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

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.

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

BMJ Global Health ◽

10.1136/bmjgh-2020-003147 ◽

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.

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Gestational weight gain in low-income and middle-income countries: a modelling analysis using nationally representative data

BMJ Global Health ◽

10.1136/bmjgh-2020-003423 ◽

2020 ◽

Vol 5 (11) ◽

pp. e003423

Author(s):

Dongqing Wang ◽

Molin Wang ◽

Anne Marie Darling ◽

Nandita Perumal ◽

Enju Liu ◽

...

Keyword(s):

Weight Gain ◽

North Africa ◽

Low Income ◽

Sub Saharan Africa ◽

Middle Income ◽

Middle Income Countries ◽

Gestational Weight ◽

Latin America And Caribbean ◽

Nationally Representative ◽

Sub Saharan

IntroductionGestational weight gain (GWG) has important implications for maternal and child health and is an ideal modifiable factor for preconceptional and antenatal care. However, the average levels of GWG across all low-income and middle-income countries of the world have not been characterised using nationally representative data.MethodsGWG estimates across time were computed using data from the Demographic and Health Surveys Program. A hierarchical model was developed to estimate the mean total GWG in the year 2015 for all countries to facilitate cross-country comparison. Year and country-level covariates were used as predictors, and variable selection was guided by the model fit. The final model included year (restricted cubic splines), geographical super-region (as defined by the Global Burden of Disease Study), mean adult female body mass index, gross domestic product per capita and total fertility rate. Uncertainty ranges (URs) were generated using non-parametric bootstrapping and a multiple imputation approach. Estimates were also computed for each super-region and region.ResultsLatin America and Caribbean (11.80 kg (95% UR: 6.18, 17.41)) and Central Europe, Eastern Europe and Central Asia (11.19 kg (95% UR: 6.16, 16.21)) were the super-regions with the highest GWG estimates in 2015. Sub-Saharan Africa (6.64 kg (95% UR: 3.39, 9.88)) and North Africa and Middle East (6.80 kg (95% UR: 3.17, 10.43)) were the super-regions with the lowest estimates in 2015. With the exception of Latin America and Caribbean, all super-regions were below the minimum GWG recommendation for normal-weight women, with Sub-Saharan Africa and North Africa and Middle East estimated to meet less than 60% of the minimum recommendation.ConclusionThe levels of GWG are inadequate in most low-income and middle-income countries and regions. Longitudinal monitoring systems and population-based interventions are crucial to combat inadequate GWG in low-income and middle-income countries.

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P1586Research network in Africa (RNA): antihypertensive drugs strategies in 12 African countries

European Heart Journal ◽

10.1093/eurheartj/ehz748.0346 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Kane ◽

P Cavagna ◽

I B Diop ◽

B Gaye ◽

J B Mipinda ◽

...

Keyword(s):

