Medicine In South Africa Research Articles

An exploratory assessment of the legislative framework for combating counterfeit medicines in South Africa

BackgroundSubstandard and Falsified (SF) medical products are a growing global concern. They harm the individual patient, the healthcare system and the economy. The World Health Organisation (WHO) has highlighted contributing factors globally: insufficient national medicine regulation, poor enforcement of existing legislation, weak stakeholder collaboration and the rise of novel viruses, such as the COVID-19. The study aimed to assess the legislative and policy framework and institutional relationships governing pharmaceuticals and anti-counterfeiting strategies.MethodsThe study was explorative and consisted of two phases. The first phase was between 2016 and 2017. It looked at document analysis (annual reports and press releases from 2011 to 2016) from government institutions involved in medicines regulation and law enforcement for SF seizure reports between 2004 and 2017. The second phase was between 2016 and 2018 through in-depth semi-structured interviews (seven in total) with selected stakeholders.ResultsFirst Phase—the data collected and reported by various departments was sporadic and did not always correlate for the same periods indicating, a lack of a central reporting system and stakeholder collaboration. In South Africa, counterfeiting of medicines mainly involves the smuggling of non-registered goods. The most common counterfeit items were painkillers, herbal teas, herbal ointments, while some were medical devices. Furthermore, Customs identified South Africa as a transhipment point for SF infiltration to neighbouring countries with less robust regulatory systems. Second phase—interview transcripts were analysed by thematic coding. These were identified as the adequacy of legislation, institutional capacity, enforcement and post-market surveillance, stakeholder collaboration and information sharing, and public education and awareness.ConclusionDocument analysis and interviews indicate that South Africa already has a national drug policy and legislative framework consistent with international law. However, there is no specific pharmaceutical legislation addressing the counterfeiting of medicines. Law enforcement has also been complicated by poor stakeholder engagement and information sharing.

Cardiovascular medicine in South Africa

Cardiovascular medicine in South Africa

Academic entanglements with society

Howard Phillips, UCT under Apartheid: Part I, From Onset to Sit-in, 1948-1968 Jacana Media, Johannesburg, 2019 407 pp ISBN 978-1-9282-3285-8 R359 (hardcover) Howard Phillips is one of South Africa's pre-eminent academic historians, best known for his meticulous pioneering research on the social history of medicine in South Africa. Latterly, since the arrival of Coronavirus, he has enjoyed a public profile as a widely consulted expert on the history of pandemics. In addition, however, Phillips is the premier historian of the University of Cape Town (UCT), a graduate of that university, and a member of its staff in the Department of History. Intimately involved with UCT over decades, in 1993 he was the author of The University of Cape Town, 1918-1948: The Formative Years (UCT Press] and we are grateful that one of its sequels has now been published. This most recent account of the two decades that follow is an important book, well written and insightful, and a powerful reminder to us that universities in South Africa, as elsewhere, are reflections of current society but also embryos of future society - our mirrors: past, present and future.

A chronicle of alien medicinal plants used as traditional medicine in South Africa, and their status as invasive species

South Africa's colonial past has shaped its environmental history, including introductions of alien plants. Indentured Indian labourers, mainly from Tamil Nadu, that were brought to South Africa in the 1860s, acquired knowledge of Zulu healing practices and plants. This translocation of traditional medical knowledge (mostly Ayurvedic), and the adoption of new plants and traditions of practice, led to these migrants opening up some of the first muthi (traditional medicine) shops in South Africa, and also to importing and incorporating Indian medicinal plants within South African healing traditions. Given this role of traditional medicine in the introduction of alien plant taxa, we gathered data on them from published literature (including market surveys) and from a survey of 77 muthi outlets in three South African cities. There were 301 alien taxa from 76 families, of which 81 taxa were recorded in trade. Sixty-nine of the traded taxa were identified to species, of which 20 have a declared legal status requiring some form of control. Of the 81 traded taxa, 44% were sold in a non-viable form and 29% were seeds or fruit that could be germinated; the remaining 28% were sold as live plants. Seeds of these alien taxa constituted the greatest quantity and most widely traded plant part of the taxa recorded. The survey of muthi outlets generated 36 alien plant taxa, of which 26 were new records in the trade. Plant origins recorded in this survey revealed that 41% of plants were harvested in South Africa, 35% imported from India, and 24% were of unknown origin. The importance of this trade as a pathway for introduction of alien species is discussed.

