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Your search keyword '"Jacqueline Miot"' showing total 2 results
Start Over Author "Jacqueline Miot" Journal bmc public health
2 results on '"Jacqueline Miot"'

1. Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

Author

Margareth Ndomondo-Sigonda, Jacqueline Miot, Shan Naidoo, Nelson E. Masota, Brian Ng’andu, Nancy Ngum, and Eliangiringa Kaale

Subjects
East African community, Medical products regulation, Regulatory capacity, Africa regulatory harmonization, Registration, Regulatory inspection, Public aspects of medicine, RA1-1270
Abstract

Abstract Background Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. This study focused on assessing the effect of the East African Community (EAC) medicines regulatory harmonization initiative on the capacity of national medicines regulatory agencies, with a focus on registration and inspection systems. Methods An exploratory mixed-method design using both qualitative and quantitative data to access data from six national medicines regulatory authorities (NMRAs) and the EAC Secretariat. Data was collected using a combination of semi-structured interviews, questionnaires, and checklists for the period 2010/11–2015/16 with 2010/11 data serving as baseline. Heads of NMRAs, regulatory and monitoring and evaluation experts, and the EAC Secretariat Project Officer were enrolled in the study. A set of 14 indicators grouped into 6 categories were used to assess NMRAs performance. Results Policy and legal frameworks provide a foundation for effective regulation. Collaboration, harmonization, joint dossier reviews and inspections of manufacturing sites, reliance and cooperation are key factors for building trust and capacity among NMRAs. Five out of six of the EAC Partner States have comprehensive medicines laws with autonomous NMRAs. All the NMRAs have functional registration and good manufacturing practice inspection systems supported by regional harmonised guidelines for registration, inspection, quality management and information management systems with four NMRAs attaining ISO 9001:2015 certification. Conclusions The EAC regulatory harmonization initiative has contributed to improved capacity to regulate medical products. The indicators generated from this research can be replicated for evaluation of similar initiatives across and beyond the African continent and contribute to public health policy.

Published
2021
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2. Primary healthcare seeking behaviour of low-income patients across the public and private health sectors in South Africa

Author

Jacqueline Miot, Daniel Letswalo, Sarah J Girdwood, Gesine Meyer-Rath, Kerensa Govender, and Lawrence Long

Subjects
Low income, medicine.medical_specialty, NHI, Population, Primary health care, South Africa, Preferences, Epidemiology, Humans, Medicine, education, Socioeconomics, education.field_of_study, Public Sector, Health care seeking behaviour, Primary Health Care, business.industry, Research, Public health, Public sector, Public Health, Environmental and Occupational Health, Patient Acceptance of Health Care, Private sector, Utilisation, Private Sector, Public aspects of medicine, RA1-1270, Biostatistics, business, Primary healthcare
Abstract

Background The proposed National Health Insurance (NHI) system aims to re-engineer primary healthcare (PHC) in South Africa, envisioning both private sector providers and public sector clinics as independent contracting units to the NHI Fund. In 2017, 16% of the South African population had private medical insurance and predominately utilised private providers. However, it is estimated that up to 28% of the population access private PHC services, with a meaningful segment of the low-income, uninsured population paying for these services out-of-pocket. The study objective was to characterise the health seeking behaviour of low-income, patients accessing PHC services in both the public and private sectors, patient movement between sectors, and factors influencing their facility choice. Methods We conducted once-off patient interviews on a random sample of 153 patients at 7 private PHC providers (primarily providing services to the low-income mostly uninsured patient population) and their matched public PHC clinic (7 facilities). Results The majority of participants were economically active (96/153, 63%), 139/153 (91%) did not have health insurance, and 104/153 (68%) earned up to $621/month. A multiple response question found affordability (67%) and convenience (60%) were ranked as the most important reasons for choosing to usually access care at public clinics (48%); whilst convenience (71%) and quality of care (59%) were key reasons for choosing the private sector (32%). There is movement between sectors: 23/76 (30%) of those interviewed at a private facility and 8/77 (10%) of those interviewed at a public facility indicated usually accessing PHC services at a mix of private and public facilities. Results indicate cycling between the private and public sectors with different factors influencing facility choice. Conclusions It is imperative to understand the potential impact on where PHC services are accessed once affordability is mitigated through the NHI as this has implications on planning and contracting of services under the NHI.

Published
2021
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