Transparency in Nigeria's public pharmaceutical sector: perceptions from policy makers

Transparency in Nigeria's public pharmaceutical sector: perceptions from policy makers
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DOI:
10.1186/1744-8603-5-14
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发表时间:
2009-01-01
影响因子:
10.8
通讯作者:
Huisman, Anna M.
Huisman, Anna M.
中科院分区:
医学2区
文献类型:
--
作者:
Garuba, Habibat A.;Kohler, Jillian C.;Huisman, Anna M.

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背景:药品是全球卫生保健系统的一个组成部分,因此,药品系统治理方面的监管薄弱会对卫生结果产生负面影响,特别是在发展中国家。尼日利亚是制药系统受到腐败影响的若干国家之一,尼日利亚一直在努力减少不合格药物的生产和贩运。2001年,美国国家食品和药物管理局(NAFDAC)进行了组织重组,从而进行了减少假药和更好地监管药品的改革。尽管有这些变化,但仍有改进的余地。本研究评估了尼日利亚制药行业四个基本领域存在的透明度和潜在腐败脆弱性的感知水平:注册、采购、检查(分为对港口和企业的检查)和分销。方法:采用世界卫生组织评估工具的标准化问卷,对公共和私营制药系统的主要利益相关者进行半结构化访谈。对问题的回答会被统计并转换成一个数字量表的分数,分数越低表明更容易受到腐败的影响,分数越高表明更容易受到腐败的影响。结果:尼日利亚制药系统的总体得分为7.4分(满分为10分),表明该系统在腐败方面略显脆弱。最薄弱的环节是药品注册和口岸检查。对定性结果的分析显示,对腐败程度的感知并不总是与定性证据相符。结论:尽管NAFDAC报道了许多改革,但研究结果表明,尼日利亚制药系统的各个方面仍然相当容易受到腐败的影响。最明显的缺陷似乎是没有利益冲突准则,这些准则如果存在并得到一贯的执行,就会限制腐败行为的传播。其他主要的影响因素是程序文件不一致,这种文件没有公开提供,以及监测和评价方面的不足。这项研究最关键的一点是,找出仍然容易滋生腐败的领域,以及尼日利亚政府和国际社会在哪些领域需要进行更适当的制衡。
Background: Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries [1]. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC) underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals [2]. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments), and distribution.Methods: Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability.Results: The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence.Conclusion: Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of interest guidelines which, if present and consistently administered, limit the promulgation of corrupt practices. Other major contributing factors are the inconsistency in documentation of procedures, lack of public availability of such documentation, and inadequacies in monitoring and evaluation. What is most critical from this study is the identification of areas that still remain permeable to corruption and, perhaps, where more appropriate checks and balances are needed from the Nigerian government and the international community.