Deconcentrating regulation in low- and middle-income country health systems: a proposed ambidextrous solution to problems with professional regulation for doctors and nurses in Kenya and Uganda.

BACKGROUND: Regulation can improve professional practice and patient care, but is often weakly implemented and enforced in health systems in low- and middle-income countries (LMICs). Taking a de-centred and frontline perspective, we examine national regulatory actors' and health professionals' views and experiences of health professional regulation in Kenya and Uganda and discuss how it might be improved in LMICs more generally. METHODS: We conducted large-scale research on professional regulation for doctors and nurses (including midwives) in Uganda and Kenya during 2019-2021. We interviewed 29 national regulatory stakeholders and 47 subnational regulatory actors, doctors, and nurses. We then ran a national survey of Kenyan and Ugandan doctors and nurses, which received 3466 responses. We thematically analysed qualitative data, conducted an exploratory factor analysis of survey data, and validated findings in four focus group discussions. RESULTS: Kenyan and Ugandan regulators were generally perceived as resource-constrained, remote, and out of touch with health professionals. This resulted in weak regulation that did little to prevent malpractice and inadequate professional education and training. However, interviewees were positive about online licencing and regulation where they had relationships with accessible regulators. Building on these positive findings, we propose an ambidextrous approach to improving regulation in LMIC health systems, which we term deconcentrating regulation. This involves developing online licencing and streamlining regulatory administration to make efficiency savings, freeing regulatory resources. These resources should then be used to develop connected subnational regulatory offices, enhance relations between regulators and health professionals, and address problems at local level. CONCLUSION: Professional regulation for doctors and nurses in Kenya and Uganda is generally perceived as weak. Yet these professionals are more positive about online licencing and regulation where they have relationships with regulators. Building on these positive findings, we propose deconcentrating regulation as a solution to regulatory problems in LMICs. However, we note resource, cultural and political barriers to its effective implementation.

Factors influencing the uptake and utilization of cervical cancer screening services among women attending public health centers in Addis Ababa, Ethiopia: mixed methods study.

BACKGROUND: Cervical cancer is the second cause of cancer deaths among Ethiopian women. Despite multifaceted government efforts, the uptake and utilization of cervical cancer screening remain very low. This study aimed to assess factors influencing the uptake and utilization of cervical cancer screening at public health centers in Addis Ababa. METHODS: A convergent parallel mixed-method study was employed to collect data through eight focus group discussions with 66 women purposively recruited from outpatient clinics, and cross-sectional face-to-face exit interviews with 80 women attending cervical cancer clinics in four high-patient volume health centers. The group interviews were tape-recorded, transcribed in Amharic, translated into English, and a thematic analysis approach was used in the analysis. Exit interview data were collected using a structured questionnaire in the Open Data Kit tool on an android tablet. STATA version 17 was used for descriptive and inferential data analyses. Statistical significance was set at p < 0.05. RESULTS: The majority of focus group discussion participants had lack of knowledge of cervical cancer and its screening services. The major barriers to the uptake of screening were inadequate public awareness, fear of the procedure, embarrassment, provider's gender, lack of male partner support, and childcare. Women aged 40 years and above were 13.9 times more likely to utilize cervical cancer screening than those under 30 years (AOR = 13.85; 95% CI: 1.40, 136.74). There was a strong preference for a female provider (AOR = 7.07; 95% CI: 1.53, 32.75) among women screened after attending antiretroviral therapy clinics and those screened due to abnormal vaginal bleeding than women referred from family planning clinics (AOR = 6.87; 95% CI: 1.02, 46.44). Safety of screening was negatively associated with women aged 30-39 (AOR = 0.045; 95% CI: 0.003, 0.696), and those who attended primary education, and secondary education and above, (AOR = 0.016; 95% CI: 0.001, 0.262), and (AOR = 0.054; 95% CI: 0.004, 0.724), respectively. CONCLUSIONS: The study identified low public awareness, inadequate provider preference, safety concerns, and poor male partner support for cervical cancer screening. We recommend the decision-makers enhance public messages, maintain provider choices, ensure safety, and engage males to improve the uptake and utilization of cervical cancer screening.

Health practitioner regulation and national health goals.

