Availability and stock-outs of paediatric antiretroviral treatment formulations at health facilities in Kenya and Uganda.

INTRODUCTION: The large number of deaths among children with HIV is driven by poor antiretroviral treatment (ART) coverage among this cohort. The aim of the study was to assess the availability and stock-outs of paediatric and adult ART formulations in Kenya and Uganda across various regions and types of health facilities. METHODS: A survey on availability and stock-outs of paediatric ART at health facilities was adapted from the standardized Health Action International-WHO Medicine Availability Monitoring Tool. All preferred and limited-use formulations, and three phased-out formulations according to the 2021 WHO optimal formulary list were included in the survey, as well as a selection of adult ART formulations suitable for older children, adolescents, and adults. Availability data were collected in June-July 2022 and stock-out data were obtained over the previous year from randomly selected public and private-not-for-profit (PNFP) facilities registered to dispense paediatric ART across six districts per country. All data were analysed descriptively. RESULTS: In total, 144 health facilities were included (72 per country); 110 were public and 34 PNFP facilities. Overall availabilities of preferred paediatric ART formulations were 52.2% and 63.5% in Kenya and Uganda, respectively, with dolutegravir (DTG) 10 mg dispersible tablets being available in 70.2% and 77.4% of facilities, respectively, and abacavir/lamivudine dispersible tablets in 89.8% and 98.2% of facilities. Of note, availability of both formulations was low (37.5% and 62.5%, respectively) in Kenyan PNFP facilities. Overall availabilities of paediatric limited-use products were 1.1% in Kenya and 1.9% in Uganda. At least one stock-out of a preferred paediatric ART formulation was reported in 40.0% of Kenyan and 74.7% of Ugandan facilities. Nevirapine solution stock-outs were reported in 43.1% of Ugandan facilities, while alternative formulations for postnatal HIV prophylaxis were not available. CONCLUSIONS: Recommended DTG-based first-line ART for children across all ages was reasonably available at health facilities in Kenya and Uganda, with the exception of Kenyan PNFP facilities. Availability of paediatric ART formulations on the limited-use list was extremely low across both countries. Stock-outs were reported regularly, with the high number of reported stock-outs of neonatal ART formulations in Uganda being most concerning.

A scoping review of continuing education models and statutory requirements for pharmacists globally.

BACKGROUND: In the dynamic field of pharmacy amongst a diverse array of countries with disparate income levels, pharmacists play a pivotal role in integrating emerging scientific knowledge into their practice while adapting to evolving therapeutic interventions and expanding service delivery responsibilities. Lifelong Learning (LLL) is cultivated through continuing professional education (CPE) and continuing professional development (CPD), indispensable components ensuring sustained professional competence and heightened patient care quality. The global landscape witnesses diverse LLL activities tailored to pharmacists' learning needs and preferences. This scoping review maps and synthesises a comprehensive global perspective on the existing knowledge regarding CPE/CPD models, statutory requirements, and pharmacists' preferences for LLL activities. OBJECTIVE: To comprehensively investigate global models of CPE/CPD for pharmacists' and examine the statutory requirements governing pharmacists' registration and licensure. METHOD: A literature search of PubMed, Google Scholar, Web of Science, and the University of KwaZulu-Natal library search engine was undertaken for studies between January 2012 and February 2023. The article selection and reporting followed the recommendations made by PRISMA (Preferred Reporting Items of Systematic Reviews and Meta-Analyses) guidelines. The articles were tabulated based on their respective country's income level, continuing education models employed, country-specific statutory requirements, and pharmacists' preferences for LLL activities. RESULTS: Of the initial 3974 publications identified through the database search, 24 studies met the review criteria. The majority of the articles originated from high-income countries (HICs) (14/24, 58.3%), and most employed the mandatory CPD points system (21/24, 87.5%). However, in some HICs and upper-middle income countries (UMICs), the CPE/CPD is non-mandatory. While most countries (19/24, 79.2%) offer various LLL formats, the preference of pharmacists remains primarily face-to-face learning (13/24, 54.2%). However, workplace learning (3/24, 12.5%) and blended learning (7/24, 29.1%) are mentioned in some studies. CONCLUSION: Diverse models of CPE/CPD alongside statutory requirements persist globally and evolve, shaped by varied implementation experiences. HICs lead in CPD models, while the implementation in low- and middle-income countries (LMICs) and low-income countries (LICs) requires further exploration for inclusivity and effectiveness. A few UMICs are either initiating or in early stages of implementing the CPD models. Structured planning for LLL activities is increasingly a global requirement for pharmacists' licensure. The essential progression of pharmacy practice in developing healthcare systems necessitates a mandatory CPD model. Ongoing research is crucial to fortify the implementation, align and unify the CPD model with evolving pharmacy profession needs.

Young graduates and economic recession: Lessons from the pandemic to prevent the (re)incidence of mental health symptoms.

