TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

Consultation: OTC cough medicines for oral use: proposed advisory statements for medicines

Related information

28 March 2014

This consultation closed on 5 May 2014.

The TGA sought comments from interested parties on proposed advisory statements for OTC cough medicines for oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated.

Timetable

Document released for consultation on Friday 28 March 2014.

Interested parties responded by close of business on Monday 5 May 2014.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

The proposed advisory statements would be required on the labels of OTC cough medicines for oral use.

Through the consultation process, the TGA requested comments that will help ensure that the proposed advisory statements are appropriate and support the quality use of the medicines.

This consultation will contribute to the update of the RASML.

Background

The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) sets out the level of control on the availability of medicines and poisons in Australia. The majority of medicines that are included in the SUSMP fall under one of the following classifications.

Schedule 2 - Pharmacy Medicine (available from a pharmacy without a prescription)

Schedule 3 - Pharmacist Only Medicine (available from a pharmacist without a prescription)

Schedule 4 - Prescription Only Medicine (available from a pharmacist with a prescription)

Medicines that are not included in the SUSMP are freely available from both pharmacies and other retail outlets, and are referred to as 'unscheduled' medicines. Medicines that are unscheduled or included in Schedule 2 or Schedule 3 of the SUSMP are collectively referred to as 'non-prescription' or 'over-the-counter' (OTC) medicines.

Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively. In the case of non prescription medicines, the label of the medicine contains information and directions for appropriate use, as well as any advisory statements (warnings) that are needed for safe and effective use of the medicines.

The need for a new advisory statement might arise from:

  • The registration of a new medicine, or a review of an existing medicine
  • When new risks for currently available medicines have been identified
  • A request from stakeholders and/or expert advisory committees is received
  • When a medicine undergoes a change in scheduling, hence reducing the level of control and making it more widely available to consumers for self-selection or available without a prescription.

Under these circumstances there may be a need to ensure that appropriate advisory statements are included on the labelling of these medicines to ensure consumers are able to self-select (where applicable) and use these medicines safely and effectively.

OTC cough medicines for oral use

OTC medicines indicated for cough include ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pholcodine, and senega and ammonia. Some of these medicines are unscheduled and others are included in Schedule 2 or Schedule 3 to the SUSMP.

The TGA proposes to amend the RASML by introducing the following advisory statement for these medicines.

  • "If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist"

This proposal arose during the recent development of the OTC medicine monograph: Pholcodine, where the need for such statement was identified based on its consistent and relevant presence on current labelling of medicines approved for supply in Australia.

The statement is intended to prompt consumers to seek medical or pharmacist advice for further investigation of the underlying condition if their cough persists or worsens. The proposed RASML requirement will formalise the similar statement already included on the majority of OTC cough medicines labels and will maintain consistency of the advisory statement across all OTC cough medicine labels.

This statement has been included in the draft OTC medicine monograph: Pholcodine which went through a recent consultation process. In the draft OTC medicine monograph, the wording "If coughing worsens or does not go away after a few days, consult your doctor or pharmacist" was proposed. However, after further consideration, the words "if coughing does not go away after a few days" may be unrealistic given that acute cough caused by viral upper respiratory tract infection (e.g. the common cold) lasts between 7 to 10 days1. The monograph will be amended accordingly.

The word 'symptoms' is proposed as an alternative to the word 'cough' because some medicines are indicated for multiple cough, cold or flu ymptoms. It is intended that the word 'coughing' in the proposed warning statement would be used for single active medicines when indicated specifically for cough, while 'symptoms' could be used for multiple-active medicines when indicated for cough and cold/flu. However, even for products indicated only for cough there should be no concern if the word 'symptoms' is used instead of 'coughing'.

Summary of existing RASML statements for OTC cough medicines

The current RASML does not require any advisory statements for medicines containing ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pholcodine, or senega and ammonia.

However, following the recommendations of the final outcomes of the TGA cough and cold review in 2012, the updated RASML (yet to be implemented) requires the following statements for these medicines (as published in the consultation Proposed advisory statements for medicines - cough and cold medicines for use in children): "Do not give to children under 12 years of age" if there are no dosages for children <12, or "Do not give to children under 'x' years of age" and "Do not give to children between 'x' and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner" if there are dosages for children from 'x' to 11 years (where 'x' is 6, 7, 8, 9, 10 or 11).

Footnote

  1. Australian Pharmaceutical Formulary and Handbook 2012

Proposed statements

With this current consultation, the TGA sought comments on the following proposed statement, as an additional RASML requirement for these medicines:

  • "If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist"

Submissions

See: Submissions & TGA response

Submissions may address the proposed advisory statements and other identified issues. In addition, submissions might include:

  • Whether or not you support the wording of the advisory statement. If you do not support the wording of the statement you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site.

It is proposed that the advisory statements will then be included in the next update of the RASML.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission cover sheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries

Enquiries should be directed via email to rasml@tga.gov.au


Proposal

The TGA proposes that the RASML entries for ammonia and ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, pholcodine, or senega, in oral preparations indicated for cough, cold or flu, should be amended to include the following additional requirement (see Tables 1 to 8).

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

Table 1: Proposed advisory statements for ammonia and ammonium salts in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)

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) or worsen(s), consult your doctor or pharmacist.
Table 2: Proposed advisory statements for bromhexine in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Bromhexine In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist.
Table 3: Proposed advisory statements for dextromethorphan in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Dextromethorphan In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist.
Table 4: Proposed advisory statements for dihydrocodeine in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Dihydrocodeine In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist.
Table 5: Proposed advisory statements for guaifenesin in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Guaifenesin In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist.
Table 6: Proposed advisory statements for ipecacuanha in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Ipecacuanha In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist.
Table 7: Proposed advisory statements for pholcodine in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Pholcodine In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist.
Table 8: Proposed advisory statements for senega in oral cough, cold and flu medicines
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Senega In oral preparations indicated for cough, cold or flu If [coughing/symptoms] persist(s) or worsen(s), consult your doctor or pharmacist.