(2003; 67 pages)
Full data and detailed results
Seven of the eight participant countries (Gabon, Ghana, Kenya, Mali, Mozambique, Sudan and Zimbabwe) submitted samples to CENQAM for sample analysis (Table I). Samples from Tanzania were not collected in time for the initial analysis due to logistical problems. The full data and detailed results are annexed at the end of this report.
Summary of results
Table I and Figures 1-5 show the combined results from all countries with the results expressed as a percentage of the samples failing pharmacopoeial standards out of the total number of samples analysed. Failed samples were found in all countries for at least one of the three formulations (CQT, CQS, SPT). Most failures were “low” failures, i.e. sample content found to be below the minimum levels recommended for the products. The average percentage failures for the active ingredients were 38.3% for CQT, 23.0% for CQS and 7.6% for SPT. The average percentage failures for dissolution tests were 12.2% for CQT and 91.1%b for SPT. Every country had low failures for ingredient content for CQT and for SPT dissolution indicating these as the most serious problems (Figures 2a and 5a). Ghana, Zimbabwe and Mali had the highest CQT ingredient content failures with 67%, 57% and 47.3% respectively. All participating countries had high failure levels of SPT dissolution (greater than 75%), except for Gabon where there were insufficient samples for this analysis. Only Mozambique had some “high” content failures, i.e. samples above the upper limit of specification. These failures were in the ingredient content for CQS (25%) and SPT (3%).
Table II and Figures 6-10 show the combined results from samples collected at each distribution channel and expressed as a percentage of the samples failing to meet the respective pharmacopoeial specifications. The highest percentage failures in ingredient content for CQT were found at the district hospital (70.0%), followed by district medical stores (58.3%), vendors/shops (50.0%), health centres (46.1%), teaching hospitals (44.4%), pharmacies (43.3%), and households (35.0%). For CQS, the highest percentage ingredient content failures were recorded at the district medical stores (27.2%), household (26.7%), and vendors/shops (21.0%). SPT had the highest percentage ingredient failures at household level (30.7%) followed by district hospitals at 18.2%. High SPT dissolution failures were found at all collection points (ranging from 58.8-100%) topped by households (100%), health centres (85.8%), vendors/shops at 73.0%, district hospitals 72.2%, district medical stores 72.2%, pharmacies 69.8%, and the lowest failures in teaching hospitals, at 58.8%. The high failures in ingredient content found on CQS and SPT in Mozambique were collected at district hospitals and pharmacies.
Table III and Figure 11 show the combined country results (excluding the samples collected in Sudan), according to the origin of the manufacturer, expressed as percentages. For active ingredient content the local versus foreign manufactured products results were: CQT 56.2% (27/48) versus 47.2% (17/36), CQS 28% (7/25) versus 13.0% (3/23). For the dissolution test the local versus foreign manufactured products results were: CQT 20.8% (10/48) versus 13.0% (5/36). The high failures in ingredient content found in CQS and SPT in Mozambique were from foreign manufacturers.