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HIV-related stigma represents a potent risk factor for a range of poor health outcomes, including mental health symptoms, treatment non-adherence, and substance use. Understanding the role of HIV-related stigma in promoting healthcare outcomes is critical for vulnerable populations, such as pregnant women living with HIV, in contexts with continued high rates of HIV and associated stigma, such as sub-Saharan Africa. The current study examined a range of risk and protective factors for HIV-related stigma with 742 pregnant women (

OBJECTIVENeuronavigation has become a crucial tool in the surgical management of CNS pathology in higher-income countries, but has yet to be implemented in most low- and middle-income countries (LMICs) due to cost constraints. In these resource-limited settings, neurosurgeons typically rely on their understanding of neuroanatomy and preoperative imaging to help guide them through a particular operation, making surgery more challenging for the surgeon and a higher risk for the patient. Alternatives to assist the surgeon improve the safety and efficacy of neurosurgery are important for the expansion of subspecialty neurosurgery in LMICs. A low-cost and efficacious alternative may be the use of intraoperative neurosurgical ultrasound. The authors analyze the preliminary results of the introduction of intraoperative ultrasound in an LMIC setting.METHODSAfter a training program in intraoperative ultrasound including courses conducted in Dar es Salaam, Tanzania, and Aurora, Colorado, neurosurgeons at the Muhimbili Orthopaedic and Neurosurgical Institute began its independent use. The initial experience is reported from the first 24 prospective cases in which intraoperative ultrasound was used. When possible, ultrasound findings were recorded and compared with postoperative imaging findings in order to establish accuracy of intraoperative interpretation.RESULTSOf 24 cases of intraoperative ultrasound that were reported, 29.2% were spine surgeries and 70.8% were cranial. The majority were tumor cases (95.8%). Lesions were identified through the dura mater in all 24 cases, with 20.8% requiring extension of craniotomy or laminectomy due to inadequate exposure. Postoperative imaging (typically CT) was only performed in 11 cases, but all 11 matched the findings on post–dural closure ultrasound.CONCLUSIONSThe use of intraoperative ultrasound, which is affordable and available locally, is changing neurosurgical care in Tanzania. Ultimately, expanding the use of intraoperative B-mode ultrasound in Tanzania and other LMICs may help improve neurosurgical care in these countries in an affordable manner.

Funding: European and Developing Countries Clinical Trials Partnership (EDCTP) under Streamlining Health Research Ethics Review and Regulatory Framework in Tanzania (SMERT) project. 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. Publisher PDF

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.

Background Surgical Site Infections are a major cause of morbidity and mortality among operated patients. In spite of the accessibility of universal and national guidelines for surgical prophylaxis, recent studies surveying the present routine of prophylaxis have demonstrated overutilization of a wide range antibacterial medication for a single patient. Few studies have shown qualitatively factors influencing this and perceptions of surgeons on surgical antibiotic prophylaxis use. Unfortunately, none of these studies have been done in Tanzania. Objective To describe the perceptions of surgeons on surgical antibiotic prophylaxis use at an urban tertiary hospital. Methods A qualitative study involving in-depth interviews with surgeons was conducted in English by the primary investigator. The interviews were audio-recorded and transcribed verbatim. Systematic text condensation by Malterud was used for data analysis. Findings Fourteen surgeons and obstetrics and gynaecologists participated. Their perceptions were summarized into three main categories: Inadequate data to support practice; one who sees the patient decides the antibiotic prophylaxis; prolonged antibiotic use for fear of unknown. The participants perceived that choice of antibiotic should be based on local hospital data for bacterial resistance pattern, however the hospital guidelines and data for surgical site infection rates are unknown. Fear of getting infection and anticipating complications led to prolonged antibiotics use. Conclusion The study provides an understanding of surgical antibiotic prophylaxis use and its implementation challenges. This was partly expressed by unavailability of local data and guidelines to enhance practice. To improve this, there is a need of guidelines that incorporates local resistance surveillance data and enhanced antibiotic stewardship programmes. A strong consideration should be placed into ways to combat the fears of surgeons for complications, as these significantly affect the current practise with use of surgical antibiotic prophylaxis.