Economic conditions affect the youth labour market and can leave deep scars. This exploratory study examines the emotional responses and mental health symptoms of young graduates during their transition into the labour market in the pandemic context. It draws on 42 news articles with statements from 86 graduates from a set of European and non-European countries. The graduates had jobs or internships cancelled, numerous applications unanswered or were dismissed from jobs they had recently started. Young people adopt a variety of coping strategies, which are often invisible and cause deep suffering due to anxiety, disappointment, fear, and depression. Their apprehension and uncertainty leave them in a state of limbo. The specific impacts of the pandemic on young people's lives serve as a warning of the need to protect future generations of graduates. More support is required worldwide to manage the mental health issues that affect young graduates, especially during economic recessions.

Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Pregnancy in Sub-Saharan Africa: A 6-Country Retrospective Cohort Analysis.

BACKGROUND: Few data are available on COVID-19 outcomes among pregnant women in sub-Saharan Africa (SSA), where high-risk comorbidities are prevalent. We investigated the impact of pregnancy on SARS-CoV-2 infection and of SARS-CoV-2 infection on pregnancy to generate evidence for health policy and clinical practice. METHODS: We conducted a 6-country retrospective cohort study among hospitalized women of childbearing age between 1 March 2020 and 31 March 2021. Exposures were (1) pregnancy and (2) a positive SARS-CoV-2 RT-PCR test. The primary outcome for both analyses was intensive care unit (ICU) admission. Secondary outcomes included supplemental oxygen requirement, mechanical ventilation, adverse birth outcomes, and in-hospital mortality. We used log-binomial regression to estimate the effect between pregnancy and SARS-CoV-2 infection. Factors associated with mortality were evaluated using competing-risk proportional subdistribution hazards models. RESULTS: Our analyses included 1315 hospitalized women: 510 pregnant women with SARS-CoV-2, 403 nonpregnant women with SARS-CoV-2, and 402 pregnant women without SARS-CoV-2 infection. Among women with SARS-CoV-2 infection, pregnancy was associated with increased risk for ICU admission (adjusted risk ratio [aRR]: 2.38; 95% CI: 1.42-4.01), oxygen supplementation (aRR: 1.86; 95% CI: 1.44-2.42), and hazard of in-hospital death (adjusted sub-hazard ratio [aSHR]: 2.00; 95% CI: 1.08-3.70). Among pregnant women, SARS-CoV-2 infection increased the risk of ICU admission (aRR: 2.0; 95% CI: 1.20-3.35), oxygen supplementation (aRR: 1.57; 95% CI: 1.17-2.11), and hazard of in-hospital death (aSHR: 5.03; 95% CI: 1.79-14.13). CONCLUSIONS: Among hospitalized women in SSA, both SARS-CoV-2 infection and pregnancy independently increased risks of ICU admission, oxygen supplementation, and death. These data support international recommendations to prioritize COVID-19 vaccination among pregnant women.

Missing data on accessibility of children's medicines.

Child-appropriate medicines are essential for the safe and effective treatment of children, yet we have observed a large gap in the data required to adequately monitor access to these medicines. We have examined data on the availability and pricing of child-appropriate medicines across 50 surveys. Child-appropriate medicines for nine out of 12 priority diseases in children were infrequently surveyed or not at all. A similar data deficit on age-appropriate medicines is detectable in the broader scientific literature. We also note that existing instruments for collecting data on the availability or prices of medicines are limited in their ability to generate the required data for children. We have identified four priorities as key for improved monitoring of access to medicines for children: (i) dedicated child medicine surveys are needed on availability and prices of child-appropriate medicines; (ii) standardized survey instruments should include age-appropriate medicines and dosages; (iii) health facility service readiness survey tools should include the collection of data on the price of child-appropriate medicines in addition to the availability of medicines; and (iv) sustainable development goal indicator 3.b.3 should be modified to enable the monitoring of access to medicines for children. These deficiencies need to be addressed to ensure the monitoring of access to child medicines as part of the sustainable development goal agenda for 2030 and to implement appropriate interventions for improving access for this vulnerable population.

Disposer de médicaments adaptés aux enfants est essentiel à l'administration d'un traitement sûr et efficace. Pourtant, nous avons observé de vastes lacunes dans les données requises pour évaluer l'accès à ces médicaments. Nous avons passé 50 enquêtes au crible, à la recherche d'informations sur la disponibilité et le prix des médicaments pédiatriques. Dans le cas de neuf maladies infantiles prioritaires sur douze, les médicaments adaptés aux enfants n'étaient pas ou peu étudiés. Même constat dans le contexte plus large de la littérature scientifique. Nous avons également remarqué que les instruments servant à récolter des données sur la disponibilité ou le prix des médicaments avaient leurs limites et ne permettaient pas d'obtenir les informations requises concernant les enfants. Nous avons identifié quatre priorités majeures en vue d'améliorer la surveillance de l'accès aux médicaments pédiatriques: (i) la réalisation d'enquêtes sur les médicaments pédiatriques afin d'en connaître la disponibilité et le prix; (ii) l'intégration des médicaments et dosages adéquats dans les instruments d'enquête standard; (iii) outre la disponibilité, la prise en compte du prix des médicaments à usage pédiatrique dans les outils d'évaluation de l'état de préparation des services au sein des établissements de santé; et enfin, (iv) la modification de l'indicateur 3.b.3 des objectifs de développement durable, qui prévoirait dès lors un contrôle de l'accès aux médicaments adaptés aux enfants. Ces lacunes doivent être comblées pour assurer un suivi en matière d'accès aux médicaments pédiatriques dans le cadre du Programme de développement durable à l'horizon 2030, mais aussi pour adopter les mesures correspondantes afin d'améliorer la prise en charge de cette population vulnérable.

