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Assessment of generic psychotropic drugs therapy costs in Poland
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Abstracts – XIX Congress PTF / Pharmacological Reports 67S (2015) 2–45
other functions of the organism, such as immunological response and responsibility for activation of toxic substances. One of the best-known and clinically relevant isoenzymes of cytochrome P450 with genetic variability is CYP2D6. In a population, carriers of genotypes and alleles responsible for extensive or poor metabolism occur. Extensive metabolism may result in an accelerated activation or detoxification of xenobiotics whereas poor metabolism may be associated with accumulation of toxic compounds or their metabolites. Analyses of polymorphism in CYP2D6 involved in the metabolism of xenobiotics may contribute to expanding our knowledge in terms of BP pathogenesis. The aim of the study was to find out whether there was any relationship between the CYP2D6 gene polymorphism and the development of bullous pemphigoid (BP). The study included 221 subjects, 71 patients with bullous pemphigoid and 150 healthy volunteers constituting a control group. The identification of CYP2D6 (CYP2D6*1, CYP2D6*3, CYP2D6*4) gene alleles was performed using the PCR-RFLP method. A higher frequency of the CYP2D6*3/CYP2D6*4 genotype was observed in patients with bullous pemphigoid BP (p = 0.0033) than in controls. The relative risk of developing BP expressed with the odds ratio (OR) was nearly 4-time higher in subjects in whom the presence of the CYP2D6*3 allele was detected (OR = 3.8; p = 0.0234). The study results may imply the impact of the CYP2D6 gene polymorphism (A2637 deletion) on a higher prevalence of bullous pemphigoid. http://dx.doi.org/10.1016/j.pharep.2015.06.114 Sensitivity to paroxetine-induced inhibition of lymphocyte growth in depressed patients as state marker of depression Szymon Rzez´niczek 1,*, Małgorzata Obuchowicz 1, Wojciech Datka 2, Marcin Siwek 2, Dominika Dudek 2, Katarzyna Kmiotek 2, Andrzej Pilc 1 1
Department of Neurobiology, Institute of Pharmacology PAS, Krako´w, Poland 2 Department of Affective Disorders, Chair of Psychiatry, Jagiellonian University Medical College, Krako´w, Poland *Corresponding author. Selective serotonin reuptake inhibitors (SSRIs) used as a firstline treatment are effective in less than 70% of depressive patients. Since the slow onset of action of the SSRIs is a great problem in the therapy of depression, there is a need to find the biomarkers of sensitivity for antidepressants. Expression of serotonin transporter in human lymphocytes as well as an influence of the SSRIs on these cells, shown in the previous studies, indicated a possible linkage between growth inhibition of lymphocytes and molecular mechanism involving SERT. The aim of our study was to test whether paroxetine-induced growth inhibition of peripheral blood mononuclear cells (PBMCs) varies in major depression disorder (MDD) patients vs. control. We studied reaction of PBMCs obtained from 66 MDD patients and 24 healthy volunteers for paroxetine. The patients population consisted of 33 treatment-sensitive patients (TS) – first diagnosed and 33 treatment resistance (TR) patients. Blood from TS patients was collected 3 times during the therapy (before treatment – TS I, after 4 weeks – TS II and after 7 weeks – TS III). PBMCs were cultured with several concentrations of the drug. There were significant differences between the healthy vs. TS I and healthy vs. TR in terms of the growth inhibition levels
for paroxetine. The reversion of the sensitivity of the TS patients towards higher paroxetine-induced growth inhibition of PMBCs may indicate that the PBMC sensitivity for paroxetine reflects a state marker of depression. http://dx.doi.org/10.1016/j.pharep.2015.06.115 Assessment of generic psychotropic drugs therapy costs in Poland Katarzyna Sejbuk-Rozbicka 1,2,*, Bartosz Łoza 2,3, Marta Da˛browska 1,2, Grzegorz Cessak 1,2,4, Konrad Rokita 1,2, Dagmara Mirowska-Guzel 1,2, Ewa Bałkowiec-Iskra 1,2,4 1 Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warszawa, Poland 2 Agency for Health Technology Assessment, Warszawa, Poland 3 Department of Psychiatry, Physiotherapy Division, Medical University of Warsaw, Warszawa, Poland 4 Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Warszawa, Poland *Corresponding author.