BACKGROUND 'Mchuchume' is a ready to eat fermented cassava food used for breakfast, lunch, and/or snack purposes. Its diverse consumption modes attract many studies, including regarding its fortification with inexpensive food materials rich in beneficial nutritional qualities. This study is aimed at investigating the effect of soya bean flour and Moringa oleifera leaves powder on the micronutrient composition of mchuchume. RESULTS Enrichment significantly increased iron (0.001 g kg-1 in control to 0.03 g kg-1 in cassava-soya, 0.06 g kg-1 in cassava-moringa and 0.09 g kg-1 in cassava-soya-moringa) and potassium (1.01 g kg-1 in control to 5.14 g kg-1 in cassava-soya, 3.45 g kg-1 in cassava-moringa and 7.43 g kg-1 in cassava-soya-moringa). Compared with the control (0.10 g kg-1 sodium), sodium content either decreased significantly (to 0.09 g kg-1 in cassava-soya) or increased significantly (to 0.37 g k g-1 in cassava-moringa and 0.36 g kg-1 in cassava-soya-moringa). β-Carotene was below the instrument's limit of detection (

Intimate partner violence (IPV) exacts a heavy burden on women, resulting in poor health outcomes. This study had the following aims: (1) estimate the prevalence of IPV post-disclosure of HIV status among pregnant women living with HIV and depression; and (2) evaluate risk and protective factors for IPV post-disclosure. Participants were women accessing PMTCT services at 16 health facilities in Dar es Salaam and screened at the threshold of 9 on the PHQ-9. Generalized linear equations with a log link and standard errors clustered at the facility level were used to calculate associations between predictors and IPV post-disclosure. Among 659 women who were in an intimate relationship, 10.2% had experienced physical violence and 11.6% had reported sexual violence from their partner in the past six months; 327 had disclosed their HIV status to their partners. After disclosure to their partners 279 women (85.3%) experienced IPV. HIV-related stigma was associated with increased risk of IPV following disclosure and appreciative relationships with partners and higher hope were associated with reduced risk of IPV. There is a need to identify and advance approaches to HIV disclosure that prevent IPV. Interventions should be developed based on known risk and protective factors for IPV following HIV disclosure in Tanzania and similar settings.

Hiiti Sillo and colleagues reveal how the East African Community's Medicines Regulatory Harmonization initiative improves access to important medicines in Africa.

IntroductionAdequate and sustainable funding of national medicine regulatory agencies (NMRAs) is key for assurance of quality, safety and efficacy of medical products circulating in a market. The study aimed to determine factors affecting NMRAs funding in five East African Community (EAC) countries namely: Burundi, Kenya, Rwanda, Tanzania (Mainland and Zanzibar) and Uganda.MethodologyAn exploratory, mixed method design using both qualitative and quantitative data, was employed. Data from six NMRAs was collected through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs and monitoring and evaluation experts of the respective agencies. NMRA's financing was assessed using six indicators namely, funding policy, financial autonomy, the total annual budget, actual funding per annum, funds received from various sources, and the NMRA expenditure.ResultsThe average total annual budget for all the EAC countries during the study period 2011-2015 ranged from USD 824,328.67 to USD 10,724,536.50. The low budget in Zanzibar may be attributed to population and pharmaceutical market size. Uganda's attainment of 98.75% (USD 10,656,704) revenue from industry fees is a result of deliberate government policy change from 100% reliance on donor funding over a period of 10 years (1995-2015). On average, the proportion of revenue against budget per annum is 54.8% (USD 458,970.11), 98.7% (USD 10,302,295.25) and 100% (USD 7,375,802.08) for Zanzibar Food & Drugs Agency (ZFDA), Uganda National Drug Authority (NDA) and Tanzania Medicines and Medical Devices Authority (TMDA) respectively. Governments, industry fees and donors are the major sources of funding across all NMRAs in the EAC region, with TMDA and Uganda NDA relying more on industry fees by 73.20% (USD 4,664,777.59) and 98.25% (USD 8,077,238.20) respectively. While Burundi relies solely on government funding, ZFDA, on the other hand, received on average 50.40% (USD 252,557.22) from government and 40.60% (USD 165,303.34) from industry fees and the remaining 9% from donors and other sources. An overall contribution of funds received from donors by each NMRA was the least among other sources of financing. Observation of expenditure patterns indicated operational costs to be the major expense in the majority of the NMRAs, followed by salaries and infrastructure development. The Kenya NMRA has the highest degree of average expenditure across all three categories, with the least average expenditures being marked by Burundi NMRA. The operational costs on average increased considerably in all the NMRAs during the study period.ConclusionEvidence from the EAC suggests that government and industry fees are the main sources of funding while donor contributions vary from country to country. Government policy, legal framework, and fees structure are the key enablers of NMRAs funding sustainability.