Blood Pressure ◽

Low Income ◽

Democratic Republic ◽

Antihypertensive Drugs ◽

Sub Saharan Africa ◽

Low Income Countries ◽

African Countries ◽

Middle Income ◽

Middle Income Countries ◽

Sub Saharan

Abstract Background High Blood Pressure is the worldwide leading global burden of disease risk factor. In Sub-Saharan Africa, the number of adults with raised blood pressure has alarmingly increased from 0.59 to 1.13 billion between 1975 and 2015. Blood pressure-lowering medicines are cornerstone of cardiovascular risk reduction. Data on management of anti-hypertensive drugs in sub-Saharan Africa are squarce. Purpose Our study aims to describe antihypertensive drugs strategies in Africa. Methods We conducted a cross-sectional survey in urban clinics during outpatient consultation specialized in hypertension cardiology departments of 29 medical centers from 17 cities across 12 African countries (Benin, Cameroon, Congo, Democratic Republic of Congo, Gabon, Guinea, Ivory Coast, Mauritania, Mozambic, Niger, Senegal, Togo). Data were collected on demographics, treatment and standardized BP measures were made among the hypertensive patients attending the clinics. Country income was retrieved from the World Bank database. All analyses were performed through scripts developed in the R software (3.4.1 (2017–06–30)). Results A total of 2198 hypertensive patients (58.4±11.8 years; 39.9% male) were included. Among whom 2123 (96.6%) had at least one antihypertensive drug. Overall, 30.8% (n=653) received monotherapy and calcium-channel blockers (49.6%) were the most common monotherapy prescribed follow by diuretics (18.7%). Two-drug strategies were prescribed for 927 patients (43.6%). Diuretics and Angiotensin-converting enzyme inhibitors was the combination most frequently prescribed (33.7%). Combination of three drugs or more was used in 25.6% (n=543) of patients. The proportion of drugs strategies differed significantly according to countries (p<0.001), monotherapy ranged from 12.7% in Niger to 47.1% in Democratic Republic of the Congo (figure). Furthermore we observed a significantly difference of strategies between low and middle income countries (55.3% and 44.7% of monotherapy respectively) (p<0.001). According to hypertension grades 1, 2 and 3, the proportion of three-drugs or more combination was 25%, 28% and 34% in middle-income and lower in low-income countries (18%, 19% and 25%). Furthermore, Grade 3 hypertension in low income countries was still treated with monotherapy (36%) instead of 19% in middle income countries (p<0.01). Antihypertensive strategies by country Conclusion Our study described antihypertensive drugs use across 12 sub-Saharan countries, and identified disparities specific to the income context. Inequity in access to drugs combination is a serious barrier to tackle the burden of hypertension in Africa.

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Strategies used to establish palliative care in rural low- and middle-income countries: an integrative review

Health Policy and Planning ◽

10.1093/heapol/czaa051 ◽

2020 ◽

Vol 35 (8) ◽

pp. 1110-1129

Author(s):

Atsede Aregay ◽

Margaret O’Connor ◽

Jill Stow ◽

Nicola Ayers ◽

Susan Lee

Keyword(s):

Palliative Care ◽

Low Income ◽

Rural Areas ◽

Urban Areas ◽

Care Home ◽

Sub Saharan Africa ◽

Integrative Review ◽

Middle Income ◽

Middle Income Countries ◽

Low And Middle Income

Abstract Globally, 40 million people need palliative care; about 69% are people over 60 years of age. The highest proportion (78%) of adults are from low- and middle-income countries (LMICs), where palliative care still developing and is primarily limited to urban areas. This integrative review describes strategies used by LMICs to establish palliative care in rural areas. A rigorous integrative review methodology was utilized using four electronic databases (Ovid MEDLINE, Ovid Emcare, Embase classic+Embase and CINAHL). The search terms were: ‘palliative care’, ‘hospice care’, ‘end of life care’, ‘home-based care’, ‘volunteer’, ‘rural’, ‘regional’, ‘remote’ and ‘developing countries’ identified by the United Nations (UN) as ‘Africa’, ‘Sub-Saharan Africa’, ‘low-income’ and ‘middle- income countries’. Thirty papers published in English from 1990 to 2019 were included. Papers were appraised for quality and extracted data subjected to analysis using a public health model (policy, drug availability, education and implementation) as a framework to describe strategies for establishing palliative care in rural areas. The methodological quality of the reviewed papers was low, with 7 of the 30 being simple programme descriptions. Despite the inclusion of palliative care in national health policy in some countries, implementation in the community was often reliant on advocacy and financial support from non-government organizations. Networking to coordinate care and medication availability near-patient homes were essential features of implementation. Training, role play, education and mentorship were strategies used to support health providers and volunteers. Home- and community-based palliative care services for rural LMICs communities may best be delivered using a networked service among health professionals, community volunteers, religious leaders and technology.

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Evidence gap map of performance measurement and management in primary healthcare systems in low-income and middle-income countries

BMJ Global Health ◽

10.1136/bmjgh-2019-001451 ◽

2019 ◽

Vol 4 (Suppl 8) ◽

pp. e001451 ◽

Cited By ~ 2

Author(s):

Wolfgang Munar ◽

Birte Snilstveit ◽

Ligia Esther Aranda ◽

Nilakshi Biswas ◽

Theresa Baffour ◽

...

