Regulating e-pharmacy: challenges and opportunities for access and quality of care in LMIC health systems

获得基本药物是卫生系统的一个重要组成部分，但许多中低收入国家在确保药物的可获得性、可负担性和质量方面继续面临重大挑战。最近网上药品销售的增长对药房供应造成了重大破坏，给地球仪带来了挑战和机遇。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，它们在低收入国家迅速增长，并因公共卫生问题而受到关注，包括销售没有处方的处方药;销售不合格和伪造的药品;向患者提供的信息不足;以及医生-药剂师-患者关系的侵蚀。其他非健康相关风险包括消费者欺诈和缺乏数据隐私。COVID-19疫情促使网上销售进一步激增，并导致网络犯罪增加。然而，电子药房也提供了机会，以增加获得药品的机会，特别是对于那些在获得传统药房服务方面有困难或需要定期服药的人。监管制度在管理这些风险和机会方面至关重要，但由于在适当做法上缺乏共识，监管机构缺乏技能和能力，以及难以利用国家监管框架来控制跨国经营的市场，监管制度受到阻碍。然而，从卫生系统的角度对LMIC电子药房市场的分析仍然非常有限。我们将通过评估印度和肯尼亚电子药房的表现并分析监管它们的系统来解决这一知识差距。我们将根据其市场结构和商业模式来描述每个环境中的电子药店市场。然后，我们将使用在线标准化患者，从药品供应的质量、安全性和可负担性方面评估电子药房的绩效。将对获得的一组药品的质量进行检测。我们将通过绘制现有的监管框架和问责机制来严格评估电子药房监管，并与广泛的国家和国际利益相关者一起探索实践中的实施情况和监管替代方案。最后，反映围绕电子药房的辩论激烈的争议性质，我们将研究影响其监管的设计和实施的政策过程，记录所涉及的利益相关者和影响他们的机构，利益，想法和网络。这项研究将指导政策制定者、监管机构和其他利益攸关方如何加强对电子药房的监管，提高药品供应的质量、安全性和可及性。

Access to essential medicines is a critical building block of the health system, but many low and middle-income countries (LMICs) continue to face substantial challenges in ensuring medicine accessibility, affordability and quality. The recent growth of medicine sales online represents a major disruption to pharmacy provision, presenting both challenges and opportunities across the globe. Whilst e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in LMICs, and have gained attention due to public health concerns, including the sale of prescription-only medicines without a prescription; the sale of substandard and falsified medicines; inadequate provision of information to patients; and erosion of the doctor-pharmacist-patient relationship. Further non-health-related risks include consumer fraud and lack of data privacy. The COVID-19 pandemic is encouraging a further surge in online sales, and an associated rise in cybercrime. However, e-pharmacy also presents opportunities for enhancing access to medicines, particularly for those with problems accessing traditional pharmacy services, or requiring regular medication. Regulatory systems are crucial in managing these risks and opportunities, but are hampered by lack of consensus on appropriate approaches, lack of skills and capacity among regulators, and difficulties in using national regulatory frameworks to control markets operating across country boundaries. However, analysis of LMIC e-pharmacy markets from a health systems perspective remains very limited.We will address this knowledge gap by assessing the performance of e-pharmacies in India and Kenya, and analysing the systems that regulate them. We will characterize the e-pharmacy market in each setting in terms of its market structure and business models. We will then assess e-pharmacy performance in terms of the quality, safety and affordability of medicine provision, using online standardised patients. The quality of a sub-set of medicines obtained will be tested. We will critically appraise e-pharmacy regulation by mapping existing regulatory frameworks and accountability mechanisms, and explore implementation in practice and views on regulatory alternatives with a wide range of national and international stakeholders. Finally, reflecting the hotly contested nature of debates around e-pharmacy, we will study the policy processes that influence the design and implementation of its regulation, documenting the stakeholders involved and the institutions, interests, ideas and networks that influence them. The research will guide policy makers, regulators and other stakeholders on approaches for strengthening regulation of e-pharmacy and improving the quality, safety and accessibility of medicine provision.