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The registration and control of medicines in South Africa: legal issues.

In the provision of health care medicines occupy a central position, both at primary and more advanced levels. Sound medicines have the capability to control and prevent common diseases, and to alleviate suffering. People's confidence in the health services that are provided by the state and by the private sector (as the case may be) is influenced by their knowledge that the medicines that they receive are of good quality and proven efficacy and safety, and that they are continuously available at reasonable cost. A sound national policy for the provision of safe and cost-effective medicines needs to be based on several elements. The most important are: A sound pharmaceutical industry that is able to function in an atmosphere of confidence, with the knowledge that its efforts in support of the public health are understood and respected; and a drug regulatory authority that is trusted for its expertise, independence and integrity. This is as true for a country such as South Africa as it is for a fully industrialised country such as the United States. The regulation and control of medicines in South Africa falls under the aegis of the Medicines Control Council, a statutory body established in accordance with the Medicines and Related Substances Act. In terms of the Act, the council has the mandate to ensure that the medicines available to the South African public are safe, effective, and of high quality, and that their availability is in the public interest. In considering this, the council may take into account only the scientific data available.(ABSTRACT TRUNCATED AT 250 WORDS)

Confidentiality↗

Satisfaction with clinical practice environments among early-career health professionals in South Africa: Findings from the WiSDOM cohort study.

BACKGROUND: The work or practice environments of health professionals play a central role in their retention in the healthcare system and their ability to provide quality patient care. The aim of the study was to examine and compare the satisfaction of early-career health professionals in the WiSDOM (Wits longitudinal Study to Determine the Operation of the labour Market among its health professional graduates) study with their clinical practice environments (CPEs) in South Africa, and the factors influencing their satisfaction. METHODS: WiSDOM, a prospective longitudinal cohort study, consists of eight health professions: clinical associates, dentists, doctors, nurses, occupational therapists, oral hygienists, pharmacists, and physiotherapists. Every year we collect information on the cohort's involvement in direct patient care, their perceived workload, availability of medicines and equipment for patients in their care, and their satisfaction with the clinical practice environment (CPE).We used Stata&#xae;19 for analysis. We used panel linear regression to investigate factors associated with the cohort's satisfaction with their clinical practice environments from 2018 to 2024, and logistic regression to evaluate the association between CPE and intention to leave in 2024. RESULTS: In 2024, the mean age of the cohort was 30.9 (&#xb1; 2.0), the majority were female (74.4%) and working in urban areas (92.7%). In 2024, 59.7% of the overall cohort reported a heavy workload compared to 69.2% in 2018. Over the follow-up period, reported problems with the availability of medicines or equipment were worse in the public sector and in rural areas, compared to the private sector and urban areas respectively.The cohort's satisfaction score with the CPE was 6.7 out of 10 in 2018 and 6.9 in 2024. The predictors of CPE were year of follow-up, health profession, employment sector, and geographic location. Nurses (&#x3b2;=-1.2; 95% CI -1.7, -0.7; p&#x2009;<&#x2009;0.001), and pharmacists (&#x3b2;=-0.7; 95% CI -1.1, -0.4; p&#x2009;<&#x2009;0.001) scored their CPE significantly lower compared to the other professional groups. Health professionals in the public sector (&#x3b2;=-1.1; 95% CI -1.3, -0.9; p&#x2009;<&#x2009;0.001) and in rural areas (&#x3b2;=-0.6; 95% CI -0.9, -0.3; p&#x2009;<&#x2009;0.001) were less satisfied with their CPE compared to those in the private sector and urban areas respectively. Dissatisfaction with the CPE was significantly associated with intention to leave the workplace and the profession. CONCLUSION: The study findings underscore the need for positive clinical practice environments for early-career health professionals in South Africa both as a health workforce and patient safety imperative.

South Africa↗

Strategic management of technology in public health sector in Kenya and South Africa.

OBJECTIVE: To investigate factors contributing to health care equipment problems and associated technological investments in public hospitals. DESIGN: The article reviews the processes of equipment planning, procurement and management. Analysis of results and observations from experts leads to recommendations and suggestions on good equipment management practices in public hospitals. It also provides recommendations for competitive utilisation of equipment in the public health sector. SETTINGS: Health care equipment management in Kenya and South Africa in 1999/2000. INSTITUTIONS: A total of 10 public equipment maintenance institutions, and 38 equipment maintenance experts participated in the survey. Majority of the participants were drawn from teaching hospitals. RESULTS: It is evident that the way health technology is managed in health care institutions directly affects the quality of treatment patients receive. Although strategic importance of technology in health care has been documented widely in scientific literature; equipment planning, procurement and management have not received the attention they deserve in the transformation of health care services in the two countries under the survey. CONCLUSIONS: The growing demand for more and better health care greatly expands the role of health care equipment in the delivery of health services. Kenya and South Africa have tried various strategies to improve access, quality and cost-efficiency in the health care delivery systems. However it is clear that the optimal method has yet to be found. Good management of health care equipment increases efficiency in health care services and enhances health outcomes.

