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 nasal decongestant preparations for topical 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 nasal decongestant preparations for topical 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 nasal decongestant preparations for topical use.

Through the consultation process, the TGA is requesting 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 nasal decongestant preparations for topical use

Topical nasal preparations containing naphazoline, oxymetazoline, tetrahydrozoline, tramazoline, tymazoline or xylometazoline, or more than 1% of methoxamine or phenylephrine, are included in Schedule 2 of the SUSMP (Pharmacy Medicines). Nasal preparations containing 1% or less of methoxamine or phenylephrine are unscheduled.

The TGA proposes to amend the RASML by applying new label advisory statements regarding rebound congestion to OTC topical nasal decongestants. This proposal arose during the recent development of an OTC medicine monograph for topical nasal decongestants, where the need for such statements was identified based on its consistent and relevant presence on current labelling of medicines approved for supply in Australia. These statements were included in the draft monograph published in the TGA's recent consultation OTC medicine monograph: Topical nasal decongestants.

Rebound congestion (rhinitis medicamentosa) has long been associated with topical nasal decongestants. The exact cause is unknown but short-acting products, preservative agents and long duration of therapy have been suspected to contribute to the problem. Currently, 3 to 5 days is the recommended duration of therapy to avoid rebound congestion1.

Given that topical nasal decongestants are available for self-selection by consumers (Pharmacy Medicine or unscheduled), the TGA considers that the labels of these medicines should include the following warning statements to inform consumers about rebound congestion, and to reduce the risk of it occurring.

  1. Proposed advisory statement: "Do not use for more than three days at a time unless advised by a doctor or pharmacist."

    This proposed statement will give consumers clear instructions on the maximum time that the medicine should be used for self-medication.

    Having a set duration of use will ensure consistent information across all OTC topical nasal decongestant medicines. Currently, most labels state a 3-day duration of use while some state a 5-day duration.

    For self-medication, a maximum of three days' duration is consistent with the following clinical reference texts.

    • The AHFS2 recommends the following maximum duration for use: "Oxymetazoline / phenylephrine nasal solutions should not be used for self-medication for longer than 3 days; if symptoms persist, the drug should be discontinued and a clinician consulted." and "Intranasal tetrahydrozoline should be used for no longer than 3-5 days."
    • Current Australian clinical reference texts such as the eTG3 and the eAMH4 and pharmacist reference texts such as from the PSA5 and APF226 recommend that topical nasal decongestants should not be used continuously for more than five days or in higher than recommended doses to reduce the risk of rebound congestion occurring.

    If consumers require use of the medicine for more than 3 days' duration, they should seek advice from a doctor or pharmacist.

  2. Proposed advisory statement "Frequent or prolonged use may cause nasal congestion to recur or worsen."

    This advisory statement will provide clear information to consumers as to why the medicine should not be used frequently, or for more than three days at a time, for self-medication.

Summary of existing RASML statements for OTC nasal decongestant preparations for topical use

The RASML currently requires the warning statement "If congestion persists, consult your doctor or pharmacist" on the labels these medicines.

Following the recommendations of the final outcomes of the TGA cough and cold review in 2012, the updated RASML (yet to be implemented) will also require the following statements for cough and cold medicines containing oxymetazoline or xylometazoline for topical nasal use (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. Handbook of Nonprescription Drugs 17th edition
  2. American Hospital Formulary Service Drug Information - EENT Preparations - Vasoconstrictors
  3. Therapeutic Guidelines - Respiratory
  4. Australian Medicines Handbook
  5. PSA's Non-prescription Medicines in the Pharmacy 2012
  6. Australian Pharmaceutical Formulary and Handbook 2012

Proposed statements

With this current consultation, the TGA sought comments on the following proposed statements, as additional RASML requirements for these medicines:

  • "Do not use for more than three days at a time unless advised by a doctor or pharmacist"
  • "Frequent or prolonged use may cause nasal congestion to recur or worsen".

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 nasal decongestant preparations for topical use should be amended to include the following additional requirements (see Tables 1 to 9, below).

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

Table 1: Proposed advisory statements for OTC nasal decongestant preparations
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)

Nasal decongestant preparations, including:

  • Methoxamine
  • Naphazoline
  • Oxymetazoline
  • Phenylephrine
  • Tetrahydrozoline
  • Tramazoline
  • Tymazoline
  • Xylometazoline
When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 2: Proposed advisory statements for methoxamine in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Methoxamine When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 3: Proposed advisory statements for naphazoline in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Naphazoline When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 4: Proposed advisory statements for oxymetazoline in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Oxymetazoline When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 5: Proposed advisory statements for phenylephrine in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Phenylephrine When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 6: Proposed advisory statements for tetrahydrozoline in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 7: Proposed advisory statements for tramazoline in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Tramzoline When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 8: Proposed advisory statements for tymazoline in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Tymazoline When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.
Table 9: Proposed advisory statements for xylometazoline in nasal decongestant preparations for topical use
Column 1
Substance(s)
Column 2
Conditions
Proposed for RASML
Required statement(s)
Xylometazoline When in nasal decongestant preparations for topical use Do not use for more than three days at a time unless advised by a doctor or pharmacist.
Frequent or prolonged use may cause nasal congestion to recur or worsen.