Priority Setting in Selection and Distribution of new Antimalarials in Tanzania, Analysis and Evaluation against Accountability for Reasonableness

Tanzania like many other malaria endemic countries changed its National Malaria Treatment Policy in 2006 due to Sulphadoxine/Pyrimethamine (SP). Selection of Artemether-Lumefantrine (ALu) as the first line antimalarial drug and its selective distribution to public and Faith based health facilities were two priority-setting decisions underlying the policy change. However, today, there are people who are still using Sulphadoxine/Perimethamine because they have no access to Artemether-Lumefantrine. To analyze and evaluate whether the priority decisions for selection and distribution of subsidized Artemether-Lumefantrine satisfies the conditions of fair process as suggested in the ethical framework of accountability for reasonableness. A Qualitative study involving review of the guidelines and in depth interviews with key informants from the task force was conducted. The analysis followed an editing organizing style. The audio data was transcribed into text and loaded into QDA program whereby coding, connections and analysis was performed. The result are presented under the four thematic areas of the accountability for reasonableness (AfR) framework which are publicity, relevance, appeals &revision and enforcement conditions. Publicity: The decision and the rationales for selection of Artemether-Lumefantrine were made public, contrary to the selective distribution decision and its rationales. Public and the patients were indirectly but inadequately represented. There was no explicit mechanism to involve the stakeholders and as a result the task force lacked professional, institutional and countrywide representation. Relevance: Selection of Artemether-Lumefantrine was based on relevant evidence; however its selective distribution was partly based on donor requirement. Appeals & Revision: there was no well defined and reliable appeal mechanism, apart from the use of newspapers. Enforcement: There was any enforcement mechanism to ensure the other three conditions are fulfilled. The change of National Malaria Treatment Policy was necessary, however the priority decisions of selection and distribution of Artemether-Lumefantrine which underlined this change does not fully satisfy the four conditions of fair process prescribed in the the ethical framework of accountability for reasonableness. Decision making in priority is considered to be a technical area for experts and their views are assumed to represent those of other people in the society. This study suggests involvement by inputs obtained from large scale survey studies, four group discussions and by rapid appraisal method. Task forces or committees are formed to oversee priority setting decisions; however, the whole process is conducted in ad hoc and under limited freedom to discuss issues of significant implications. Reliable appeal and revision mechanisms need to be put in place to accommodate new findings, arguments and deliberations once priority decisions have been made. This will make the whole process of policy to be continuous rather than an event

Implementing standard antenatal care interventions: health system cost at primary health facilities in Tanzania

Background Since 2002, Tanzania has been implementing the focused Antenatal Care (ANC) model that recommended four antenatal care visits. In 2016, the World Health Organization (WHO) reintroduced the standard ANC model with more interventions including a minimum of eight contacts. However, cost-implications of these changes to the health system are unknown, particularly in countries like Tanzania, that failed to optimally implement the simpler focused ANC model. We compared the health system cost of providing ANC under the focused and the standard models at primary health facilities in Tanzania. Methods We used a micro-costing approach to identify and quantify resources used to implement the focused ANC model at six primary health facilities in Tanzania from July 2018 to June 2019. We also used the standard ANC implementation manual to identify and quantify additional resources required. We used basic salary and allowances to value personnel time while the Medical Store Department price catalogue and local market prices were used for other resources. Costs were collected in Tanzanian shillings and converted to 2018 US$. Results The health system cost of providing ANC services at six facilities (2 health centres and 4 dispensaries) was USD185,282 under the focused model. We estimated that the cost would increase by about 90% at health centres and 97% at dispensaries to USD358,290 by introducing the standard model. Personnel cost accounted for more than one third of the total cost, and more than two additional nurses are required per facility for the standard model. The costs per pregnancy increased from about USD33 to USD63 at health centres and from about USD37 to USD72 at dispensaries. Conclusion Introduction of a standard ANC model at primary health facilities in Tanzania may double resources requirement compared to current practice. Resources availability has been one of the challenges to effective implementation of the current focused ANC model. More research is required, to consider whether the additional costs are reasonable compared to the additional value for maternal and child health.publishedVersio

