2 resultados para drug quality

em Aston University Research Archive


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The pharmaceutical qualities of 34 ceftriaxone generic products were compared with Rocephin as the reference standard. Quality standards specified in the European and US Pharmacopoeias were violated on 18 occasions, including those for sterility (4 products) and impurities (5 products). All 34 generics tested failed to meet Roche specifications for Rocephin, with 100 contraventions of the Roche Pharmaceutical standards. The most common failures amongst generic drug products were clarity of solution (30 products) and presence of thiotriazinone (33 products).

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Purpose – The purpose of this paper is to develop a comprehensive framework for improving intensive care unit performance. Design/methodology/approach – The study introduces a quality management framework by combining cause and effect diagram and logical framework. An intensive care unit was identified for the study on the basis of its performance. The reasons for not achieving the desired performance were identified using a cause and effect diagram with the stakeholder involvement. A logical framework was developed using information from the cause and effect diagram and a detailed project plan was developed. The improvement projects were implemented and evaluated. Findings – Stakeholders identified various intensive care unit issues. Managerial performance, organizational processes and insufficient staff were considered major issues. A logical framework was developed to plan an improvement project to resolve issues raised by clinicians and patients. Improved infrastructure, state-of-the-art equipment, well maintained facilities, IT-based communication, motivated doctors, nurses and support staff, improved patient care and improved drug availability were considered the main project outputs for improving performance. The proposed framework is currently being used as a continuous quality improvement tool, providing a planning, implementing, monitoring and evaluating framework for the quality improvement measures on a sustainable basis. Practical implications – The combined cause and effect diagram and logical framework analysis is a novel and effective approach to improving intensive care performance. Similar approaches could be adopted in any intensive care unit. Originality/value – The paper focuses on a uniform model that can be applied to most intensive care units.