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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.

Abstract:Over the recent years, there has been an alarming increase in the market penetration of the so-called "counterfeit" medicinal products in the European Union and worldwide. These products usually contain substandard (lower quality) or false ingredients, do not contain the necessary ingredients, or contain substances or active pharmaceutical ingredients, which are wrongly or incorrectly dosed. Bulgarian experience has shown that the counterfeit medicinal products enter the market not only through illegal channels, but are also distributed in and/or through lawful channels and distribution chains of medicinal products manufacturers (importers), wholesalers and retailers (pharmacies and drugstores). A special phenomenon is the distance selling of medicinal products, including on-line marketing (internet trade)-perhaps the riskiest way the counterfeit medicinal products reach the patients. Counterfeit medicinal products are one of the most significant threats to human health and their market penetration can lead to loss of confidence in the drug distribution systems and in the public health system as a whole.

ObjectiveTo bridge gaps identified during the 2009 H1N1 influenza pandemic by developing a system that provides public health departments improved capability to manage and track medical countermeasures at the state and local levels and to report their inventory levels to the Centers for Disease Control and Prevention (CDC).Materials and MethodsThe CDC Countermeasure Tracking Systems (CTS) program designed and implemented the Inventory Management and Tracking System (IMATS) to manage, track, and report medical countermeasure inventories at the state and local levels. IMATS was designed by CDC in collaboration with state and local public health departments to ensure a “user-centered design approach.” A survey was completed to assess functionality and user satisfaction.ResultsIMATS was deployed in September 2011 and is provided at no cost to public health departments. Many state and local public health departments nationwide have adopted IMATS and use it to track countermeasure inventories during public health emergencies and daily operations.DiscussionA successful response to public health emergencies requires efficient, accurate reporting of countermeasure inventory levels. IMATS is designed to support both emergency operations and everyday activities. Future improvements to the system include integrating barcoding technology and streamlining user access. To maintain system readiness, we continue to collect user feedback, improve technology, and enhance its functionality.ConclusionIMATS satisfies the need for a system for monitoring and reporting health departments’ countermeasure quantities so that decision makers are better informed. The “user-centered design approach” was successful, as evident by the many public health departments that adopted IMATS.

Background:Arterial hypertension is prevalent and remains one of the most significant causes of mortality worldwide. Over 1.7 million Bulgarians (24%) have a blood pressure (BP) value equal to or higher than 140/90 mmHg and therefore are at increased risk of complications. Adherence to antihypertensive medications is the cornerstone for achieving hypertension control. Methods:The aim of this study was to assess whether the patients of both sexes with hypertension exhibit equal adherence to medication during the COVID-19 pandemic and to explore how the pandemic has affected the adherence of patients with high BP to prescribed antihypertensive drugs. This multicentre observational study utilized self-completed questionnaires among patients visiting several healthcare centres, including the cardiology outpatient clinic of a university hospital, a private cardiology practice, general practice offices, and a pharmacy between June and November 2020. Results:Overall, 442 patients were included in the study. The likelihood of adherence was assessed using the 5‐item version of the Medication Adherence Report Scale (MARS-5©Professor Rob Horne). The average MARS score of the sample was 16.81, the median was 4.162, and the most common value was 3 (24.5% of respondents).Conclusions:Overall, 18.1% had a high degree of adherence to the prescribed therapy, and almost 1/3 of the respondents (30.7%) had a low degree of adherence to the prescribed therapy. In the present study, approximately one-third of the participants complied with pharmacological treatment. The study suggests that several sociodemographic factors but not the COVID pandemic play a role in treatment adherence.

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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.

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.