Efficacy of ivermectin and albendazole combination in suppressing transmission of lymphatic filariasis following mass administration in Tanzania: a prospective cohort study.

BACKGROUND: Preventive chemotherapy with ivermectin and albendazole (IA) in mass drug administration (MDA) programs for all at-risk populations is the core public health intervention to eliminate lymphatic filariasis (LF). Achieving this goal depends on drug effectiveness in reducing parasite reservoirs in the community to halt transmission. We assessed the efficacy of ivermectin and albendazole in clearing microfilariae and circulating filarial antigens (CFA) following MDA. METHODS: This community-based prospective study was conducted in Mkinga district, Tanga region, Tanzania, from November 2018 to June 2019. A total of 4115 MDA-eligible individuals were screened for CFA using Filarial test strips. CFA positives were re-examined for microfilariae by microscopy. CFA and microfilariae positive individuals were enrolled and received IA through MDA campaign. The status of microfilariae and CFA was monitored before MDA, and on day 7 and six-month following MDA. The primary efficacy outcomes were the clearance rates of microfilariae on day 7 and six-months, and CFA at 6 months of post-MDA. The McNemar test assessed the proportions of microfilariae positive pre- and post-MDA, while Chi-square tests were utilized to examine factors associated with CFA status six months post-MDA. RESULTS: Out of 4115 individuals screened, 239 (5.8%) tested positive for CFA, of whom 11 (4.6%) were also positive for microfilariae. Out of the ten microfilariae-positive individuals available for follow-up on day 7, nine tested negative, yielding a microfilariae clearance rate of 90% [95% confidence interval (CI): 59.6-98.2%]. Participants who tested negative for microfilariae on day 7 remained free of microfilariae six months after MDA. However, those who did not clear microfilariae on day-7 remained positive six-months post-MDA. The McNemar test revealed a significant improvement in microfilariae clearance on day 7 following MDA (P = 0.02). Out of 183 CFA-positive individuals who were available at 6-month follow-up, 160 (87.4%) remained CFA positive, while 23 became CFA negative. The CFA clearance rate at 6 months post-MDA was 12.6% (95% CI: 8.5-8.5%). There was no significant association of variability in ivermectin plasma exposure, measured by maximum concentration or area under the curve, and the clearance status of microfilariae or CFA post-MDA. CONCLUSIONS: Preventive chemotherapy with IA effectively clears microfilariae within a week. However, it is less effective in clearing CFA at six months of post-MDA. The low clearance rate for filarial antigenemia underscores the need for alternative drug combinations and additional preventive measures to achieve LF elimination by 2030.

Utilization Trends of Phosphodiesterase Type-5 Inhibitors for Erectile Dysfunction Between 2019 and 2023 in Tanzania.

Introduction Erectile dysfunction (ED) profoundly affects millions of people globally, including interfering with mental health and quality of life. Phosphodiesterase type-5 inhibitors (PDE5Is) such as sildenafil are pivotal in ED treatment. This study aimed to examine the utilization patterns of PDE5Is in Tanzania. Materials and methods In this retrospective longitudinal study, data on sildenafil and other similar PDE5Is imported between 2019 and 2023 were sourced from the Tanzania Medicines and Medical Devices Authority (TMDA). Pre-processing and visualization were performed using Microsoft Power BI Desktop, and further analysis was performed using IBM SPSS Statistics for Windows, Version 26 (Released 2019; IBM Corp., Armonk, New York, United States). Utilization trends were ascertained through curve fitting, Holt's linear trend model, and autoregressive integrated moving average (ARIMA) models. The defined daily doses (DDDS) per 1000 inhabitants (DID) were calculated using the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) Classification System and the DDD methodology endorsed by the WHO Collaborating Centre for Drug Statistics Methodology. Results Between 2019 and 2023, there was a pronounced increase in the importation of approximately 587 consignments of PDE5Is. Employing the Holt model (R-square = 0.843), a substantial increase from 0.220910 DID in 2019 to 0.534272 DID by 2025 was observed and anticipated. The period witnessed sildenafil dominating 75.5% of the total use, with Erecto being the most consumed brand (37.6% of total DID). Notably, 2022 had the highest surge (27.2% of the total), albeit a slight decline was observed in 2023 (20.5%). This trend was supported by a linear regression model (R-square = 0.889). Conclusion We found increasing annual trends of PDE5Is of utilization. This requires critical oversight and effective policies to ensure appropriate use and risk minimization.

