Post Marketing Surveillance of Anti-malarial Medicines in Tanzania

Mziray, Sophia; Mwamwitwa, Kissa W.; Kisoma, Sunday; Augustine, Siya; Fimbo, Adam M.; Hipolite, Danstan; Sillo, Hiiti; Kaale, Eliangiringa

doi:10.4172/2167-7689.1000191

Cited by 10 publications

(23 citation statements)

References 11 publications

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“…The Tanzania registration number enables easy identification of pharmaceutical products authorized by TMDA to be in the market and prevents availability of falsified products on the market. These results are consistent with PIR results from previous survey study conducted in Tanzania for other categories of medicines [10,11].…”

Section: Laboratory Tier II Confirmatory Testingsupporting

confidence: 92%

“…Adherence to regulatory requirements of individual countries as well as harmonization efforts on technical requirements across the regions could explain the continuing improvement. Compared with PIR results for other medicine categories in the implementation of PMS programs, these results are far much better [10,11,31].…”

Section: Laboratory Tier II Confirmatory Testingmentioning

confidence: 99%

“…Scrutiny on the quality of medicines available in Sub Saharan African countries markets has revealed poor quality medicines that are either falsified or substandard [10][11][12][13][14][15][16][17][18][19][20][21][22][23]. This has been documented in a number of countries including Tanzania [10][11][12][13][14][15][16][17][18][19][20][21][22][23]. Poor quality ART poses a major public health threat such as treatment failure, drug toxicity, poor diseases prognosis and emergence of resistant strains, increased co-morbidity and healthcare cost to government and individual [12,[22][23][24].…”

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confidence: 99%

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Quality Of Selected Anti-retroviral Medicines: Tanzania Mainland Market As A Case Study

Mziray¹,

Maganda

Mwamwitwa³

et al. 2020

Preprint

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Background Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (HIV/AIDS) is still health problem worldwide, particularly in sub-Saharan African countries, such as Tanzania. Anti-retroviral medicines (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Thus, good quality ARVs is amongst the key factors which guarantee successful therapeutic outcomes and prevention of development of drug resistant strains. This study was aimed at monitoring the quality of ARVs circulating on the Tanzania Mainland market.Methodology This was a prospective cross sectional study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All samples were subjected to screening testing using the Global Pharma Health Fund ® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and ten percent (10%) of all that complied with the screening test requirements were subjected to confirmatory testing using full pharmacopoeia monographs at the Tanzania Medicines and Medical Devices Authority (TMDA), quality control laboratory prequalified by the World Health Organisation. Samples collected from the medicine distribution outlets were also subjected to product information review.Results A total of 2,630 samples were collected, of which 83.7% (2200/2630) were from port of entry (POEs). Out of the 430 samples which were subjected to product information review, 25.6% (110/430) failed to comply with the packaging and labelling requirements. All sampled ARV’s that were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27% (7/2630) and lamivudine/zidovudine/nevirapine 0.27% (7/2630) that failed the disintegration test. In confirmatory testing using full pharmacopoeia monographs, all samples conformed to the requirements, except of FDC stavudine/lamivudine/nevirapine which failed disintegration 2% (2/100) and assay tests 1% (1/100) respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%).Conclusion The quality of majority of ARVs circulating on the Tanzania Mainland market was good. The existence of number of ARVs circulating on Tanzania Mainland market which do not comply with product information requirements was significant. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.

