The entry of the biological medicinal products (BMPs) in the clinical practice more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of treatment is higher than the costs of the conventional products. The “data exclusivity” of BMPs expired and biosimilar medicinal products (BSMPs) are available on the market. The market share of BSMPs is expected to increase gradually and lead to cost reductions of biological treatment. Aim: To analyze the availability, affordability and drug utilization of BSMPs containing monoclonal antibodies in Bulgaria. Materials and methods: Retrospective study of the public data from EMA, National Council on Prices and Reimbursement and National Health Insurance Fund for 2015–2019. Descriptive statistical analysis was performed. Results and Discussion: On the ЕU level, BSMPs with Marketing Authorization are Adalimumab, Infliximab, Rituximab, Bevacizumab and Trastuzumab. In the Bulgarian Positive Drug List, there are 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMPs is 691 673 158 BGN – the share of BSMPs is 34 139 639 BGN (4.7%). The access of BSMPs in Bulgaria is still very limited. BSMPs are available with the lower price, but the reference products are the preferred treatment. The reason for this could be the lack of national standards for the switching/interchangeability of BMPs with BSMPs, and the prescribers distrust of the so-called replacement therapies and aggressive drug promotion to the healthcare professionals are also of great importance.
Background. In an attempt to stop the distribution of falsified medicinal products, the EU has adopted Directive 2011/62/EU. Since 9th February 2019, each package of medicinal product must be given a unique number in combination with a mandatory indicator of integrity. The Directive requires the creation of a system of serialization and verification of the medicinal products. Aim of the study: To determine the level of awareness about the serialization and verification system among masters of pharmacy and the preparedness of Bulgarian pharmacies to meet the new challenges. Materials and methods: A pilot survey was conducted in 25 pharmacies in Sofia. 41 specialists in pharmacy holding a master degree were interviewed using the “direct individual survey” method. Results and discussion: The knowledge about the availability of new regulatory requirements is in serious dissonance with the established high level of non-awareness of the forthcoming initiatives. Over 2/3 (78%) of the respondents do not know what the practical challenges to their pharmacy practices will be.
Diabetes mellitus (DM) is a metabolic disease characterized by hyperglycemia, which is caused by impaired insulin secretion, insulin action, or both. Four complications of DM have been identified – diabetes microangiopathy including nephropathy, retinopathy and polyneuropathy and diabetes macroangiopathy. DM is diagnosed on the basis of one of the following criteria: 1. Presence of typical symptoms – polyuria, polyphagia, polydipsia, weight loss and accidental plasma glucose value ≥ 11.1 mmol/l. 2. Fasting plasma glucose level ≥ 7.0 mmol/l. 3. Oral Glucose Tolerance Test (OGTT) – 2-hour blood glucose level ⩾ 11.1 mmol/l. 4. Test for glycated hemoglobin HbA1c⩾6.5%. Regular monitoring of blood glucose is crucial for good control of diabetes. Two are the most commonly available methods for glycemic monitoring – 1) home self-assessment; 2) HbA1c test. In this paper we discuss the diagnostic and prognostic value of HbA1c in comorbid patients with DM and diseases, where there are deviations in hemoglobin and erythrocyte values. In the scientific literature, single reports are available that give scarce guidance on how to manage these patients. It is mentioned that anemia should be treated individually, however no data could be found on what should be the standard behavior in such patients. According to the American Diabetes Association, only the blood glucose should be used when the relationship between HbA1c and glycemia is altered. Because of the diverse gene pool of the US population, different variants of hemoglobin may interfere with HbA1c measurements, although tests in the USA are standardized. Discrepancies between HbA1c and plasma glucose should suggest that testing for HbA1c may not be reliable for a particular patient. We present a clinical case of a comorbid patient with DM and thalassemia minor, whose glycemic control with glycated hemoglobin HbA1c is unreliable.
This article presents a study of mental resilience, stability (emotional intelligence), and in particular the levels of aggressive response, according to the practices of judo, fitness, basketball, and tennis by students at Sofia University. The levels of aggression as an indicator of students' ability to manage, influence and control their emotions, attitudes, behaviours and the mental and volitional state of the individual were examined with the questionnaire of Bues&Durke. The study aims to determine, through the levels of aggressive reaction and depression, what is the impact of the sports of judo, fitness, basketball, and tennis practiced at the University of Sofia for the students' mental stability, stability (emotional intelligence). The object of study is the level of physical aggression of students practicing these sports. The subject of the study is the levels of mental resilience of students practicing judo, fitness, tennis, and basketball, broken down by gender, faculty, and age. As a result of the study, it can be summarized that physical aggression can and should be corrected. Family is the main factor that educates the individual and sets his or her direction of development, but sports at the University can correct and compensate for family gaps.
Aim: To analyze drug utilization and rational drug use in treatment of essential arterial hypertension in Bulgaria by using quantitative and qualitative parameters at national level. To assess generic penetration as a part of rational drug use. Materials and methods: Design: retrospective study of publicly accessible data from registries of National health insurance fund for the period January–December 2017. The analyses are in accordance with ATC/DDD methodology of WHO. The data was processed via descriptive statistical methods. Results: The analyzed population includes 185 671 patients with essential arterial hypertension—13.33% of all hypertensive patients. The expenses for 2017 are 9 796 940.12 BGN (Bulgarian leva; 1 Euro=1.95,585 BGN). The expense per patient per year is 52.76 BGN, monthly expense is 4.40 BGN and daily expense is 0.14 BGN. The sum of 9 796 940.12 BGN is divided into two groups—expenses for monoproducts 65.88% and expenses for combined products 34.12%. Blockbusters are INNs lercanidipine and nebivolol. The total expenses for uncomplicated essential arterial hypertension are 1.22% of the total expenses. With this resource, 1.6 DDD/Patient/Day is provided. Discussion: In Bulgarian therapeutic practice, the most prescribed products are beta-blockers nebivolol and bisoprolol, calcium antagonist lercanidipine, and centrally acting antiadrenergic agents rilmenidine and moxonidine. Sartanes are represented mainly by valsartan. In all section analyses, the considerable use of lercanidipine is evident. Reference (original) medicinal products are mainly prescribed, while the market share of generic products, both in terms of costs and DDD, is significantly lower. Obtained results are inconsistent with European recommendation, while lack of national pharmacotherapeutic guideline poses a serious challenge.
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