Keyword(s):

Performance Measurement ◽

Systematic Reviews ◽

Low Income ◽

Primary Healthcare ◽

Implementation Strategies ◽

Sub Saharan Africa ◽

Audit And Feedback ◽

Unintended Effects ◽

Middle Income ◽

Middle Income Countries

IntroductionWe mapped available evidence on performance measurement and management (PMM) strategies in primary healthcare (PHC) systems of low-income and middle-income countries (LMICs). Widely used, their effectiveness remains inconclusive. This evidence gap map characterises existing research and evidence gaps.MethodsSystematic mapping of performance measurement and management research in LMICs from 2000 to mid-2018; literature searches of seven academic databases and institutional repositories of impact evaluations and systematic reviews. Using a combination of manual screening and machine learning, four reviewers appraised 38 088 titles and abstracts, and extracted metadata from 137 impact evaluations and 18 systematic reviews that met the inclusion criteria. The resulting visual representation of the evidence base was uploaded to a web-based platform.ResultsSince 2000, the number of studies has increased; the first systematic reviews were completed in 2010. Two-thirds of the studies were conducted in sub-Saharan Africa and South Asia. Randomised controlled trials were the most frequently used study design. The evidence is concentrated in two types of PMM strategies: implementation strategies (in-service training, continuing education, supervision) and performance-based financing. Major gaps exist in accountability arrangements particularly the use of audit and feedback. The least studied types of outcomes were unintended effects, harm and social equity.ConclusionsThe evidence is clustered around interventions that are unlikely to achieve transformational change in health outcomes. The gaps identified suggest that routinely used PMM strategies are implemented without sufficient knowledge of their effects. Future efforts at redesigning PHC systems need to be informed by evidence on the most effective approaches for using PMM strategies.

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Is overseas volunteering beneficial to the NHS? The analysis of volunteers’ responses to a feedback questionnaire following experiences in low-income and middle-income countries

BMJ Open ◽

10.1136/bmjopen-2017-017517 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017517 ◽

Cited By ~ 5

Author(s):

Daniel Yeomans ◽

Grace Le ◽

Hemant Pandit ◽

Chris Lavy

Keyword(s):

Professional Development ◽

Low Income ◽

Personal Development ◽

Positive Impact ◽

Sub Saharan Africa ◽

Middle Income ◽

Middle Income Countries ◽

Feedback Questionnaire ◽

Sub Saharan ◽

The Uk

IntroductionLocally requested and planned overseas volunteering in low-income and middle-income countries by National Health Service (NHS) staff can have benefits for the host or receiving nation, but its impact on the professional development of NHS staff is not proven. The Knowledge and Skills Framework (KSF) and Leadership Framework (LF) are two tools used by employers as a measure of individuals' development. We have used dimensions from both tools as a method of evaluating the benefit to NHS doctors who volunteer overseas.Methods88 NHS volunteers participating with local colleagues in Primary Trauma Care and orthopaedic surgical training courses in sub-Saharan Africa were asked to complete an online self-assessment questionnaire 6 months following their return to the UK. The survey consisted of questions based on qualities outlined in both the KSF and LF.Results85 completed responses to the questionnaire were received. In every KSF domain assessed, the majority of volunteers agreed that their overseas volunteering experience improved their practice within the NHS. Self-assessed pre-course and post-course scores evaluating the LF also saw a universal increase, notably in the ‘working with others’ domain.DiscussionThere is a growing body of literature outlining the positive impact of overseas volunteering on NHS staff. Despite increasing evidence that such experiences can develop volunteers’ essential skills, individuals often find it difficult to gain support of their employers. Our study, in line with the current literature, shows that overseas volunteering by NHS staff can provide an opportunity to enhance professional and personal development. Skills gained from volunteering within international links match many of the qualities outlined in both KSF and LF, directly contributing to volunteers’ continued professional development.

