The South African Medicines Control Council: Comparison of Its Registration Process With Australia, Canada, Singapore, and Switzerland

© 2019 Keyter, Salek, Banoo and Walker.Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders’ demands. The aims of this study were to compare the registration process and the regulatory review model of the South African Medicines Control Council (MCC) to that of four other similar-sized regulatory authorities and to identify areas for improvement that may inform recommendations to the South African Health Products Regulatory Authority (SAHPRA) as it looks to re-engineer and enhance the registration process in South Africa. Methods: A questionnaire describing the organisational structure, the registration process, good review and decision-making practices of the MCC was completed by the author (AK) for the purpose of this study and validated by the Registrar of the MCC. Similar questionnaires were also completed and validated by Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, Singapore’s Health Science Authority (HSA) and Switzerland’s Swissmedic. Results: A comparison of the MCC regulatory process with the four comparative agencies indicated that they all have similar requirements and employ a full-review model although the timelines for the MCC were considerably longer. However, similar quality measures were implemented by all authorities as part of their good review practices (GRevP) including prioritising transparency, communication, continuous improvement initiatives and training. Conclusion: Comparisons made through this study provided insight into the areas of the MCC registration process that may be improved and have informed recommendations to SAHPRA including the implementation of facilitated regulatory pathways, definition of targets for key milestones in regulatory review and formal implementation and monitoring of GRevP. In order to build quality into the review process the application of a standardised template for the clinical assessment of medicines such as the Universal Methodology for Benefit-Risk Assessment (UMBRA) could be considered as well as enhancing transparency and communication through the application of an electronic management system and the development of publicly available summaries for the basis of approval.Peer reviewedFinal Published versio

Hypernatraemic dehydration in acute gastroenteritis a descriptive audit of the pre hospital management and predisposing factors in children

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand Johannesburg, in fulfillment of the requirements for the degree of Master of Medicine in the branch of Paediatrics Johannesburg, 2017Introduction: Diarrhoeal illness is a major contributor to morbidity and mortality in children under five years. Hypernatraemia is a serious electrolyte disturbance associated with diarrhoea. There is a paucity of data of the incidence and possible risk factors of hypernatraemia in acute gastroenteritis amongst the paediatric population in South Africa. Objective: To document the incidence of hypernatraemia in children admitted with diarrhoea and any associations between hypernatraemia and potential risk factors. Method: This study used a prospective cross - sectional convenience sample of children between the ages of one and 24 months, who were admitted for diarrhoea complicated by dehydration. Caregivers were interviewed and demographic, clinical and laboratory variables were obtained. Results: A total of a 125 children were included into the study. Fifty one of the 125 children (41%) had hypernatraemia. Their serum sodium levels ranged between 154 and 171 mmol/l. Age below one year (p< 0.001) and severe dehydration (p = 0.003) were risk factors for hypernatraemia in the univariate analysis but only infancy remained significant after the multivariate analysis (Odds ratio 10.6, 95% CI: 3.5 – 32.6, p<0.001). Three patients demised and all were part of the hypernatraemic group (6% vs. 0%, p = 0.24). Hypernatraemia was significantly associated with neurological deficits (14% vs. 0%, p = 0.013). Conclusion: This study illustrated a high incidence of paediatric hypernatraemic dehydration, which has not been reported in other studies. An age of less than one year old was a statistically significant risk factor.MT201

Formulation of the Boltzmann Equation as a Multi-Mode Drift-Diffusion Equation

We present a multi-mode drift-diffusion equation as reformulation of the Boltzmann equation in the discrete momentum space. This is shown to be similar to the conventional drift-diffusion equation except that it is a more rigorous solution to the Boltzmann equation because the current and carrier densities are resolved into M x 1 vectors, where M is the number of modes in the discrete momentum space. The mobility and diffusion coefficient become M M matrices which connect the M momentum space modes. This approach is demonstrated by simulating electron transport in bulk silicon

Review of current policies which are impacting on the sustainability of natural woodlands in African communal rural areas in South Africa.

