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Criminal liability in the handling of narcotic drugs and psychotropic substances in the health care sector
Jedličková, Kristýna ; Bohuslav, Lukáš (advisor) ; Drápal, Jakub (referee)
The present thesis deals with the criminal liability in the handling of narcotic drugs and psychotropic substances in the health care sector, which is accompanied by a number of nooks and crannies that I try to reveal in the thesis. The thesis explores the duties and responsibilities of health service providers, whose role is crucial to ensuring quality care and patient safety. The first part of the thesis focuses on defining basic terms in the field of health service delivery. Then the thesis analyses the obligations that health service providers, especially doctors, have to comply with. The key term is the duty of lege artis, and the thesis discusses in detail the various aspects of this duty, its violation in the form of non lege artis procedure, and then provides examples from practice. The second part of the thesis is devoted to medicinal products, whereby their development up to registration is first presented, followed by their prescription. An important topic is also off-label medication, which "gained popularity" especially in the period of the COVID-19 pandemic. The third part of the thesis deals with criminal liability and its basic aspects, together with circumstances precluding illegality, which are focused on the area of provision of health services. This part then discusses in detail...
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Principles of preparation and administration of selected Medicaments in the Intensive Care
ZÁRUBA, Petr
According to the European Union, medication errors are among the most common adverse events connected with the provision of healthcare services. The safety of nursing care is a basic indicator of the quality of health care providers. One of the basic activities of general nurses is the preparation and administration of medicines, during which, especially in intensive care, even the slightest non-compliance can harm the patient. When preparing and administering medicines it is therefore essential that general nurses consistently follow safety regulations, internal guidelines of health care providers, recommendations of the World Health Organization and national nursing standards, which can effectively prevent potential errors. In clinical practice general nurses may not adhere to these measures for a variety of reasons, so it is important to establish and analyse them. In the theoretical part, the legislative framework for the preparation and administration of medicines in the Czech Republic is defined. This part also describes general principles of handling medicines connected with the problem of medication errors in the context of the quality of health services and defines forms of medicines and their application methods. The practical part of the paper sets out to determine what knowledge nurses working in intensive care have, whether they apply this knowledge in their work process and whether they observe failings of their colleagues relating to the preparation and administration of medicines. With this in mind, four hypotheses and six research questions were established. A quantitative method, non-standardised questionnaire technique was used to collect data. After the quantitative method, the method of qualitative investigation by observation and the technique of an in-depth semi-structured interview were conducted. The research population comprised non-medical health care workers (general nurses and paramedics) working in anaesthesiology-resuscitation departments and intensive care units of district-type hospitals. The quantitative data was processed using descriptive statistics with tables and graphs, while the qualitative data was processed using charts and diagrams.
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Registrované léčivé přípravky ve formě bylinných čajů
Žabčíková, Hana
The diploma thesis deals with the issue of herbal tea, which is registered as medicinal product. The consumer market research has shown that these kinds of tea are put on the market by Megafyt Pharma s.r.o. and Leros s.r.o. An overview of all single-species medicinal tea and tea mixtures from both producers was created. In the practical part, the content of essential oil in the medicinal tea leaves of chamomile and sage from the producer Megafyt Pharma s.r.o. and the content of tannins in the tea leaves of Agrimonia eupatoria from the same producer were determined. The samples of individual drugs of different ranks were used for the determination and the evaluation was performed according to the Český lékopis 2017. The results were statistically evaluated. The obtained results showed that the essential oil content of chamomile corresponds to the pharmaceutical quality, but for the sage sample the essential oil content does not correspond to the given standard. In the case of Agrimonia eupatoria, the content of tannins was lower than determined by the Český lékopis 2017, only one sample of the given rank showed a higher content. Furthermore, the frequency of occurrence of individual species of herbs contained in the registered tea mixtures was evaluated.
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Price and reimbursement regulation of medicinal products in the Czech Republic
Němeček, Ondřej ; Lang, Roman (advisor) ; Tomšej, Jakub (referee)
Price and reimbursement regulation of medicinal products in the Czech Republic Price and reimbursement regulation of medicinal products is an integral and important part of the public health insurance system. The aim of the thesis is to describe the methods of regulation in the Czech Republic, to evaluate some of its elements and to give real examples or experiences that are known to the author of the thesis from his work experience at the State Institute for Drug Control. Apart from outlining the issues in the introduction and evaluating them in the conclusion, the thesis is divided into five chapters. The first chapter defines the basic concepts that are necessary for understanding the mechanisms of price and reimbursement regulation of medicinal products. The second chapter focuses on the historical development of price and reimbursement regulation, or the situation before and after 2008, which can undoubtedly be considered the most important milestone so far, marking the transition to the current legislation, where the maximum price and the level of reimbursement conditions are set in an administrative procedure. The third chapter then discusses price regulation, its general background and the methods of setting the maximum price. The author also describes the standard course of administrative...
