Browsing Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation) by Title
Now showing items 1-20 of 22
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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)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 availability of persons nominated for adverse drug reporting and associated challenges in Gauteng regional and district public hospitals
(University of the Western Cape, 2019)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 ... -
Community pharmacists’ knowledge, attitude and practices on adverse drug reaction reporting in South Africa
(University of the Western Cape, 2018)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 ... -
Cost-Effectiveness of selecting an Enantiopure formulation over a racemic mixture
(University of the Western Cape, 2017)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 ... -
Disposal Practices for Unwanted Medicines from Households in Johannesburg
(University of the Western Cape, 2017)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 ... -
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)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 ... -
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)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 ... -
Innovator Medicines Versus Generic Medicine Package Inserts Safety Amendments, the Reality in South Africa
(University of the Western Cape, 2017)Availability 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 ... -
Investigating the Economic Impact of Mandatory Electronic Prescribing Requirements in the United States
(University of the Western Cape, 2017)Technological 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) ... -
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)The 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 ... -
Knowledge, perceptions and practices of risk-based monitoring among clinical practitioners in the United States
(University of the Western Cape, 2018)This 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 ... -
Knowledge-based integration of Zimbabwean traditional medicines into the National Healthcare System: A case study of prostate cancer
(University of the Western Cape, 2017)This 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 ... -
Mobile phone applications targeted towards medicine adherence in Africa: A systematic review
(University of Western Cape, 2020)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 ... -
Ongoing development of guidelines for biosimilar medicines assessment in Uganda: Critical evaluation and recommendations for inclusion
(University of Western Cape, 2020)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 ... -
Pharmacoeconomic evaluation in Egypt and its role in the medicine reimbursement
(University of the Western Cape, 2018)Aim: 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 ... -
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)AIM 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, ... -
Review of medicine registration system in Tanzania
(University of the Western Cape, 2019)Registration 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 ... -
Review of medicine registration system in Tanzania
(University of the Western Cape, 2019)Registration 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 ... -
Review of the effectiveness of the medicines regulatory systems in Zambia over the period 1995 to 2015
(University of the Western Cape, 2018)Due 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 ... -
Review of the effectiveness of the medicines regulatory systems in Zambia over the period 1995 to 2015
(University of the Western Cape, 2018)Due 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 ...
