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Allergics reactions to herbal medicines in childern
Meincke, Ricarda ; Pokladníková, Jitka (advisor) ; Marešová, Helena (referee)
Background: The use of herbal medicines in children and adolescents is continually on the rise. Contrary to popular belief, herbal products (HPs) are not always a safe alternative to conventional drugs and can cause a variety of adverse events such as severe and fatal allergic reactions. In regards to herbal medicine use in children, a recently published systematic review that searched PubMed, Embase, PsycINFO and AMED included 58 studies from 19 countries and found overall herbal lifetime use to be between 0.8-85.5 % and 2.2-8.9 % for current use. Unlike most synthetically produced drugs, the adverse event profile of such "natural" preparations in children has rarely been studied. To this date, effective systems that monitor adverse drug events (ADRs) and long term side effects associated with HPs are either non-existent or still developing in many countries. Due to insufficient and inconsistent ADR reporting, little is known about the ADR spectrum of herbals in pediatric patients. Awareness of the potential of HPs to cause ADRs, particularly in children and adolescents, needs to be increased and reporting to national pharmacovigilance centers (PVCs) reinforced. Objectives: This project analyzed the worldwide adverse event data for herbal drugs related to hypersensitivity reactions as recorded in...
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Pharmacovigilance: Drug regulation development and legislation overview.
Manišová, Michaela ; Kostřiba, Jan (advisor) ; Zimčíková, Eva (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Social and Clinical Pharmacy Candidate Mgr. Michaela Manišová Consultant PharmDr. Jan Kostřiba, Ph.D. Title of Thesis Pharmacovigilance: Drug regulation development and legislation overview. Introduction: Pharmacovigilance is a scientific discipline relating to the detection and evaluation of adverse drug reactions and other risks associated with the use of the medicinal products after marketing authorisation and implementation of the risk minimisation measures. Objectives: To analyze the legislation requirements in the area of pharmacovigilance for the medicinal products for human use in the European Union and their implementation in practice. Trends in adverse drug reactions reporting in the various pharmacovigilance systems (United States, Czech Republic, European Union), evaluation of the factors affecting reporting and the main benefits of spontaneous reporting. Methods: The legal requirements of the European Union, the Czech Republic and the United States was used as the source of information, followed by the official website of the Drug Regulatory Authorities, the best practices guidelines prepared by the European Medicines Agency and by the Food and Drug Administration, the harmonization guidelines issued by...
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Competitive Intelligence in pharmaceutical industry
Hubálková, Pavla ; Papík, Richard (advisor) ; Horváth, David (referee)
This diploma thesis describes and analyzes an area of competitive intelligence in the pharmaceutical industry. The work is divided into five parts. The first part deals with competitive intelligence and related aspects, the second part is dedicated to the pharmaceutical industry, with all specifics. The third part deals with competitive intelligence in the intersection with the pharmaceutical industry, the fourth part contains the classification and description of information resources appropriate for the activities of CI and a fifth part presents research, which consists of a questionnaire survey among pharmaceutical companies on the state of competitive intelligence and semi-structured interview with an expert in the area of CI in pharmaceutical company. The survey results represent a certain sub-probe, which demonstrates the strong position of CI as a common standard of pharmaceutical companies. Keywords competitive intelligence, pharmaceutical industry, information needs, drugs, pharmacovigilance, patents, information resources
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Analysis of spontaneous adverse drug reactions reporting hormonal contraception and hormone replacement therapy
Ryndová, Vendula ; Malá, Kateřina (advisor) ; Horký, Pavel (referee)
Analysis of spontaneous adverse drug reactions reporting hormonal contraception and hormone replacement therapy Author: Vendula Ryndová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hormonal contraception (HC) is the most widely used method to prevent pregnancy worldwide. In addition to pregnancy planning and other non-contraceptional benefits, it also has certain risks. Hormone replacement therapy (HRT) is used primarily for treatment of estrogen deficiency in postmenopausal women. HRT is associated with a number of risks, in particularly for women 60+ of age. Analysis of spontaneous adverse drug reactions (ADRs) reporting contribute to detection of potential risks associated with pharmacotherapy, thereby increases the safety of the drugs. Aim: The aim of this thesis was to analyse spontaneous ADRs reports of HC and HRT registered in the Czech Central Database of ADRs of the State Institute for Drug Control (SÚKL). Methods: Retrospective analysis of the spontaneous ADRs reports of HC and HRT registered in the database of SÚKL from 10/2004 to 6/2017. Mainly, method of receiving the report, reporting person, patient information, seriousness, and...
