Introduction. A significant part of scientific publications on ensuring the availability of medicines in Ukrainian scientific and specialized publications is devoted, in particular, to the following issues: selection and optimization of methods for calculating prices for medicines and reference pricing, monitoring of prices for medicines, assessment of the availability of medicines, assessment of health technologies (medical technology assessment). The publications also address the issues of pricing for personalized medicines (extemporaneous manufacturing) and accounting for the release of medicines of different groups. However, the aspects of informatization of medicines price regulation from the point of view of pharmaceutical informatics have not been specifically considered. Therefore, the purpose of the study was to analyze the presented structures of information on nomenclature items of medicinal products in the regulatory legal acts on the regulation of prices for medicinal products in Ukraine. Based on the data obtained: to substantiate the feasibility of using a single identifier of the nomenclature position of a medicinal product in regulatory legal acts, to determine and systematize the format, scope and level of its application; to identify possible ways to reduce the number of regulatory legal acts regulating the prices of medicinal products in Ukraine. Material & methods. The objects of the study were information sources on the state regulation of pricing for medicines: regulatory acts, analytical documents, official websites of government agencies and specialized publications, scientific works of domestic scientists. The following methods were used in the study: descriptive statistics, systematization, grouping and generalization of the results. Results & discussion. The article analyzes the state of information on nomenclature items of medicinal products in the regulatory legal acts of the Ministry of Health of Ukraine on pricing: international nonproprietary names / common names of active pharmaceutical ingredients, names of manufacturers of medicinal products and codes of anatomical, therapeutic and chemical classification. The results of the work are presented as statistical data and examples of nonstandardized names of the above objects. Based on the data obtained, the problems caused by the state of submission of non-standardized information are described and ways to solve them are proposed. Conclusion. The basic method of information structure for recording information about medicinal products in the relevant registers and regulatory acts with regard to unique identifiers of nomenclature items is proposed. The author substantiates the need to create and use unified registers to ensure the possibility of automated generation of information on nomenclature items of medicinal products for regulatory legal acts. The lack of unified standards for the presentation of information on medicinal products in regulatory acts and medicinal product identifiers makes it impossible to use automated methods of information analysis, especially in the time dynamics. This, in turn, makes it impossible to use the results of the analyzes when making forecasts. The current structure of regulation and information provision may lead to cases where information in some regulations contradicts each other. The constant change in the validity of regulatory legal acts makes it impossible to create an up-to-date permanent reference to the latest information, and creates additional difficulties for practicing pharmacists who must comply with the standards and data specified in these legal acts in their daily work. The author substantiates the expediency of creating a single regulatory legal act on the regulation of prices for medicinal products for each of the regulatory authorities/structures. The author proposes to create a single legally approved URL with only relevant information on pricing aspects and the availability of an online chat and a public web forum where experts will provide quick responses to requests from practitioners.
Keywords: information, identification, standardization, regulations, registers, wholesale prices
The aim. To study the biocomplex of surfactants based on rhamnolipids Pseudomonas sp. PS-17 (biocomplex PS) as an emulsifier and co-emulsifier by using the method of modelling the composition of emulsions for use in dermatology.
Materials and methods. The biocomplex PS is a biogenic surface-active complex synthesized by bacteria of the genus Pseudomonas, which is a viscous mass that includes rhamnolipids, which make up to 80 % of the biocomplex, as well as alginate and water. The methods of computer simulation of semi-automated selection of the composition of the oil phase and emulsifiers of medicinal or cosmetic emulsions developed in the MO Excel program were used. In modelling processes, the biocomplex PS was studied as an independent emulsifier in o/w type emulsions, as well as a co-emulsifier of this type of emulsions in combination with type II emulsifiers.
Results. The substantiation of the concentration of emulsifiers in the composition of emulsion medicinal and cosmetic products is mainly carried out based on experimental studies; therefore, it requires a long time and is expensive. To reduce the number of technological experiments in the development of emulsion products stabilized by a biocomplex of surfactants based on biocomplex PS, a method of computer simulation of the composition of emulsions in the MO Excel program was developed and used. A method based on the application of the hydrophilic- lipophilic balance system. Two examples of solving specific problems of choosing a complex emulsifier and the composition of the oil phase components of the emulsion product are given.
