Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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Exploring the acceptance of a long-acting cabotegravir injectable as pre-exposure prophylaxis among university students at the University of the Western Cape.
(University of the Western Cape, 2024) Manyaka, Lethukuthula
The HIV pandemic has been for many decades a global health challenge and South Africa has carried the highest burden of the disease having experienced one of the worst mortalities. Though the burden of the disease has drastically improved in the past decade, the spread of the disease continues with an annual incidence rate of about 232,400 infections in 2022, thus necessitating improved prevention measures. A highly effective method of HIV prevention is the use of Pre-exposure prophylaxis (PrEP). Often termed oral PrEP, the oral tablets containing emtricitabine and tenofovir have been available in South Africa since 2016. Since then, its use has slowly increased particularly among certain key populations, however, its overall uptake remains lower than anticipated. The newly developed long-acting cabotegravir (CAB-LA) injectable provides an opportunity to increase PrEP coverage. This is an injection containing cabotegravir, a novel antiretroviral agent against HIV. With its minimal dosing schedule of two-month intervals, a low tendency to resistance and high safety tolerance, this injectable PrEP addresses issues associated with oral PrEP usage such as poor adherence. In December 2022, the South African Health Products Regulatory Authority (SAHPRA) approved the use of CAB-LA in South Africa, consequently, the country is currently planning its rollout to the public.
Improving access to chronic medicines through a last kilometre medicine delivery service in low-income communities: a case study from Cape Town, South Africa
(University of the Western Cape, 2024) Patel, Haseena
In South Africa, access to healthcare services remains a considerable challenge, especially for low-income communities where transportation obstacles and prolonged waiting periods at healthcare facilities hinder prompt medical treatment. This study assessed a last kilometre home medicine delivery service aimed at overcoming these barriers and enhancing healthcare accessibility for low-income communities. The fundamental objective of this research was to assess the effectiveness of the last kilometre delivery service by analysing its operational efficiency, stakeholder satisfaction, health outcomes, sustainability and scalability and also, to assess the hinderances to a successful operation of community-based medicine delivery services aimed at facilitating access to medicine and decongesting healthcare facilities. A qualitative approach was used which employed semi-structured interviews with stakeholders, comprising of an entrepreneur in a community-based medicine delivery company and healthcare workers that were purposefully selected and interviewed to obtain comprehensive insights into their experiences with the service. Thematic analysis was performed utilising Atlas.ti software to identify key themes and patterns within the collected data that provided comprehensive understanding on the effectiveness of the services and the perspectives of participants.
Exploration of the current health policies regulating medical cannabis in Lesotho in relation to stringent international regulatory standards
(University of the Western Cape, 2024) Ntsohi Manti
Background: Medical cannabis refers to the cannabis used as a medicine or drug to diagnose, treat or prevent diseases or symptoms of illnesses. Globally there has been a rapid interest in the regulation and decriminalisation of medical cannabis. Lesotho recently became one of the first countries in Africa to legalise the exportation of medical cannabis. The country issued licenses and released the Lesotho Drug of Abuse (Cannabis) Regulation in 2018 which permitted and captivated the establishment of companies to cultivate, manufacture, store, distribute and export cannabis grade for medicinal purposes to various nations globally. Aim: This study aims to evaluate whether Lesotho's current health policies regulating medical cannabis conform with the stringent international regulatory standards envisioned to harmonise, standardise, control and ensure the safety, quality and efficacy of cannabis-based products Method: An exploratory-descriptive qualitative research method was utilised to conduct this study, where a thematic literature review was used to explore, map and review the relevant data while identifying comparable themes and patterns between Lesotho and the stringent regulatory authorities as well as other countries that Lesotho trades medical cannabis with. Health policies from the United Nations, International Narcotic Council Board and World Health Organisation were also explored with Lesotho and other countries. The study design involved exploring relevant peer-reviewed literature from published online sources and electronic databases including; Google Scholar, PubMed, and Science Direct. Thematic and descriptive analyses were used to categorically read through various data sources and summarise relevant themes and patterns of the non-numeric information. Results: The results from the selected countries and Lesotho exhibited similarities regarding compliance as far as international legislations, conventions or treaties of medical cannabis are concerned. The recently established Lesotho Narcotic Bureau was found to be lacking some of the fundamental aspects necessary to regulate or monitor the cultivation, manufacturing and exportation of medical cannabis. There are no clear and specific national guidelines controlling medical cannabis administration to the global and local markets such as; Good Manufacturing Practices, Quality Management System, Pharmacovigilance System, and Supply Chain Management as well as a coherent national regulatory framework on prescribing, acquisition, and dispensing of medical cannabis for qualifying conditions. Conclusion: Cannabis, medical cannabis, legislation, and current health policies regulating medical cannabis in Lesotho and other countries were explored. Lesotho Narcotic Bureau (LNB) was found to be deficient in some of the crucial systems, guidelines and regulations particularly those that are needful for harmonisation of medical cannabis to march the global standards. The incapability of LNB was increased by the inactive LMMDCA recently established which could have facilitated the drafting of guidelines and regulations for local and global markets. Therefore, Lesotho needs to gear up infrastructural and financial resources to capacitate and strengthen LNB and LMMDCA regulatory systems to fulfil their roles efficiently. More investments still need to be made for research and development of medical cannabis in Lesotho for evidence-based therapy addressing local and global demands.