Patient and health system costs of managing pregnancy and birth-related complications in sub-Saharan Africa: a systematic review

Background Morbidity and mortality due to pregnancy and childbearing are high in developing countries. This study aims to estimate patient and health system costs of managing pregnancy and birth-related complications in sub-Saharan Africa. Methods A systematic review of the literature was conducted to identify costing studies published and unpublished, from January 2000 to May 2019. The search was done in Pubmed, EMBASE, Cinahl, and Web of Science databases and grey literature. The study was registered in PROSPERO with registration No. CRD42019119316. All costs were converted to 2018 US dollars using relevant Consumer Price Indices. Results Out of 1652 studies identified, 48 fulfilled the inclusion criteria. The included studies were of moderate to high quality. Spontaneous vaginal delivery cost patients and health systems between USD 6–52 and USD 8–73, but cesarean section costs between USD 56–377 and USD 80–562, respectively. Patient and health system costs of abortion range between USD 11–66 and USD 40–298, while post-abortion care costs between USD 21–158 and USD 46–151, respectively. The patient and health system costs for managing a case of eclampsia range between USD 52–231 and USD 123–186, while for maternal hemorrhage they range between USD 65–196 and USD 30–127, respectively. Patient cost for caring low-birth weight babies ranges between USD 38–489 while the health system cost was estimated to be USD 514. Conclusion This is the first systematic review to compile comprehensive up-to-date patient and health system costs of managing pregnancy and birth-related complications in sub-Saharan Africa. It indicates that these costs are relatively high in this region and that patient costs were largely catastrophic relative to a 10 % of average national per capita income.publishedVersio

The cost-effectiveness of incentive-based active case finding for tuberculosis (TB) control in the private sector Karachi, Pakistan

Background: In Asia, over 50% of patients with symptoms of tuberculosis (TB) access health care from private providers. These patients are usually not notified to the National TB Control Programs, which contributes to low notification rates in many countries. Methods: From January 1, 2011 to December 31, 2012, Karachi’s Indus Hospital - a private sector partner to the National TB Programme - engaged 80 private family clinics in its catchment area in active case finding using health worker incentives to increase notification of TB disease. The costs incurred were estimated from the perspective of patients, health facility and the program providing TB services. A Markov decision tree model was developed to calculate the cost-effectiveness of the active case finding as compared to case detection through the routine passive TB centers. Pakistan has a large private health sector, which can be mobilized for TB screening using an incentivized active case finding strategy. Currently, TB screening is largely performed in specialist public TB centers through passive case finding. Active and passive case finding strategies are assumed to operate independently from each other. Results: The incentive-based active case finding program costed USD 223 per patient treated. In contrast, the center based non-incentive arm was 23.4% cheaper, costing USD 171 per patient treated. Cost-effectiveness analysis showed that the incentive-based active case finding program was more effective and less expensive per DALY averted when compared to the baseline passive case finding as it averts an additional 0.01966 DALYs and saved 15.74 US$ per patient treated. Conclusion: Both screening strategies appear to be cost-effective in an urban Pakistan context. Incentive driven active case findings of TB in the private sector costs less and averts more DALYs per health seeker than passive case finding, when both alternatives are compared to a common baseline situation of no screening.publishedVersio

Reforms: A Quest for Efficiency or an Opportunity for Vested Interests'? A Case Study of Pharmaceutical Policy Reforms in Tanzania.

