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.

Bulgarian Experience with Adverse Drug Reaction Reports from Patients and Consumers - Retrospective Data-base Study.

BACKGROUND: Since 2012, in compliance with the changes in the European legislation, the Bulgarian Drug Agency (BDA) has been receiving adverse drug reaction (ADR) reports directly from patients as well as from healthcare professionals and marketing authorization holders (MAH). Adverse reaction reports from patients and consumers have different characteristics from those sent by healthcare professionals. Moreover, they may require specific algorithm and assessment methods in order to be informative and beneficial to the pharmacovigilance system. AIM: The study aims to analyze the data-base of consumer reports in Bulgaria in order to distinguish and classify the main characteristics of the ADR reports from non-healthcare professionals. MATERIALS AND METHODS: In-depth analysis of the Bulgarian data-base of consumer ADR reports for 2012-2016 was conducted. The criteria include patient demographic characteristics, preferred method of reporting, seriousness and expectedness criteria and most frequently reported pharmacological groups. RESULTS: The data showed the current trends in patient reporting in the country. It also marked new courses for development of the spontaneous reporting system and collection of safety data. The analysis of the data-base showed a rather stable level of patient reporting with a tendency for constant growth every year. Bulgaria follows the world tendencies for high number of reports for insufficiently studied ADRs which meet the seriousness criteria. The review of the most frequently reported ATC codes could lead to the conclusion that the current pharmacovigi-lance methods are not sensitive enough for specific groups of medicines. CONCLUSIONS: The results from the conducted study confirm the importance of patient reporting as a valuable source of information on adverse drug reactions. Moreover, it draws the attention to the lack of more sensitive methods for evaluation of drug safety in specific pharmacological groups. Maintenance of consumer-friendly ADR reporting system and innovative assessment algorithms should be the future directions for development in post-marketing surveillance.