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Pharmacovigilance of active substance zolpidem
Vorel, Roman ; Kostřiba, Jan (advisor) ; Zimčíková, Eva (referee)
Charles University, Faculty of Pharmacy in Hradci Králové Department of: Social and Clinical Pharmacy Author: Roman Vorel Supervisor: PharmDr. Jan Kostřiba, Ph.D. Title of Diploma Thesis: Pharmacovigilance of active substance zolpidem Introduction: Drug safety became very important topic in the second half of 20th century, even beyond pharmacy. It relates to increasing impact on testing of drugs before launch onto the market, but also following monitoring, so the benefit and risk ratio of drug can be determined. Pharmacovigilance takes care of monitoring of drug use risk. Zolpidem is active substance from class hypnotics and it is used for short-term treatment of insomnia. Most professionals recommend zolpidem as first line treatment of acute insomnia. That is why it can be considered as one of the most important hypnotic drugs. Objectives: The aim of this diploma thesis is to analyze spontaneous reports for adverse drug reaction for zolpidem from years 2004 to 2017. The thesis focus on reports from the Czech republic but also from the whole world. The information in SPC of medicinal products containing zolpidem which were distributed from 2004 to 2017 are compared. Methods: Following data from years 2004 to 2017 were used: 1) List of spontaneous reports for adverse reaction from the Czech republic...
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Analysis of spontaneous adverse drug reactions reporting hormonal contraception and hormone replacement therapy
Ryndová, Vendula ; Malá, Kateřina (advisor) ; Horký, Pavel (referee)
Analysis of spontaneous adverse drug reactions reporting hormonal contraception and hormone replacement therapy Author: Vendula Ryndová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hormonal contraception (HC) is the most widely used method to prevent pregnancy worldwide. In addition to pregnancy planning and other non-contraceptional benefits, it also has certain risks. Hormone replacement therapy (HRT) is used primarily for treatment of estrogen deficiency in postmenopausal women. HRT is associated with a number of risks, in particularly for women 60+ of age. Analysis of spontaneous adverse drug reactions (ADRs) reporting contribute to detection of potential risks associated with pharmacotherapy, thereby increases the safety of the drugs. Aim: The aim of this thesis was to analyse spontaneous ADRs reports of HC and HRT registered in the Czech Central Database of ADRs of the State Institute for Drug Control (SÚKL). Methods: Retrospective analysis of the spontaneous ADRs reports of HC and HRT registered in the database of SÚKL from 10/2004 to 6/2017. Mainly, method of receiving the report, reporting person, patient information, seriousness, and...
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Analysis of spontaneous adverse events reports of hypolipidemics
Škabradová, Anežka ; Malá, Kateřina (advisor) ; Doseděl, Martin (referee)
Analysis of spontaneous adverse events reports of hypolipidemics Author: Anežka Škabradová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hypolipidemic drugs are widely used in today's medicine and their consumption is still rising. Besides all benefits, their usage includes also some risks that needs to be reconsidered regularly. Analysis of spontaneous adverse effects (AEs) reports contributes to a safer therapy by detecting especially serious and unexpected adverse drug reactions. Objective: The aim of this thesis was to analyse spontaneous adverse events reports of hypolipidemic drugs, which were sent to the State Institute for Drug Control (SÚKL) database in the period from June 2004 to October 2017. Methods: The data obtained from SÚKL during the above mentioned period was analysed using descriptive statistics. The frequency of occurrence of certain AEs, which were categorized according to MedDRA and distinguished by hypolipidemics, was analysed, as well as their severity and expectability. Part of the analysis was for example also by whom was the report submitted and which way they used to submit it. Results: Overall 290 reports were obtained,...
