Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)
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Item Knowledge-based integration of Zimbabwean traditional medicines into the National Healthcare System: A case study of prostate cancer(University of the Western Cape, 2017) Chawatama, Brighton Itayi; Bapoo, RafikThis study sought to identify the bottlenecks in the promotion of Zimbabwean Traditional Medicines (ZTMs) towards improving the national healthcare delivery system. The indigenous medicines lost value and recognition to the Conventional Western Medicines introduced by the British colonialist since 1871 and is still dominating the national healthcare delivery system. There are growing challenges to ensure accessibility of affordable drugs especially for primary healthcare. The World Health Organization (WHO) and United Nations (UN) is in support of re-engaging indigenous medical interventions to achieve the Millennium development goals. Indigenous Traditional Medicine Knowledge-Based Systems (ITMKS) form the basis of the main source of health care for about 80% of the population in the developing countries. The implementation of the Zimbabwe Traditional Medicines Policy (ZTMP) has been at a stand-still since inception in 2007. The research used mixed methods involving qualitative and quantitative approaches. Data was collected through desk and field research. Questionnaires and focus group discussions were used to record perceptions and attitudes of key informants. The stakeholders included Traditional Health Practitioners (THPs), Medical Doctors, Pharmacists, Medical Research Council of Zimbabwe (MRCZ) staff, Medicines Control Authority of Zimbabwe (MCAZ), Traditional Medical Practitioner’s Council (TMPC), Zimbabwe National Traditional Healers Association (Zinatha), Ministry of Health and Childcare, WHO, Higher Education Institutions (UZ School of Pharmacy staff and students), Christian Groups, NGOs and Prostate Cancer Patients in Harare CBD. The stakeholders sampling framework was obtained from the list of registered practitioners. The stakeholder mapping involved selection of 5 key informants from each focus group obtained through random selection. The Snowball sampling technique was used to follow the closest 5 key informants in each focus group. The key findings established that 80% of respondents agreed to the integration of ZTM. The major bottlenecks were lack of modern dosage forms and standardization to determine quality, safety and efficacy of the ZTM. The study suggests that in order to fast track the integration process, a bottom up implementation strategy providing ZTM advocacy, capacity building in the institutionalization and training of ZTMPs, pharmacists and CMP need to be engaged for a favorable and quick buy-in. The study also recommends further analysis of the Indigenous Knowledge Systems (IKS) areas of specialization in pharmaceutical practice in order to improve treatment outcomes.Item Investigating the Economic Impact of Mandatory Electronic Prescribing Requirements in the United States(University of the Western Cape, 2017) Kent, Michelle; Parker, MiriamTechnological advancements applied to healthcare may holistically improve the economic burden of prescription medication costs. United States legislative actions requiring utilization of electronic prescribing (e-prescribing) will drive provider utilization to decrease healthcare spending. Federal and state e-prescribe requirements have been met with resistance by the prescribing community, due to claims that the requirements create an economic burden for them. This research intends to demonstrate the long-term economic value of electronic prescribing regulations across the healthcare spectrum.Item An investigation into the competency framework required for the responsible pharmacist in the pharmaceutical manufacturing sector in South Africa(The University of the Western Cape, 2017) Dockrat, Leila; Bheekie, AngeniThe pharmaceutical manufacturing sector operates within a highly regulated environment, with companies accountable to South African statutory bodies. The responsible pharmacist (RP) is responsible for their company’s adherence to the legislation requirements. Whilst the Pharmacy and the Medicines Acts outline the RP’s, there is no mandatory training requirement prior to registration as an RP, nor thereafter. This study investigated the role and competencies required of newly registered RPs in meeting their professional responsibilities in the pharmaceutical manufacturing sector. An online survey questionnaire elicited responses from RPs (n=102) about views and perceptions pertaining to their role and responsibilities. In addition, semi-structured interviews were conducted with statutory (n=3) and non-statutory representatives (n=5). Survey findings indicated that the majority (89,5%) of RPs felt competent and that they possessed the necessary skills and training. Almost two-thirds of respondents (63,2%) were experienced RPs who shared some reservations, that RPs may be excluded from far-reaching decisions with potential