scholarly journals Results from the first South African Health Products Regulatory Authority-approved randomised trial evaluating supplementation of standard antibiotic therapy with a commercially available probiotic in South African women with bacterial vaginosis

2020 ◽  
Author(s):  
Anna-Ursula Happel ◽  
Ravesh Singh ◽  
Nireshni Mitchev ◽  
Koleka Mlisana ◽  
Heather B. Jaspan ◽  
...  
Keyword(s):  
South African ◽  
Randomised Trial ◽  
African Women ◽  
The South ◽  
African Health ◽  
Health Products ◽  
Vaginal Health ◽  
South African Women ◽  
Cure Rates ◽  
South African Health

AbstractBackgroundBacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes in women. The standard-of-care (SOC) for BV is antibiotic treatment; however, cure rates are low and recurrence frequent. In South Africa, no trial comparing probiotics to SOC for BV has been approved by the South African Health Products regulatory Authority (SAHPRA). We aimed to explore the South African regulatory and ethics environment to evaluate adjunctive probiotics for improvement of BV treatment in a randomized single-blinded trial of a locally sourced oral-vaginal-combination probiotic for vaginal health.MethodsSouth African women with symptomatic vaginal discharge were screened for BV and sexually transmitted infections (STIs) including Trichomonas vaginalis, Mycoplasma genitalium, Neisseria gonorrhoae and Chlamydia trachomatis. BV positive (by Nugent Scoring) STI negative women were randomized to Metrogel™ alone (n=12) or Metrogel™ followed by a commercially available South African oral/vaginal probiotic (Vagiforte PLUS® Combo Pack; n=18). BV cure at one month was the primary endpoint. Secondary endpoints were recurrence, symptoms, vaginal microbiota and genital inflammation over five months post-treatment, and acceptability of the administered probiotic.ResultsSAHPRA reviewed and acknowledged this trial. Overall, 44.8% of women cleared BV one month post-treatment. Despite confirmed viability of probiotic species contained in the commercial oral/vaginal probiotic, they did not appear to colonize the female genital tract of most women in the intervention group. No significant differences in BV cure rates, vaginal pH, microbiota nor IL-1α concentrations were found between SOC and intervention groups, although we were underpowered to detect small differences. Acceptability and adherence to the probiotic product was high.ConclusionNavigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial has laid the path for future trials of improved probiotic products for vaginal health in South Africa with adequate sample sizes. Acceptability of vaginally applied probiotics was high in South African women. Improvements in both the content and delivery of commercially available probiotic products for vaginal health should be considered.Trial registrationThis trial was registered on 17 October 2017 with the South African National Clinical Trial Register of the Department of Health (DOH-27-1117-5579).

scholarly journals A Proposed Regulatory Review Model to Support the South African Health Products Regulatory Authority to Become a More Efficient and Effective Agency

2020 ◽  
Author(s):  
Andrea Keyter ◽  
Sam Salek ◽  
Shabir Banoo ◽  
Stuart Walker
Keyword(s):  
South African ◽  
Regulatory Authority ◽  
The South ◽  
Regulatory Review ◽  
Regulatory Systems ◽  
African Health ◽  
Health Products ◽  
Review Model ◽  
South African Health ◽  
Regulatory Performance

Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new regulatory review model for improved regulatory performance, underpinned by the parameters of the World Health Organization Global Benchmarking Tool (WHO GBT) that support strengthening of regulatory systems. Methods: A new enhanced model for regulatory review, was developed based on the key recommendations from 6 studies, previously conducted by the authors, that were identified as fundamental elements in enhancing regulatory performance. The elements selected to define the new regulatory review model were endorsed through the integration of the parameters of the WHO GBT that, when embedded within regulatory systems, support enhanced regulatory performance. Results: Opportunities for improvement in regulatory performance were identified and include quality measures; monitoring and evaluating review times; a risk-based evaluation; transparency and communication; and training and education. An improved model for the South African regulatory review and benefit-risk (BR) assessment supported by quality decision-making was proposed as well as recommendations for the application of risk-stratification strategies, strengthening of reliance networks, reinforcing good regulatory practices (GRPs) and enhancing transparency. Conclusion: If implemented the proposed improved regulatory model may pave the way towards more efficient and transparent, streamlined review processes, coupled with increased consistency, evidence-based decision-making practices, reduced timelines and improved patients’ access to new medicines in South Africa.

scholarly journals Consulting the South African experts in physiotherapeutic stroke rehabilitation

2001 ◽  
Vol 57 (2) ◽  
pp. 32-40 ◽  
Author(s):  
L. A. Hale ◽  
C. J. Eales
Keyword(s):  
South Africa ◽  
Health Care ◽  
South African ◽  
Stroke Rehabilitation ◽  
Delphi Technique ◽  
Rehabilitation Services ◽  
The South ◽  
Innovative Methods ◽  
African Health ◽  
South African Health