Hloniphaand health: ancestors, taboos and social medicine in South Africa

AbstractThis article examines the abandonment of an important food taboo – the prohibition of milk consumption by newly married women – in rural KwaZulu-Natal, South Africa in the 1940s and 1950s. Offering a detailed exploration of thishloniphacustom in three rural communities, I start from the position that food always reflects the entanglements of its material and symbolic attributes. By tracing health and illness, shifting livelihoods, diets and an important social medicine intervention, this article reveals that in the 1950s milk was a symbolically and materially different food than it had been in the 1930s. I argue that this difference determined whether or nothloniphawould be abandoned. By centring on understandings of food, health and taboos as material and symbolic, this article draws on scholarship on livestock in Southern Africa and contributes to scholarship on food taboos andhloniphacustoms, pushing for the incorporation of material aspects of those customs.

From Farm-to-Fork: E. Coli from an Intensive Pig Production System in South Africa Shows High Resistance to Critically Important Antibiotics for Human and Animal Use.

Antibiotic resistance profiles of Escherichia coli were investigated in an intensive pig production system in the uMgungundlovu District, South Africa, using the ‘farm-to-fork’ approach. Four hundred seventeen (417) samples were collected from pig and pig products at different points (farm, transport, and abattoir). E. coli was isolated and enumerated using the Colilert® 18/Quanti-Tray® 2000 system. Ten isolates from each Quanti-tray were selected randomly and putatively identified on eosin methylene blue agar. Real-time PCR targeting the uidA gene was used to confirm isolates to the genus level. The Kirby–Bauer disc diffusion method was used to determine the isolates’ antibiotic susceptibility profiles against 20 antibiotics. A total of 1044 confirmed E. coli isolates were obtained across the three critical points in the food chain. Resistance was observed to all the antibiotics tested with the highest and lowest rates obtained against tetracycline (88.5%) and meropenem (0.2%), respectively. Resistance was also observed to chloramphenicol (71.4%), ampicillin (71.1%), trimethoprim-sulfamethoxazole (61.3%), amoxicillin-clavulanate (43.8%), cephalexin (34.3%), azithromycin (23.9%), nalidixic acid (22.1%), cefoxitin (21.1%), ceftriaxone (18.9%), ciprofloxacin (17.3%), cefotaxime (16.9%), gentamicin (15.5%), cefepime (13.8%), ceftazidime (9.8%), amikacin (3.4%), piperacillin-tazobactam (1.2%), tigecycline (0.9%), and imipenem (0.3%). Multidrug resistance (MDR) was observed in 71.2% of the resistant isolates with an overall multiple antibiotic resistance (MAR) index of 0.25, indicating exposure to high antibiotic use environments at the farm level. A high percentage of resistance was observed to growth promoters and antibiotics approved for veterinary medicine in South Africa. Of concern was resistance to critically important antibiotics for animal and human use and the watch and reserve categories of antibiotics. This could have adverse animal and human health consequences from a food safety perspective, necessitating efficient antibiotic stewardship and guidelines to streamline antibiotic use in the food-animal production chain.

Prevalence and Predictors of Antimicrobial Resistance Among Enterococcus spp. From Dogs Presented at a Veterinary Teaching Hospital, South Africa.