Regulation of the pharmaceutical sector is a challenging task for most governments in the developing countries. In Tanzania, this task falls under the Food and Drugs Authority and the Pharmacy Council. In 2010, the Pharmacy Council spearheaded policy reforms in the pharmaceutical sector aimed at taking over the control of the regulation of the business of pharmacy from the Tanzania Food and Drugs Authority. This study provides a critical analysis of these reforms. The study employed a qualitative case-study design. Data was collected through in-depth interviews, focus group discussions and document reviews. Data was analyzed thematically using a policy triangle framework. The analysis was done manually. The reforms adopted an incremental model of public policy-making and the process was characterized by lobbying for political support, negotiations and bargaining between the interest groups. These negotiations were largely centred on vested interests and not on the impact of the reforms on the efficiency of pharmaceutical regulations in the country. Stakeholders from the micro and meso levels were minimally involved in the policy reforms. Recent pharmaceutical regulation reforms in Tanzania were overshadowed by vested interests, displacing a critical analysis of optimal policy options that have the potential to increase efficiency in the regulation of the business of pharmacy. Politics influenced decision-making at different levels of the reform process

Priority setting for the implementation of artemisinin-based combination therapy policy in Tanzania: evaluation against the accountability for reasonableness framework

\ud Priority setting for artemisinin-based antimalarial drugs has become an integral part of malaria treatment policy change in malaria-endemic countries. Although these drugs are more efficacious, they are also more costly than the failing drugs. When Tanzania changed its National Malaria Treatment Policy in 2006, priority setting was an inevitable challenge. Artemether-lumefantrine was prioritised as the first-line drug for the management of uncomplicated malaria to be available at a subsidized price at public and faith-based healthcare facilities. This paper describes the priority-setting process, which involved the selection of a new first-line antimalarial drug in the implementation of artemisinin-based combination therapy policy. These descriptions were further evaluated against the four conditions of the accountability for easonableness framework. According to this framework, fair decisions must satisfy a set of publicity, relevance, appeals, and revision and enforcement conditions.In-depth interviews were held with key informants using pretested interview guides, supplemented with a review of the treatment guideline. Purposeful sampling was used in order to explore the perceptions of people with different backgrounds and perspectives. The analysis followed an editing organising style. Publicity: The selection decision of artemether-lumefantrine but not the rationale behind it was publicised through radio, television, and newspaper channels in the national language, Swahili. Relevance: The decision was grounded on evidences of clinical efficacy, safety, affordability, and formulation profile. Stakeholders were not adequately involved. There was neither an appeals mechanism to challenge the decision nor enforcement mechanisms to guarantee fairness of the decision outcomes. The priority-setting decision to use artemether-lumefantrine as the first-line antimalarial drug failed to satisfy the four conditions of the accountability for reasonableness framework. In our understanding, this is the first study to evaluate priority-setting decisions for new drugs in Tanzania against the accountability for reasonableness framework. In addition to the demand for enhanced stakeholder involvement, publicity, and transparency, the study also calls for the institution of formal appeals, revision, and regulatory mechanisms in the future change of malaria treatment policies.\u

Projected health impact of post-discharge malaria chemoprevention among children with severe malarial anaemia in Africa.

Children recovering from severe malarial anaemia (SMA) remain at high risk of readmission and death after discharge from hospital. However, a recent trial found that post-discharge malaria chemoprevention (PDMC) with dihydroartemisinin-piperaquine reduces this risk. We developed a mathematical model describing the daily incidence of uncomplicated and severe malaria requiring readmission among 0-5-year old children after hospitalised SMA. We fitted the model to a multicentre clinical PDMC trial using Bayesian methods and modelled the potential impact of PDMC across malaria-endemic African countries. In the 20 highest-burden countries, we estimate that only 2-5 children need to be given PDMC to prevent one hospitalised malaria episode, and less than 100 to prevent one death. If all hospitalised SMA cases access PDMC in moderate-to-high transmission areas, 38,600 (range 16,900-88,400) malaria-associated readmissions could be prevented annually, depending on access to hospital care. We estimate that recurrent SMA post-discharge constitutes 19% of all SMA episodes in moderate-to-high transmission settings

Global, regional, and national under-5 mortality, adult mortality, age-specific mortality, and life expectancy, 1970–2016: a systematic analysis for the Global Burden of Disease Study 2016

