Конвенція «Медикрим» як інструмент протидії підробленню медичної продукції в Україні

Aim. To study the compliance of the measures provided for by the “Medicrime Convention” with the organizational and legal measures used in Ukraine in order to increase the effectiveness of countering counterfeiting of medicinal products, as well as developing recommendations for their improvement.Results. The “Medicrime Convention” contains an effective international legal mechanism to combat the counterfeiting of medical products and similar crimes involving threats to public health. The Convention provides for the establishment of criminal liability for certain types of crimes in this area and the possibility of international legal cooperation in identifying and detecting these crimes, the search for criminals,their detention, other international cooperation in this area. The effectiveness of this mechanism at the international and national levels, including Ukraine, is directly proportional to the following two factors:the breadth of dissemination of this mechanism among countries and the quality of the implementation of the relevant provisions of the Convention in the national legislation and the practice of its application.Conclusions. A serious obstacle to the proper use of the “Medicrime Convention” mechanism by Ukraine is the substantial incompleteness of the implementation of its provisions in the current national legislation and practice of its application, as well as the relatively small number of countries that have joined this mechanism. To eliminate these shortcomings, it is necessary: to adopt a regulatory act at the national level to bring the national legislation in line with the “Medicrime Convention”; to use the available opportunities at the international level to popularize these provisions.Цель: исследование соответствия мер, предусмотренных Конвенцией «Медикрим», органи-зационно-правовым мерам, применямым в Украине с целью повышения эффективности противодействия подделке медицинской продукции, а также выработка на этой основе рекомендаций по совершенствованию такого противодействия.Результаты. Конвенция «Медикрим» содержит действенный международно-правовой механизм противодействия подделке медицинской продукции и подобным преступлениям, посягающим на здоровье человека. Конвенция предусматривает установление уголовной ответственности за определенные виды преступлений в этой сфере и возможность международно-правового сотрудничества в вопросах выявления и раскрытия этих преступлений, розыска преступников, их задержания и т.п. Эффективность заложенного в ней механизма на международном и национальном уровнях, в том числе для Украины, находится в прямо пропорциональной зависимости от следующих двух факторов: широта распространения этого механизма среди стран мира и качество имплементации соответствующих положений Конвенции в национальное законодательство и практику его применения.Выводы. Серьезным препятствием в надлежащем использовании Украиной механизма Конвенции «Медикрим» является существенная неполнота имплементации ее положений в действующее национальное законодательство и практику его применения, а также относительно небольшое количество стран мира, которые присоединились к этому механизму. Для устранения этих недостатков необходимо: на национальном уровне принять нормативно-правовой акт по приведению национального законодательства в соответствие с Конвенцией «Медикрим», на международном – использовать существующие возможности для популяризации ее положений.Мета: дослідження відповідності заходів, передбачених Конвенцією «Медикрим», організаційно-правовим заходам, які застосовуються в Україні з метою підвищення ефективності протидії підробленню медичної продукції, а також вироблення на цій підставі рекомендацій щодо удосконалення такої протидії.Результати. Конвенція «Медикрим» передбачає дієвий міжнародно-правовий механізм протидії підробленню медичної продукції та подібним злочинам, що загрожують охороні здоров’я. Конвенція передбачає установлення кримінальної відповідальності за певні види злочинів у цій сфері та можливість міжнародно-правового співробітництва з питань виявлення та розкриття цих злочинів, розшуку злочинців, їх затримання тощо. Ефективність закладеного в ній механізму на міжнародному та національному рівнях, зокрема і для України, знаходиться у прямо пропорційній залежності від таких двох факторів: широта розповсюдження цього механізму серед країн світу та якість імплементації відповідних положень конвенції в національне законодавство і практику йогозастосування.Висновки. Серйозною перешкодою для дієвого використання Україною механізму Конвенції «Медикрим» є суттєва неповнота імплементації її положень у чинне національне законодавство та практику його застосування, а також відносно невелика кількість країн світу, які приєднались до цього механізму. З метою усунення цих недоліків необхідно: на національному рівні ухвалити нормативно-правовий акт щодо приведення національного законодавства у відповідність до Конвенції «Медикрим», на міжнародному – використовувати існуючі можливості для популяризації її положень

