Availability and Access to Orphan Drugs for Rare Cancers in Bulgaria: Analysis of Delays and Public Expenditures.

Rare cancers are defined by an annual incidence of fewer than 6 per 100,000. Bearing similarities to rare diseases, they are associated with substantial health inequalities due to diagnostic complexity and delayed access to innovative therapies. This situation is further aggravated in Southeastern European countries like Bulgaria, where limited public resources and expertise underscore the need for additional policy and translational research on rare cancers. This study aimed to explore the availability and access to orphan drugs for rare cancers in Bulgaria for the period of 2020-2023. We cross-compared data from both the European Union and national public sources to evaluate the number of available and accessible orphan drugs for rare cancers, the delay from market authorization to reimbursement, the dynamics of public expenditures, and regional disparities in access across the country. We juxtaposed the main characteristics of oncological and non-oncological orphan drugs as well. Only 15 out of 50 oncological orphan drugs that were authorized by the European Medicine Agency were accessible for rare cancer patients in Bulgaria. The median delay between market authorization and inclusion in the Bulgarian Positive Drug List was 760 days. The total expenditures for all orphan drugs for rare cancers amounted to EUR 74,353,493 from 2020 to 2023. The budgetary impact of this group rose from 0.24% to 3.77% of total public medicinal product expenditures for the study period. Rare cancer patients represent a vulnerable population that often faces limited to no access to treatment. We call for targeted European and national policies to address this major inequality.

Survey Study among Dentist in Bulgaria to Develop a Model for Risk Management in Dental Practice.

Background: Quality control and risk management in the field of dental services is an important part of improving patient safety as well as that of the dentists. The introduction of a risk management model would simplify and facilitate this process. Aim: The aim of the study is to gather information about the structurе and organization of work processes in Bulgarian dental practices, which will serve as a basis for building a risk management model. Material and Methods. A survey was conducted among randomly selected dental associations in Bulgaria-Plovdiv, Sofia, Varna, and Burgas through an anonymized questionnaire, containing 30 questions. The respondents meet the main criteria, namely, to be dentists and to practice in Bulgaria. The study includes demographic data, information on the attitude of Bulgarian dentists towards issues related to quality management, and safety and risk in respect to dental practice. The results have been processed and analyzed through descriptive and graphical analysis using the statistical program SPSS 20.0. Results: A total of 103 Bulgarian dentists took part in the study, out of which 25.24% ± 4.28% have acquired a specialty. Women are 52.43% ± 4.92%, and men -47.57% ± 4.92%. The largest is the relative share of the respondents in the age range of 25-35 years -63.10% ± 4.75% and with work experience of 6-15 years -52.43% ± 4.92%. Most of the respondents do not define in writing the main tasks and activities -52.43% ± 4.92%, and do not use checklists in their practice -54.73%. The majority of the respondents do not hold regular meetings with their teams -50.49% ± 4.93%, as well as they do not conduct surveys among their patients -68.93% ± 4.56%. The majority of the respondents -41.75% ± 4.86% are guided by their personal judgment in respect to whether the written information provided to patients is comprehensible and accessible. The majority of dentists -45.63% ± 4.91% take informed consent only for expensive procedures in written and oral form -53.40% ± 4.92%. Out of all the respondents, 75.73% ± 4.22% have not analyzed the risk of slipping in their practices for the last two years. Conclusion: There is a lack of written definition of the main tasks and processes, as well as no use of checklists in the practices of most of the interviewed dentists. Meetings with teams are held irregularly. There is a lack of surveys among patients, as well as no objective feedback from patients regarding the comprehensibility of the information materials provided. Informed consent is obtained from patients mainly in written and oral form and only for costly manipulations. In the practices of most of the interviewed dentists, there has been no assessment of the risk of slipping and falling for the last 2 years.

Occlusal Indicators Used in Dental Practice: A Survey Study.

