Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward.

Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern African Development Community (SADC) medicines registration collaborative initiative, ZaZiBoNa. Countries participate in the initiative by contributing to regulatory reviews and good manufacturing practices inspections. The aim of this study was to review and compare the registration processes of regulatory authorities of Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe to identify strategies for better alignment. Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardises the review process, allowing key milestones, activities and practices of the six regulatory authorities to be identified and compared. The completed questionnaires were validated by the heads of the respective agencies. Results: The six countries vary in population and in the size of their respective regulatory agency and the resources allocated to regulatory reviews. The review processes of the six agencies were similar; however, differences were noted in the milestones recorded; for example, two of the countries did not record the start of the scientific assessment. Additionally, decisions for marketing authorisation were made by an expert committee in four of the countries and by the head of the agency and the Minister of Health in two countries. All six agencies implemented the majority of good review practices; however, the need for improvement in the areas of transparency and communication and quality decision making practices was a common finding for all six countries. Conclusions: Participation in the ZaZiBoNa initiative has improved the way in which the six agencies perform regulatory reviews in their countries, highlighting the realisation of one of the key objectives of the initiative, which was building the expert capacity of member countries. Other agencies in the SADC region and beyond can use the results of this study to identify best practices, which in turn, could improve their regulatory performance.

Quality of selected anti-retroviral medicines: Tanzania Mainland market as a case study.

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 development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. 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 sampled ARVs 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 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. 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). All sampled ARVs 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. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply 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 TMDA packaging and labelling requirements. CONCLUSIONS: The quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market.

National Consumption of Antimicrobials in Tanzania: 2017-2019.

Objective: Surveillance of antimicrobial consumption is essential to the national action plan for antimicrobial resistance (AMR) as stipulated in the Global Action Plan on AMR and the Tanzanian National Action Plan on AMR. Given the paucity of antimicrobial consumption data in sub-Saharan Africa region, the objective of this study was to measure antimicrobial consumption in Tanzania. Methods: From 2017 to 2019, data on all antimicrobials imported into Tanzania were obtained from the Tanzania Medicines and Medical Devices Authority Data, augmented with purchasing data from the Medical Stores Department and data from local manufacturers. Data were collected and analyzed in accordance with the World Health Organization Anatomical Therapeutic Chemical and defined daily doses (DDD) methodology. Results: The average DDD per 1,000 inhabitants per day (DDD/1,000/D) for all antimicrobials was 80.8 ± 39.35. The DDD/1,000/D declined from 136.41 in 2017 to 54.98 in 2018 and 51.02 in 2019. Doxycycline, amoxicillin, and trimethoprim-sulfamethoxazole were the most frequently consumed antibiotics during these years, accounting for 20.01, 16.75, and 12.42 DDD/1,000/D, respectively. The majority of antimicrobial consumption in Tanzania occurred in the private sector, with the proportion of private-sector antibiotic consumption increasing annually from 2017 to 2019. Based on AWaRe classification >90% of antimicrobial consumption was Access class medications, with Watch and Reserve class medications accounting for <10% and <1%, respectively. Conclusion: The private sector use of antimicrobials is significantly increasing and should be carefully monitored in accordance with national policies. Future work is necessary to increase reporting of antimicrobial consumption patterns in sub-Saharan Africa.