Aspekty prawne pozarejestracyjnego leczenia „medyczną marihuaną” pacjentów chorych terminalnie – eksperyment medyczny czy realizacja prawa pacjenta do pobierania świadczeń zgodnych z aktualną wiedzą medyczną?

The subject of the use of medicinal products containing “medical marijuana” during the therapy of terminal patients has been the subject of extensive discussion until recently. Currently, such action is legal, but questions still arise not so much about the possibility of using medical marijuana in the treatment of terminally ill patients, but about the implementation of off-label use treatment. The analysis of the applicable legal provisions, views of scholars in the field, and the case law allow us to conclude that treatment involving medical marijuana inconsistently with the SmPC (Summary of Product Characteristics) is an acceptable action that should not be equated with a therapeutic experiment in the strict sense. The above is confirmed by the admissibility of using marijuana raw materials as the basis for the preparation of a pharmacy-compounded (prescription) medicine. The production of pharmacy-compounded drugs requires the use of pharmaceutical raw materials, the amount and composition of which depend on an independent decision of the person prescribing the medicine. The admissibility of any composition of the contents of a pharmacy-compounded drug containing medical marijuana speaks for the admissibility of its use in any way. The above leads to adoption of similar requirements in relation to pre-made drugs containing marijuana. Regardless of the admissibility of using medical marijuana outside the SmPC or in the form of a compounded drug, medical marijuana treatment is the implementation of the patient’s right to treat pain and receive health services in accordance with the current state of medical knowledge.Tematyka stosowania produktów leczniczych zawierających „marihuanę medyczną” w terapii pacjentów terminalnych była do niedawna przedmiotem szerokiej dyskusji. Obecnie takie działanie jest legalne, ale wciąż pojawiają się pytania, związane nie tyle z możliwością stosowania medycznej marihuany w leczeniu pacjentów nieuleczalnie chorych, ile z wdrożeniem leczenia poza wskazaniami rejestracyjnymi. Analiza obowiązujących przepisów prawa, stanowiska doktryny i linii orzeczniczej pozwala stwierdzić, że leczenie marihuaną medyczną poza ChPL (Charakterystyka Produktu Leczniczego) jest działaniem dopuszczalnym, którego nie należy utożsamiać z eksperymentem leczniczym sensu stricto. Potwierdzeniem powyższego jest dopuszczalność wykorzystania surowców marihuany jako podstawy do przygotowania leku aptecznego (recepturowego). Produkcja leków farmaceutycznych wymaga użycia surowców farmaceutycznych, których ilość i skład zależy od samodzielnej decyzji osoby przepisującej lek. Dopuszczalność dowolnej kompozycji zawartości leku aptecznego zawierającego medyczną marihuanę przemawia za dopuszczalnością jej użycia w jakikolwiek sposób. Powyższe prowadzi do przyjęcia podobnych rygorów w stosunku do gotowych leków zawierających marihuanę. Niezależnie od dopuszczalności stosowania marihuany medycznej poza ChPL lub w postaci leku aptecznego, leczenie marihuaną medyczną jest realizacją prawa pacjenta do leczenia bólu i korzystania ze świadczeń zdrowotnych zgodnie z aktualnym stanem wiedzy medycznej

Organizacja i zarządzanie służbą meteorologiczną w Polsce

Today, climate services are one of the most important tools for determining changes and adapting to climate change. In order to expand the existing climate information, members of the WMO and partner institutions from the United Nations Organization established a programme of a Global Framework for Climate Services-GFCS. In Poland, the principal and the parent institution engaged in meteorological and hydrological service is the Institute of Meteorology and Water Management - National Research Institute. Conducted in the IMWM-NRI National Hydrological and Meteorological Service includes the following subsystems: observation and measurement, ICT and communications, data processing, forecasting and warning. The institute continuously provides information to the state authorities and the public about the current state of the atmosphere and hydrosphere, as well as forecasts and warnings.Współcześnie usługi klimatyczne są jednym z najważniejszych narzędzi określania zmian i adaptacji do zmian klimatu. W celu poszerzenia istniejących informacji klimatycznych, członkowie WMO i instytucje partnerskie z ONZ utworzyli program Globalne Ramy Służb Klimatycznych – GFCS (Global Framework for Climate Services). W Polsce główną i nadrzędną jednostką zajmującą się służbą meteorologiczną oraz hydrologiczną jest Instytut Meteorologii i Gospodarki Wodnej – Pań- stwowy Instytut Badawczy (IMGW-PIB). Prowadzona w IMGW-PIB Państwowa Służba Hydrologiczno-Meteorologiczna (PSHM) obejmuje następujące podsystemy: obserwacyjno-pomiarowy, teleinformatyczny i łączności, przetwarzania danych, prognozowania i ostrzegania. Instytut w sposób ciągły zapewnia organom państwa i społeczeństwu informacje o aktualnym stanie atmosfery i hydrosfery, a także prognozy i ostrzeżeni