The role of health practitioner regulation in ensuring patient safety is well recognized. Less recognized is the role of regulation in addressing broader health system priorities. These goals include managing the costs, capacities and distribution of health professional education institutions; ensuring the competence and equitable distribution of health workers; informing workforce planning and mobilization; enabling the use of digital technologies; and addressing challenges related to the international mobility of health workers. Even where health practitioner regulation is designed to advance these goals, important gaps exist between the potential of regulatory systems and their performance. The response to the coronavirus disease 2019 (COVID-19) pandemic led many countries to introduce regulatory changes to allow more flexibility and innovations in the mobilization of health practitioners. Building on this experience, we need to critically re-examine health practitioner regulatory systems to ensure that these systems support rather than impede progress towards national health goals. We discuss the role of health practitioner regulation in contemporary health systems, highlighting recent regulatory reforms in selected countries, including during the COVID-19 pandemic. We identify the importance of dynamic, effective and flexible health practitioner regulatory systems in progress towards universal health coverage and health security.

Le rôle qu'exerce la réglementation relative aux professionnels de la santé pour la sécurité du patient est bien connu. En revanche, celui qu'elle joue dans la définition des grandes priorités du système de santé l'est moins. Elle comporte ainsi plusieurs objectifs, notamment: assurer la gestion des coûts, des capacités et de la distribution des établissements de formation des professionnels de la santé; garantir une répartition équitable d'agents de santé compétents; guider la planification et la mobilisation de la main-d'œuvre; permettre l'intégration des technologies numériques; et enfin, relever les défis liés à la mobilité internationale des acteurs du secteur. Même dans les endroits où une telle réglementation est conçue pour atteindre ces objectifs, des écarts considérables subsistent entre le potentiel des systèmes de réglementation et leurs performances réelles. La lutte contre la pandémie de maladie à coronavirus 2019 (COVID-19) a encouragé de nombreux pays à modifier les règles en vigueur en vue d'offrir une plus grande flexibilité et davantage d'innovations en matière de mobilisation des agents de santé. En nous fondant sur cette expérience, nous devons impérativement réexaminer les systèmes de réglementation propres aux praticiens afin qu'ils constituent un moteur, et non un frein, à la poursuite des objectifs nationaux en matière de santé. Dans le présent document, nous évoquons le rôle de la réglementation relative aux professionnels de la santé dans les systèmes de santé actuels, en mentionnant les récentes réformes entreprises par une série de pays dans ce domaine, y compris durant la pandémie de COVID-19. Nous soulignons également l'importance d'instaurer des systèmes de réglementation dynamiques, efficaces et flexibles pour les praticiens sur la voie menant à la sécurité sanitaire et à une couverture sanitaire universelle.

La función de la reglamentación de los profesionales sanitarios para garantizar la seguridad de los pacientes es bien conocida. Sin embargo, se reconoce menos la función de la reglamentación para atender prioridades más amplias del sistema sanitario. Estos objetivos incluyen: gestionar los costes, las capacidades y la distribución de las instituciones de formación de profesionales sanitarios; asegurar la competencia y la distribución equitativa de los trabajadores sanitarios; informar la planificación y movilización del personal; permitir el uso de tecnologías digitales; y abordar los retos relacionados con la movilidad internacional de los trabajadores sanitarios. Incluso en los casos en que la reglamentación de los profesionales sanitarios está concebida para promover estos objetivos, existen diferencias considerables entre el potencial de los sistemas de reglamentación y sus resultados. La respuesta a la pandemia de enfermedad por coronavirus de 2019 (COVID-19) llevó a muchos países a introducir cambios en la reglamentación para permitir una mayor flexibilidad e innovaciones en la movilización de los profesionales sanitarios. A partir de esta experiencia, es necesario volver a examinar de forma crítica los sistemas de reglamentación de los profesionales sanitarios para garantizar que estos sistemas apoyen y no impidan el progreso hacia los objetivos sanitarios nacionales. En este artículo se analiza la función de la reglamentación de los profesionales de la salud en los sistemas sanitarios contemporáneos y se destacan las recientes reformas reglamentarias introducidas en algunos países, en particular durante la pandemia de COVID-19. Asimismo, se destaca la importancia de que los sistemas de reglamentación de los profesionales sanitarios sean dinámicos, eficaces y flexibles para avanzar hacia la cobertura sanitaria universal y la seguridad sanitaria.

How much does effective health facility inspection cost? An analysis of the economic costs of Kenya's Joint Health Inspection innovations.

