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Labelling and packaging of cough and cold medicines - proposed changes to requirements

Consultation

22 October 2009

This consultation closed on 18 December 2009.

This document is to advise stakeholders and the Australian public of the recommended changes to the labelling, packaging and scheduling of medicines for the treatment of symptoms of cough and cold in children. Details of the proposed changes and the TGA's review of the safety and efficacy of these medicines that led to these proposals for change are detailed below.

TGA review of OTC cough and cold medicines for children aged 2-12 years

1. Issue

The Therapeutic Goods Administration (TGA) has carried out a review of the safety and efficacy of registered over-the-counter (OTC) cough and cold medicines for children aged 2-12 years and is considering some significant changes to the availability, labelling, packaging and scheduling of these medicines for use in children.

The medicines reviewed and affected by the regulatory actions being considered contain one or more of the following drug substances:

Antihistamines: Brompheniramine, Chlorpheniramine, Dexchlorpheniramine, Diphenhydramine, Doxylamine, Pheniramine, Promethazine, Triprolidine
Antitussives: Codeine, Dextromethorphan, Dihydrocodeine, Pentoxyverine, Pholcodine
Expectorants/Mucolytics: Ammonium chloride, Bromhexine, Guaifenesin, Ipecacuanha, Senega and Ammonia
Decongestants: Oxymetazoline, Phenylephrine, Pseudoephedrine, Xylometazoline

2. Background

Each of the regulatory authorities in the USA, Canada, the United Kingdom, New Zealand and Australia have reviewed the safety and efficacy of OTC cough and cold medicines for children under 2 years of age and have concluded that these medicines should not be used for children in that age group. Appropriate regulatory actions have been taken and labelling changes have been made to enforce these conclusions. These actions are summarised in A summary of actions taken by the TGA and other regulatory agencies regarding cough and cold medicines in the treatment of children.

How to access a pdf document

Subsequently, the focus of review was extended to the use of cough and cold medicines for the treatment of children aged 2-12 years. The US, Canadian and UK regulatory authorities have carried out extensive independent reviews. Similarly, the TGA has carried out its own independent external and internal review.

An external review of the available safety and efficacy data, as published in the medical literature and supplemented with additional (mostly confidential) information provided by sponsors of cough and cold medicines, was carried out for the TGA by independent, medical experts. The resulting report Review of cough and cold medicines in children together with Tabulated summaries of clinical trials referred to in the external review report (prepared by the TGA to accompany that Report) and the external reviewers' assessment of the additional, confidential data submitted by sponsors, together with additional safety data from TGA records, have been considered by a TGA internal panel of medical and scientific staff and by the TGA's Medicines Evaluation Committee. Their deliberations are summarised in the TGA Internal Panel Report on a Review of the Safety and Efficacy of Cough and Cold Medicines in the Treatment of Children aged 2-12 Years, Minutes of the TGA Internal Panel's Discussions and Extract from Minutes of Medicines Evaluation Committee Meeting 30 July 2009.

The ongoing demand for OTC cough and cold medicines for the treatment of children may be presented as evidence of their effectiveness. However, as result of this extensive review, the TGA and the Medicines Evaluation Committee have concluded that the available clinical data do not provide evidence of efficacy of these medicines in children, and their use is not without attendant risks. Consequently, the following recommendations are being considered for adoption by the TGA:

(a) Safety, efficacy and availability

In light of the current lack of evidence of efficacy and the historical profile of adverse drug reactions (ADRs) in Australia and overseas, it is likely that the risks associated with the use of cough and cold preparations in children outweigh the likely benefits for children below the age of 6 years. There is currently a lack of evidence of efficacy for cough and cold medicines in children aged 6 to 12 years of age and the historical profile of ADRs indicates that there are potential risks involved in use of these medicines in that age group also. For this reason,

it is recommended that over-the-counter cough and cold medicines should not be used for the treatment of children under 6 years of age, and they should only be administered to children aged 6-12 years on the advice of a doctor or pharmacist.

To this end, it is recommended that:

commencing on 1 July 2010, 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

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.

This approach would bring the regulation of cough and cold preparations in Australia into line with measures in place in the UK and Canada. The need for such limitations on use in children should be reviewed if and when robust efficacy data becomes available.

(b) Packaging

The current requirements under Therapeutic Goods Order No 80 "Child-Resistant Packaging Requirements for medicines" are for most, but not all, of the drugs in OTC liquid cough and cold medicines to be in child-resistant packaging. In the interests of consistency and improved safety,

it is recommended that, commencing on 1 July 2010, all over-the-counter cough and cold medicines should be marketed in containers with child-resistant closures.

This requirement would bring the packaging of cough and cold preparations in Australia into line with measures in place in the UK and with recommendations made by the regulators in the USA.

(c) Scheduling

The current scheduling of most cough and cold medicines as S2 (pharmacy only) medicines ensures that advice is available but does not ensure that such advice is given regarding use in children. Such advice is more likely to be given if these medicines were S3 (pharmacist only) medicines. For this reason,

it is recommended that the NDPSC be asked to consider including substances used in cough and cold medicines in Schedule 3 when intended for use in children aged 6-12 years, and in Schedule 4 for use in children under 6 years of age.

(d) Public awareness

The changes recommended above would need to be widely promoted and explained to medical practitioners, pharmacists, parents and caregivers. For this reason,

it is recommended that particular efforts be directed towards educating consumers, medical practitioners and pharmacists that OTC cough and cold medicines have not been shown to be effective, and are potentially harmful in children under 6 years of age. Education campaigns should be directed through the National Prescribing Service (NPS), professional associations and colleges such as the Royal Australian College of General Practitioners, Australian College of Rural and Remote Medicine and the Royal Australian College of Physicians Paediatrics and Child Health Division, Australian College of Pharmacy Practice and Management, Pharmaceutical Society of Australia, Pharmacy Guild, Consumers Health Forum and the pharmaceutical industry.

3. Action required

Prior to making any final decisions regarding adoption or otherwise of these recommendations, the TGA is required to consult stakeholders and the general public and to take into account submissions received.

4. Request to stakeholders and the public

Stakeholders and members of the public are invited to review and comment on the proposed changes. Responses should include:

  • Whether or not you support the proposed changes. If you do not support a change, 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.

5. Submissions

This consultation closed on 18 December 2009.

The TGA specifically invited comment on the proposed amendments from the following organisations. Stakeholders were able to submit responses to one of these organisations, for incorporation in its overall response, rather than submitting direct to the TGA if they wished.

  • Australian College of Pharmacy Practice and Management
  • Australian College of Rural and Remote Medicine
  • Australian Consumers Association (Choice)
  • Australian Self-Medication Industry Inc (ASMI)
  • Consumers' Health Forum
  • Medicines Australia
  • National Prescribing Service
  • Pharmaceutical Society of Australia
  • Pharmacy Guild of Australia
  • Royal Australian College of General Practitioners
  • Royal Australasian College of Physicians (Paediatrics and Child Health Division)

Notes on submissions

A list of names of parties making submissions will be published on the TGA website.

All submissions will be placed on the TGA's website unless marked confidential. 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. Confidential material should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the submission coversheet.