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Submissions and TGA response: OTC cough medicines for oral use: proposed advisory statements for medicines

9 September 2014

The TGA would like to thank the respondents who have submitted written comments or made submissions in response to the consultation: OTC cough medicines for oral use: proposed advisory statements for medicines.

Submissions received

A total of five submissions were received. Of these, the following three respondents consented to have their submissions published:

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TGA response

1. Advisory statement: "If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist."

Summary of issues

All the five respondents supported the proposed advisory statement for OTC cough medicines for oral use. Two respondents argued that the words "or worsens" in the statement may be considered synonymous with, or a subset of, a persistent cough, and that it can cause consumer confusion as during a cough cycle the symptoms may get worse before getting better. A suggestion was made to revise the proposed warning statement so that the words "or worsens" was optional.

A respondent also queried about acceptance of existing wordings on the labels if already worded to the same effect or stricter.

TGA response

The TGA concurs with the comments that reference to "or worsen(s)" is unnecessary as it can be considered similar to a persistent cough. Therefore, the TGA supports the proposed amendment of the warning statement from "If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist" to "If [coughing/symptoms] persist(s), consult your doctor or pharmacist."

There are some approved labels that already include "or worsen(s)" as part of their warning statement or "If symptoms persist for more than 7 days, consult your doctor." The RASML permits variation of the wording of the warning statements specified in the document provided that the intent is not changed. The TGA would consider the above statement(s) that include the additional words "or worsens" and/or "for more than 7 days" to be examples of acceptable alternative wording.

Outcome

The amended advisory statement "If [coughing/symptoms] persist(s), consult your doctor or pharmacist" is proposed for inclusion on the labelling of all OTC cough medicines containing ammonia and ammonium salts, bromhexine, codeine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pentoxyverine, pholcodine and senega.

Consequently, the additional instructions in the current OTC medicine monograph: Pholcodine will be amended from "If coughing persists or worsens, consult your doctor or pharmacist" to "If coughing persists, consult your doctor or pharmacist" to reflect the outcome of this consultation.

2. Other issues

Summary of issues

The majority of respondents queried about the transition period.

One respondent expressed concern that this consultation process, in which the proposal for inclusion of a warning statement in RASML arose during the development of an OTC medicine monograph, would repeat itself with any new OTC monograph created.

TGA response

The transition period for this new requirement will be 18 months from the date of publication on the Federal Register of Legislative Instruments (FRLI) of the new RASML update. For those sponsors who are affected, the TGA will allow sponsors to submit a change application (C1) using the change code 'LLO' to include the new proposed RASML warning statement provided that there are no other changes made in that application with the exception of other C1 changes. In cases where sponsors cannot meet the implementation date, the TGA usually considers a reasonable request for an exemption.

During development of the OTC medicine monograph for pholcodine, the TGA identified statements applied consistently during the evaluation of medicine labelling, in terms of safety and efficacy, of such medicine registration applications. Consolidating the requested statements would provide clarity to sponsors about such requirements and maintain consistency of labelling statements in Australia.

Final proposal

The advisory statement "If [coughing/symptoms] persist(s), consult your doctor or pharmacist" are proposed for the RASML entries for ammonia and ammonium salts, bromhexine, codeine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pentoxyverine, pholcodine, or senega, when supplied as a non-prescription medicine under the conditions stated (see Table 1).

Table 1. Proposed advisory statement for OTC cough medicines
Substances Conditions Required statements

Ammonia and ammonium salts, including:

  • ammonium chloride
  • ammonium bicarbonate
  • ammonium carbonate
In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s), consult your doctor or pharmacist.
Bromhexine
Codeine
Dextromethorphan
Dihydrocodeine
Guaifenesin
Ipecacuanha
Pentoxyverine
Pholcodine
Senega

Note: the RASML Schedule 2 requirements arising from the TGA cough and cold review have not been reproduced in the tables.