Los medicamentos indicados para los niños son esenciales para su tratamiento seguro y eficaz, pero se ha observado un gran vacío en los datos necesarios para supervisar de manera adecuada el acceso a estos medicamentos. Se han analizado los datos sobre la disponibilidad y el precio de los medicamentos indicados para los niños en 50 encuestas. Estos medicamentos para nueve de las 12 enfermedades prioritarias infantiles se encuestaron con poca frecuencia o no se encuestaron en absoluto. En la literatura científica más general, se detecta un déficit de datos similar sobre los medicamentos adecuados para la edad. También se observa que los instrumentos existentes para recopilar los datos sobre la disponibilidad o los precios de los medicamentos son limitados en su capacidad para generar los datos necesarios en el caso de los niños. Se han identificado cuatro prioridades para mejorar el seguimiento del acceso a los medicamentos pediátricos: (i) se necesitan encuestas específicas sobre la disponibilidad y los precios de los medicamentos indicados para los niños; (ii) los instrumentos de encuesta estandarizados deben incluir medicamentos y dosis adecuados para la edad; (iii) las herramientas de encuesta sobre la disponibilidad de los servicios sanitarios deben incluir la recopilación de los datos sobre el precio de los medicamentos indicados para los niños, además de la disponibilidad de los medicamentos; y (iv) el indicador 3.b.3 del Objetivo de Desarrollo Sostenible se debe modificar para permitir el seguimiento del acceso a los medicamentos pediátricos. Es preciso solucionar estas deficiencias para garantizar el seguimiento del acceso a los medicamentos pediátricos como parte de la agenda de los objetivos de desarrollo sostenible para 2030 y aplicar las intervenciones adecuadas para mejorar el acceso de esta población vulnerable.

Health Technology Assessment in Support of National Health Insurance in South Africa.

South Africa has embarked on major health policy reform to deliver universal health coverage through the establishment of National Health Insurance (NHI). The aim is to improve access, remove financial barriers to care, and enhance care quality. Health technology assessment (HTA) is explicitly identified in the proposed NHI legislation and will have a prominent role in informing decisions about adoption and access to health interventions and technologies. The specific arrangements and approach to HTA in support of this legislation are yet to be determined. Although there is currently no formal national HTA institution in South Africa, there are several processes in both the public and private healthcare sectors that use elements of HTA to varying extents to inform access and resource allocation decisions. Institutions performing HTAs or related activities in South Africa include the National and Provincial Departments of Health, National Treasury, National Health Laboratory Service, Council for Medical Schemes, medical scheme administrators, managed care organizations, academic or research institutions, clinical societies and associations, pharmaceutical and devices companies, private consultancies, and private sector hospital groups. Existing fragmented HTA processes should coordinate and conform to a standardized, fit-for-purpose process and structure that can usefully inform priority setting under NHI and for other decision makers. This transformation will require comprehensive and inclusive planning with dedicated funding and regulation, and provision of strong oversight mechanisms and leadership.

From Easing Lockdowns to Scaling Up Community-based Coronavirus Disease 2019 Screening, Testing, and Contact Tracing in Africa-Shared Approaches, Innovations, and Challenges to Minimize Morbidity and Mortality.

The arrival of coronavirus disease 2019 (COVID-19) on the African continent resulted in a range of lockdown measures that curtailed the spread of the infection but caused economic hardship. African countries now face difficult choices regarding easing of lockdowns and sustaining effective public health control measures and surveillance. Pandemic control will require efficient community screening, testing, and contact tracing; behavioral change interventions; adequate resources; and well-supported, community-based teams of trained, protected personnel. We discuss COVID-19 control approaches in selected African countries and the need for shared, affordable, innovative methods to overcome challenges and minimize mortality. This crisis presents a unique opportunity to align COVID-19 services with those already in place for human immunodeficiency virus, tuberculosis, malaria, and non communicable diseases through mobilization of Africa's interprofessional healthcare workforce. By addressing the challenges, the detrimental effect of the COVID-19 pandemic on African citizens can be minimized.

The Critical Need for Pooled Data on Coronavirus Disease 2019 in African Children: An AFREhealth Call for Action Through Multicountry Research Collaboration.

Globally, there are prevailing knowledge gaps in the epidemiology, clinical manifestations, and outcomes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among children and adolescents; and these gaps are especially wide in African countries. The availability of robust age-disaggregated data is a critical first step in improving knowledge on disease burden and manifestations of coronavirus disease 2019 (COVID-19) among children. Furthermore, it is essential to improve understanding of SARS-CoV-2 interactions with comorbidities and coinfections such as human immunodeficiency virus (HIV), tuberculosis, malaria, sickle cell disease, and malnutrition, which are highly prevalent among children in sub-Saharan Africa. The African Forum for Research and Education in Health (AFREhealth) COVID-19 Research Collaboration on Children and Adolescents is conducting studies across Western, Central, Eastern, and Southern Africa to address existing knowledge gaps. This consortium is expected to generate key evidence to inform clinical practice and public health policy-making for COVID-19 while concurrently addressing other major diseases affecting children in African countries.