BACKGROUND: In most low- and middle-income countries, health facility regulation is fragmented, ineffective and under-resourced. The Kenyan Government piloted an innovative regulatory regime involving Joint Health Inspections (JHI) which synthesized requirements across multiple regulatory agencies; increased inspection frequency; digitized inspection tools; and introduced public display of regulatory results. The pilot significantly improved regulatory compliance. We calculated the costs of the development and implementation of the JHI pilot and modelled the costs of national scale-up in Kenya. METHODS: We calculated the economic costs of three phases: JHI checklist development, start-up activities, and first year of implementation, from the providers' perspective in three pilot counties. Data collection involved extraction from expenditure records and key informant interviews. The annualized costs of JHI were calculated by adding annualized development and start-up costs to annual implementation costs. National level scale-up costs were also modelled and compared to those of current standard inspections. RESULTS: The total economic cost of the JHI pilot was USD 1,125,600 (2017 USD), with the development phase accounting for 19%, start-up 43% and the first year of implementation 38%. The annualized economic cost was USD 519,287, equivalent to USD 206 per health facility visit and USD 311 per inspection completed. Scale up to the national level, while replacing international advisors with local staff, was estimated to cost approximately USD 4,823,728, equivalent to USD 103 per health facility visit and USD 155 per inspection completed. This compares to an estimated USD 86,997 per year (USD 113 per inspection completed) spent on a limited number of inspections prior to JHI. CONCLUSION: Information on costs is essential to consider affordability and value for money of regulatory interventions. This is the first study we are aware of costing health facility inspections in sub-Saharan Africa. It has informed debates on appropriate inspection design and potential efficiency gains. It will also serve as an important benchmark for future studies, and a key input into cost-effectiveness analyses.

Healthcare clinic and pharmacy chains in Kenya and Nigeria: A qualitative exploration of the opportunities and risks they present for healthcare regulatory systems.

BACKGROUND: Regulating fragmented healthcare markets is a major challenge in low- and middle-income countries. Although a recent transformation towards consolidation could improve regulatory efficiency, there are concerns over risks to client safety and market functioning. We investigated market consolidation through the emergence of clinic and pharmacy chains in Kenya and Nigeria and explored resultant regulatory opportunities and risks. METHODS: The study was conducted in Nairobi Kenya and Abuja Nigeria. Data were collected through document reviews and 26 interviews with chain operators, professional associations and regulators between September and December 2018. A thematic analysis was conducted. RESULTS: We characterised two broad types of chains: organic chains that started as single business locations and expanded gradually, and investor-driven chains that expanded rapidly following external capital injection. In both countries, chains and independents were regulated similarly, with regulators failing to both capitalize on opportunities and guard against risks. For instance, chains' brand visibility and centralised management systems made them easier to regulate and more suitable for self-regulation. On the other hand, chains were perceived to pose the risks of market dominance, commercialisation of healthcare, and regulatory capture. CONCLUSION: As healthcare chains expand, regulators should build on opportunities presented and guard against emerging risks.

Understanding Women's Choices: How Women's Perceptions of Quality of Care Influences Place of Delivery in a Rural Sub-County in Kenya. A Qualitative Study.

BACKGROUND: Maternal mortality is still unacceptably high in Kenya. The Kenyan Government introduced a free maternity service to overcome financial barriers to access. This policy led to a substantial increase in women's delivery options. This increase in coverage might have led to a reduction in quality of care. This study explores women's perceptions of quality of delivery services in the context of the free policy and how the perceptions lead to the choice of a place for delivery. METHODS: Our study site was Naivasha sub-County in Kenya, a rural context, whose geography encompasses pastoralists, rural agrarian, and high population density informal settlements near flower farms. Women from this area are from the lowest wealth quintile in Kenya. We conducted a qualitative study to explore the women's perceptions of quality of care based on their experiences during maternity care. The participants were women of reproductive age (18-49 years) attending antenatal care clinics at six health facilities in the sub-county. Six focus group discussions with 55 respondents were used. For inclusion, the women needed to have delivered a baby within the six months preceding the study. Interviews were recorded with consent, translated and transcribed. The interviews were analyzed using a thematic content approach. RESULTS: Four broad themes that determined the choice of health facility for delivery were identified: women's perceptions of clinical quality of care; the cost of delivery; distance to the health facility and management of primary health facilities. An unexpected theme was the presence of home deliveries amongst pastoralist women. These findings suggest that in this setting both process and structural dimensions of quality of care and financial and physical accessibility influence women's choices for place of delivery. CONCLUSION: This study expands our understanding of how women make choices regarding place of delivery. Understanding women's perceptions can provide useful insights to policy makers and facility managers on providing high quality patient centered maternity care necessary to sustain the increased utilization of maternity services at health facilities under the free maternity policy and further reductions in maternal mortality.

