(2003; 67 pages)
4.1 Is there a problem?
Significant quality problems were detected in this study. Table I shows that CQS had content failure rates averaging 23.0% and headed by Mali with 66.7% failures, Sudan 26.6%, and Kenya and Mozambique with 25% each. Content failure for CQT was very significant, with the highest levels being in the samples from Ghana (66.7%), followed by Zimbabwe (57,1%), Mali (47.3%), Kenya (42.8%), Gabon (29.0%), Mozambique (20.0%) and Sudan (5.2%). This indicates a very serious problem which warrants further investigation and intervention. Dissolution failure rates for CQT were generally below 10%, except for Kenya and Ghana with 28.6% and 20% respectively.
SPT had problems mostly with the dissolution of the pyrimethamine component of the formulation, and averaged at 91.1%. Mali, Mozambique and Zimbabwe all had a failure level of 100% for the SPT samples analysed. Kenya had a failure level of 91.7%, Sudan 80.0% and Ghana 75.0%. Samples from Gabon were not sufficient to carry out this test. These findings indicate another very serious problem that warrants further investigation and intervention.
SPT content (pyrimethamine) failures were generally low (10% or lower) except for samples from Ghana, which showed a significant level at 37.5%.
These figures suggest a significant problem of substandard products being found in most countries and at all levels of the distribution chain. The main problem seemed to be samples below the lower limit of specification. Generally there were no “high” failures except in Mozambique where there was 25% failure in CQS ingredient content and 2.8% high failure of active ingredient content of SPT.