Trends in Utilization of Emergency Contraceptives in Tanzania: A Retrospective Longitudinal Study From 2018 to 2023.

Introduction Emergency contraceptives (ECs) are a critical method for preventing unwanted pregnancies following unprotected sexual intercourse. However, Tanzania is experiencing an alarming surge in the misuse of ECs among reproductive-aged females, particularly younger girls and women. Reports of their use as regular contraceptives are a rising concern. Deviations from their intended use in emergencies may not only increase the risk of contraceptive failure but also increase the risk of adverse health events. This study aims to delineate and evaluate the utilization patterns of ECs over six consecutive years using importation data obtained from the Tanzania Medicines and Medical Devices Authority (TMDA). Materials and methods We analyzed the EC data collected by TMDA over six consecutive years using a retrospective longitudinal design. Microsoft Power BI (Microsoft® Corp., Redmond, WA) was used to clean, organize, and aggregate the data. IBM SPSS Statistics for Windows, Version 26 (Released 2019; IBM Corp., Armonk, New York, United States) was used to analyze annual trend utilization using linear regression. Results We analyzed 114 importation consignments for ECs, identifying 95.6% (109 records) as oral ECs and 4.4% (five records) as intrauterine devices (IUDs) between 2018 and 2023. This data revealed a significant increase in the volume of EC imports, with its contribution increasing from 1.9% in 2018 to 60.1% in 2023. This highlights the marked increase in EC consumption in Tanzania. In 2023, the defined daily dose per 1000 inhabitants per year (DID) peaked at 3.917826, indicating an unprecedented increase of 4,983.06% compared to the lowest DID observed in 2019 at 0.0873552. The year 2023 alone accounted for 41.63% of the total DID (9.43) over the entire study period. In 2019 and 2020, there was a decrease in EC consumption, followed by a rapid increase from 2021 to 2023. The reduction in EC consumption from 2019 to 2020 was 36.9% compared to that between 2021 and 2022. Conclusions The significant rise in EC importation and utilization in Tanzania between 2018 and 2023, marked by fluctuating consumption trends and a notable surge, highlights the urgent need for targeted educational and policy intervention. This will guide the rational and informed use of ECs, ensuring access aligns with best practices for reproductive health.

The comparison of the quality of selected brands of antibiotics in Tanzania sourced from different geographical regions.

OBJECTIVES: The quality of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets was evaluated to determine whether there is any difference in quality when comparing the country of origin. This was undertaken because it has been claimed that antibiotics manufactured in Europe are of superior quality to those originating from Africa or Asia. METHODS: Samples of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets were collected from three randomly selected wholesale pharmacies in each city, namely Arusha, Dar es Salaam and Mwanza, Tanzania. The collected samples of collected brands were subjected to quality control testing as per their respective pharmacopoeial monographs. Amoxil 250 mg capsules (Glaxo Wellcome, Mayenne, France), Rocephin (Roche, Switzerland) and Cipro-Denk 500 (Allphamed Pharbil Arzneimittel GmbH, Gottingen, Germany) were used as reference brands for the other generic brands of amoxicillin, ceftriaxone and ciprofloxacin, respectively. RESULTS: A total of 31 brands (10 different brands of amoxicillin capsules, 9 of ceftriaxone sodium injections, and 12 of ciprofloxacin tablets) were collected from the targeted regions and subjected to quality control testing. All samples of collected brands complied with the requirements of their respective pharmacopoeial monographs. CONCLUSIONS: There was no significant difference in quality between brands of amoxicillin capsules, ceftriaxone for injection, and ciprofloxacin tablets manufactured in Africa and Asia against those manufactured in Europe in terms of compliance with the respective pharmacopoeial monographs.

Antibiotic utilization patterns in Tanzania: a retrospective longitudinal study comparing pre- and intra-COVID-19 pandemic era using Tanzania Medicines and Medical Devices Authority data.

