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The referral procedure as a tool for influence the regulatory status of medicinal product in EU.
Závodská, Gabriela ; Zimčíková, Eva (advisor) ; Fuksa, Leoš (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Social and Clinical Pharmacy Author: Mgr. Gabriela Závodská Consultant: PharmDr. Eva Zimčíková, Ph.D. Title of Thesis: The referral procedure as a tool for influence the regulatory status of medicinal product in EU. The referral procedure is very important possibility how the medical agencies in EU can influence the regulatory status of a medical product - change, suspend or revoke the registration. Our first aim was to describe the referral procedures defined in "The rules governing medicinal products in the European Union" - reasons for initiation, course and possible outcomes. One chapter deals with procedures concerning risk of venous and arterial thromboembolism in users of combined hormonal contraceptive. Our second aim was to observe the number of procedures during 2005-2014. We were interested in reason for initiation and outcomes of some procedures. We observed an increase in the number of procedures which are initiated from safety reasons on the basis of pharmacovigilance data.
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Adherence to calcium and vitamin D supplementation in women with postmenopausal osteoporosis
Holcová, Radka ; Vytřísalová, Magda (advisor) ; Fuksa, Leoš (referee)
Adherence to calcium and vitamin D supplementation in women with postmenopausal osteoporosis Author: Radka Holcová Supervisor: Magda Vytřísalová Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Department of Social and Clinical Pharmacy Introduction: The insufficient medication adherence is a very frequent problem with chronic asymptomatic diseases as osteoporosis which significantly influences the treatment outcome. The successful osteoporosis therapy is based on adequate supply of calcium and vitamin D. A lot of studies are focused on the adherence to antiresorptive treatment but the adherence to supplementation therapy is rarely evaluated. Aims: The aim of the study was to evaluate the adherence to calcium and vitamin D supplementation in women with postmenopausal osteoporosis. Methods: The adherence was evaluated using two different methods: self-reported questionnaire and the electronic monitoring by bottles type Medication Event Monitoring System (MEMS). This partial analysis of a multicentre study includes and assesses data from Osteocentre in Pardubice Regional Hospital. Results: The analysis was performed with 15 women (the average age of 73). The patients were treated with Caltrate 600 mg/400 IU D3 once a day for three months. The adherence during the entire period...
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Investigation of Drug Interactions on Hepatic and Renal Transport Proteins
Fuksa, Leoš ; Štaud, František (advisor) ; Fusek, Josef (referee) ; Slanař, Ondřej (referee)
STUDY OF DRUG-DRUG INTERACTIONS BASED ON MODULATION OF THE FUNCTION OF LIVER AND KIDNEY ACTIVE TRANSPORTERS Leos Fuksa, M.Sc. ABSTRACT The present thesis focused on closer research of drug-induced changes in the expression and function of the main hepatic and renal transporters and their effects on the pharmacokinetics of the model substrates. The subject of our particular interest were ABC efflux transporters (namely P-gp and Mrp2) localized in the apical membranes of polarized epithelium cells in the excretory organs, and also Oatp2 transporter playing an important role in the basolateral uptake of drugs. Dexamethasone and amiodarone were employed to bring about changes in the active transport. Dexamethasone is a potent corticosteroid that showed capability to increase elimination processes, i.e. to induce enzymes and transporters both in vitro and in vivo. Amiodarone, a life-saving antiarrhythmic, is a well-known inhibitor of drug metabolism. Its direct inhibitory effects on the active transport have recently been reported. The summarized results of the included publications describe various aspects of the pharmacokinetic drug-drug interactions, where the underlying mechanism of the interaction is a modulation (either induction/activation or inhibition) of the active transport. Such modulation is...
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Pharmacoeconomic Analysis of Direct Costs of Treatment of Migraine Disease
Hárovník, Jan ; Klimeš, Jiří (advisor) ; Fuksa, Leoš (referee)
6 1. ABSTRACT Background: This study is primarily aimed at describing migraine illnesses, the existing patient care algorithm with this diagnosis and to estimate the direct costs of treatment of migraine from the point of view of the health care system in the Czech Republic. In the theoretical part, the basic concepts and procedures of health economics and the health technologies assessment are examined, especially the cost-of-illness of the analysis that is conducted in the practical part, namely just on the illness of migraine. Methods: The cost of drugs used to treat migraine is determined using FNHK (Fakultni nemocnice Hradec Kralove) prescription data. Further, using the data on health care (both ambulatory and inpatient care), these services are being appraised and this way the cost of treatment of a patient with the disease estimated from the point of view of the health system in the Czech Republic. Results: The average annual cost of treatment of one patient with episodic migraine was assessed at CZK 1,182 for outpatient care, CZK 786 for hospitalization and CZK 2,707 for medication. For chronic migraines, the average cost is higher and estimated at CZK 3,321 for outpatient care, CZK 2,745 for hospitalization and CZK 7,415 for medication. Conclusions: The total direct annual cost of the patient was...
