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Submissions & TGA response: Proposed advisory statements for medicines - cough and cold medicines for use in children

28 September 2012

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 received

Submissions were received from the following industry group and organisations:

TGA response to submission - proposed advisory statement - cough and cold medicines for use in children

Summary of comments and TGA's response
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.
  • The TGA notes the comments with respect to documents containing errors. These errors will be corrected.
  • The numbering system to the RASML 6 consultation document has changed in response to comments received for that consultation. The TGA will advise this in future consultation documents.
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.
  • The TGA notes the comment with respect to allowing sufficient time period for consultation. The TGA will follow a standard period for RASML consultation allowing sufficient time for 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.
  • The advisory statements contained the Section 28 letter and RASML/ARGOM documents are consistent and their intent is similar. Both the RASML document and the section 28 letter sent to sponsors advise that variations to the wording of advisory statements are permitted as long as the intent remains the same.
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.
  • In the review of the cough and cold medicines for use in children, it was identified that the meaning of health care professional encompasses a number of professions who are not qualified to give advice on the use of medicines in children. To ensure the safe use of cough and cold medicines in the paediatric population, the advisory statement identifies doctor, pharmacist and nurse practitioners to ensure there is no ambiguity as to who can give this advice.
  • The term 'healthcare professionals' will continued to be accepted for products other than those indicated for cough and colds.
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.

  • The TGA has carried out an independent review of the safety and efficacy data for OTC cough and cold medicines. It was the TGA's conclusion that none of the 22 drugs concerned should be used for the treatment of cough and cold in children aged less than 6 years and that they should only be used in children aged 6 to 11 years on the advice of a doctor, pharmacist or nurse practitioner. The TGA considered but was not convinced by arguments that an exception should be made for some of the drugs reviewed. For further information about the review and its outcomes see OTC cough and cold medicines for children - Final outcomes of TGA review.
  • The TGA will correct the list in ARGOM Appendix 5 to include bromhexine and delete the exemption for oxymetazoline and xylometazoline.
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.
  • The TGA will refer this issue to the labelling and packaging review.

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