Quality Surveillance of Anti-Tuberculosis Medicines in Tanzania, 2012-2018

Abstract

Background: The use of substandard and falsified (SF) anti-tuberculosis (ant-TB) medicines may lead to treatment failure and development of drug resistance. SF medicinal products are claimed to be more prevalent in developing countries with high burden of tuberculosis disease. National Regulatory Authorities therefore, should ensure that the quality of these life-saving medicines is systematically monitored. We conducted a post marketing surveillance study to determine the quality of anti-tuberculosis medicines circulating on the market in Tanzania Mainland. Methods: This was a prospective cross sectional study conducted between 2012 and 2018. Purposive sampling technique was used in collecting a total of 777 samples of anti-tuberculosis medicines. Samples were collected from ports of entry, Medical Stores Department (MSD) and healthcare facilities in 16 regions of Tanzania Mainland. All collected samples were subjected quality screening using Global Pharma Health Fund® (GPHF) Mini-Lab kits. Only samples collected from MSD and healthcare facilities were subjected to product information review. Samples collected from MSD and healthcare facilities that did not comply with GPHF protocol requirements or yielded doubtful results and ten percent (10%) of all those that complied were subjected to tier II confirmatory testing using full pharmacopoeia monographs at the Tanzania Medicines and Medical Device (TMDA) Quality Control Laboratory which is prequalified by the World Health Organization. Results: All 777 collected samples complied with the requirements of both GPHF minilab protocol and respective compendial monographs when subjected to screening and confirmatory testing, respectively. Of the samples collected from medicine distribution outlets 71.3% (176/247) samples did not comply with product information requirements as per TMDA labelling requirements and approved product information. Conclusion: These Results calls for continuously reinforcing and monitoring of Ant-TB medicines to ensure that only those of good quality and proper information are circulating on the Tanzanian mainland market.