Around the Globe

Australia Works to Simplify Consumer Medicines Information Leaflets
Ric Day
University of New South Wales
@osbornidayius
I

n Australia, the Consumer Medicines Information leaflet contains information on the safe and effective use of a prescription medicine and certain over-the-counter medicines. The CMI leaflet can be provided to patients by doctors or pharmacists, or directly and freely accessed by patients through various websites. In certain circumstances it may be required to include the CMI in the medicine packet. The CMI is similar to the Medication Guides provided for some medicines in the US and to the Package Leaflets used in Europe.

However, doctors, pharmacists, and consumer health advocates have raised numerous concerns about the complexity and readability of these documents for non-professional users. In early 2019, the Therapeutic Goods Administration (TGA) was tasked with reviewing the current CMI template to develop a simpler format that provides key information in a more accessible form.

Development and Testing

The Hon Greg Hunt MP, the Australian Minister for Health, wrote to drug companies and health professional organizations this past January in search of collaborations to improve the CMI format. After a TGA-facilitated stakeholder workshop on 1 February, a revised format based on a template developed under the Investigating Consumer Medicine Information Research Project some years earlier was agreed upon.

Some more recent changes recommended by the Electronic Distribution Working Group (EDWG) under the auspices of Medicines Australia, the primary local body for innovator drug companies, were also included. With the assistance of EDWG, three example CMIs for a variety of dosage forms – a solid dose form tablet, an inhaler, and an injectable – were prepared in this new format.

Next, independent user testing of these documents was undertaken by consultants guided by input from Professor Parisa Aslani, University of Sydney. Consumer testing included consideration of digital enhancements, their implementation, and how well the revised format worked in print-based delivery. Based on these findings, iterative improvements were made to the CMI documents between the three rounds of testing. This new format received excellent feedback from participants: an overwhelming majority found it easier to use and understand than the current CMI format.

A final stakeholder workshop was conducted on 6 June 2019, where the findings and template were presented to industry, health professionals, and consumer representatives. The template received unanimous stakeholder support.

Benefits and Implementation

The new CMI template is shorter, laid out better, and features a single-page summary that succinctly provides the most critical information relating to safe and effective use of that medicine. Digital enhancements for CMI were also explored and may be introduced in the future.

TGA will publish the new template along with instructions on its use and is working closely with industry bodies to encourage use of this new resource. The government will update relevant regulations later in 2019 to clarify and standardize CMI requirements for industry and will continue to consult on implementation details. Because there are several thousand CMIs, drug companies will progressively revise their materials during a transition period.

It is important, however, to acknowledge that the useability of the CMI will continue to rely heavily on the quality of the content produced by the drug companies responsible for these products in Australia.

This project has shown the benefits of TGA’s collaborative and inclusive approach with industry, patients, academia, and healthcare professionals.

The author is indebted to Professor John Skerrit, Deputy Secretary of the Australian Department of Health and responsible for Australia’s Therapeutic Goods Administration, and to Prof. Skerrit’s colleagues for their help with this report.

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