Quality analysis of selected Pediatric HIV/AIDS/TB Medicines in Livingstone District, Zambia

Abstract

Introduction :Counterfeiting affects all medical products, from medicines and pharmaceutical ingredients to medical devices and diagnostics. Counterfeit drugs including overt forgeries, pharmaceutically-sound close imitations, substandard generic medications, gray pharmaceuticals, and repackaged expired drugs are not only a problem of the developing world. It is therefore important to know or ascertain the quality of medicines or drugs being consumed by the population for public health protection. This study was designed to evaluate the quality of selected pediatric HIV/AIDS and TB drugs in Livingstone district health facilities of Zambia. Methodology :The study was a cross sectional study that involved the collection of samples of different brands/lots of pediatric Nevirapine (NVP) suspension as well as Rifampicin-Isoniazid (RH) tablets in Livingstone District health facilities. A total of 400 RH tablets and 50 bottles of NVP suspension of different brands and batches were collected, kept and transported to Lusaka for analysis at ambient temperature. The analysis involved assessing for presence of Active Pharmaceutical Ingredients, percentage content, packaging, appearance and labeling standards with reference to the official monographs in this case the International Pharmacopoeia 2011 (IP) and the United State Pharmacopeia 36 (USP). Results :A total of 450 drug samples were included in the study and 100% were correctly identified, had the active pharmaceutical ingredient in the right quantities, appeared, labeled and packaged in conformity with the official monographs of the USP 36 and IP 2011. Conclusion :This study provided objective evidence that the selected pediatric medicines available in Livingstone District Health facilities of the Republic of Zambia are of good quality and meet the requirements as stipulated in the official monographs of the USP and IP.