Anti-malarial medicine quality field studies and surveys: a systematic review of screening technologies used and reporting of findings.

BACKGROUND: Assessing the quality of medicines in low-middle income countries (LMICs) relies primarily on human inspection and screening technologies, where available. Field studies and surveys have frequently utilized screening tests to analyse medicines sampled at the point of care, such as health care facilities and medicine outlets, to provide a snap shot of medicine quality in a specific geographical area. This review presents an overview of the screening tests typically employed in surveys to assess anti-malarial medicine quality, summarizes the analytical methods used, how findings have been reported and proposes a reporting template for future studies. METHODS: A systematic search of the peer-reviewed and grey literature available in the public domain (including national and multi-national medicine quality surveys) covering the period 1990-2016 was undertaken. Studies were included if they had used screening techniques to assess the quality of anti-malarial medicines. As no standardized set of guidelines for the methodology and reporting of medicine quality surveys exist, the included studies were assessed for their standard against a newly proposed list of criteria. RESULTS: The titles and abstracts of 4621 records were screened and only 39 were found to meet the eligibility criteria. These 39 studies utilized visual inspection, disintegration, colorimetry and Thin Layer Chromatography (TLC) either as components of the Global Pharma Health Fund (GPHF) MiniLab® or as individual tests. Overall, 30/39 studies reported employing confirmatory testing described in international pharmacopeia to verify the quality of anti-malarials post assessment by a screening test. The authors assigned scores for the 23 criteria for the standard of reporting of each study. CONCLUSIONS: There is considerable heterogeneity in study design and inconsistency in reporting of field surveys of medicine quality. A lack of standardization in the design and reporting of studies of medicine quality increases the risk of bias and error, impacting on the generalizability and reliability of study results. The criteria proposed for reporting on the standard of studies in this review can be used in conjunction with existing medicine quality survey guidelines as a checklist for designing and reporting findings of studies. The review protocol has been registered with PROSPERO (CRD42015026782)

A cross-sectional study to identify the distribution and characteristics of licensed and unlicensed private drug shops in rural Eastern Uganda to inform an iCCM intervention to improve health outcomes for children under five years

Introduction: Malaria, pneumonia and diarrhea are leading causes of death in young children in Uganda. Between 50-60% of sick children receive treatment from the private sector, especially drug shops. There is an urgent need to improve quality of care and regulation of private drug shops in Uganda. This study was conducted to determine the distribution, the licensing status and characteristics of drug shops in four sub-districts of Kamuli district. Methods: This study was part of a pre-post cross sectional study that examined the implementation of an integrated Community Case Management (iCCM) intervention for common childhood illness in rural private drug shops in Kamuli District in Eastern Uganda. This mapping exercise used a snowball sampling technique to identify licensed and unlicensed drug shops and collect information about their characteristics. Data were collected using a questionnaire. GPS data were collected for all drug shops. Analysis: Quantitative data were analyzed using SPSS for descriptive statistics. Open ended questions were entered into NVivo 10 and analyzed using thematic analysis strategies. Results: In total, 215 drug shops in 284 villages were located. Of these, 123 (57%) were open and consented to an interview. Only 12 (10%) drug shops were licensed, 93 (76%) were unlicensed, and the licensing status of 18 (15%) was unknown. Most respondents were the owner of the drug shop (88%); most drug sellers reported their qualification as nursing assistants (70%). Drug sellers reported licensing fees and costs of contracting an "in-charge" as barriers to licensing. Nearly all drug shops sold drugs for malaria (91%) and antibiotics (79%)

Private retail drug shops: what they are, how they operate, and implications for health care delivery in rural Uganda