consequences for the company and patients. They added that RP performance monitoring was not regular, which may indicate that some companies view the RP as an appointment of convenience. The majority of respondents (89,5 %) were in favour of the development of training guidelines Findings from the semi-structured interviews indicated that RPs were not fully aware of their scope of duties and the implications thereof. The interviewees were also concerned that some companies, by not giving the RP role the level of importance and authority it required, were practicing tokenism. Further, that not all RPs had the necessary in-depth knowledge of the applicable laws, regulations, guidelines and codes. A competency framework for newly appointed RPs is needed to streamline their roles and responsibilities in the pharmaceutical manufacturing sectorItem The use of complementary and alternative medicines in the treatment of menopausal symptoms by private healthcare patients in Pretoria, South Africa(University of the Western Cape, 2017) Randall, Lynn; van Huyssteen, M.; Bapoo, R.BACKGROUND The use of complementary and alternative medicine (CAM) is widespread in the treatment of menopausal symptoms. While observational studies indicate that CAMs can bring some relief of symptoms, there is mixed evidence of this based on clinical trials and other studies (Thompson, 2010 and Newton et al., 2006), with very little available research specific to South Africa.Item Pharmacovigilance: An Assessment of Knowledge, Attitude and Practice of Healthcare Professionals towards Adverse Drug Reactions Reporting In Central Region of Malawi(University of the Western Cape, 2017) Chulu, Chrissy M.W; Butler, NadineAIM OF THE STUDY: To assess level of knowledge, attitude and practices of dispensing healthcare professionals towards adverse drug reactions (ADR) reporting and to determine if there are any differences in knowledge, attitude and practices among dispensing healthcare professionals METHODOLOGY: A descriptive cross-sectional survey using stratified random sampling technique was employed to draw 114 health facilities using categories of public hospitals, private clinics/hospitals and community pharmacies as strata. Every dispensing healthcare professional found in the main pharmacy of the sampled facilities was targeted. RESULTS: Dispensing healthcare professionals have positive attitude but limited knowledge and poor practice towards ADR reporting. There is significant difference on knowledge towards ADR reporting among healthcare professionals as more of pharmaceutical personnel and medical doctors indicated having knowledge than the other dispensing cadres but there is no significant difference in attitude and practice towards ADR reporting. CONCLUSION: Healthcare professionals in central region of Malawi have limited knowledge and poor practice but positive attitude towards ADR reporting. Lack of training, unavailability of reporting tools and lack of information on how to report has greatly influenced the poor practice of ADR reporting. Educational and awareness interventions on pharmacovigilance, use of appropriately trained personnel and provision of required support to healthcare professionals would greatly improve ADR reporting.Item Innovator Medicines Versus Generic Medicine Package Inserts Safety Amendments, the Reality in South Africa(University of the Western Cape, 2017) Mabunda, Hitekani Tolerance; O'Donoghue, Miriam; Eagles, PeterAvailability of clinically relevant and unbiased medicine information goes a long way in promoting rational use of medicines. The package insert (PI) is one of the sources of information utilised by healthcare professionals for accessing relevant medicine information such as indications, contra-indications and special precautions (Singh, Mohan, Kumar, & Gupta,2016). It is important that the PI contains updated safety information. The safety information in the PIs of the innovator and generic medicines are expected to be the similar since they contain the same active ingredients. Generic medicines have the same efficacy and safety as innovator medicines and are considered bioequivalent. Generic medicines are interchangeable with innovator medicines.Item Disposal Practices for Unwanted Medicines from Households in Johannesburg(University of the Western Cape, 2017) Mashiane, Mathabo Matopong; Obikeze, KeneA 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.Item Cost-Effectiveness of selecting an Enantiopure formulation over a racemic mixture(University of the Western Cape, 2017) Lekuni, Olivia; Kapp, ErikaThe 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.Item 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, AdmireRegulatory 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.Item Pharmacoeconomic evaluation in Egypt and its role in the medicine reimbursement(University of the Western Cape, 2018) Mohamed Khalil; Bapoo, RafikAim: The purpose of this research was to assess the validity of pharmacoeconomic evaluation in Egypt three years after the guideline was issued and analyse challenges and