Background: Antimicrobial resistance (AMR) is a growing public health concern globally, and misuse of antibiotics is a major contributor. Objective: This study investigated antibiotic utilization patterns before and during the COVID-19 pandemic in Tanzania using data from the Tanzania Medicines and Medical Devices Authority (TMDA). Methods: This retrospective longitudinal study analysed secondary data. The study compared antibiotics consumption in defined daily doses per 1000 inhabitants per day (DID) in two distinct eras: 2018-2019 as the pre-COVID-19 era and 2020-2021 as the intra-COVID-19 era. A sample t-test was conducted using Statistical Package for the Social Sciences. Results: The study analysed 10 614 records and found an overall increase in antibiotics consumption from 2018 to 2021. We found that the consumption was 61.24 DID in the intra-COVID-19 era and 50.32 DID in the pre-COVID-19 era. Levofloxacin had the highest percentage increase in use, with a 700% increase in DID during the intra-COVID-19 era. Azithromycin had a 163.79% increase, while cefotaxime had a 600% increase. By contrast, some antibiotics exhibited a decrease in usage during the intra-COVID-19 era, such as nalidixic acid, which had a 100% decrease, and cefpodoxime, which had a 66.67% decrease. Conclusions: Increased antibiotic consumption during the COVID-19 pandemic highlights the importance of implementing effective antimicrobial stewardship strategies to prevent AMR, especially during pandemics.

Incidence and determinants of adverse events in individuals with HIV commencing Dolutegravir-based antiretroviral therapy in mainland Tanzania.

Tanzania adopted a Dolutegravir (DTG)-based regimen as first-line treatment in 2019 following the World Health Organization recommendation. Data on the DTG safety profile from sub-Saharan Africa including Tanzania are limited. We investigated the incidence of DTG-related adverse events (AEs) and associated factors among people living with HIV (PLHIV) initiated on a DTG regimen. A prospective cohort study was conducted from 25 Care and Treatment Clinics in mainland Tanzania. PLHIV aged 12 years and above who were initiated on a DTG-based regimen were actively followed up for three months. The Cox regression model was used to determine the predictors of occurrence of AEs over time. A p-value of 0.05 was considered statistically significant. From January 2020 to June 2022, a cohort of 935 participants who were both newly diagnosed and ART-experienced who transitioned to a DTG-based regimen was enrolled. Out of 935 participants, 59 (6.3%) reported a total of 62 AEs. The most frequently experienced AE was skin itching and rashes (15/62; 24.2%). DTG-associated neuropsychiatric AEs were less common and included headache (6 [9.6%]) and sleep disturbances (3 [4.8%]). The overall incidence of occurrence of the first AEs was 96.7 per 1000 person-months [95% C.I: 74.4-125.7] with the highest incidence observed among the elderly (≥ 60 years). Individuals on WHO HIV Clinical Stage 2 had a 2.7 significantly higher risk of developing AEs (adjusted hazard ratio = 2.73, 95% CI = 1.46-5.12, p = 0.017). We report a low incidence of grade I (mild) and grade II (moderate) DTG-associated AEs suggesting that the regimen is generally safe in the population. Continued monitoring of DTG safety in the population is recommended.

Population pharmacokinetics of ivermectin after mass drug administration in lymphatic filariasis endemic communities of Tanzania.