European collaborations on medicine and vaccine procurement.

To ensure equitable access to medicines and vaccines, organizational efforts and purchase volumes have been pooled in joint procurements and negotiations for decades in some regions of the world, as well as globally through supranational procurement mechanisms. In Europe, countries started to collaborate on procurement and negotiations recently when it became increasingly difficult to ensure access to high-priced medicines, even in high-income countries. Two European country collaborations (the Nordic Pharmaceutical Forum and the Baltic Procurement Initiative) have successfully concluded at least one joint tender process for medicines and vaccines and the Beneluxa Initiative has concluded its first successful joint price negotiation. This article describes the experiences of these country collaborations. Challenges observed included: legal barriers; institutional and organizational differences between health-care systems in member countries; and the risk that suppliers will be reluctant to cooperate with country collaborations. Although these collaborations helped improve access to medicines and vaccines for the countries involved, in situations such as a global health crisis, larger-scale, more-inclusive initiatives are needed. In the current coronavirus disease 2019 (COVID-19) pandemic, COVID-19 Vaccines Global Access (COVAX) initiative established a global procurement mechanism to ensure the equitable distribution of COVID-19 vaccines globally. Despite differences in organization and scale, the European country collaborations and COVAX have some similarities: (i) their success depends on the increased purchasing power associated with pooled order volumes; (ii) expert knowledge and previous procurement experience is pooled; (iii) they perform other collaborative activities that go beyond procurement alone; and (iv) they actively involve external partners and stakeholders.

Depuis des décennies, certaines régions du monde ont uni leurs efforts pour s'organiser, négocier et effectuer des achats groupés de grandes quantités afin d'assurer un accès équitable aux médicaments et vaccins. Des mécanismes d'acquisition supranationaux ont fait de même à l'échelle planétaire. En Europe, des États ont récemment commencé à collaborer en matière d'achat et de négociation lorsqu'il est devenu de plus en plus difficile de garantir l'accès à des médicaments coûteux, y compris dans les pays à haut revenu. Deux collaborations entre pays européens (le Forum pharmaceutique nordique et l'Initiative d'acquisition de la Baltique) ont mené à bien au moins un processus d'offre conjoint pour des médicaments et vaccins, tandis que l'Initiative Beneluxa a conclu sa première négociation tarifaire conjointe. Cet article décrit les expériences liées à ces collaborations entre nations. Plusieurs défis se sont posés, notamment des obstacles juridiques; des différences institutionnelles et organisationnelles entre les systèmes de santé des États membres; et enfin, le risque que les fournisseurs soient peu enclins à accepter ces collaborations entre pays. Bien que ces collaborations aient amélioré l'accès aux médicaments et vaccins pour les pays impliqués, des initiatives plus globales et à plus grande échelle sont nécessaires dans des situations telles qu'une crise sanitaire mondiale. Durant l'actuelle pandémie de maladie à coronavirus 2019 (COVID-19), l'initiative COVAX (COVID-19 Vaccines Global Access) a abouti à un dispositif d'approvisionnement mondial pour veiller à distribuer équitablement des vaccins contre la COVID-19 dans le monde. Malgré des variations d'organisation et d'échelle, les collaborations entre États européens partagent des similitudes avec le COVAX: (i) le succès de ces deux démarches dépend d'un accroissement du pouvoir d'achat combiné à des volumes de commande groupés; (ii) elles mettent en commun les connaissances approfondies et expériences passées; (iii) elles mènent d'autres activités collectives qui dépassent le simple cadre de l'acquisition; et enfin, (iv) elles impliquent activement une série d'intervenants et de partenaires externes.

Para garantizar un acceso equitativo a los medicamentos y las vacunas, los esfuerzos organizativos y los volúmenes de compra se han unido en adquisiciones y negociaciones conjuntas durante décadas en algunas regiones del mundo, así como a nivel mundial a través de mecanismos de adquisición supranacionales. En Europa, los países empezaron a colaborar en las adquisiciones y negociaciones recientemente, cuando se hizo cada vez más difícil garantizar el acceso a los medicamentos con precios altos, incluso en los países de renta alta. Dos colaboraciones de países europeos (el Foro Farmacéutico Nórdico y la Iniciativa de Adquisición del Báltico) han concluido con éxito al menos un proceso de licitación conjunta de medicamentos y vacunas, y la Iniciativa Beneluxa ha concluido con éxito su primera negociación conjunta de precios. Este artículo describe las experiencias de estas colaboraciones entre países. Entre los retos observados se encuentran: las barreras legales, las diferencias institucionales y organizativas entre los sistemas sanitarios de los países miembros y el riesgo de que los proveedores se muestren reacios a cooperar con las colaboraciones entre países. Aunque estas colaboraciones ayudaron a mejorar el acceso a los medicamentos y las vacunas para los países implicados, en situaciones como una crisis sanitaria mundial, se necesitan iniciativas a mayor escala y más inclusivas. En la actual pandemia de la enfermedad por coronavirus (COVID-19), la iniciativa Acceso global a las vacunas de la COVID-19 (COVAX, por sus siglas en inglés) estableció un mecanismo de adquisición mundial para garantizar la distribución equitativa de las vacunas contra la COVID-19 en todo el mundo. A pesar de las diferencias de organización y escala, las colaboraciones de los países europeos y COVAX tienen algunas similitudes: i) su éxito depende del mayor poder adquisitivo asociado a los volúmenes de pedidos mancomunados; ii) se ponen en común los conocimientos de los expertos y la experiencia previa en materia de adquisiciones; iii) realizan otras actividades de colaboración que van más allá de la mera adquisición; e iv) implican activamente a socios y partes interesadas externas.