Thesis (M.A.)-University of Durban-Westville, 2002.South Africa has a fragmented past. Attempts to redress inequalities must acknowledge and understand the context of rural South Africa in terms of natural ecosystems. We are used to be being told that forests are good for us all. Certainly, the range of benefits that can be derived from forests, specifically natural woodlands are legion. The woodlands in South Africa are essential in the lives of many South Africans. It is for this reason that woodland resources are regarded as extremely important, not only for the maintenance of rural livelihoods but also as a potential contributor to the national economy. The woodlands are a diverse resource, extending over a vast area of the country and across several provincial boundaries. This as well as varied tenure systems as well as management objectives which exist, make the woodlands of South Africa a complex, yet essential resource to manage, monitor and sustain on a national level. Policy should therefore be able to ensure some kind of balance so that woodlands can be conserved, developed and sustainably managed in the most suitable ways possible. The findings of previous studies conducted on the woodland biome have highlighted the lack of sufficient knowledge of community perceptions with regards to the policy issues. This has been the catalyst in promoting informed reviews of current policies, in effect, which are affecting woodlands in African communal rural areas in South Africa. This particular study illustrates that there are a range of policies, both national and international, that impact either directly or indirectly on the woodlands in South Africa. The research identifies some of the key limitations in the various existing policies. Furthermore, the key concern raised is that current policies remain fragmented and are not in synergy with each other. Additionally, the ability to translate policy intentions into practice (that is, the implementation of policy directives) remain problematic. The gaps in the policy environment as well as the failure to implement are the key threats to ensuring the effective use of policy in promoting the sustainability of the woodlands in the South Africa context

Neuropharmacological interactions in the rat pineal gland a study of antidepressant drugs

The rat pineal gland provides a convenient model for investigating nor adrenergic receptor neurotransmission and the effects of various drugs on these processes in health and disease. The effect of a variety of antidepressant drugs on rat pineal gland function following acute and chronic administration is described. Antidepressants from several different classes increase melatonin synthesis in rat pineal gland cultures when administered acutely. This effect appears to be mediated by noradrenaline acting on postsynaptic β-adrenoceptors. Activation of these receptors, in turn, activates the enzyme serotonin N-acetyltransferase via a cyclic adenosine monophosphate (cAMP) second messenger system. Serotonin N-acetyltransferase catalyses the rate-limiting conversion of serotonin to melatonin. Blockade of postsynaptic β-adrenoceptors prevents the antidepressant-induced increase in melatonin synthesis. The possibility that atypical antidepressants as well as those that selectively inhibit serotonin reuptake may increase melatonin synthesis via a β-adrenoceptor mechanism is discussed. In contrast, however, antidepressants from different classes have variable effects on rat pineal gland function when administered repeatedly. Chronic treatment with antidepressants that selectively inhibit noradrenaline reuptake appear to down-regulate the β-adrenoceptor system while, simultaneously, increasing melatonin output. Atypical antidepressants and those that selectively inhibit serotonin reuptake appear to be without these effects when administered repeatedly. The pineal gland of normal rats may therefore not represent a suitable model for evaluating the biochemical effects of chronic antidepressant treatment. In an attempt to investigatc pineal gland function in rats with "model depression" , antidepressants were administered to chronically reserpinized rats. Treatment with reserpine produced an increase in the density of pineal β-adrenoceptors. In addition, pineal cyclic AMP accumulation and N-acetyltransferase activity were increased in reserpinized rats following exogenous catecholamine stimulation. Reserpine, by depleting intraneuronal catecholamine stores, prevented the nocturnal induction of N-acetyltransferase activity and reduced the synthesis of melatonin in pineal gland cultures. A variety of antidepressants, irrespective of their acute pharmacological actions, reversed these effects when administered chronically to resepinized rats. Acute antidepressant administration was not associated with a reversal of the reserpine-induced effects. These findings provide additional evidence against the hypothesis that antidepressant drugs act by reducing noradrenergic neurotransmission and casts doubt on the importance of β-adrenoceptor down-regulation in the mechanism of antidepressant action. The possibility that the pineal gland of the reserpinized rat may represent an alternative model for evaluating antidepressant therapies is discussed

Normalized factorial moments of spatial distributions of particles in high multiplicity events: A Toy model study

Scaling behavior of normalized factorial moments ($F_{q}$) of spatial distributions of the particles comprising a system may be studied to probe and to determine its characteristics. In heavy-ion collisions at ultra-relativistic energies, a strongly interacting complex system of quarks and gluons is created. The nature of the system created and multi particle production mechanism in these collisions is predicted to be revealed by the study of normalized factorial moments ($F_{{\rm{q}}}$) as function of various parameters. In this work, observations from the Toy model study of the scaling behavior of $F_{{\rm{q}}}$ moments, resilience of these moments to detector efficiencies and sensitivity towards fluctuations in the system will be presented.Comment: 6 pages, 9 figure

The resilience of mothers who have experienced home burglaries

Abstract: This study explores the resilience of mothers who experienced a home burglary with a view to understanding how or whether such experience affected their parenting. The study identified the resilience factors which helped mothers cope with the aftermath of the home burglary. A qualitative approach with a descriptive design was used, with all eight participants residing from Centurion, in Gauteng. The study used a strengths-based perspective to identify resilient factors from participants during their narratives and experiences...M.A. (Social Work

Uptake and acceptability of genetic counselling amongst breast cancer patients and their families in the uMgungundlovu Municipality in 2004.

