Assessment of patients’ awareness on drugs use and adherence to drug therapy as an element of Medication Review service

The administration of an excessive amount of or unnecessary drugs is a prerequisite for numerous drug-related problems, non-compliance, non-adherence to medicinal therapy, exacerbation and poor control of chronic diseases, and failure in achieving the treatment goals. The aim of this study was to assess patients’ awareness on drug use (administration, adherence to drug therapy) and to identify the possible drug-related problems with patients, using 5 or more medicines on Bulgarian territory. The data were collected implementing a structured study tool – a questionnaire for assessment of patients’ therapy using 5 or more drugs prescribed by a physician, including OTC and/or food supplements. The study provided an identification of factors affecting skipping of doses, modification of regime and analyzed the relationships and interdependencies between number of diagnoses and adverse drug effects rate; number of administered drugs and reported problems and unawareness of the medicinal product indications and health state. The results showed that it was necessary to introduce the Medication Review (MR) service in Bulgarian pharmaceutical practice. That will provide possibilities for development of pharmacists’ role in dispensing medical products, it will help in reducing drug-related problems and increasing the effectiveness of the treatment and adherence to medical therapy

Health Emergency Preparedness and Response Authority’s (HERA) role in dealing with the monkeypox emergency in the European Union

The current article examines and analyzes the actions taken by the European Commission, specifically through the Directorate-General Health Emergency Preparedness and Response Authority (HERA) – an organization that anticipates threats and potential health crises, through intelligence gathering and building the necessary response capacities), aimed at supporting member states in limiting the spread of MPOX (monkeypox – an infectious disease caused by the monkeypox virus). It explores specific pharmaceutical products and vaccines procured by HERA and how they have been distributed among member states. The article raises questions about the compliance in purchasing pharmaceutical products and vaccines lacking approval for use within the European Union, highlighting the potential new regulatory challenges for Bulgaria if it needs to secure medications for treatment of human smallpox disease such as Jynneos and TPOXX (Tecovirimat) for its citizens. In conclusion, the article notes the swift response of HERA through the procurement of the Jynneos vaccine and TPOXX medicinal product. This swift response may have contributed to the decline of MPOX cases in the European region, potentially due to collaborative efforts among health authorities at both European and national levels. This success underscores the importance of cooperation among health authorities at various levels in combating infectious diseases

Survey on Sildenafil, Tadalafil, and Vardenafil Concentrations in Food Supplements for Erectile Dysfunction

The aim of the study was to analyze the presence of undeclared sildenafil, tadalafil, and vardenafil in food supplements (FSs) for erectile dysfunction. The presence of sildenafil, tadalafil, and vardenafil was determined using the generated ultraviolet (UV)-spectra and mass-spectrometry (MS)-spectra as well as chromatograms produced by the photodiode array (PDA)-detector and ion trap MS-detector. The results were processed by Xcalibur ver. 2.0.7. Fourteen of the 20 analyzed FSs contained undeclared ingredients. Sildenafil was present in 12 of them. Many violations and discrepancies between the label information and the real composition of the FS were identified. 70% of the samples contained undeclared ingredients of an erectile dysfunction medicinal product. The quantities varied within broad limits from 2 mg per tablet to 116.55 mg per tablet. Sildenafil was present in amounts exceeding 16.55 mg that is the maximum recommended dose, thus creating risk of overdose. Besides that, food supplements adulterated with sildenafil analogues are a health risk for consumer’s health as there is no evidence of modified sildenafil toxicity. All analyzed FSs were claimed to be 100% natural, not provoking side effects. No information for any FS contained indications of age limits or risk for interaction with other FSs or medical products

Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings

Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production processes. Aim: To present analysis of the deficiencies reported following Good Manufacturing Practice inspections in Bulgaria in two consecutive years (2016, 2017) and to compare them with results from similar inspections reported by other EU member states. Materials and methods: A retrospective study was carried out by reviewing the complete Good Manufacturing Practice inspection reports of all manufacturers conducted by the Bulgarian Drug Agency in 2016 and 2017, according to relevant requirements and applicable local legislation. The items reviewed were scope of inspection, type of companies, classification of deficiencies – ‘critical’, ‘major’ and ‘other significant deficiencies’, their nature and reference to EU Good Manufacturing Practice. Results: The analyzed data included 55 inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major. Twenty inspections were performed in 2016 vs. 35 inspections in 2017.The pattern of deficiencies was similar to the findings of other EU regulatory agencies, showing that equivalent requirements were applied. Our analysis showed that Bulgarian Drug Agency inspectors rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel and Qualification of Suppliers unlike other EU regulators agents. Conclusions: Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements.Publishing the results from the inspections performed by the national competent authorities enhances the regulatory transparency that can be useful for industry to improve its Good Manufacturing Practice compliance

Cost analysis of neonates after prenatal corticosteroid prophylaxis of Respiratory Distress Syndrome

Preterm birth is a vital global health-economic problem. Health disorders provoked by it generate a high neonatal mortality rate. Prenatal corticosteroid prevention aims to reduce postnatal complications in premature infants. This survey covered two basic baby groups: work group of 89 premature infants that had been subjected to prenatal corticosteroid prophylaxis and a control group of 78 premature babies without prenatal prevention. The analysis of the pharmacoeconomic aspects of prenatal corticosteroid prevention enabled the comparison of clinical and therapeutic results, treatment costs, therapeutic expenditures, shortterm therapeutic effect, benefits and sequences from premature infants’ therapy. The analysis of clinical data obtained during this survey enabled the conclusion that when analyzing the combined effect of Dexamethasone prophylaxis, gestation week at birth and the age of the mother of premature infants with RDS, respiratory obstuction occurrence was mediated by the earlier gestation week at birth, older mother’s age and, at this background, it was restricted to a certain extent by prenatal corticosteroid administration. Conclusions: Prenatal corticosteroids cause reduction of premature infants’ treatment costs. The implementation of a smaller number of dexamethasone applications leads to smaller expenditures for premature infants’ treatment and care compared to those that have more dexamethasone applications

Cost analysis of neonates after prenatal corticosteroid prophylaxis of Respiratory Distress Syndrome

Preterm birth is a vital global health-economic problem. Health disorders provoked by it generate a high neonatal mortality rate. Prenatal corticosteroid prevention aims to reduce postnatal complications in premature infants. This survey covered two basic baby groups: work group of 89 premature infants that had been subjected to prenatal corticosteroid prophylaxis and a control group of 78 premature babies without prenatal prevention. The analysis of the pharmacoeconomic aspects of prenatal corticosteroid prevention enabled the comparison of clinical and therapeutic results, treatment costs, therapeutic expenditures, shortterm therapeutic effect, benefits and sequences from premature infants’ therapy. The analysis of clinical data obtained during this survey enabled the conclusion that when analyzing the combined effect of Dexamethasone prophylaxis, gestation week at birth and the age of the mother of premature infants with RDS, respiratory obstuction occurrence was mediated by the earlier gestation week at birth, older mother’s age and, at this background, it was restricted to a certain extent by prenatal corticosteroid administration. Conclusions: Prenatal corticosteroids cause reduction of premature infants’ treatment costs. The implementation of a smaller number of dexamethasone applications leads to smaller expenditures for premature infants’ treatment and care compared to those that have more dexamethasone applications

Pilot Study of Pharmacists’ Attitudes towards and Expectations for Remuneration of Valueadded Pharmacy Services (VAPS) in Bulgaria

