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Regulatory impact statement (RIS) - update to the Required Advisory Statements for Medicine Labels (RASML)

May 2013

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7. Communication and consultation

'RASML 5' and 'RASML 6' consultations

Extensive consultation has been conducted for the currently proposed RASML update. The objective of the consultation was to obtain feedback on the level of support for the proposed changes, as well as any suggested improvements, and the likely benefits and costs of the revisions to stakeholders.

The consultation was conducted by publication of the proposed document together with explanatory information and request for public submissions. The most recent consultation period, in 2011, was three months.

In response to the consultation documents for the 'RASML 6' update, a total of 22 submissions were received, originating from peak industry group representatives (including the ASMI and the Complementary Healthcare Council (CHC)), individual pharmaceutical companies, pharmacy profession representative groups (Pharmacy Guild of Australia, Pharmaceutical Society of Australia, Pharmaceutical Council of Western Australia) and the consumer advocate group the Consumer Health Forum. Two individual stakeholders also provided comments.

None of the submissions included any general objections to updating the RASML document to reflect current requirements of the SUSMP, ARGOM, ELF and current standards and regulatory requirements for medicine labels.

There were a number of concerns about some individual statements, all of which were given thorough consideration by the TGA. The outcomes (including agreement to suggested changes where appropriate) were published on the TGA website.

Overall, the updating of the RASML was welcomed and considered long overdue.

The CHC stated that it "... strongly supports that the community be provided with appropriate information regarding medicines to enable them to make informed choices regarding their use, particularly medicines selected at retail". The CHC was concerned that Update 5 was never finalised, stating that this "...created uncertainty in relation to required statements".

The ASMI stated that "ASMI members affected by these changes have, in general, commented that several of these proposed statements or similar are already on labels, having been required by the TGA as part of the registration/listing process. For these statements therefore, this consultation is merely formalising the requirement for all products by inclusion in RASML". ASMI also stated that it was hopeful that the new legislative instrument status of RASML "...will indeed allow for this document to be updated more easily and more frequently. From both a safety perspective and that of practicality for implementation we suggest that the frequency of the update should be on a regular (e.g. annual) basis, rather than by whether there are sufficient statements to make consultation worthwhile".

The TGA acknowledged the stakeholder suggestions that there would be a benefit in a formalised process of informing stakeholders of the introduction of new advisory statements when the need arises, prior to the update of the RASML. Therefore in response to the stakeholder feedback, the TGA has implemented a change from the practice of accumulating the advisory statements which have arisen for one major consultation at the end of the year, to conducting individual "minor" consultations on new advisory statements for specific products as the need is first perceived. It is also hoped that this will assist in the provision of lead-in times for transition to new arrangements.

The submissions also raised concerns that a number of the advisory statements, both current and proposed, appeared to have a duplication of intent. It was suggested that current advisory statements be reviewed, with a view to consolidating, revising or archiving statements as appropriate. The TGA noted the merits of these comments and will consider the recommendations for inclusion in future consultations.

There was some concern from industry that the time period allocated for the implementation of the changes was not sufficient. It was suggested that for those products which do not have immediate safety concerns, the implementation period for existing periods be changed from a 12-month period to 18-24 months. The TGA proposes to increase the transition period to 18 months, to assist in minimising the impact of the changes to industry.

Cough and cold medicines for use in children- consultation on proposed advisory statements

In February 2012, the TGA sought comments from interested parties on proposed advisory statements for cough and cold medicines for use in children (for inclusion in the RASML document when it is next updated).

The TGA response to submissions included clarification of a number of issues, including the need to specify very clearly which professions are considered qualified to give advice on the use of medicines in children. The TGA also confirmed that it was the explicit conclusion of the safety review that no exceptions should be made for any of the 22 drugs reviewed.

Consultations for loperamide, fexofenadine, famciclovir, loratadine, desloratadine, azelastine, kunzea ambigua

In 2012 and 2013 the TGA has published requests for submissions in relation to proposed advisory statements for loperamide, fexofenadine, famciclovir, loratadine, desloratadine, azelastine and kunzea ambigua. Only two objections were raised, both in relation to proposed statements for famciclovir. The respondent was concerned about the potential for ‘information overload’ in relation to the proposed advisory statements 'If you have high blood pressure, heart problems, liver problems, diabetes or other medical conditions, consult your pharmacist or doctor before use' and 'If you have symptoms and signs of an infection other than your cold sore, consult your pharmacist or doctor before use'. However, the TGA responded that the proposed advisory statements would be retained in order to clearly identify patients in 'at risk' groups (who may have kidney problems or suppressed immune function).

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