Provision of cost-effective drug treatment is of particular importance in patients with psychiatric diseases. Most of the therapies in question requires life-long treatment and consists of more than one medicine. Introduction of generic drugs is one of the major strategies for reducing contribution of costs of medications to total healthcare costs. The primary evidence required both by FDA and EMA for marketing approval of a new generic drug is acceptable bioequivalence between the generic drug product and its corresponding reference product. The price of the generic drug is estimated to be 25% lower comparing with the reference product. In the present study a comprehensive cost analysis of a twoyear psychotropic drug treatment in one of high reference Polish psychiatric hospitals has been performed. The total real costs have been compared with predictable costs of treatment with reference products if used instead of the available generic drugs. Our study due to the comprehensive analysis of both the availability and costs of psychotropic medicinal products in Poland. http://dx.doi.org/10.1016/j.pharep.2015.06.116 Lyme disease (Borreliosis) treatment – Questionaire study Paulina Skałka *, Dariusz Boron´, Halina Brus, Ryszard Brus Department of Nursing, High School of Strategic Planning, Da˛browa Go´rnicza, Poland *Corresponding author. Lyme disease (Borreliosis) is the multisystem disease which attacks many organs such as nervous and skeletal system, heart muscle and skin. Presented study concern clinical model, epidemiology and treatment methods of Lyme disease (recommended treatment scheme and unconventional methods as well). In the study and anonymous questionnaire was used. Questions concern effectiveness and rating of diagnostics methods, analysis of the most common complications during Borrelia burgdorferi infection treatment. The study was performed in Małopolskie region in 2012/2013. Data based on surveys refilled by patients. Following conclusion from presented study once can withdraw: 1. Effective methods of Lyme disease diagnosis doesn’t exist.
Abstracts – XIX Congress PTF / Pharmacological Reports 67S (2015) 2–45
other functions of the organism, such as immunological response and responsibility for activation of toxic substances. One of the best-known and clinically relevant isoenzymes of cytochrome P450 with genetic variability is CYP2D6. In a population, carriers of genotypes and alleles responsible for extensive or poor metabolism occur. Extensive metabolism may result in an accelerated activation or detoxification of xenobiotics whereas poor metabolism may be associated with accumulation of toxic compounds or their metabolites. Analyses of polymorphism in CYP2D6 involved in the metabolism of xenobiotics may contribute to expanding our knowledge in terms of BP pathogenesis. The aim of the study was to find out whether there was any relationship between the CYP2D6 gene polymorphism and the development of bullous pemphigoid (BP). The study included 221 subjects, 71 patients with bullous pemphigoid and 150 healthy volunteers constituting a control group. The identification of CYP2D6 (CYP2D6*1, CYP2D6*3, CYP2D6*4) gene alleles was performed using the PCR-RFLP method. A higher frequency of the CYP2D6*3/CYP2D6*4 genotype was observed in patients with bullous pemphigoid BP (p = 0.0033) than in controls. The relative risk of developing BP expressed with the odds ratio (OR) was nearly 4-time higher in subjects in whom the presence of the CYP2D6*3 allele was detected (OR = 3.8; p = 0.0234). The study results may imply the impact of the CYP2D6 gene polymorphism (A2637 deletion) on a higher prevalence of bullous pemphigoid. http://dx.doi.org/10.1016/j.pharep.2015.06.114 Sensitivity to paroxetine-induced inhibition of lymphocyte growth in depressed patients as state marker of depression Szymon Rzez´niczek 1,*, Małgorzata Obuchowicz 1, Wojciech Datka 2, Marcin Siwek 2, Dominika Dudek 2, Katarzyna Kmiotek 2, Andrzej Pilc 1 1
