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

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

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

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

Abstract 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

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 sub-national 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

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

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

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