Background Retail drug shops play a significant role in managing pediatric fevers in rural areas in Uganda. Targeted interventions to improve drug seller practices require understanding of the retail drug shop market and motivations that influence practices. This study aimed at describing the operational environment in relation to the Uganda National Drug Authority guidelines for setup of drug shops; characteristics, and dispensing practices of private retail drug shops in managing febrile conditions among under-five children in rural western Uganda. Methods Cross sectional survey of 74 registered drug shops, observation checklist, and 428 exit interviews using a semi-structured questionnaire with care-seekers of children under five years of age, who sought care at drug shops during the survey period. The survey was conducted in Mbarara and Bushenyi districts, South Western Uganda, in May 2013. Results Up to 90 and 79% of surveyed drug shops in Mbarara and Bushenyi, largely operate in premises that meet National Drug Authority requirements for operational suitability and ensuring medicines safety and quality. Drug shop attendants had some health or medical related training with 60% in Mbarara and 59% in Bushenyi being nurses or midwives. The rest were clinical officers, pharmacists. The most commonly stocked medicines at drug shops were Paracetamol, Quinine, Cough syrup, ORS/Zinc, Amoxicillin syrup, Septrin® syrup, Artemisinin-based combination therapies, and multivitamins, among others. Decisions on what medicines to stock were influenced by among others: recommended medicines from Ministry of Health, consumer demand, most profitable medicines, and seasonal disease patterns. Dispensing decisions were influenced by: prescriptions presented by client, patients’ finances, and patient preferences, among others. Most drug shops surveyed had clinical guidelines, iCCM guidelines, malaria and diarrhea treatment algorithms and charts as recommended by the Ministry of Health. Some drug shops offered additional services such as immunization and sold non-medical goods, as a mechanism for diversification. Conclusion Most drug shops premises adhered to the recommended guidelines. Market factors, including client demand and preferences, pricing and profitability, and seasonality largely influenced dispensing and stocking practices. Improving retail drug shop practices and quality of services, requires designing and implementing both supply-side and demand side strategies

The paradoxical surplus of health workers in Africa: The need for research and policy engagement.

In many countries in Africa, there is a 'paradoxical surplus' of under and unemployed nurses, midwives, doctors and pharmacists which exists amidst a shortage of staff within the formal health system. By 2030, the World Health Organisation Africa Region may find itself with a shortage of 6.1 million health workers alongside 700,000 un- or underemployed health staff. The emphasis in policy debates about human resources for health at most national and global levels is on staff shortage and the need to train more health workers. In contrast, these 'surplus' health workers are both understudied and underacknowledged. Little time is given over to understand the economic, political and social factors that have driven their emergence; the ways in which they seek to make a living; the governance challenges that they raise; nor potential interventions that could be implemented to improve employment rates and leverage their expertise. This short communication reflects on current research findings and calls for improved quantitative and qualitative research to support policy engagement at national, regional and global levels

Crossover-use of human antibiotics in livestock in agricultural communities: a qualitative cross-country comparison between Uganda, Tanzania and India

Antibiotic use in animal agriculture contributes significantly to antibiotic use globally and is a key driver of the rising threat of antibiotic resistance. It is becoming increasingly important to better understand antibiotic use in livestock in low-and-middle income countries where antibiotic use is predicted to increase considerably as a consequence of the growing demand for animal-derived products. Antibiotic crossover-use refers to the practice of using antibiotic formulations licensed for humans in animals and vice versa. This practice has the potential to cause adverse drug reactions and contribute to the development and spread of antibiotic resistance between humans and animals. We performed secondary data analysis of in-depth interview and focus-group discussion transcripts from independent studies investigating antibiotic use in agricultural communities in Uganda, Tanzania and India to understand the practice of antibiotic crossover-use by medicine-providers and livestock-keepers in these settings. Thematic analysis was conducted to explore driving factors of reported antibiotic crossover-use in the three countries. Similarities were found between countries regarding both the accounts of antibiotic crossover-use and its drivers. In all three countries, chickens and goats were treated with human antibiotics, and among the total range of human antibiotics reported, amoxicillin, tetracycline and penicillin were stated as used in animals in all three countries. The key themes identified to be driving crossover-use were: (1) medicine-providers’ and livestock-keepers’ perceptions of the effectiveness and safety of antibiotics, (2) livestock-keepers’ sources of information, (3) differences in availability of human and veterinary services and antibiotics, (4) economic incentives and pressures. Antibiotic crossover-use occurs in low-intensity production agricultural settings in geographically distinct low-and-middle income countries, influenced by a similar set of interconnected contextual drivers. Improving accessibility and affordability of veterinary medicines to both livestock-keepers and medicine-providers is required alongside interventions to address understanding of the differences between human and animal antibiotics, and potential dangers of antibiotic crossover-use in order to reduce the practice. A One Health approach to studying antibiotic use is necessary to understand the implications of antibiotic accessibility and use in one sector upon antibiotic use in other sectors

Antibiotic Prescribing Patterns in Ghana, Uganda, Zambia and Tanzania Hospitals: Results from the Global Point Prevalence Survey (G-PPS) on Antimicrobial Use and Stewardship Interventions Implemented