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On the Initial Establishment of Quality Assurance System for Indemnificatory Housing

Applied Mechanics and Materials ◽

10.4028/www.scientific.net/amm.94-96.2213 ◽

2011 ◽

Vol 94-96 ◽

pp. 2213-2216

Author(s):

Wei Xu ◽

Yan Yan

Keyword(s):

Quality Assurance ◽

Low Income ◽

Large Scale ◽

Control Measures ◽

Urban Residents ◽

Quality Assurance System ◽

Housing Project ◽

Construction Enterprises ◽

Assurance System ◽

Strict Requirement

The comfortable housing project for low-income urban residents possess many special characteristics such as large numbers, dispersed distribution, the large-scale of construction, urgent time schedule and strict requirement of high quality. To ensure reasonable period and construction cost, it is also necessary to reform and innovate the way of construction management thinking and working methods. Pre-control measures of construction quality are put with emphasis on transforming passivity supervision into initiative forewarning. Management efficiency of the comfortable housing project can be enhanced. The comfortable housing project for low-income urban residents is built into environmental project taken to develop energy-saving and ground-saving residential in our country. It is a realistic and sharp contradiction that construction enterprises are pursuing profit when indemnificatory housing constructing is weak of profit, and that it is an easily occurred problem that the quality of indemnificatory housing is not security. In this paper, based on the six sigma quality management the Quality Assurance System of indemnificatory housing is put forward, which can be regarded as guidance for construction enterprises.

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Acquired heart disease in low-income and middle-income countries

Archives of Disease in Childhood ◽

10.1136/archdischild-2016-312521 ◽

2017 ◽

Vol 103 (1) ◽

pp. 73-77 ◽

Cited By ~ 4

Author(s):

Chris Curry ◽

Liesl Zuhlke ◽

Ana Mocumbi ◽

Neil Kennedy

Keyword(s):

Heart Disease ◽

Low Income ◽

Burden Of Illness ◽

Sub Saharan Africa ◽

Endomyocardial Fibrosis ◽

Middle Income ◽

Mortality And Morbidity ◽

Middle Income Countries ◽

Acquired Heart Disease ◽

Sub Saharan

The burden of illness associated with acquired cardiac disease in children in low-income and middle-income countries (LMIC) is significant and may be equivalent to that of congenital heart disease. Rheumatic heart disease, endomyocardial fibrosis, cardiomyopathy (including HIV cardiomyopathy) and tuberculosis are the most important causes. All are associated with poverty with the neediest children having the least access to care. The associated mortality and morbidity is high. There is an urgent need to improve cardiac care in LMIC, particularly in sub-Saharan Africa and parts of Southeast Asia where the burden is highest.

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

Acta Radiologica ◽

10.1177/0284185116658681 ◽

2016 ◽

Vol 58 (4) ◽

pp. 442-448 ◽

Cited By ~ 3

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.

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COVID-19 preparedness—a survey among neonatal care providers in low- and middle-income countries

Journal of Perinatology ◽

10.1038/s41372-021-01019-4 ◽

2021 ◽

Author(s):

Claus Klingenberg ◽

◽

Sahil K. Tembulkar ◽

Anna Lavizzari ◽

Charles C. Roehr ◽

...

Keyword(s):

Low Income ◽

Care Delivery ◽

Neonatal Care ◽

Sub Saharan Africa ◽

World Health ◽

Care Providers ◽

Clinical Practices ◽

Middle Income ◽

Middle Income Countries ◽

Low And Middle Income

Abstract Objective To evaluate COVID-19 pandemic preparedness, available resources, and guidelines for neonatal care delivery among neonatal health care providers in low- and middle-income countries (LMICs) across all continents. Study design Cross-sectional, web-based survey administered between May and June, 2020. Results Of 189 invited participants in 69 LMICs, we received 145 (77%) responses from 58 (84%) countries. The pandemic provides significant challenges to neonatal care, particularly in low-income countries. Respondents noted exacerbations of preexisting shortages in staffing, equipment, and isolation capabilities. In Sub-Saharan Africa, 9/35 (26%) respondents noted increased mortality in non-COVID-19-infected infants. Clinical practices on cord clamping, isolation, and breastfeeding varied widely, often not in line with World Health Organization guidelines. Most respondents noted family access restrictions, and limited shared decision-making. Conclusions Many LMICs face an exacerbation of preexisting resource challenges for neonatal care during the pandemic. Variable approaches to care delivery and deviations from guidelines provide opportunities for international collaborative improvement.

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