Observations of infection prevention and control practices in primary health care, Kenya.

OBJECTIVE: To assess compliance with infection prevention and control practices in primary health care in Kenya. METHODS: We used an observational, patient-tracking tool to assess compliance with infection prevention and control practices by 1680 health-care workers during outpatient interactions with 14 328 patients at 935 health-care facilities in 2015. Compliance was assessed in five domains: hand hygiene; protective glove use; injections and blood sampling; disinfection of reusable equipment; and waste segregation. We calculated compliance by dividing the number of correct actions performed by the number of indications and evaluated associations between compliance and the health-care worker's and facility's characteristics. FINDINGS: Across 106 464 observed indications for an infection prevention and control practice, the mean compliance was 0.318 (95% confidence interval, CI: 0.315 to 0.321). The compliance ranged from 0.023 (95% CI: 0.021 to 0.024) for hand hygiene to 0.871 (95% CI: 0.866 to 0.876) for injection and blood sampling safety. Compliance was weakly associated with the facility's characteristics (e.g. public or private, or level of specialization) and the health-care worker's knowledge of, and training in, infection prevention and control practices. CONCLUSION: The observational tool was effective for assessing compliance with infection prevention and control practices across multiple domains in primary health care in a low-income country. Compliance varied widely across infection prevention and control domains. The weak associations observed between compliance and the characteristics of health-care workers and facilities, such as knowledge and the availability of supplies, suggest that a broader focus on behavioural change is required.

Implementing Global Fund programs: a survey of opinions and experiences of the Principal Recipients across 69 countries.

BACKGROUND: Principal Recipients (PRs) receive money from the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund) to manage and implement programs. However, little research has gone into understanding their opinions and experiences. This survey set out to describe these, thereby providing a baseline against which changes in PR opinions and experiences can be assessed as the recently introduced new funding model is rolled out. METHODOLOGY: An internet based questionnaire was administered to 315 PRs. A total of 115 responded from 69 countries in Africa, Asia, Eastern Europe and Latin America. The study was conducted between September and December 2012. FINDINGS: Three quarters of PRs thought the progress update and disbursement request (PU/DR) system was a useful method of reporting grant progress. However, most felt that the grant negotiation processes were complicated, and that the grant rating system did not reflect performance.While nearly all PRs were happy with the work being done by sub-Recipients (92%) and Fund Portfolio Managers (86%), fewer were happy with the Office of the Inspector General (OIG). Non-government PRs were generally less happy with the OIG's work compared to government PRs.Most PRs thought the Global Fund's Voluntary Pooled Procurement system made procurement easier. However, only 29% said the system should be made compulsory.When asked which aspects of the Global Fund's operations needed improvement, most PRs said that the Fund should re-define and clarify the roles of different actors, minimize staff turnover at its Secretariat, and shorten the grant application and approval processes. All these are currently being addressed, either directly or indirectly, under a new funding model. Vigorous assessments should nonetheless follow the roll-out of the new model to ensure the areas that are most likely to affect PR performance realize sustained improvement. CONCLUSIONS: Opinions and experiences with the Global Fund were varied, with PRs having good communication with Fund Portfolio Managers and sub-Recipients, but being unhappy with the grant negotiation and grant rating systems. Recommendations included simplifying grant processes, finding performance assessment methods that look beyond numbers, and employing Local Fund Agents who understand public health aspects of programs.

A concept in flux: questioning accountability in the context of global health cooperation.

