SP09-74: Optimizing Written Information for Prescription Medicines
The University of Sydney Australia
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 will be expected to adopt the revised format by end of 2020.
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 with healthcare professional (HCP) students (pharmacy n=25, dentistry n=5, medicine n=3); and 2 rounds with HCPs (pharmacists n=16, GPs n=4).
The overall study consisted of 3 stages - needs analysis, user testing with HCP students, user testing with HCPs. 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, design and readability of the content. In stage 2, an existing TGA-AUS-PI was evaluated through an iterative process of user testing (3 rounds) with 33 HCP student participants. 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 study AUS-PI Version 1 (S-AUS-PI-1) was developed and evaluated in round 2. The findings were used to improve the TGA-AUS-PI and the next version, S-AUS-PI-2, was evaluated in the 3rd round. In the 1st and 2nd rounds, the TGA-AUS-PI and S-AUS-PI-1 did not adequately communicate the key medicines information to the participants. However, in the 3rd round, the modified medicine information in the S-AUS-PI-2 showed greater improvements in communicating information to the participants compared to the previous 2 rounds. In the final stage of the study, the TGA-AUS-PI was further redesigned and improved to address any outstanding issues, and participant recommendations from the HCP needs analysis and HCP students, using principles of good information writing and design. An electronic version was also produced and evaluated. Two further rounds of user testing were conducted with 20 HCPs (pharmacists and physicians) with 10 HCPs per round. 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 dispending responsibilities with their patients.
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 using:
1) Qualitative data from healthcare professionals identifying their needs from PI, the issues they saw in the document that were problematic, and features that they felt improved usability and readability of the PI document.
2) Principles of good information writing and design
3) Iterative process of user testing, evaluating the PI, and making revisions.
The main issues in the PI that required changing were; complex and/or technical wording, disorganized categorization and/or arrangement of information, and inadequate application of the principles of good information writing and design.
Our recommendations for an improved TGA-AUS-PI format are to include: a summary information section, a table of contents, concise and succinct information, and information sections organized in the order of importance with least 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 improvement were particularly for 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.