ESTIMATION OF MATERIAL LOSSES DURING THE REGISTRATION OF THE DRUG «AMOXICILLIN + CLAVULANIC ACID» IN INFUSION THERAPY OF COMMUNIT Y-ACQUIRED PNEUMONIA IN CHILDREN

Yu. A. Abdullina, S. N. Egorova, S. A. Sidullina, A. Kabanova
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Abstract

Patients diagnosed with community-acquired pneumonia are recommended to receive anti- biotic therapy. In case of severe pneumonia in hospital, infusion of Amoxicillin preparations is used. In the Russian pharmaceutical market during the study period, there are no solutions for parenteral administration in pediatric dosages, which leads to high financial losses of medical organization and environmental risks in the disposal of antibiotics. Objective of the study evaluation of losses of drug weight and financial losses when using «adult» doses of anti- bacterial agents for infusion therapy of community-acquired pneumonia in children (on the example of the drug «Amoxicillin+clavulanic acid, powder for preparation of solution for intravenous injection»). Materials and methods the objects of the study were clinical guidelines on treatment of community-acquired pneu- monia in children, information from the State Register of Medicines, instructions for medical use. The source of data on prices was the information from the State Register of maximum selling prices. Analytical, statistical, logical, and computational-constructive methods of re- search were used in the work. Results: the study calculated the material losses of the drug in mg per vial and 12 vials (treat- ment course of 4 days). With a single therapeutic dose of 300 mg, the material losses of the drug, using a dosage of 1200 mg, were: 1200 - 300 = 900 mg (75% of the dosage form). Fi- nancial losses in rubles calculated for the course of treatment with the drug Amoxicillin + clavulanic acid 1200 mg amounted to 756.00 rubles (79.05%) per 1 child, and for treatment with the dosage of 600 mg - 252.00 rubles (52.70% of the cost of the drug). The development of the dosage forms for intravenous administration of Amoxicillin + clavu- lanic acid in the doses of 180 and 240 mg would allow decreasing considerably the losses of the drug during preparation of infusion solutions in pediatric practice. Conclusion 1. When administering antibacterial therapy for community-acquired pneumonia in chil- dren, the drug Amoxicillin + clavulanic acid, powder for preparation of solution for intrave- nous injection, manufactured in doses of 1200 mg and 600 mg, is used. 2. Modeling of weight losses of Amoxicillin + clavulanic acid powder for intravenous solu- tion preparation for treatment of community-acquired pneumonia in children aged 1 year showed that when 1200 mg dosage was used, losses were 900 mg/ vial (10800 mg per treat- ment course), and in 600 mg dosage - 300 mg/ vial (3600 mg per course); 75 and 50% of drug weight respectively. 3. Calculations have been made and significant financial losses have been established in treatment of community-acquired pneumonia in children under 5 years old with the drug «Amoxicillin + clavulanic acid, powder for preparation of solution for intravenous injection» 1200 mg and 600 mg, due to incomplete use of the package. The financial loss for the course of treatment with the drug Amoxicillin + clavulanic acid in the dosage of 1200 mg amounted to 756.00 rubles (79.05%) for 1 child aged 1 year, and for treatment with the dosage of 600 mg - 252.00 rubles (52.70% of the cost of the drug for the course of treatment). 4. For treatment of community-acquired pneumonia in children aged 5-11 years it is reason- able to use Amoxicillin + clavulanic acid 600 mg dosage. 5. For treatment of community-acquired pneumonia in children under 5 years old it is advis- able to commercially release the medicinal product «Amoxicillin + clavulanic acid, powder for preparation of solution for intravenous injection» in doses of 180 mg (150+30 mg) and 240 mg (200+40 mg).
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估计药物“阿莫西林+克拉维酸”输注治疗儿童社区获得性肺炎注册期间的物质损失
确诊为社区获得性肺炎的患者建议接受抗生素治疗。在医院重症肺炎的情况下,使用阿莫西林制剂输注。在研究期间的俄罗斯医药市场中,没有针对儿科剂量的非肠外给药的解决方案,这导致医疗机构的财务损失很大,抗生素处置存在环境风险。研究的目的是评估使用“成人”剂量的抗菌药物输液治疗儿童社区获得性肺炎时的药物重量损失和经济损失(以药物“阿莫西林+克拉维酸,制备静脉注射溶液的粉末”为例)。材料和方法研究的对象是社区获得性儿童肺炎的临床治疗指南、国家药品注册信息和医疗使用说明。价格数据的来源是国家最高销售价格登记册的资料。在工作中使用了分析、统计、逻辑和计算构建的研究方法。结果:以mg /瓶和12瓶(疗程4 d)为单位计算药物的物质损失。单次治疗剂量为300 mg时,使用剂量为1200 mg的药物的物质损失为:1200 - 300 = 900 mg(剂型的75%)。按卢布计算,阿莫西林+克拉维酸1200毫克治疗期间的经济损失为每1名儿童756.00卢布(79.05%),600毫克治疗期间的经济损失为252.00卢布(占药物费用的52.70%)。阿莫西林+克拉武-兰酸180和240毫克静脉给药剂型的发展将大大减少儿科输液溶液制备过程中药物的损失。结论1。在对儿童社区获得性肺炎进行抗菌治疗时,使用阿莫西林+克拉维酸药物,用于制备静脉注射溶液的粉剂,剂量为1200毫克和600毫克。2. 对1岁儿童治疗社区获得性肺炎静脉溶剂阿莫西林+克拉维酸粉剂的体重损失建模显示,当剂量为1200 mg时,体重损失为900 mg/瓶(每个疗程10800 mg),而剂量为600 mg时,体重损失为300 mg/瓶(每个疗程3600 mg);分别为药物重量的75%和50%。3.经计算,在使用“阿莫西林+克拉维酸,用于制备静脉注射溶液的粉末”1200毫克和600毫克药物治疗5岁以下儿童的社区获得性肺炎时,由于包装使用不完全,造成了重大经济损失。1名1岁儿童服用阿莫西林+克拉维酸1200毫克药物治疗的经济损失为756.00卢布(79.05%),服用600毫克药物治疗的经济损失为252.00卢布(占整个治疗过程药物费用的52.70%)。4. 对于5-11岁儿童社区获得性肺炎的治疗,合理使用阿莫西林+克拉维酸600毫克剂量。5. 为治疗5岁以下儿童的社区获得性肺炎,建议商业发行药物“阿莫西林+克拉维酸,制备静脉注射溶液的粉末”,剂量为180毫克(150+30毫克)和240毫克(200+40毫克)。
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