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.
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'.
The Therapeutic Goods Administration (TGA) is requesting feedback on the current usage of the information included with boxed injectables and whether the requirement to include a paper Product Information (PI) as a package insert in boxed injectables is still relevant for those administered by healthcare professionals.
In Australia the PI is required to be provided both in the box of injectables and also as an electronic document available on the TGA website. The PI provides healthcare professionals with a summary of the scientific information about the safe and effective use of a prescription medicine.
The TGA aims to engage with the Australian public, healthcare professionals, and the industry to collect their views on the usefulness of including the paper PI inside the box of an injectable product.
We note different groups may or may not use included information when provided in hard copy with the product and may be satisfied that it only be accessible online.
We seek your views and feedback on the value of the Product Information (PI) as a package insert in boxed injectables that are administered by a healthcare professional (e.g. vaccines).
The TGA is requesting feedback to determine if the PI is a necessary package insert in boxed injectables administered by healthcare professionals and ensure that any changes do not result in negative patient outcomes.
You can find details about this consultation and a graphical representation of the information contained in the Product Information (PI) below.
The TGA will present the feedback to the Govenment for development of further options and for consideration to shape regulatory reforms and policy, noting that further consultations may be required with more user groups and stakeholders.
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