Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?

OBJECTIVE: In today's context of globalisation of pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa. We evaluated the compliance of a sample of pharmaceutical distributors active in sub-Saharan Africa with the standards of the WHO guideline 'Model Quality Assurance System (WHO MQAS) for procurement agencies', and we investigated factors favouring or hindering the adequate implementation of the guideline. METHODS: We used mixed-methods methodology to analyse quantitative and qualitative data. The quantitative study consisted of a retrospective secondary analysis of data collected by QUAMED (Quality Medicines for all), a partnership that pleads for universal access to quality-assured medicines. The qualitative survey consisted of formal and informal interviews with key informants. We adopted an embedded multiple-case study design. FINDINGS: Our analysis suggests that international distributors based in Europe perform, on average, better than sub-Saharan African distributors. However, some weaknesses are ubiquitous and concern critical processes, such as the initial selection of the products and the ongoing reassessment of their quality. This is due to several different factors: weak regulatory oversight, insufficient human/financial resources, weak negotiating power, limited judicial autonomy and/or lack of institutional commitment to quality. CONCLUSIONS: Our findings suggest that pharmaceutical distributors active in sub-Saharan Africa generally do not apply stringent criteria for selecting products and suppliers. Therefore, product quality is not consistently assured but depends on the requirements of purchasers. While long-term solutions are awaited, the WHO MQAS guideline should be used as an evaluation and training tool to upgrade current standards.

Cost and impact of policies to remove and reduce fees for obstetric care in Benin, Burkina Faso, Mali and Morocco.

BACKGROUND: Across the Africa region and beyond, the last decade has seen many countries introducing policies aimed at reducing financial barriers to obstetric care. This article provides evidence of the cost and effects of national policies focussed on improving financial access to caesarean and facility deliveries in Benin, Burkina Faso, Mali and Morocco. METHODS: The study uses a comparative case study design with mixed methods, including realist evaluation components. This article presents results across 14 different data collection tools, used in 4-6 research sites in each of the four study countries over 2011-13. The methods included: document review; interviews with key informants; analysis of secondary data; structured extraction from medical files; cross-sectional surveys of patients and staff; interviews with patients and observation of care processes. RESULTS: The article finds that the policies have contributed to continued increases in skilled birth attendance and caesarean sections and a narrowing of inequalities in all four countries, but these trends were already occurring so a shift cannot be attributed solely to the policies. It finds a significant reduction in financial burdens on households after the policy, suggesting that the financial protection objectives may have been met, at least in the short term, although none achieved total exemption of targeted costs. Policies are domestically financed and are potentially sustainable and efficient, and were relatively thoroughly implemented. Further, we find no evidence of negative effects on technical quality of care, or of unintended negative effects on untargeted services. CONCLUSIONS: We conclude that the policies were effective in meeting financial protection goals and probably health and equity goals, at sustainable cost, but that a range of measures could increase their effectiveness and equity. These include broadening the exempted package (especially for those countries which focused on caesarean sections alone), better calibrated payments, clearer information on policies, better stewardship of the local health system to deal with underlying systemic weaknesses, more robust implementation of exemptions for indigents, and paying more attention to quality of care, especially for newborns.

A detailed analysis of phytochrome decay and dark reversion in mustard cotyledons.

During the first 10 min after a saturating dose of red light, 72 h dark-grown mustard cotyledons show no phytochrome decay. Within the same time interval there exists a transient form of P fr (=P fr (T) ) which is no longer photoconvertible at 0°C, but is at 25°C. This P fr (T) converts in the dark to P fr and P r . These "dark reversions" take about 10 min. After a lag phase of 10 min the P fr decay can be described by a single, first order kinetic curve. The time courses of these reactions are functions of the time of etiolation.

On the phytochrome phototransformation kinetics in mustard seedlings.

The in vivo phototransformation kinetics of mustard hook and cotyledon phytochrome exhibit a deviation from a single first order curve, quite similar to that for pumpkin hooks as reported in a previous paper (Boisard, Marmé and Schäfer, 1971). The P fr→Prkinetics can be characterized by the ratios ɛ fr,λ (I) · P fr (I) /ɛ fr,λ (II) · P fr,λ (II) and [Formula: see text] where P fr (I) and P fr (II) are two populations of phytochrome molecules which convert to P rwith a first order half-life of [Formula: see text] and [Formula: see text]. These ratios depend on the length of time of etiolation. The ratio ɛ fr,λ (I) · P fr (I) /ɛ fr,λ (II) · P fr,λ (II) is independent of the amount of total P frpresent at the beginning of the P fr→Prphototransformation after a non-saturating dose of red light. The half-lives of the two populations, however, depend on the concentration of total P frinitially present. P fr→Prphototransformation kinetics with different light intensities show that reciprocity holds.