Ehealth and telepharmacy: knowledge, perception and adoption of health technology by pharmacists in a Western Cape private sector context
(Universty of the Western Cape, 2023) Bester, Ezanda; McCartney, Jane
The aim of this study was to determine the knowledge, attitudes, and perceptions of community pharmacists regarding the implementation of telepharmacy in current pharmacy practice in the Western Cape province of South Africa. Telepharmacy, the delivery of pharmaceutical care through telecommunications, has gained popularity worldwide, particularly in rural and underserved areas. Despite its potential benefits, the adoption of telepharmacy in South Africa remains limited, highlighting the need to explore the perspectives of community pharmacists in this region. A descriptive, non-experimental, cross-sectional, mixed-methods approach was conducted among community pharmacists in the Western Cape's private sector. The study was predominantly quantitative in nature, supported by some qualitative data. Data collection was carried out through a structured self-administered questionnaire that was electronically distributed to pharmacists meeting the study's inclusion criteria. The quantitative data was analysed using descriptive statistics, while the responses to open-ended questions were analysed thematically.
Feasibility of an internationally recognized conformitè europëenne equivalent mark for medical devices in Africa: a review of current literature
(Universty of the Western Cape, 2024) Nkuku, Khanyisile Zachia; Egieyeh, Samuel
Medical devices are crucial to health systems and are critical to addressing the disease burden of African countries. In light of the importance of diagnosis and surgical intervention in healthcare, medical devices such as radiation emitting devices and devices incorporating a substance, are held to a high standard of quality and safety. Hence, the regulation of medical devices is required to optimize their use in healthcare within Africa. To successfully transition from the existing unregulated medical device sector to a thorough regulatory framework, many nations lack both the financial and technological resources. Consequently, organizations attempting to manufacture and market medical devices confront numerous obstacles, such as navigating the regulatory frameworks of various other nations and creating sustainable business models for imported medical devices. Many nations, including countries in Africa such as South Africa, Nigeria, and Ghana, require Conformitè Europëenne (CE) marked products which can only be obtained in Europe, making it extremely costly for local African manufacturers of medical devices to bring their products onto the market in these African countries. This study examined the feasibility of establishing an African-based equivalent of Conformitè Europëenne mark (CE mark) with a similar standard to that in Europe for indigenous African medical device manufacturers. The study also explored how such African-based CE mark will encourage innovation and expand access to medical devices in Africa.
Competition in the radioisotopes market: evaluation and analysis of drivers which affect mo-99 market share
(Universty of the Western Cape, 2023) Moremi, Lesedi Maiphepi; Kapp, Erika
This research aims to evaluate competition in the radioisotopes market and to analyze drivers that affect the market share of radioisotopes, particularly Molybdenum 99 (Mo-99), the most widely used radioisotope in medical procedures. Radioisotopes are safe radioactive substances used globally primarily for diagnosing and treating medical conditions (e.g. oncology, cardiology, thyroid disorders, and neurology). These radioactive substances include, but are not limited to Mo-99, Iodine-131 (I-131), Lutetium 177 non-carrier-added (Lu-177 n.c.a.) & Fluorine-18 (F-18)), that are used as Active Pharmaceutical Ingredients (APIs) for the manufacture of radiopharmaceuticals. The most prevalent diagnostic radioisotope among these fission isotopes, Mo-99, which is used to create Technetium-99m(Tc-99m), is estimated to be utilized in roughly 85% of nuclear medicine diagnostic scans carried out globally (National Academies Press, 2009).
