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Submissions & TGA response: Proposed advisory statements for medicines - cough and cold medicines for use in children
The TGA would like to thank the organisations who have submitted written comments or made submissions in response to the consultation: Proposed advisory statements for medicines - Cough and cold medicines for use in children.
Submissions were received from the following industry group and organisations:
- Consultation submission: Australian Self Medication Industry (ASMI) (pdf,99kb)
- Consultation submission: Consumer Health Forum (CHF) (pdf,105kb)
TGA response to submission - proposed advisory statement - cough and cold medicines for use in children
|Topic||Summary of issues||TGA response|
|Quality of consultation document||The document did not provide clear numbering of the advisory statements and differed from the numbers allocated in the RASML 6 document.||
|Inadequacy of time allocated for consultation process.||There is inconsistency in the TGA nominated closing date for the consultation - 29 February 2012 in the consultation document and 22 February 2012 on the TGA website and this Consultation cover sheet. In either case, the allowed period of time does not allow for considered response.||
|Inconsistency in the wordings for the statements between Section 28 and the RASML/ARGOM consultation documents||There is inconsistency in the wordings for the statements between the Section 28 and the RASML/ARGOM consultation. The wordings in RASML/ARGOM have been made consistent with standard RASML formats. This includes changing the wording in warning statements C and E from 'use in children aged 'x' only on the advice of a doctor, pharmacist or nurse practitioner' to 'do not give to children aged between 'x' and 11 years except on the advice of a doctor, pharmacist or nurse practitioner'. There is a concern that sponsors complying with the Section 28 wording will be required to change their labelling again in future to comply with RASML wording.||
|Substitution of 'health care professional' with 'doctor, pharmacist or nurse practitioner'||Section 28 requirement that 'health/healthcare professional' will not be an acceptable substitute for the words 'doctor, pharmacist or nurse practitioner' in the Australian regulatory context. All labelling statements should be prepared based on a consumer's understanding. The average consumer does not take the time to consult legislation to determine what a health/healthcare professional is. Health/healthcare professional has been widely approved for use on labelling and in use for a long period of time, without any adverse effect. We also hold concern as to what this means to existing labels using this terminology.||
|Consistent labelling requirements for ANTZPA - Bromhexine, Oxymetazoline and Xylometazoline||
The New Zealand (NZ) Cough and Cold Review Group considered the risk/benefit profile of cough and cold active ingredients separately, rather than as a group. Determinations were therefore also provided separately. In relation to medicines containing only bromhexine, the NZ Cough and Cold Review Group recommended they should remain restricted to adults and children two years of age and over as they appeared to be associated with lower risk of causing serious side effects.
In relation to intra-nasal decongestants (such as oxymetazoline and xylometazoline), the NZ Cough and Cold Review Group recommended that oxymetazoline and xylometazoline-containing medicines indicated for treatment of the symptoms of the common cold could be considered for use in children 2 years of age and over.
It was also noted that ARGOM Appendix 5, Paediatric Cough Cold and Flu Products (page 41), did not list bromhexine, thus implying that the under 6 years of age ruling did not apply to this active.
In addition, the list indicates products containing oxymetazoline and xylometazoline in nasal sprays are exempt from the determination relating to the cough/cold review.
To allow sponsors a harmonised trans-Tasman pack and avoid the cost burden of a potential two-step label change after an ANZTPA reconsideration, clarification on the acceptability of the use of a statement allowing use in children 2 years of age and above is requested.
|Guideline requiring all medicines to include clear directions for use.||Respondent recommended the provision of a guideline requiring all medicine labels to include clear directions for use, avoiding vague or negative language where possible and ensuring that all directions appear in plain English. Respondent also recommended that he document should specify that the directions for use and the advisory statements should be distinguished from the remainder of the label through the use of a larger font size.||