Budgets↗

Gender disparity amongst TB suspects and new TB patients according to data recorded at the South African Institute of Medical Research laboratory for the Western Cape Region of South Africa.

OBJECTIVE: To describe the sex and age distribution of sputum submission and smear positivity in the Western Cape Province of South Africa. METHOD: Laboratory registers of the South African Institute of Medical Research were examined retrospectively for the year 1999. RESULTS: Male tuberculosis (TB) suspects outnumbered females by 1.45:1, whereas amongst confirmed TB cases the ratio was 2.08:1. The odds ratio (OR) for smear positivity amongst males and females was 1.544. The proportion of male sputum positives significantly exceeded the proportion of males in the general population, as measured by the 1996 census. Not only did the number of male TB suspects and confirmed cases exceed that of females in absolute terms, but the proportion of male suspects proving smear-positive exceeded that of females. The age by sex distribution of new smear-positive patients followed the trend reported in recent literature. CONCLUSION: The gendered incidence of tuberculosis identified from this census is consistent with that of other developing countries. However, the smaller proportion of female TB suspects proving smear-positive suggests a higher index of suspicion in females and/or longer delays prior to care seeking amongst males.

Adolescent↗

Hepatitis E seroprevalence in selected individuals in South Africa.

Antibodies to the hepatitis E virus (HEV) were detected by an enzyme immunoassay using synthetic HEV peptides. Positive anti-HEV results were confirmed by a neutralization assay and Western blot analysis. Anti-HEV was detected in 10 of 555 canoeists (1.8%) with regular exposure to sewage-polluted water and in 6 of 227 (2.6%) medical students with minimal exposure. The overall prevalence of 16 per 782 individuals (2.05%) suggests that HEV may be endemic in South Africa. This is confirmed by indications of infection earlier than the third decade of life, and by individuals with anti-HEV who had rarely or never been out of the country. The prevalence data suggest that regular exposure to sewage-polluted water was not a particular risk factor. None of the individuals with anti-HEV had a history of clinical hepatitis E, suggesting sporadic low level subclinical cases of infection. This is in agreement with the absence of reports on clinical cases or outbreaks of hepatitis E in South Africa.

Adult↗

Molecular epidemiology of canid rabies in Zimbabwe and South Africa.

The epidemiology of rabies in southern Africa is complex, due to a large number of vector species and the presence of at least two distinct biotypes of the virus. Our objective was to contribute to the understanding of the epidemiology of rabies in the southern African subcontinent by studying the genetic relationship of 89 rabies virus isolates from this region. In this study, we have focused on an analysis of viruses that cycle in canid host species (canid biotype) throughout South Africa and Zimbabwe. By phylogenetic analysis of the cytoplasmic domain of the glycoprotein and the non-coding G-L intergenic region, all the southern African canid viruses were found to be closely related and no apparent general distinction could be made between them. Although there was a minor degree of phylogenetic branching, with certain branches associated with cycles defined by species, location and time, the phylogenetic pattern indicated that canid rabies in southern Africa is derived from a single virus lineage, which has spread opportunistically within whatever canid host population is ecologically capable of sustaining prolonged cycles. This molecular epidemiological study presents the first comprehensive comparison of rabies viruses from South Africa and Zimbabwe and has demonstrated the need for multinational approaches towards the control of this important zoonotic disease in Africa.

Animals↗

Medicinal plant use in the Bredasdorp/Elim region of the Southern Overberg in the Western Cape Province of South Africa.

There are many individuals in the Bredasdorp/Elim area who still use plants as medicines to treat many conditions. This study aimed to document some of this knowledge and present an inventory of all the plants in use in the area. Over 40 individuals were interviewed from old age homes, community centres for the elderly as well as people who were known for their knowledge in this matter. The information was gathered by means of questionnaires. In total, 36 plant species from 19 families were found to be in general use in the area. Only 58% of these plants are indigenous to South Africa, 33% are introduced species and 9% are naturalized species. The dominant families were Asteraceae, Lamiaceae, Alliaceae and the Solanaceae. Many of the plants in use are commonly used in traditional medicine around South Africa and share many of the same uses. Some uses, which have not been seen in the consulted literature, have also been documented. A more structured questionnaire was used to determine which plants were most popular for particular ailments. It was found that Artemisia afra and Ruta graveolens were the most popular.

