Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs’ capacity in Africa.

BackgroundSystematic and transparent approaches to priority setting are needed, particularly in low-resource settings, to produce decisions that are sound and acceptable to stakeholders. The EVIDEM framework brings together Health Technology Assessment (HTA) and multi-criteria decision analysis (MCDA) by proposing a comprehensive set of decision criteria together with standardized processes to support decisionmaking. The objective of the study was to field test the framework for decisionmaking on a screening test by a private health plan in South Africa.MethodsLiquid-based cytology (LBC) for cervical cancer screening was selected by the health plan for this field test. An HTA report structured by decision criterion (14 criteria organized in the MCDA matrix and 4 contextual criteria) was produced based on a literature review and input from the health plan. During workshop sessions, committee members 1) weighted each MCDA decision criterion to express their individual perspectives, and 2) to appraise LBC, assigned scores to each MCDA criterion on the basis of the by-criterion HTA report.Committee members then considered the potential impacts of four contextual criteria on the use of LBC in the context of their health plan. Feedback on the framework and process was collected through discussion and from a questionnaire.ResultsFor 9 of the MCDA matrix decision criteria, 89% or more of committee members thought they should always be considered in decisionmaking. Greatest weights were given to the criteria "Budget impact", "Cost-effectiveness" and "Completeness and consistency of reporting evidence". When appraising LBC for cervical cancer screening, the committee assigned the highest scores to "Relevance and validity of evidence" and "Disease severity". Combination of weights and scores yielded a mean MCDA value estimate of 46% (SD 7%) of the potential maximum value. Overall, the committee felt the framework brought greater clarity to the decisionmaking process and was easily adaptable to different types of health interventions.ConclusionsThe EVIDEM framework was easily adapted to evaluating a screening technology in South Africa, thereby broadening its applicability in healthcare decision making.

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The Global Action Plan on antimicrobial resistance calls for the use of antimicrobial medicines in human and animal health to be optimized, in tandem with a strengthening of the knowledge and evidence base through surveillance and research. However, there is a paucity of consumption data for African countries such as South Africa. Determining antimicrobial consumption data in low-resource settings remains a challenge. This article describes alternative mechanisms of assessing antimicrobial consumption data, such as the use of Intercontinental Marketing Services (IMS) data and contract data arising from tenders (an open Request for Proposal, RFP), as opposed to the international norms of daily defined doses per 100 patient-days or per 1000 population. Despite their limitations, these serve as indicators of antimicrobial exposure at the population level and represent an alternative method for ascertaining antimicrobial consumption in human health. Furthermore, South Africa has the largest antiretroviral treatment programme globally and carries a high burden of tuberculosis. This prompted the inclusion of antiretroviral and anti-tuberculosis antibiotic consumption data. Knowledge of antimicrobial utilization is imperative for meaningful future interventions. Baseline antimicrobial utilization data could guide future research initiatives that could provide a better understanding of the different measures of antibiotic use and the level of antibiotic resistance.

South Africa has a long history of community health workers (CHWs). It has been a journey that has required balancing constrained resources and competing priorities. CHWs form a bridge between communities and healthcare service provision within health facilities and act as the cornerstone of South Africa’s Ward-Based Primary Healthcare Outreach Teams. This study aimed to document the CHW policy implementation landscape across six provinces in South Africa and explore the reasons for local adaptation of CHW models and to identify potential barriers and facilitators to implementation of the revised framework to help guide and inform future planning. We conducted a qualitative study among a sample of Department of Health Managers at the National, Provincial and District level, healthcare providers, implementing partners [including non-governmental organizations (NGOs) who worked with CHWs] and CHWs themselves. Data were collected between April 2018 and December 2018. We conducted 65 in-depth interviews (IDIs) with healthcare providers, managers and experts familiar with CHW work and nine focus group discussions (FGDs) with 101 CHWs. We present (i) current models of CHW policy implementation across South Africa, (ii) facilitators, (iii) barriers to CHW programme implementation and (iv) respondents’ recommendations on how the CHW programme can be improved. We chronicled the differences in NGO involvement, the common facilitators of purpose and passion in the CHWs’ work and the multitude of barriers and resource limitations CHWs must work under. We found that models of implementation vary greatly and that adaptability is an important aspect of successful implementation under resource constraints. Our findings largely aligned to existing research but included an evaluation of districts/provinces that had not previously been explored together. CHWs continue to promote health and link their communities to healthcare facilities, in spite of lack of permanent employment, limited resources, such as uniforms, and low wages.