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The role of nurse in the pharmacotherapy team
Hašková, Martina ; Heczková, Jana (advisor) ; Jeřábková, Lenka (referee)
This diploma thesis deals with current pharmacotherapeutic care with a focus on activities that nurses take part in. The aim was to collect and evaluate the views and experiences of selected nurses regarding their role in pharmacotherapy team, particularly what activities they perform in such team and how their pharmacotherapy teams work in general. SWOT analysis was then used firstly to evaluate the current role of nurses and secondly to suggest a way of implementation of possible extension of nurses' competencies in pharmacotherapy. In order to collect the required data, semi-structured interviews were conducted. These were recorded, so they could be easily processed afterwards. During transcription of the interviews into written text, all the collected data was briefly analysed. The data was further analysed using the open coding method, when three main categories with specific subcategories and subcodes were identified. All the selected men and women, which were asked for cooperation, are people working as a nurse without supervision and mentoring. Based on their career history all of them were expected to have a more specific experience with the issue. The respondents were mainly nurses with long-term working experience, often working in middle or senior management. When selecting the future...
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Regulation of prices and reimbursements of medicinal products
Hric, Tomáš ; Staša, Josef (advisor) ; Svoboda, Petr (referee)
Regulation of prices and reimbursement of medicinal products Abstract Medicinal products are essentially part of every human life. It is therefore desirable to ensure that they are offered on the market at a fair and affordable price, precisely through price and reimbursement regulation. The aim of this diploma thesis is to analyse how the regulation of prices and reimbursements applies to human medicinal products in the provision of outpatient health care, the price and reimbursement of which is decided by the State Institute for Drug Control in administrative proceedings. In order to achieve this goal, the thesis is divided into four parts. The first part defines the basic concepts needed understand the meaning and purpose of the system of price and reimbursement regulation, such as a medicinal product, price or reimbursement. Furthermore, this part is devoted to the types of administrative acts occurring in the field of price and reimbursement regulation and introduces the Ministry of Health and the State Institute for Drug Control as the most important administrative authorities operating in this field. The second part analyses the legislation effective until 31st December 2007. The forms of administrative activity then performed by the Ministry of Health and the Ministry of Finance are analysed in more...
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Price regulation of preparations for medical treatment
Beutlová, Lenka ; Staša, Josef (advisor) ; Svoboda, Petr (referee)
Price regulation of preparations for medical treatment Abstract The present master thesis describes and analyzes the system of medicinal product's pricing regulation in the Czech Republic after the year 1989. The aim is to execute an analysis of the current legal regulation in the context of previous regulation, of particular phases of the process of regulation of medicinal product's prices and to provide a summary of the principles and recommendations as well as to attempt a proposition of future development possibilities. The thesis focuses on Czech legal regulation, decision-making by the judicial bodies, public bodies' activity, as well as on European legislative and jurisdiction. The thesis is divided into five chapters. The first chapter involves the system of pricing and reimbursement regulation of medicinal products into pharmaceutic legislation. The second chapter is divided into two sub-chapters. The first presents the current legal regulation of pricing and reimbursement regulation of medicinal products in the context of international legislation, European legislation and European jurisdiction, as well as domestic legislation. The second chapter also considers public bodies - the Ministry of Health of the Czech Republic and the State Institute for Drug Control - and their activity regarding this...
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Clinical trials of pharmaceuticals
Horáková, Kateřina ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
Clinical trials of medicinal products is increasingly important area of pharmaceutical law. Number of clinical trials and amount of financial resources is constantly rising and therefore the rules and principles of the clinical trials itself are being clarified overtime. This diploma thesis aims to provide an overview of the basic aspects of clinical trials of medicinal products for human use from a legal point of view. The author focuses in particular on the national legislation of clinical trials, which is complemented by the legislation of the European Union and important sources of the international law. Author is more closely analysing the particular procedures performed within the clinical trials, especially from the point of view of the administrative law. Particular attention is paid to the ethical review of the clinical trials, their particular aspects and the overall concept. The thesis is divided into twelve chapters. In the introduction, the author focuses on the development of the clinical trials and mentions the crucial moments that contributed to the formulation of the basic rules of the clinical trials. The following chapter focuses on the sources of law. Firstly, sources of international law are described, where more general sources and specific sources of law of medicinal products...
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Clinical trials of pharmaceuticals
Nedvědová, Michaela ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
This master thesis is a description of the clinical trial, which is part of medical law un- der the law aspects. This thesis is split to topic, whose a brief outline is in the introduction. Process of the clinical trial and their institutions are discussed under the law and medical aspects. Resources of this thesis are a professional literature, knowledge of experts from pharmaceutical company and my own experience from part-time job in this type of com- panies. Aim of the thesis is to bring more resources and information about that topic to experts and other people who are interested in. This thesis is devided into five chapters. First chapter is speaking about a general insti- tute in the clinical trial. There are listed sources of the law. In the next chapter I deal with the process of the clinical trial from the begining i.e. from the development of a new sub- stance through the clinical trial to the final registration. The chapter about the european law regulation is following. In the fourth chapter I deal with the ethical aspects, which are conected with clinical trial. In that part I emphasised the influence of the international ethical documents. The last chapter is conclusion, where I describe the goal of this master thesis and also I am linking to the opinions of authorities regarding the...
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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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Effectiveness of price regulation of drugs from a social point of view in the Czech Republic
Půžová, Kateřina ; Pažitný, Peter (advisor) ; Lešetický, Ondřej (referee)
The aim of this thesis is to determine the effectiveness of price regulation of drugs from a social point of view in the Czech Republic. The first part focuses on the theoretical basis for subsequent processing practical part. Theoretical solutions include a description of the objectives and instruments of health and drug policies, and a more detailed description of price regulation in the Czech Republic as a tool of drug policy. The practical part is composed of two parts. The first of them covers three models that show how you can set a maximum price of producer. This first part is the starting point for the second part. Second part deals with the analysis of administrative proceedings in which it exercised its right to express their views to the documents MAH medicine. The analysis shows that price controls are not efficient in these cases, and it burdens the society's interests. The thesis also recommendations for increasing efficiency.
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Distribution network of the pharmaceutical industry
Novotná, Ivana ; Drozen, František (advisor) ; Šípek, Ladislav (referee)
This thesis deals with the descriptive analysis of entire process of the pharmaceutical industry's distribution and the verification of its effective functioning in the Czech Republic. The first part is focused on the definition of key terms and presents the theoretical basis for this thesis (specifics of pharma industry, history of pharmaceutics and pharma industry, actual situation and predictions of pharma industry). The second part is concerned the individual subjects of the distribution - pharmaceutical company, wholesaler and pharmacy.
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