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Regulatory impact statement (RIS) - update to the Required Advisory Statements for Medicine Labels (RASML)
3. The problem
3.1 The need for an updated RASML
Since publication of the current RASML in 2008, the TGA and its statutory advisory committees have recommended inclusion of a significant number of additional advisory statements in the RASML. The currently proposed update to the RASML includes over 50 new and/or changed requirements affecting 68 medicines; which will result in changes to the labels of over 500 individual products (and affecting over 70 sponsors).
Some of the new advisory statements have been recommended as part of decisions to approve new medicines. Others have been considered necessary to reduce new risks due to changes to the level of scheduling of medicines that have resulted in greater consumer access. In other cases, statements have been recommended to mitigate new risks that have been identified for existing medicines (i.e. medicines that are already on the ARTG), through post-market pharmacovigilance and regulatory activities in Australia or overseas, or from publication of new scientific or clinical information related to the medicine.
When warning statements are considered necessary for reasons of consumer safety, the TGA will require sponsors to include these statements on medicine labels regardless of whether or not the statements are included in the RASML.
For example, in 2012 the TGA published changes to cough and cold medicines for use in children arising from a review of the safety and efficacy of over-the counter medicines containing one or more of 22 medicine substances. The outcomes of the review included recommendations that over-the-counter cough and cold medicines should not be used by children under 6 years of age, and that there should be advisory statements on the labels of products that have doses for children aged 6 to 11 years, to the effect that the products should only be given to children in this age range on the advice of a doctor, pharmacist or nurse practitioner. The TGA sent Section 28 notices to sponsors who currently had products included on the ARTG to ensure that the labels were updated. To ensure that future products are also labelled correctly, the TGA also proposed that the advisory statements would be included in the next update of the RASML document.
The TGA also routinely incorporates other newly recommended advisory statements into guideline documents, such as the Australian regulatory guidelines for over-the-counter medicines ('the ARGOM')4, and negotiates with individual sponsors on a case-by-case basis as part of individual applications to approve new or varied medicine labels.
For example, a new advisory statement is proposed for anticholinergic medicines (including Atropa belladonna, Datura spp., Hyoscyamus niger, and compounds of atropine [excluding atropine methonitrate], hyoscine and hyoscyamine), which are used for conditions such as travel sickness, stomach aches and diarrhoea. The proposed new advisory statement was recommended for inclusion in the RASML by the National Drugs and Poisons Schedule Committee (NDPSC) in October 2007, but could not be included in the current RASML due to publication deadlines. The NDPSC was concerned about the potential for anticholinergic agents to mask serious conditions if used for an extended period of time. Therefore, the NDPSC made a recommendation that all anticholinergic products should include a warning statement not to use the medicine for more than 2-3 days without medical advice. Currently the TGA asks sponsors to include this statement on labels that are submitted for TGA review. Sponsors regularly comply with this request, for reasons of consumer safety.
However, the existence of multiple sources of recommendations and requirements for advisory statements is inconsistent with the intention of the RASML document, which is to be a complete and comprehensive source of the advisory statements that are required to be included on the labels of non-prescription medicines supplied in Australia.
The lack of transparency caused by the multiple sources of requirements and recommendations, together with the TGA's inability to enforce recommendations that are not in the RASML, has consequences for consumers, health professionals, industry and Government.
Where advisory statements are necessary for safe and effective use of a medicine, the absence of these statements could potentially result in harm to consumers and impact on public health. The size of the detriment that is currently occurring is unknown, although likely to be low. This will be discussed further under Impact Analysis, below.
The lack of transparency also leads to direct costs to sponsors resulting from delays to the processing of applications due to the need for label revisions. Any costs that are incurred by sponsors due to inconsistent and confusing application of requirements for advisory statements may also be transferred to consumers in the form of increased prices.
- The ARGOM describes the information to be supplied with applications to register OTC medicines in the ARTG. These medicines will be subject to evaluation by the TGA, in accordance with Section 25 of the Act, prior to inclusion in the ARTG.