opportunities for improvement. Objectives: To conduct a literature review of pricing, medicine reimbursement, and pharmacoeconomic evaluation. Examine, in conjunction with relevant stakeholders, the progress of the pharmacoeconomic evaluation. To present examples of pharmacoeconomic evaluation deployment. To propose recommendations on how to optimize the pharmacoeconomic implementation. Methods: A literature review and a qualitative research method that was conducted using a semi-structured interview with stakeholders of the reimbursement process in Egypt. In addition, examples were analysed to determine the impact of pharmacoeconomic methods on medicine reimbursement in Egypt. Results: The Egyptian Pharmacoeconomic Evaluation Unit was established in 2013, it supports various reimbursement decisions, especially for new technologies. The unit evaluations depended mainly on the available international data. However, fragmentation of the health care system in Egypt is a major obstacle to progress. The guidelines are still non-compulsory for implementation, and accordingly some reimbursement committees do not consider its evaluation in its decision making. Conclusion and Recommendations: The pharmacoeconomic evaluation has demonstrated a good start in Egypt. To gain the full benefit of pharmacoeconomic evaluation, authorities need to consider reducing the complexity of health care system, setting clear strategies, building capabilities to improve pharmacoeconomic awareness; endorsing risk sharing strategy and building a proper health related information system along with creation of full Health Technology Assessment program. The above-mentioned recommendations could be associated together under the Universal Health Coverage road map that Egypt committed to achieve by 2030.Item The development of a study protocol, and ethics and regulatory approval documentation, for evaluation of clinical efficacy of Sutherlandia frutescens in adult type-2 diabetics(University of the Western Cape, 2018) Swead, Ramadan; Syce, James A.The prevalence of diabetes mellitus is increasing worldwide and it is becoming a significant medical problem in low- and middle-income countries. The condition can be controlled with a lifelong commitment to blood sugar monitoring, weight management, proper nutrition, exercise, and pharmacotherapy. Additional new pharmacotherapies are however needed to combat the increased prevalence and various traditionally used herbs, such as Sutherlandia frutescens (S, frutescens), are being advocated to supplement the management of type 2 diabetes mellitus. However, the clinical efficacy of S. frutescens in the management of type 2 diabetes mellitus has not yet been scientifically established.Item Review of the effectiveness of the medicines regulatory systems in Zambia over the period 1995 to 2015(University of the Western Cape, 2018) Kabali, Emmanuel; Ward, KimDue to inadequacy of data on the effectiveness of medicines regulatory systems in Zambia, this study was framed. The aim was to evaluate legislative provisions for medicines regulation under three legalregulatory- frameworks in place over the period from 1995 to 2015. The study was structured in two distinct phases: the first involved document review of available legislation and secondary data relevant to the subject matter, covering the study period; the second involved a questionnaire survey for health practitioners to gather opinions on the effectiveness of the medicines regulatory systems in Zambia. Assessment of secondary data reported by Ministry of Health, and World Health Organisation on treatment outcomes and medicines regulation was conducted. Reviewed data showed relative reduction in incidence of some selected diseases of national importance. It was also evident that the regulatory systems had improved considerably over the study period. Responses from Health Practitioners and other players in the health and pharmaceutical sectors indicated that they were aware of medicines regulatory requirements, supported the need for medicines regulation, and indicated the need for regional collaboration and increased public awareness raising as means for improving current medicines regulatory systems. It was recommended that more comprehensive studies be undertaken to establish causal relationships between medicines regulatory systems, and disease outcomes. A further recommendation was made to implement more integrated information management systems in the Ministry of Health, and the Zambia Medicines Regulatory Authority.Item Knowledge, perceptions and practices of risk-based monitoring among clinical practitioners in the United States(University of the Western Cape, 2018) Hockin, Jennifer; Egieyeh, SamuelThis study investigated the current knowledge, perceptions, and practices of Risk-Based Monitoring (RBM) using written and verbal responses to an ethics review board approved questionnaire. Responses were collected from individuals involved in the practice, oversight, and implementation of clinical trial monitoring in the USA. RBM was viewed as a positive force with a