Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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    A Comprehensive Study on the Global Regulatory Requirements for the submission of a Post-Approval Change, specifically a Change in Manufacturing Site
    (University of the Western Cape, 2017) Hoey, Barbara; Dube, Admire
    Regulatory requirements for post-approval changes vary for different countries around the world. It is a challenging and costly process for pharmaceutical companies to manage changes to the approved regulatory dossier over the lifecycle of the product when it is registered in many countries. In practice the process can be complex, unpredictable and time consuming because of regional differences and frequent changes in regulatory procedures, requirements and timelines. The global regulatory requirements for the submission of a post-approval change, specifically a change in manufacturing site, were reviewed for six jurisdictions for this study. These include United States of America (US), Europe (EU), South Africa, Brazil, Russia and China. The study centred on the differences in the documentation required when submitting a post-approval change for a change in manufacturing site in these countries. The study compared and contrasted the differences and similarities between the jurisdictions. An analysis of the challenges for implementation of the change was performed. The study also examined what resources a company may need in order to meet the requirements. Some notable similarities but also many differences in the post-approval submission requirements between the countries were identified. Some of the similarities included classification of the type of variation, the submission application process, and the requirement to provide supportive stability data and updates to the common technical dossier (CTD). Differences highlighted were the types of application forms required, the amount of stability data required to support the change and the time lines for review of post-approval changes in each jurisdiction. The challenge for pharmaceutical companies arises in the effective management of these differences. Investment in a robust regulatory change management team is an essential resource requirement for pharmaceutical companies. Adoption of a QbD approach and careful consideration of the global requirements during the product development phase could potentially be of use in strategic planning within a company in order to ensure continued product access globally.
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    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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    The availability of persons nominated for adverse drug reporting and associated challenges in Gauteng regional and district public hospitals
    (University of the Western Cape, 2019) Modau, Tumelo; Van Huyssteen, Mea; Bapoo, Rafik
    Background and Objectives: The reporting of adverse drug reactions (ADRs) is a major public health necessity. It is estimated that only six to 10 percent of all ADRs are reported worldwide. This number is far less than the actual cases of ADRs which occur in healthcare facilities. There appears to be lack of knowledge, awareness and willingness of healthcare professionals to report ADRs, which prompted some countries to nominate a person for ADR reporting in facilities. The objectives of this study were to ascertain which facilities had a nominated person or committee for ADR reporting, describe the knowledge and training of these individuals, describe the processes followed by the facilities for ADR reporting, determine the most commonly reported ADRs and causative drug classes, and, determine the factors which facilitate or hinder ADR reporting. Method: This was an exploratory, multicenter study. A structured questionnaire with closed and open-ended questions was used for data collection. The study was conducted in Gauteng province, where stratified non-random sampling was used to collect data in the selected regional and district public hospitals. Results: Six regional hospitals and five district hospitals participated in the study. Five (45.5%) of these hospitals had a person nominated for ADR reporting, of which all were pharmacists. All the respondents nominated for ADR reporting stated their knowledge and confidence in identification of ADRs as average and above. One (20%) of the nominated persons for ADR reporting did not have pharmacovigilance training. The reported number of ADRs over the past 12 months ranged between zero and 199. Only two (40%) of the hospitals with a nominated person for ADR reporting received feedback on the submitted reports from a committee. Only one (16.7%) of the six hospitals that did not have a nominated person or committee for ADR reporting had plans to nominate a person for this function. ADR reporting in these hospitals were performed by the pharmacy that collated the identified ADRs into a report and distributed these to the Pharmacy and Therapeutics Committee (PTC) and South African Health Products Regulatory Authority (SAHPRA). Only one hospital out of all the hospitals (n=11) did not use the national ADR reporting form and rather used an incident report. Out of all the participating hospitals, only two (18.2%) of the hospitals had an algorithm in place to assist with the identification of ADRs. The researcher went through the file where ADR reporting forms were kept for the past 12 months, and reported that the most commonly reported ADR type across participating facilities was allergic reactions such as rash and angioedema reported by eight of the facilities, followed by administration errors and quality issues each from three facilities. While the most frequently reported drug class associated with these ADRs included antiretrovirals (ARVs) and angiotensin converting enzyme (ACE) inhibitors reported at eight and six facilities, respectively. The most common challenge to ADR reporting at participating facilities was non-reporting of ADRs, followed by fear of litigation and patient’s unwillingness. Although all the hospitals in this study had facility PTCs, only one hospital had a pharmacovigilance subcommittee and the others included ADRs as an agenda point of the PTC meetings. Conclusion: Less than half of the facilities had a person nominated for ADR reporting. Pharmacists and the pharmacy were synonymous with ADR reporting as all nominated persons were pharmacists and in facilities were there were no nominated person, the responsible pharmacist was identified as the contact person for ADR reporting. Although all hospitals had PTCs, there was rarely a subcommittee dedicated to pharmacovigilance or ADR reporting, which culminated in a lack of feedback to healthcare workers that could promote it in the facility. Underreporting of ADRs by health care workers was the major challenge to effective ADR reporting as this function was considered to be too time consuming.
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    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.
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    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.
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    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.
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    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.
