no strategy for solving the problem of utilizing biological waste from patients during radionuclide therapy. Long-term task for ensuring the sanitary and epidemiological well-being of the population of the Russian Federation could be the solution for the problem.



Science research experience in the use of radiopharmaceuticals at the N.N. Petrov NMRC of Oncology
Abstract
Radionuclide diagnostics and therapy with open radionuclide sources are one of the most promising and fast-growing areas of modern oncology. The paper presents the main achievements of the N.N. Petrov National Medical Research Center of Oncology, one of the leading departments of radionuclide diagnostics in Russia. Scientific and clinical results of using the new hybrid device in everyday clinical practice have been submitted. The advantages and opportunities of using hybrid SPECT-CT and PET-CT devices to diagnose different types of cancer, to assess the degree of its spread and to monitor the results of therapy have been demonstrated. The problems associated with the demand for new radiopharmaceuticals in practice have been highlighted. The need to simplify normative documents regulating the use of modern therapeutic radionuclide drugs has been substantiated.



Epidemiology and survival rates of patients with malignant tumors in the Russian Federation
Abstract
Malignant tumors remain the most important public health problem in the world, being the second or even the leading cause of death in some countries. Cancer incidence is greatly influenced by the ever-increasing environmental hazards. Population-based Cancer Registries (PCRs) provide necessary data to monitor and assess cancer incidence. PCRs collect obligatory data on incidence rate with time series analysis, mortality and survival rates in patients diagnosed with malignant tumors. The study presents the results of the operation of PCRs as exemplified in the analysis of the PCR of Saint Petersburg and the Northwestern Federal District of the Russian Federation.



Review of the practice-based experience of radiopharmaceutical waste management in healthcare institutions
Abstract
The paper aims to review the latest requirements of regulatory acts and consider the practice-based experience of waste handling of radiopharmaceuticals in the Russian Federation. The issues of legislative regulation of waste management of radiopharmaceuticals are considered.



Approaches to training and supply of qualified personnel for radiation medicine facilities
Abstract
The report presents the results of a review and discussion on providing qualified personnel for radiation medicine facilities and suggests approaches to personnel training. Qualified personnel availability comes first among the principles of quality control of radiopharmaceuticals (RP), supply of modern equipment, access to up-to-date regulatory documents, validated control methods and the organization of internal audit system. Also, radiation medicine facilities workers are inevitably exposed to harmful hygienic factors of the working environment throughout the entire life cycle of RP: the development, testing, production and civil circulation. Nuclear and radiation medicine facilities place the environment at risk of negative impact. Highly qualified specialists (responsible parties) should have knowledge, skills and abilities provided by special basic education are required to assess sanitary, hygienic and environmental risks and to comply with the quality management system requirements for the stable operation of radiation medicine facilities.



Practical experience in reactor and cyclotron radiopharmaceuticals production at the V.G. Khlopin Radium Institute
Abstract
The V.G. Khlopin Radium Institute, one of the oldest Russian research institutes, will celebrate its centenary in 2022. To date, the Institute remains at the forefront of the radiopharmaceuticals production. It provides Saint Petersburg clinics with the necessary substances for diagnosis and treatment on a daily basis. New drugs are being developed: based on 203Pb and 212Pb, as well as 131I.



Quality control management in the production of radiopharmaceuticals at the A.M. Granov Russian Scientific Centre for Radiology and Surgical Technologies
Abstract
To date, radiopharmaceutical preparations (RP) are subject to the same production and quality control requirements as non-radioactive pharmaceuticals. Although there are specific requirements for the production of RP, which complicate the fulfillment of some general requirements. For example, it is allowed to release radiopharmaceutical preparations containing some short shelf-life radionuclides for use before the completion of quality control test. This makes it difficult to work with deviations, going beyond the specification limits. There is a number of issues with validation. It is difficult to perform the Media Fill Test due to low volume production of RP. All these problems need to be addressed.



