scholarly journals Quality assurance systems of pharmaceutical distributors in low-income and middle-income countries: weaknesses and ways forward

2020 ◽  
Vol 5 (10) ◽  
pp. e003147
Author(s):  
Ariadna Nebot Giralt ◽  
Anthony Bourasseau ◽  
Gareth White ◽  
Corinne Pouget ◽  
Patricia Tabernero ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Low Income ◽  
Poor Quality ◽  
Health Coverage ◽  
Quality Systems ◽  
Model Quality ◽  
Convenience Sample ◽  
Middle Income ◽  
For Profit ◽  
Middle Income Countries

IntroductionAccess to quality-assured medicines is an essential prerequisite for universal health coverage, and pharmaceutical distributors play an important role to assure the quality of medicines along the supply chain.MethodsWe retrospectively assessed the compliance with WHO quality standards, that is, the Model Quality Assurance System for Procurement Agencies (MQAS) or the good distribution practices (GDP), of a convenience sample of 75 public, private-for-profit and non-for-profit distributors, audited by QUAMED in 14 low-income and middle-income countries (LMICs) between 2017 and 2019. We calculated the compliance per quality assurance activity, and we defined the percentage of compliant distributors, that is, the percentage (%) of distributors with MQAS or GDP levels of >2 for each activity.ResultsThe distributors in our sample were mainly private for-profit (66/75). Only one MQAS-audited distributor out of 11 was found compliant with all MQAS-activities, while none out of 64 GDP-assessed distributors were found compliant with all GDP activities. The GDP-assessed distributors were generally less compliant with WHO standards than MQAS-audited distributors. Common weaknesses and strengths were observed. The activities with lowest compliance were quality control, and physical storage conditions, while those with highest compliance were warehouse organisation and stock control.ConclusionsThe quality systems of pharmaceutical distributors in LMICs remain weak. For preventing harm caused by poor-quality medicines, a comprehensive and stringent regulatory oversight should be urgently implemented; the WHO MQAS-standards and GDP-standards should be incorporated in national regulations; and reliable information on the quality systems of distributors (and manufacturers from which they buy) should be publicly available.

scholarly journals Pharmaceutical quality assurance of local private distributors: a secondary analysis in 13 low-income and middle-income countries

2018 ◽  
Vol 3 (3) ◽  
pp. e000771 ◽  
Author(s):  
Kerlijn Van Assche ◽  
Ariadna Nebot Giralt ◽  
Jean Michel Caudron ◽  
Benedetta Schiavetti ◽  
Corinne Pouget ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Low Income ◽  
Poor Quality ◽  
Sub Saharan Africa ◽  
Cold Chain ◽  
Quality Assurance System ◽  
Evaluation Tool ◽  
Middle Income ◽  
Middle Income Countries ◽  
Assurance System

IntroductionThe rapid globalisation of the pharmaceutical production and distribution has not been supported by harmonisation of regulatory systems worldwide. Thus, the supply systems in low-income and middle-income countries (LMICs) remain exposed to the risk of poor-quality medicines. To contribute to estimating this risk in the private sector in LMICs, we assessed the quality assurance system of a convenient sample of local private pharmaceutical distributors.MethodsThis descriptive study uses secondary data derived from the audits conducted by the QUAMED group at 60 local private pharmaceutical distributors in 13 LMICs. We assessed the distributors’ compliance with good distribution practices (GDP), general quality requirements (GQR) and cold chain management (CCM), based on an evaluation tool inspired by the WHO guidelines ’Model Quality Assurance System (MQAS) for procurement agencies'. Descriptive statistics describe the compliance for the whole sample, for distributors in sub-Saharan Africa (SSA) versus those in non-SSA, and for those in low-income countries (LICs) versus middle-income countries (MICs).ResultsLocal private pharmaceutical distributors in our sample were non-compliant, very low-compliant or low-compliant for GQR (70%), GDP (60%) and CCM (41%). Only 7/60 showed good to full compliance for at least two criteria. Observed compliance varies by geographical region and by income group: maximum values are higher in non-SSA versus SSA and in MICs versus LICs, while minimum values are the same across different groups.ConclusionThe poor compliance with WHO quality standards observed in our sample indicates a concrete risk that patients in LMICs are exposed to poor-quality or degraded medicines. Significant investments are needed to strengthen the regulatory supervision, including on private pharmaceutical distributors. An adapted standardised evaluation tool inspired by the WHO MQAS would be helpful for self-evaluation, audit and inspection purposes.