Background: While surveillance of antimicrobial drug resistance is ongoing in human medicine in South Africa, there is no such activity being performed in veterinary medicine. As a result, there is a need to investigate antimicrobial resistance among enterococci isolated from dogs in South Africa to improve understanding of the status of antimicrobial drug resistance given its public and veterinary public health importance. This study investigated antimicrobial resistance and factors associated with resistance profiles of enterococci isolated from dogs presented for veterinary care at a veterinary teaching hospital in South Africa.Methods: In total 102 Enterococcus isolated between 2007 and 2011 by a bacteriology laboratory at a teaching hospital were included in this study. Antimicrobial susceptibility of the isolates was determined against a panel of 18 antimicrobials using the Kirby Bauer disc diffusion technique. Univariate analysis was used to assess simple associations between year, season, breed group, age group, sex, and specimen as covariates and extensive drug resistance (XDR) as the outcome. Variables that were significant in the univariate analysis at a generous p-value ≤ 0.2 were included in the multivariable logistic models to investigate predictors of XDR.Results: All the Enterococcus isolates were resistant to at least one antimicrobial. High proportions of isolates were resistant against lincomycin (93%), kanamycin (87%), orbifloxacin (85%), and aminogycoside-lincosamide (77%). Ninety three percent (93%), 35.3, and 8.8% of the isolates exhibited multi-drug, extensive-drug and pan-drug resistance, respectively. Only year was significantly (p = 0.019) associated with extensive-drug resistance.Conclusion: Given the zoonotic potential of Enterococcus spp., the high antimicrobial resistance and multi-drug resistance observed in this study are a public health concern from one health perspective. The identified resistance to various antimicrobials may be useful in guiding clinicians especially in resource scarce settings where it is not always possible to perform AST when making treatment decisions.

Fatal pyrrolizidine alkaloid poisoning of infants caused by adulterated Senecio coronatus

Senecio coronatus (known as izonkozonko and ubulibazi in Zulu) is commonly used in traditional medicine in South Africa as purification purgative and enemas for infants during weaning. We show for the first time that this species does not contain pyrrolizidine alkaloids and that reported cases of fatal hepatic sinusoidal obstruction syndrome in infants were caused by wrongly identified Senecio species containing large amounts of retrorsine-N-oxide. A validated ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the detection and quantitation of pyrrolizidine alkaloids is described.

Death Investigation and Forensic Medicine in South Africa: Historical Perspectives, Status Quo, and Quo Vadis?

Death Investigation and Forensic Medicine in South Africa: Historical Perspectives, Status Quo, and Quo Vadis?

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

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.

Cissampelos capensis L.f. (Menispermaceae): Review of its medicinal uses, phytochemical and pharmacological properties

Cissampelos capensis L.f. is a perennial climber widely used as a traditional medicine in South Africa. This study was aimed at providing a critical review of medicinal uses, phytochemical and pharmacological properties of C. capensis. Documented information on the pharmacological properties, phytochemistry and medicinal uses of C. capensis was collected from several online sources such as Scopus, Google Scholar, PubMed and Science Direct, and pre-electronic sources such as book chapters, books, journal articles and scientific publications obtained from the university library. This study revealed that leaf, rhizome and root infusions and decoctions of C. capensis are mainly used as a blood purifier, and traditional medicines for respiratory problems, ulcers, sores and wounds, skin and stomach cancers, snakebite, sexually transmitted infections, skin diseases, diabetes and gastrointestinal problems. Phytochemical compounds identified from the species include alkaloids, essential oils, flavonoids, phenolics, saponins and tannins. Pharmacological research revealed that C. capensis extracts and compounds isolated from the species have anthelmintic, antibacterial, antifungal, antidiabetic, antimalarial, hepatotoxicity, spermatozoa and cytotoxicity activities. Documentation of the medicinal uses, phytochemistry and pharmacological properties of C. capensis is vital as this information provides baseline data required for future research and development of health-promoting and pharmaceutical products. There is a need for extensive toxicological evaluations of crude extracts and compounds isolated from the species since C. capensis contains potentially toxic compounds.