Feasibility of an internationally recognized conformitè europëenne equivalent mark for medical devices in africa: a review of current literature
(University of the Western cape, 2024) Nkuku, Khanyisile Zachia; Egieyeh, Samuel
Medical devices are crucial to health systems and are critical to addressing the disease burden of African countries. In light of the importance of diagnosis and surgical intervention in healthcare, medical devices such as radiation emitting devices and devices incorporating a substance, are held to a high standard of quality and safety. Hence, the regulation of medical devices is required to optimize their use in healthcare within Africa. To successfully transition from the existing unregulated medical device sector to a thorough regulatory framework, many nations lack both the financial and technological resources. Consequently, organizations attempting to manufacture and market medical devices confront numerous obstacles, such as navigating the regulatory frameworks of various other nations and creating sustainable business models for imported medical devices. Many nations, including countries in Africa such as South Africa, Nigeria, and Ghana, require Conformitè Europëenne (CE) marked products which can only be obtained in Europe, making it extremely costly for local African manufacturers of medical devices to bring their products onto the market in these African countries
Monitoring and evaluation of medical products regulatory systems and harmonization in west Africa
(University of the Western Cape, 2023) Hettige, Navoda Lakshani; Egieyeh, Samuel A
The Food & Drug Authority (FDA) defined regulatory harmonization as a process where regulatory agencies align technical guidelines for marketing and the development of pharmaceutical products all over the world. Regulatory harmonization can increase efficiencies in regulatory agencies worldwide and reduce duplication of efforts. The African Medicines Regulatory Harmonization (AMRH) initiative is recognized as the bedrock of medicine regulations in the African region. As the first step, the AMRH initiative established the East African Community Medicines Regulation Harmonization (EAC-MRH) program in 2012 in the East African Community (EAC). The Medicines Regulatory Harmonization project harmonized the different aspects and legal frameworks within that regional economic community and proposed a reliance model for medicine registration. As a result, there was increased access to quality medicines and the emergence of medicine manufacturers in Africa. In 2015, the AMRH initiative established the Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) program in Ghana to enhance medicine regulation in West Africa with the collaboration of the World Health Organization (WHO) and the New Partnership for Africa's Development (AUDA-NEPAD). The AMRH initiative conducts monitoring & evaluation studies to assess the performance of quality management systems (QMS), good manufacturing practices (GMP), information management systems (IMS), and registration systems in national medicines regulatory authorities of countries within a respective regional economic community. This study aimed to analyze the monitoring and evaluating data from the ongoing implementation of the Medicines Regulatory Authorities’ (MRAs) regulatory systems and harmonization program in the ECOWAS region by AUDA-NEPAD. The data were collected by administering a previously validated questionnaire to the heads of the departments in each National Medicines Regulatory Authority (NMRA) and Regional Economic Community (REC) Secretariat. The questionnaire was designed based on nine categories following the WHO Global Benchmarking Tool (GBT). All these nine categories were further divided into sixteen indicators for ease of understanding. This project used the data collected by AUDA-NEPAD as a secondary data source. The data collected were qualitative and quantitative; therefore, a mixed-method approach was used to analyze the data.
A critical review of the who global report on traditional and complementary medicine 2019: implications for harmonization of traditional and complementary medicine regulation in Africa.
(University of the Western Cape, 2022) Mukeshimana, Martin Kamuhanda; Egieyeh, Samuel A
A broad range of Traditional and Complementary Medicine (TCM) practices and products is available and accessible to the population in many countries in Africa, and worldwide. Therefore, an effective and harmonized medicines regulatory system is required for TCM. The World Health Organization (WHO, 2019) global report on TCM highlighted the progress that was globally achieved in the regulation of TCM by countries that have implemented and adopted TCM services over the past two decades. Within the African continent, the African Medicines Regulatory Harmonization (AMRH) Initiative aims to strengthen regulatory capacity, encourage harmonization of regulatory requirements, and expedite access to good quality, safe, and effective medicines. However, several studies have shown a limited capacity to regulate TCM and medical products in general, hence the need to assess. Aim: This study assessed the status of TCM regulation in some African countries and deduced how the current status can advance the harmonization efforts in Africa. Method: A desk research on the status of African countries in adopting and implementing the WHO, 2019 TCM indicators was conducted, and a qualitative descriptive approach was used to analyze the data. Results: A total of 28 African countries responded to the (WHO, 2019) global report. The results showed remarkable progress on some WHO indicators such as the National policy and the National Office for TCM. For the primary WHO indicators that are fundamental to achieving harmonization such as the regulation and monitoring of the manufacturing of herbal medicine, results showed less than 50% of implementation by African countries.
