Ivanovska Verica, Leufkens Hubert G, Rademaker Carin Ma, Zisovska Elizabeta, Pijnenburg Mariëlle W, van Dijk Liset, Mantel-Teeuwisse Aukje K
Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Faculty of Medical Sciences, University "Goce Delcev-Stip," Republic of Macedonia.
Arch Dis Child. 2017 Apr;102(4):352-356. doi: 10.1136/archdischild-2016-311933. Epub 2017 Jan 24.
There is a global call for formulations, which are better suited for children of different age categories and in a variety of settings. One key public health area of interest is age-appropriate paediatric antibiotics. We aimed to identify clinically relevant paediatric formulations of antibiotics listed on pertinent formularies that were not on the WHO Essential Medicines List for Children (EMLc).
We compared four medicines lists versus the EMLc and contrasted paediatric antibiotic formulations in relation to administration routes, dosage forms and/or drug strengths. The additional formulations on comparator lists that differed from the EMLc formulations were evaluated for their added clinical values and costs.
The analysis was based on 26 EMLc antibiotics. Seven oral and two parenteral formulations were considered clinically relevant for paediatric use. Frequently quoted benefits of oral formulations included: filling the gap of unmet therapeutic needs in certain age/weight groups (phenoxymethylpenicillin and metronidazole oral liquids, and nitrofurantoin capsules), and simplified administration and supply advantages (amoxicillin dispersible tablets, clyndamycin capsules, cloxacillin tablets, and sulfamethoxazole+trimethoprim tablets). Lower doses of ampicillin and cefazolin powder for injection could simplify the dosing in newborns and infants, reduce the risk of medical errors, and decrease the waste of medicines, but may target only narrow age/weight groups.
The identified additional formulations of paediatric antibiotics on comparator lists may offer clinical benefits for low-resource settings, including simplified administration and increased dosing accuracy. The complexity of both procuring and managing multiple strengths and formulations also needs to be considered.
全球都在呼吁研发更适合不同年龄组儿童且适用于多种环境的制剂。一个关键的公共卫生关注领域是适合儿童年龄的儿科抗生素。我们旨在确定相关处方集上列出但未列入世界卫生组织儿童基本药物清单（EMLc）的具有临床相关性的儿科抗生素制剂。
我们将四份药品清单与EMLc进行比较，并对比了儿科抗生素制剂在给药途径、剂型和/或药物强度方面的差异。对比较清单上与EMLc制剂不同的额外制剂进行了附加临床价值和成本评估。
分析基于26种EMLc抗生素。七种口服制剂和两种注射用制剂被认为具有儿科临床相关性。口服制剂经常被提及的益处包括：填补某些年龄/体重组未满足的治疗需求空白（苯氧甲基青霉素和甲硝唑口服液，以及呋喃妥因胶囊），以及简化给药和供应优势（阿莫西林分散片、克林霉素胶囊、氯唑西林片和磺胺甲恶唑+甲氧苄啶片）。较低剂量的注射用氨苄西林和头孢唑林粉可简化新生儿和婴儿的给药，降低医疗差错风险，并减少药品浪费，但可能仅针对狭窄的年龄/体重组。
在比较清单上确定的额外儿科抗生素制剂可能为资源匮乏地区带来临床益处，包括简化给药和提高给药准确性。同时也需要考虑采购和管理多种强度和制剂的复杂性。
