| Summary: | Background: A high proportion of people in Sub-Saharan Africa receive treatment from specialized drug shops (SDSs) such as pharmacies and drug stores because they provide convenient access to medicines. There is increasing interest in how policy makers can work with such retailers, but little knowledge on how their operation relates to legal and regulatory frameworks, and what factors influence regulatory behaviour of providers and front-line regulatory staff. This thesis aims to address these gaps in the context of Western Kenya. Methodology: Document reviews and key informant interviews were used to map the legal and regulatory framework governing retail provision of medicines in Kenya. Provider and mystery shopper surveys were used to investigate regulatory compliance among SDSs in two districts in Western Kenya. Finally, qualitative methods were used to describe factors underlying regulatory behaviour of SDS and regulatory staff, comprising focus group discussions with SDS operators and in-depth interviews with front-line and senior regulatory staff. Key findings: Low regulatory compliance was observed, especially among rural shops, to both structural and dispensing requirements. Compliance was not influenced significantly by the frequency of regulatory inspections. Qualitative data suggested that relationships between front- line staff and SDS operators strongly influenced regulatory behaviour of SDSs, often resulting in perverse outcomes such as corruption. In practice, separate regulatory streams operated in urban and rural locations, based on the differing relationships between inspectors and operators, and broader differences in the competitive environment. Moreover, the regulatory system lacked effective incentive structures to encourage regulatory enforcement. Key recommendations: The main recommendations include developing appropriate incentive contracts for front-line staff, and considering the introduction of lower retail practice requirements for rural SDSs in recognition of the vast differences in rural and urban SDS practice environments, allowing shops currently operating unlawfully to be brought within the regulatory framework without compromising the relatively higher quality among urban SDSs.
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