Review of the Quality of Pediatric Medications in Developing Countries

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.