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

监管电子药房：中低收入国家卫生系统中获取医疗服务和提高医疗质量的挑战和机遇

• 批准号: MR/V02096X/1
• 负责人: Catherine Goodman
• 金额: $ 112.73万
• 依托单位: London School of Hygiene & Tropical Medicine
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FV02096X%2F1
• 关键词: Regulating; pharmacy; challenges; opportunities; access

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.

获得基本药物是卫生系统的关键组成部分，但许多低收入和中等收入国家 (LMIC) 在确保药物的可及性、可负担性和质量方面继续面临重大挑战。最近在线药品销售的增长对药品供应造成了重大干扰，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，但在过去十年中，它们在中低收入国家迅速增长，并因公共健康问题而受到关注，包括在没有处方的情况下销售处方药；销售伪劣药品；向患者提供的信息不足；以及医患关系的侵蚀。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 大流行促使在线销售进一步激增，网络犯罪也相应增加。然而，电子药房也提供了增加获得药品的机会，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。监管体系对于管理这些风险和机遇至关重要，但由于缺乏对适当方法的共识、监管机构缺乏技能和能力以及利用国家监管框架控制跨国市场运作的困难而受到阻碍。然而，从卫生系统角度对中低收入国家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绩效并分析监管它们的系统来解决这一知识差距。我们将从市场结构和商业模式方面描述每种情况下的电子药房市场的特征。然后，我们将使用在线标准化患者来评估电子药房在药品供应的质量、安全性和可负担性方面的表现。将测试所获得的一组药物的质量。我们将通过绘制现有监管框架和问责机制来批判性地评估电子药房监管，并与广泛的国内和国际利益相关者探讨实践中的实施情况和对监管替代方案的看法。最后，为了反映围绕电子药房的争论的激烈争论，我们将研究影响其监管设计和实施的政策流程，记录所涉及的利益相关者以及影响他们的机构、利益、想法和网络。该研究将为政策制定者、监管机构和其他利益相关者提供加强电子药房监管和提高药品供应质量、安全性和可及性的方法指导。