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.

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.

Physicians' knowledge and attitude towards adverse event reporting system and result to intervention--randomized nested trial among Bulgarian physicians.

AIM: To identify the factors that influence physicians' under-reporting in Bulgaria and their attitude towards adverse event reporting system and to estimate the role of self-education by providing educational materials. METHODS: A randomized nested trial among physicians-general practitioners and specialists in Bulgaria was conducted by a validated questionnaire in order to evaluate their knowledge and attitude towards adverse event reporting system. One month after the intervention the participants were re-visited and were asked to answer the same questions again in order to estimate the change in their knowledge and attitude towards pharmacovigilance system and to obtain their evaluation for the materials provided. RESULTS: The response rate was 91. Fifty seven (46.3%) physicians were not familiar with the pharmacovigilance system. The most common reason for non-reporting adverse drug reactions (ADRs) was uncertainty concerning the relationship between the suspected drug and ADRs, the ADRs were already known and the fact that the physician was not aware where they should report. Although 103 (83.7%) respondents in the entry survey and by 102 (82.9%) of those participating in the exit survey consider ADRs reporting as their obligation (p more than 0.05), only 50 (40.7%) and 31 (25.2%), respectively answered that they had ever reported ADRs; 109 (88.6%) of the surveyed physicians assessed the provided educational materials as useful for them. CONCLUSION: The physicians in Bulgaria have poor knowledge for the pharmacovigilance system; however self-education leads to a better knowledge and positive attitude towards ADRs reporting system. National drug regulatory authority should play a more active role in improving physicians' adherence to the ADRs reporting systems and the developed educational pack can be used in nationwide campaign.

Safety assessment of newly marketed herbal medicines--methodological approach (Ginkgo biloba example in Bulgaria).

This study presents a proposal for the methodological approach for postmarketing safety profile assessment based on sales data and information for adverse drug reactions of newly introduced herbal medicinal products in the market. The study covers all herbal medicinal products containing dry extract of Ginkgo biloba leaves allowed for sale in Bulgaria. The methodological approach we create should be used for the establishment of the national herbal drugs policy complying with the recent European regulatory changes and specificity of the therapeutic practice in the country.