Antimicrobial resistance (AMR) remains an important global public health issue with antimicrobial misuse and overuse being one of the main drivers. The Global Point Prevalence Survey (G-PPS) of Antimicrobial Consumption and Resistance assesses the prevalence and the quality of antimicrobial prescriptions across hospitals globally. G-PPS was carried out at 17 hospitals across Ghana, Uganda, Zambia and Tanzania. The overall prevalence of antimicrobial use was 50% (30–57%), with most antibiotics prescribed belonging to the WHO ‘Access’ and ‘Watch’ categories. No ‘Reserve’ category of antibiotics was prescribed across the study sites while antimicrobials belonging to the ‘Not Recommended’ group were prescribed infrequently. Antimicrobials were most often prescribed for prophylaxis for obstetric or gynaecological surgery, making up between 12 and 18% of total prescriptions across all countries. The most prescribed therapeutic subgroup of antimicrobials was ‘Antibacterials for systemic use’. As a result of the programme, PPS data are now readily available for the first time in the hospitals, strengthening the global commitment to improved antimicrobial surveillance. Antimicrobial stewardship interventions developed included the formation of AMS committees, the provision of training and the preparation of new AMS guidelines. Other common interventions included the presentation of findings to clinicians for increased awareness, and the promotion of a multi-disciplinary approach to successful AMS programmes. Repeat PPS would be necessary to continually monitor the impact of interventions implemented. Broader participation is also encouraged to strengthen the evidence base

Towards a functioning retail health market : Evaluating the integrated Community Case Management Intervention for Pediatric Febrile Illness in Drug Shops in Rural South Western Uganda

Objectives: This thesis examined the health systems effects of implementing the integrated Community Case Management (iCCM) intervention for paediatric febrile illnesses in a retail health market in South Western Uganda. More specifically, it evaluated drug seller interpretation of malaria Rapid Diagnostics Test (RDT) results (study I), adherence to iCCM guidelines (study II) and the intervention effect on households’ perceived quality of drug seller fever care and care-seeking choice. Study IV qualitatively analysed the iCCM intervention implementation and causal mechanisms for observed effects. Improved understanding of such retail health markets will inform policy decisions and interventions for Universal Health Coverage. Methods: The study used mixed-methods design with an intervention and comparison arm, and pre-test assessment in both study arms. Data collection methods included care-seeker drug shop exit interviews and household surveys using structured questionnaires, focus group discussions, in-depth interviews, review of secondary data and a laboratory analysis of finger-prick capillary blood samples. Results: Among those tested for malaria parasites, there was 93% (95% CI 88.3, 96.2) agreement between drug sellers and laboratory scientist re-reading and with a kappa value of 0.84 (95% CI 0.75, 0.92) (Study I). The drug seller compliance with the reported malaria RDT results was 92.5% (95% CI 87.9, 95.7) (Study I). The iCCM intervention improved appropriate treatment for uncomplicated malaria by 34.5% (95% CI 8.6, 60.4), for pneumonia symptoms by 54.7% (95% CI 28.4, 81.0) and reduced appropriate treatment for non-bloody diarrhoea -11.2% (95% CI -65.5, 43.1), after adjusting for extraneous variables (Study II). Implementing the iCCM intervention in drug shops decreased the odds of households perceiving drug seller fever care as good but increased the household odds of choosing to seek care from private health facilities versus within the community (Study III). Drug sellers operated in a retail market system influenced by knowledge and actions of care-seekers, CHWs, government health workers and regulators, and also how formal and informal rules and norms were applied (Study IV). Implementation of the iCCM intervention at drug shops was modified and shaped by the emerging actor perceptions and behaviours (Study IV). Conclusions: This thesis demonstrates the implementation, causal mechanisms and contextual factors of the iCCM intervention in a rural retail health market. Fidelity and quality of iCCM intervention by drug sellers was acceptably high, probably as a result of co-interventions. Interventions in retail health markets should comprise of components that target the multiple actors or influences that shape that market. Multi-component health system interventions are complex to implement and also create complexity in their evaluation. When technologies are involved, their analysis should go beyond their substance as products and view them as items that encapsulate interests of different actors, some of which maybe converging with or competing against societal goals

Towards a functioning retail health market : Evaluating the integrated Community Case Management Intervention for Pediatric Febrile Illness in Drug Shops in Rural South Western Uganda