Conclusions. The use of a semi-automated modelling system provides a reasoned choice of the composition of the oil phase of the emulsion when using the PS biocomplex as an independent emulsifier or the choice of the ratio between the PS biocomplex and the type II emulsifier when using a complex emulsifier and allows rational experimental study
Keywords: emulsions, emulsifiers, rhamnolipids Pseudomonas sp. PS-17, medicines, cosmetics, hydrophilic-lipophilic balance, emulsions, emulsifiers, rhamnolipids Pseudomonas sp. PS-17, medicines, cosmetics, hydrophilic-lipophilic balance
Зважаючи на високу розповсюдженість мігрені серед жінок репродуктивного віку, вплив вказаної патології на стан здоров’я матері та плоду підбір адекватної фармакотерапії є надзвичайно важливим процесом.
Мета роботи ‒ проаналізувати можливість застосування кожного з зареєстрованих на фармацевтичному ринку України триптанів для лікування мігренозних пароксизмів у жінок під час вагітності на підставі інструкцій, даних наукової літератури тощо.
Матеріали дослідження ‒ дані інформаційно-довідкової та наукової літератури, Державний реєстр лікарських засобів України, УТІС. Методи дослідження ‒ вебометричний та порівняльний аналізи, систематизація даних.
Станом на вересень 2022 р. в Україні зареєстровано елетриптан, золмітриптан, ризатриптан, суматритптан, фроватриптан.
Найповнішу інформацію щодо застосування суматриптану в період вагітності представлено в інструкціях до Сумамігрен та Антимігрен-Здоров’я. Узагальнено та стисло з усіх інструкцій інформація така: «Застосування суматриптану можливе лише у випадках, коли очікувана користь для матері перевищує можливі ризики для плоду». Інформація в інструкціях ризатрпитану є практично ідентичною для Різамігрену та Різоптану, а для Ризатриптан-Фарматен подана суттєво стисліше: «У період вагітності ризатриптан слід застосовувати лише у разі нагальної потреби». В інструкції до золмітриптану Золмігрен спрей вказано: «Застосування препарату вагітними можливе лише тоді, коли очікуваний терапевтичний ефект для жінки перевищує потенційний ризик для плода/дитини.» Вітчизняні та закордонні виробники таблетованих лікарських засобів вказують аналогічну інформацію. В Україні зареєстровано 1 лікарський засіб фроватриптану, де вказано: «Безпечність застосування у вагітних не встановлена», та 1 ЛЗ елетриптану: «Досвід клінічного застосування у вагітних відсутній».
Станом на вересень 2022 року в Україні зареєстровано: суматриптан, ризатриптан, золмітриптан. фроватриптан, елетриптан. Форми випуску: таблетки, таблетки вкриті оболонкою або плівковою оболонкою, таблетки, що диспергуються у ротовій порожнині, капсули, спрей назальний дозований. Інформація в інструкціях для медичного застосування кожної окремо взятої для аналізу міжнародної непатентованої назви лікарських засобів триптанів за змістом є подібною, проте не ідентичною. Суматриптан вважають єдиним відносно безпечним триптаном для лікування мігренозних пароксизмів у вагітних жінок. Перспективним напрямом розвитку та розширення вітчизняного фармацевтичного ринку триптанів є реєстрація нових лікарських форм та діючих речовин (алмотриптан, ласмідитан, наратриптан).
More than 1 month since Russia began its illegal invasion of Ukraine the tragic human suffering and loss of life are clear. Each day brings more death, injuries, and stories of people fighting for their lives. The implications of the war extend beyond the military and civilian casualties. There are geopolitical, financial, infrastructural, and health impacts. And the effects of this war, particularly on health and health care within and outside Ukraine, will continue long after violent conflict ends.
The war has brought immense pressures and demands for the Ukrainian health sector. There have been 3039 civilian casualties recorded, including 104 children and 1075 adults killed as of March 28, 2022.The risk of infectious disease outbreaks, particularly COVID-19, cholera, polio, tuberculosis, and diarrhoeal diseases, is rising as people are forced to shelter in overcrowded spaces with inadequate or no access to water and sanitation facilities.The UN High Commissioner for Refugees stated the war has forced 10 million Ukrainians to flee their homes,of whom about 6·4 millionare displaced internally and in desperate need of urgent aid, treatment for recent injuries and illness, and continued care for chronic conditions. Food shortages are arising because of damage to agricultural infrastructure and disruptions in food supply chains.The risks of mental health and psychosocial deterioration are growing as people face traumatic events and stress from acute conflict.Attacks on and around maternity hospitals mean many women do not have access to the obstetric care they need, increasing the risks of maternal and neonatal morbidity and mortality.It is estimated that more than 2 million children younger than 5 years and pregnant and breastfeeding women in Ukraine are in need of nutrition assistance.There could also be health risks related to potential Russian use of nuclear, chemical, or biological weapons against Ukrainian civilians.