Browsing by Subject "quality"
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(2023)This qualitative study was carried out as a semi-structured interview study, which was supplemented with quantitative information from centralized cytotoxic preparation units in Finland hospital pharmacies and with information about interviewees. Quantitative information was collected using questionnaires. The proportion of centralized cytotoxic preparation units that responded to the background information questionnaire was 95% (19/20) of all centralized cytotoxic preparation units in mainland Finland. In the autumn of 2022, hospital pharmacy employees (n=23) participating in the reconstitution of cancer drugs were interviewed. On average, the interviewees had 14 years of work experience in the reconstitution of anticancer medicines. They represented 75% (15/20) of the centralized cytotoxic preparation units in mainland Finland, covering centralized cytotoxic preparation units of different sizes and locations in different parts of Finland. In 2021, 88% of the anticancer medicines in all centralized cytotoxic preparation units in Finland were reconstituted at the workplaces of interviewed. According to the interviews, the reconstitution of anticancer medicinal products involves the possibility of an error in several stages of the process. An error can occur when prescribing the medicine, transferring prescription information, when selecting the raw materials, reconstituting of the cancer medicine and during transport. The interviewees identified 24 risks associated with these stages, that could lead to patient safety incidents. Safeguards have been built to avert errors or promote the detection of the errors. Based on the research data, the safeguards were classified into six categories: the development of the technology, guiding work through guidelines, strengthening competence, standardizing practices, controlled working environment and learning from deviations. In Finland, it has not previously been studied or classified with which functions and principles the centralized cytotoxic preparation units have built safeguards to prevent patient safety incidents. This study shows that reconstitution of cancer medicines is a risky process. To improve the quality of reconstituted cancer medicines and patient safety, both the system- and person-focused safeguards have been built into the risk points of the processes of the centralized cytotoxic preparation units, but their utilization varied between centralized cytotoxic preparation units. Based on comprehensive data, the research result can be generalized to centralized cytotoxic preparation units in Finland hospital pharmacies.
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(2012)In pharmaceutical industry GMP compliance and quality of operations can be ensured with quality management system (QMS). QMS is an operational system, which consist of multiple different elements depending on the size of the company and nature and complexity of its operations. For the QMS to be functional, documented and defined operations need to be managed and monitored systematically. Conducting internal audits has been considered necessary with regard to QMS, though it has not always been perceived as adding value or seen as an opportunity to utilise more fully. Internal audits are mainly utilized to control compliance to requirements. However, there are possibilities to utilise it more in improving and developing operations, preparation to external audits, quality risk assessment, finding out the best practices, basis for decision making, learning experience as well as the assessment of functionality and effectiveness of the QMS. The aim of this study was to examine the utilisation of internal audits in Orion (Espoo) and find solutions to improve the utilisation of internal audits with QMS. The focus was on how internal audits can monitor and guide QMS and what is required from internal audits for monitoring and guidance of QMS. These aims were approached qualitatively by conducting semi-standardized open-ended interviews. Interviewees (n=9) were selected from both auditor and auditee side and they had their background in quality assurance or production. Data compiled from these interviews was analysed mainly by qualitative methods, using also some quantitative analysis. Monitoring of the QMS can be looked at as the starting point to guide QMS. Valuable information can be gathered with internal audits with regard to QMS. By utilising this information, internal audit process and QMS can be improved and the quality of operations can be ensured. Based on this work internal audits can be utilised to monitor and have the potential to guide QMS under certain conditions. Internal audit topics need to be systematically selected, QMS needs to be monitored and guided based on the internal audit findings, flow and distribution of information needs to be efficient and flexible, and internal audits should be better utilised and managed. Further research is needed on the development and deployment of tools to aid better utilisation of internal audits in the control of QMS. Also ways to measure the effects of internal auditing should be further investigated.
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