Quality Assessment of Some Essential Children’s Medicines Sold in Licensed Outlets in Ashanti Region, Ghana

Quality Assessment of Some Essential Children’s Medicines Sold in Licensed Outlets in Ashanti Region, Ghana Grace Frimpong,1,2 Kwabena Ofori-Kwakye,1 Noble Kuntworbe,1 Kwame Ohene Buabeng,3 Yaa Asantewaa Osei,1 Mariam El Boakye-Gyasi,1 and Ofosua Adi-Dako4 1Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana 2Department of Pharmaceutical Sciences, Faculty of Medicine and Health Sciences, Kumasi Technical University, Kumasi, Ghana 3Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana 4Department of Pharmaceutics and Microbiology, University of Ghana School of Pharmacy, Legon, Accra, Ghana Correspondence should be addressed to Kwabena Ofori-Kwakye; moc.oohay@eykawkirofok Received 23 December 2017; Revised 2 April 2018; Accepted 11 April 2018; Published 21 May 2018 Academic Editor: Marcel Tanner Copyright © 2018 Grace Frimpong et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract The quality of 68 samples of 15 different essential children’s medicines sold in licensed medicine outlets in the Ashanti Region, Ghana, was evaluated. Thirty-two (47.1%) of the medicines were imported, mainly from India (65.6%) and the United Kingdom (28.1%), while 36 (52.9%) were locally manufactured. The quality of the medicines was assessed using content of active pharmaceutical ingredient (API), pH, and microbial limit tests, and the results were compared with pharmacopoeial standards. Twenty-six (38.2%) of the samples studied passed the official content of API test while 42 (61.8%) failed. Forty-nine (72.1%) of the samples were compliant with official specifications for pH while 19 (27.9%) were noncompliant. Sixty-six (97.1%) samples passed the microbial load and content test while 2 (2.9%) failed. Eighteen (26.5%) samples passed all the three quality evaluation tests, while one (1.5%) sample (CFX1) failed all the tests. All the amoxicillin suspensions tested passed the three evaluation tests. All the ciprofloxacin, cotrimoxazole, flucloxacillin, artemether-lumefantrine, multivitamin, and folic acid samples failed the content of API test and are substandard. The overall API failure rate for imported products (59.4%) was comparable to locally manufactured (63.9%) samples. The results highlight the poor quality of the children’s medicines studied and underscore the need for regular pharmacovigilance and surveillance systems to fight this menace. 1. Introduction Children’s medicines are generally intended for the diagnostic use, management, and treatment of diseases of children up to 12 years of age. Access to affordable and quality children’s medicines in developing countries such as Ghana is important in reducing the high morbidity and mortality associated with malaria and other infectious diseases of children. To address the special medication needs of children up to age 12, the World Health Organization (WHO) in October 2007 introduced the WHO Model List of Essential Medicines for children (EMLc), with the current edition published in March 2017 (6th Edition). The EMLc consists of a core list and a supplementary list of medicines. The core list contains the most efficacious, safe, and cost-effective medicines for priority conditions and has the minimum medicines required for a basic healthcare system, while the supplementary list contains essential medicines for priority diseases which requires specialized medical care, specialized training or specialized diagnostic or monitoring facilities [1]. The presence of a medicine on the WHO EMLc is however not an assurance of the pharmaceutical quality of the medicine. It is therefore the responsibility of the relevant national and regional medicines regulatory authorities to ensure that medicines within their jurisdiction are of the right quality and stability through the application of integrated pharmacovigilance and drug surveillance systems [2]. The Standard Treatment Guidelines (STG) published by the Ministry of Health, Ghana, under the auspices of the Ghana National Drugs Programme are to ensure, among others, the availability of quality essential medicines for children and adults in all healthcare settings in the country [3]. The STG of Ghana incorporates some essential children’s medicines contained in the WHO EMLc and others which are not on the list. The healthcare system in Ghana has 5 levels of providers comprising health posts, health centers/clinics, district hospitals, regional hospitals, and tertiary or teaching hospitals. Most health facilities are found in the urban areas while the rural areas have poor health infrastructure. The country has 39. (...truncated)