scholarly journals Multimorbidity Patterns and Function Among Adults in Low- and Middle-income Countries: a Scoping Review Protocol

2021 ◽  
Author(s):  
Karina Berner ◽  
Nassib Tawa ◽  
Quinette Louw
Keyword(s):  
Scoping Review ◽  
Low Income ◽  
Data Extraction ◽  
Rehabilitation Services ◽  
Health Coverage ◽  
Policy Planning ◽  
Functional Impairments ◽  
Middle Income ◽  
Middle Income Countries ◽  
And Function

Abstract BackgroundA fifth of adults in low-income and middle-income countries (LMICs) have multimorbid conditions, which are linked to socio-economic deprivation and aging. Multimorbidity is associated with high rates of functional problems and disability, increased healthcare utilization and lower quality of life. Literature on multimorbidity and associations with function is mostly from high-income countries (HICs) and focused among adults. Data regarding patterns and their impact on person-centered outcomes are limited. There is need for research into understanding common patterns of multimorbidity, and their association with functional impairment, particularly in LMICs. Therefore, the need for evidence-based, and context-relevant strategic policy, planning and delivery models for health and rehabilitation services is imperative in attaining Universal Health Coverage (UHC). The planned scoping review aims to provide an overview of the scope and nature of existing literature on multimorbidity patterns and function among adults in LMICs. MethodsA scoping review will be conducted according to a five-step framework guidance. The PRISMA-ScR guidelines will be followed in reporting. A comprehensive electronic search of PubMed, Scopus, EBSCOhost (including MEDLINE and the Cumulative Index to Nursing and Allied Health Literature [CINAHL]), Scielo, Cochrane and Google Scholar will be conducted from January 1976 onwards. Studies will be included if they are primary or secondary, qualitative or quantitative research reported in English, published (between January 1976 and the search date) in a peer-reviewed journal, and describe multimorbidity patterns and associations with physical functional impairments, activity limitations or participation restrictions among adults in LMICs. Search results will be independently screened by two reviewers and data extraction will cover; study characteristics, participants’ characteristics, multimorbidity measures, patterns analysis and functional measures. Descriptive statistics and narrative synthesis will be used to synthesize and summarize the findings.DiscussionPatients with multimorbidity have unique and cross-cutting needs, hence the need for an integrated and person-centered approaches to policy, planning and delivery of medical and rehabilitation services. Considering the shift towards primary healthcare-led management of chronic diseases and UHC, the proposed scoping review is timely and the findings will provide insights into the current extent and scope of multimorbidity research, and guide future inquiry in the field. Protocol registrationOpen Science Framework (OSF), osf.io/gcy7z

scholarly journals Closing the inequality gaps in reproductive, maternal, newborn and child health coverage: slow and fast progressors

2020 ◽  
Vol 5 (1) ◽  
pp. e002230 ◽  
Author(s):  
Agbessi Amouzou ◽  
Safia S Jiwani ◽  
Inácio Crochemore Mohnsam da Silva ◽  
Liliana Carvajal-Aguirre ◽  
Abdoulaye Maïga ◽  
...  
Keyword(s):  
Maternal Health ◽  
Child Health ◽  
Low Income ◽  
Health Surveys ◽  
Health Coverage ◽  
Middle Income ◽  
Child Illness ◽  
Middle Income Countries ◽  
The Past ◽  
And Child Health