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Regulation of advertisements in pharmaceutical industry
Metelka, Jan ; Patěk, Daniel (advisor) ; Rozehnal, Aleš (referee)
Abstract, Jan Metelka The main aim of this diploma thesis was to firstly explain the field of human pharmaceuticals and regulation of advertisement regarding them, from the general point of view and then in details. In order to achieve this it was required to define advertisement and pharmaceuticals because these terms and crucial for the whole thesis. Both definitions may be off the scope of this text however it plays an important role in understanding all necessary issues. Advertisements in pharmaceutical industry have some specifics as described in chapter 2. There are two kinds of recipients - experts (doctors and pharmacists) and ordinary people (mostly patients). Every kind is special and regulated in a different way. Third chapter described all steps in administrative proceedings related to Act on Advertisement, forming a public branch of law against unfair competition. It summarises and divides all misdemeanours, statistically describes how often they occur and deeply analyses possible breaches of Act on Advertisement. The main part of this thesis is Chapter seven, dealing with unfair competition in private law, as mentioned in early chapters, however here it is specifically described how to apply the general clause and the more important kinds of unfair competition such as deceptive adverts and...
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Marketing authorisation in the Czech Republik
Švestka, Miroslav ; Svoboda, Petr (advisor) ; Handrlica, Jakub (referee)
Marketing authorisation in the Czech Republic The purpose of the thesis is to provide an overview of essential principles of a process of medicinal products' marketing authorisation in the Czech Republic. Every medicinal product produced on a large-scale must be registered by responsible authority before launching on the market, this process guarantees its effectiveness and safety. Even though the topic is a subject of quickly evolving legislation, in the Czech Republic has not been elaborated any coherent monograph on the issue yet. The diploma thesis is composed of seven chapters, starting with the overview of the historical legislation of medicinal products' marketing authorisation and ending with today's legislation affected by European Union legislation. The second chapter is dealing with the history of the marketing authorisation of medicinal products, which has its beginnings in 1920s, such dating argues that this is not a new field of a legislation. Following a brief outline of the history the third chapter of the diploma thesis explains today's legislation and gives an overview of European legislation and jurisdiction of Court of Justice of the European Union that have important impact on the Czech legislation. In the fourth chapter the thesis focuses on State Institute for Drug Control...
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Legal regulation of securing availability of humane pharmaceuticals
Verosta, Stanislav ; Rajchl, Jiří (advisor) ; Svoboda, Petr (referee)
Legislation for securing the availability of human pharmaceuticals Abstract Medicinal products are a specific type of goods necessary for effective provision of health services. The Act on Pharmaceuticals entrusts legal instruments to the Ministry of Health, the State Institute for Drug Control and other entities in order to prevent shortages of medicinal products. The goal of this thesis is to introduce and analyse specific instruments that can be used to resolve potential or existing shortages of medicinal products in the Czech Republic. For the purpose of clarity, the diploma thesis is divided into a total of 10 chapters. The first two chapters define the basic terms, which are then used throughout the thesis, and administrative bodies that are important participants in securing the availability of medicinal products. Regarding the basic terms, they are a medicinal product, availability of medicinal products, the marketing authorisation holder and placement of a medicinal product on the market in the Czech Republic. The competence of administrative bodies in the area of securing the availability of medicinal products is also elaborated in more detail in the second chapter. The third chapter introduces the sources of knowledge in determining the potential shortages of medicinal products. The market...
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Dispensing of medicinal products under the act on pharmaceuticals
Krchňáková, Klára ; Handrlica, Jakub (referee)
Dispensing of medicinal products under the Act on Pharmaceuticals Medicinal products are an important part of almost everyone's life due to their ability to minimize, prevent or eliminate undesirable external influences. Given the need to ensure the safety of the use of medicinal products and the protection of public health, the dispensing of medicinal products needs to be highly regulated. The aim of this thesis is to analyze and describe the legal regulation of the process of dispensing medicinal products in pharmacies, with emphasis on the mail-order dispensing of medicinal products, to point out to legislative shortcomings and to propose changes de lege ferenda. In order to fulfil these objectives, the thesis is divided into five parts. The first part of this thesis deals with basic legislative concepts in the field of dispensing of medicinal products and sources of legislation at the Czech and European level, including a detailed analysis of the guidelines of the State Institute for Drug Control and their ability to regulate the rights and obligations of their recipients in a binding manner. Finally, the first part covers the public authorities regulating the dispensing of medicinal products. The second part of the thesis provides an analysis of the current regulation of dispensing of...
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Dispensing of medicinal products under the Act on Pharmaceuticals
Krchňáková, Klára ; Staša, Josef (advisor) ; Svoboda, Petr (referee)
Dispensing of medicinal products under the Act on Pharmaceuticals Medicinal products are an important part of almost everyone's life due to their ability to minimize, prevent or eliminate undesirable external influences. Given the need to ensure the safety of the use of medicinal products and the protection of public health, the dispensing of medicinal products needs to be highly regulated. The aim of this thesis is to analyze and describe the legal regulation of the process of dispensing medicinal products in pharmacies, with emphasis on the mail-order dispensing of medicinal products, to point out to legislative shortcomings and to propose changes de lege ferenda. In order to fulfil these objectives, the thesis is divided into five parts. The first part of this thesis deals with basic legislative concepts in the field of dispensing of medicinal products and sources of legislation at the Czech and European level, including a detailed analysis of the guidelines of the State Institute for Drug Control and their ability to regulate the rights and obligations of their recipients in a binding manner. Finally, the first part covers the public authorities regulating the dispensing of medicinal products. The second part of the thesis provides an analysis of the current regulation of dispensing of...
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