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Assessment of the availability and rationality of unregistered fixed dose drug combinations in Nepal: a multicenter cross-sectional study

机译：尼泊尔未注册固定剂量药物组合的可用性和合理性评估：多中心横断面研究

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BackgroundThe medications that are registered and available in a country are meant for the prevention and treatment of ailments and diseases. However, a lack of effective regulatory bodies and operative control mechanisms, especially in developing countries, promotes irrational and inappropriate use of medicines. This study aims to evaluate the availability and rationality of unregistered fixed-dose drug combinations (FDCs) in Nepal. MethodsA snowball sampling method with visits to 20 retail pharmacies in each of five major cities in Nepal was used to assess the availability of unregistered FDCs. To justify the rationality of the FDCs obtained from these five cities, the toolkit developed by Health Action International Asia-Pacific (HAI-AP) was used. ResultsAltogether, 41 unregistered FDCs were obtained from the five cities. Among the total 41 FDCs, a majority were anti-inflammatory/analgesic/antipyretics. A maximum of eight drugs and a minimum of two drugs per combination were present among the total 41 FDCs, with a majority in the form of tablets followed by suspensions. The cost ranges from a minimum of 3.7 Nepalese Rupees (NRs) (= USD 0.05) to a maximum of 240 NRs (= USD 3.15). None of the FDCs fulfilled all the fundamental requirements as stated in the toolkit; thus, they were categorized as ‘irrational’. ConclusionsUnregistered FDCs are available in the Nepalese pharmaceutical market. All the unregistered FDCs found in our study were ‘irrational’ as per the HAI-AP toolkit. Regulatory authorities should initiate strict monitoring and appropriate regulatory mechanisms to prohibit the use of unregistered and irrational FDCs.
机译：背景技术在一个国家注册并可以买到的药物旨在预防和治疗疾病。但是，缺乏有效的监管机构和操作控制机制，特别是在发展中国家，导致不合理和不适当地使用药物。这项研究旨在评估尼泊尔未注册的固定剂量药物组合（FDC）的可用性和合理性。方法采用雪球抽样方法，访问尼泊尔五个主要城市的20个零售药店，以评估未注册FDC的可用性。为了证明从这五个城市获得的FDC的合理性，使用了国际亚太卫生行动组织（HAI-AP）开发的工具包。结果总共从这五个城市获得了41个未注册的FDC。在全部41个FDC中，大多数是抗炎/止痛/退烧药。在总共41个FDC中，每种组合最多存在8种药物，而最少2种药物，大多数为片剂形式，其次是混悬剂。费用从最低3.7尼泊尔卢比（= 0.05美元）至最高240尼泊尔卢比（= 3.15美元）不等。没有一个金融发展中心能够满足工具包中规定的所有基本要求;因此，它们被归类为“不合理”。结论尼泊尔制药市场上有未注册的FDC。根据HAI-AP工具包，在我们的研究中发现的所有未注册FDC都是“不合理的”。监管机构应启动严格的监控和适当的监管机制，以禁止使用未经注册和不合理的FDC。

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