Aged↗

Problems with prostate specific antigen screening for prostate cancer in the primary healthcare setting in South Africa.

OBJECTIVES: To assess the feasibility of detecting early-stage prostate cancer in the primary healthcare setting, and to investigate whether there is a higher incidence of prostate cancer in Black African men. PATIENTS AND METHODS: The study was a collaboration with registrars in the authors' institutions and primary healthcare centres serving mainly a Black African or mixed ancestry (Coloured) population in the semi-urban Cape Town metropolitan area of South Africa. Men aged 50-70 years attending the clinics were counselled about prostate cancer and invited to have a digital rectal examination (DRE), serum prostate-specific antigen (PSA) assay and transrectal ultrasonography-guided sextant prostate biopsy if the DRE was clinically suspicious of malignancy or the serum PSA was > or = 4.0 ng/mL. An American Urological Association Symptom Index (AUA-SI) was obtained, and urine analysed using dipsticks. RESULTS: From May 2000 to November 2001, 660 men were assessed (mean age 59.4 years, range 30-82); 60.6% were Black African, 37.3% mixed (Coloured), 1.8% White (Caucasian) and 0.2% Asian (Indian). The mean (range) AUA-SI was 5.98 (0-35) in the whole group; the DRE was recorded as clinically suspicious of malignancy in 3.2%. The mean PSA was 20.39 (0.04-10 000) ng/mL in the whole group, but when two outliers (1865 and 10 000 ng/mL) were disregarded, it was 2.4 ng/mL. In Black patients the mean PSA was 31.8 (0.04-10 000) ng/mL, and without the outliers, 2.1 ng/mL; in Coloured patients it was 2.94 (0.05-50) ng/mL. The PSA was > or = 4.0 ng/mL in 9.6% of the whole group, in 7.8% of Black and in 13% of Coloured patients. Prostate biopsies were taken in 21 patients (3.2% of the whole group and a third of those with a PSA of > or = 4.0 ng/mL); in Black patients, biopsies were taken in 1.5% and 19.4%, respectively, and in Coloured patients in 6.1% and 46.9%, respectively. The prostate biopsy showed cancer in 43% of the whole group, in a third of Black and in 47% of Coloured patients; prostate cancer was detected in 1.4%, 0.5% and 2.8%, respectively. CONCLUSIONS: That prostate biopsies were obtained in only 19% of Black and in only 47% of Coloured men with a serum PSA of > or = 4.0 ng/mL is of concern. This indicates that there is a significant problem in getting men with an elevated serum PSA level to undergo a prostate biopsy in the primary healthcare setting in South Africa.

Adult↗

Mechanisms of racial inequalities in prevalence of diarrhoea in South Africa.

Decades of apartheid policies have resulted in marked racial inequalities in health in South Africa. The black:white rate ratio of diarrhoea among children aged less than five years, one of the five most common causes of infant and child deaths, stood at 6.5 in 1998. Using data from the 1998 South African Demographic and Health Survey, this paper examines the mechanisms of this racial disparity. The research confirms the presence of persistent racial inequalities in access to safe drinking-water and sanitation and in maternal education and household wealth, with the black population constituting the most disadvantaged group. While the living environment and access to safe drinking-water explain the excessive risk of diarrhoea among the black population compared to the coloured and Indian populations, the excessive risk of diarrhoea among the black population compared to the white population cannot be explained by disparities in the living environment, hygiene levels, and socioeconomic factors.

Black People↗

Policies and protocols for preventing transmission of HIV infection in oral health care in South Africa.

