Author: Robert Stringer, Senior Director, Operations
Australia’s Therapeutic Goods Administration (TGA) has long required that parenterally administered products include a hard copy of the product information (PI) in the packaging.
But, after broad consultation last year, the TGA will drop the requirement for PI to be included in packaging for injectable products administered by healthcare professionals.
The change comes into effect on September 1, 2023.
Background
The legislation regulating therapeutic goods in Australia provides various powers allowing specific conditions on marketing authorization approvals – for example, when products are first entered or subsequently varied on the Australian Register of Therapeutic Goods (ARTG). For more than 30 years, under the powers of Section 28(2B) of the Therapeutic Goods Act, the TGA has required a printed version of the PI (often referred to in other regulatory jurisdictions as the approved “labeling”) to be enclosed as a package leaflet in the market presentation of parenterally administered (i.e. injectable) products. The rationale for this was that it provides healthcare professionals immediate access to information relating to the correct administration of the product (i.e. routes of administration, reconstitution/dilution requirements, incompatibilities etc) and the safety profile associated with use.
Implementation of Package Leaflets and Communication Changes
Importantly, when the legislative scheme was devised and implemented (1989-1991), printed reference materials were the primary sources of information to healthcare professionals and patients. At the time this was considered best practice. On the introduction of patient-oriented product information (the consumer medicine information, or CMI), incorporation of a second package leaflet to injectable products was required, creating a logistical challenge to insert additional materials into the often small cartons protecting items such as single-use vials and ampoules.
Following the introduction of the CMI, new approaches to distribution of leaflets were developed, including the introduction of a database available to dispensing pharmacists who could print the leaflet and hand it directly to the patient with the medicine. As the database could be updated relatively quickly, these printed CMI documents contained more up-to-date safety and use information than materials provided as a package insert, which could only be accurate at the time of production and were often several years old for products with long shelf lives.
Over the subsequent decades, with the growth of the internet and cloud-based software the original printed information was replaced by electronic distribution channels, with significant advantages in terms of currency of information, reduced production costs and dramatic reductions in physical resource requirements (e.g.paper), with corresponding benefits to the environmental footprint.
Specific Considerations in Package Leaflet Requirements
In recognition of the changing reference material landscape, and in response to broad stakeholder consultation, the TGA will cease mandatory requirements for package leaflets. The specific conditions are:
- The change applies only to products administered by healthcare professionals. Products that are self-administered, or can be administered by healthcare practitioners or patients, are still required to include a package leaflet of the PI; and
- The TGA retains the authority to impose the PI package insert requirement where they consider it necessary for the safe and effective use of a product.
Advantages
This change reflects the reality that the primary source of information for prescription pharmaceutical products is web/cloud-oriented databases, no longer via printed material. This change will therefore ensure that superseded versions of the PI are not routinely distributed in product packs and so the quality of medicine use is improved. It will also facilitate a faster launch of new injectable products since final production will no longer have to await the TGA approval date before proceeding with packaging runs (noting that the TGA approval data is a mandatory requirement of the PI document).
Call To Action
What will these changes mean for your organization and have you considered how you will implement them? If you need assistance or have feedback, contact PharmaLex. We are happy to discuss the issues with you.
