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Proposed advisory statements for medicines: Cough and cold medicines for use in children

Related information

Consultation

8 February 2012

This consultation closed on 22 February 2012

The TGA sought comments from interested parties on the proposed advisory statements for cough and cold medicines for use in children for inclusion in the RASML document when it is next updated.

Consultation documents

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Enquiries

Enquiries should be directed via email to otc.medicines@tga.gov.au or by telephone to 02 6232 8160.

Timetable

Document released for consultation on Wednesday, 8 February 2012.

Interested parties were to respond by close of business Wednesday, 22 February 2012.

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

Background

The Therapeutic Goods Administration has carried out a comprehensive review of the safety and efficacy of over-the counter medicines containing one or more of the 22 medicine substances listed below for the treatment of symptoms of cough and cold in children.

  • Antihistamines: brompheniramine, chlorpheniramine, dexchlorpheniramine, diphenhydramine, doxylamine, pheniramine, promethazine, triprolidine;
  • Antitussives: codeine, dextromethorphan, dihydrocodeine, pentoxyverine, pholcodine;
  • Mucolytics/expectorants: bromhexine, Guaiphenesin, ipecacuanha, senega and ammonia;
  • Decongestants: phenylephrine, pseudoephedrine, oxymetazoline, xylometazoline

The review considered the data published in the medical literature, information available from the TGA's adverse drug reaction database, and other relevant information from external organizations such as Australian Poisons Information Centres, and the Australian Institute of Health and Welfare (AIHW). Sponsors of these medicines were also invited to provide literature references and information that they considered relevant and useful to the review.

The collated literature and other items of information were reviewed externally by a clinical toxicologist and a paediatrician specializing in respiratory disease. Their report and recommendations were considered by an internal panel composed of senior TGA personnel with expertise in medicine, pharmacy, toxicology, pharmacology and pharmaceutical sciences, as well as by the Medicines Evaluation Committee (MEC).

The outcomes of this review were published in October 2009 for public and stakeholder consultation.

It has been recommended that:

  1. The labelling of over-the-counter cough and cold medicines should not include dosage instructions for children under 6 years of age; if doses are included for children aged 6-11 years, the labelling must include:
    1. a warning statement advising against use in children under the lowest specified age, AND
    2. a statement advising that the product should only be administered to children between the lowest specified age and 12 years on the advice of a doctor or pharmacist; and
  2. The labelling of all over-the-counter cough and cold medicines with dosage specified only for adults and/or for those aged 12 and above should contain a warning statement specifically advising against their use in children under 12 years of age.

Section 28 notices have been sent to sponsors who currently have products included on the ARTG. However the recommendations arising from this review of OTC cough and cold medicines apply equally to such medicines added to the ARTG in the future. To ensure that future products are labelled accordingly, the proposed advisory statements are recommended for inclusion in the RASML document.

Content of submissions

Submissions may address any, or all, of 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. Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.

The proposed advisory statements will then be included in the next update of the RASML document.

Confidentiality

All submissions will be placed on the TGA's 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 coversheet.

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.

More information

The TGA has specifically invited comment on the proposed amendments from the following organisations. You may wish to consider submitting your response to one of these organisations, for incorporation in its overall response, rather than submission direct to the TGA:

  • ACCORD Australasia Limited
  • Australian Self-Medication Industry Inc. (ASMI)
  • Complementary Healthcare Council of Australia (CHC)
  • Consumers' Health Forum (CHF)
  • Generic Medicines industry Association (GMiA) of Australia
  • Medicines Australia (MA)
  • Pharmaceutical Society of Australia (PSA)
  • Pharmacy Guild of Australia

The RASML Edition 1 including update 4 (dated September 2008) remains the current version which sponsors should continue to refer to.