Neglected Global Diseases Initiative, University of British Columbia, Vancouver, British Columbia V6T 1Z3, Canada.
J Pharm Sci. 2013 May;102(5):1419-33. doi: 10.1002/jps.23474. Epub 2013 Feb 28.
The quality of essential medicines for pediatric populations in developing countries is largely unknown. This review examines quality studies (2000-2011) of medicines on the WHO Essential Medicine List for Children, the quality of a subset of pediatric formulations, and the association of these poor quality medicines with adverse clinical outcomes. We searched Embase, Medline, BIOSIS, and IPA using MeSH subject terms for quality measures, medicine formulations, and substandard medicines and combined these with 267 medicines, and 91 low-income and lower-middle-income countries. Seventy articles met our inclusion criteria examining the quality of 75 medicines from 28 countries. Content and dissolution tests were utilized most often. Results indicate that antibacterials, antifungals, and antiretrovirals were consistently of good quality. Quality tests on pediatric formulations were performed on 55 of 75 of the medicines studied and followed the general trend of quality results. Three studies were included that examined clinical consequences of substandard medicines-two cases of diethylene glycol poisoning and one case of substandard malaria drugs. We conclude that there is a need for more quality studies of pediatric formulations of essential medicines in developing countries and their clinical consequences.
发展中国家儿科人群基本药物的质量在很大程度上是未知的。本综述检查了 2000 年至 2011 年期间关于世界卫生组织儿童基本药物清单上的药物、一部分儿科制剂的质量以及这些劣质药物与不良临床结果之间的关系的质量研究。我们使用质量措施、药物制剂和劣药的 MeSH 主题术语在 Embase、Medline、BIOSIS 和 IPA 上进行了搜索，并将这些术语与 267 种药物和 91 个低收入和中低收入国家结合起来。有 70 篇文章符合我们的纳入标准，检查了来自 28 个国家的 75 种药物的质量。最常使用含量和溶解试验。结果表明，抗菌药、抗真菌药和抗逆转录病毒药物的质量始终良好。对研究的 75 种药物中的 55 种进行了儿科制剂的质量测试，结果符合质量测试的总体趋势。有三项研究检查了劣药的临床后果——两例二甘醇中毒和一例劣药疟疾药物。我们的结论是，需要对发展中国家儿科基本药物制剂及其临床后果进行更多的质量研究。