Ivermectin (IVM) is a drug of choice used with albendazole for mass drug administration (MDA) to halt transmission of lymphatic filariasis. We investigated IVM pharmacokinetic (PK) variability for its dose optimization during MDA. PK samples were collected at 0, 2, 4, and 6 h from individuals weighing greater than 15 kg (n = 468) receiving IVM (3-, 6-, 9-, or 12 mg) and ALB (400 mg) during an MDA campaign in Tanzania. Individual characteristics, including demographics, laboratory/clinical parameters, and pharmacogenetic variations were assessed. IVM plasma concentrations were quantified by liquid-chromatography tandem mass spectrometry and analyzed using population-(PopPK) modeling. A two-compartment model with transit absorption kinetics, and allometrically scaled oral clearance (CL/F) and central volume (Vc /F) was adapted. Fitting of the model to the data identified 48% higher bioavailability for the 3 mg dose compared to higher doses and identified a subpopulation with 97% higher mean transit time (MTT). The final estimates for CL/F, Vc /F, intercompartment clearance, peripheral volume, MTT, and absorption rate constant for a 70 kg person (on dose other than 3 mg) were 7.7 L/h, 147 L, 20.4 L/h, 207 L, 1.5 h, and 0.71/h, respectively. Monte-Carlo simulations indicated that weight-based dosing provides comparable exposure across weight bands, but height-based dosing with capping IVM dose at 12 mg for individuals with height greater than 160 cm underdoses those weighing greater than 70 kg. Variability in IVM PKs is partly explained by body weight and dose. The established PopPK model can be used for IVM dose optimization. Height-based pole dosing results in varying IVM exposure in different weight bands, hence using weighing scales for IVM dosing during MDA is recommended.

Can a Smartphone Application Help Address Barriers to Reporting Substandard/Falsified Medical Products? A Pilot Study in Tanzania and Indonesia.

INTRODUCTION: Reporting is an essential component of efforts to combat the distribution and circulation of substandard and falsified (SF) medical products worldwide. However, little is known about why health care professionals (HCPs) do not report suspect products to the national medicine regulatory authority (NMRA) and what measures might address this. This pilot study aimed to assess the utility of a smartphone application for reporting SF medical products in Tanzania and Indonesia. METHODS: At baseline, in 2017, HCPs completed a survey describing perceived barriers to reporting and received training in the identification of SF products and received use of the smartphone reporting application (N=309). The application reporting system was piloted for 6 months. Evaluations took place with HCPs and NMRA staff at the midpoint and endline of the pilot study (2018). RESULTS: At baseline, HCPs surveyed (n=254) identified the following key barriers to reporting: difficulties identifying SF products, frustrations with existing reporting systems, and fears that reporting may have personal or reputational repercussions. During the pilot period, HCPs submitted a total of 36 reports of 27 products to the NMRAs in their respective countries; of these, 8 products were determined to be SF and 2 were unregistered. In all 10 cases, appropriate regulatory action was taken. Feedback from HCPs and NMRA staff was positive in both countries, suggesting that the application addressed several barriers to reporting as it was convenient and, importantly, opened a line of communication between HCPs and the NMRA. However, the application did not address all barriers to reporting, such as concerns of repercussions. CONCLUSION: The findings suggest that this smartphone application may be useful for improving HCPs' reporting of suspected SF products. Developing and piloting similar reporting applications in other countries and contexts is required.

Effectiveness of a structured stimulated spontaneous safety monitoring of medicines reporting program in strengthening pharmacovigilance system in Tanzania.

Under-reporting of adverse drug events (ADEs) is a challenge facing developing countries including Tanzania. Given the high magnitude of under-reporting, it was necessary to develop and assess the effectiveness of a 'structured stimulated spontaneous safety monitoring' (SSSSM) reporting program of ADEs which aimed at strengthening pharmacovigilance system in Tanzania. A quasi-experimental design and data mining technique were used to assess the effect of intervention after the introduction of program in seven tertiary hospitals. ADEs reports were collected from a single group and compared for 18 months before (July 2017 to December, 2018) and after the program (January 2019 to June 2020). Out of 16,557 ADEs reports, 98.6% (16,332) were reported after intervention and 0.1% (23) death related to adverse drug reactions (ADRs) were reported. Reports increased from 20 to 11,637 after intervention in Dar es salaam, 49 to 316 in Kilimanjaro and 17 to 77 in Mbeya. The population-based reporting ratio per 1,000,000 inhabitants increased from 2 reports per million inhabitants in 2018 to 85 reports in 2019. The SSSSM program can increase the reporting rate of ADEs and was useful in detecting signals from all types of medicines. This was first effective developed spontaneous program to monitor medicine safety in Tanzania.

Post marketing surveillance of selected veterinary medicines in Tanzania mainland.