BACKGROUND: Accountability in global health is a commonly invoked though less commonly questioned concept. Critically reflecting on the concept and how it is put into practice, this paper focuses on the who, what, how, and where of accountability, mapping its defining features and considering them with respect to real-world circumstances. Changing dynamics in global health cooperation - such as the emergence of new health public-private partnerships and the formal inclusion of non-state actors in policy making processes - provides the backdrop to this discussion. DISCUSSION: Accountability is frequently reduced to one set of actors holding another to account. Changes in the global health landscape and in relations between actors have however made the practice of accountability more complex and contested. Currently undergoing a reframing process, participation and transparency have become core elements of a new accountability agenda alongside evaluation and redress or enforcement mechanisms. However, while accountability is about holding actors responsible for their actions, the mechanisms through which this might be done vary substantially and are far from politically neutral.Accountability in global health cooperation involves multipolar relationships between a large number of stakeholders with varying degrees of power and influence, where not all interests are realised in that relationship. Moreover, accountability differs across finance, programme and governance subfields, where each has its own set of policy processes, institutional structures, accountability relations and power asymmetries to contend with. With reference to the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, this paper contributes to discussions on accountability by mapping out key elements of the concept and how it is put into practice, where different types of accountability battle for recognition and legitimacy. SUMMARY: In mapping some defining features, accountability in global health cooperation is shown to be a complex problem not necessarily reducible to one set of actors holding another to account. Clear tensions are observed between multi-stakeholder participatory models and more traditional vertical models that prioritise accountability upwards to donors, both of which are embodied in initiatives like the Global Fund. For multi-constituency organisations, this poses challenges not only for future financing but also for future legitimacy.

The policy-practice gap: describing discordances between regulation on paper and real-life practices among specialized drug shops in Kenya.

BACKGROUND: Specialized drug shops (SDSs) are popular in Sub-Saharan Africa because they provide convenient access to medicines. There is increasing interest in how policymakers can work with them, but little knowledge on how their operation relates to regulatory frameworks. This study sought to describe characteristics and predictors of regulatory practices among SDSs in Kenya. METHODS: The regulatory framework governing the Kenya pharmaceutical sector was mapped, and a list of regulations selected for inclusion in a survey questionnaire. An SDS census was conducted, and survey data collected from 213 SDSs from two districts in Western Kenya. RESULTS: The majority of SDSs did not comply with regulations, with only 12% having a refrigerator and 22% having a separate dispensing area for instance. Additionally, less than half had at least one staff with pharmacy qualification (46%), with less than a third of all interviewed operators knowing the name of the law governing pharmacy.Regulatory infringement was more common among SDSs in rural locations; those that did not have staff with pharmacy qualifications; and those whose operator did not know the name of the pharmacy law. Compliance was not significantly associated with the frequency of inspections, with over 80% of both rural and urban SDSs reporting an inspection in the past year. CONCLUSION: While compliance was low overall, it was particularly poor among SDSs operating in rural locations, and those that did not have staff with pharmacy qualification. This suggested the need for policy to introduce levels of practice in recognition of the variations in resource availability. Under such a system, rural SDSs operating in low-resource setting, and selling a limited range of medicines, may be exempted from certain regulatory requirements, as long as their scope of practice is limited to certain essential services only. Future research should also explore why regulatory compliance is poor despite regular inspections.

"I'll take them another day": A qualitative study exploring the socio-behavioral complexities of childhood vaccination in urban poor settlements.

Despite improvement over recent decades, childhood vaccination uptake remains a concern across countries. The World Health Organization observed that over 25 million children missed out on one or more vaccines in 2021, with urban poor and other marginalized groups being the most affected. Given the higher risk of disease transmission and vaccine-preventable diseases (VPD) outbreaks across densely populated urban slums, identifying effective interventions to improve childhood vaccination in this vulnerable population is crucial. This study explored the behavioral and social factors influencing childhood vaccination uptake in urban informal settlements in Nairobi, Kenya. A grounded theory approach was employed to develop a theoretical account of the socio-behavioral determinants of childhood vaccination. Five focus group discussions (FGDs) were conducted with purposively sampled caregivers of children under five years of age residing in informal settlements. The Theory of Planned Behavior guided the structuring of the FGD questions. An iterative process was used to analyze and identify emerging themes. Thirty-nine caregivers (median age 29 years) participated in the FGDs. From the analysis, four main thematic categories were derived. These included attitude factors such as perceived vaccine benefits, cultural beliefs, and emotional factors including parental love. Additionally, subjective norms, like fear of social judgment, and perceived behavioral control factors, such as self-control and gender-based influences, were identified. Furthermore, a number of practical factors, including the cost of vaccines and healthcare providers attitude, also affected the uptake of vaccination. Various social, behavioral, cultural, and contextual factors influence caregiver vaccination decisions in urban poor settings. Community-derived and context-specific approaches that address the complex interaction between socio-behavioral and other contextual factors need to be tested and applied to improve the timely uptake of childhood vaccinations among marginalized populations.

