Objective: The aim of this study is to assess the specificity of the patient information provided in the leaflets accompanying the most commonly used medicines in Bulgaria, with special attention paid to the relationship between the type of pharmaceutical form and the recommendations for consultation with a specific medical specialist.
Materials and methods: The object of the study are 2500 patient leaflets for medicines classified by the annual reports of the Bulgarian Medicines Agency (BMA) as the most frequently used medicinal products available on the market in our country. Тhe study was conducted in three steps: 1) Collection of data from the electronic versions of the patient leaflets; 2) Summarizing and systematizing the information required by Regulation No. 38/13.9.2007 regarding the "special recommendation for consultation with the doctor or pharmacist (depending on the case) in case of need for clarifications regarding the use of the product", by using specialized text analysis software; 3) Data analysis according to a pre-developed protocol based on the list of standard terms of the European Directorate for the Quality of Medicines and Healthcare, specifically concerning the dosage forms and the classification of the professional qualifications of medical specialists.
Results: After selecting the leaflets of the medicines, in which it is written that only the physician provides additional information about the intake of the product (n=82), an analysis was made of the type of pharmaceutical form of these products. Half of the cases in this selection are oral forms, followed by injection forms with 24%, in third place are infusion forms with 19%. In the leaflets where it is mentioned that “physician, pharmacist and nurse” are the ones providing information (n=192), the most frequently encountered are oral forms (54%), followed by injectable (19%) and infusion (17%). In the leaflets where the physician and nurse are mentioned as the source of information (n=155), infusion forms prevail - 52%, followed by injectable (33%), oral (10%) and implants (5%).
Conclusion: This study of specific regulatory drug data analyses the relationship between the type of pharmaceutical forms and the healthcare professionals who are mentioned in the leaflets as persons providing information to patients. Based on the results obtained, it can be concluded that for infusion and injectable forms, the physician and nurse are mentioned in over half of the selected leaflets. These medications require the use of medical devices for their application and sometimes special equipment, which is why they require specialized consultation.
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