Department of Neurobiology, Institute of Pharmacology PAS, Krako´w, Poland 2 Department of Affective Disorders, Chair of Psychiatry, Jagiellonian University Medical College, Krako´w, Poland *Corresponding author. Selective serotonin reuptake inhibitors (SSRIs) used as a firstline treatment are effective in less than 70% of depressive patients. Since the slow onset of action of the SSRIs is a great problem in the therapy of depression, there is a need to find the biomarkers of sensitivity for antidepressants. Expression of serotonin transporter in human lymphocytes as well as an influence of the SSRIs on these cells, shown in the previous studies, indicated a possible linkage between growth inhibition of lymphocytes and molecular mechanism involving SERT. The aim of our study was to test whether paroxetine-induced growth inhibition of peripheral blood mononuclear cells (PBMCs) varies in major depression disorder (MDD) patients vs. control. We studied reaction of PBMCs obtained from 66 MDD patients and 24 healthy volunteers for paroxetine. The patients population consisted of 33 treatment-sensitive patients (TS) – first diagnosed and 33 treatment resistance (TR) patients. Blood from TS patients was collected 3 times during the therapy (before treatment – TS I, after 4 weeks – TS II and after 7 weeks – TS III). PBMCs were cultured with several concentrations of the drug. There were significant differences between the healthy vs. TS I and healthy vs. TR in terms of the growth inhibition levels
for paroxetine. The reversion of the sensitivity of the TS patients towards higher paroxetine-induced growth inhibition of PMBCs may indicate that the PBMC sensitivity for paroxetine reflects a state marker of depression. http://dx.doi.org/10.1016/j.pharep.2015.06.115 Assessment of generic psychotropic drugs therapy costs in Poland Katarzyna Sejbuk-Rozbicka 1,2,*, Bartosz Łoza 2,3, Marta Da˛browska 1,2, Grzegorz Cessak 1,2,4, Konrad Rokita 1,2, Dagmara Mirowska-Guzel 1,2, Ewa Bałkowiec-Iskra 1,2,4 1 Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warszawa, Poland 2 Agency for Health Technology Assessment, Warszawa, Poland 3 Department of Psychiatry, Physiotherapy Division, Medical University of Warsaw, Warszawa, Poland 4 Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Warszawa, Poland *Corresponding author.
Provision of cost-effective drug treatment is of particular importance in patients with psychiatric diseases. Most of the therapies in question requires life-long treatment and consists of more than one medicine. Introduction of generic drugs is one of the major strategies for reducing contribution of costs of medications to total healthcare costs. The primary evidence required both by FDA and EMA for marketing approval of a new generic drug is acceptable bioequivalence between the generic drug product and its corresponding reference product. The price of the generic drug is estimated to be 25% lower comparing with the reference product. In the present study a comprehensive cost analysis of a twoyear psychotropic drug treatment in one of high reference Polish psychiatric hospitals has been performed. The total real costs have been compared with predictable costs of treatment with reference products if used instead of the available generic drugs. Our study due to the comprehensive analysis of both the availability and costs of psychotropic medicinal products in Poland. http://dx.doi.org/10.1016/j.pharep.2015.06.116 Lyme disease (Borreliosis) treatment – Questionaire study Paulina Skałka *, Dariusz Boron´, Halina Brus, Ryszard Brus Department of Nursing, High School of Strategic Planning, Da˛browa Go´rnicza, Poland *Corresponding author. Lyme disease (Borreliosis) is the multisystem disease which attacks many organs such as nervous and skeletal system, heart muscle and skin. Presented study concern clinical model, epidemiology and treatment methods of Lyme disease (recommended treatment scheme and unconventional methods as well). In the study and anonymous questionnaire was used. Questions concern effectiveness and rating of diagnostics methods, analysis of the most common complications during Borrelia burgdorferi infection treatment. The study was performed in Małopolskie region in 2012/2013. Data based on surveys refilled by patients. Following conclusion from presented study once can withdraw: 1. Effective methods of Lyme disease diagnosis doesn’t exist.