Availability of pediatric-evaluated formulations in Serbia. 2017

Bojana Božić, and Sanja Stupar, and Duško Stupar, and Uroš Babić, and Milica Bajčetić
Department of Pharmacology, Clinical Pharmacology and Toxicology, School of Medicine, University of Belgrade, Belgrade, Serbia.

OBJECTIVE The aim of this study is to analyze the availability and coverage by health insurance reimbursement of pediatric formulations labeled for children up to the age of 12 in Serbia. To provide good insight in general availability of pediatric medicines, results were compared with the World Health Organization's (WHO) "Model List of Essential Medicines for Children" and with published evidence. METHODS Sources of information about medicines are the Summary of Product Characteristics, National Health Insurance Fund (NHIF) Drug Lists, WHO Model Lists of Essential Medicines for Children, and Serbia's official drug registry (2013). RESULTS Out of total number of medicines in Serbia, only 49% (496) were available for children. Of all available drugs for children, 66% were with license and majority were parenteral formulation (57%), followed by drugs for local use (28%) and formulations for oral use (23%). The lowest availability of medicines was for children 0-27 days. From the total number of licensed medicines for children up to 12 years old, NHIF covers 64% of drugs. The availability of the WHO essential medicines for children in Serbia was 51%, from which 92% were licensed for pediatric use. CONCLUSIONS Our results demonstrated the alarming lack of pediatric suitable formulations in Serbia. Significant differences in the availability of drugs suitable for children exist worldwide. From global health point of view, the differences in the access to children formulations should, therefore, be of the highest priority.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D006297 Health Services Accessibility The degree to which individuals are inhibited or facilitated in their ability to gain entry to and to receive care and services from the health care system. Factors influencing this ability include geographic, architectural, transportational, and financial considerations, among others. Access To Care, Health,Access to Care,Access to Contraception,Access to Health Care,Access to Health Services,Access to Medications,Access to Medicines,Access to Therapy,Access to Treatment,Accessibility of Health Services,Availability of Health Services,Contraception Access,Contraceptive Access,Medication Access,Accessibility, Health Services,Contraceptive Availability,Health Services Geographic Accessibility,Program Accessibility,Access to Cares,Access to Contraceptions,Access to Medication,Access to Medicine,Access to Therapies,Access to Treatments,Access, Contraception,Access, Contraceptive,Access, Medication,Accessibilities, Health Services,Accessibility, Program,Availability, Contraceptive,Care, Access to,Cares, Access to,Contraception, Access to,Contraceptive Accesses,Health Services Availability,Medication Accesses,Medication, Access to,Medicine, Access to,Medicines, Access to,Therapy, Access to,Treatment, Access to
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000067576 Child Health The concept covering the physical and mental conditions of CHILDREN. Child Wellbeing,Child Well Being,Child Well-Being,Children's Health,Childrens Health,Health, Child,Health, Children's,Health, Childrens,Well Being, Child,Well-Being, Child,Wellbeing, Child
D014944 World Health Organization A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples. Organization, World Health,WHO
D055771 Serbia A republic located south of HUNGARY, west of ROMANIA and BULGARIA, and part of the former YUGOSLAVIA. The capital is Belgrade.
D018954 Drugs, Essential Drugs considered essential to meet the health needs of a population as well as to control drug costs. Essential Drugs

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