Regulatory compliance among over-the-counter medicine sellers facilities within the Upper East Region of Ghana.
Regulatory compliance among over-the-counter medicine sellers facilities within the Upper East Region of Ghana.
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DOI：
10.1186/s40545-021-00363-2
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发表时间：
2021-08-24
影响因子：
4.2
通讯作者：
Akuffo KO
中科院分区：
文献类型：
--
作者：
Frempong BK;Amalba A;Donkor N;Akuffo KO
私人药品零售设施（包括非处方药品零售商）提供的药品的便捷获取在撒哈拉以南非洲已受到重视。尽管非处方药销售商 (OTCMS) 设施在医疗保健服务中发挥着不可或缺的作用，但有关其监管环境及其运营是否符合监管规定的信息不足。因此，本研究旨在调查加纳非处方药销售商监管实践的特征和预测因素。这是一项横断面研究，参与者来自加纳上东区八 (8) 个市和区 (MDA) 的 208 个 OTCMS 设施。 2016 年 5 月至 8 月期间对该地区的设施进行了初步普查，并于 2016 年 12 月至 2017 年 3 月期间进行了后续调查。这确保了选定 MDA 内所有 OTCMS 设施的识别和位置，用于研究规划和数据收集。主要结果变量是监管合规性，它是监管实践（在现场保留药品供应商的发票和收据）、许可和注册要求（适当的标牌）以及设备和材料要求（参考材料的可用性）三个指标的组合。使用双变量和多变量逻辑回归分析评估监管合规性。在本次调查中，分别有 21.5%、38.2% 和 23.1% 的受访设施具有良好的维修状态、设施所有者在场，并且在不到 12 个月内接受过监管访问。只有 29.2% 的设施符合监管要求。统计调整后，OTCMS 设施位置（与农村：城市相比，AOR = 4.2，95% CI 1.74–10.17，p = 0.001）和员工培训时间不到 1 年（AOR = 2.78，95% CI 1.02–7.62， p = 0.046）与法规遵从性显着相关。加纳上东地区的监管合规性较低，特别是在农村地区，大多数设施未能满足药房委员会关于执业、人员和场地要求的规定。这可能是由于这些地区资源匮乏。政策制定者被要求针对 OTCMS 设施的位置和监管要求采取务实措施，以解决合规方面的不平等问题。
Easy access to medicines provided by private medicine retailing facilities including that of over-the-counter medicine retailers, have gained prominence in sub-Saharan Africa. Although over-the-counter medicine-sellers (OTCMS) facilities play an indispensable role in healthcare delivery, there is inadequate information about their regulatory environment and whether their operations conform to regulatory provisions. Hence, this study sought to investigate the characteristics and predictors of regulatory practices among over-the-counter medicine sellers in Ghana. This was a cross-sectional study involving participants from 208 OTCMS facilities in eight (8) municipalities and districts (MDA’s) of the Upper East Region of Ghana. An initial census of facilities in the region was conducted between May and August 2016 and a follow-up conducted between December 2016 and March 2017. This ensured the identification and location of all OTCMS facilities within the selected MDA’s for study planning and data collection. The main outcome variable was regulatory compliance which is a composite of three indicators for regulatory practices (retention of medicine supplier’s invoices and receipts on-premises), licensing and registration requirements (appropriate signage), and equipment and material requirements (availability of reference material). Regulatory compliance was assessed using bivariate and multivariate logistic regression analyses. In this survey, 21.5%, 38.2%, and 23.1% of the facilities surveyed had a good state of repair, had the owner of the facility available on the premises, and had received regulatory visit(s) in less than 12 months, respectively. Only 29.2% of facilities were regulatory compliant. After statistical adjustment, OTCMS facility location (compared with Rural: Urban, AOR = 4.2, 95% CI 1.74–10.17, p = 0.001) and staff trained in less than 1 year (AOR = 2.78, 95% CI 1.02–7.62, p = 0.046) were significantly associated with regulatory compliance. Regulatory compliance was low in the Upper East Region of Ghana, particularly across rural locations, where most of the facilities failed to meet the laid down provisions of the Pharmacy Council regarding practice, staff and premises requirements. This could be attributed to the fact that these areas are poorly resourced. Policymakers are been called on to put in place pragmatic measures in relation to OTCMS facility’s location and regulatory requirements to address the inequities in compliance.
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影响因子：
3.2
作者：
Mayhew, S;Nzambi, K;Adjei, S
通讯作者：
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影响因子：
5.4
作者：
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影响因子：
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影响因子：
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通讯作者：
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