Background Medicines with a stereogenic center (asymmetric carbon) mainly presents 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. Worldwide there is no mandatory regulatory requirement to enforce the development of new chiral medicines as exclusively pure active single enantiomers. This has contributed to the existence of both single enantiomers and racemates on the market. Moreover, literature shows the tendency of regulatory approval of medicines towards the development of pure single enantiomers 60%, only 5–10% racemates and 30–35% as achiral. This status has not been established particularly in African countries including Tanzania. Therefore, we aimed to establish the chirality status of registered medicines in Tanzania. Methodology: A retrospective cross-sectional study was conducted by reviewing all human medicines registered in Tanzania for the past 15 years from 2003 to 2018. Data were extracted from TMDA-IMIS database to Microsoft excel for analysis. Medicines were assessed to determine if they were chiral (racemates or single enantiomers) or achiral. Results A total of 3,573 human medicines had valid registration. Most of these medicines 2,150 (60%) are chiral and 1,423 (40%) are achiral. Out of the chiral medicines, 1,591 (74%) and 559 (26%) were racemates and single enantiomers, respectively. The percentage of chiral medicines for anti-infective (35%) was significantly higher (p

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.

Background Hope or hopefulness enhances coping and improves quality of life in persons with chronic or incurable illnesses. Lack of hope is associated with depression and anxiety, which impact negatively on quality of life. In Tanzania, where HIV prevalence is high, the rates of depression and anxiety are over four times higher among people living with HIV (PLH) compared to persons not infected and contribute annual mortality among PLH. Tanzania has a shortage of human resources for mental health, limiting access to mental health care. Evidence-based psychosocial interventions can complement existing services and improve access to quality mental health services in the midst of human resource shortages. Facilitating hope can be a critical element of non-pharmacological interventions which are underutilized, partly due to limited awareness and lack of hope measures, adapted to accommodate cultural context and perspectives of PLH. To address this gap, we developed and validated a local hope measure among PLH in Tanzania. Methods Two-phased mixed methods exploratory sequential study among PLH. Phase I was Hope-related items identification using deductive, inductive approaches and piloting. Phase II was an evaluation of psychometric properties at baseline and 24 months. Classical test theory, exploratory, confirmatory factor analysis (CFA) were used. Results Among 722 PLH, 59% were women, mean age was 39.3 years, and majority had primary school level of education. A total of 40 hope items were reduced to 10 in a three-factor solution, explaining 69% of variance at baseline, and 93% at follow-up. Internal consistency Cronbach's alpha was 0.869 at baseline and 0.958 at follow-up. The three-factor solution depicted: positive affect; cognition of effectiveness of HIV care; and goals/plans/ future optimism. Test-retest reliability was good (r = 0.797) and a number of indices were positive for CFA model fit, including Comparative Fit Index of 0.984. Conclusion The developed local hope scale had good internal reliability, validity, and its dimensionality was confirmed against expectations. The fewer items for hope assessment argue well for its use in busy clinical settings to improve HIV care in Tanzania. Hope in this setting could be more than cognitive goal thinking, pathway and motivation warranting more research. Trial registration The intervention was registered in USA ClinicalTrials.gov on September 26, 2012, Registration number: NCT01693458.

Background Perinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; however, in Tanzania there is limited access to services provided by mental health professionals. This paper presents a protocol and baseline characteristics for a study evaluating a psychosocial support group intervention facilitated by lay community-based health workers (CBHWs) for perinatal women living with HIV and depression in Dar es Salaam. Methods A cluster randomized controlled trial (RCT) is conducted comparing: 1) a psychosocial support group intervention; and 2) improved standard of mental health care. The study is implemented in reproductive and child health (RCH) centers providing PMTCT services. Baseline characteristics are presented by comparing sociodemographic characteristics and primary as well as secondary outcomes for the trial for intervention and control groups. The trial is registered under clinicaltrials.gov (NCT02039973). Results Among 742 women enrolled, baseline characteristics were comparable for intervention and control groups, although more women in the control group had completed secondary school (25.2% versus 18.2%). Overall, findings suggest that the population is highly vulnerable with over 45% demonstrating food insecurity and 17% reporting intimate partner violence in the past 6 months. Conclusions Baseline characteristics for the cluster RCT were comparable for intervention and control groups. The trial will examine the effectiveness of a psychosocial support group intervention for the treatment of depression among women living with HIV accessing PMTCT services. A reduction in the burden of depression in this vulnerable population has implications in the short-term for improved HIV-related outcomes and for potential long-term effects on child growth and development. Trial registration The trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.