Novel kinase platform for the validation of the anti-tubercular activities of Pelargonium sidoides (Geraniaceae)

BackgroundPelargonium sidoides is an important traditional medicine in South Africa with a well-defined history of both traditional and documented use of an aqueous-ethanolic formulation of the roots of P. sidoides (EPs 7630), which is successfully employed for the treatment of respiratory tract infections. There is also historical evidence of use in the treatment of tuberculosis. The aim of this study was to develop a platform of Mycobacterium tuberculosis (Mtb) kinase enzymes that may be used for the identification of therapeutically relevant ethnobotanical extracts that will allow drug target identification, as well as the subsequent isolation of the active compounds.ResultsMtb kinases, Nucleoside diphosphokinase, Homoserine kinase, Acetate kinase, Glycerol kinase, Thiamine monophosphate kinase, Ribokinase, Aspartokinase and Shikimate kinase were cloned, produced in Escherichia coli and characterized. HPLC-based assays were used to determine the enzyme activities and subsequently the inhibitory potentials of varying concentrations of a P. sidoides extract against the produced enzymes. The enzyme activity assays indicated that these enzymes were active at low ATP concentrations. The 50% inhibitory concentration (IC50) of an aqueous root extract of P. sidoides against the kinases indicated SK has an IC50 of 1.2 μg/ml and GK 1.4 μg/ml. These enzyme targets were further assessed for compound identification from the P. sidoides literature.ConclusionThis study suggests P. sidoides is potentially a source of anti-tubercular compounds and the Mtb kinase platform has significant potential as a tool for the subsequent screening of P. sidoides extracts and plant extracts in general, for compound identification and elaboration by selected extract target inhibitor profiling.

A human resources for health analysis of registered family medicine specialists in South Africa: 2002-19.

In South Africa, there is a need to clarify the human resources for health policy on family physicians (FPs) and to ensure that the educational and health systems are well aligned in terms of the production and employment of FPs. To analyse the human resource situation with regard to family medicine in South Africa and evaluate the requirements for the future. A retrospective review of the Health Professions Council of South Africa's (HPCSA) database on registered family medicine practitioners from 2002 until 2019. Additional data were obtained from the South African Academy of Family Physicians and published research. A total of 1247 family medicine practitioners were registered with the HPCSA in 2019, including 969 specialist FPs and 278 medical practitioners on a discontinued register. Of the 969, 194 were new graduates and 775 from older programmes. The number of FPs increased from 0.04/10 000 population in 2009 to 0.16/10 000 in 2019, with only 29% in the public sector. On average, seven registrars entered each of nine training programmes per year and three graduated. New graduates and registrars reflect a growing diversity and more female FPs. The number of FPs differed significantly in terms of age, gender, provincial location and population groups. South Africa has an inadequate supply of FPs with substantial inequalities. Training programmes need to triple their output over the next 10 years. Human resources for health policy should substantially increase opportunities for training and employment of FPs.

Empty shelves: selected essential medicines stockouts in South Africa

Abstract Background Access to essential medicines in South Africa has been compromised by stockouts in health facilities. This study describes the occurrence of stockouts for a selection of essential medicines. Methods This cross-sectional study used secondary data retrieved from the Stop Stock Outs Project (SSP). A descriptive analysis was conducted on data from the 2013-2015 SSP case management database of routinely reported stockouts. Chi square tests of independence was conducted on data from the SSP 2015 annual telephonic survey to investigate associations between the occurrence of stockouts, the level of health facility and the type of health professional. Results 231 facilities reported 609 stockouts. Antiretroviral medication had the most stockout reports (78%; n = 475/609), followed by anti-infectives (17.1%; n = 104/609) and tuberculosis medication (4.9%; n = 30/609). The highest number of stockout reports were received from Gauteng province and the majority (71.09%; n = 150/211) of facilities reporting stockouts were in urban areas. There were more stockouts at ambulatory, rather than inpatient care, facilities however, this was not statistically significant. Conclusions This study confirms that South Africa experiences medicine stockouts for many of the essential medicines, with antiretroviral medication being the category most affected. The stockouts vary between provinces and the urban-rural divide but are an equal threat to both ambulatory and inpatient facilities. Key messages The pattern of stockouts experienced over a three-year period suggest that stockouts are ‘normal’ despite the substantive effects of treatment interruption – especially patients with HIV and/or TB. Antiretroviral therapy is at risk as a result of stockouts.