Objectives: This thesis examined the health systems effects of implementing the integrated Community Case Management (iCCM) intervention for paediatric febrile illnesses in a retail health market in South Western Uganda. More specifically, it evaluated drug seller interpretation of malaria Rapid Diagnostics Test (RDT) results (study I), adherence to iCCM guidelines (study II) and the intervention effect on households’ perceived quality of drug seller fever care and care-seeking choice. Study IV qualitatively analysed the iCCM intervention implementation and causal mechanisms for observed effects. Improved understanding of such retail health markets will inform policy decisions and interventions for Universal Health Coverage. Methods: The study used mixed-methods design with an intervention and comparison arm, and pre-test assessment in both study arms. Data collection methods included care-seeker drug shop exit interviews and household surveys using structured questionnaires, focus group discussions, in-depth interviews, review of secondary data and a laboratory analysis of finger-prick capillary blood samples. Results: Among those tested for malaria parasites, there was 93% (95% CI 88.3, 96.2) agreement between drug sellers and laboratory scientist re-reading and with a kappa value of 0.84 (95% CI 0.75, 0.92) (Study I). The drug seller compliance with the reported malaria RDT results was 92.5% (95% CI 87.9, 95.7) (Study I). The iCCM intervention improved appropriate treatment for uncomplicated malaria by 34.5% (95% CI 8.6, 60.4), for pneumonia symptoms by 54.7% (95% CI 28.4, 81.0) and reduced appropriate treatment for non-bloody diarrhoea -11.2% (95% CI -65.5, 43.1), after adjusting for extraneous variables (Study II). Implementing the iCCM intervention in drug shops decreased the odds of households perceiving drug seller fever care as good but increased the household odds of choosing to seek care from private health facilities versus within the community (Study III). Drug sellers operated in a retail market system influenced by knowledge and actions of care-seekers, CHWs, government health workers and regulators, and also how formal and informal rules and norms were applied (Study IV). Implementation of the iCCM intervention at drug shops was modified and shaped by the emerging actor perceptions and behaviours (Study IV). Conclusions: This thesis demonstrates the implementation, causal mechanisms and contextual factors of the iCCM intervention in a rural retail health market. Fidelity and quality of iCCM intervention by drug sellers was acceptably high, probably as a result of co-interventions. Interventions in retail health markets should comprise of components that target the multiple actors or influences that shape that market. Multi-component health system interventions are complex to implement and also create complexity in their evaluation. When technologies are involved, their analysis should go beyond their substance as products and view them as items that encapsulate interests of different actors, some of which maybe converging with or competing against societal goals

Towards a functioning retail health market : Evaluating the integrated Community Case Management Intervention for Pediatric Febrile Illness in Drug Shops in Rural South Western Uganda

Objectives: This thesis examined the health systems effects of implementing the integrated Community Case Management (iCCM) intervention for paediatric febrile illnesses in a retail health market in South Western Uganda. More specifically, it evaluated drug seller interpretation of malaria Rapid Diagnostics Test (RDT) results (study I), adherence to iCCM guidelines (study II) and the intervention effect on households’ perceived quality of drug seller fever care and care-seeking choice. Study IV qualitatively analysed the iCCM intervention implementation and causal mechanisms for observed effects. Improved understanding of such retail health markets will inform policy decisions and interventions for Universal Health Coverage. Methods: The study used mixed-methods design with an intervention and comparison arm, and pre-test assessment in both study arms. Data collection methods included care-seeker drug shop exit interviews and household surveys using structured questionnaires, focus group discussions, in-depth interviews, review of secondary data and a laboratory analysis of finger-prick capillary blood samples. Results: Among those tested for malaria parasites, there was 93% (95% CI 88.3, 96.2) agreement between drug sellers and laboratory scientist re-reading and with a kappa value of 0.84 (95% CI 0.75, 0.92) (Study I). The drug seller compliance with the reported malaria RDT results was 92.5% (95% CI 87.9, 95.7) (Study I). The iCCM intervention improved appropriate treatment for uncomplicated malaria by 34.5% (95% CI 8.6, 60.4), for pneumonia symptoms by 54.7% (95% CI 28.4, 81.0) and reduced appropriate treatment for non-bloody diarrhoea -11.2% (95% CI -65.5, 43.1), after adjusting for extraneous variables (Study II). Implementing the iCCM intervention in drug shops decreased the odds of households perceiving drug seller fever care as good but increased the household odds of choosing to seek care from private health facilities versus within the community (Study III). Drug sellers operated in a retail market system influenced by knowledge and actions of care-seekers, CHWs, government health workers and regulators, and also how formal and informal rules and norms were applied (Study IV). Implementation of the iCCM intervention at drug shops was modified and shaped by the emerging actor perceptions and behaviours (Study IV). Conclusions: This thesis demonstrates the implementation, causal mechanisms and contextual factors of the iCCM intervention in a rural retail health market. Fidelity and quality of iCCM intervention by drug sellers was acceptably high, probably as a result of co-interventions. Interventions in retail health markets should comprise of components that target the multiple actors or influences that shape that market. Multi-component health system interventions are complex to implement and also create complexity in their evaluation. When technologies are involved, their analysis should go beyond their substance as products and view them as items that encapsulate interests of different actors, some of which maybe converging with or competing against societal goals