Researchers and advocates have increasingly called for adolescent participation in clinical trials for new HIV prevention products, particularly adolescent girls in areas most affected by the epidemic. However, recent trials have highlighted the challenges for young women and adolescents to be able to effectively use new products that require daily dosing. This analysis provides a highly relevant context for this challenging environment by examining community members acceptability of adolescent girls' participation in clinical trials for new HIV prevention products. We conducted 41 in-depth interviews in Dar es Salaam, Tanzania and Pune, India with 22 key informants (KIs). Cultural perspectives on adolescent sexuality varied between countries, with KIs in Tanzania more readily acknowledging adolescent girls' sexual activity than KIs in India. KIs in both countries felt strongly adolescents must be well-informed about research concepts prior to participation, and emphasis should be given to preventative misconception. Despite concern in both countries that the trials might be seen as encouraging sexual behavior, KIs in Tanzania overwhelmingly supported adolescent inclusion, whereas KIs in India were more cautious. Involving adolescent girls in clinical trials for new HIV prevention products is potentially acceptable, although meaningful community engagement will be necessary.

Scombroid fish poisoning is a mild to moderate form of food poisoning caused by eating spoiled or bacterial contaminated fish after capture or during subsequent handling and storage. Its symptoms are similar to those of fish allergy though it gives negative results to allergy tests. Because of that, most clinicians misdiagnose scombroid or histamine fish poisoning, and erroneously advise their patients never to eat the same fish again. A prospective descriptive cross-sectional study was carried out to assess the contributing factors of scombroid fish poisoning among fish consumers and health care personnel residents in Dar es Salaam. Results showed 49.6% of fish consumers and 60% of health care workers were aware of scombroid fish poisoning. Among those with awareness, 2.2% of fish consumers had average knowledge and the remainder had low knowledge, while 6.3% of health care workers had good knowledge, and 42.9% and 50.8% had average to low knowledge, respectively. Mackerel was frequently listed among the scombroid fish associated with scombroid fish poisoning followed by tuna and king fish. Rashes (59%), diarrhoea (21.6%) and skin itching (19.4%) were the frequently mentioned symptoms by respondents. Aggressive health promotion interventions should be designed and implemented to increase awareness of histamine fish poisoning to general public including the health care personnel.

BackgroundUpper gastrointestinal bleeding (UGIB) is a common emergency department (ED) presentation with high morbidity and mortality. There is a paucity of data on the profile and outcome of patients who present with UGIB to EDs, especially within limited resource settings where emergency medicine is a new specialty. We aim to describe the patient profile, clinical severity and outcomes of the patients who present with UGIB to the ED of tertiary referral hospitals in Tanzania.MethodsThis was a prospective cohort study of consecutive adult (≥18 years) patients presenting to the EDs of Muhimbili National Hospital (ED-MNH) and MUHAS Academic Medical Centre (ED-MAMC), in Tanzania with non-traumatic upper gastrointestinal bleeding (UGIB) from July 2018 to December 2018. Patient demographic data, clinical presentation, and ED and hospital management provided were recorded. We used the clinical Rockall score to assess disease severity. The primary outcome of 7- day mortality was summarized using descriptive statistics. Regression analysis was performed to identify predictors of mortality.ResultsDuring the study period, 123 patients presented to one of the two EDs with an UGIB. The median age was 42 years (Interquartile range (IQR) 32–64 years), and 87 (70.7%) were male. Hematemesis with melena was the most frequently encountered ED complaint 39 (31.7%). Within 7 days, 23 (18.7%) patients died and one-third 8 (34.8%) of these died within 24 h. There were no ED deaths. About 65.1% of the patients had severe anemia but only 60 (48.8%) received blood transfusion in the ED. Amongst those with history of (h/o) esophageal varices 7(41.2%) did not receive octreotide. Upper GI endoscopy, was performed on 46 (37.4%) patients, of whom only 8 (17.4%) received endoscopy within 24 h (early UGI endoscopy). All patients who received early UGI endoscopy had a low or moderate clinical Rockall score i.e. 4 received early UGI endoscopy. Age > 40 years was a significant independent predictor of mortality (OR = 7.00 (95% CI 1.7–29.2). Having a high clinical Rockall score of ≥ 4 was a significant independent predictor of mortality (OR = 6.4 (95% CI 1.8–22.8).ConclusionsIn this urban ED in Sub-Saharan Africa, UGIB carried a high mortality rate. Age > 40 years and clinical Rockall score ≥ 4 were independent predictors of higher mortality. Future studies should focus on evaluating how to improve access to UGI endoscopy so as to improve outcomes.