Introduction: Value-added pharmacy services (VAPS) are additional services to the traditional pharmacy activities, which do not in­clude dispensing of medicinal products and professional consultation. These services have cost reduction effect on the healthcare system and add value to the work of the pharmacist as a healthcare professional.Aim: To assess the pharmacists’ attitudes and expectations towards the remuneration of value-added pharmacy services (VAPS) in Bulgaria.Materials and methods: A cross-sectional study including pharmacists working in community pharmacies was carried out between August 2018 and October 2018. A web-based 15-item questionnaire was developed. The questionnaire was distributed to all members of the Bulgarian Pharmaceutical Union (n=5165). Two hundred thirty-three questionnaires were filled in and returned (response rate of 4.5%). Data were processed by SPSS v. 24.0.Results: Over 51% of the community pharmacies in Bulgaria offer VAPS, mainly measuring blood pressure (67.4%) and blood glucose (12.9%). Over two-thirds of the pharmacists considered charging a remuneration fee for blood pressure measurement irrelevant. About 30.5% of those who held the opposite opinion proposed that the fee charged should not be higher than EUR 2.56. Over 44% of the re­spondents proposed that the fee for blood glucose measurement should not be higher than the same amount. Most pharmacists (98.3%) supported the idea of charging a remuneration fee for injections and influenza vaccination in a pharmacy.Conclusion: The study shows that pharmacists in Bulgaria are ready to offer VAPS, but additional remuneration for the services should be provided

The Role Of Games In The Development Of Dialogue Speech Of Middle Age Nursery Children

Comprehensive characterization of defects formed in bulk ZnO single crystals co-implanted with N and Zn as well as N and O atoms is performed by means of optically detected magnetic resonance (ODMR) complemented by Raman and photoluminescence (PL) spectroscopies. It is shown that in addition to intrinsic defects such as Zn vacancies and Zn interstitials, several N-related defects are formed in the implanted ZnO. The prevailed configuration of the defects is found to depend on the choices of the co-implants and also the chosen annealing ambient. Specifically, co-implantation with O leads to the formation of (i) defects responsible for local vibrational modes at 277, 511, and 581 cm−1; (ii) a N-related acceptor with the binding energy of 160 ± 40 meV that is involved in the donor-acceptor pair emission at 3.23 eV; and (iii) a deep donor and a deep NO acceptor revealed from ODMR. Activation of the latter defects is found to require post-implantation annealing in nitrogen ambient. None of these defects are detected when N is co-implanted with Zn. Under these conditions, the dominant N-induced defects include a deep center responsible for the 3.3128 eV PL line, as well as an acceptor center of unknown origin revealed by ODMR. Formation mechanisms of the studied defects and their role in carrier recombination are discussed.Funding Agencies|Swedish Research Council|621-2010-3971|</p

Defects in N, O and N, Zn implanted ZnO bulk crystals

Comprehensive characterization of defects formed in bulk ZnO single crystals co-implanted with N and Zn as well as N and O atoms is performed by means of optically detected magnetic resonance (ODMR) complemented by Raman and photoluminescence (PL) spectroscopies. It is shown that in addition to intrinsic defects such as Zn vacancies and Zn interstitials, several N-related defects are formed in the implanted ZnO. The prevailed configuration of the defects is found to depend on the choices of the co-implants and also the chosen annealing ambient. Specifically, co-implantation with O leads to the formation of (i) defects responsible for local vibrational modes at 277, 511, and 581 cm−1; (ii) a N-related acceptor with the binding energy of 160 ± 40 meV that is involved in the donor-acceptor pair emission at 3.23 eV; and (iii) a deep donor and a deep NO acceptor revealed from ODMR. Activation of the latter defects is found to require post-implantation annealing in nitrogen ambient. None of these defects are detected when N is co-implanted with Zn. Under these conditions, the dominant N-induced defects include a deep center responsible for the 3.3128 eV PL line, as well as an acceptor center of unknown origin revealed by ODMR. Formation mechanisms of the studied defects and their role in carrier recombination are discussed.Funding Agencies|Swedish Research Council|621-2010-3971|</p

Digitalization of health care and aspects of implementing electronic prescriptions in Bulgaria

The digitization of health systems is a topic of immense significance for the modern world. It holds the potential to transform the delivery of healthcare services, enhancing their quality, efficiency, and accessibility. Electronic prescriptions are a key element of this process, but it is crucial to ensure their implementation protects patients’ personal data and privacy. This article examines the digitization of health systems in Bulgaria, with a focus on electronic prescriptions. It highlights aspects of data protection, the potential risks associated with data misuse, and the advantages of electronic prescriptions