Frimpong Grace, Ofori-Kwakye Kwabena, Kuntworbe Noble, Buabeng Kwame Ohene, Osei Yaa Asantewaa, Boakye-Gyasi Mariam El, Adi-Dako Ofosua
Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
Department of Pharmaceutical Sciences, Faculty of Medicine and Health Sciences, Kumasi Technical University, Kumasi, Ghana.
J Trop Med. 2018 May 21;2018:1494957. doi: 10.1155/2018/1494957. eCollection 2018.
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.
对加纳阿散蒂地区持牌药品销售点出售的15种不同儿童基本药物的68个样本的质量进行了评估。其中32种（47.1%）药品为进口药品，主要来自印度（65.6%）和英国（28.1%），而36种（52.9%）为本地生产。通过活性药物成分（API）含量、pH值和微生物限度测试对药品质量进行评估，并将结果与药典标准进行比较。所研究的样本中有26个（38.2%）通过了API官方含量测试，而42个（61.8%）未通过。49个（72.1%）样本符合pH值官方规格，19个（27.9%）不符合。66个（97.1%）样本通过了微生物负荷和含量测试，2个（2.9%）未通过。18个（26.5%）样本通过了所有三项质量评估测试，而1个（1.5%）样本（CFX1）所有测试均未通过。所有测试的阿莫西林混悬液均通过了三项评估测试。所有环丙沙星、复方磺胺甲恶唑、氟氯西林、蒿甲醚-本芴醇、多种维生素和叶酸样本均未通过API含量测试，为不合格产品。进口产品的总体API不合格率（59.4%）与本地生产的样本（63.9%）相当。结果突出了所研究儿童药品质量较差的问题，并强调需要建立定期的药物警戒和监测系统来应对这一威胁。
