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.

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 in-clude 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 re-spondents 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.

Written Health Education Materials for Women with Gestational Diabetes Mellitus - Evaluation of Usefulness and Patients' Satisfaction.

BACKGROUND: Written health educational materials are an integral part of the treatment process. Because of the constantly increasing gestational diabetes mellitus (GDM) global rate, pregnant women require accessible, easy-to-understand and evidence-based medical information about this pregnancy complication. AIM: To adapt and elaborate printed educational materials on GDM and to evaluate the usefulness of the produced training materials and pregnant women's satisfaction. MATERIALS AND METHODS: The present study implemented a methodological approach covering three phases: (1) systematic literature review; (2) compilation of printed educational materials for pregnant women with GDM; (3) evaluation of the usefulness and satisfaction with the produced educational materials through a focus group consisting of pregnant women. A seven-item self-administered feedback questionnaire was adopted for evaluation of patient satisfaction after the use of educational materials. RESULTS: An educational manual was developed in compliance with the main requirements for effectiveness of educational materials referring to content, structure, language, layout and illustrations. The usefulness of the educational manual and patient satisfaction were evaluated by a sample group of 20 women with GDM. Approximately 95% agreed or strongly agreed that the information in the educational manual was useful. The patients' assessment of the understanding and readability of the written materials showed a satisfaction rate of 85%. The overall assessment for the educational materials was very high - excellent (65%), very good (30%) and good (5%). CONCLUSION: The provision of educational materials on GDM can enhance pregnant women's health literacy as well as their responsibility, motivation and attitude to their personal health.

Regulatory Requirements for Food Supplements in the European Union and Bulgaria.

Data provided by the European Commission show that public expenditures for food supplements have been constantly increasing over the last decade. The aim of the present study was to analyze the major food supplements regulations in the European Union and in Bulgaria. Relevant publications were searched and found in MEDLINE/PubMed, Scopus Database, Web of Knowledge, and in Internet-based search with predefined keywords. Numerous authors support the opinion that there is a real risk that low quality products may be distributed in countries with poor production control. Bulgarian national legislation have 6 regulations with different legal force for provision of healthy and safe food supplements on the market. Currently, the European Community is concerned about food products, including FS, launched on the market because the citizens require reliable protection of their health. This concern provoked the European Parliament and the Council to undertake a number of legislative initiatives in the field of production and control of food products. It is necessary to set more precise quality and safety criteria in future strategies associated with those products.