Дисертації: "Medicine"

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Yuan, Hsiu-Chun. "Optimising written medicine information for prescription medicines." Thesis, University of Sydney, 2020. https://hdl.handle.net/2123/23676.

Повний текст джерела

Анотація:

Optimising written medicine information for prescription medicines Aims: to improve the current and recently revised Australian Therapeutic Goods Administration (TGA) Product Information for prescription medicines (AUS-PI and TGA-AUS-PI, respectively) and recommend a PI format for the future. All current AUS-PI are expected to adopt the revised TGA format by the end of 2020. Methods: The overall study consisted of 3 stages – needs analysis (qualitative interviews with pharmacists n=16, GPs n=9), user testing with HCP students, and user testing with HCPs. Five rounds of face-to-face user-testing interviews were conducted to iteratively evaluate and re-design the TGA-AUS-PI for a prescription medicine – 3 rounds (n=11 per round) with healthcare professional (HCP) students (pharmacy n=25, dentistry n=5, medicine n=3) (Stage 2); and 2 rounds (n=10 per round) with HCPs (pharmacists n=16, GPs n=4) (Stage 3). An electronic version was also developed and evaluated in Stage 3. Results: Findings of the needs analysis (qualitative study) demonstrated that the current AUS-PI and the revised TGA-AUS-PI did not meet the needs identified by HCPs in terms of location and order of information, and design and readability of the content. In stage 2, an existing TGA-AUS-PI was first evaluated through an iterative process of user testing and the findings from the 1st round, as well as the participant recommendations from the needs analysis, and principles of good information writing and design were used to improve the TGA-AUS-PI. The improved AUS-PI was further evaluated and improved in two rounds of user testing to ensure that the final version was able to adequately communicate the key medicines information to the participants. Overall, significant improvements were made to the TGA-AUS-PI, with the exception of two sections (related to therapeutic indications and contraindications) which needed further work. In the final stage of the study, the TGA-AUS-PI was further redesigned and improved to address the outstanding issues from stage 2, with the evaluation being conducted by practising pharmacists and physicians. By the final user testing round, the study finalized AUS-PI (F-AUS-PI) (electronic and hard-copy versions) effectively communicated the key medicines information to the HCPs and the HCP considered the F-AUS-PI a much preferred document to use during consulting, prescribing and dispensing responsibilities with their patients. The overall main issues in the PI that required changing during both user testing stages were; complex and/or technical wording, disorganized categorization and arrangement of information, and inadequate application of the principles of good information writing and design. Conclusion: In this study, we were able to revise the TGA-AUS-PI (AUS equivalent of SmPC) so that the document was better able to communicate key medicines information to its intended audience, health care professionals. We were able to do this through a process of needs analysis, document design using principles of good writing and design, and iterative rounds of user testing evaluation and revision. Our recommendations for an improved TGA-AUS-PI format based on the study findings are to include: a summary information section, a table of contents, concise and succinct information, and information sections organized in the order of HCP perceived importance with least perceived important information such as clinical trials section at the end or as a separate document. Given that the primary use of the PI for HCPs is to use it as an on the spot, quick reference, the ability to locate and understand medicine information quickly is critical. Although, the changes and improvements were specific to the TGA-AUS-PI, the findings are applicable and can be utilized in the EU SmPC (especially the TGA-AUS-PI’s format appears to directly follow the SmPC format) and US-PI.