Cannabidiol: A medicine, health supplement or foodstuff? Analysis of South African policies relating to the introduction of cannabidiol into the market
(University of the Western Cape, 2022) Boshoff, Suné; van Huyssteen, Mea
With the recent rise in the popularity of cannabidiol (CBD) around the world, there are many cultivators, manufacturers, and sellers of CBD on the market. It is sold in different dosage forms including oils, used to treat a wide variety of lifestyle diseases and medical conditions. Despite the increasing availability of CBD and its products, there are many controversies and uncertainties regarding the legality and regulation thereof in various countries. The main question is whether CBD is regarded as a medicine, health supplement or merely a foodstuff.
Situation analysis study on nanomedicines regulation and assessment practices in Zazibona active countries
(University of Western Cape, 2021) Mudyiwenyama, Linda Gracious; Dube, Admire
Nanomedicines are loosely defined as medicines that seek to apply nanotechnology. Currently, nanomedicines are available for clinical use, including treatments for cancer, high cholesterol, hepatitis, COVID-19 vaccination, among other uses (Patra et al., 2018; Gao et al., 2021). Most of the nanomedicines meet the definition of medicines according to various national legislations. Consequently, these products are regulated as medicines. Nanomedicines present major differences in biological details and increased complexity of clinical use. They integrate different technology subsets from therapeutics to imaging and integrated non-invasive diagnosis (Gaspar, 2007). These complexities require extra regulatory effort.
Exploration of the training/educational background and the roles of regulatory affairs associates/officers in selected South African based pharmaceutical companies in Gauteng province
(University of Western Cape, 2021) Mukoma, Collins; Egieyeh, Samuel A.
Regulatory Affairs (RA), within the pharmaceutical business, could be a profession that covers different registration parameters of a pharmaceutical product. This is a profession that was developed to protect the public by providing smart, quality, safe and efficacious pharmaceutical products. However, it is not clear if the personnel possess the fundamental education and training required to perform the roles and responsibilities in this profession. The study aimed to explore the educational training and role of RA associates/officers in pharmaceutical corporations in Gauteng, South Africa. The study was a cross-sectional survey, which utilized Google forms with both open and closed-ended questions. Using descriptive statistics, it was found that the majority of the participants (78.3%) (RA assistants, officers, and scientists) indicated that the knowledge for most of the responsibilities they carry out was acquired through informal training (i.e., learning on the job).
Awareness regarding non-steroidal anti-inflammatory drug-related side effects in Johannesburg, South Africa
(University of Western Cape, 2021) Padayachee, Vaneshree; Butler, Nadine
Non-steroidal anti-inflammatory drugs (NSAIDs) are amongst the most commonly used medications globally, as they are highly effective and easily accessible. The NSAIDs are indicated for mild to moderate pain management. The increasing incidence of NSAID related side effects and hospitalisations has raised a concern about these medications’ safety. The prevalence of these side effects has drastic consequences to a challenged South Africanpublic healthcare system. The implications of not treating severe, potentially preventable upper gastrointestinal complications attributed to NSAIDs’ consumption continue to be a significant problem that healthcare professionals (HCP) face.
Exploring the factors influencing the sustainability of mobile clinics for the delivery of the expanded programme on immunisation to the rural areas of the Northern Cape.
(University of Western Cape, 2021) Losper, Julia; Bheekie, Angeni
The Northern Cape province has not been able to achieve the 90% immunization target recommended for South Africa’s expanded programme on immunisation (EPI). The situation has been attributed to the lack of access to EPI in the rural community. The Northern Cape’s poor infrastructure renders the provision of equitable preventive care service to rural communities a complex and costly task. The province is predominantly a rural setting consisting of farmland, with low population densities, and many residents have poor access to public transport to receive primary health care services from surrounding fixed or satellite clinics. Consequently, mothers often do not adhere to the immunization schedules, and lack awareness of the risks associated with the failure to have their infants vaccinated against communicable diseases. EPI services delivered via mobile clinics serve the primary health care needs for rural communities, but their sustainability remains a challenge. Additional barriers are found in literature which highlighted the shortage of health professionals, unreliable funding, limited transportation within rural areas and deficiencies in maintenance and suitability of mobile clinic vehicles.