Assessing the influence of the health system on access to cervical cancer prevention, screening, and treatment services at public health centers in Addis Ababa, Ethiopia.

BACKGROUND: Cervical cancer is the second leading cause of cancer death among Ethiopian women. This study aimed to assess the influence of the health system on access to cervical cancer prevention, screening, and treatment services at public health centers in Addis Ababa, Ethiopia. METHODS: This study used a cross-sectional survey design and collected data from 51 randomly selected public health centers in Addis Ababa. Open Data Kit was used to administer a semi-structured questionnaire on Android tablets, and SPSS version 26 was used to analyze the descriptive data. RESULTS: In the study conducted at 51 health centers, cervical cancer prevention and control services achieved 61% HPV vaccination for girls, 79% for cervical cancer awareness messages, 80% for precancer lesion treatment, and 71% for cervical screening of women. All health centers were performing cervical screening mostly through visual inspection with acetic acid due to the inconsistent availability of HPV DNA tests and the lack of Pap smear tests. In 94% of health centers, adequate human resources were available. However, only 78% of nurses, 75% of midwives, 35% of health officers, and 49% of health extension workers received cervical cancer training in the 24 months preceding the study. Women had provider choices in only 65% of health centers, and 86% of the centers lacked electronic health records. In 41% of the health centers, the waiting time was 30 minutes or longer. About 88% and 90% of the facilities lacked audio and video cervical cancer messages, respectively. CONCLUSION: This study revealed that the annual cervical cancer screening achievement was on track to fulfill the WHO's 90-70-90 targets by 2030. We recommend that decision-makers prioritize increasing HPV vaccination rates, enhancing messaging, reducing wait times, and implementing electronic health records to improve access to cervical cancer services in Addis Ababa.

Regional and temporal trends in malaria commodity costs: an analysis of Global Fund data for 79 countries.

BACKGROUND: Although procurement consumes nearly 40% of Global Fund's money, no analyses have been published to show how costs vary across regions and time. This paper presents an analysis of malaria-related commodity procurement data from 79 countries, as reported through the Global Fund's price and quality reporting (PQR) system for the 2005-2012 period. METHODS: Data were analysed for the three most widely procured commodities for prevention, diagnosis and treatment of malaria. These were long-lasting insecticide-treated nets (LLINs), malaria rapid diagnostic tests (RDTs) and the artemether/lumefantrine (AL) combination treatment. Costs were compared across time (2005-2012), regions, and between individual procurement reported through the PQR and pooled procurement reported through the Global Fund's voluntary pooled procurement (VPP) system. All costs were adjusted for inflation and reported in US dollars. RESULTS: The data included 1,514 entries reported from 79 countries over seven years. Of these, 492 entries were for LLINs, 330 for RDTs and 692 for AL. Considerable variations were seen by commodity, although none showed an increase in cost. The costs for LLINs, RDTs and AL all dropped significantly over the period of analysis. Regional variations were also seen, with the cost for all three commodities showing significant variations. The median cost for a single LLIN ranged from USD 4.3 in East Asia to USD 5.0 in West and Central Africa. The cost of a single RDT was lowest in West and Central Africa at US$ 0.57, and highest in the Latin American region at US$ 1.1. AL had the narrowest margin of between US$ 0.06 per tablet in sub-Saharan Africa and South Asia, and US$ 0.08 in the Latin American and Eastern Europe regions. CONCLUSION: This paper concludes that global procurement costs do vary by region and have reduced overall over time. This suggests a mature market is operating when viewed from the global level, but regional variation needs further attention. Such analyses should be done more often to identify and correct market insufficiencies.

Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature.

BACKGROUND: Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. METHODS: We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. RESULTS: We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory enforcement and practices of specialized drug shops. CONCLUSIONS: Evidence suggests that characteristics and practices of specialized drug shops differ across rural and urban locations, and that these providers are highly responsive to client demand. However, there is a dearth in knowledge on how regulatory enforcement influences their characteristics and practices, and what strategies can be employed to strengthen the governance of the retail pharmaceutical sector.