INTRODUCTION: The function of the masticatory apparatus is complete when the dentition is intact with contact between the individual teeth and proper occlusion with the antagonists. For years, occlusal contacts have been studied to determine their exact location and describing various materials and methods for their registration such as paper foil, silk, and Shimstock foil. For years, occlusal contacts have been studied to determine their exact location and describe various materials and methods for their registration such as paper foil, silk, shim stock foil, the T-Scan system, and more recently the OccluSense system. The primary aim of the study was at evaluating which of the occlusal indicators is the most commonly used in practice, and the secondary aim was whether dentists are willing to use digital methods to examine occlusion. MATERIALS AND METHODS: The main primary information of the survey was collected by sending electronically anonymous questionnaires to 2014 dentists, randomly selected from all regions of the country. 228 questionnaires were filled in and returned. To achieve the goal of the study, the self-developed questionnaire was created and tested to survey the opinion about the use of occlusal indicators in dental practice. Each questionnaire contains questions about the sociodemographic and professional status of the people in the group and their opinion about the positives and negatives and the effectiveness of occlusal indicators. RESULTS: The obtained results confirm the statement that the most frequently used occlusal indicator in dental practice is the articulation paper. Articulation foil and silk are used less frequently than articulation paper. Of the listed quality indicators, Shimstock foil is rarely used in practice. Of the indicated quantitative indicators, the T-Scan system is more used than the OccluSense system. In the era of rapid technology development, the opinion and desire of dentists to increasingly want to introduce in their clinical practice quantitative methods are the digital diagnosis of occlusion. CONCLUSION: In any dental practice, if technically possible, digital methods would be used, giving more accurate and reliable data on the registered occlusal contacts.

Comparative Study Qualitative and Quantitative Techniques in the Study of Occlusion.

INTRODUCTION: The wide variety of methods for recording occlusal contacts and the contradictory data on the interpretation of the obtained markings provoked us to make a comparative laboratory study between different occlusal indicators. PURPOSE: Evaluation of a qualitative and quantitative method for registration of occlusal contacts in static occlusion in laboratory conditions. MATERIALS AND METHODS: In completion of the objective, we designed an apparatus for registration of the occlusal contacts (AROC) in static occlusion which is used, corresponding to the MIP in clinical conditions. The occlusal indicators that were included in the study were articulating paper 100 µ, articulating foil 12 µ, and T-Scan Novus system with a sensor thickness of 100 µ. The collected primary statistical information was entered and processed with the statistical package SPSS Statistics 19.0, and the graphs were prepared using Microsoft Office 2019. We performed descriptive statistical analysis in this study. Comparisons were performed using one-way analysis of variance (ANOVA), Student's t-test, and Pearson coefficient method. For a significance level, p < 0.05 was chosen. Result and Discussion. With quality occlusal indicators, it is possible only to visually determine the size, number, and intensity of the marked contacts. After the statistical processing of the obtained data on the number of registered contacts, a significant difference is found in the number of contacts of certain teeth (18, 24, 25, 28, 38, 35, 34, 33, 44, 45, and 48) registered with articulating paper and articulating foil. The maximum force that is reported during the study with the T-Scan system is 93.72% and the forces in the right half of the dentition are 51.7% and in the left 48.9%. To visualize the location of the registered occlusal contacts with the system, it is intraoral to use a quality indicator and we recommend the use of articulating foil. CONCLUSION: Based on findings from the current in vitro simulation, we can conclude that the type of occlusal indicator influences the registration of contacts, and therefore, we propose as a method of choice to achieve a balanced occlusion in clinical practice to combine the use of one conventional and one quantitative method.

Quality of life improvement after a three-year course of sublingual immunotherapy in patients with house dust mite and grass pollen induced allergic rhinitis: results from real-life.

