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Improving medicines regulation can lead to better population health, but how this process works in low- and middle-income countries remains underexplored. Tanzania's pharmaceutical sector is often cited as a successful example of a well-functioning regulatory system in a developing country, attributed to the work of the Tanzania Food and Drugs Authority (TFDA), now the Tanzania Medicines and Medical Devices Authority (TMDA). This raises the question: how was this regulatory capacity developed, and what lessons can other countries learn from Tanzania's experience? This paper analyzes changes in Tanzania's pharmaceutical regulation over three periods of significant sectoral reform. A desk review was conducted of Tanzania's policies, laws, regulations, guidelines, procedures, and institutional reports. The study reveals that Tanzania's regulatory capacity improved significantly through targeted reforms that addressed challenges in key regulatory areas. The three key periods examined are: 1) The separation of medicines regulation from food safety (1978-2003), 2) The expansion of regulatory domains and the establishment of a semi-autonomous regulatory agency (2003-2011), and 3) The expanded role of the Pharmacy Council to include premises regulation (2011-2020). The development of a well-functioning regulatory system in Tanzania resulted from advancements in four key areas: 1) The evolution of a legal regulatory framework, 2) Strong stakeholder engagement, 3) Continuous capacity building, and 4) Effective organizational leadership. Tanzania's regulatory system has evolved from being relatively ineffective to leading regional harmonization efforts in East Africa. This progress was not linear, requiring sustained effort, collaboration, and support from key development partners such as the Global Fund, WHO, and UNDP. Future efforts to enhance regulatory effectiveness should focus on creating adaptive systems that respond to changing needs, rather than solely prescriptive functions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Fimbo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Paracetamol, also known as acetaminophen, is categorized as an analgesic and antipyretic medication and is available as over the counter (OTC) medication. It is commonly used in conditions associated with pain and fever. There is a tendency for community to prefer using imported paracetamol tablets from Europe and United States than from Asia and Africa worrying of the quality of the products. Safety, effectiveness, and efficacy of a medicine can be guaranteed when its quality is reliable; however, there is limited data on the quality of locally manufactured paracetamol tablets, thus necessitating this study. Aim: This study is aimed at assessing the quality of paracetamol tablets 500 mg manufactured by local companies by evaluating their physical parameters, assay results, and dissolution profiles. The compliance of these tablets with the specifications outlined in the British Pharmacopoeia (BP) was analyzed. Additionally, a comparative dissolution test was conducted to assess dissolution profile for innovator product and generics. Method: Five different brands from East African countries with 76 tablets from each brand were compared with the innovator product regarding weight variation, hardness, friability, assay, and dissolution test based on the BP specifications. Results and discussion: All samples of paracetamol tablets 500 mg from the local manufacturers in this study met the specifications set by the BP for physical parameters, including weight variation, friability, hardness, and disintegration tests. The weight variation test, directly related to drug content variation, demonstrated compliance within the acceptable deviation of 5%. Similarly, the assay test, which determines the concentration of the active pharmaceutical ingredient (API), confirmed that all samples complied with the acceptable concentration range of 90%-110% for paracetamol. The dissolution test, assessing the percentage release of the API within a specified time, demonstrated that at 15 min, two samples (diodol and enamol) exhibited lower concentration releases than the required 80%, indicating potential delays in their bioavailability and onset of action. Conclusion: To conclude, all samples had good quality and they can be used for their therapeutic purposes., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Gerald Marisa et al.)