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Pharmacovigilance: Drug regulation development and legislation overview.
Manišová, Michaela ; Kostřiba, Jan (advisor) ; Zimčíková, Eva (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Social and Clinical Pharmacy Candidate Mgr. Michaela Manišová Consultant PharmDr. Jan Kostřiba, Ph.D. Title of Thesis Pharmacovigilance: Drug regulation development and legislation overview. Introduction: Pharmacovigilance is a scientific discipline relating to the detection and evaluation of adverse drug reactions and other risks associated with the use of the medicinal products after marketing authorisation and implementation of the risk minimisation measures. Objectives: To analyze the legislation requirements in the area of pharmacovigilance for the medicinal products for human use in the European Union and their implementation in practice. Trends in adverse drug reactions reporting in the various pharmacovigilance systems (United States, Czech Republic, European Union), evaluation of the factors affecting reporting and the main benefits of spontaneous reporting. Methods: The legal requirements of the European Union, the Czech Republic and the United States was used as the source of information, followed by the official website of the Drug Regulatory Authorities, the best practices guidelines prepared by the European Medicines Agency and by the Food and Drug Administration, the harmonization guidelines issued by...
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Pharmacovigilance of active substance zolpidem
Vorel, Roman ; Kostřiba, Jan (advisor) ; Zimčíková, Eva (referee)
Charles University, Faculty of Pharmacy in Hradci Králové Department of: Social and Clinical Pharmacy Author: Roman Vorel Supervisor: PharmDr. Jan Kostřiba, Ph.D. Title of Diploma Thesis: Pharmacovigilance of active substance zolpidem Introduction: Drug safety became very important topic in the second half of 20th century, even beyond pharmacy. It relates to increasing impact on testing of drugs before launch onto the market, but also following monitoring, so the benefit and risk ratio of drug can be determined. Pharmacovigilance takes care of monitoring of drug use risk. Zolpidem is active substance from class hypnotics and it is used for short-term treatment of insomnia. Most professionals recommend zolpidem as first line treatment of acute insomnia. That is why it can be considered as one of the most important hypnotic drugs. Objectives: The aim of this diploma thesis is to analyze spontaneous reports for adverse drug reaction for zolpidem from years 2004 to 2017. The thesis focus on reports from the Czech republic but also from the whole world. The information in SPC of medicinal products containing zolpidem which were distributed from 2004 to 2017 are compared. Methods: Following data from years 2004 to 2017 were used: 1) List of spontaneous reports for adverse reaction from the Czech republic...
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Competitive Intelligence in pharmaceutical industry
Hubálková, Pavla ; Papík, Richard (advisor) ; Horváth, David (referee)
This diploma thesis describes and analyzes an area of competitive intelligence in the pharmaceutical industry. The work is divided into five parts. The first part deals with competitive intelligence and related aspects, the second part is dedicated to the pharmaceutical industry, with all specifics. The third part deals with competitive intelligence in the intersection with the pharmaceutical industry, the fourth part contains the classification and description of information resources appropriate for the activities of CI and a fifth part presents research, which consists of a questionnaire survey among pharmaceutical companies on the state of competitive intelligence and semi-structured interview with an expert in the area of CI in pharmaceutical company. The survey results represent a certain sub-probe, which demonstrates the strong position of CI as a common standard of pharmaceutical companies. Keywords competitive intelligence, pharmaceutical industry, information needs, drugs, pharmacovigilance, patents, information resources
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