Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania.

In 2012, the WHO launched its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, with the aim of improving the quality of reporting and using the data to inform post-market surveillance and build regulatory capacity. However, from a regulatory governance perspective, its effectiveness depends on the willingness and ability of actors 'on the ground' to identify, report and investigate possible infringements and to enforce penalties. This paper presents findings from 27 interviews with representatives of agencies charged with regulating pharmaceutical markets and 4 interviews with pharmaceutical industry representatives in Tanzania. Their experiences provide important insights into how the theorised mechanism between reporting and a reduction in undesirable behaviours can play out in a low-income context, revealing hidden assumptions about regulator behaviour and motivations. A combination of chronic under-resourcing, information gaps and enforcement challenges conspires to limit the efforts of local regulators to achieve the GSMS goals, shedding new light on the relationship between apparent 'misconduct' and structural constraints.

Geographical and behavioral risks associated with Schistosoma haematobium infection in an area of complex transmission.

BACKGROUND: Schistosoma haematobium infection in endemic areas varies depending on the nature and complexity of the transmission networks present. Studies of micro-geographical transmission of S. haematobium infection indicate that discrepancy in prevalence between households is associated with diverse water contact behaviors and transmission that is restricted to particular sites harboring snail intermediate hosts. Detection of variations in the transmission sources with complex transmission networks of water bodies is required for optimization of malacological control. Longitudinal parasitological and malacological surveys were conducted to investigate geographical variations in transmission of urogenital schistosomiasis in Ikingwamanoti village, Shinyanga District, Tanzania. METHODS: Urine samples were collected at baseline and follow-up time points from 282 school-aged children and examined microscopically for the presence of S. haematobium eggs. Malacological surveys involved collection of Bulinus nasutus every month from 30 sites. Snails were examined for patent infections. Global positioning system was used to map household distances from S. haematobium transmission sites, while water contact behavior was assessed using a questionnaire. RESULTS: Schistosoma haematobium infection was observed to be prevalent among older children (12-14 years) compared to younger groups prior to treatment, but no significant difference in infection prevalence was observed at one-year. Boys were highly infected than girls at both time points. No spatial influence was observed between children's infection and the distance from child's residence to the nearby snail habitats nor was any significant association observed between children's reported water contact behavior with S. haematobium infection. However, malacological surveys with cercarial shedding combined with GPS data detected significant variation among different water sources in the transmission of S. haematobium with children living in households near to ponds with high B. nasutus populations having the highest prevalence of infection. CONCLUSIONS: Interaction between malacological surveys with cercarial shedding combined with GPS mapping in endemic settings can help detection of transmission sources even in areas with complex transmission networks. Subsequent studies are needed to determine whether the combination of GPS mapping and parasitology screens can aid the detection of transmission hotspots across varied transmission settings to enhance schistosomiasis control programmes.