Background Elevated serum lactate levels have been shown in numerous studies to be associated with serious adverse events, including mortality. Point of care lactate level is increasingly available in resource-limited emergency department (ED) settings. However, little is known about the predictive ability of for serious adverse events. Aim of the study We aimed to describe the utility of serum lactate level as a predictor of 24-h serious adverse events among adult patients presenting at the Emergency Medicine Department (EMD) of Muhimbili National Hospital (MNH) and MUHAS Academic Medical Center (MAMC). Methods This was a prospective observational study involving adult patients presenting to the EMD-MNH and MAMC from 1 September 2018 and 31 October 2018. Eligible patients with at least one lactate level test drawn while in the ED were examined in terms of their demographics, relevant clinical characteristics, and any serious adverse event (SAE) within 24 h of arrival. The sensitivity and specificity of lactate level to predict outcomes of interest were determined using the best cut-off point constructed from AUROC to see how well lactate level could discriminate which patients would have adverse events in the next 24 h. Categorical and continuous variables were compared with the chi-square test and two-sample t test, respectively. Results We screened 2057 (20.9%) out of 9828 patients who presented during study period, and enrolled 387 (18.8%). The overall median age was 54 years (interquartile range 40–68 years) and 206 (53.2%) were male. Using local triaging system, a total of 322 (83.2%) was triaged as an emergency category. The mean lactate level was 3.2 ± 3.6 mmol/L, 65 (16.8%) patients developed at least one SAE, with 42 (11%) who required ICU/HDU, 37 (10%) needed ventilator support, 10 (3%) required inotropes, and 9 (2%) developed cardiac arrest. The overall 24-h mortality was 28 (7%). The AUC of serum lactate level for overall 24-h mortality was 0.801 (95%CI, 0.7–0.9, P ≤ 0.001). At the optimal cutoff value (3.8 mmol/L), lactate level had a sensitivity and specificity for 24-h mortality of 64% and 85%, respectively. Mortality of the high-lactate level group (33.8 mmol/L) was significantly higher than that of the low-lactate level group (p Conclusion The utility of lactate level in predicting mortality was similar to that seen in high-resource settings. A serum lactate level of 33.8 mmol/L predicted 24-h serious adverse events in unselected patients seen in the high-acuity area of our ED. Incorporating serum lactate level in ED in lower- and middle-income countries (LMICs) can help identify patients at risk of developing serious adverse events.

Counterfeit and substandard medicines still constitute a worldwide problem and do not only affect healthcare systems in low and middle income countries but also in the industrialized world. Whereas in the developed world the quality of pharmaceutical preparations is assured by a dense network of quality control laboratories utilizing modern analytical techniques the situation is completely diverse in resource constraint countries. Implementing full monograph testing according to the American or the European Pharmacopoeia represents an extreme challenge. The respective quality control organs easily become overburdened and face central problems when supplying immaculate medicines. This review collected information on the prevalence of counterfeit and substandard pharmaceuticals in Tanzania and discusses suitable analytical approaches for their analysis, e.g. non-sophisticated HPLC, low-field NMR, capillary electrophoresis, or vibrational spectroscopy. Due to the limited validity and reproducibility of field assay kits like the Minilab ® the impact of precise, simple, and robust analytical methods is highlighted.

BackgroundTo assess the extent to which foreign pharmaceutical imports vary from year to year and identifying leading generic and branded formulations, key countries and key importers of pharmaceuticals in private sector supply chain.MethodologyA systematic analysis of data for pharmaceutical imports from the Ministry of Health.Data from 2013 to 2016 fiscal years and relevant documents were accessed from the Tanzania Food and Drugs Authority (TFDA). Data cleaning was carried out to remove duplicate entries and to exclude pharmaceutical imports for individual uses, promotion purpose, donations, raw material, medical devices, government institutions and veterinary products.ResultsA total of 397 different suppliers imported pharmaceutical in Tanzania mainland from 2013 to 2016 fiscal years. In the 2013-2014 fiscal year, the private sector suppliers imported pharmaceutical worth 216 U.S million dollars. India ranked as the first country for exporting highest value of pharmaceutical into the country. It displays a 54% cumulative market share of total imports from 2013-2016, followed by Egypt (11.7%), Switzerland and the USA hold 4.1% of cumulative market share. By 2020-2021 fiscal years, we forecast for imported pharmaceuticals to reach a total value of 906 U.S million dollars for the private sector supply chain. All analysis in this study and the forecasted figures are limited to private sector pharmaceutical supply chain only and does not include data for government pharmaceutical supply chain.ConclusionsOur result shows that the vast majority of pharmaceutical imports in the private sector supply chain are dominated by imports from India. India is competing with other countries such as Egypt, Switzerland, USA and South Africa among the top importing countries. There was almost an equal distribution of pharmaceutical for both communicable and non-communicable diseases. Data presented shows a growing trend for the market segment for medicines required for the management of non-communicable diseases. Generally, the private sector pharmaceutical market is keeping on rising at a rapid pace. By the year 2021, the growth is forecasted to increase by 28% compared to the current market value. The projected growth rate could be good news for foreign pharmaceutical companies seeking new sources of growth in international pharmaceutical trading. It is also good news to the poor patients if the availability of drugs previously unavailable in the country is significantly increased.

