Department of Pharmacy, The Islamia University of Bahawalpur, Railway Road Campus, Bahawalpur, 63100, Pakistan.
Faculty of Pharmacy and Health Sciences, University of Balochistan, Quetta, Pakistan.
Ther Innov Regul Sci. 2020 May;54(3):492-506. doi: 10.1007/s43441-019-00081-7. Epub 2020 Jan 6.
The unavailability of appropriate pediatric drug pack size is a global issue. Antibiotics are the lifesaving and most frequently prescribed therapeutic agents given to pediatrics. The objective of this study was to assess the compliance of pediatric antibiotic pack size with the standard dosage regimen.
A descriptive study design was employed. Data were collected from a community pharmacy in Bahawalpur, Pakistan, between August 1, 2017, and September 30, 2017. Five most commonly prescribed antibiotics were selected and calculations were made to check the appropriateness of packaging size by comparing the quantity of product in the available pack with the dosage regimen recommended by the British National Formulary for Children (BNFC).
Only 16 clarithromycin, 9 amoxicillin, 1 cefotaxime, and 1 metronidazole packaging sizes were sufficient to meet the dosage regimen for treatment. None of the available pack sizes for gentamicin matched the recommended duration of treatment. The study findings revealed that the available pack sizes either had leftover or a shortfall of antibiotic formulation. Highly inappropriate dosage forms (containing either excess and less quantity) of antibiotics were intravenous infusions and oral suspensions.
The study concluded that the packaging sizes of antibiotics failed to supply the recommended dosage regimen to pediatrics for common indications. This may contribute to development of antibiotic resistance among pediatric patients. Health policy makers should devise strict rules and regulations to ensure the availability of child-specific antibiotic pack sizes.
儿童药物包装规格不足是一个全球性问题。抗生素是儿科救命和最常开的治疗药物。本研究的目的是评估儿科抗生素包装规格与标准剂量方案的符合程度。
采用描述性研究设计。数据于 2017 年 8 月 1 日至 9 月 30 日在巴基斯坦 Bahawalpur 的一家社区药房收集。选择了五种最常开的抗生素，并通过将现有包装中的产品数量与英国儿童国家处方（BNFC）推荐的剂量方案进行比较，计算包装规格的适宜性。
只有 16 个克拉霉素、9 个阿莫西林、1 个头孢噻肟和 1 个甲硝唑包装规格足以满足治疗剂量方案。没有一种可供选择的庆大霉素包装规格与推荐的治疗持续时间相符。研究结果表明，现有的包装规格要么有剩余，要么抗生素制剂不足。抗生素的高度不适宜剂型（含有过量或不足的剂量）为静脉注射和口服混悬剂。
研究得出结论，抗生素的包装规格无法为儿科常见适应症提供推荐的剂量方案。这可能导致儿科患者对抗生素产生耐药性。卫生政策制定者应制定严格的规则和条例，以确保提供特定于儿童的抗生素包装规格。