BACKGROUND: Along with its high prevalence, the burden of allergic rhinitis rests upon the serious impact on quality of life of patients. Allergic rhinitis is associated with impairments in daily activities, work and school performance, and practical problems. Patients suffer from sleep disorders and emotional problems. Тhe advantages of sublingual immunotherapy on quality of life have only recently begun to emerge. The objective of this prospective real-life study was to evaluate the effect of a three-year course of sublingual immunotherapy with house dust mite (HDM) and grass pollen extracts on quality of life in adults with allergic rhinitis. METHODS: A total number of 191 adult patients [105 (54,979%) men; mean age 27.3 years (SD-6.14)] with moderate to severe allergic rhinitis and clinically relevant sensitization to house dust mites or grass pollen were prospectively evaluated in the course of management of their disease. Health-related quality of life was assessed by Rhinoconjunctivitis Quality of Life Questionnaire at baseline and after three-year course of sublingual immunotherapy. RESULTS: The mean overall Qol score assessed at baseline and at the end of the third year of treatment decreased significantly in patients treated with HDM extract (from 2.95 to 0.76) as well as with Grass pollen extract (from 2.83 to 1.22) (р < 0.001). The improvements in treated with HDM extract were as followed: activities - 3.52 to 0.68; sleep- 2.48 to 0.31; general problems - 1.79 to 0.49; practical problems - 3.57 to 0.68; nasal symptoms - 3.91 to 0.74; eye symptoms - 2.92 to 0.39; emotions - 3.03 to 0.39. The improvements in grass pollen group were: activities - 3.68 to 1.69; sleep- 1.85 to 0.84; general problems - 1.74 to 0.97; practical problems - 3.52 to 1.37; nasal symptoms - 3.72 to 1.57; eye symptoms - 3.58 to 1.3; emotions - 2.48 to 1.19. CONCLUSION: Our study conducted in real life provided evidence that a three-year course of SLIT with HDM extract as well as with grass pollen extract significantly increased QoL in patients with allergic rhinitis.

Risk factors for development of chronic periodontitis in Bulgarian patients (pilot research).

The aim of this work was to assess the risks and analyse the risk factors for development of chronic periodontitis in Bulgarian patients. The quality of life was investigated in a cohort of 228 patients with chronic periodontitis. Within the frame of this study, pilot research (a case-control study) was conducted among 80 patients (20 cases and 60 control patients without periodontitis) to evaluate the risk for development of chronic periodontitis. The minimum sample size of patients was determined based on power analysis for sample-size calculation. The mean age of participants in the control group was 31.33 ± 9.38 years and in the case group, 33.00 ± 11.52. Data were accumulated by clinical and sociological methods. Descriptive statistics and multi-factor logistic regression analysis (Backward Conditional procedure) were used. One-factor dispersion analysis showed that, of the 12 studied risk factors, the following variables were significant: stress, diabetes, presence of calculus, overlapping and misaligned teeth (P < 0.05). Multiple logistic regressions were applied to evaluate the association between the variables. Three predictors were selected in the final logistic regression equation: diabetes (B = 4.195; P = 0.001), crooked and overlapping teeth (B = 3.022; P = 0.010) and stress (B = 2.882; P = 0.014). The logistic risk assessment model for development of periodontitis has a predictive value of 93.80% (χ2 = 63.91; P = 0.000). Our results confirmed some proven risk factors for periodontal disease. In the studied population, diabetes was the single, most important predictor for development of periodontitis.

Validation of a scale assessing the impact of periodontal diseases on patients' quality of life in Bulgaria (pilot research)

The aim of the paper is to present the validation of a scale for assessing the impact of periodontal diseases on individuals' quality of life in Bulgaria. A pilot research was made among 30 diagnosed patients with periodontitis visiting the Department of Periodontology, Faculty of Dental Medicine, Medical University of Plovdiv, Bulgaria. The minimum sample size of 30 people was established based on a power analysis for sample size calculation. The mean age of participants was 48.95 ± 11.85 years, being 56.67 ± 9.05 years for males and 43.33 ± 9.05 years for females. Standard interviews were conducted using a specific instrument: self-designed questionnaire and a 5-degree ranked scale, containing initially 11 questions. The interviews were repeated after 3 months with the same patients for retest analysis. The data was statistically processed using SPSS v.13 software. Results received after the initial interviews: Cronbach's coefficient (α=0.882), Spearman-Brown coefficient (r sb=0.998), average inter-item correlation coefficient (R=0.426), difficulty of the questions from 0.173 to 0.757 and discrimination power from 0.405 to 0.809. Results after the second interviews: α=0.883, r sb=0.998, R=0.507, difficulty from 0.287 to 0.757 and discrimination power from 0.524 to 0.809. In two of the questions, a low level of inter-item correlation with the rest of the items was found and they were excluded. The final version of the questionnaire contained 9 questions. The validation proved that the developed scale is sufficiently reliable and will be used in the final research, the first one to use such an instrument for measuring oral health-related quality of life in Bulgaria.

