|
|
Analysis of Spontaneous Adverse Events Reports of InfanrixHexa vaccine
Kovaříková, Klára ; Zimčíková, Eva (advisor) ; Rejmanová, Anna (referee)
Analysis of spontaneous adverse events reports of Infanrix hexa vaccine Author: Klára Kovaříková Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Infanrix hexa vaccine is used for vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b. Analysis of spontaneous adverse drug reactions (ADRs) reports is one of the most important sources of information to evaluate drug-related risks. Objective: The aim of this study was to analyse spontaneous ADRs reports of Infanrix hexa vaccine, which were sent to the State Institute for Drug Control (SÚKL) database in the period from 2004 to 2017. Methods: The data was analysed using descriptive statistic in MS Excel. ADRs were classified according to the MedDRA. Seriousness and expectedness of ADRs were evaluated. Results: Overall 1288 reports were obtained containing 4334 ADRs, approximately 3.4 ADRs per report. Infanrix hexa vaccine was the only suspected drug in most of the reports (75.9%). Physicians were the most frequent reporters (70.2%). Serious ADRs were found in 84.3% of reports. The most frequent ADRs were general disorders and administration site...
|
|
|
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...
|
|
|
Similar biotherapeutic agents (Biosimilars) Consumption in Czech Republic
Vlachová, Kristýna ; Horký, Pavel (advisor) ; Zimčíková, Eva (referee)
Consumption of similar biological medicinal products (biosimilars) in the Czech Republic Author: Kristýna Vlachová Supervisor: PharmDr. Pavel Horký, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Biological treatment is a modern alternative to chemotherapeutics especially in patients with difficult-to-treat diseases of autoimmune origin, as well as patients with other diseases. Biosimilars are biological medicinal products similar to the original biologics. They are increasingly used in a wide range of indications. A new biosimilar drug is registered every year, as soon as the patent protection of the original biologics expires. The assumption is that the consumption of biosimilars and biologists in the Czech Republic will increase. The question is to what extent it will increase and what is the market share of biosimilars. Objective: The aim of the diploma thesis was to analyze the consumption of biosimilar epoetin, adalimumab, infliximab and etanercept in the Czech Republic in 2010-2020. Methods: A retrospective analysis of the consumption of biosimilars epoetin, adalimumab, infliximab and etanercept was performed from 1. 1. 2010 to 31. 12. 2020. The selection of specific biosimilars was made on the basis of their wide...
|
|
|
Analysis of utilisation and spontaneous adverse events reports related to human papillomavirus vaccines
Schrommová, Tereza ; Zimčíková, Eva (advisor) ; Kolmanová, Eliška (referee)
Analysis of utilisation and spontaneous adverse events reports related to human papillomavirus vaccines Author: Tereza Schrommová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University INTRODUCTION: HPV vaccination is one of the most effective types of prevention against the human papillomavirus infection that can lower the probability of its incidence up to 80-90 %. Besides the benefits of vaccination, there can also occur among many individuals certain risks and adverse effects. Spontaneous adverse events reports are used to identify these serious and unexpected adverse effects, their monitoring leads to increasing safety of therapy. Drug consumption is monitored to uncover the ratio of population exposure to certain drug during specific time in specific socioeconomic group. OBJECTIVE: The objective of this diploma was analysis of spontaneous adverse events reports of vaccines against the human papillomavirus that are registered in database of State Institute for Drug Control in the period from May 2007 to October 2017. Another aim of this work was to evaluate consumption of HPV vaccines in the Czech Republic in the period from 2006 to 2019 using data from State Institute for Drug Control again. METHODS:...
|
|
|
Analysis of Spontaneous Adverse Events Reports of Measles, Mumps, and Rubella Vaccine
Kulhavá, Jana ; Zimčíková, Eva (advisor) ; Horký, Pavel (referee)
Analysis of Spontaneous Adverse Events Reports of Measles, Mumps, and Rubella Vaccine Author: Jana Kulhavá Supervisor: PharmDr. Eva Zimčíková, Ph.D. Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Department of Social and Clinical Pharmacy Keywords: vaccination, measles, mumps, rubella, adverse events reports Introduction: The MMR vaccine is a combined vaccine used to vaccinate children against measles, mumps and rubella. Spontaneous reporting of adverse reactions is an important source of information to identify potential risks of medicinal products. Objective: The aim of this diploma thesis is the analytical evaluation of spontaneous reports of suspected adverse reactions after vaccination with MMR vaccine registered in the database of the State Institute for Drug Control during the period 2004 to 2017. Methods: The data were analyzed in Microsoft Excel spreadsheet software using descriptive statistics methods. The reported adverse reactions were classified into appropriate organ system classes according to the MedDRA Glossary of Medical Terminology. The expectability and severity of adverse reactions were assessed. Results: A total of 805 cases of suspected adverse reactions were reported between 2004 and 2007, which included 2,812 adverse reactions. Most suspected adverse...
