9 de setembro de 2019

TGA NEWS: Improved Consumer Medicine Information template

From: www.tga.gov.au

The TGA, in consultation with consumer, health professional and pharmaceutical industry representatives, has developed an improved template for Consumer Medicine Information (CMI).

CMIs are intended to provide consumers reliable and easy-to-understand information about the safe and effective use of prescription medicines and certain over-the-counter medicines.

The new template has been developed in response to concerns raised about the complexity and readability of CMIs. It is shorter, better laid-out and features a one-page summary that provides people with the most critical information about their medicine at a glance.

The template and high-level instructions for its use are provided below for the information of interested stakeholders.

Implementation and transition period

There are several thousand products marketed in Australia that have CMIs. As such it may be some time before consumers begin seeing CMI in the new format, as pharmaceutical companies will need reasonable time to implement the changes across their products.

The TGA will be updating the Therapeutic Goods Regulations 1990 to clarify and standardise CMI requirements. In the meantime, we will continue to consult with pharmaceutical companies regarding implementation details, including how the template is to be used for prescription and over-the-counter medicines, issues relating to when CMI is provided in or attached to the packaging, and an appropriate transition period.

The TGA will also continue to develop guidance and other resources, including examples of products in the new template and a webinar, to support companies to use the template.

It is important to note that usability of CMI will continue to heavily rely on the quality of the content produced by the pharmaceutical companies who are responsible for these products.
Development and user testing

In January 2019, the Minister for Health, the Hon Greg Hunt MP, wrote to pharmaceutical company and health professional groups about the issues identified with the current format of CMI. He requested that a group, coordinated by the TGA, be convened to develop an improved template.

The first step was a TGA-facilitated stakeholder workshop held on 1 February.

Participants at this workshop drew on the findings of previous research and user-testing undertaken by the University of Sydney and the Electronic Distribution Working Group (EDWG) – an independent committee that promotes and facilitates the electronic distribution of CMIs to health professionals and their patients.

The workshop agreed on a revised format based on a template proposed by the University of Sydney's Investigating Consumer Medicine Information research project, with some changes based on a design tested by EDWG. This template was subjected to independent user testing and received excellent feedback from participants (see below for the evaluation report).

The template and findings were presented to a final stakeholder workshop on 6 June, where they received unanimous support from doctor, pharmacist, industry and consumer representatives.

Additional targeted consultation has since been undertaken and the TGA will continue to work closely with stakeholders regarding implementation.

Information for stakeholders

Improved CMI template
Improved CMI guide
Improved CMI usability evaluation report