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...

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...

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,...

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...

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...

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

Diploma thesis is focused on specifications in pharmaceutical business. It is based on knowledge of pharmacy and economy and their synthesis is describing the most significant differences in pharmacy business and other markets. Overall goal of diploma thesis was to create overview about pharmaceutical industry, its progress, trends and behavior of companies to this high risk and volatile market with keeping the rules and norms of Czech and European authorities. Target was also to form group of recommendations for companies participated in this market. To keep this target I described in the first part of diploma thesis basic terminology and theoretical knowledge about pharmaceutical market including research and development, marketing and sales and pharmakovigilance. Practical part was based on case studies specifying the most common and difficult problems and steps leading to their solutions. My personal contribution in diploma thesis is based on detailed and professional handling of the topic and in the choice of parametres which influence the most timing and capital demands of R&D projects in pharmacy and mitigation of their negative aspects.

The aim of the diploma thesis is to describe and basically analyze representative databases and digital libraries that focus on pharmaceutical disciplines. The introductory chapter is concerned with related terminology, while the following chapters refer to significant subjects and principles in the field of pharmaceutical industry, and also to important classification systems and retrieval languages that can be found in some of the described resources. The fifth chapter focuses on pharmaceutical information resources which are offered by some of the world's leading database service companies. The sixth chapter contains a description and a basic analysis of 10 representative electronic resources for pharmaceutical disciplines. The empirical section of this diploma thesis consists of three major parts. One of them is a subject coverage analysis of bibliographic databases MEDLINE and EMBASE from the viewpoint of pharmaceutical information. Secondly, it contains a presentation of an indicative survey that is related to using electronic information resources by a commercial and a nonprofit subject. The last chapter deals with information brokering that is presented on example of the Medistyl company. Keywords Pharmaceutical industry, pharmacy, pharmacovigilance, factographic databases, bibliographic...