alexa Post Marketing Surveillance of Anti-malarial Medicines
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Research Article

Post Marketing Surveillance of Anti-malarial Medicines in Tanzania

Sophia Mziray1, Kissa Mwamwitwa1, Sunday Kisoma1, Siya Augustine1, Adam Fimbo1, Danstan Hipolite1, Hiiti Sillo1 and Eliangiringa Kaale2,3*

1Tanzania Food and Drugs Authority, Dar es Salaam, Tanzania

2School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

3Department of Medicinal Chemistry, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania

*Corresponding Author:
Eliangiringa Kaale
Department of Medicinal Chemistry
School of Pharmacy, Muhimbili University of Health and Allied Sciences
P.O. Box 65013, Dar es Salaam, Tanzania
Tel: +255-22-2151244
Fax: +255-22-2150465
E-mail: [email protected]

Received date: June 16, 2017; Accepted date: June 21, 2017; Published date: June 26, 2017

Citation: Mziray S, Mwamwitwa K, Kisoma S, Augustine S, Fimbo A, et al. (2017) Post Marketing Surveillance of Anti-malarial Medicines in Tanzania. Pharm Regul Aff 6:191. doi: 10.4172/2167-7689.1000191

Copyright: © 2017 Mziray S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

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 21 out 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.

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