Assessing the prices and affordability of oncology medicines for three common cancers within the private sector of South Africa.

BACKGROUND: Prices of cancer medicines are a major contributor to the cost of treatment for cancer patients and the comparison of these cost needs to be assessed. OBJECTIVES: To assess the prices of cancer medicines for the three most common cancers ((breast, prostate and colorectal) in the private healthcare sector of South Africa. METHODS: The methodology was adapted from the World Health Organization (WHO)/ Health Action International (HAI) methodology for measuring medicine prices. The Single Exit Price (SEP) variations between product types of the same medicine between the highest- and lowest-priced product and between Originator Brand (OB) and its Lowest Priced Generic (LPG) of the same medicine brand was compared, as of March 2020. The affordability of those medicines for cancer usage based on treatment affordability in relation to the daily wage of the unskilled Lowest-Paid Government Worker (LPGW) was also determined. Also, a comparison of the proportion of the population below the poverty line (PL) before (Ipre) and after (Ipost) procurement of the cancer medicines was determined. RESULTS: SEP Price differences ranged from 25.46 to 97.33% between highest- and lowest-priced products and a price variation of 72.09% more for the OB than the LPG medicine, except for one LPG that was more expensive than the OB. Affordability calculations showed that All OB treatments for all three cancers (breast, prostate and colorectal), except for paclitaxel 300 mg (0.2 days wage) and Fluorouracil (Fluroblastin) 500 mg (0.3 days wage) costs respectively were more than 1 day's wage, with patients diagnosed with colorectal cancer needing 32.5 days wages in order to afford a standard course of treatment for a month. CONCLUSION: There was a considerable variation in the price of different brands of cancer medicines available in the South African private sector.

Quality of care in public sector family planning services in KwaZulu-Natal, South Africa: a qualitative evaluation from community and health care provider perspectives.

BACKGROUND: Quality of care is a multidimensional concept that forms an integral part of the uptake and use of modern contraceptive methods. Satisfaction with services is a significant factor in the continued use of services. While much is known about quality of care in the general public health care service, little is known about family planning specific quality of care in South Africa. This paper aims to fill the gap in the research by using the Bruce-Jain family planning quality of care framework. METHODS: This formative qualitative study was conducted in South Africa, Zambia, and Kenya to explore the uptake of family planning and contraception. The results presented in this paper are from the South African data. Fourteen focus group discussions, twelve with community members and two with health care providers, were conducted along with eight in-depth interviews with key informants. Thematic content analysis using the Bruce-Jain Quality of Care framework was conducted to analyse this data using NVIVO 10. RESULTS: Family planning quality of care was defined by participants as the quality of contraceptive methods, attitudes of health care providers, and outcomes of contraceptive use. The data showed that women have limited autonomy in their choice to either use contraception or the method that they might prefer. Important elements that relate to quality of care were identified and described by participants and grouped according to the structural or process components of the framework. Structure-related sub-themes identified included the lack of technically trained providers; integration of services that contributed to long waiting times and mixing of a variety of clients; and poor infrastructure. Sub-themes raised under the process category included poor interpersonal relations; lack of counselling/information exchange, fear; and time constraints. Neither providers nor users discussed follow up mechanisms which is a key aspect to ensure continuity of contraceptive use. CONCLUSION: Using a qualitative methodology and applying the Bruce-Jain Quality of Care framework provided key insights into perceptions and challenges about family planning quality of care. Identifying which components are specific to family planning is important for improving contraceptive outcomes. In particular, autonomy in user choice of contraceptive method, integration of services, and the acceptability of overall family planning care was raised as areas of concern.

Introducing health technology assessment in Tanzania.

OBJECTIVES: Health technology assessment (HTA) is a cost-effective resource allocation tool in healthcare decision-making processes; however, its use is limited in low-income settings where countries fall short on both absorptive and technical capacity. This paper describes the journey of the introduction of HTA into decision-making processes through a case study revising the National Essential Medicines List (NEMLIT) in Tanzania. It draws lessons on establishing and strengthening transparent priority-setting processes, particularly in sub-Saharan Africa. METHODS: The concept of HTA was introduced in Tanzania through revision of the NEMLIT by identifying a process for using HTA criteria and evidence-informed decision making. Training was given on using economic evidence for decision making, which was then put into practice for medicine selection for the NEMLIT. During the revision process, capacity-building workshops were held with reinforcing messages on HTA. RESULTS: Between the period 2014 and 2018, HTA was introduced in Tanzania with a formal HTA committee being established and inaugurated followed by the successful completion and adoption of HTA into the NEMLIT revision process by the end of 2017. Consequently, the country is in the process of institutionalizing HTA for decision making and priority setting. CONCLUSION: While the introduction of HTA process is country-specific, key lessons emerge that can provide an example to stakeholders in other low- and middle-income countries (LMICs) wishing to introduce priority-setting processes into health decision making.