РЕЗУЛЬТАТИ ПОГЛИБЛЕНОГО АНАЛІЗУ ПАРАМЕТРИЧНИХ ПОКАЗНИКІВ ТЕЛЕРЕКЛАМИ ЛІКІВ, ПАРАФАРМАЦІЇ, ПИВО-ГОРІЛЧАНИХ ВИРОБІВ - ДОКАЗОВА БАЗА ДЛЯ РОЗРОБКИ НОРМАТИВНО-ПРАВОВИХ ЗАСАД ЕФЕКТИВНОГО ДЕРЖАВНОГО УПОРЯДКУВАННЯ Ї Ї ДІЯЛЬНОСТІ

There was conducted the analysis of parametric indices of monitoring of television advertising of medicines, parapharmaceutical production and alcoholic drinks in 2011 on the main Ukrainian television channels. There were determined key differences and mechanisms of the development of television advertising business.Проведен анализ параметрических показателей мониторинга телерекламы лекарственных средств, парафармацевтической продукции и пиво-водочных изделий за 2011 год на основных телеканалах Украины. Установлены ключевые отличия и закономерности развития телерекламного бизнеса.Проведено аналіз параметричних показників моніторингу телереклами лікарських засобів, парафармацевтичноїпродукції та пиво-горілчаних виробів за 2011 рік на основних телеканалах України. Встановлено ключові відмінностіта закономірності розвитку телерекламного бізнесу

Cost analysis of botulinum therapy of spastic forms of cerebral palsy in Ukraine

Cerebral palsy (CP) represents a group of disorders of the mechanisms of movement and body position, causing limitations of activity, which are caused by non-progressive damage to the developing brain, fetus or child. About 80% of cases are spastic forms of cerebral palsy. Along with motor rehabilitation, the use of botulinum toxin type A (BoNT-A) is considered one of the main methods of treatment of choice for focal spastic and dystonic syndromes, regardless of their etiology. At present, there are no studies in Ukraine on the analysis of the costs of using drugs based on BoNT-A, taking into account the recommended dose and frequency of administration. The aim of the work. Carrying out an analysis of minimizing the cost of botulinum therapy for spastic forms of cerebral palsy in patients aged two years and older. The annual dosage and frequency of administration of abobotulotoxin and onabotolutoxin for the treatment of dynamic equinus deformity of the foot caused by focal spasticity due to cerebral palsy in children over two years of age were obtained from the instructions for use. The cost of abobotulotoxin and onabotolutoxin was obtained from the Register of Wholesale Prices of the Ministry of Health of Ukraine. Cost analysis for a model cohort of children in different weight categories showed that abobotulotoxin 500 U will be the least expensive treatment technology in the weight category of 21–33 kg at a dosage of 15 U/kg in the treatment of diplegia. Abobotulotoxin 300 U is most rationally used in weight categories 10–20 kg and 34–40 kg with a dosage of 15 U/kg in the treatment of hemiplegia and in the weight category 17–20 kg with a dosage of 30 U/kg in the treatment of diplegia. Weight categories were identified in which the costs of using abobotulotoxin 300 U and abobotulotoxin 500 U were equal to and less than the costs of onabotolutoxin treatment. The study was the first to analyze the cost of botulinum therapy, which identified the benefits of abobotulotoxin in the symptomatic treatment of hemiplegia and diplegia in cerebral palsy in the focus of different weight groups of children. Possible variability in the dosage and frequency of administration of onabotolutoxin per year indicates the relevance of collecting additional information on the application in real clinical practice and further pharmacoeconomic studies