BACKGROUND: Veterinary medicines have been widely used for the prevention and treatment of animal diseases. Globally, the veterinary medicine industry is growing. However, there is a significant increase of concern on the quality of veterinary medicines in various developing countries' legal markets. Poor-quality medicines are associated with treatment failure, development of drug resistance, increased healthcare cost, and death. These reasons warrant a need for monitoring the quality of the medicines circulating in the Tanzania Mainland. METHODS: This was a survey study and veterinary medicines samples were collected from 9 out of 26 regions of Tanzania mainland between 2014 and 2017. Veterinary medicines were sampled from wholesale pharmacies, retail pharmacies, veterinary clinics and Veterinary Accredited Drug Dispensing Outlets (ADDO-vet). All sampled medicines were subjected to product information review and full quality control testing at the Tanzania Medicines and Medical Devices Authority-World Health Organization prequalified laboratory. RESULTS: A total of 238 samples of veterinary medicines were collected. Out of these, 97.1% (231/238) were subjected to full quality control testing and product information review. All sampled veterinary medicines conformed to visual appearance, clarity, pH, solubility and sterility tests. Also, of the sampled veterinary medicines 97.8% (226/231) and 89.2% (206/231) passed identification and assay tests, respectively. As well as, the majority of the collected samples 92% (219/238) failed to comply with product information requirements. The most observed deficiencies on product information were inadequate information on the package insert 94.1% (224/238), inappropriate storage conditions 55.5% (132/238) and lack of Tanzania registration number 27% (64/238). CONCLUSION: Veterinary medicines with poor quality were found circulating in the legal markets of Tanzania. This can potentiate treatment failure and the development of drug resistance in animals and humans. Post marketing surveillance program will continue to be implemented to ensure that only good quality, safe and efficacious medicines are circulating in the Tanzania Mainland market.

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study.

Ivermectin and albendazole (IA) combination preventive chemotherapy to all at-risk populations is deployed to eliminate lymphatic filariasis. Although safety monitoring is imperative, data from Sub-Saharan Africa is scarce. We conducted a large-scale active safety surveillance of adverse events (AEs) following IA mass drug administration (MDA) to identify the type, incidence, and associated risk factors in Tanzania. After recording sociodemographic, clinical, and medical histories, 9640 eligible residents received single-dose IA combination preventive chemotherapy. Treatment-associated AEs were actively monitored through house-to-house visits on day 1, day 2, and day 7 of MDA. Events reported before and after MDA were cross-checked and verified to identify MDA-associated AEs. 9288 participants (96.3%) completed the seven-day safety follow-up, of whom 442 reported 719 MDA-associated AEs. The incidence of experiencing one or more type of MDA-associated AE was 4.8% (95% CI = 4.3−5.2%); this being significantly higher among those with Pre-MDA clinical events than those without (8.5% versus 4.1%, p < 0.001). AEs were mild (83.8%), moderate (15.9%), and severe (0.3%), and most resolved within 72 h. The incidence of experiencing one, two, ≥ three types of AEs were 2.8%, 1.3%, and 0.6%, respectively. The most common AEs were headache (1.23%), drowsiness (1.15%), fever (1.12%), and dizziness (1.06%). A chronic illness, or clinical manifestation of lymphatic filariasis, or being female or pre-existing clinical symptoms were independent significant predictors of AEs. IA combination preventive chemotherapy is safe and tolerable, and associated AEs are mild-to-moderate and transient, with few severe AEs. Safety monitoring during MDA campaigns in individuals with underlying clinical conditions is recommended for timely detection and management of AEs.

National Antibiotics Utilization Trends for Human Use in Tanzania from 2010 to 2016 Inferred from Tanzania Medicines and Medical Devices Authority Importation Data.

