The current reimbursement decision-making framework in Bulgaria seems to be generalised and not sufficiently transparent. It is unable to precisely assess innovative health technologies. The availability of a therapeutic alternative emerges as a key reimbursement decision-making criterion for orphan drugs, as these innovative products nominally provide the first medicinal therapy alternative to rare diseases.

Viral hepatitis, particularly hepatitis B and C, are diseases with worldwide distribution that present a significant public health problem. Seroprevalence studies allow assessment of the extent of the disease burden, the identification of populations at risk and the monitoring trends over time. A multi-center seroprevalence study, carried out in Bulgaria (covering the five largest cities - Sofia, Plovdiv, Varna, Pleven, and Stara Zagora) in 1999-2000 estimated a crude seroprevalence rate of 3.9% for HBsAg and 1.3% for anti-HCV. A decade later, comparable rates were observed in a study including 865 outpatients consulting a clinical laboratory in Plovdiv, the second largest administrative region in Bulgaria. The crude seroprevalence rate measured for hepatitis B (HBsAg) was 3.9%. The HBsAg prevalence rate in individuals ≤19 years of age (targeted by vaccination) was significantly lower compared to the rate in adults ≥20 years of age -1% versus 4.8%. The lack of dynamics in the overall level of HBsAg carriers is likely related to the excessively low hepatitis B vaccine coverage in individuals, born before the introduction of the universal vaccination of newborns in August 1991. Anti-HCV antibodies were detected in 0.7% of the subjects.

А series of European Union (EU) political decisions have made rare diseases one of the cornerstones of the common European health policy. Adopted in 2009, Council Recommendation on an action in the field of rare diseases aimed to serve as a policy-making guideline. However, the implementation report, which followed it, neither performed detailed cross-country comparison, nor assessed the impact of the policies. Areas covered: A 10-indicator set was elaborated to structure the review and to describe rare disease activities in 14 Eastern European countries. Expert commentary: Taking into account all indicators, EU member states outperform candidate and potential candidate countries in terms of rare disease policy planning and implementation. Hungary is the top performer, followed by Bulgaria and Czech Republic. Non-EU countries form the bottom tier, with Serbia being the best ranked among them. While EU adhesion is a major facilitator for planning and adopting rare disease policies, local stakeholders are the triggering factor for their successful implementation. European reference networks are likely to be the future of rare disease activities in the EU. They need to synchronize and closely collaborate with all important EU projects in the field of rare diseases if they are to achieve their objectives.

Introduction: Nosocomial infections (NI) are frequent complications in neonatal intensive care units (NICU) which result in high morbidity and mortality. Aim: To determine and analyze the incidence, risk factors and etiologic agents of NI in newborns admitted in the NICU to help plan-ning future surveillance and prevention strategies. Materials and methods: A prospective cohort study was carried out at the NICU of St George University Hospital, Plovdiv, Bul-garia from January 1, 2017 to June 31, 2018. The number of neonates included in the study was 507. Descriptive statistics such as count,  percent, mean and standard deviation was used. Chi-square test was performed to prove associations. Odds ratios, with 95% confidence intervals, were computed from the results of the binominal logistic regression analyses. Results: Of the 507 hospitalized newborns in NICU, 48 presented with 54 NI. The incidence and the density incidence rates were 9.5% and 7.67 per 1,000 patient-days, respectively. Nosocomial infections were detected in neonates from all birth weight (BW) classes, but it was low BW and premature neonates that were at major risk to acquire them. The most common infection sites were ventilator-asso-ciated pneumonia (VAP) (67.27%), bloodstream infection (23.64%) and conjunctivitis (9.09%). Major pathogens were Gram-negative such as Klebsiella pneumoniae, E. coli, Pseudomonas aeruginosa and Acinetobacter baumannii. In the multivariate logistic regression analysis NIs were strongly associated with intubation, presence of a venous catheter, the duration of antibiotic treatment and increased CRP> 10 mg/l. Conclusions: This report highlights the burden of NIs, identifies the major focus for future NI control and prevention programs.

Aim: &#1058;&#1086; investigate the serum levels of vitamin D in newly diagnosed patients with multiple myeloma. Patients and methods: In this study we measured the serum levels of vitamin D in 37 patients (19 women, 18 men) at a median age of 68 years and a diagnosis of MM according to the International Myeloma Working Group (IMWG) criteria. The immunoassay tests used for the quantification of 25 (OH) &ndash; Vitamin D were original ELISA kits Immundiagnostic and the measurement was done before starting the treatment. Results: Serum levels below the optimum (<30 ng/ml) were recorded in all 37 patients. The median value of vitamin D was 4.3&plusmn;6.5 mg/ml, the maximum value measured was 24.7 mg/ml, which is below the lower limit of the reference value for deficiency. Conclusions: In this study, we found extremely low serum vitamin D levels in most of the newly diagnosed MM patients.

Introduction: Bisphosphonate-associated osteonecrosis of the jaws (BAONJ) is a side effect of treatment with bisphosphonate (BP). Reports of this complication have increased recently. Aim: To evaluate the level of knowledge of dentists from Plovdiv, Bulgaria, about possible complications of bisphosphonate therapy of patients in dental practice. Materials and methods: Three hundred and twenty-three dental practitioners from Plovdiv, Bulgaria, took part in an anonymous survey containing 25 questions, designed to evaluate the knowledge of dentists about the complications of BP therapy. Results: Oral and maxillofacial surgeons have the best knowledge about the indications and side effects of BP therapy, while dentists with a specialty in Pediatric Dentistry and General Dentistry have insufficient knowledge. Of the respondents, 17.03% are absolutely uninformed about BP and their side effects, and 1/2 declare that they have never had a patient with complications from BP therapy in their practice, probably due to a lack of awareness of the problem. Approximately half of the dentists we surveyed agree to carry out prophylactic examinations of patients receiving BP and know what the prophylactic examination includes. Only 15.48% of the respondents have correctly responded that in order to be treated as clinically healthy, patients should have stopped taking BP for more than 10 years. Conclusion: With the exception of specialists in Oral and Maxillofacial Surgery, dental practitioners in Plovdiv and the region are poorly informed about the complications associated with BP therapy. Therefore, efforts must be made to make these dentists better informed about BAONJ, especially about the methods and means of preventing this condition.

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