This paper presents the opinions of expert physiotherapists on what constitutes optimal stroke rehabilitation in South Africa. Data were collected by the use of the Delphi technique. Consensus was reached after two rounds, and the respondents’ views are summarised and discussed within the framework of South African health care. Results showed that physiotherapy was felt to be very important after stroke, and the survey created a profile of the skills that physiotherapists may require in order to work in this field. However, no new or innovative methods by which appropriate rehabilitation services could be delivered in South Africa were generated by the survey.The Delphi technique is described and its use in this survey considered.

scholarly journals Exploring corruption in the South African health sector

2015 ◽  
Vol 31 (2) ◽  
pp. 239-249 ◽  
Author(s):  
Laetitia C Rispel ◽  
Pieter de Jager ◽  
Sharon Fonn
Keyword(s):  
South African ◽  
Health Sector ◽  
The South ◽  
African Health ◽  
South African Health

scholarly journals Effects of Brain Drain on the South African Health Sector; Analysis of the Dynamics of its Push Factors

2017 ◽  
Vol 9 (4(J)) ◽  
pp. 62-72
Author(s):  
Victor H. Mlambo ◽  
Toyin Cotties Adetiba
Keyword(s):  
South Africa ◽  
South African ◽  
Brain Drain ◽  
Health Professionals ◽  
Health Workers ◽  
Health Sector ◽  
The South ◽  
Push Factors ◽  
African Health ◽  
South African Health

While there has been a plethora of studies that addresses migration in Africa, many have yet to successfully unpack the effects of brain drain on the South African health sector. Using textual analysis of the available literature relevant to the topic under consideration; this work seeks to identify the major structural and socio-economic push factors that drive the migration of health professionals in South Africa, relying on Revestain’s laws of migration and Lee’s push/pull theory of migration. The study also looks at explaining other factors that contribute to the migration of health professionals in South Africa. We argue that for South Africa to retain health professionals, the government needs to increase the training of health workers, improve their working conditions and security, upgrade infrastructure and ensure availability of resources as well as develop a more open immigration policy prioritizing skilled immigration.

scholarly journals PROTECTING A WIFE FINANCIALLY AT THE TIME OF DIVORCE – A COMPARISON BETWEEN SOUTH AFRICAN WOMEN MARRIED IN TERMS OF SOUTH AFRICAN CIVIL LAW AND ISLAMIC LAW, WITH SPECIFIC REFERENCE TO THE MAHR

Obiter ◽  
2021 ◽  
Vol 33 (3) ◽  
Author(s):  
Marita Carnelley ◽  
Suhayfa Bhamjee
Keyword(s):  
South African ◽  
Islamic Law ◽  
Civil Law ◽  
African Women ◽  
Specific Reference ◽  
The South ◽  
Protective Measures ◽  
Marriage Contracts ◽  
Marriage Contract ◽  
South African Women

This article compares the South African civil-law and Islamic-law positions with regard to the financial protective measures available to a wife at the time of marriage and divorce. In this regard, the respective matrimonial property systems are discussed, with special emphasis on civil antenuptial and Muslim marriage contracts. In addition, other protective measures inherent to the two systems to prevent prejudice both during the marriage and at the time of divorce, are discussed. It is submitted that, although the provisions of Islamic law do not provide the same financial protection for wives compared to the South African civil law, the Islamic concept of mahr could potentially be used in the Muslim marriage contract to enhance financial security of a Muslim wife at the time of divorce. The article also considers dual marriages where the same spouses marry each other in terms of both civil and Islamic law. In particular, the incorporation of the Islamic concept of mahr into civil antenuptial contracts is discussed with reference to the legal position in Canada to illustrate potential legal problems. 

scholarly journals Occupational segregation of work and income disparities among South African women

2002 ◽  
Vol 5 (1) ◽  
pp. 111-122 ◽  
Author(s):  
P. Lalthapersad
Keyword(s):  
Labour Market ◽  
South African ◽  
African Women ◽  
The South ◽  
Female Workers ◽  
Income Disparities ◽  
Different Types ◽  
South African Women ◽  
Wage Disparities ◽  
Made In

Despite the increase in the number of women participating in the South African labour market in recent years, little progress has been made in removing wage disparities, eradicating women's marginality in the labour market, reassessing women's work or changing the traditional occupational ghettos of women. Not only does the South African labour market exhibit anomalies in respect of the gender composition of occupations, there are substantial differences by race. A good barometer of determining the extent to which men and women undertake different types of jobs, is to analyse the percentage of male and female workers per occupational category.

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