Master of Medical Science in Public Health Medicine. University of KwaZulu-Natal, Howard College 2015.Awareness of genetic counselling and risk assessment is imperative for women to seek out genetic services. The purpose of this study is to determine the level of genetic counselling and acceptability of genetic counselling by breast cancer survivors, at the time of diagnosis, and the female members of their families, after the diagnosis of the patient within their family, with a view to developing recommendations based on the findings of the study. Two questionnaires were administered to a conveniently selected sample of 48 women; 28 were breast cancer survivors from the Cancer Association of South Africa’s breast cancer support group and 20 women from the general public. Interviews were then conducted with four randomly selected patients and their family members. A total of 12 participants were interviewed: four breast cancer survivors and eight family members, including two spouses and six children. During the interviews one breast cancer patient who was counselled by a psychologist indicated that she was not satisfied with the information she had been given and that further information on the genetics, recurrence, prognosis and family risk should have been provided as she considered this to be essential. The three patients who were not counselled were of the opinion that counselling on the genetics and risks of breast cancer would have been very useful. Four (50%) of the eight family members interviewed, indicated that they were not offered genetic counselling and would not be interested in knowing about the risks associated with breast cancer. Of the remaining four, two (25%) indicated that although they were not offered genetic counselling they would be interested in genetic counselling and learning about the risks associated with breast cancer as such information would be of great value. In terms of a breast cancer risk assessment, four of the eight family members (50%) indicated they were not interested with one further explaining that she might be interested at a later stage. The remaining four family members (50%) indicated their interest in attending a breast cancer risk assessment. In conclusion, educational interventions are required to increase awareness of genetic counselling and risk assessment

Biliary Ascariasis with Gallbladder Invasion: A Unique Entity

Intestinal Ascariasis is a common helminthic infection in developing countries and in some rare cases, worms migrate to the biliary tract and gall bladder. Extraintestinal biliary ascariasis presents with jaundice, right upper quadrant abdominal pain, and vomiting. Ultrasonography is a useful diagnostic modality. Albendazole and Mebendazole are commonly used anti-helmintic agents for conservative management, whereas endoscopic removal is needed in rare cases

Managing the professional development of primary school teachers by means of action research

In the climate of poor student achievement and a lack of skilled teachers in natural science and mathematics, the main research question of this study was: How can the professional development of primary school teachers be managed by means of action research? The aim of the study was to develop, implement and evaluate a site-based collaboration programme to promote the professional development of the teachers in these subjects within a home-based or semi home-based teaching context. The theory of situated learning within a community of practice (CoP) was used as conceptual framework. Purposeful and convenient sampling was implemented to select participants. Five grade 4 teachers, five grade 5 teachers, four grade 6 teachers and eight members of the school management team participated in the three year study. During the planning phase a needs analysis was done. During the action phase, lead teachers were responsible for the planning in one or two subjects. The teachers met once every six school days (about 30 meetings per year), for up to two hours to discuss content and methodological issues, plan assessment strategies, analyse and reflect on results and decide on intervention strategies. The grade 4, 5 and 6 groups completed six, four and two action research cycles respectively, and the school management team six action research cycles of about six months each. To evaluate the professional development that resulted, data collection was by means of observation, field notes, typed minutes, four focus groups, 12 individual interviews, teachers’ files, a questionnaire and students’ books and achievements. The results indicate that the professional development of primary school teachers could be managed and constantly improved by means of action research. When school managers organise teachers into communities of practice and implement action research cycles, the teachers learn in a context-sensitive way. This learning is characterised by two social stages involving participation in the subject and grade CoP, and an independent stage of personal involvement when teachers internalise knowledge and practices of other teachers. The professional development of the teachers was in the areas of content knowledge, pedagogic content knowledge, assessment literacy and professional attitudes. Student achievement improved.Educational Leadership and ManagementD. Ed. (Education Management