Drug shop regulation and malaria treatment in Tanzania--why do shops break the rules, and does it matter?

Drug shop regulation and malaria treatment in Tanzania--why do shops break the rules, and does it matter?
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DOI:
10.1093/heapol/czm033
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发表时间:
2007-11
影响因子:
3.2
通讯作者:
Mills A
Mills A
中科院分区:
医学3区
文献类型:
--
作者:
Goodman C;Kachur SP;Abdulla S;Bloland P;Mills A

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在低收入国家,特别是在药品零售方面,违规行为极为普遍。除了更严格的监管执行之外,几乎没有关于公共政策反应的实际建议,而政府往往不能或不愿意这样做。本文通过坦桑尼亚农村疟疾治疗的案例研究,探讨了监管零售药品销售商的挑战和潜在的解决方案,在坦桑尼亚农村,小药店是一种常见的药物来源。违反卫生条例的情况极为普遍。大多数商店没有有效的许可证,非法储存处方药和未包装的药片是常态。库存药品以未注册药品居多,从业人员无一符合资质要求。违规行为很可能反映了监管检查不频繁、监管机构未能实施制裁、成功隐瞒违规行为以及当地监管人员的默许。消除违反规章制度的行为不大可能可行,如果基本药物的获取减少,这种做法可能也不可取。替代办法包括使官方药物监管更接近当地合法做法;更多地利用对供应商的积极激励措施;以及消费者参与。这种方法上的改变有可能为公私合作提供一个更坚实的平台,以改善基于商店的待遇。
Regulatory infringements are extremely common in low income countries, especially with respect to retail pharmaceutical sales. There have been few practical suggestions on public policy responses other than stricter regulatory enforcement, which governments are often unable, or unwilling, to do. This paper explores the challenges of regulating retail drug sellers, and potential solutions, through a case study of malaria treatment in rural Tanzania where small drug shops are a common source of medicine. Infringement of health-related regulation was extremely common. Most stores lacked valid permits, and illegal stocking of prescription-only medicines and unpackaged tablets was the norm. Most stocked unregistered drugs, and no serving staff met the qualification requirements. Infringements are likely to have reflected infrequent regulatory inspections, a failure of regulatory authorities to implement sanctions, successful concealment of regulatory violations, and the tacit permission of local regulatory staff. Eliminating regulatory infringements is unlikely to be feasible, and could be undesirable if access to essential medicines is reduced. Alternatives include bringing official drug regulation closer into line with locally legitimate practices; greater use of positive incentives for providers; and consumer involvement. Such a change in approach has the potential to provide a firmer platform for public-private collaboration to improve shop-based treatment.
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