Substandard and falsified medicines in African pharmaceutical markets: A case study from Ethiopia.

Background: Substandard and falsified (SF) medicines are a global health problem. Their high prevalence is a threat to public health in low- and middle-income countries (LMICs). However, there are few street-level investigations of how this market works. This case study examines the supply and demand for SF medicines in Southern Ethiopia.

Methods: A cross sectional qualitative design, using semi-structured interviews supplemented by participant observation, was adopted. Study participants were selected using purposive, convenience, and snowball sampling techniques. They included pharmacists, physicians, wholesalers, pharmacy owners, regulatory staff, law enforcement agents and the local community. A total of 43 interviews were conducted. The study used Actor-Network Theory (ANT) as an analytic framework.

Results: The findings show that efforts to address the problem of SF medicines in Ethiopia struggle because of the lack of a clear framing of the issue and consensus on how it should be understood. The pharmaceutical market in Wolaita Zone, Southern Ethiopia is supplied with a wide variety of SF medicines from diverse sources. This complex supply chain emerges due to barriers to accessing essential medicines that are in demand. Control of SF medicines will require a range of interventions thoughtfully tailored to the local contexts and determinants of both supply and demand.

Conclusion: The evidence of confusion, ambiguity, and uncertainty in defining the problem of SF medicines suggest that more research and policy work is required to refine understanding of the issue, and of the local market conditions that join demand and supply for different medicines in Southern Ethiopia. These are likely to apply more widely in comparable contexts throughout sub-Saharan Africa. The current global policy emphasis on stricter regulation and enforcement alone does not adequately address the social and economic factors that collectively create and shape user demand that is met by SF medicines.