Background Psychosocial factors have been linked with loss to follow-up (LTFU) and clinical outcomes among people living with HIV (PLH), however little is known about the effect of psychosocial support on LTFU among PLH in treatment and care. The purpose of this study was to explore the effect of NAMWEZA (“Yes, together we can”) friends’ psychosocial support intervention on clinical outcomes and LTFU among PLH. NAMWEZA is based on a novel program using “appreciative inquiry”, positive psychology approaches to empower, promote positive attitudes and foster hope. Methods PLH participating in the NAMWEZA intervention in HIV care clinics in Dar es Salaam Tanzania were compared with non-exposed PLH obtained from facilities that routinely collect clinical information and both followed longitudinally for 24 months. Baseline sociodemographic, clinical measures (CD4 cell count, hemoglobin (HGB), weight), and LTFU measures were collected. Chi square, Fisher’s exact tests, and t-tests were used to compare the frequencies for categorical variables and the means of continuous variables from the intervention and the comparison groups to identify variables that were significantly different across the two groups. Random effects models were performed to examine the bivariate associations between the intervention status and clinical outcomes. Results At the end of 24 months of follow-up mean CD4 count and HGB levels increased significantly in both intervention and comparison groups (p = 0.009 and p

Background: Presence of substandard and falsified anti-malarial medicines is a major concern in countries with high prevalence of malaria. Systematic assessment and monitoring of anti-malarial medicines circulating on the market is critical to National Medicines Regulatory Authorities (NMRAs) in ensuring quality of these products in the fight against the burden of malaria disease. Objectives: This survey was conducted by Tanzania Food and Drugs Authority (TFDA) with the aim of monitoring the quality of registered anti-malarial medicines circulating on the market in Tanzania Mainland. Methodology: Purposive sampling method was used in obtaining the samples of anti-malarial medicines from 21 out of 26 regions of Tanzania Mainland between 2012 and 2015. These medicines were collected from ports of entry, domestic manufacturers, Medical Stores Department (MSD), wholesalers, hospitals, health centres, dispensaries and retail pharmacy outlets. Samples were subjected to product information review and quality screening using Global Pharma Health Fund® (GPHF) Mini-Lab kits. Samples failing or yielding doubtful results and ten percent (10%) of passed samples were subjected to tier two confirmatory testing using full pharmacopeial monographs at TFDA-WHO prequalified quality control laboratory. Results: A total of 1,444 samples of oral solid formulations from different types of anti-malarials were sampled. Out of these, 132 (9.1%) failed labelling product information requirements. A high percentage of samples passed identification test by TLC (97.9%) and disintegration test (99.8%). A 4.8% (7/145) failure rate was observed in confirmatory testing of which one of the failed samples namely quinine sulphate 300 mg tablets was confirmed to be falsified. Conclusion: These results indicate the importance of post marketing surveillance as an additional measure of assuring the quality of medicines by Regulators following marketing authorization and as a way of detecting falsified medicines circulating on the market.

Under-representation of female adolescents in HIV clinical trials may inhibit their access to future prevention technologies. Domestic violence, broadly defined as violence perpetrated by intimate partners and/or family members, may affect trial participation. This study describes violence in the lives of adolescents and young women in Tanzania, explores use of the Women's Experience with Battering (WEB) Scale to measure battering, and examines the associations between battering and socio-demographic and HIV risk factors. Community formative research (CFR) and a mock clinical trial (MCT) were conducted to examine the challenges of recruiting younger (15-17) versus older (18-21) participants into HIV prevention trials. The CFR included qualitative interviews with 23 participants and there were 135 MCT participants. The WEB was administered in both the CFR and MCT. Nineteen CFR participants experienced physical and/or sexual violence and 17 % scored positive for battering. All married participants reported partner-related domestic violence, and half scored positive for battering. Many believed beatings were normal. None of the single participants scored positive on battering, but one-third reported abuse by relatives. Among MCT participants, 15 % scored positive for battering; most perpetrators were relatives. Younger participants were more likely to report battering. Adolescents experienced high rates of domestic violence and the WEB captured battering from both partners and relatives. The level of familial violence was unexpected and has implications for parental roles in study recruitment. Addressing adolescent abuse in HIV prevention trials and in the general population should be a public health priority.