Use and consumer perceptions of dietary supplements in the fitness community of Gaborone, Botswana
(University of Western Cape, 2020) Phaladi, Kagiso; Obikeze, Kenechukwu
Health authorities around the world, including stringent ones, struggle to regulate dietary supplements. Health claims and actual effects of these products on users therefore are not adequately studied and monitored. In Gaborone, there has been a notable rise in the presence of these products in health stores, retail pharmacies, and gyms. The purpose of this study is to explore the prevalence of use and consumer perception of dietary supplements in the fitness community of Gaborone, Botswana
Change Management in a Biopharmaceutical Company
(University of the Western Cape, 2020) Terblanche, Thersia; Egieyeh, S.
This study aimed to review the change management implemented in a Biopharmaceutical company in Cape Town in the light of existing literature on change management theory. Three main constructs were identified: process of change, readiness for change and climate of change. A quantitative pencil-and-paper survey were used to explore and describe employee experience of the change management process within a single department of a biopharmaceutical company in Cape Town. Cronbach alpha coefficient confirmed internal reliability (α = 0.94) of the questionnaire constructs. Employees across all ages reported average scores for all constructs (M ≥ 2.5 < 4), indicating a similar experience regardless of age. A medium-strong positive correlation (p < 0.01; r = 0.49) was observed between process of change and climate of change. Based on the findings from the literature review and empirical research, recommendations were made to improve the change management processes and experience within biopharmaceutical companies. This study not only contributes to the body of knowledge on change management literature in the biopharmaceutical context, but also provides insight to a biopharmaceutical company to improve future change management practices.
Change Management in a biopharmaceutical company
(University of Western Cape, 2020) Terblanche, Thersia; Egieyeh, S.
This study aimed to review the change management implemented in a Biopharmaceutical company in Cape Town in the light of existing literature on change management theory. Three main constructs were identified: process of change, readiness for change and climate of change. A quantitative pencil-and-paper survey were used to explore and describe employee experience of the change management process within a single department of a biopharmaceutical company in Cape Town. Cronbach alpha coefficient confirmed internal reliability (α = 0.94) of the questionnaire constructs. Employees across all ages reported average scores for all constructs (M ≥ 2.5 < 4), indicating a similar experience regardless of age. A medium-strong positive correlation (p < 0.01; r = 0.49) was observed between process of change and climate of change.
Perceptions of the pharmaceutical industry and regulators in South Africa towards registration harmonisation in the Southern African Development Community (SADC)
(University of the Western Cape, 2021) Dhanraj, Keshnee; Dube, Admire; Ward, Kim
Medicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The process of medicines registration is lengthy, costly, and document-heavy. Many countries have limited expertise and resources at national medicines regulatory authorities (NMRAs) and some countries have adopted unified approaches to medicines registration legislation. Harmonised guidelines and initiatives have been adopted in South Africa and the Southern African Development Community (SADC). However, there are no studies that have identified the effects of these initiatives and guidelines on major stakeholders such as the pharmaceutical industry and regulators.
The impact of universal health coverage and national health expenditure on the main health determinants on central America countries and the Caribbean
(University of Western Cape, 2020) López, Alejandra; Obikeze, Kenechukwu; Bapoo, Rafik. A
Health is considered as a sensitive marker of the sustainable development of a population. In Central America and Caribbean (CAC) region, the majority of countries are considered middle-income economies with significant inequalities mainly between the different types of health coverage and health expenditure.The main objective of the dissertation is to identify a possible relationship between universal health coverage and health investment in the main health and some sociodemographic determinants defined by the WHO/PAHO from 2009 to 2018. Additional characterizations of current types of health coverage, investment in health and the main health and socio-demographic indicators of the region were made.
Additional regulatory review pathways can facilitate faster dossier approvals in South Africa
(University of the Western Cape, 2019) Mattew, Ilona; Joubert, Jacques
The objective of the study was to perform a comparative review of pathways, timelines and improvements of countries with markets that the South African Health Products Authority (SAHPRA) benchmark themselves against. Furthermore, this study intends to identify the factors that improved and accelerated submissions and approval process in investigated countries and potential introduction of these strategies into the South African market.

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