Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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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.
The effect of dossier farming on medicine registration in South Africa.
(University of the Western Cape, 2020) Molokwane, Mmamaswa Flucia; Upton, Edward
In this study, the researcher wanted to determine the effect of dossier farming in medicine registration in South Africa by comparing the number of generic registrations of products tendered for the government for the molecules enalapril, amlodipine and losartan, before and after innovator patent expiration and quantified the extent it is practiced and how it affected medicine registration backlog.
Mobile phone applications targeted towards medicine adherence in Africa: A systematic review
(University of Western Cape, 2020) Masoga, Nora Makgwara; Parker, Mariam
According to the WHO (2017), non-communicable diseases (NCDs) which include stroke, cancer, heart disease, chronic respiratory disease and diabetes is the leading cause of death and is responsible for seventy one percent of deaths worldwide. Beaglehole et al., (2009) reported that management of chronic diseases depends primarily on early detection of early disease, identification of high-risk status, interventions including pharmacological and psychosocial intercessions and long term follow up with monitoring and promotion of adherence to treatment.
Ongoing development of guidelines for biosimilar medicines assessment in Uganda: Critical evaluation and recommendations for inclusion
(University of Western Cape, 2020) Nantongo, Eva; Dube, Admire
A Biosimilar is defined as a biologic product that is similar but not identical to the reference/originator biologic product. Biologic products have raised hopes of improving the quality of life especially in the treatment of chronic non-communicable diseases (NCDs). Of all the major health threats to emerge since the start of this century, none has challenged the very foundations of public health as profoundly as the rise of NCDs. However, the increasing cost of treatment of biologic products has raised many questions regarding its access in the context of multiple inequalities. The arrival of the patent cliff in this sector has given rise to biosimilars. The emergence of biosimilars is expected to go a long way in reducing the cost of care of NCDs. The use of biosimilars is based on the assumption that they are of assured quality and of the same pharmaceutical standard as the reference biologicals. Their quality should therefore be rigorously controlled and assured. Uganda has had biologicals on its market that are claimed to be copies of the originator biologicals also known as biosimilars. Most of these products have not been approved through a biosimilar approval procedure, but have instead been licensed (by the Uganda National Drug Authority (NDA)) using the same requirements as generics or small molecule medicines. According to the World Health Organization (WHO) Guidelines on the Evaluation of Similar Biotherapeutic Products, a biosimilar that has not been demonstrated to be similar to a reference product through head-to-head comparisons should not be described as similar or be called a biosimilar. Although these products are on the Ugandan market, based on the above, they cannot be referred to as biosimilars. In November 2017 however, NDA embarked on the process of developing guidelines for assessment of biologics, and a specific guideline for assessment of biosimilars.

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