Background: In 2003 the government of Tanzania enacted the Tobacco Products (Regulation) Act 2003, which, among other things, prohibited smoking in public places. However, smoking has persisted despite the existence of the Act. This study aims to establish the reasons behind the persistence of tobacco smoking in public places. ②Methods: This was a cross-sectional study where data were collected using pre-tested, self-administered questionnaires with both open and closed questions and documentary reviews. The study was conducted in urban, rural and semi-rural areas in three districts located in eastern, central and northern Tanzania. Quantitative data were analyzed using SPSS ver. 15. Qualitative data were analyzed manually using a thematic content approach. ③Results: The study involved 240 participants, of whom 67% were males. Overall smoking prevalence was 26.5% (36.3% for males and 6.4% for females, p 0.05). About 40% of the smokers were between 25-35 years old and 52.4% had primary school as their highest level of education. About 56% of participants said they were aware of the Tobacco Regulation Act, but the majority could neither define it nor state the penalties for its infringement. Only 59.5% were aware that tobacco smoking causes lung cancer. About 4 out of 10 cigarette smokers do not adhere to NO SMOKING warnings. ④ Conclusions: Cigarette smoking in public places in Tanzania has persisted mainly due to low awareness and passive implementation of the Tobacco Regulation Act, 2003. Other causes are aggressive advertising and promotion by the tobacco industry and insufficient awareness about the health effects associated with tobacco smoking. This study calls for an increase in cigarette taxation, sensitization about the dangers of both smoking and second-hand smoke and active enforcement of the act as immediate intervention strategies.

Introduction: Poisoning is a public health challenge in low and middle income countries. Advances in technology and social development have led to an extensive use of medicines and chemical substances in these countries, hence increasing the prevalence of poisoning. Success in the management of a poisoning case depends on a number of factors including the availability of trained personnel, availability of support information and the understanding of local context. There is paucity of evidence from Tanzania showing the causes and management of reported cases of poisoning in healthcare facilities. Methodology: A retrospective cross-sectional study which was conducted at Muhimbili National Hospital, in Dar es Salaam. Data were collected by review of files of patient who were admitted due to poisoning for the past three years (2005-2008) and in-depth interviews with key informants using pre-tested semi-structured interview guides. Results: A total of 215 patients were admitted due to poisoning during the study period, 123 were males and 92 were females. Prevalence of poisoning was 3.28 cases per 1,000 hospitalizations. Majority of poisoning cases were observed in the age group between 16-40 years (>80%). Intentional poisoning by others was the most common pattern of poisoning (>36%). In more than 50% of the cases the poisoning substances had not been identified. Antibiotics and antiparasitics were the common medicines implicated in poisonings (17%). More than 90% of the poisoning victims recovered. Major fatalities occurred in the age group between 26-40 years at 58%. The mortality rate in men was higher giving a male to female ratio of 10:1. None of the healthcare personnel interviewed had received any specialized training on poisoning. Main sources of information mentioned included Drug Information reference formulary and senior colleagues. Increasing public awareness, availability of resources and organizational restructuring, and provision of specialized training are likely to have positive impact on poisoning management. Conclusion: Poisoning is one of the causes of hospital admission and mortalities at Muhimbili National Hospital. Effective management of poisoning cases is a multidisciplinary team approach which can be improved by several interventions such as establishment of poison information center, training of healthcare providers and ensuring easy access to anti-dotes. KeywordsPoisoning; Hospital Management; Poison Information Centre; Antidote