O objetivo deste artigo é apresentar a validação de uma escala que mede o impacto das doenças periodontais sobre a qualidade de vida das pessoas na Bulgária. Foi feito um estudo piloto com 30 indivíduos diagnosticados com doença periodontal, entre os pacientes do Departamento de Periodontologia da Faculdade de Medicina Odontológica da Universidade de Medicina de Plovdiv, Bulgária. A amostra mínima de 30 pessoas foi estabelecida baseada em análise de potência para cálculo do tamanho de amostra. A idade média dos participantes foi de 48,95 ± 11,85 anos, sendo de 56,67 ± 9,05 para homens e de 43,33 ± 9,05 para mulheres. Foram feitas entrevistas padronizadas usando um instrumento específico: um questionário com uma escala de 5 graus, contendo 11 perguntas iniciais. As entrevistas foram repetidas 3 meses depois, com os mesmos pacientes, para reanalisar o teste. Os dados foram processados estatisticamente pelo programa SPSS v.13. Os resultados das entrevistas iniciais foram: coeficiente de Cronbach (α=0,882), coeficiente de Spearman-Brown (rsb=0,998), coeficiente de correlação média inter-item (R=0,426), dificuldade das questões de 0,173 a 0,757 e potência de discriminação de 0,405 a 0,809. Os resultados da segunda série de entrevistas foram: α=0,883, rsb=0,998, R=0,507, dificuldade de 0,287 a 0,757 e potência de discriminação de 0,524 a 0,809. Duas das questões apresentaram baixo nível de correlação inter-item e foram excluídas. A versão final do questionário continha 9 perguntas. A validação comprovou que a escala desenvolvida é suficientemente confiável e será usada na pesquisa final, a primeira a utilizar tal instrumento para mensurar a qualidade de vida relacionada à saúde oral na Bulgária.

Validation of a scale assessing the impact of periodontal diseases on patients' quality of life in Bulgaria (pilot research).

The aim of the paper is to present the validation of a scale for assessing the impact of periodontal diseases on individuals' quality of life in Bulgaria. A pilot research was made among 30 diagnosed patients with periodontitis visiting the Department of Periodontology, Faculty of Dental Medicine, Medical University of Plovdiv, Bulgaria. The minimum sample size of 30 people was established based on a power analysis for sample size calculation. The mean age of participants was 48.95 ± 11.85 years, being 56.67 ± 9.05 years for males and 43.33 ± 9.05 years for females. Standard interviews were conducted using a specific instrument: self-designed questionnaire and a 5-degree ranked scale, containing initially 11 questions. The interviews were repeated after 3 months with the same patients for retest analysis. The data was statistically processed using SPSS v.13 software. Results received after the initial interviews: Cronbach's coefficient (α=0.882), Spearman-Brown coefficient (r(sb)=0.998), average inter-item correlation coefficient (R=0.426), difficulty of the questions from 0.173 to 0.757 and discrimination power from 0.405 to 0.809. Results after the second interviews: α=0.883, r(sb)=0.998, R=0.507, difficulty from 0.287 to 0.757 and discrimination power from 0.524 to 0.809. In two of the questions, a low level of inter-item correlation with the rest of the items was found and they were excluded. The final version of the questionnaire contained 9 questions. The validation proved that the developed scale is sufficiently reliable and will be used in the final research, the first one to use such an instrument for measuring oral health-related quality of life in Bulgaria.