Pharmaceutical policies: effects of educational or regulatory policies targeting prescribers.

BACKGROUND: Pharmaceuticals make an important contribution to people's health. Medicines, however, are frequently not used appropriately. Improving the use of medicines can improve health outcomes and save resources. On the other hand, regulatory and educational policies may have unintended effects on health and costs. OBJECTIVES: To assess the effects of pharmaceutical educational and regulatory policies targeting prescribers on medicine use, healthcare utilisation, health outcomes and costs (expenditures). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two trial registries in March 2018 and several other databases between 2014 and 2018. We reviewed the reference lists of included studies and other relevant reviews, contacted authors of relevant reviews and studies to identify additional studies, and did a citation search for all included studies using ISI Web of Science (searched 05 January 2016). SELECTION CRITERIA: Randomised trials, non-randomised trials, interrupted time series studies, repeated measures studies and controlled before‒after studies of policies regulating who can prescribe medicines and other policies targeted at prescribers. We included in this category monitoring and enforcement of restrictions, generic prescribing, programmes to implement treatment guidelines, system-wide policies regarding monitoring medicine safety, and legislated or mandatory continuing education or quality improvement specifically targeted at prescribing. We defined 'policies' in this review as laws, rules, financial and administrative orders made by governments, non-governmental organisations or private insurers. We excluded interventions applied at the level of a single facility. For us to include a study, it had to include an objective measure of at least one of the following outcomes: medicine use, healthcare utilization, health outcomes, or costs. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed abstracts and reference lists of relevant reports, assessed full-text studies for inclusion, extracted data, and assessed risk of bias and certainty of the evidence (GRADE). For all the steps in the above process we resolved disagreements by discussion. MAIN RESULTS: We identified two studies that met our selection criteria: a controlled interrupted time series study evaluating a regulatory policy involving the monitoring of prescribing of benzodiazepines; and a controlled before‒after study of an educational policing involving mailed educational materials on prescribing for physicians and Health Maintenance Organization (HMO) members as well as an intervention to regulate drug reimbursement. We are uncertain about the effects on medicine use of a regulatory policy involving the monitoring of prescribing with triplicate prescriptions, compared with no regulatory intervention (very low certainty evidence). We are also uncertain about the effects on medicine use, assessed through doctors' prescribing, and costs of an educational policy involving mailed educational materials on prescribing for physicians and HMO members, compared to no educational intervention or an intervention to regulate drug reimbursement (very low certainty evidence). Neither of the included studies measured healthcare utilization, health outcomes, or additional costs, if any, to patients. AUTHORS' CONCLUSIONS: We are uncertain of the effects of educational or regulatory policies targeting prescribers due to very limited evidence of very low certainty. The impacts of these policies therefore need to be evaluated rigorously using appropriate study designs. Evaluations are needed across a range of settings, including low- and middle-income countries, and across different types of prescribers and medicines.

Male partner influence on family planning and contraceptive use: perspectives from community members and healthcare providers in KwaZulu-Natal, South Africa.

BACKGROUND: South Africa faces numerous reproductive challenges that include high rates of unplanned and adolescent pregnancies. The uptake and utilization of family planning services and modern contraception methods depend on numerous factors. The male partner plays a key role in reproductive health but data on this topic are outdated or have a predominant HIV prevention focus. The purpose of this paper is to explore the influence of male partners on family planning and contraceptive (FP/C) uptake and use within the contemporary South African setting, and to identify further areas of exploration. METHODS: This qualitative study was conducted in a community and healthcare provision setting in the eThekwini District in KwaZulu-Natal province, South Africa. Data were collected from twelve community-based focus group discussions (n = 103), two healthcare providers focus group discussions (n = 16), and eight key informant individual in-depth interviews. Following a constructionist paradigm and using the health utilization behaviour model, data were analysed using thematic analysis, allowing a robust and holistic exploration of the data. RESULTS: The data from this study revealed the complex and evolving role that male partners play in FP/C uptake and use within this setting. Key themes from the data elucidated the dual nature of male involvement in FP/C use. Culturally influenced gender dynamics and adequate understanding of FP/C information were highlighted as key factors that influenced male attitudes and perceptions about contraceptive use, whether positively or negatively. Male opposition was attributed to limited understanding; misunderstandings about side-effects; male dominance in relationships; and physical abuse. These factors contributed to covert or discontinued use by female partners. Pathways identified through which male partners positively influenced FP/C uptake and access include: social support, adequate information, and shared responsibility. CONCLUSIONS: Understanding the role that male partners play in FP/C uptake and use is important in preventing unintended pregnancies and improving family planning policy and service delivery programmes. By identifying the barriers that male partners present, appropriate strategies can be implemented. Equally important is identifying how male partners facilitate and promote adherence and use, and how these positive strategies can be incorporated into policy to improve the uptake and use of FP/C.

