Božić Bojana, Stupar Sanja, Stupar Duško, Babić Uroš, Bajčetić Milica
Department of Pharmacology, Clinical Pharmacology and Toxicology, School of Medicine, University of Belgrade, Belgrade, Serbia.
"Dr. Selakovic" Clinic, Belgrade, Serbia.
Indian J Pharmacol. 2017 Mar-Apr;49(2):189-193. doi: 10.4103/ijp.IJP_66_16.
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.
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).
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.
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.
本研究旨在分析塞尔维亚标注适用于12岁以下儿童的儿科制剂的可获得性以及医疗保险报销覆盖情况。为深入了解儿科药物的总体可获得性，将结果与世界卫生组织（WHO）的《儿童基本药物示范清单》以及已发表的证据进行了比较。
药物信息来源包括产品特性摘要、国家健康保险基金（NHIF）药品清单、WHO儿童基本药物示范清单以及塞尔维亚官方药品登记处（2013年）。
在塞尔维亚的所有药品中，仅有49%（496种）有儿童适用剂型。在所有可获得的儿童用药中，66%有许可证，大多数为注射剂型（57%），其次是局部用药物（28%）和口服制剂（23%）。0至27天龄儿童的药品可获得性最低。在12岁以下儿童的所有有许可证药品中，NHIF覆盖了64%的药物。塞尔维亚的WHO儿童基本药物可获得性为51%，其中92%有儿科使用许可证。
我们的结果表明塞尔维亚令人震惊地缺乏适合儿童的制剂。全球范围内，适合儿童的药物可获得性存在显著差异。因此，从全球健康角度来看，儿童制剂获取方面的差异应成为最优先考虑的事项。