Bioinformation analysis of rotavirus vaccine efficiency

A couple of studies have shown that viruses cause from 25 to 60% of acute intestinal infections (AII) cases, among which rotaviruses play a leading role in the structure of children's AII of viral etiology. According to the WHO recommendations, vaccination against rotavirus infection should be included into national immunization programs. Due to a wide diversity of circulating rotavirus genotypes, the issue of RVI vaccine efficiency, taking into account the dynamics of the molecular-genetic spectrum of RVI pathogens over time, remains relevant. The aim of the work – мodeling the dynamics of the molecular genetic spectrum of RVI pathogens and bioinformation analysis of f rotavirus vaccine efficiency. The object of the analysis was the results of molecular and epidemiological studies of RVI in Kyiv, conducted from 2007 to 2015. The dynamics of the genotypic spectrum was modeled using a Markov model, which involved replacing shares of the molecular genetic spectrum of rotaviruses with others ones according to homology with the vaccine strain: homology in both G and P genotypes, homology in G genotype or P genotype, no homology in both G and P genotypes. The method of rotavirus vaccine efficiency evaluation is based on data from clinical observations of vaccine efficiency, where different degrees of its efficiency against severe gastroenteritis caused by rotaviruses with different genotypes were shown. The shares of each genotype group in the general circulation of genotypes were taken as weights of the degree of homology relative to the vaccine strain, and the effectiveness of the vaccine against the strains of a specific homology group was obtained from clinical observations. The results of the analysis based on the constructed distribution curves of the molecular genetic spectrum of rotaviruses due to rotavirus vaccine strain homology in Kiev showed that, despite the observed dynamics of the molecular genetic spectrum of RVI pathogens, the expected genotype-specific efficiency of rotavirus vaccine would be constant with a value of 0.835 or 83.5% against rotavirus gastroenteritis with a Vesikari severity of > 11 points. It was proposed mathematical model for prediction of molecular genetic spectrum of rotaviruses dynamics, taking into account the homology of the genotypes of RVI pathogens with respect to the vaccine strain. According to the literature data of molecular and epidemiological studies of rotaviruses in Kyiv, the parameters of the proposed mathematical model and the dynamics of the molecular genetic spectrum of RVI pathogens were determined. Using mathematical modeling, the expected genotype-specific efficiency of the rotavirus vaccine was determined based on Kyiv regional retrospective molecular and epidemiological data

ЕТІОЛОГІЧНА ДІАГНОСТИКА ГОСТРИХ ВІРУСНИХ ІНФЕКЦІЙ: РОЛЬ У СУЧАСНІЙ СИСТЕМІ ОХОРОНИ ЗДОРОВ’Я ТА ЕКОНОМІЧНА ЕФЕКТИВНІСТЬ

The aim of the work – to determine the role of etiological diagnosis of acute viral infections in the modern health care system and methods for assessing its economic effectiveness.Results. Innovations of recent years in the etiological diagnosis of viral diseases, including molecular biological technologies, immuno-chromatographic analysis, biochips and others, have shown positive diagnostic and clinical results and are important for improvement into the health system. The main operational characteristics of laboratory tests are sensitivity, specificity, reproducibility, accuracy, quality control and performance time.Conclusions. Qualitative provision of medical care to patients with viral diseases can be achieved by focusing on the goals of the health care system to improve the quality and usefulness of medical care, including the etiological diagnosis of viral infections. Its result can also be used to predict the effectiveness of choosing alternative patient care tactics, as well as to monitor the effectiveness of treatment regimens and their correction.Мета роботи – визначити роль етіологічної діагностики гострих вірусних інфекцій в сучасній системі охорони здоров’я та методи оцінки її економічної ефективності.Результати. Інновації останніх років в етіологічній діагностиці вірусних захворювань, серед яких молекулярно-біологічні технології, технології на основі імунохроматографічного аналізу, використання біочипів та інші, показали позитивні діагностичні та клінічні результати та мають важливе значення для вдосконалення системи охорони здоров’я. Основними операційними характеристиками лабораторних тестів є чутливість, специфічність, відтворюваність, точність, контроль якості та час виконання.Висновки. Якісне надання медичної допомоги пацієнтам з вірусними захворюваннями може бути досягнуто, орієнтуючись на цілі системи охорони здоров’я для підвищення якості та корисності медичної допомоги, в тому числі етіологічної діагностики вірусних інфекцій

Analysis of antiviral use efficiency criteria in the complex pharmacotherapy of community acquired pneumonia

