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M-11: Barriers and Facilitators to Using Current and Revised Australian Product Information: Perceptions of Healthcare Professionals

Poster Presenter

Tony Yuan

PhD Candidate
The University of Sydney
Australia

Objectives

To understand how healthcare professionals (HCPs) use PI as part of their practice; to explore HCPs’ expectations of, and needs for, information from current and revised PIs; and to develop strategies to optimize the effective use of PI. Revised PIs will supersede existing PI at the end of 2020.

Method

Qualitative face-to-face interviews were conducted with consenting physicians (n=9) and pharmacists (n=16) in Sydney, Australia, to address the study objectives. All interviews were audio recorded, transcribed verbatim and content analyzed.

Results

Participating HCPs indicated that generally the PI’s purpose was to inform them about the full medicine profile, specifically to check dosage, indications, contraindications, precautions, side effects, use in pregnancy; and to learn about a new medicine or one that they rarely prescribed/dispensed. Pharmacists mainly used a PI to check dosage and administration, and to find excipients for patients with known allergies. Physicians mainly used the PI when they were not able to remember the medicine information and when receiving queries from patients. Overall, HCPs tended to use PI more for patient education than self-education. The frequency of PI use for pharmacists was about 2-3 times and for physicians about 5-6 times/day. HCPs reported the top 5 most used and needed sections of the PI as adverse effects, contraindications, precautions, dosage and use in pregnancy and special conditions, all of which were recommended to be arranged according to their importance. HCPs liked the current PI as it had the information they required and they were familiar with the format after years of use. However, when comparing with the revised PI, the HCPs considered it to be well structured, and better organized with meaningful headings and subheadings than the current PI. There were similar issues for both the current and revised PI which did not meet HCPs’ expectations, such as difficulty locating information, too much information, some information that is not required, too much statistical data, and important information not at the front. HCPs felt that the level of information detail in the revised PI had not changed compared with the current PI. They reported that they did not use some PI due to the length, highly technical language and technical content too difficult to digest. The HCPs preferred a summary section at the start of the PI, table of contents, and graphs and tables rather than words to assist with effective use of the PI.

Conclusion

The study demonstrated that the PI serves the HCPs as a complete medicine information document with the scientific information relevant to the safe and effective use of the prescription medicine. Both the pharmacists and physicians have their own ways of using the PI due to their different responsibilities in consulting, prescribing and/or dispensing for their patients. There were similar issues for both the current and the revised PIs that did not meet the HCPs’ needs and expectations. Most HCPs required medicine information to be succinct, easily navigated, arranged according to their importance, and unnecessary information removed. The current PI format has not been revised since 2011, and the recently revised PI format introduced by the Australian Therapeutic Goods Administration at the beginning of 2018 will replace the current PI format by the end of 2020. However, the recently revised PI format appears to directly follow the format of the European Summary of Product Characteristics (SmPC) without full evidence for its validity or application to the Australian context and without full evidence of whether the changes are appropriate for achieving optimal patient outcomes. Therefore, future strategies to optimize the effective use of the Australian PI are needed, such as to evaluate the insertion of a summary and/or a table of contents section at the start of the PI (similar to the US prescribing information/package insert), and improved visual aids in the PI (e.g. graphs, tables and figures).