Legal aspects of teleservices in oncology

The use of teleinformatic tools and other means of communication in specialist care, including oncological care, is completely admissible and in accordance with currently binding law. Key legal acts on principles of providing health services, including the Act on the Profession of Doctor and Dentist and the Act on Medical Activity, allow adjudicating on patient’s health status and providing all activities of health service nature with the use of teleinformatic means and other communication systems. No organizational standards on televisits in specialist care were established to date, imposing per analogiam use of the regulations on organizational standards of teleservices in primary health care. However, such a solution should be considered temporary and imprecise, therefore the regulation dedicated to providing televisits within specialist care, including its specificity and concerning areas, is essential. Simultaneously it is necessary to eliminate the use of announcements and guidelines of the National Health Fund which refer to admissibility of televisits as binding legal form. Announcements, guidelines, recommendations and positions may only serve as advice for proceeding, which should be eventually reflected in the current law

Off-label use of medicinal products in oncology: exercising due diligence or experimental activity?

One of the primary responsibilities of a physician is to diagnose and treat diseases with due diligence. Exercising due diligence in treatment process involves, among others, the use of optimal diagnostic, therapeutic and follow-up mana­gement in accordance with the current state of medical knowledge. Each medicinal product has the Summary of Product Characteristics which defines, among others, registered indications, the age group for which the product is registered, the dosing scheme, and route of administration of the product. Polish law does not refer directly to the admissibility of products that use off-label nor does it include regulations forbidding such activities. Considering a number of problems associated with products which use off-label and, on the other hand, commonness of such activities, it is necessary to introduce legal regulations defining the legitimacy and admissibility of such methods of proceeding

Benefits of nutritional yeast for children on vegan diet

Introduction: Nutritional yeast are a food product that can be fortified with valuable components. They are a product suitable for introducing into the diet of vegan children due to their friendly form, good taste and relatively low cost. Aim of the study: Summarize current knowledge on the benefits of introducing nutritional yeast into children's diets as supplementation for deficiencies in a vegan diet. Demonstrate the positive impact of the product on the health of the body. Methods and materials: : A review of the literature available in the PubMed database and Google Scholar, the following keywords were used: "nutritional yeast", "vegan diet in children", "nutritional yeast impact on health". Results: Introducing nutritional yeast into the diet of a child restricting animal products has measurable benefits. It reduces the risk of deficiencies such as deficiency of vitamin B12, zinc, protein and the following disease symptoms. Conclusion: The constantly growing number of infants and older children on vegan diets is a challenge for modern pediatrics, but also an opportunity to find new products that meet the high nutritional requirements of children during the developmental period. Nutritional yeast can be considered such a product thanks to their richness in nutrients that meat products contain but are not found in plant based foods. Nutritional yeast, however, cannot be a reason to completely abandon other sources of vitamin B12 supplementation

The effect of air pollution on the risk of inflammatory bowel disease, colorectal cancer and appendicitis

Introduction and objective Intense industrial development is contributing to increased emissions of air pollutants. Numerous studies indicate a link between air pollution and a higher risk of pulmonary and cardiovascular diseases. Our goal is to analyze available scientific studies to demonstrate the relationship between air pollution and the risk of developing and complicating inflammatory bowel disease, colorectal cancer and appendicitis. Brief description of the state of knowledge Air pollution is a global health challenge. Particles such as PM, nitrogen oxides, sulfur oxides or ozone have a significant impact on health. Studies suggest a link between pollution and intestinal diseases (IBD, CRC, appendicitis). Air pollutants can affect the gut by causing inflammation, oxidative stress and disruption of the gut microbiota. Exposure to PM2.5 can increase the risk of IBD, CRC, and PM10 can increase the risk of UC. There is a correlation between pollution and the rate of hospitalization for IBD. In addition, exposure to PM2.5 increases the risk of colorectal cancer mortality. Short-term exposure to air pollution is associated with more hospitalizations for appendicitis. Summary Air pollution is a real health risk. Reducing air pollution could potentially reduce the risk of developing these intestinal diseases and their complications. Despite the potential links, further research is required to better understand the mechanisms of action of pollutants on intestinal health. Urgent and coordinated global and local action is needed to reduce air pollution emissions and protect the health of the public