bright future. However the results suggested that a renewed focus on change management strategies is needed to ensure RBM practices penetrate all levels of clinical trial management. The site sponsor/site operational relationship was identified as a key RBM component. Shortcomings in this relationship were identified as significant operational barriers to effective RBM practice. Respondents indicated that current RBM training efforts were lacking. Because RBM is new and its practices deviate significantly from the past total monitoring efforts, both industry and the clinic need to work harder to ensure that everyone involved in clinical trial monitoring understands these differences. Fortunately, overcoming the identified barriers will not require massive changes to current RBM practice. By refocusing efforts on the sponsor/CRO and investigative sites to attain RBM governance, develop quality control plans, institute an optimal RBM platform, and improve training, the true promise of RBM is within reach. Each of these are critical pieces to an effective RBM implementation methodology and correcting initial stumbles in their implementation can assure the RBM future is as promised.Item Review of the effectiveness of the medicines regulatory systems in Zambia over the period 1995 to 2015(University of the Western Cape, 2018) Kabali, Emmanuel; Ward, KimDue to inadequacy of data on the effectiveness of medicines regulatory systems in Zambia, this study was framed. The aim was to evaluate legislative provisions for medicines regulation under three legalregulatory- frameworks in place over the period from 1995 to 2015. The study was structured in two distinct phases: the first involved document review of available legislation and secondary data relevant to the subject matter, covering the study period; the second involved a questionnaire survey for health practitioners to gather opinions on the effectiveness of the medicines regulatory systems in Zambia. Assessment of secondary data reported by Ministry of Health, and World Health Organisation on treatment outcomes and medicines regulation was conducted. Reviewed data showed relative reduction in incidence of some selected diseases of national importance. It was also evident that the regulatory systems had improved considerably over the study period. Responses from Health Practitioners and other players in the health and pharmaceutical sectors indicated that they were aware of medicines regulatory requirements, supported the need for medicines regulation, and indicated the need for regional collaboration and increased public awareness raising as means for improving current medicines regulatory systems. It was recommended that more comprehensive studies be undertaken to establish causal relationships between medicines regulatory systems, and disease outcomes. A further recommendation was made to implement more integrated information management systems in the Ministry of Health, and the Zambia Medicines Regulatory Authority.Item Community pharmacists’ knowledge, attitude and practices on adverse drug reaction reporting in South Africa(University of the Western Cape, 2018) Mayne, Rensche; Bheekie, AngeniPharmacovigilance 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.Item Review of medicine registration system in Tanzania(University of the Western Cape, 2019) Kisoma, Sunday Ally; Obikeze, KeneRegistration of medicines is an essential function of the national medicine regulatory system of any country. Since the start of the medicine registration system in Tanzania in early 2000s, no systematic review has been carried out to document the status of the system and its impact on availability and access to quality assured medicines to the people of Tanzania. Objectives The study was aimed at reviewing the medicine registration system in Tanzania as implemented by the Tanzania Food and Drugs Authority in order to come up with status of the medicine registration system implemented in Tanzania, and evaluate how the system contributes to the availability and access of essential medicines, particularly those needed to support the essential medicines lists and standard treatment guidelines.Item 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.Item Additional regulatory review pathways can facilitate faster dossier approvals in South Africa(University of the Western Cape, 2019) Mattew, Ilona; Joubert, JacquesThe 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.Item Review of medicine registration system in Tanzania(University of the Western Cape, 2019) KISOMA, SUNDAY; OBIKEZE, KENECHUKWURegistration of medicines is an essential function of the national medicine regulatory system of any country. Since the start of the medicine registration system in Tanzania in early 2000s, no systematic review has been carried out to document the status of the system and its impact on availability and access to quality assured medicines to the people of Tanzania.Item 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, MichelleIntroduction: 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).