What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya's Health Facility Inspection Reforms.

BACKGROUND: Health facility regulation in low- and middle-income countries (LMICs) is generally weak, with potentially serious consequences for safety and quality. Innovative regulatory reforms were piloted in three Kenyan counties including: a Joint Health Inspection Checklist (JHIC) synthesizing requirements across multiple regulatory agencies; increased inspection frequency; allocating facilities to compliance categories which determined warnings, sanctions and/or time to re-inspection; and public display of regulatory results. The reforms substantially increased inspection scores compared with control facilities. We developed lessons for future regulatory policy from this pilot by identifying key factors that facilitated or hindered its implementation. METHODS: We conducted a qualitative study to understand views and experiences of actors involved in the one-year pilot. We interviewed 77 purposively selected staff from the national, county and facility levels. Data were analyzed using the framework approach, identifying facilitating/hindering factors at the facility, inspection system, and health system levels. RESULTS: The joint health inspections (JHIs) were generally viewed as fair, objective and transparent, which enhanced their perceived legitimacy. Interactions with inspectors were described as friendly and supportive, in contrast to the punitive culture of previous inspections when bribery had been common. Inspector training and use of an electronic checklist were strongly praised. However, practical challenges with transport, route planning and budgets highlighted the critical nature of strong logistical management. The effectiveness of inspection in improving compliance was hampered by limitations in related systems, particularly facility licensing, enforcement of closures and, in the public sector, control of funds. However, an inclusive reform development process had led to high buy-in across regulatory agencies which was key to the system's success. CONCLUSION: Effective facility inspection involves more than "hardware" such as checklists, protocols and training. Cultural, relational and institutional "software" are also crucial for legitimacy, feasibility of implementation and enforceability, and should be carefully integrated into regulatory reforms.

When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries.

The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation-through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.

Are interventions for improving the quality of services provided by specialized drug shops effective in sub-Saharan Africa? A systematic review of the literature.

PURPOSE: We set out to determine effectiveness of interventions for improving the quality of services provided by specialized drug shops in sub-Saharan Africa. DATA SOURCES: We searched PubMed, CAB Abstracts, Web of Science, PsycINFO and Eldis databases and websites for organizations such as WHO and Management Sciences for Health. Finally, we searched manually through the references of retrieved articles. STUDY SELECTION: Our search strategy included randomized trials, time-series studies and before and after studies evaluating six interventions; education, peer review, reorganizing administrative structures, incentives, regulation and legislation. DATA EXTRACTION: We extracted information on design features, participants, interventions and outcomes assessed studies for methodological quality, and extracted results, all using uniform checklists. RESULTS OF DATA SYNTHESIS: We obtained 10 studies, all implementing educational interventions. Outcome measures were heterogeneous and included knowledge, communication and dispensing practices. Education improved knowledge across studies, but gave mixed results on communication between sellers and clients, dispensing of appropriate treatments and referring of patients to health facilities. Profit incentives appeared to constrain behaviour change in certain instances, although cases of shops adopting practices at the expense of sales revenue were also reported. CONCLUSION: Evidence suggests that knowledge and practices of pharmacies and drug shops can be improved across a range of diseases and countries/regions, although variations were reported across studies. Profit incentives appear to bear some influence on the level of success of interventions. More work is required to extend the geographical base of evidence, investigate cost-effectiveness and evaluate sustainability of interventions over periods longer than 1 year.

'We just look at the well-being of the baby and not the money required': a qualitative study exploring experiences of quality of maternity care among women in Nairobi's informal settlements in Kenya.

