Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients

Wafula, Francis; Dolinger, Amy; Daniels, Benjamin; Mwaura, Njeri; Bedoya, Guadalupe; Rogo, Khama; Goicoechea, Ana; Das, Jishnu; Olayo, Bernard

doi:10.1007/s40801-016-0100-7

Cited by 18 publications

(13 citation statements)

References 18 publications

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“…Regarding antibiotics, Mwambete and colleagues (2014) found "variability in the effectiveness of antibiotics available" in the northern border region of Tanzania [53], and in Uganda, Kitutu and the Uganda Medicines Transparency Alliance (2017) reported various antibiotic samples that failed a thin layer chromatography (TLC) test [54]. Poor-quality drugs have been detected also in public health facilities, for example, in Kenya, where Wafula and colleagues (2017) documented drug samples (including antibiotics), which did not pass compendial tests [55].…”

Section: Aspects Of Qualitymentioning

confidence: 99%

Addressing antimicrobial resistance by improving access and quality of care—A review of the literature from East Africa

et al. 2021

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Universal access to healthcare, including quality medicines, is a fundamental human right but is still out of reach for many in low- and middle-income countries (LMICs). An existing framework capturing variability of access to healthcare in low-resource settings includes the 5 dimensions: availability, accessibility, affordability, adequacy, and acceptability. This framework encompasses key components, including health infrastructure and means to access it as well as service organisation, costs, and factors that influence users’ satisfaction. However, in reality, the effectiveness of accessed healthcare is measured by the likelihood of a positive outcome. We therefore propose an expansion of this framework to include an additional dimension, “aspects of quality,” incorporating quality, which critically influences the ability of the accessed services to generate optimal health outcomes. Within this framework, we explore literature from East Africa likely relevant to a range of LMIC contexts, mainly focusing on the provision of widely used antimicrobials such as antimalarials and antibiotics. We argue that major inadequacies exist across all 6 dimensions of access and quality of drugs and their provision. While the global focus is on curbing excessive antimicrobial use to tackle the antimicrobial resistance (AMR) crisis, major constraints around access shape patients’ health-seeking decisions leading to potentially problematic practices that might exacerbate the AMR problem. We advocate for a holistic approach to tackling these inadequacies, encompassing all dimensions of access and quality of healthcare in order to improve health outcomes while simultaneously counteracting the AMR crisis.

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Section: Aspects Of Qualitymentioning

confidence: 99%

Addressing antimicrobial resistance by improving access and quality of care—A review of the literature from East Africa

et al. 2021

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“…use techniques like Likert scales. Second, if collecting data on things like medication use or food supplies, collect, for example, the brand name of the product, the generic name of the product, a coded identifier for the item, and the broad category to which each product belongs (for example, "antibiotics" or "staple foods") (for an example, see Wafula et al 2017).…”

Section: Programming Electronic Survey Instrumentsmentioning

confidence: 99%

Development Research in Practice: The DIME Analytics Data Handbook

Bjärkefur¹,

Andrade²,

Daniels³

et al. 2021

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Some rights reserved 1 2 3 4 24 23 22 21This work is a product of the staff of The World Bank with external contributions. The findings, interpretations, and conclusions expressed in this work do not necessarily reflect the views of The World Bank, its Board of Executive Directors, or the governments they represent. The World Bank does not guarantee the accuracy, completeness, or currency of the data included in this work and does not assume responsibility for any errors, omissions, or discrepancies in the information, or liability with respect to the use of or failure to use the information, methods, processes, or conclusions set forth. The boundaries, colors, denominations, and other information shown on any map in this work do not imply any judgment on the part of The World Bank concerning the legal status of any territory or the endorsement or acceptance of such boundaries.Nothing herein shall constitute or be construed or considered to be a limitation upon or waiver of the privileges and immunities of The World Bank, all of which are specifically reserved.

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“…Standardised patient actors (SPs) are an evidence-based training method for improving provider competency and quality of care. [22][23][24][25][26] SPs have been used to train providers in a variety of clinical skills, 27 leading to improved patient outcomes. 28 29 Increasingly, SPs are used as 'mystery shoppers' posing as real patients to assess provider compliance with clinical guidelines.…”

Section: Trial Registration Number Nct03875950mentioning

confidence: 99%

Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial

et al. 2020

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IntroductionAdolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) demonstration projects observe that AGYW uptake and adherence to PrEP during risk periods is suboptimal. Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW. Improving HCW competency and communication to support PrEP delivery to AGYW requires new strategies.Methods and analysisPrEP Implementation for Young Women and Adolescents Program-standardised patient (PrIYA-SP) is a cluster randomised trial of a standardised patient actor (SP) training intervention designed to improve HCW adherence to PrEP guidelines and communication skills. We purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya. At baseline, unannounced SP ‘mystery shoppers’ present to clinics portraying AGYW in common PrEP scenarios for a cross-sectional assessment of PrEP delivery. Twelve facilities will be randomised to receive a 2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing. Unannounced SPs will repeat the assessment in all 24 sites following the intervention. The primary outcome is quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist by SPs blinded to intervention assignment. An intention-to-treat (ITT) analysis will evaluate whether the intervention resulted in higher scores within intervention compared with control facilities, adjusted for baseline SP scores and accounting for clustering by facility. We hypothesise that the intervention will improve quality of PrEP counselling compared with standard of care. Results from this study will inform guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve service delivery for this high-risk group.Ethics and disseminationThe protocol was approved by institutional review boards at Kenyatta National Hospital and University of Washington. An external advisory committee monitors social harms. Results will be disseminated through peer-reviewed journals and presentations.Trial registration numberNCT03875950

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Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients

Cited by 18 publications

References 18 publications

Addressing antimicrobial resistance by improving access and quality of care—A review of the literature from East Africa

Addressing antimicrobial resistance by improving access and quality of care—A review of the literature from East Africa

Development Research in Practice: The DIME Analytics Data Handbook

Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial

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