Measurement of Vaginal Microbicide Adherence Using Visual Inspection as Compared to Ultra Violet Light Assessment of Returned Empty Gel Applicators.

Accurate and objective measurement of adherence is critical in microbicide trials. We compared two applicator tests: visual inspection of returned empty tenofovir gel applicators (VIREA) and ultraviolet light (UVL) assessment in terms of sensitivity and specificity, and for concordance. Sensitivity and specificity analysis of 24 control applicators (12 known-inserted and 12 sham-inserted) at 4-months after receipt was 75.0 and 66.7 % for VIREA and 83.3 and 91.7 % for UVL, respectively. After an additional 3 months of storage sensitivity and specificity was 100 and 58.3 % for VIREA and 100 and 66.7 % for UVL, respectively. In January 2015, 1316 empty applicators were returned as used by 115 participants enrolled at one site in a randomized controlled trial. Assessment outcomes showed 78.8 % agreement between the techniques. Methods concurred that 22.0 % of the returned empty applicators appeared unused. By UVL assessment, 40.0 % of returned empty applicators had no evidence of vaginal insertion, translating to a potential 28.0 % less product used as compared to that returned as used by women. UVL assessment may be considered a more accurate and less subjective measure of adherence as compared to VIREA.

Delivery arrangements for health systems in low-income countries: an overview of systematic reviews.

BACKGROUND: Delivery arrangements include changes in who receives care and when, who provides care, the working conditions of those who provide care, coordination of care amongst different providers, where care is provided, the use of information and communication technology to deliver care, and quality and safety systems. How services are delivered can have impacts on the effectiveness, efficiency and equity of health systems. This broad overview of the findings of systematic reviews can help policymakers and other stakeholders identify strategies for addressing problems and improve the delivery of services. OBJECTIVES: To provide an overview of the available evidence from up-to-date systematic reviews about the effects of delivery arrangements for health systems in low-income countries. Secondary objectives include identifying needs and priorities for future evaluations and systematic reviews on delivery arrangements and informing refinements of the framework for delivery arrangements outlined in the review. METHODS: We searched Health Systems Evidence in November 2010 and PDQ-Evidence up to 17 December 2016 for systematic reviews. We did not apply any date, language or publication status limitations in the searches. We included well-conducted systematic reviews of studies that assessed the effects of delivery arrangements on patient outcomes (health and health behaviours), the quality or utilisation of healthcare services, resource use, healthcare provider outcomes (such as sick leave), or social outcomes (such as poverty or employment) and that were published after April 2005. We excluded reviews with limitations important enough to compromise the reliability of the findings. Two overview authors independently screened reviews, extracted data, and assessed the certainty of evidence using GRADE. We prepared SUPPORT Summaries for eligible reviews, including key messages, 'Summary of findings' tables (using GRADE to assess the certainty of the evidence), and assessments of the relevance of findings to low-income countries. MAIN RESULTS: We identified 7272 systematic reviews and included 51 of them in this overview. We judged 6 of the 51 reviews to have important methodological limitations and the other 45 to have only minor limitations. We grouped delivery arrangements into eight categories. Some reviews provided more than one comparison and were in more than one category. Across these categories, the following intervention were effective; that is, they have desirable effects on at least one outcome with moderate- or high-certainty evidence and no moderate- or high-certainty evidence of undesirable effects. Who receives care and when: queuing strategies and antenatal care to groups of mothers. Who provides care: lay health workers for caring for people with hypertension, lay health workers to deliver care for mothers and children or infectious diseases, lay health workers to deliver community-based neonatal care packages, midlevel health professionals for abortion care, social support to pregnant women at risk, midwife-led care for childbearing women, non-specialist providers in mental health and neurology, and physician-nurse substitution. Coordination of care: hospital clinical pathways, case management for people living with HIV and AIDS, interactive communication between primary care doctors and specialists, hospital discharge planning, adding a service to an existing service and integrating delivery models, referral from primary to secondary care, physician-led versus nurse-led triage in emergency departments, and team midwifery. Where care is provided: high-volume institutions, home-based care (with or without multidisciplinary team) for people living with HIV and AIDS, home-based management of malaria, home care for children with acute physical conditions, community-based interventions for childhood diarrhoea and pneumonia, out-of-facility HIV and reproductive health services for youth, and decentralised HIV care. Information and communication technology: mobile phone messaging for patients with long-term illnesses, mobile phone messaging reminders for attendance at healthcare appointments, mobile phone messaging to promote adherence to antiretroviral therapy, women carrying their own case notes in pregnancy, interventions to improve childhood vaccination. Quality and safety systems: decision support with clinical information systems for people living with HIV/AIDS. Complex interventions (cutting across delivery categories and other health system arrangements): emergency obstetric referral interventions. AUTHORS' CONCLUSIONS: A wide range of strategies have been evaluated for improving delivery arrangements in low-income countries, using sound systematic review methods in both Cochrane and non-Cochrane reviews. These reviews have assessed a range of outcomes. Most of the available evidence focuses on who provides care, where care is provided and coordination of care. For all the main categories of delivery arrangements, we identified gaps in primary research related to uncertainty about the applicability of the evidence to low-income countries, low- or very low-certainty evidence or a lack of studies.