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Section: Laboratory Tier II Confirmatory Testingsupporting

confidence: 92%

Section: Laboratory Tier II Confirmatory Testingmentioning

confidence: 99%

mentioning

confidence: 99%

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Quality Of Selected Anti-retroviral Medicines: Tanzania Mainland Market As A Case Study

Mziray¹,

Maganda

Mwamwitwa³

et al. 2020

Preprint

Self Cite

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“…More recent surveys, however, have revealed an improvement of medicine quality in other African countries. A study conducted in Tanzania has reported a failure rate of only 4.8% for antimalarial drugs collected between 2012 and 2015 . A likewise low prevalence of substandard and falsified antimalarial medicines (and also in the case of antibiotic pharmaceutical preparations) has recently been found in Southern Malawi …”

Section: Introductionmentioning

confidence: 99%

“…A study conducted in Tanzania has reported a failure rate of only 4.8% for antimalarial drugs collected between 2012 and 2015. 13 A likewise low prevalence of substandard and falsified antimalarial medicines (and also in the case of antibiotic pharmaceutical preparations) has recently been found in Southern Malawi. 14 Therefore, the aim of this study was to assess the quality of the antimalarial medicine artemether-lumefantrine sold in DRC as part of the post-marketing surveillance.…”

Section: Introductionmentioning

confidence: 99%

Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo

Mufusama

Ioset

Feineis

et al. 2018

Drug Testing and Analysis

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In the context of post-marketing surveillance supporting public-health authorities to take evidence-based decisions to fight the spread of poor-quality medicines, the quality of antimalarial artemether-lumefantrine (AL) medicines was assessed in the Democratic Republic of the Congo (DRC). A total of 150 samples of AL-containing products was collected from private pharmaceutical outlets in 8 main cities: Goma, Kikwit, Kinshasa, Kisangani, Lubumbashi, Matadi, Mbandaka, and Mbuji-Mayi. All drug samples were successively analyzed by visual inspection, thin-layer chromatography (TLC), and high-performance liquid chromatography (HPLC) following The International Pharmacopoeia. Of the 150 collected drug samples, 3 (2%) failed the visual inspection as they had shelf lives different from those of other samples with the same brand name. Four samples (2.7%) did not pass the TLC test as they contained only 1 or even none of the 2 declared active pharmaceutical ingredients (APIs). HPLC assays showed that 46 (30.7%) samples had artemether contents below 90% and 17 (11.3%) above 110% of the content claimed on the label. For lumefantrine, 32 (21.7%) samples had contents below 90%, and 8 (5.3%) had contents above 110%. This survey in DRC gives evidence that poor-quality antimalarial medicines are widely present. Based on 3 detection techniques, the study shows the necessity to equip developing countries with modern techniques such as HPLC, which, if combined with affordable techniques like TLC, could provide a pertinent analytical strategy to combat drug counterfeiting and poor manufacturing.

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A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

Mwamwitwa

Kaibere

Fimbo³

et al. 2020

Sci Rep

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Medicines with a stereogenic center (asymmetric carbon) are mainly present as racemates with a mixture of equal amounts of enantiomers. One enantiomer may be active while the other inactive, alternatively one may produce side-effects and even toxicity. However, there is lack of information on the chirality status (either racemates, single active enantiomer or achiral) of medicines circulated on the market particularly in African countries. We established the chirality status of registered medicines in Tanzania by conducting a retrospective cross-sectional study. Registration data for the past 15 years from 2003 to 2018 were extracted from TMDA-IMIS database to Microsoft excel for review and analysis. A total of 3,573 human medicines had valid registration. Out of which 2,150 (60%) were chiral and 1,423 (40%) achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single active enantiomers, respectively. The proportion of racemates within chiral medicines was considerably higher than single enantiomer medicines. The use of racemates may cause harm to the public and may contribute to antimicrobial resistance due to potential existence of inactive and toxic enantiomers. In order to protect public health, regulatory bodies need to strengthen control of chiral medicines by conducting analysis of enantiomeric impurity.

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Post Marketing Surveillance of Anti-malarial Medicines in Tanzania

Cited by 10 publications

References 11 publications

Quality Of Selected Anti-retroviral Medicines: Tanzania Mainland Market As A Case Study

Quality Of Selected Anti-retroviral Medicines: Tanzania Mainland Market As A Case Study

Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo

A retrospective cross-sectional study to determine chirality status of registered medicines in Tanzania

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