When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries.
When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries.
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DOI：
10.1136/bmjgh-2021-005405
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发表时间：
2021-05
影响因子：
8.1
通讯作者：
Goodman C
中科院分区：
文献类型：
--
作者：
Miller R;Wafula F;Onoka CA;Saligram P;Musiega A;Ogira D;Okpani I;Ejughemre U;Murthy S;Garimella S;Sanderson M;Ettelt S;Allen P;Nambiar D;Salam A;Kweyu E;Hanson K;Goodman C
最近网上药品销售的增长对药店市场造成了重大破坏，COVID-19进一步鼓励了这一趋势。虽然电子药房业务最初是高收入国家的专利，但在过去十年中，它们在低收入和中等收入国家迅速增长。与电子药房有关的公共卫生问题包括销售没有处方的处方药以及销售不合格和伪造的药品。此外，还有一些非健康相关的风险，如消费者欺诈和缺乏数据隐私。然而，电子药房也有可能改善药品的获取。借鉴现有的文献和一组关键的线人在肯尼亚，尼日利亚和印度的采访，我们研究了在LMIC的电子药房监管系统。没有一个研究国家颁布了专门针对电子药房的监管框架。主要的监管挑战包括对监管模式缺乏共识、缺乏监管能力、监管跨境销售以及监管过度的风险。然而，电子药房也提供了加强药品监管的机会--通过该行业的整合，以及在线记录提供的可追溯性和透明度。需要调整监管程序，以跟上这一动态格局，并利用这些可能性。这将需要探索一系列创新的监管选择，与更大、更合规的企业合作，并与全球监管机构合作。关键的第一步必须是确保国家监管机构具备必要的意识和技术专长，以积极监督这一电子药房活动。
The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation—through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.
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影响因子：
5.2
作者：
Boyd, Sara Elizabeth;Moore, Luke Stephen Prockter;Holmes, Alison Helen
通讯作者：
Holmes, Alison Helen
影响因子：
3.4
作者：
Montoya, Isaac D.;Jano, Elda
通讯作者：
Jano, Elda
影响因子：
6.7
作者：
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通讯作者：
Nayyar, Gaurvika
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影响因子：
11.1
作者：
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通讯作者：
Yin, Xiaoxv
影响因子：
5.4
作者：
Miller, Rosalind;Hutchinson, Eleanor;Goodman, Catherine
通讯作者：
Goodman, Catherine