Thesis (MSc (Med)(Pharmacy)) -- University of Limpopo (Medunsa Campus), 2010. / Introduction: The aim of this study was to identify and assess compliance with published radiopharmacy procedures in the radiopharmacy units in the Departments of Nuclear Medicine at Steve Biko Academic Hospital, Pretoria and Dr. George Mukhari Hospital, Ga-rankuwa. Objectives: To identify current written SOPs in use by the selected hospitals and to compare them with the two selected audit documents. To describe the Operational Levels (OLs) according to the IAEA classification, staffing and workload of the selected radiopharmacy units. To assess the two selected radiopharmacy units for compliance with the South African Department of Radiation Control audit criteria and the International Atomic Energy Agency Operational Guidance on Hospital Radiopharmacy (IAEA IOG). To obtain the views of staff at operational, clinical and managerial level regarding constraints in the work situation and the potential implementation of „best practice‟ approaches. To identify the elements from the IAEA IOG (IAEA 2008), which are realistically achievable in the South African hospital setting. To compile a comparative report of the assessment and to make recommendations for practice improvement. Method: Quality assurance audit documents (local and international) for “Hot” Laboratories were sourced and compared. Only three radiopharmacy audit documents could be sourced (namely the South African Department of Radiation Control (DOH, 2007), the International Atomic Energy Agency, Operational Guidance on Hospital Radiopharmacy (IAEA, 2008) and United Kingdom Radiopharmacy Group, Radiopharmacy audit (United Kingdom, 2006). The most stringent of these documents the IAEA IOG was selected and was used to assess the equipment, facilities, practices and work flow in the selected radiopharmacy units. A pilot study was conducted at the Nuclear Medicine Department in Tygerberg Hospital to get a clear understanding of the IOG audit document and to develop a system with which to approach the audit of the two study sites. The numbers and qualifications of staff involved in preparation of radiopharmaceuticals were documented as part of the audit. The IOG audit was conducted in the Nuclear Medicine Departments of the two Gauteng Academic Hospitals. Key informants who included radiopharmacists with international experience, currently working in South Africa and the HODs of the Nuclear Medicine Departments audited. The IOG audit results together with the FGD and Key informant information were used to compile recommendations. Results: For anonymity, the hospitals are referred to as hospital X and Y in the results. In both hospitals the chief radiographer is responsible for the radiopharmacy unit. In Hospital X xiii this responsibility is shared with the medical physicist. The radiographers that work in both hospitals have had specific “hot” laboratory training. Neither hospital has a formal system of radiopharmaceutical record keeping, nor do they compile or review their SOPs in any formal or regular way. Neither hospital performs an annual performance review to check the competencies of their staff. Hospital X has equipment that was not in use at the time the research was conducted. Both hospitals are authorised to handle certain radionuclides and radiopharmaceuticals/kits. Hospital Y offers a wider range of Nuclear Medicine services as compared to Hospital X. Hospital Y had already conducted the IAEA Nuclear Medicine IOG Hospital Radiopharmacy audit on their facility, whereas Hospital X had not. Hospital Y, when assessed on verifiable items, met 70 to 100% the required standards for class A items for all components apart from staff at OL2, dispensing protocols and waste management. Hospital X met 70 to 100% of standards only for staff at OL1, facilities and purchasing. In the components of staff at OL2, dispensing, preparation, quality assurance and waste management, the percentages of items where standards were met were much lower at only 12.5 to 55%. In terms of the ease of administration of the IAEA IOG audit, the researcher found that some of the audit items (references) were difficult to interpret because they were presented as multiple questions, some were duplicated, and some lacked clarity. Conclusion: It can be concluded from the results that the one shortfall that both hospitals share is in terms of documentation and record keeping. Both the hospitals‟ waste management procedures need to be documented. Neither hospital has a radiopharmacists in charge of the radiopharmacy unit. Recommendations: Recommendations are made in terms of staff training, facility upgrades and the introduction of formal standard operating procedures (SOPs) and log books for batch traceability in both Hospitals. Radiopharmacist involvement is recommended. Since there are not enough trained radiopharmacists in South Africa, it could be a part-time function of those qualified or they could share responsibility for more than one radiopharmacy. The audit questions could be revised in order to eliminate factors that were noted by the researcher such as multiple questions, duplication and ambiguity. The IAEA is commended for its role in the promotion of Nuclear Medicine and Radiopharmacy training and audits. Regional summaries of audit results should be available from the IAEA to aid comparative benchmarking and monitoring of progress over time.

No description available.

Ph.d.

Magister Pharmaceuticae - MPharm / The purpose of this research thesis, is to evaluate the appropriateness of the current regulatory guidelines on the manufacture of medicinal products within the radiopharmaceutical industry. The manufacture of radiopharmaceuticals is governed by two main regulatory bodies. The regulatory authority responsible for the governance of the pharmaceutical product has the primary objective of ensuring the safety, efficacy and purity of the products manufactured, while the nuclear regulator has the responsibility of ensuring that the products used and manufactured are done so in a safe and responsible manner. The main problem faced by this industry is one where the requirements between the two regulators are, in some instances, in direct conflict of each other. The methodology employed in this study included the review of current regulatory guidelines applicable to the manufacture of orthodox pharmaceuticals, compared to its applicability to the radiopharmaceutical industry. This review showed that the regulatory guidelines, when adopted without industry specific concessions, resulted in an industry which is not as appropriately regulated as orthodox medicines are. It is therefore concluded that, in order for the radiopharmaceutical manufacturing industry to be as appropriately regulated as the orthodox pharmaceutical industry, industry-specific guidelines are required to be developed by the regulatory authorities and adopted by the manufacturing industry.

No description available.

Thesis (M.S.)--University of Missouri-Columbia, 2007. / The entire dissertation/thesis text is included in the research.pdf file; the official abstract appears in the short.pdf file (which also appears in the research.pdf); a non-technical general description, or public abstract, appears in the public.pdf file. Title from title screen of research.pdf file (viewed Nov. 1, 2007). Vita. Includes bibliographical references.

Title from PDF of title page (University of Missouri--Columbia, viewed on Feb 24, 2010). The entire thesis text is included in the research.pdf file; the official abstract appears in the short.pdf file; a non-technical public abstract appears in the public.pdf file. Dissertation advisor: Professor Silvia S. Jurisson and Professor Charles J. Smith. Vita. Includes bibliographical references.

Thesis (M.S.)--University of Missouri-Columbia, 2004. / Typescript. Includes bibliographical references (leaves 64-66). Also available on the Internet.

Title from PDF of title page (University of Missouri--Columbia, viewed on Feb 25, 2010). The entire thesis text is included in the research.pdf file; the official abstract appears in the short.pdf file; a non-technical public abstract appears in the public.pdf file. Dissertation advisor: Dr. Silvia Jurisson. Vita. Includes bibliographical references.

Thesis (Ph.D.)--University of Missouri-Columbia, 2004. / Typescript. Vita. Includes bibliographical references. Also available on the Internet.