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The referral procedure as a tool for influence the regulatory status of medicinal product in EU.
Závodská, Gabriela ; Zimčíková, Eva (advisor) ; Fuksa, Leoš (referee)
Charles University in Prague, Faculty of Pharmacy in Hradec Králové Department of Social and Clinical Pharmacy Author: Mgr. Gabriela Závodská Consultant: PharmDr. Eva Zimčíková, Ph.D. Title of Thesis: The referral procedure as a tool for influence the regulatory status of medicinal product in EU. The referral procedure is very important possibility how the medical agencies in EU can influence the regulatory status of a medical product - change, suspend or revoke the registration. Our first aim was to describe the referral procedures defined in "The rules governing medicinal products in the European Union" - reasons for initiation, course and possible outcomes. One chapter deals with procedures concerning risk of venous and arterial thromboembolism in users of combined hormonal contraceptive. Our second aim was to observe the number of procedures during 2005-2014. We were interested in reason for initiation and outcomes of some procedures. We observed an increase in the number of procedures which are initiated from safety reasons on the basis of pharmacovigilance data.
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Adherence to calcium and vitamin D supplementation in women with postmenopausal osteoporosis
Holcová, Radka ; Vytřísalová, Magda (advisor) ; Fuksa, Leoš (referee)
Adherence to calcium and vitamin D supplementation in women with postmenopausal osteoporosis Author: Radka Holcová Supervisor: Magda Vytřísalová Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Department of Social and Clinical Pharmacy Introduction: The insufficient medication adherence is a very frequent problem with chronic asymptomatic diseases as osteoporosis which significantly influences the treatment outcome. The successful osteoporosis therapy is based on adequate supply of calcium and vitamin D. A lot of studies are focused on the adherence to antiresorptive treatment but the adherence to supplementation therapy is rarely evaluated. Aims: The aim of the study was to evaluate the adherence to calcium and vitamin D supplementation in women with postmenopausal osteoporosis. Methods: The adherence was evaluated using two different methods: self-reported questionnaire and the electronic monitoring by bottles type Medication Event Monitoring System (MEMS). This partial analysis of a multicentre study includes and assesses data from Osteocentre in Pardubice Regional Hospital. Results: The analysis was performed with 15 women (the average age of 73). The patients were treated with Caltrate 600 mg/400 IU D3 once a day for three months. The adherence during the entire period...
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Investigation of Drug Interactions on Hepatic and Renal Transport Proteins
Fuksa, Leoš ; Štaud, František (advisor) ; Fusek, Josef (referee) ; Slanař, Ondřej (referee)
STUDY OF DRUG-DRUG INTERACTIONS BASED ON MODULATION OF THE FUNCTION OF LIVER AND KIDNEY ACTIVE TRANSPORTERS Leos Fuksa, M.Sc. ABSTRACT The present thesis focused on closer research of drug-induced changes in the expression and function of the main hepatic and renal transporters and their effects on the pharmacokinetics of the model substrates. The subject of our particular interest were ABC efflux transporters (namely P-gp and Mrp2) localized in the apical membranes of polarized epithelium cells in the excretory organs, and also Oatp2 transporter playing an important role in the basolateral uptake of drugs. Dexamethasone and amiodarone were employed to bring about changes in the active transport. Dexamethasone is a potent corticosteroid that showed capability to increase elimination processes, i.e. to induce enzymes and transporters both in vitro and in vivo. Amiodarone, a life-saving antiarrhythmic, is a well-known inhibitor of drug metabolism. Its direct inhibitory effects on the active transport have recently been reported. The summarized results of the included publications describe various aspects of the pharmacokinetic drug-drug interactions, where the underlying mechanism of the interaction is a modulation (either induction/activation or inhibition) of the active transport. Such modulation is...
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