According to modern view, bacterial pathogens are the leading and most common cause of community-acquired pneumonia (CAP), but at the same time the results of numerous microbiological studies conducted in recent years showed that viruses confidently play the next leading role of CAP causes. Today, antiviral therapy is successfully used within the complex therapy of respiratory diseases, which allows reduction of the disease severity and minimizes the risk of complications. The main requirements for the antiviral drug are fully responsive to the new antiviral drug vitaglutam, the active component of which is pentanedioic acid imidazolyl ethanamide, is a low molecular weight compound, an analogue of the natural peptidoamine. The aim of the work. Mathematical modeling and analysis of clinical and laboratory indicators dynamics of CAP with additional antiviral pharmacotherapy based on pentanedioic acid imidazolyl ethanamide. In the study, it was used retrospective data of 106 patients with mild form of CAP of viral and bacterial etiology. Patients were randomly divided into two groups. In the 1st main group (50 patients), antibacterial therapy was combined with the antiviral drug vitaglutam. Analysis of antiviral therapy efficiency was provided by grouping of patients and determination of their distribution by gradations of clinical and laboratory indicators, as well as the construction of a mathematical model of their dynamics. According to modeling results, the rate of body temperature normalization, which was higher in patients taking vitaglutam, was a clear criterion for the efficiency of antiviral therapy. With additional antiviral therapy, the dynamics of sputum in the lungs was less intense. Positive clinical changes were accompanied by an improvement in the clinical blood analysis indicators, namely, more significant was the dynamics of ESR decrease. At the same time, dynamics of leukocytes number in patients’ blood was approximately the same in both groups. Analysis of dynamics of clinical and laboratory indicators using the proposed mathematical model suggests that additional prescription of vitaglutam to empirical stepwise antibiotic therapy can significantly reduce the time to achieve clinical and laboratory results of treatment of patients with CAP of viral and bacterial etiology

A simple epidemic model of COVID-19 and its application to Ukrainian, Indonesian, and the global data

At the beginning of 2020, one of the most significant health problems for humanity is the pandemic of coronavirus disease 2019 (COVID-19). Here, we identify features and develop simple epidemic model of COVID-19 on the basis of available epidemiological data and existing trends worldwide. Modeling of COVID-19 epidemic process was based on a classic model. A key parameter of the model, i.e. transmission parameter of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was determined numerically with the use of available epidemiological daily reports of COVID-19 from 17 April to 23 May 2020. Numerical determination of transmission parameter of SARS-CoV-2 according to the absolute number of COVID-19 cases in Ukraine, Indonesia and worldwide data showed its global tendency to decrease over time. Approximation of the obtained numerical values of the transmission parameter of SARS-CoV-2 was carried out using the exponential function. The results of prognostic modeling showed that by the end of summer 2020, above 30 thousand COVID-19 cases are expected in Ukraine, 100 thousand COVID-19 cases in Indonesia, and 12 million COVID-19 cases worldwide. Thus, predicting the possible consequences of the implementation of various health care control programs COVID-19 involves a comprehensive study of the epidemic process of the disease as a whole and for certain periods of time with the subsequent construction of an adequate prediction model

СИСТЕМНІ ПІДХОДИ У СТВОРЕННІ НЕОБХІДНОГО АСОРТИМЕНТУ ЛІКАРСЬКИХ ЗАСОБІВ ДЛЯ АПТЕК СІМЕЙНОЇ ФАРМАЦІЇ ТА АПТЕК ЗАГАЛЬНОГО ТИПУ ПРИ ЗАКЛАДАХ СІМЕЙНОЇ МЕДИЦИНИ