Background : There is a great need for physicians in Tanzania. In 2012, there were approximately 0.31 physicians per 10,000 individuals nationwide, with a lower ratio in the rural areas, where the majority of the population resides. In response, universities across Tanzania have greatly increased the enrollment of medical students. Yet evidence suggests high attrition of medical graduates to other professions and emigration from rural areas where they are most needed. Objective : To estimate the future number of physicians practicing in Tanzania and the potential impact of interventions to improve retention, we built a model that tracks medical students from enrollment through clinical practice, from 1990 to 2025. Design : We designed a Markov process with 92 potential states capturing the movement of 25,000 medical students and physicians from medical training through employment. Work possibilities included clinical practice (divided into rural or urban, public or private), non-clinical work, and emigration. We populated and calibrated the model using a national 2005/2006 physician mapping survey, as well as graduation records, graduate tracking surveys, and other available data. Results : The model projects massive losses to clinical practice between 2016 and 2025, especially in rural areas. Approximately 56% of all medical school students enrolled between 2011 and 2020 will not be practicing medicine in Tanzania in 2025. Even with these losses, the model forecasts an increase in the physician-to-population ratio to 1.4 per 10,000 by 2025. Increasing the absorption of recent graduates into the public sector and/or developing a rural training track would ameliorate physician attrition in the most underserved areas. Conclusions : Tanzania is making significant investments in the training of physicians. Without linking these doctors to employment and ensuring their retention, the majority of this investment in medical education will be jeopardized. Keywords : workforce; modeling; doctor shortage; Tanzania (Published: 27 June 2016) Citation: Glob Health Action 2016, 9 : 31597 - http://dx.doi.org/10.3402/gha.v9.31597

Introduction The purpose of this study was to investigate the quality of a select group of medicines sold in accredited drug dispensing outlets (ADDOs) and pharmacies in different regions of Tanzania as part of an in-depth cross-sectional assessment of community access to medicines and community use of medicines. Methods We collected 242 samples of amoxicillin trihydrate, artemether-lumefantrine (ALu), co-trimoxazole, ergometrine maleate, paracetamol, and quinine from selected ADDOs and pharmacies in Mbeya, Morogoro, Singida, and Tanga regions. The analysis included physical examination and testing with validated analytical techniques. Assays for eight of nine products were conducted using high-performance thin-layer chromatography (HPTLC). For ALu tablets, we used a two-tiered approach, where tier 1 was a semi-quantitative Global Pharma Health Fund-Minilab® method and tier 2 was high-performance liquid chromatography (HPLC) as described in The International Pharmacopoeia’s monograph for artemether-lumefantrine. Results and Discussion The physical examination of samples revealed no defects in the solid and oral liquid dosage forms, but unusual discoloration in an injectable solution, ergometrine maleate. For ALu, the results showed that of 38 samples, 31 (81.6%) passed tier 1 testing and 7 (18.4%) gave inconclusive drug content results. The inconclusive ALu samples were submitted for tier 2 testing and all met the quality standards. The pass rate using the HPTLC and TLC/HPLC assays was 93.8%; the failures were the ergometrine maleate samples purchased from both ADDOs and pharmacies. The disintegration testing of the solid dosage forms was conducted in accordance with US Pharmacopeia monographs. Only two samples of paracetamol, 1.2% of the solid dosage forms, failed to comply to standards. The study revealed a high overall rate of 92.6% of samples that met the quality standards. Although the overall failure rate was 7.4%, it is important to note that this was largely limited to one product and likely due to poor distribution and storage rather than poor manufacturing practices. Conclusions Over 90% of the medicines sold in ADDOs and pharmacies met quality standards. Policy makers need to reconsider ergometrine maleate’s place on the list of medicines that ADDOs are allowed to dispense, by either substituting a more temperature-stable therapeutically equivalent product or requiring those sites to have refrigerators, which is not a feasible option for rural Tanzania.

Objective To estimate the economic cost of substandard and falsified human medicines and cosmetics with banned ingredients in Tanzania from 2005 to 2015. Design A retrospective review of data. Setting Tanzania Food and Drugs Authority and premises dealing with importations and distributions of pharmaceuticals. Eligibility criteria Confiscation reports of substandard human medicines, falsified human medicines and cosmetics with banned ingredients. Primary and secondary outcome measures Quantities and costs of pharmaceutical products, costs of transportation, storage, court cases and disposal of products. Results The economic cost of substandard and falsified human medicines and cosmetics with banned ingredients was estimated at US$16.2 million, that is, value of substandard medicines US$13.7 million (84.4%), falsified medicines US$0.1 million (1%), cosmetics with banned ingredients US$1.3 million (8%) and other/operational costs US$1.1 million (6.6%). Some of the identified substandard and falsified human medicines include commonly used antibiotics such as phenoxymethylpenicillin, amoxicillin, cloxacillin and co-trimoxazole; antimalarials such quinine, sulfadoxine–pyrimethamine, sulfamethoxypyrazine–pyrimethamine and artemether–lumefantrine; antiretroviral drugs; antipyretics and vitamins among others. Conclusion The economic cost of substandard and falsified human medicines and cosmetics with banned ingredients represent a relatively large loss of scarce resources for a poor country like Tanzania. We believe that the observed increase in the quantities and the economic cost of these products over time could partly be due to the improvement in the regulatory capacity in terms of human resources, infrastructure and frequency of inspections.