BACKGROUND: Detailed assessments of mortality patterns, particularly age-specific mortality, represent a crucial input that enables health systems to target interventions to specific populations. Understanding how all-cause mortality has changed with respect to development status can identify exemplars for best practice. To accomplish this, the Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016) estimated age-specific and sex-specific all-cause mortality between 1970 and 2016 for 195 countries and territories and at the subnational level for the five countries with a population greater than 200 million in 2016. METHODS: We have evaluated how well civil registration systems captured deaths using a set of demographic methods called death distribution methods for adults and from consideration of survey and census data for children younger than 5 years. We generated an overall assessment of completeness of registration of deaths by dividing registered deaths in each location-year by our estimate of all-age deaths generated from our overall estimation process. For 163 locations, including subnational units in countries with a population greater than 200 million with complete vital registration (VR) systems, our estimates were largely driven by the observed data, with corrections for small fluctuations in numbers and estimation for recent years where there were lags in data reporting (lags were variable by location, generally between 1 year and 6 years). For other locations, we took advantage of different data sources available to measure under-5 mortality rates (U5MR) using complete birth histories, summary birth histories, and incomplete VR with adjustments; we measured adult mortality rate (the probability of death in individuals aged 15-60 years) using adjusted incomplete VR, sibling histories, and household death recall. We used the U5MR and adult mortality rate, together with crude death rate due to HIV in the GBD model life table system, to estimate age-specific and sex-specific death rates for each location-year. Using various international databases, we identified fatal discontinuities, which we defined as increases in the death rate of more than one death per million, resulting from conflict and terrorism, natural disasters, major transport or technological accidents, and a subset of epidemic infectious diseases; these were added to estimates in the relevant years. In 47 countries with an identified peak adult prevalence for HIV/AIDS of more than 0·5% and where VR systems were less than 65% complete, we informed our estimates of age-sex-specific mortality using the Estimation and Projection Package (EPP)-Spectrum model fitted to national HIV/AIDS prevalence surveys and antenatal clinic serosurveillance systems. We estimated stillbirths, early neonatal, late neonatal, and childhood mortality using both survey and VR data in spatiotemporal Gaussian process regression models. We estimated abridged life tables for all location-years using age-specific death rates. We grouped locations into development quintiles based on the Socio-demographic Index (SDI) and analysed mortality trends by quintile. Using spline regression, we estimated the expected mortality rate for each age-sex group as a function of SDI. We identified countries with higher life expectancy than expected by comparing observed life expectancy to anticipated life expectancy on the basis of development status alone. FINDINGS: Completeness in the registration of deaths increased from 28% in 1970 to a peak of 45% in 2013; completeness was lower after 2013 because of lags in reporting. Total deaths in children younger than 5 years decreased from 1970 to 2016, and slower decreases occurred at ages 5-24 years. By contrast, numbers of adult deaths increased in each 5-year age bracket above the age of 25 years. The distribution of annualised rates of change in age-specific mortality rate differed over the period 2000 to 2016 compared with earlier decades: increasing annualised rates of change were less frequent, although rising annualised rates of change still occurred in some locations, particularly for adolescent and younger adult age groups. Rates of stillbirths and under-5 mortality both decreased globally from 1970. Evidence for global convergence of death rates was mixed; although the absolute difference between age-standardised death rates narrowed between countries at the lowest and highest levels of SDI, the ratio of these death rates-a measure of relative inequality-increased slightly. There was a strong shift between 1970 and 2016 toward higher life expectancy, most noticeably at higher levels of SDI. Among countries with populations greater than 1 million in 2016, life expectancy at birth was highest for women in Japan, at 86·9 years (95% UI 86·7-87·2), and for men in Singapore, at 81·3 years (78·8-83·7) in 2016. Male life expectancy was generally lower than female life expectancy between 1970 and 2016, an

Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016

As mortality rates decline, life expectancy increases, and populations age, non-fatal outcomes of diseases and injuries are becoming a larger component of the global burden of disease. The Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016) provides a comprehensive assessment of prevalence, incidence, and years lived with disability (YLDs) for 328 causes in 195 countries and territories from 1990 to 2016