Human immunodeficiency virus (HIV) infection constitutes an unparalleled public health challenge. The unique nature of most oral health procedures, instrumentation and patient-care settings requires specific strategies and protocols aimed at preventing the transmission of HIV/AIDS between oral health care providers and patients, as well as between patients themselves. The present study investigated the level of information and training about protocols and policies for preventing the transmission of HIV/AIDS in oral health care settings in South Africa. The data collection techniques utilised available information, in-depth interviews and an open-ended questionnaire. The respondents were 20 purposively selected key informants who were senior officers for HIV/AIDS programmes and/or oral health organisations. Sixteen (80%) of the respondents reported that there were no existing oral health policies on HIV/AIDS in their health care institutions or organisations. None of the interviewees knew of any specific protocols on HIV/AIDS in the oral health care setting that emanated from South Africa. In addition, none of the dental professional associations had established an infection control committee or a support system for members who might become infected with HIV and develop AIDS. Territorial boundaries existed between sectors within the medical disciplines, as well as between the medical and oral health disciplines. Numerous general impediments were identified, such as prejudice, denial and fear, inadequate training and/or information about the infection, lack of representation and resources for policy planning, a lack of interest from the business sector, and approaching HIV/AIDS in the workplace as a 'one-time issue' Other obstacles identified included unemployment, poverty, illiteracy, disempowerment of women and inadequate communication of policies to service providers. Additional issues raised included the migrant labour systeM, complexities of language and culture, the large unstructured sex industry, high prevalence of sexually transmitted infections and lack of funding. All of these have an impact on oral health. Future policy directions identified included 'increasing access to HIV information and postexposure prophylaxis' 'shift towards care and support for those living with HIV/AIDS with emphasis on community and home-based care' and 'improving intersectoral co-ordination and collaboration'. The study demonstrated gaps in availability and access to policies and protocols on HIV/AIDS by managers and health workers. Specific strategic recommendations are made for oral health.

Clinical Competence↗

Absence of 'true' minimal change nephrotic syndrome in African children in South Africa.

Minimal change nephrotic syndrome (MCNS) which is a well defined clinical, histopathological and therapeutic entity accounts for the majority of childhood nephrosis throughout the world except Africa. We describe 15 (13%) of 115 biopsy-confirmed African children with nephrotic syndrome who had minimal change on light microscopy. These are compared to 42 biopsied Indian children with typical MCNS. The critical differences between African children and children with classical MCNS were the lack of a predictable response in eight of the former to steroids and cyclophosphamide and in a later peak age of presentation (7-8 years). These patients differed in most respects from minimal change seen in the malarial zones of North Africa except for clinical presentation. Minimal change in West and East Africa more closely approximates typical MCNS. Two of the African patients with minimal change had endemic syphilis and responded clinically to penicillin therapy. The clinical presentation in all the African children, the favourable short-term outcome in 12 of these patients, immunofluorescent (13 patients) and electron microscopic (three patients) findings, and selectivity of proteinuria (eight patients) paralleled that of classical MCNS. The implications of this study are that African children in South Africa with MCNS should not be treated with steroids or cyclophosphamide. There is no clear benefit in the use of these drugs in nephrotic children with obvious glomerular lesions and therefore it follows that such therapy should be avoided in all African children in South Africa with this disease.

Black or African American↗

Genetic divergence between Atlantic and Indo-Pacific stocks of bigeye tuna (Thunnus obesus) and admixture around South Africa.

Two mitochondrial DNA segments of the bigeye tuna (Thunnus obesus) were amplified by polymerase chain reaction (PCR), and restriction fragment length polymorphism (RFLP) analyses of these segments were used for the genetic stock study. The variation in a segment flanking the ATPase and COIII genes was low; only two genotypes (alpha and beta) were detected by RsaI digestion. Yet a large difference in the genotype distribution was observed between ocean basin samples. The alpha type predominated in four Atlantic samples, where 178 of 244 individuals were the alpha type. In contrast, only one of 195 individuals collected in the Indo-Pacific was the alpha type? The frequency of the alpha type varied considerably from 0 to 80% among seven samples collected off the Cape of Good Hope. The variation found in the other segment, containing the D-loop region, was much higher; two endonucleases (DpnII and RsaI) detected five genotypes each and 15 composite genotypes. A highly significant difference in genotype frequencies was observed between the Atlantic and Indo-Pacific samples, but no heterogeneity was observed among the four Atlantic or among four Indo-Pacific samples. These results clearly indicate that not only gene flow, but also fish migration, between the Atlantic and Indian Oceans are severely restricted, and that fishes from these distinct stocks are intermingling around South Africa. The simple and diagnostic genetic marker found in this study can be used to estimate mixing ratios between Atlantic and Indian stocks around South Africa.

Animals↗

On the risk of multiple sclerosis according to age at immigration to South Africa.