|
|
|
Analysis of Spontaneous Adverse Events Reports after Tick-borne Encephalitis Vaccine
Brázdová, Tereza ; Zimčíková, Eva (advisor) ; Rejmanová, Anna (referee)
Analysis of Spontaneous Adverse Events Reports after Tick-Borne Encephalitis Vaccine Author: Tereza Brázdová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Consultant: PharmDr. Kateřina Malá, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction and aim: Tick-borne meningoencephalitis is one of the most frequent causes of viral meningitis in Europe. In recent years, the number of cases of this infection in the Czech Republic has begun to rise. Vaccination is the only reliable protection against infection, but it also comes with some risks. Analysis of spontaneous adverse reaction reports is a key source of information for signal detection, which is used to identify drug risks. The aim of this thesis was to analyse the spontaneous reporting of suspected adverse drug reactions (ADRs), using the data from the Central Database of ADRs provided by the State Institute for Drug Control. Methodology: Descriptive statistics were performed from reporting data in the period from June 2004 to October 2017. For example, the total number of reports, the number of ADRs and the patient characteristics were analysed. We compared the adverse reactions with the Vigibase database and evaluated the expectability of reported reactions. Results: During the...
|
|
|
Knowledge and attitudes to HPV immunisation IV
Jelínková, Tereza ; Zimčíková, Eva (advisor) ; Kolmanová, Eliška (referee)
Knowledge and attitudes to HPV immunisation IV Author: Tereza Jelínková Thesis supervisor: PharmDr. Eva Zimčíková, Ph.D. Introduction HPV infection is one of the most common sexually transmitted diseases causing, apart from genital warts, other malignancies, most often cervical cancer. The most effective way of prevention is vaccination. So far, there have been 3 types of vaccines, most recent one being the nonavalent vaccine providing up to 90 % protection against cervical cancer- causing HPV, in contrast to the previously available 70 % protection from bivalent or quadrivalent vaccines. Aims The main aim of this thesis was to investigate the knowledge and attitudes towards vaccination against HPV, and knowledge about HPV in general, among secondary school students. Furthermore, to determine their vaccination status and compare the findings with data from previous theses, including a comparison of their knowledge about HPV and relevant prevention. Methodology The data was obtained by means of a questionnaire survey, which took place at three secondary schools. In December 2017 at Gymnázium in Mladá Boleslav, then during June 2018 at Gymnázium in Brandýs nad Labem, and finally in September 2018 at Gymnázium Chotěboř. The obtained data was recorded in a Microsoft Excel spreadsheet and then...
|
|
|
Analysis of drug-related problems in a health facility IV.
Šubrtová, Linda ; Malý, Josef (advisor) ; Zimčíková, Eva (referee)
Analysis of drug-related problems in a health facility IV. Author: Linda Šubrtová Tutor: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Increasing use of drugs leads to a growing risk of occurence of drug-related problems. These problems can often endanger patient's health and increase the economic cost of the treatment. However, many of these problems can be prevented by controls and collaboration of all health care subjects. Objective: The aim of this work was to carry out a revision of pharmacotherapy in a rehabilitation health facility and to analyse acquired drug-related problems. Methodology: The collection of data took place from 13 to 15 February 2017 in health facility in the Czech Republic. The review of pharmacotherapy was performed by a three-member team (clinical pharmacist, pharmacist, work researcher). The data obtained from the provided medical records were recorded into the database, which was prepared for the purpose of the pharmacotherapy review. Recorded were: the patient's age and sex, allergic, family, work, social and personal history, physical and laboratory examinations and complete pharmacotherapy, which included over-the-counter drugs and dietary supplements, including dosage...
|
|
|
Analysis of drug-related problems in a health facility IV.
Šubrtová, Linda ; Malý, Josef (advisor) ; Zimčíková, Eva (referee)
Analysis of drug-related problems in a health facility IV. Author: Linda Šubrtová Tutor: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Increasing use of drugs leads to a growing risk of occurence of drug-related problems. These problems can often endanger patient's health and increase the economic cost of the treatment. However, many of these problems can be prevented by controls and collaboration of all health care subjects. Objective: The aim of this work was to carry out a revision of pharmacotherapy in a rehabilitation health facility and to analyse acquired drug-related problems. Methodology: The collection of data took place from 13 to 15 February 2017 in health facility in the Czech Republic. The review of pharmacotherapy was performed by a three-member team (clinical pharmacist, pharmacist, work researcher). The data obtained from the provided medical records were recorded into the database, which was prepared for the purpose of the pharmacotherapy review. Recorded were: the patient's age and sex, allergic, family, work, social and personal history, physical and laboratory examinations and complete pharmacotherapy, which included over-the-counter drugs and dietary supplements, including dosage...
|
|
|
Analysis of spontaneous adverse events reports of antiepileptic drugs
Šoborová, Ivana ; Zimčíková, Eva (advisor) ; Malá, Kateřina (referee)
Analysis of spontaneous adverse events reports of antiepileptic drugs Author: Ivana Šoborová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Epilepsy is one of the most common neurological diseases, which occurs worldwide. Antiepileptic drugs (AED) suppress the onset of an epileptic seizure. Analysis of spontaneous adverse drug reactions (ADRs) analysis is important data source for generating the potential risks signals in pharmacotherapy. Objective: The aim of this work was to analyse spontaneous reports of ADRs from the Czech Central Database of ADRs of the State Institute for Drug Control (SÚKL) in the period from June 2004 to October 2017. The analyses of potential drug interactions of all medicinal products mentioned in the reports and the assessment of the reported ADRs expectability was the secondary goal. Methods: Retrospective analyses of the spontaneous ADR reports of antiepileptic drugs obtained from the SÚKL in the given period. Anonymized data was processed using the descriptive statistics in MS Excel. For example, the patient characteristics or seriousness and expectability of the ADRs were evaluated. The specific adverse drug reactions were divided according to the system...
|
guest ::
