Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market

Sillo, Hiiti; Masota, Nelson E.; Kisoma, Sunday; Rägo, Lembit; Mgoyela, Veronica; Kaale, Eliangiringa

doi:10.1371/journal.pone.0197490

Cited by 18 publications

(17 citation statements)

References 22 publications

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“…Few leaflets in either study contained pictograms, and the local language was used in only 2% and 38%, respectively. A further multi-country study assessed the basic content of 99 PIs for six commonly used medicines in Tanzania, Uganda and Kenya, finding that while the majority included most of the required information, some sections were absent or incomplete [ 38 ].…”

Section: Resultsmentioning

confidence: 99%

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

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Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.

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Section: Resultsmentioning

confidence: 99%

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

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“…Information on package inserts is necessary since it is associated with drug safety, adherence to treatment, rational drug use and reporting adverse drug reactions [39]. Our ndings revealed absence of package inserts from majority of the collected samples.…”

Section: Discussionmentioning

confidence: 69%

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: Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure, and prolonged illness, development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. Thus, to ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market.Methods: This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All collected 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 selected for full quality control testing in the World Health Organisation prequalified laboratory at Tanzania Medicines and Medical Devices Authority (TMDA). 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). Of the 2200 samples screened, all 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. Also, of the 100 samples selected for full quality control testing, 3% of them failed to compile with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2% (2/100) and 1% (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%). 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. Conclusion: The quality of majority of ARVs circulating on the Tanzania Mainland market was good but, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.

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“…Information on package inserts is necessary since it is associated with drug safety, adherence to treatment, rational drug use and reporting adverse drug reactions [35]. Our findings revealed absence of package inserts from majority of the collected samples.…”

Section: Laboratory Tier II Confirmatory Testingmentioning

confidence: 61%

“…This situation poses potential risk to patients on poisoning, adverse drug reactions, development of window for drug resistant strains, as well as treatment failure due to lack of important information [35].…”

Section: Laboratory Tier II Confirmatory Testingmentioning

confidence: 99%

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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Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market

Cited by 18 publications

References 22 publications

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

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

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