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    Community pharmacists’ knowledge, attitude and practices on adverse drug reaction reporting in South Africa
    (University of the Western Cape, 2018) Mayne, Rensche; Bheekie, Angeni
    Pharmacovigilance involves the management of sub-standard drugs, medication errors, ―off-licence‖ drugs, abuse and misuse, lack of efficacy, poisoning, adverse drug reactions (ADRs), drug interactions, expired stock destruction and drug-related mortality. Regulators and the pharmaceutical industry rely on healthcare professionals, including pharmacists, to report ADRs. The majority of pharmacists work in retail community pharmacies and they are often the first point of contact when ADRs are experienced, since self-medication, misuse of over-the-counter (OTC) medicines, vitamins and traditional medicines, increase the probability of ADRs. In South Africa (SA) ADRs have been known to cause adult deaths and hospital admissions. In first-world communities, pharmacovigilance is more common among pharmacists, however in South Africa, ADR reporting compares poorly. Studies in the public sector have found that pharmacists lack pharmacovigilance knowledge and underreport ADRs. In comparison the pharmacovigilance knowledge and practice patterns among retail community pharmacists is poorly documented.
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    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).
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    Cost-Effectiveness of selecting an Enantiopure formulation over a racemic mixture
    (University of the Western Cape, 2017) Lekuni, Olivia; Kapp, Erika
    The aim of this study is to provide more information in terms of the cost-effectiveness of selecting an enantiopure formulation over a racemic mixture in the context of promoting rational use of medicines. This was done by comparing costs and efficacy of escitalopram versus citalopram and esomeprazole versus omeprazole since they are the most commonly used medicines with both racemate and enantiopure products registered.
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    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.
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    Disposal Practices for Unwanted Medicines from Households in Johannesburg
    (University of the Western Cape, 2017) Mashiane, Mathabo Matopong; Obikeze, Kene
    A mixed research method was used where quantitative research facilitated qualitative research. Three questionnaires were drafted and distributed by email to respondents in the Johannesburg area. One questionnaire was for households. The second questionnaire was targeted at pharmacists who work in community pharmacies. The third questionnaire was aimed at South African Pharmacy Council (SAPC) registered Responsible Pharmacists for community pharmacies. In order to reduce bias the household questionnaire was also distributed as hard copies to access respondents in lower Living Standards Measures. Data analysis was done by using the Survey Monkey data analysis package.
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    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.
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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.
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    Evaluation and comparison of current legal and regulatory framework for traditional medicines in five selected African countries: A move towards harmonization of regulation of traditional medicines in Africa.
    (University of the Western Cape, 2019) Chikwari, John Ratiso; Egieyeh, Samuel A.
    Background: In Africa, traditional medicine (TM) practice has been in existence since time immemorial as the major source of pharmacotherapy. However, unlike orthodox medicines TM policies and regulations are not formalised let alone standardised. African nations have different approaches and regulatory requirements whereas in some states policies are even non-existent. Aim: The aim of the mini thesis was to assess the current policies and guidelines for regulation of TM in five selected sub-Saharan African countries relative to the WHO recommendations on traditional medicine policy. Method: The mini thesis was a desk review of current policy frameworks and guidelines for regulation of traditional medicines relative to WHO recommendations on TM policy in sub- Saharan Africa using five selected countries. Result: The results from the five selected countries showed significant difference in the current policies and guidelines on the regulation of TM, but no significant difference in the actual WHO TM policy indicators that the countries implemented. Discussion: Regularisation of TM practice by integrating it into main health systems could make it more acceptable. The complexity of TM/herbal products needs a different yet integrated approach. Harmonisation of regulatory requirements eliminates the need for redundant testing, ensures consistency across regions and improves implementation of WHO TM policy indicators.
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    Evaluation of reporting all types of adverse drug reactions by parents of children younger than 18 years in South Africa
    (University of the Western Cape, 2019) Pillay, Shavani; Viljoen, Michelle
    Introduction: Medicines are created with the intention of helping patients but may be harmful to the patient by causing adverse reactions. The effect of adverse drug reactions (ADRs) on patients has become more evident over the last two decades and reporting of ADRs in South Africa is low. This results in many patients, particularly children, potentially being exposed to medicinal products with an uncertain safety profile. Due to parents’ typical caring and protective role, they could play a part in detecting and reporting ADRs in children, thereby contributing to making safer medicines available to children. Aim: This research study evaluated the awareness and knowledge in South Africa of parental reporting of suspected ADRs in their children. Method: A quantitative descriptive study was conducted based on an anonymous web-based self-administered questionnaire that was distributed through Facebook® and LinkedIn™ to parents in South Africa. The questionnaire, which was distributed between July 2018 and August 2018, was standardized for all participants and consisted of closed (n=28) and open-ended (n=4) questions. The questions were coded, data was analysed using descriptive statistics (percentage and frequency counts). Associations between categorical demographic variables were determined using the Pearson Chi-square test. Results: The questionnaire was voluntarily completed by 206 participants. Majority of the respondents were female (n=155, 75.2%) and the most relevant age category for all respondents was 31-40 years (n=100, 48.5%). The majority of participants (n=146, 70.9%) were aware of the term ADR and significant associations between awareness of ADRs and ethnicity, marital status, education level, medical aid and access to general medical services were found. Being white (p<0.001), having a degree (p=0.001) and having private medical aid (p=0.004) were independently associated with being significantly more aware of the term ADR compared to being black (p<0.001), coloured (p=0.004), a single parent (p=0.003), not finishing school (p<0.001), having matriculated (p<0.001), having no private medical aid (p=0.004) and receiving general medical services from public clinics (p = 0.003).
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    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).
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    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.
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    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
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    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.