Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems.

Access to quality-assured medical products improves health and save lives. However, one third of the world's population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes

Malaria treatment in the retail sector: Knowledge and practices of drug sellers in rural Tanzania

<p>Abstract</p> <p>Background</p> <p>Throughout Africa, the private retail sector has been recognised as an important source of antimalarial treatment, complementing formal health services. However, the quality of advice and treatment at private outlets is a widespread concern, especially with the introduction of artemisinin-based combination therapies (ACTs). As a result, ACTs are often deployed exclusively through public health facilities, potentially leading to poorer access among parts of the population. This research aimed at assessing the performance of the retail sector in rural Tanzania. Such information is urgently required to improve and broaden delivery channels for life-saving drugs.</p> <p>Methods</p> <p>During a comprehensive shop census in the districts of Kilombero and Ulanga, Tanzania, we interviewed 489 shopkeepers about their knowledge of malaria and malaria treatment. A complementary mystery shoppers study was conducted in 118 retail outlets in order to assess the vendors' drug selling practices. Both studies included drug stores as well as general shops.</p> <p>Results</p> <p>Shopkeepers in drug stores were able to name more malaria symptoms and were more knowledgeable about malaria treatment than their peers in general shops. In drug stores, 52% mentioned the correct child-dosage of sulphadoxine-pyrimethamine (SP) compared to only 3% in general shops. In drug stores, mystery shoppers were more likely to receive an appropriate treatment (OR = 9.6), but at an approximately seven times higher price. Overall, adults were more often sold an antimalarial than children (OR = 11.3). On the other hand, general shopkeepers were often ready to refer especially children to a higher level if they felt unable to manage the case.</p> <p>Conclusion</p> <p>The quality of malaria case-management in the retail sector is not satisfactory. Drug stores should be supported and empowered to provide correct malaria-treatment with drugs they are allowed to dispense. At the same time, the role of general shops as first contact points for malaria patients needs to be re-considered. Interventions to improve availability of ACTs in the retail sector are urgently required within the given legal framework.</p

Can working with the private for-profit sector improve utilization of quality health services by the poor? A systematic review of the literature

BACKGROUND: There has been a growing interest in the role of the private for-profit sector in health service provision in low- and middle-income countries. The private sector represents an important source of care for all socioeconomic groups, including the poorest and substantial concerns have been raised about the quality of care it provides. Interventions have been developed to address these technical failures and simultaneously take advantage of the potential for involving private providers to achieve public health goals. Limited information is available on the extent to which these interventions have successfully expanded access to quality health services for poor and disadvantaged populations. This paper addresses this knowledge gap by presenting the results of a systematic literature review on the effectiveness of working with private for-profit providers to reach the poor. METHODS: The search topic of the systematic literature review was the effectiveness of interventions working with the private for-profit sector to improve utilization of quality health services by the poor. Interventions included social marketing, use of vouchers, pre-packaging of drugs, franchising, training, regulation, accreditation and contracting-out. The search for published literature used a series of electronic databases including PubMed, Popline, HMIC and CabHealth Global Health. The search for grey and unpublished literature used documents available on the World Wide Web. We focused on studies which evaluated the impact of interventions on utilization and/or quality of services and which provided information on the socioeconomic status of the beneficiary populations. RESULTS: A total of 2483 references were retrieved, of which 52 qualified as impact evaluations. Data were available on the average socioeconomic status of recipient communities for 5 interventions, and on the distribution of benefits across socioeconomic groups for 5 interventions. CONCLUSION: Few studies provided evidence on the impact of private sector interventions on quality and/or utilization of care by the poor. It was, however, evident that many interventions have worked successfully in poor communities and positive equity impacts can be inferred from interventions that work with types of providers predominantly used by poor people. Better evidence of the equity impact of interventions working with the private sector is needed for more robust conclusions to be drawn

Human exposure to fumonisins from home grown maize in Tanzania

Fumonisins contaminate maize worldwide resulting in unacceptable fumonisin exposures in people relying on maize as staple food. This study determined fumonisins B1 (FB1) and B2 (FB2) in maize from 120 rural households: 30 from each of four main maize producing regions of Tabora, Ruvuma, Iringa and Kilimanjaro in Tanzania in order to estimate total fumonisin (FB1 + FB2) exposures to adult individuals in the households. The average daily per capita maize consumption of 771 g, recommended by the Tanzania Food and Nutrition Centre (TFNC) for an adult relying on it as a main meal, and also average daily per capita maize consumptions of 129, 308 and 356 g documented for Tanzania, were used in the exposure estimation. The fumonisins were determined by HPLC using fluorescence detection. Total fumonisins exposure (µg/kg body weight (bw)/day) was determined by multiplying average daily per capita maize consumption (kg) by fumonisin level in maize (µg/kg) from a given household and then dividing by an average bw of an adult of 60 kg. Of the 120 samples, 52% were contaminated with fumonisins at levels of up to 11,048 µg/kg (median; 363 µg/kg). Based on the recommended maize consumption of 771 g/person/day, fumonisin exposures to adult individuals in 38% of the households would exceed the provisional maximum tolerable daily intake (PMTDI) of 2 µg/kg bw, recommended by the Joint FAO/WHO Expert Committee on Food Additives. At the least documented maize consumption of 129 g/person/day, fumonisin exposures in 16% of the households were still above the PMTDI. Reduction of the maize consumption level to 40 g/person/day is an impractical, and reduction of the maximum contamination level to 155 µg/kg is a possibly practical, option for effective minimisation of fumonisin exposures in these communities. A relatively larger study is needed in order to generate comprehensive data for the formulation of appropriate strategies to minimise fumonisin exposures in Tanzania

