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，但许多低收入和中等收入国家在确保获得药物、负担得起和质量方面继续面临重大挑战。最近在线药品销售的增长代表着对药房供应的重大颠覆，在全球范围内既带来了挑战，也带来了机遇。虽然电子药房业务最初是高收入国家的专利，但在过去十年里，它们在小岛屿发展中国家迅速增长，并因公共卫生问题而受到关注，包括销售未经处方的纯处方药；销售不合格和假药；向患者提供的信息不足；以及医生-药剂师-患者关系受到侵蚀。其他与健康无关的风险包括消费者欺诈和缺乏数据隐私。新冠肺炎的流行正在鼓励在线销售进一步飙升，以及相应的网络犯罪增加。然而，电子药房也为增加获得药品的机会提供了机会，特别是对于那些难以获得传统药房服务或需要定期用药的人。监管制度在管理这些风险和机会方面至关重要，但由于对适当办法缺乏共识、监管者缺乏技能和能力以及难以利用国家监管框架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的电子药房的业绩并分析监管它们的系统来解决这一知识差距。我们将根据市场结构和商业模式来描述每种环境下的电子药房市场的特点。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表现。将对获得的子集药物的质量进行测试。我们将通过绘制现有的监管框架和问责机制，对电子药房监管进行批判性评估，并与广泛的国家和国际利益攸关方探讨在实践中的实施情况和对监管替代方案的看法。最后，反映围绕电子药房的激烈辩论的性质，我们将研究影响其法规设计和实施的政策过程，记录涉及的利益相关者以及影响他们的机构、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采取措施，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.