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Regulating e-pharmacy

Challenges and opportunities for access and quality of care in LMIC health systems.

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About

This 3-year project funded by the UKRI Health Systems Research Initiative started in 2021 and aims to assess the performance of e-pharmacies in India and Kenya and analyse regulatory systems for improving medicine quality, safety and accessibility.

Research

The project uses mixed methods to generate high-quality evidence on the performance of LMIC e-pharmacy markets and potential policy options to guide policy makers, regulators and other stakeholders in LMICs on approaches for strengthening regulation and improving the quality, safety and accessibility of medicine provision.

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About
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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, represents a major disruption to pharmacy provision across the globe. Whilst e-pharmacy was initially the preserve of high-income countries, 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 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.

This project is a collaboration between The George Institute for Global Health – India, Strathmore University Business School, and the London School of Hygiene & Tropical Medicine, which seeks to generate such high-quality evidence and potential policy options to guide policy makers, regulators and other stakeholders in LMICs on approaches for strengthening regulation and improving the quality, safety and accessibility of medicine provision.

Research
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Work packages

The project is generating high-quality evidence on the performance of LMIC e-pharmacy markets and potential policy options through four interlinked work packages (WPs):

  • WP1 activities characterise the e-pharmacy markets in India and Kenya through a review of e-pharmacy websites and in-depth interviews with staff from both large- and small-scale e-pharmacies.
  • WP2 activities 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 activities 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 activities examine 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 is being conducted in Kenya and India. We adopt a national perspective for both countries. In addition, given the devolved nature of regulation in India, WP3 and WP4 also investigate state level regulation. We draw on a body of regulatory theories to both analyse the performance of regulation and explain its evolution.

Team
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The George Institute for Global Health – India

  • Dr Mohammad Abdul Salam
  • Dr Devaki Nambiar
  • Gautam Satheesh
  • Sasi Tiruttani
  • Jaison Joseph

Strathmore University Business School

  • Dr Francis Wafula
  • Emmanuel Kweyu
  • Sammy Masibo
  • Irene Khayoni

London School of Hygiene & Tropical Medicine

Resources
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Relevant resources

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. When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries. BMJ Glob Health. 2021 May;6(5):e005405. doi: 10.1136/bmjgh-2021-005405.

Project outputs and publications

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