IntroductionUniversal Health Coverage (UHC) is a critical goal under the Sustainable Development Goals (SDGs) for health. Achieving this goal for reproductive, maternal, newborn and child health (RMNCH) service coverage will require an understanding of national progress and how socioeconomic and demographic subgroups of women and children are being reached by health interventions.MethodsWe accessed coverage databases produced by the International Centre for Equity in Health, which were based on reanalysis of Demographic and Health Surveys, Multiple Indicator Cluster Surveys and Reproductive and Health Surveys. We limited the data to 58 countries with at least two surveys since 2008. We fitted multilevel linear regressions of coverage of RMNCH, divided into four main components—reproductive health, maternal health, child immunisation and child illness treatment—to estimate the average annual percentage point change (AAPPC) in coverage for the period 2008–2017 across these countries and for subgroups defined by maternal age, education, place of residence and wealth quintiles. We also assessed change in the pace of coverage progress between the periods 2000–2008 and 2008–2017.ResultsProgress in RMNCH coverage has been modest over the past decade, with statistically significant AAPPC observed only for maternal health (1.25, 95% CI 0.90 to 1.61) and reproductive health (0.83, 95% CI 0.47 to 1.19). AAPPC was not statistically significant for child immunisation and illness treatment. Progress, however, varied largely across countries, with fast or slow progressors spread throughout the low-income and middle-income groups. For reproductive and maternal health, low-income and lower middle-income countries appear to have progressed faster than upper middle-income countries. For these two components, faster progress was also observed in older women and in traditionally less well-off groups such as non-educated women, those living in rural areas or belonging to the poorest or middle wealth quintiles than among groups that are well off. The latter groups however continue to maintain substantially higher coverage levels over the former. No acceleration in RMNCH coverage was observed when the periods 2000–2008 and 2008–2017 were compared.ConclusionAt the dawn of the SDGs, progress in coverage in RMNCH remains insufficient at the national level and across equity dimensions to accelerate towards UHC by 2030. Greater attention must be paid to child immunisation to sustain the past gains and to child illness treatment to substantially raise its coverage across all groups.

scholarly journals Level of confidence in and endorsement of the health system among internet users in 12 low-income and middle-income countries

2020 ◽  
Vol 5 (8) ◽  
pp. e002205
Author(s):  
Sanam Roder-DeWan ◽  
Anna Gage ◽  
Lisa R Hirschhorn ◽  
Nana A Y Twum-Danso ◽  
Jerker Liljestrand ◽  
...  
Keyword(s):  
Health System ◽  
Low Income ◽  
Internet Survey ◽  
Health Coverage ◽  
Middle Income ◽  
Middle Income Countries ◽  
Internet Users ◽  
Effective Care ◽  
Universal Health

IntroductionPeople’s confidence in and endorsement of the health system are key measures of system performance, yet are undermeasured in low-income and middle-income countries (LMICs). We explored the prevalence and predictors of these measures in 12 countries.MethodsWe conducted an internet survey in Argentina, China, Ghana, India, Indonesia, Kenya, Lebanon, Mexico, Morocco, Nigeria, Senegal and South Africa collecting demographics, ratings of quality, and confidence in and endorsement of the health system. We used multivariable logistic regression to assess the association between confidence/endorsement and self-reported quality of recent healthcare.ResultsOf 13 489 respondents, 62% reported a health visit in the past year. Applying population weights, 32% of these users were very confident that they could receive effective care if they were to ‘become very sick tomorrow’; 30% endorsed the health system, that is, agreed that it ‘works pretty well and only needs minor changes’. Reporting high quality in the last visit was associated with 4.48 and 2.69 greater odds of confidence (95% CI 3.64 to 5.52) and endorsement (95% CI 2.33 to 3.11). Having health insurance was positively associated with confidence and endorsement (adjusted odds ratio (AOR) 1.68, 95% CI 1.49 to 1.90 and AOR 1.34, 95% CI 1.22 to 1.48), while experiencing discrimination in healthcare was negatively associated (AOR 0.67, 95% CI 0.56 to 0.80 and AOR 0.63, 95% CI 0.53 to 0.76).ConclusionConfidence and endorsement of the health system were low across 12 LMICs. This may hinder efforts to gain support for universal health coverage. Positive patient experience was strongly associated with confidence in and endorsement of the health system.