Human exposure to fumonisins from home grown maize in Tanzania

Fumonisins contaminate maize worldwide resulting in unacceptable fumonisin exposures in people relying on maize as staple food. This study determined fumonisins B1 (FB1) and B2 (FB2) in maize from 120 rural households: 30 from each of four main maize producing regions of Tabora, Ruvuma, Iringa and Kilimanjaro in Tanzania in order to estimate total fumonisin (FB1 + FB2) exposures to adult individuals in the households. The average daily per capita maize consumption of 771 g, recommended by the Tanzania Food and Nutrition Centre (TFNC) for an adult relying on it as a main meal, and also average daily per capita maize consumptions of 129, 308 and 356 g documented for Tanzania, were used in the exposure estimation. The fumonisins were determined by HPLC using fluorescence detection. Total fumonisins exposure (µg/kg body weight (bw)/day) was determined by multiplying average daily per capita maize consumption (kg) by fumonisin level in maize (µg/kg) from a given household and then dividing by an average bw of an adult of 60 kg. Of the 120 samples, 52% were contaminated with fumonisins at levels of up to 11,048 µg/kg (median; 363 µg/kg). Based on the recommended maize consumption of 771 g/person/day, fumonisin exposures to adult individuals in 38% of the households would exceed the provisional maximum tolerable daily intake (PMTDI) of 2 µg/kg bw, recommended by the Joint FAO/WHO Expert Committee on Food Additives. At the least documented maize consumption of 129 g/person/day, fumonisin exposures in 16% of the households were still above the PMTDI. Reduction of the maize consumption level to 40 g/person/day is an impractical, and reduction of the maximum contamination level to 155 µg/kg is a possibly practical, option for effective minimisation of fumonisin exposures in these communities. A relatively larger study is needed in order to generate comprehensive data for the formulation of appropriate strategies to minimise fumonisin exposures in Tanzania

Co-occurrence of fumonisins with aflatoxins in home-stored maize for human consumption in rural villages of Tanzania

This study determined maize-user practices that influence the presence of fumonisin and aflatoxin contamination of maize in food consumed in the rural areas of Tanzania. Samples of the 2005 maize harvest in Tanzania were collected from 120 households and examined for fumonisins and aflatoxins. Information on whether the maize was sorted to remove defective (visibly damaged or mouldy) maize before storage and whether the damaged and mouldy maize or the non-dehulled maize was used as food was also collected. In addition, the percentage of defective kernels in the samples was determined. Ninety per cent of the households sorted out defective maize, 45% consumed the defective maize and 30% consumed non-dehulled maize. In 52% of the samples fumonisins were determined at levels up to 11,048 g kg-1 (median = 363 g kg-1) and in 15% exceeded 1000 g kg-1; the maximum tolerable limit (MTL) for fumonisins in maize for human consumption in other countries. Aflatoxins were detected in 18% of the samples at levels up to 158 g kg-1 (median = 24 g kg-1). Twelve per cent of the samples exceeded the Tanzanian limit for total aflatoxins (10 g kg-1). Aflatoxins co-occurred with fumonisins in 10% of the samples. The percentage defective kernels (mean = 22%) correlated positively (r = 0.39) with the fumonisin levels. Tanzanians are at a risk of exposure to fumonisins and aflatoxins in maize. There is a need for further research on fumonisin and aflatoxin exposure in Tanzania to develop appropriate control strategies

Co-occurrence of fumonisins with aflatoxins in home-stored maize for human consumption in rural villages of Tanzania

This study determined maize-user practices that influence the presence of fumonisin and aflatoxin contamination of maize in food consumed in the rural areas of Tanzania. Samples of the 2005 maize harvest in Tanzania were collected from 120 households and examined for fumonisins and aflatoxins. Information on whether the maize was sorted to remove defective (visibly damaged or mouldy) maize before storage and whether the damaged and mouldy maize or the non-dehulled maize was used as food was also collected. In addition, the percentage of defective kernels in the samples was determined. Ninety per cent of the households sorted out defective maize, 45% consumed the defective maize and 30% consumed non-dehulled maize. In 52% of the samples fumonisins were determined at levels up to 11,048 µg kg-1 (median = 363 µg kg-1) and in 15% exceeded 1000 µg kg-1; the maximum tolerable limit (MTL) for fumonisins in maize for human consumption in other countries. Aflatoxins were detected in 18% of the samples at levels up to 158 µg kg-1 (median = 24 µg kg-1). Twelve per cent of the samples exceeded the Tanzanian limit for total aflatoxins (10 µg kg-1). Aflatoxins co-occurred with fumonisins in 10% of the samples. The percentage defective kernels (mean = 22%) correlated positively (r = 0.39) with the fumonisin levels. Tanzanians are at a risk of exposure to fumonisins and aflatoxins in maize. There is a need for further research on fumonisin and aflatoxin exposure in Tanzania to develop appropriate control strategies