OBJECTIVE: To examine how women living in an informal settlement in Nairobi perceive the quality of maternity care and how it influences their choice of a delivery health facility. DESIGN: Qualitative study. SETTINGS: Dandora, an informal settlement, Nairobi City in Kenya. PARTICIPANTS: Six focus group discussions with 40 purposively selected women aged 18-49 years at six health facilities. RESULTS: Four broad themes were identified: (1) perceived quality of the delivery services, (2) financial access to delivery service, (3) physical amenities at the health facility, and (4) the 2017 health workers' strike.The four facilitators that influenced women to choose a private health facility were: (1) interpersonal treatment at health facilities, (2) perceived quality of clinical services, (3) financial access to health services at the facility, and (4) the physical amenities at the health facility. The three barriers to choosing a private facility were: (1) poor quality clinical services at low-cost health facilities, (2) shortage of specialist doctors, and (3) referral to public health facilities during emergencies.The facilitators that influenced women to choose a public facility were: (1) physical amenities for dealing with obstetric emergencies and (2) early referral to public maternity during antenatal care services. Barriers to choosing a public facility were: (1) perception of poor quality clinical services, (2) concerns over security for newborns at tertiary health facilities, (3) fear of mistreatment during delivery, (4) use of unsupervised trainee doctors for deliveries, (5) poor quality of physical amenities, and (6) inadequate staffing. CONCLUSION: The study provides insights into decision-making processes for women when choosing a delivery facility by identifying critical attributes that they value and how perceptions of quality influence their choices.

Understanding what women want: eliciting preference for delivery health facility in a rural subcounty in Kenya, a discrete choice experiment.

OBJECTIVE: To identify what women want in a delivery health facility and how they rank the attributes that influence the choice of a place of delivery. DESIGN: A discrete choice experiment (DCE) was conducted to elicit rural women's preferences for choice of delivery health facility. Data were analysed using a conditional logit model to evaluate the relative importance of the selected attributes. A mixed multinomial model evaluated how interactions with sociodemographic variables influence the choice of the selected attributes. SETTING: Six health facilities in a rural subcounty. PARTICIPANTS: Women aged 18-49 years who had delivered within 6 weeks. PRIMARY OUTCOME: The DCE required women to select from hypothetical health facility A or B or opt-out alternative. RESULTS: A total of 474 participants were sampled, 466 participants completed the survey (response rate 98%). The attribute with the strongest association with health facility preference was having a kind and supportive healthcare worker (ß=1.184, p<0.001), second availability of medical equipment and drug supplies (ß=1.073, p<0.001) and third quality of clinical services (ß=0.826, p<0.001). Distance, availability of referral services and costs were ranked fourth, fifth and sixth, respectively (ß=0.457, p<0.001; ß=0.266, p<0.001; and ß=0.000018, p<0.001). The opt-out alternative ranked last suggesting a disutility for home delivery (ß=-0.849, p<0.001). CONCLUSION: The most highly valued attribute was a process indicator of quality of care followed by technical indicators. Policymakers need to consider women's preferences to inform strategies that are person centred and lead to improvements in quality of care during delivery.

Eliciting women's preferences for place of child birth at a peri-urban setting in Nairobi, Kenya: A discrete choice experiment.

OBJECTIVE: Maternal and newborn mortality rates are high in peri-urban areas in cities in Kenya, yet little is known about what drives women's decisions on where to deliver. This study aimed at understanding women's preferences on place of childbirth and how sociodemographic factors shape these preferences. METHODS: This study used a Discrete Choice Experiment (DCE) to quantify the relative importance of attributes on women's choice of place of childbirth within a peri-urban setting in Nairobi, Kenya. Participants were women aged 18-49 years, who had delivered at six health facilities. The DCE consisted of six attributes: cleanliness, availability of medical equipment and drug supplies, attitude of healthcare worker, cost of delivery services, the quality of clinical services, distance and an opt-out alternative. Each woman received eight questions. A conditional logit model established the relative strength of preferences. A mixed logit model was used to assess how women's preferences for selected attributes changed based on their sociodemographic characteristics. RESULTS: 411 women participated in the Discrete Choice Experiment, a response rate of 97.6% and completed 20,080 choice tasks. Health facility cleanliness was found to have the strongest association with choice of health facility (ß = 1.488 p<0.001) followed respectively by medical equipment and supplies availability (ß = 1.435 p<0.001). The opt-out alternative (ß = 1.424 p<0.001) came third. The attitude of the health care workers (ß = 1.347, p<0.001), quality of clinical services (ß = 0.385, p<0.001), distance (ß = 0.339, p<0.001) and cost (ß = 0.0002 p<0.001) were ranked 4th to 7th respectively. Women who were younger and were the main income earners having a stronger preference for clean health facilities. Older married women had stronger preference for availability of medical equipment and kind healthcare workers. CONCLUSIONS: Women preferred both technical and process indicators of quality of care. DCE's can lead to the development of person-centered strategies that take into account the preferences of women to improve maternal and newborn health outcomes.