In a national prevalence study of multiple sclerosis (M.S.) in the Republic of South Africa based on census day 1960 there were 118 individuals with M.S. who were born in Northern Europe (United Kingdom and other parts of North and Central Europe) and who had emigrated to the Republic by 1960. Their prevalence rate was 49 per 100,000 immigrants in comparison with a prevalence of 11 per 100,000 among native-born English-speaking white South Africans.To study the possible effect of age at immigration it was necessary to relate the M.S. immigrants to the appropriate denominator-the population at risk according to age at immigration. The population at risk by age at immigration has been estimated by two methods in an indirect fashion with the assistance of the Bureau of Census (1960) and by surveys of the population at risk 1968-9. Both studies suggest that the risk of developing M.S. was reduced to less than a third of the expected risk among those who immigrated under the age of 15 or 16.This study is further evidence that M.S. is an acquired exogenous disease, the precise nature of which is still not certain but, according to present knowledge, has as its leading contender the class of slow, latent, or temperate viruses.

Adolescent↗

Impact of haemophilus influenzae type b conjugate vaccine in South Africa and Argentina.

INTRODUCTION: Haemophilus influenzae type b (Hib) persists as a major cause of pediatric meningitis and pneumonia in developing countries in which Hib conjugate vaccines are not used. Demonstration of decreases in severe Hib disease after countries introduce Hib conjugate vaccine will help justify the resources necessary to purchase and provide the vaccine. Because surveillance for culture-confirmed Hib meningitis is not available in many countries, alternative means to measure the impact of Hib conjugate vaccine would be useful. METHODS: Laboratory records from the years before and after introduction of the Hib conjugate vaccine were reviewed at 4 hospitals, 2 in Argentina and 2 in South Africa. Potential indicators of bacterial meningitis including cerebrospinal fluid (CSF) culture, white blood cell count, appearance, protein and glucose were recorded. RESULTS: After introduction of Hib conjugate vaccine, culture-confirmed Hib meningitis declined significantly at 3 of 4 hospitals (2 in Argentina and 1 in South Africa). In the same 3 hospitals, there was a significant decline after vaccine introduction in some of the following CSF indicators of bacterial meningitis: proportion of CSF specimens with white blood cell count > or = 100 x 10(6)/L, 500 x 10(6)/L and 1,000 x 10(6)/L; glucose <40 mg/dL; protein >100 mg/dL; and turbid appearance. CONCLUSIONS: Culture-confirmed Hib meningitis declined at 3 of the 4 hospitals after Hib vaccine introduction. Surrogate indicators of bacterial meningitis also declined and might be useful measures of Hib conjugate vaccine impact at hospitals where capacity to culture Hib is not available.

Age Distribution↗

Indicators of substance abuse treatment demand in Cape Town, South Africa (1997-2001).

Few studies have investigated the demand for substance abuse treatment in South Africa. This article uses data collected from specialist substance abuse treatment centres to describe substance abuse treatment demand and patterns of service utilisation in Cape Town for the period January 1997 to December 2001. Findings suggest that although treatment demand for alcohol-related problems remains high, treatment demand for substances other than alcohol has increased over time. Patterns of treatment service utilisation suggest that women and black South Africans remain underserved. The need for comprehensive and accessible substance abuse treatment services in Cape Town is highlighted and recommendations are made for improving access to treatment services, and undertaking comprehensive evaluations of existing treatment facilities.

Adolescent↗

The role of forensic dentistry in South Africa.

Forensic dentistry has become an integral part of forensic medicine over the past 100 years. This has been due to the dedication of people like Amoedo, Gustafson, Sognaes, Keiser-Nielsen and Suzuki, to name but a few. They established the essential role which forensic dentistry plays mainly in the identification of human remains. Dental hard tissues are extremely resistant to fire and are usually the only remains after an extended period of burial. If antemortem dental records are available for an individual then dental identification is as certain as those of fingerprints. In South Africa forensic dentistry had its beginning in 1969 during the Windhoek air disaster. Since then there have been several cases of interest throughout the country, one of which was the crash of the Helderberg off the coast of Mauritius. Other aspects of forensic dentistry are the examination of bite marks and the recognition of facial trauma especially in cases of child abuse; the determination of age, sex and race of skeletal remains; dental ethics and jurisprudence as well as malpractice also form part of the duties of the forensic dentist. The five dental schools in South Africa each have a forensic team which is consulted on a regular basis by forensic pathologists and district surgeons. Forensic dentists are active members of the medicolegal team and should be consulted on a regular basis especially in cases where identification is concerned.

Forensic Dentistry↗

Rinderpest in South Africa--100 years ago.

To commemorate the centenary of the outbreak of rinderpest in South Africa, the historical events leading up to and following this major epidemic are recounted. Its impact on livestock and human populations, as well as initial and eventual successful attempts to control it are discussed.

Animals↗