Peculiarities in the regime of dispensing medicinal products in Bulgaria and the other member states of the European Union


Peculiarities in the regime of dispensing medicinal products in Bulgaria and the other member states of the European Union
Oral presentation


assoc. prof. Dr. Lyubina Todorova, MD1, MPharm. Gergana Lazarova2
1Bulgarian Drug Agency, University "Prof. Dr. Asen Zlatarov", Burgas, Bulgaria 2Bulgarian Drug Agency


The general classification for supply of the medicinal products differs in the countries of the European Union. This is due to the fact that these are national decisions, which are based on both Community and national regulatory requirements, as well as the different interpretations of some Community recommendations by Member states. In Bulgaria, the method of dispensing medicinal products is regulated by the MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT (Chapter Seven) (Anon., 2007) and Ordinance No. 3 of the Ministry of Health of 03.04.2008 on the criteria for the classification of medicinal products and the documentation requirements for making a change in classification. Directive 2001/83/EU, Notice to Applicants and Resolution ResAP (2007)1 (EDQM, 2007) of the European Directorate for the Quality of Medicines (EDQM) were used as the basis for the preparation of these regulatory documents. When evaluating medicinal products before issuing a marketing authorization or in the event of a requested change in the medication dispensing regime, BDA experts also refer to their instructions, although they are not mandatory (legally binding). The criteria are well defined in the aforementioned regulatory documents. Over-the-counter (OTC) medicines are medicines that can be sold without a prescription directly to the patient/consumer. Over-the-counter medicines are often the first choice for patients/users as they help to manage the symptoms of a wide range of common ailments, such as headache, common cold, cough, musculoskeletal pain, allergies, tobacco addiction, heartburn, emergency contraception, etc. Many, at first glance, harmless drugs are freely dispensed in the pharmacy network. The risks of such behavior, both on the part of pharmacists and on the part of patients, are often not known to drug users. Examples of such risks are antibiotics, which are widely used in any febrile condition, especially in childhood, and their use is gradually increasing, leading to the development of resistance by the most common pathogens. The use of expectorant products (eg, acetylcysteine, ambroxol) in the pediatric population without prior examination and evaluation by a specialist in pediatric diseases could lead to the inability of the child to expectorate the accumulated secretions, due to the immaturity of the child's organism. Prolonged use of proton pump inhibitors (PPI) leads to consequences, such as dyspeptic disorders, changes in the body's electrolyte balance, etc. There is a huge amount of literature on the risks of improper use of non-steroidal anti-inflammatory drugs (NSAIDs). They start with the most frequently commented reactions from the gastrointestinal tract, go through the danger of difficult-to-control bleeding (due to the peculiarities of the mechanism of action of this group of active substances) and arrive at risks for the cardiovascular system, which are considered with increased attention and interest on the part of drug safety experts not only in the EU countries, but also around the world. The reason for this overview is that Bulgaria is known as one of the countries with a fairly liberal regime for dispensing medicinal products.
Keywords: classification as regard of their supply dispensing mode, non-prescription, regulatory framework