Is South Africa being spared the global opioid crisis? A review of trends in drug treatment demand for heroin, nyaope and codeine-related medicines in South Africa (2012–2017)

IntroductionSouth Africa has seen a sharp increase in treatment admission trends for opioids despite beliefs that rates of opioid use remain low and do not represent a major problem. To advocate for the extension of Opioid Use Disorder (OUD) treatment and harm minimisation services in South Africa, better estimates of the extent of opioid use is needed. This paper responds to this need by describing (i) trends in treatment utilization for opioid-related problems in South Africa and (ii) differences in the profile of patients accessing treatment for different classes of opioids - heroin, ‘nyaope’ and codeine use. MethodsData were collected from 83 specialist treatment centres participating in the South African Community Epidemiology Network on Drug Use between 2012 and 2017. Descriptive analyses were conducted to describe the sociodemographic profile of patients and multiple logistic regression was used to explore socio-demographic and clinical factors associated with admission to treatment for opioid use disorders (OUD) . ResultsFrom January 2012 to December 2017, data from 11 2032 treatment episodes were collated. Of these, 20 319 (18.1%) were from patients admitted for an OUD. Over time, the proportion of overall opioid-related admissions increased significantly from 16.1% of all admissions in 2012 to 20.0% in 2017 (p <0.001). Data also suggests a significant increase in the overall proportion of patients reporting injection drug use, from 1.6% in 2013 to 3.5% in 2017 (p <0.001). Clear differences in employment status, referral sources between classes of opioids were also noted. ConclusionOver the last 5 years, South Africa has seen an increase in the proportion of opioid related disorders (OUD) treatment admissions. Public health interventions, evidence-based harm reduction approaches and improving access to treatment are among the interventions urgently needed to reduce the harms associated with the increased use of opioids in South Africa.

African Traditional Medicine Research between 1998 and 2018: An Informetrics Analysis in South Africa

Traditional knowledge, especially with health-related issues, has become crucial across the world. This can be attributed to the assistance which humans and animals now require. In Africa, traditional healers have strived to offer health remedies through the support of plants with the aim of curing different ailments believed to have been either inherited or caused by attack from spiritual forces. This, to an ordinary person, is difficult to understand; hence the assistance and support of traditional healers play an important role in the treatment of health issues for many people, irrespective of the context. This is commonly referred to as “African traditional medicine” (ATM), being a holistic healthcare system that has attracted numerous researchers. Nonetheless, there is still a paucity of updated, comprehensive collation of research conducted across South Africa. The study that directed this article aimed to assess the publication trends on ATM between 1998 and 2018. The study used interpretive document analysis, where data were harvested from the Web of Science Citation Index Expanded. Findings indicate that 469 documents were retrieved from the database, and the majority of published papers were research articles. A downward trend in terms of the number of publications in 2018 was of concern, considering efforts that were made to encourage research in traditional medicine in South Africa. Results indicate that social sciences contributed the highest number of research publications, while the universities of KwaZulu-Natal, Witwatersrand and Pretoria were the top three contributors with the largest number of publications. The study recommends integrating traditional medicine into the curricula of all South African universities.

Kesaveloo Goonaruthnum Naidoo: anti-apartheid campaigner

Few have done as much to forge an individual identity as “Dr Goonam”, the name Kesaveloo Goonaruthnum Naidoo (1906–98) adopted as the first woman of colour to practise medicine in South Africa during the 1930s. She demanded women's inclusion in political organisations representing her Indian community, and joined others in passionate opposition to the apartheid policies that oppressed them.

