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Analysis of vaccine utilization and spontaneous adverse events reports in influenza vaccine
Podskalská, Markéta ; Zimčíková, Eva (advisor) ; Kolmanová, Eliška (referee)
Analysis of vaccine utilization and spontaneous adverse events reports in influenza vaccine Author: Markéta Podskalská Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction and goal: Influenza is a contagious disease of the respiratory system. It is caused by influenza viruses and appears in annual outbreaks. The best form of influenza prevention is vaccination against influenza viruses on yearly basis. The vaccination has many benefits, but some side effects may appear as well. Goal of this thesis was to analyse and evaluate reports of side effects of influenza vaccination between years 2004-2017 and to evaluate the use of influenza vaccines from 2004 to 2022. Methodology: The Central Database of Adverse Events Reporting of the State Institute for Drug Control was used as the data source. Reports with the ATC code J07BB in the period from 2004 to 2017 were evaluated. Information about the patient, reporting person, the region where the notification was filed, the method of reporting and details concerning adverse events were analysed. These details included the number and severity of adverse effects, their predictability and final outcome. Data on influenza vaccine usage were provided by SÚKL....
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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:...
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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...
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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:...
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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...
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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...
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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...
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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...
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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 of Medicines
Dvořáková, Ilona ; Lešetický, Ondřej (advisor) ; Filipová, Markéta (referee)
The objective of my Bachelor thesis is to analyse development of pharmacovigilance and adverse event reporting in the Czech Republic and other countries, with a focus on the changes in the number of adverse event reports over the last thirty years in Czech Republic and comparison with development of adverse event reports in other countries and prediction the possible trends in adverse event reporting in the future. My Bachelor thesis will also contain definitions of adverse events in accordance with the Medicinal Products Act No. 378/2007, as well as a detailed description of the adverse event reporting procedure, the persons who are obliged to report adverse events, and the systems in place for reporting adverse events by pharmaceutical companies. I will also include a chapter on the history of pharmacovigilance in the Czech Republic and in other countries and a description of how the Uppsala Monitoring Centre, WHO's centre for monitoring adverse events, works. A section will be dedicated to pharmacovigilance tools used by State Institute for Drug Control, with a detailed focus on selected side effects of drugs reported in the recent years. In the final chapter of my Bachelor thesis, I will map the development of the number of adverse event reports in the Czech Republic and in the other countries with the aim of predicting potential trends in adverse event reporting in the future.
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