Дискуссионная сессия
Application of the Environmental Safety terms and definitions in pharmaceutical organizations
Abstract
The article describes the applying of pharmaceutical terminology in the Environmental Safety area and the reasons for the emergence of multiple concepts. The study was based on the definitions approved in the scientific industry and in the regulatory documents of the Russian Federation, the EAEU and the EU. It has been found that it is still not possible to unify the existing variations of the terms. Nevertheless, it is necessary to develop a manual, which will provide guidelines on the use of certain terms.



FATTY LIVER DYSTROPHY MODELING BY USING STRONTIUM SULFATE
Abstract
In recent years, the problem of the increasing number of the hepatobiliary system disorders has acquired particular importance for veterinary medicine. These disorders have negative impact on normal physiology of an animal's body. It is important to continue the search for effective hepatoprotective agents. To test the pharmaceutical activity of new drugs, methods of modeling hepatopathies are constantly being improved. The study suggested a model of fatty liver dystrophy using strontium sulfate.



ACUTE RADIATION INJURY: COURSE AND OUTCOME IN A RAT MODEL WITH THE IODINE AND SELENIUM PREPARATIONS ADMINISTRATION
Abstract
The study was carried out to determine the radioprotective and therapeutic efficacy of the complex use of the feed additive DAFS-25k and iodophore preparation Monclavit-1. It has been shown that a dose of 7.0 Gy of 137Cs γ-radiation at the exposure power of 0.99 Gy/min induces severe acute radiation injuries in rats. However, with the intragastric administration of the DAFS-25k oil soultion three hours before exposure to γ-radiation, followed by aqueous solution of Monclavit-1 18 hours later, the lethality of irradiated animals has reduced to 30% versus 80% in controls. The frequency of gastrointestinal syndrome manifestations has also reduced to 40-50% versus 100% in controls.



Ecotecture of the extreme Arctic environment
Abstract
The extreme natural climate and weather environment, socioeconomic degradation of the region and the progressive psychological and emotional depression of the population pose a question for specialists. How to reduce these negative impacts on humans? By means that no one had thought about before: architecture, design and art therapy.
The paper covers a new direction of harmonization of the built environment in extreme conditions, which is called circumpolar environmental ecodesign. Ecodesign is an integral part of the new direction of Arctic architecture – the eco-architecture of extreme environments. 35 years of experience in design and construction, scientific, artistic, pedagogical and administrative activities of the author have led to the idea to develop this direction.
The fundamental components of ecodesign are art-therapeutic functions and maximum adaptability to various factors:
– natural, meteorological and climatic conditions;
– circumpolar anthropogeographic environment;
– the peculiarities of the light-color-tonal arctic environment.



Development of the environmentally safe habitat based on local life-support systems
Abstract
Biogenic pollution around the world is constantly increasing. To create a full-fledged and favorable habitat, it is important to use waste-free technology, which includes the technologies for domestic and agricultural wastewater treatment.
The article presents a wastewater treatment facility developed by specialized enterprises from Saint Petersburg and Moscow. Based on the use of physicochemical and baromembrane treatment method combination, it has provided a sufficient degree of wastewater treatment to be discharged into fisheries. This facility ensures a short payback period for the project.



PRELIMINARY RISK ANALYSIS METHOD FOR POTENTIAL CAUSES OF MEDICAL DEVICE FAILURE WITH THE USE OF DEDUCTIVE LOGIC IN CASE OF A MAN-MADE EMERGENCY SITUATION
Abstract
The article demonstrates the environmental risk calculation and assessment. Resulting from a man-made accident at the production site of a pharmaceutical corporation, it may have a negative impact on the environment. The methods of deductive and probabilistic logic based on the fault tree analysis have been used to assess the risk of the transition to an emergency (dangerous) state of a cyclotrone. The study was based on the analysis of public information sources: scientific publications in Environmental Risk Reduction based on the result of economic enterprise activity of and the system of occupational safety standards. The test case has shown the ability to assess the risk of an event occurring with sufficient accuracy for practical application.



Решение
The decision of the scientific and practical conference " Environmental Protection. Assessment of environmental risks in the handling of radiopharmaceutical drug waste"