scholarly journals Identifying health policy and systems research priorities on multisectoral collaboration for health in low-income and middle-income countries

2018 ◽  
Vol 3 (Suppl 4) ◽  
pp. e000970 ◽  
Author(s):  
Douglas Glandon ◽  
Ankita Meghani ◽  
Nasreen Jessani ◽  
Mary Qiu ◽  
Sara Bennett
Keyword(s):  
Low Income ◽  
Health Sector ◽  
Research Priorities ◽  
Implementation Strategies ◽  
Health Coverage ◽  
Middle Income ◽  
The Sustainable Development ◽  
Middle Income Countries ◽  
Systems Research ◽  
Review Articles

IntroductionWhile efforts to achieve Universal Health Coverage (UHC) and the Sustainable Development Goals (SDGs) have reinvigorated interest in multisectoral collaborations (MSCs) among the global health and development community, there remains a plethora of questions about how best to conceptualise, plan, implement, evaluate and sustain MSCs. The objective of this paper is to present research priorities on MSC for health from researchers and policymakers around the globe, with an emphasis on low-income and middle-income countries.MethodsThe authors identified 30 priority research questions from two sources: (1) 38 review articles on MSC for health, and (2) interviews and focus groups with a total of 81 policymakers, including government officials (largely from ministries of health and state/provincial departments of health, but also offices of planning, public service, social development, the prime minister and others), large multilateral or bilateral organisations, and non-governmental organisations. In a third phase, questions were refined and ranked by a diverse group of researchers from around the globe using an online voting platform.ResultsThe top-ranked questions focused predominantly on pragmatic questions, such as how best to structure, implement and sustain MSCs, as well as how to build stakeholder capacity and community partnerships. Despite substantial variation between review articles, policymakers’ reflections and online ranking by researchers, two topics emerged as research priorities for all three: (1) leadership, partnership and governance structures for MSCs; and (2) MSC implementation strategies and mechanisms. The review articles underscored the need for more guidance on appropriate study designs and methods for investigating MSCs, which may be a prerequisite for other identified research priorities.ConclusionThese findings could inform efforts within and beyond the health sector to better align research objectives and funding with the evidence needs of policymakers grappling with questions about how best to leverage MSCs to achieve UHC and the SDGs.

scholarly journals Diagnostic reference levels in low- and middle-income countries: early “ALARAm” bells?

2016 ◽  
Vol 58 (4) ◽  
pp. 442-448 ◽  
Author(s):  
Steven Meyer ◽  
Willem A Groenewald ◽  
Richard D Pitcher
Keyword(s):  
Quality Assurance ◽  
Low Income ◽  
Low Income Countries ◽  
Dose Optimization ◽  
Radiological Protection ◽  
Diagnostic Reference Levels ◽  
Reference Levels ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Background In 1996 the International Commission on Radiological Protection (ICRP) introduced diagnostic reference levels (DRLs) as a quality assurance tool for radiation dose optimization. While many countries have published DRLs, available data are largely from high-income countries. There is arguably a greater need for DRLs in low- and middle-income-countries (LMICs), where imaging equipment may be older and trained imaging technicians are scarce. To date, there has been no critical analysis of the published work on DRLs in LMICs. Such work is important to evaluate data deficiencies and stimulate future quality assurance initiatives. Purpose To review the published work on DRLs in LMICs and to critically analyze the comprehensiveness of available data. Material and Methods Medline, Scopus, and Web of Science database searches were conducted for English-language articles published between 1996 and 2015 documenting DRLs for diagnostic imaging in LMICs. Retrieved articles were analyzed and classified by geographical region, country of origin, contributing author, year of publication, imaging modality, body part, and patient age. Results Fifty-three articles reported DRLs for 28 of 135 LMICs (21%), reflecting data from 26/104 (25%) middle-income countries and 2/31 (6%) low-income countries. General radiography (n = 26, 49%) and computerized tomography (n = 17, 32%) data were most commonly reported. Pediatric DRLs (n = 14, 26%) constituted approximately one-quarter of published work. Conclusion Published DRL data are deficient in the majority of LMICs, with the paucity most striking in low-income countries. DRL initiatives are required in LMICs to enhance dose optimization.

