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

Background

Access to essential medicines is a critical building block of the health system, but many low-and middle-income countries (LMICs) continue to face major challenges in ensuring medicine accessibility, affordability and quality. The sale of medicines online (or e-pharmacy, we use the terms interchangeably)  represents a major disruption to pharmacy provision across the globe. Whilst e-pharmacy was initially the preserve of high-income countries (HICs), in the past decade it has been growing rapidly in LMICs, and this growth was further catalysed by widespread lockdowns during the COVID-19 pandemic.

This rapid expansion of e-pharmacy has been largely uncontrolled and accompanied by significant public health concerns, the most commonly cited being the sale of prescription-only medicines (POMs) without a prescription, including opioids and antibiotics; the sale of substandard or falsified (counterfeit) medicines; inadequate provision of information to patients; and erosion of the doctor-pharmacist-patient relationship. While in LMICs these problems are often widespread in traditional “brick-and-mortar” pharmacies, they may be amplified in the online sphere. In addition, non-health-related risks include consumer fraud and lack of data privacy. However, e-pharmacy also presents opportunities for enhancing access to medicines, especially among the elderly, those with chronic conditions, and those living in rural areas. Regulatory systems —crucial in managing these risks and opportunities—are hampered by a lack of consensus on appropriate approaches and lack of national regulatory frameworks. With political attention focussed on health systems, online medicine sales soaring, and online scams receiving publicity, the current climate may present a ‘window of opportunity’ for policy change and enacting effective regulation for e-pharmacies in LMICs. However, this requires evidence on the performance of LMIC e-pharmacy from a public health perspective, and analysis of potential policy options.

Aim

We aim to address the knowledge gap by assessing the performance of e-pharmacies in India and Kenya and analysing the regulatory systems for improving medicine quality, safety and accessibility through four work packages (WPs):

• WP1: We will characterize the e-pharmacy market in each setting through review of e-pharmacy websites and in-depth interviews with staff from both large- and small-scale e-pharmacies.
• WP2: We will assess e-pharmacy performance in terms of quality, safety, and affordability of medicine provision, by attempting to purchase medicines online, acting as standardised patients.
• WP3: We will critically appraise current e-pharmacy regulations by mapping existing regulatory frameworks and explore regulatory alternatives through in-depth interviews with a wide range of national and international stakeholders.
• WP4: We will study past and ongoing policy processes influencing the design and implementation of e-pharmacy regulation through document review and interviews with the involved stakeholders.

Research Methodology

This is a mixed methods study employing online data extraction, standardised patient surveys, document review and qualitative interviews. A key focus will be methodological innovation in adapting approaches for studying the public health implications of brick-and-mortar pharmacies to the digital world.

The study will be conducted in Kenya and India. We will adopt a national perspective for both countries. In addition, given the devolved nature of regulation in India, objectives 3 and 4 will also investigate state level regulation. We will draw on a body of regulatory theories to both analyse the performance of regulation and explain its evolution.

Current Status

Website review has been completed, and in-depth interviews are currently being conducted in India and Kenya. WP2 is scheduled to begin in early 2024.