Antimicrobial use (AMU) is one of the major drivers of emerging antimicrobial resistance (AMR). The surveillance of AMU, which is a pillar of AMR stewardship (AMS), helps devise strategies to mitigate AMR. This descriptive, longitudinal retrospective study quantified the trends in human antibiotics utilization between 2010 and 2016 using data on all antibiotics imported for systemic human use into Tanzania's mainland. Regression and time series analyses were used to establish trends in antibiotics use. A total of 12,073 records for antibiotics were retrieved, totaling 154.51 Defined Daily Doses per 1000 inhabitants per day (DID), with a mean (±standard deviation) of 22.07 (±48.85) DID. The private sector contributed 93.76% of utilized antibiotics. The top-ranking antibiotics were amoxicillin, metronidazole, tetracycline, ciprofloxacin, and cefalexin. The DIDs and percentage contribution of these antibiotics were 53.78 (34.81%), 23.86 (15.44), 20.53 (13.29), 9.27 (6.0) and 6.94 (4.49), respectively. The time series model predicted a significant increase in utilization (p-value = 0.002). The model forecasted that by 2022, the total antibiotics consumed would be 89.6 DIDs, which is a 13-fold increase compared to 2010. Government intervention to curb inappropriate antibiotics utilization and mitigate the rising threat of antibiotic resistance should focus on implementing AMS programs in pharmacies and hospitals in Tanzania.

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.

Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward.

Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development Community (SADC) collaborative medicines registration initiative. ZaZiBoNa has resulted in great savings in time and resources; however, identified challenges include lack of clear information regarding the participating countries registration processes and requirements as well as lengthy registration times. The aim of this study, therefore, was to compare the data requirements and review models employed in the assessment of applications for registration, the target timelines for key milestones and the metrics of applications received and approved in 2019 and 2020 by Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe. Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardizes 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 majority of applications received and approved by all six agencies in 2019 and 2020 were for generics. The mean approval times for generics varied across the countries, with ranges of 218-890 calendar days in 2019 and 158-696 calendar days in 2020. All three types of scientific assessment review models were used by the six agencies and data requirements and extent of scientific assessment were similar for five countries, while one conducted full reviews for new active substances. A large variation was observed in the targets set by the six agencies for the different milestones as well as overall approval times. Conclusions: The study identified the strengths of the countries as well as opportunities for improvement and alignment. Implementation of the recommendations made as in this study will enhance the countries' individual systems, enabling them to efficiently support the ZaZiBoNa initiative.

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.

Comparative Assessment of the Pharmacovigilance Systems within the Neglected Tropical Diseases Programs in East Africa-Ethiopia, Kenya, Rwanda, and Tanzania.

Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing.

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

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.

Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned.

Jane H. Mashingia and colleagues reveal the progress made to date for the East African Community Medicines Regulatory Harmonization initiative.

Optimizing the East African Community's Medicines Regulatory Harmonization initiative in 2020-2022: A Roadmap for the Future.

Margareth Ndomondo-Sigonda outlines future challenges for the East African Medicines Regulatory Harmonization initiative.

Prevalence and Correlates of Lymphatic Filariasis Infection and Its Morbidity Following Mass Ivermectin and Albendazole Administration in Mkinga District, North-Eastern Tanzania.

Lymphatic filariasis (LF) is a neglected tropical disease targeted for elimination as public health problem through morbidity management and preventive annual mass drug administration (MDA). This cross-sectional community-based surveillance assessed the prevalence and correlates of LF infection in Mkinga district, Tanga-region, Tanzania. A total of 4115 individuals (49.7% males, 35.2% children) were screened for circulating filarial antigens (CFA), microfilaremia (mf) and disease manifestations in 15 villages between November 2018 and January 2019. MDA uptake in the previous year was assessed. Overall prevalence of CFA-positivity was 5.8% (239/4115; 95% CI: 5.1-6.6), with significant heterogeneity between villages (range 1.2% to 13.5%). CFA-positivity was higher in males (8.8%) than females (3.3%), and correlated with increasing age (p < 0.001). Prevalence of mf among CFA-positives was 5.2%. Only 60% of eligible inhabitants in the study area took MDA in the previous year, and CFA-positivity was 2-fold higher in those who missed MDA (p < 0.0001). Prevalence of scrotal enlargement, hydrocele, arms or legs swelling, lymphoedema and lymphadenopathy was 6.4%, 3.7%, 1.35%, 1.2% and 0.32%, respectively. Compared to baseline data, 16 years of MDA intervention significantly reduced LF transmission and morbidity, although the intended elimination target of <1% mf and <2% antigenemia to level where recrudescence is unlikely to occur by the year 2020 may not be attained. The finding of hotspots with ongoing transmission calls for intensified control measures.