Background: Glycaemic control is essential for improving the quality of life in patients with Diabetes Mellitus (DM). Untreated hyperglycaemia can result in numerous severe and life-threatening complications, such as damage to the eyes, kidneys, nerves, heart, and peripheral vascular system. Appropriate glycaemic control and management is fundamental to prevent and delay diabetes complications. Therefore, this study aims to assess the prevalence of poor glycaemic control, its associated factors, and the prevalence of diabetes-related complications among DM patients., Methods: A cross-sectional study was conducted among 340 DM patients treated at Bugando Medical Center from 4th - 30th April 2023 to determine the prevalence of poor glycaemic control and its predictors. Secondary data from 7952 DM patients treated between April 2022 and 30th May 2023 were used to determine DM-related complications. STATA 15 version …was used for analysis., Results: Out of 340 patients, 66.4% had poor glycaemic control with HbA1c or Random Blood Glucose greater than 7% or 7mmol/L, respectively. Older age, duration of DM of more than 10 years, insulin therapy, and those unaware of glycaemic target goals were factors associated with poor glycaemic control. (AOR: 2.46, 95% CI: 1.28-6.01, P = 0.03), (AOR: 3.15, 95% CI: 2.22-6.55, P = 0.016), (AOR: 3.07, 95% CI: 2.10-6.12, P = 0.022) and (AOR: 3.42, 95% CI: 2.17-5.97, P = 0.001), respectively. Of the 7952 patient records reviewed indicated that 44.5% had complications, of which 25.8% had neurological complications and 55.3% had multiple complications., Conclusion: Two-third of DM patients failed to achieve good glycaemic control and about half of the patient's records reviewed indicated they developed diabetic complications. Thus appropriate interventions are necessary to improve glycaemic control and prevent or control complications among DM patients., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Muchunguzi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: Children account for a significant proportion of antibiotic consumption in low- and middle-income countries, with overuse occurring in formal and informal health sectors. This study assessed the prevalence and predictors of residual antibiotics in the blood of children in the Mbeya and Morogoro regions of Tanzania., Methods: The cross-sectional community-based survey used two-stage cluster sampling to include children aged under 15 years. For each child, information on recent illness, healthcare-seeking behaviour, and use of antibiotics, as well as a dried blood spot sample, were collected. The samples underwent tandem mass spectrometry analysis to quantify the concentrations of 15 common antibiotics. Associations between survey variables and the presence of residual antibiotics were assessed using mixed-effects logistic regression., Results: In total, 1742 children were surveyed, and 1699 analysed. The overall prevalence of residual antibiotics in the blood samples was 17.4% (296/1699), the highest among children under the age of 5 years. The most frequently detected antibiotics were trimethoprim (144/1699; 8.5%), sulfamethoxazole (102/1699; 6.0%), metronidazole (61/1699; 3.6%), and amoxicillin (43/1699; 2.5%). The strongest predictors of residual antibiotics in the blood were observed presence of antibiotics at home (adjusted odds ratio [aOR] = 2.9; 95% CI, 2.0-4.1) and reported consumption of antibiotics in the last 2 weeks (aOR = 2.5; 95% CI, 1.6-3.9). However, half (145/296) of the children who had residual antibiotics in their blood, some with multiple antibiotics, had no reported history of illness or antibiotic consumption in the last 2 weeks, and antibiotics were not found at home., Discussion: This study demonstrated a high prevalence of antibiotic exposure among children in Tanzanian communities, albeit likely underestimated, especially for compounds with short half-lives. A significant proportion of antibiotic exposure was unexplained and may have been due to unreported self-medication or environmental pathways. Incorporating biomonitoring into surveillance strategies can help better understand exposure patterns and design antibiotic stewardship interventions., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives: Tanzania observed a gradual increase in the number of measles cases since 2019 with a large outbreak recorded during 2022. This study describes the trend of measles in Tanzania over a 5-year period from 2018-2022., Methods: This was a descriptive study conducted using routine measles case-based surveillance system including 195 councils of the United Republic of Tanzania., Results: Between 2018 and 2022 there were 12,253 measles cases reported. Out of 10,691 (87.25%) samples tested by enzyme-linked immunosorbent assay, 903 (8.4%) were measles immunoglobulin M positive. The highest number of laboratory-confirmed measles cases was in 2022 (64.8%), followed by 2020 (13.8%), and 2019 (13.5%). Out of 1279 unvaccinated cases, 213 (16.7%) were laboratory-confirmed measles cases compared to 77/723 (10.6%) who were partially vaccinated and 71/1121 (6.3%) who were fully vaccinated (P < 0.001). Children aged between 1-4 years constituted the most confirmed measles cases after laboratory testing, followed by those aged 5-9 years. There was a notable increase in the number of laboratory-confirmed measles cases in children <1 year and 10-14 years during 2022 compared to previous years. The vaccination coverage of the first dose of measles-containing vaccine (MCV1) was maintained >90% since 2013 while MCV2 increased gradually reaching 88% in 2022., Conclusions: Accumulation of susceptible children to measles due to suboptimal measles vaccination coverage over the years has resulted in an increase in the number of laboratory-confirmed measles cases in Tanzania with more cases recorded during the COVID-19 pandemic. Strengthening surveillance, routine immunization, and targeted strategies are key to achieving the immunity levels required to interrupt measles outbreaks., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)