Consultation: Product Information as a package insert in boxed injectables

The Therapeutic Goods Administration (TGA) sought feedback to determine if the Product Information (PI) is a necessary package insert in boxed injectables administered by healthcare professionals, or whether provision of the PI electronically on the TGA website is sufficient.

Fifty seven (57) responses were received from various stakeholder groups comprising healthcare professionals, healthcare groups, interested medicine consumers, pharmaceutical companies, and governing bodies.

The feedback we received is summarised below.

• The hard copy PI may be valuable for the first year or two for new injectables
• Most respondents noted that some sections of the PI are more useful than others
• Some respondents noted a shorter PI would be useful to ensure safety and minimise waste
• In the hard copy PI, respondents noted that administration information is easy to find without the need of technology
• The respondents noted that the hard copy PI is reliable, trusted and is available without internet access
• Most respondents expressed concerns regarding the font size of the hard copy PI being too small to read
• A QR code/2D barcode linked directly to the PI may be useful as the hard copy may not be the most up-to-date source
• Some respondents noted searching for PIs online can be difficult and a direct link may  be more useful for accessing the most up-to-date PI
• There was concern about the lag time between updated safety information being added to the PI and that information being included in the hard copy PI
• Some respondents noted it was convenient to have the hard copy available in the medication trolley for ease of access during administration rather than referring to a computer
• Some respondents noted that the hard copy PI included in the injectable box may reduce the risk of administration errors
• Respondents noted that there should be considerations made for settings that have barriers to electronic resource accessibility, for example in some rural and remote areas or rural aged care facilities
• Respondents noted that healthcare professionals are trained in administering injectables and have access to medicines information from sources other than the hard copy PI
• Some respondents noted that an electronic PI would allow for harmonised packaging with other jurisdictions
• Some respondents noted a larger box is required to accommodate the hard copy PI, which may result in increased transport and storage cost of the injectable
• Respondents noted the usefulness of the hard copy PI however, also acknowledged the high environmental impact of the paper usage
• Several respondents requested to broaden the scope of the consultation from boxed injectables to include all injectable products administered by a healthcare professional

We are using the feedback received to develop options for further consideration to shape regulatory reforms and policy, noting that further consultations may be required with more user groups and stakeholders. Implementation of some options may require government approval (regulatory change) and/or parliamentary approval (legislative change), and we will present these to the Government for consideration.

Consultation responses are published based on consent provided by respondents in line with the TGA policy. Please see related attachment 'Responses to the Product Information (PI) as a package insert consultation- consented for publishing only'.