Some H2 Antihistaminics And Ppi-S Products Authorized In Albania And Their Availability For Pediatric Groups

Abstract

The objective of this study was to evaluate the number of medicines and active ingredients for pediatric population that are authorized and marketed in Albania. For this purpose were selected two group’s medicines: H2 antihistaminics and Proton Pump Inhibitors. 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 SmPCs. 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. From evaluation of SmPCs of selected products for the authorized age - group were found that 58 products are also authorized for use in children. Two of the active ingredients are authorized only for use in adults. The analyze of aspect if the recommended dose prescribed based on the classification of pediatric age stated give these data’s: 35 products are authorized for use children and adolescents from 3–18 years and 23 products are authorized for use in children more than 1 year old. This study shows a lack of availability of pediatric medicines for selected products and shows that pediatric medicines may not be age-appropriate; 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.