Introduction.  Now in Ukraine, mortality has increased in several times due to the fact of absence of a well-defined system of medical supplies based on the principles of evidential medicine. Improvement of the patient medicinal treatment presupposes reformation family and general pharmacies and enhancing the efficiency of range of medicines according to the protocols approved by the Ministry of Health, used by pharmaceutical sales representative (pharmacist) and unified clinical care delivery service.This investigation is dedicated to the analysis of the pharmaceutical sales representative’s (pharmacist’s) protocols, and unified clinical care delivery protocols in accordance with the current regulatory framework with the further creation of necessary range of medicines for family and general pharmacies, which will be able to carry out medical supplies for the institutions of family medicine while providing primarily health care.Investigation methods. The investigations were realized through the regularization of the projects, statements, principles and rules of the family pharmacy units’ activity, medicine in the pharmaceutical market of Ukraine. Methodological strategy is based on the evidential medicine, medicine itself, valid statistics and alternative formulae.Results and discussion. The analysis indicates that currently, in 27 regions of Ukraine, with the exception of AR Crimea, Donetsk and Luhansk regions and the city of Sevastopol, as of 01.01.2016 2073 family ambulance stations are functioning in the cities, villages and urban settlements; the total sum of the assigned population  serving the mentioned ambulance stations amounts to 12234471 persons, the number of the pharmacies that serve institutions of family medicine stood at 48 city pharmacies, 8 village pharmacies and 8 urban settlements pharmacies.Pharmaceutical sales representative’s (Pharmacist’s) protocols for selling the over-the-counter medicine are compound of 34 diseases that belong to the International Classification of Diseases code – 10. Pursuant to the requirements of the Order of the Ministry of Health of Ukraine dated 28 September 2012 No. 751 “On the creation and implementation of the medical and technological standardization of the medical care documentation in the system of the Ministry of Health of Ukraine” were elaborated 56 Orders of the Ministry of Health of Ukraine which approved: medical care unified clinical protocols – 95; medical care standards – 5; adapted clinical directives recommended as a source of the best clinical practice – 67. Nonetheless, in Ukraine there is no regulatory or stipulated factor that provides legal entitlement of the role, place and importance of family pharmacy.Having reviewed the number of ambulance stations and population that is managed by the latter, and operating general pharmacies located in the cities, villages and urban settlements, that provide them with medicines, arises the feasibility of creation of legal framework for the functioning of the specialized family pharmacies according to a regulatory criterion of quantitative and name range of medicines that will correspond either to the medical activity carried out by a family doctor, and medical care benefit from the family pharmaceutical sales representative (pharmacist) in accordance with the unified medical care and pharmaceutical sales representative's protocols.Conclusions. For the further development and effective functioning of family pharmacy institutions, it is feasible to create regulatory ordered factors for the functioning of the specialized family pharmacy pharmaceutical units, re-organize pharmacies of the general type that serve institutions of family medicine into pharmacies of family medicine for its timely, constant, affordable and qualitative medical maintenance of the population resided on the territory of a functioning family pharmacy unit.Creation of necessary regulatory range of medicines for the specialized family and general pharmacies that will serve institutions of family medicine and population assigned to the latter.У статті вперше в Україні наведено результати вивчення та узагальнення аналізу діючих фармацевтичних суб’єктів під комерційною назвою «Сімейна аптека». Доведено їх позитивну діяльність у системі сімейної медицини та фармації

Cost minimization and budget impact analysis of the use of a new 6-month form of triptorelin in the treatment of patients with prostate cancer in Ukraine

Prostate cancer is one of the most serious health problems encountered by the manhood of different countries of the world. Prostate cancer is a hormone-dependent tumor – growth and proliferation of both normal and cancer cells significantly depend on level of androgens. The analogues of gonadotropin-releasing hormone have been widely applied in prostate cancer therapy for more than 15 years. In Ukraine goserelin (1 month, 1 M; 3 months, 3 M) currently occupies the major part of market among the analogues of gonadotropin-releasing hormone. The alternative to goserelin is triptorelin (1 month, 1 M; 1 months, 3 M; 6 months, 6 M) – another well-studied and widely applied analogue of gonadotropin-releasing hormone, which is used for medical castration in cases of prostate cancer. Taking this into consideration, conducting the analysis of triptorelin and goserelin application is relevant. The purpose of the work was to conduct cost minimization and budget impact analysis using triptorelin 6 M and goserelin 3 M in hormonal therapy of prostate cancer in Ukrainian patients. The research was based on treatment cost of one patient during one year under condition of equivalent efficacy and safety of goserelin and triptorelin. The pharmacoeconomic analysis was conducted according to the «cost minimization» method. For calculation of direct costs when applying goserelin and triptorelin a pharmacoeconomic decision tree model was used, according to which the costs are computed with an allowance for possibilities and expenditures on side effects. The results of pharmacoeconomic modeling showed a tendency for a yearly cost cut in the amount of 2 887.69 UAH per patient when using triptorelin in model cohort which consisted of 1 000 patients. Besides, it allows 137 additional patients per thousand of them to be treated with triptorelin. As the result of modeling the influence on budget it was estimated that the amount of cost saving on buying triptorelin would average at 4,6 million UAH per every year for five years of its implementation. Hormone therapy with application of the analogues of gonadotropin-releasing hormone is one of the major treatment methods of patients with prostate cancer. A pharmacoeconomic analysis of triptorelin application in comparison with goserelin for treating patients with prostate cancer in Ukraine was conducted. The results of pharmacoeconomic modeling showed that a significant cost cut is expected when using triptorelin. It will allow additional patients, who need hormone therapy, to be treated