Abstract

AVAILABILITY OF SOME CARDIOVASCULAR MEDICINES AUTHORIZED IN ALBANIA FOR PEDIATRIC POPULATION

Briseida Dosti* and Ledjan Malaj

ABSTRACT

Objectives: The aim of this study was to evaluate the number of medicines and active ingredients for pediatric population that are authorized and marketed in Albania, for nine active ingredients which belong to medicinal products used for treatment of cardiovascular diseases. Methods: The availability of pediatric medicines and active ingredients was studied with the help of the database of the Albanian National Agency for Medicine and Medical Devices and SmPC. Selected active ingredients were categorized based on their route of administration, type of pharmaceutical form, dosage, therapeutic indication, dose capability and suitability of the pharmaceutical form for use in children. Results: Evaluation of the SmPCs of the products suggested that only two active substances are authorized for use in children; all were for solid oral forms. Approved pharmaceutical forms are as follows: 78.5% tablets, 7.4% coated tablets, 12.4% modified-release film-coated tablets and 1.7% film coated tablets. For any active ingredient wasn’t found authorized liquid formulations, which are more appropriate for use in children. Conclusion: This study shows lack of availability of pediatric medicines for selected products and shows that pediatric medicines may not be ageappropriate; even they are authorized for such use. It was shown that few medicinal products are specifically studied in children. Therefore, are needed more efforts to increase the number of drugs authorized for the pediatric groups. Even more, it is required by pharmaceutical companies to supply data on the effects of new drugs in children.

Keywords: pediatric, medicines, forms, authorized, cardiovascular.