3D bioprinting as a future of regenerative medicine and hope for transplantology

Introduction: 3D bioprinting is a continuously refined technology that enables tissue structures to be faithfully reproduced, using specially developed bioinks and 3D printers. Thanks to its versatility, it is possible to use it in regenerative medicine and transplantation, which could have a positive impact on the survival and comfort of patients with injuries and those awaiting transplantation. Aim of the study: Summarise the current state of knowledge on the use of 3D bioprinting technology in the field of regenerative medicine and transplantation, to present the extent of the method's capabilities and examples of its applications, and to outline what role it will play in the future of medicine. Methods and materials: A review of the literature available in the PubMed database and Google Scholar from the last 5 years was conducted, using the following keywords: 3d bioprinting, regenerative medicine, tissue biofabrication. Results: Significant progress has been made in the field of bioprinting and various types of tissue are now being printed and tested. Current research into the printing of skin tissue leads us to believe that in the coming years, 3D bioprinting using stem cells will make it possible to significantly improve the treatment of skin injuries. Researchers are also working on using this technology in the field of neurology and bone damage.  Conclusion: The dynamic development of 3D bioprinting technology offers the hope of eliminating the main transplantation problem related to donor availability. However, the road to wider clinical application of this technology is still a long one, due to the numerous technological difficulties associated with the development of bioprinters, advanced printers and a thorough understanding of human tissue architecture. With the current intensified research in this field, it is expected that these problems will be eliminated in time and the technology will gain more interest from clinicians. &nbsp

Atopic dermatitis – clinical phenotypes and related therapeutic possibilities

Introduction: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. It is characterized by damaged epidermal barrier, skin dysbiosis and pruritus. It affects up to 20% of the population of developed countries. AD represents a heterogeneous condition belonging to the spectrum of atopic diseases. It occurs in the form of multiple phenotypes with varied pathogenesis requiring different therapeutic strategies.  Aim of the study: To summarize the current state of knowledge on AD phenotypes and related therapeutic options.  Methods and materials: A review of the literature available in PudMed and Google Scholar databases was conducted. The following keywords were used: "atopic dermatitis", "atopic dermatitis phenotypes", "atopic dermatitis current treatment".  Results: There are many phenotypes of AD. However, due to the lack of a consistent classification system, identifying phenotypes is greatly hindered. It is possible to use the division of phenotypes into groups based on age, lesion topography, lesion morphology and patient ethnicity. Various drugs are available for the treatment of AD, but therapeutic strategies for specific phenotypes are sparse and insufficiently understood due to the problem of identifying phenotypes and the complexity of the endotypes behind them. Treatment of AD is not currently based on phenotype-specific targeted therapy.  Conclusion: Development of personalized therapy for the treatment of AD requires additional research using uniform definitions of phenotypes and endotypes. It is necessary to create a classification system for AD phenotypes

Endometriosis - Pathogenesis, diagnosis and treatment

Introduction: Endometriosis is defined as a chronic gynecological disease characterized by endometrial tissue outside the uterus. The condition affects 5-10% of women of reproductive age worldwide and is associated with pelvic pain and infertility. Despite its prevalence, diagnosis is usually delayed for many years which postpones the introduction of appropriate treatment. Aim of the study: Summary of the current state of knowledge on endometriosis, analyzing the pathogenesis, the current diagnostic approach, highlighting the problem of fertility in this disease entity and presenting treatment options. Methods and materials: A review of the literaturę available in the PubMed database and GoogleScholar from the last 5years was conducted,using the following keywords: endometriosis”, „endometriosis pathogenesis”, „endometriosis diagnosis”, „infertility in endometriosis”, „endometriosis treatment” Results: Among the etiological factors mentioned are congenital, environmental, epigenetic, autoimmune and allergic factors. The main theory for the formation of the condition is retrograde menstruation through the fallopian tubes into the peritoneal cavity and implantation of endometrial cells. Laparoscopy is nowadays the gold standard for diagnosis, but less invasive methods that can shorten the time to diagnosis are being sought. Current treatment is limited to surgery, hormonal treatment and analgesics which are associated with many side effects. Conclusion: Endometriosis is the cause of infertility, chronic pain and reduced quality of life in many women. Non-invasive diagnostic tests such as imaging studies, genetic tests, biomarkers or miRNAs have diagnostic potential but more analysis is needed to be applied in daily clinical work. Future research should focus on learning and understanding the pathogenesis, identifying subtypes of the disease, and a modern approach to diagnosis and comprehensive treatment taking into account concomitant general symptoms