scholarly journals Allocating resources to support universal health coverage: policy processes and implementation in Malawi

2020 ◽  
Vol 5 (8) ◽  
pp. e002766 ◽  
Author(s):  
Pakwanja Twea ◽  
Gerald Manthalu ◽  
Sakshi Mohan
Keyword(s):  
Resource Allocation ◽  
Low Income ◽  
Health Sector ◽  
Health Resources ◽  
Health Coverage ◽  
Middle Income ◽  
Middle Income Countries ◽  
Distribution Of Resources ◽  
The Government ◽  
Limited Health

Optimising the use of limited health resources in low-income and middle-income countries towards the maximisation of health outcomes requires efficient distribution of resources across health services and geographical areas. While technical research exists on how efficiencies can be achieved in resource allocation, there is limited guidance on the policy processes required to convert these technical inputs into practicable solutions. In this article, we discuss Malawi’s experience in 2019 of revising its resource allocation formula (RAF) for the geographical distribution of the government health sector budget to the decentralised units in-charge of delivering primary and secondary healthcare. The policy process to revise the RAF in Malawi was initiated by district assemblies seeking a more equitable distribution of government resources, with the Ministry of Health and Population (MOHP) leading the technical and deliberative work. This article discusses all the steps undertaken by MOHP, Malawi to date as well as the steps necessary looking forward to legally establish the newly developed RAF and to start implementing it. We highlight the practical and political considerations in ensuring the acceptability and implementation feasibility of a revised RAF. It is hoped that this discussion will serve as guidance to other countries undergoing a revision of their resource allocation frameworks.

scholarly journals Strengthening medical specialisation policy in low-income and middle-income countries

2020 ◽  
Vol 5 (2) ◽  
pp. e002053 ◽  
Author(s):  
Veena Sriram ◽  
Sara Bennett
Keyword(s):  
Health Systems ◽  
Low Income ◽  
Medical Tourism ◽  
Policy Formulation ◽  
Health Systems Strengthening ◽  
Health Coverage ◽  
Secondary Importance ◽  
Middle Income ◽  
Medical Specialties ◽  
Middle Income Countries

The availability of medical specialists has accelerated in low-income and middle-income countries (LMICs), driven by factors including epidemiological and demographic shifts, doctors’ preferences for postgraduate training, income growth and medical tourism. Yet, despite some policy efforts to increase access to specialists in rural health facilities and improve referral systems, many policy questions are still underaddressed or unaddressed in LMIC health sectors, including in the context of universal health coverage. Engaging with issues of specialisation may appear to be of secondary importance, compared with arguably more pressing concerns regarding primary care and the social determinants of health. However, we believe this to be a false choice. Policy at the intersection of essential health services and medical specialties is central to issues of access and equity, and failure to formulate policy in this regard may have adverse ramifications for the entire system. In this article, we describe three critical policy questions on medical specialties and health systems with the aim of provoking further analysis, discussion and policy formulation: (1) What types, and how many specialists to train? (2) How to link specialists’ production and deployment to health systems strengthening and population health? (3) How to develop and strengthen institutions to steer specialisation policy? We posit that further analysis, discussion and policy formulation addressing these questions presents an important opportunity to explicitly determine and strengthen the linkages between specialists, health systems and health equity.

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