Parents' and guardians' perceptions on availability and pricing of medicines and healthcare for children in eThekwini, South Africa - a qualitative study.

BACKGROUND: Inadequate access to affordable essential medicines poses a challenge to achieving Universal Health Coverage. Access to essential medicines for children has been in the spotlight in recent research. However, information from the end users of medicines, i.e. patients is scarce. Obtaining information at a household level is integral to understanding how people access, obtain and use medicines. This study aimed to gather opinions and perceptions from parents/guardians on availability, affordability and quality of medicines and healthcare for children in SA. METHODS: Eight Focus group discussions were held with 41 individuals in eThekwini, South Africa (SA), from September-November 2016. Participants were parents/guardians of children up to 12 years from different ethnicities, ages, gender, and socio-economic backgrounds. Key informants identified by the principal researcher recruited participants using snowball sampling. Focus group discussions were recorded, transcribed verbatim, coded by the first author, verified by the second author, reconciled for consensus and imported into NVIVO for data analysis. RESULTS: Medicines and healthcare facilities are accessible in urban and peri-urban areas in eThekwini. Medicines may not always be available in public sector facilities due to medicine shortages, compelling parents to purchase medicines from private sector pharmacies. Common medicines were perceived as affordable for most socio-economic groups except the 'Poor' group. Quality of medicines was perceived as 'good' especially if obtained from the private sector but sometimes perceived as 'poor' and viewed with suspicion when received from public sector clinics. Quality of healthcare was perceived as 'good' but requires improvement for both sectors. CONCLUSIONS: This is the first study in SA to report on parent/guardian perceptions on availability, affordability and quality of medicines and healthcare for children. It has the potential to be up-scaled to a country-wide investigation to paint a national picture of parents' opinions of healthcare for children. This will allow for patient input into pharmaceutical and healthcare policy governing access to and availability of essential medicines and services within the country. The study recommends that patient input be sought to assess impact of policies on the intended target group in the country to ensure that the policy objectives are achieved.

Selection of essential medicines for South Africa - an analysis of in-depth interviews with national essential medicines list committee members.

BACKGROUND: The South African (SA) public health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) in the public sector since 1996. To date no studies have reported on the process of selection of essential medicines for SA EMLs and how this may have changed over time. This study reports on the decision making process for the selection of essential medicines for SA EMLs, over the years, as described by various members of the National Essential Medicines List Committee (NEMLC) and their task teams. METHODS: Qualitative in-depth interviews, guided by an interview questionnaire, were conducted with 11 members of the SA NEMLC and their task teams (both past and present members) during the period January - April 2015. Interviews were recorded and transcribed verbatim. Transcripts were then coded by the first author and verified by the second author before being reconciled and input into NVIVO, a qualitative software, to facilitate analysis of the data. RESULTS: The interviews conducted suggest that the NEMLC process of medicine selection has been refined over the years. This together with the EML review process is now essentially predominantly an evidence based process where quality, safety and efficacy of a medicine is considered first followed by cost considerations which includes pharmacoeconomic evaluations, and pricing of medicines. CONCLUSIONS: This is the first study in SA to report on how decisions are taken to include or exclude medicines on SA national EMLs and provides insight into the SA EML medicine selection, review and monitoring processes over time. The results show that the NEMLC has undergone tremendous transformation over the years. Whilst the membership of the committee largely remains unchanged, the committee has developed its policies and processes over the years. However there is still a need to strengthen the monitoring and evaluation aspects of the SA EML policy process.

Quantitative evaluation of essential medicines lists: the South African case study.

BACKGROUND: The South African (SA) health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) since 1996. To date no studies have reported the changes in SA STG/EMLs. This study describes these changes over time (1996-2013) and compares latest SA STG/EMLs with the latest World Health Organization (WHO) Model EMLs to assess alignment of these lists. METHODS: A quantitative evaluation of SA STGs/EMLs at 2 levels of healthcare was performed to assess changes in the number and ratio of molecules, dosage forms, and additions and deletions of medicines. The most recent WHO EMLs (18th list, 4th list for children) and 2012 priority life-saving medicines for women and children (PMWC) list were compared to the most recent available SA STG/EMLs (Primary Health Care (PHC 2008), Adult Hospital 2012, and Paediatric Hospital 2013) at the time of the research. RESULTS: The number of molecules over the years increased for PHC STG/EMLs but decreased slightly for Adult and Paediatric hospital STG/EMLs. The most additions and deletions over time occurred in the Adult hospital level STG/EML (27 in 2006 and 44 in 2012). A comparison between the most recent SA STG/EMLs and WHO Model EML (18th list) showed that a total of 112 medicines were absent on all SA STG/EMLs. A comparison of medicines for children between the 2013 SA Paediatric Hospital level STG/EML and PMWC indicated that these lists were somewhat aligned for most conditions as only 3 of 14 medicines and 11 of 20 vaccines were absent from SA STG/EMLs. CONCLUSION: This is the first study in SA to investigate changes in National EMLs over time in relation to molecules, dosage forms and therapeutic classes. It is also the first to compare the latest SA STG/EMLs to the WHO Model lists. The results therefore provide insight into the trends and SA STG/EML processes over time.