In a study that has captured the attention of the global health community, researchers from Strathmore University, the George Institute for Global Health (TGI, India) and the London School of Hygiene and Tropical Medicine (LSHTM) have unveiled insights into compliance practices of online pharmacies in Kenya and India.

The study, titled The Good, the Bad, and the Ugly: Compliance of E-Pharmacies Serving India and Kenya with Regulatory Requirements and Best Practices, was recently published in PLOS Global Public Health, shedding light on the urgent need for regulators to reimagine the governance of e-pharmacies (also called online pharmacies).

As healthcare becomes more digitized, online pharmacies are gaining prominence through providing convenient access to medicines. With the global e-pharmacy market size estimated to grow from US$ 92 billion in 2023 to US$ 350 billion in 2033, concerns are emerging over capacity of regulatory systems to effectively govern them for public good. Their rapid growth is outpacing regulatory adjustment, particularly in low- and middle-income countries like Kenya and India.

Sammy Masibo, Irene Khayoni, Emmanuel Kweyu, and Francis Wafula from Strathmore University’s Institute of Healthcare Management and @iLab Africa, in collaboration with partners from TGI and LSHTM, sought to uncover the extent to which online pharmacies adhere to best practices and national regulations. Their findings spark both hope and concern.

Nearly 90% of online pharmacies serving India provide an option for prescription uploads, indicating that most prescription-only medicines (POMs) were likely dispensed responsibly. On average, 74% of the National Guidelines for Internet Pharmacy Services are observed by e-pharmacies in Kenya. The study documented better  regulatory compliance among e-pharmacies located within the study countries (Kenya and India). Additionally, high-traffic e-pharmacies in both countries (by website visits) have better compliance compared to smaller platforms.

The research raised concern over risks posed to consumers. Many e-pharmacies lack complete drug information on medication side effects, contraindications, and drug interactions. In Kenya, only 42% of the pharmacy websites provided this information, with India standing at 16%.

Even more concerning was the discovery that many online pharmacies allow the purchase of prescription drugs without requiring a valid prescription. In Kenya, 42% of websites did not have a prescription upload facility.

The study also found that it is possible to purchase controlled and narcotic substances online, with 62% and 34% of Kenyan and Indian online pharmacies respectively listing such products. This poses public health concerns over the potential for illicit trade and use of controlled substances.

Further, many online pharmacies failed to display proof of registration or authorization from regulatory bodies. In Kenya, only 31% displayed the required health safety code from the Pharmacy and Poisons Board, while in India, none of the websites examined showed authorizations from the Central Drugs Standard Control Organisation (CDSCO).

The study proposes a risk-based approach to regulation, urging authorities to classify online pharmacies into three categories:

~The Good: Those that demonstrate good compliance and should work with regulators.

~The Bad: Those that partially comply and require stricter enforcement measures.

~The Ugly: Non-compliant online pharmacies that should be shut down.

The research proposed stronger enforcement of existing regulations for Kenya, and development and enactment of online pharmacy regulations for India. They also highlighted the importance of consumer awareness, encouraging the public to use verified and licensed e-pharmacies.

It worth noting that while the study revealed concerns over online pharmacy compliance, other research projects have similarly raised concern over compliance among brick-and-mortar pharmacies. The team are doing further research to understand brick and mortar practices to allow comparison and inform policy interventions more objectively.

As a leader in research and innovation, Strathmore continues to play a pivotal role in shaping policy and driving conversations around regulation and governance of healthcare markets across low- and middle-income countries. Research findings provide a platform for regulators and entrepreneurs to collaborate towards ensuring e-pharmacies serve public good.

For a deeper dive into the study, visit PLOS Global Public Health.

Article written by Stephen Wakhu