Abstract:
Background: Presence of substandard and falsified anti-malarial medicines is a major concern in countries with high prevalence of malaria. Systematic assessment and monitoring of anti-malarial medicines circulating on the market is critical to National Medicines Regulatory Authorities (NMRAs) in ensuring quality of these products in the fight against the burden of malaria disease.
Objectives: This survey was conducted by Tanzania Food and Drugs Authority (TFDA) with the aim of monitoring the quality of registered anti-malarial medicines circulating on the market in Tanzania Mainland.
Methodology: Purposive sampling method was used in obtaining the samples of anti-malarial medicines from 21out of 26 regions of Tanzania Mainland between 2012 and 2015. These medicines were collected from ports of entry, domestic manufacturers, Medical Stores Department (MSD), wholesalers, hospitals, health centres, dispensaries and retail pharmacy outlets. Samples were subjected to product information review and quality screening using Global Pharma Health Fund® (GPHF) Mini-Lab kits. Samples failing or yielding doubtful results and ten percent (10%) of passed samples were subjected to tier two confirmatory testing using full pharmacopeial monographs at TFDA-WHO prequalified quality control laboratory.
Results: A total of 1,444 samples of oral solid formulations from different types of anti-malarials were sampled.
Out of these, 132 (9.1%) failed labelling product information requirements. A high percentage of samples passed identification test by TLC (97.9%) and disintegration test (99.8%). A 4.8% (7/145) failure rate was observed in confirmatory testing of which one of the failed samples namely quinine sulphate 300 mg tablets was confirmed to be falsified.
Conclusion: These results indicate the importance of post marketing surveillance as an additional measure of assuring the quality of medicines by Regulators following marketing authorization and as a way of detecting falsified medicines circulating on the market.
Keywords: Post marketing surveillance; Medicines quality; TLC screening; Substandard; Falsified