The extent of selected essential medicines stockouts in South Africa (2013-2015)

Access to essential medicines in South Africa has been compromised by stockouts in health facilities. This study analyses the occurrence of stockouts for a selection of essential medicines for the period 2013-2015. An analytical cross-sectional design was undertaken using secondary data retrieved from the Stop Stock Outs Project (SSP). Specifically, a descriptive analysis was conducted on data from the 2013-2015 SSP’s case management database of routinely reported stockouts. The Chi-square test of independence was conducted on data from the SSP’s 2015 annual telephonic survey to investigate associations between the occurrence of stockouts, level of health facilities and type of health professionals in the facilities. Two hundred and thirty-one health facilities reported 609 stockouts. Antiretroviral medication had the most stockout reports (77.9%; n=475/609), followed by anti-infectives (17.1%; n=104/609) and tuberculosis medication (4.9%; n=30/609). The highest number of stockout reports were received from Gauteng province and the majority (71.1%; n=150/211) of facilities reporting stockouts were in urban areas. There were morestockouts in ambulatory (level 1) rather than inpatient care facilities (level 2); however, this was not statistically significant (p>0.05). There was a significant difference in the type of health professional and occurrence of stockouts with stockouts being more likely to occur with pharmacy personnel than nurses. This study confirms that South Africa experiences medicine stockouts for many of the essential medicines, with antiretroviral medication being the category most affected. The stockouts vary between provinces and urban-rural divide, but threaten both levels 1 and 2 facilities similarly. Keywords: Stockouts, essential medicines, availability, access.

Over-the-Counter Medicine Utilization by Beneficiaries Under Medical Schemes in South Africa.

BackgroundSouth African medical insurance schemes (known as medical schemes) cover about 17% of the population. Within these schemes, access to medicines for a defined set of chronic diseases is mandated by legislation. However, much of the responsibility for treatment of minor conditions with non-prescription over-the-counter (OTC) medicines has been transferred to the individuals within the medical schemes. The overall expenditure on pharmacist-assisted therapy (PAT)/OTC medicines in South Africa is considerable and medical schemes endeavor to limit amounts paid out by devising strategies that will limit their financial exposure.AimTo investigate how benefit design and other factors within two medical schemes influenced access to and payment for OTC medicines and to explore whether access to OTC medicines by individuals impacted on utilization of other health-care services.MethodsMedical scheme data were obtained from a leading administrator for two health plans: one with comprehensive benefits covering 4593 beneficiaries (designated HI) and the other with lower benefits covering 54,374 beneficiaries (LO). Extracted data included beneficiary demographics, OTC medicines prescribed by doctors and/or dispensed by pharmacists, and monetary amounts claimed by individuals and paid by the medical schemes. Doctor consultations, costs and payments were also extracted, as were beneficiaries’ records of their chronic disease(s) and any episode(s) requiring hospitalization.ResultsSome 60–70% of beneficiaries submitted claims for OTC medicines accessed directly or recommended by a pharmacist, and 80–90% claimed OTC medicines that were prescribed by a doctor during a consultation. Amounts claimed and percentages of original products prescribed were substantially higher when accessed directly by beneficiaries or recommended by pharmacists than when doctors prescribed the medicines. In multivariate analysis, there was no clear advantage of offering access to OTC medicines in order to reduce visits to general practitioners, although in the LO plan it appeared that beneficiaries with chronic diseases made less use of the OTC benefit and more use of medical specialists.ConclusionWithin these two plans, there were higher costs and greater use of original products when beneficiaries or pharmacies accessed OTC medicines than when these medicines were prescribed by doctors. A key question is whether access to these medicines and the costs thereof would be managed better if paid for directly by individuals and not as insured benefits through the medical scheme.

History of academic family medicine in South Africa - When did it start?

The literature on the history of family medicine as an academic discipline locates its beginning with the establishment of two faculties linked to the Royal College of General Practice in 1958. However, the history of Community Oriented Primary Care documents, how the Kark’s moved from Pholela in KwaZulu-Natal, were involved with the establishment of the Natal Medical School in Durban. As part of this a Department of Social, Preventative and Family Medicine was established in 1956 with Dr Sidney Kark as its first Head of Department. The South African Academy of Family Practice and Primary Care established in 1980 explicitly orientated itself in relation to public healthcare (PHC). We need to re-claim the history of Community Oriented Primary Care as part of the history of family medicine and proudly trace our current ethos and values to the seminal work of the Kark’s.