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Review of Schedule 1 to TGO 80 Child-resistant packaging requirements for medicines

Consultation

23 September 2009

The outcome of this consultation is Therapeutic Goods Order No. 80A, which takes effect on 1 October 2013.

The Therapeutic Goods Administration (TGA) invited interested parties to submit information to help inform the first review of Schedule 1 to Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80).

This review was undertaken by the Therapeutic Goods Committee (TGC)in October 2009.

TGO 80 specifies requirements relating to the child-resistant packaging (CRP) of medicines which may present a significant risk of toxicity to children if accidentally ingested.

Schedule 1 to TGO 80 identifies those substances and classes of substance which, if present in a medicine, necessitate that the medicine has CRP.

The purpose of the annual review of Schedule 1 to TGO 80 is to identify any new medicines which may warrant CRP, and to consider any new information on those substances already included in Schedule 1 which may be relevant to the requirement for CRP.

The specific information sought from stakeholders is described below.

The closing date for submission of information was Wednesday 23 September 2009.

Background

TGO 80 is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act). TGO 80 was made following a recommendation from the TGC and extensive stakeholder consultation.

TGO 80 commenced on 6 September 2008. It supersedes Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods (TGO 65) which is revoked with effect 1 September 2010. A summary of the differences between TGO 80 and TGO 65 is given in the Question and Answer section of the Guidance document to TGO 80.

The requirements of TGO 80 apply to medicines that come within the operation of the Act, Part 3-1 of which provides for the application of standards to therapeutic goods.

TGO 80 specifies requirements relating to the use of CRP for certain medicines and, in particular, requires that medicines containing any of the ingredients specified in Schedule 1 to the Order have packaging that is child-resistant. TGO 80 also specifies the performance requirements that such CRP must meet.

Schedule 1 to TGO 80 consists of three parts:

  • Part 1, which specifies the classes of substance that, when any member of the class is included in a registered medicine, result in the requirements of the Order applying to the medicine. Examples of substances falling within each class are shown in the Schedule.
  • Part 2, which identifies a number of individual substances that do not readily fall within any of the classes named in Part 1 but which, when present in either a listed medicine or a registered medicine, result in a requirement for CRP. The entry may relate only to concentrations or amounts above specified levels, or exclude specific pack sizes or type.
  • Part 3, which provides an alphabetical listing of all substances and classes of substance included in Part 1 and Part 2 to Schedule 1, including all named examples.

Further information on the classification of substances included in Schedule 1 to TGO 80 is included in both TGO 80 and its associated Guidance document.

The making of TGO 80 was recommended by the TGC at its 32nd (April 2008) meeting. This followed from a review of the adequacy of existing CRP requirements for medicines undertaken by an expert subcommittee of the TGC in preparation for the proposed but now postponed joint Australia New Zealand therapeutic products regulatory scheme. In recommending the adoption of TGO 80 as a standard for medicines, the TGC accepted the expert subcommittee recommendation that Schedule 1 should be reviewed annually.

The next meeting of the TGC, scheduled for 14 October 2009, will be undertaking the first such review.

Information sought

In its review of Schedule 1 to TGO 80, the TGC will consider:

  • medicines specifically identified by the TGC and/or TGA for inclusion in the review (see table below);
  • new medicines included on the Australian Register of Therapeutic Goods since Schedule 1 to TGO 80 was finalised and which may present a risk of accidental poisoning in children;
  • any new information on medicines that currently do not require CRP but are identified by stakeholders as possibly warranting CRP; and
  • any new information on medicines that are currently required by TGO 80 to have CRP but are identified by stakeholders as possibly being suitable for exclusion from CRP requirements.

A number of specific substances or classes of substance have been identified by the TGC and/or TGA for inclusion in this annual review of Schedule 1 to TGO 80. Those substances or classes of substance, and a brief reason for review, are outlined in the following table:

Substance or Class Reason for review
Angiotensin II antagonists Inclusion of other major anti-hypertensive classes in Schedule 1.
Azadirachta indica To facilitate the exemption for preparations for human dermal use given in the Schedule 6 entry for Azadirachta indica in the Poisons Standard.
Glucosamine sulfate potassium chloride complex (GSPCC) Potential for potassium toxicity and the current exclusion of GSPCC from the TGO 80 entry relating for potassium salts pending further review of toxicity information.
Imidazoline decongestants Stakeholder concern with the potential toxicity of very small amounts of imidazoline decongestants which are presented in volumes that would be exempt from CRP under subsection 7(d) of TGO 80.
Methyl salicylate Stakeholder concern that the current concentration cut-off is too high to prevent significant toxicity from ingestion of small volumes of medicines containing methyl salicylate.
Zolpidem Identified by the TGA's Office of Medicines Safety Monitoring for safety reasons.

Information from stakeholders that will help inform the review of the above substances or classes of substance is sought.

Information from stakeholders is invited also on other possible additions, deletions or amendments that may be warranted to the list of substances included in Schedule 1 to TGO 80.

Criteria for CRP

In preparing submissions, stakeholders should refer to the 'Introduction' to TGO 80 which describes the criteria to be used by the TGC in advising on requirements for CRP. These criteria are:

  • the toxicity of the substance contained in the medicine, and risk of harm if it is accidentally ingested by a young child;
  • the extent and patterns of availability in the community of medicines containing the substance;
  • the number and type of incidents reported to Poisons Information Centres and other relevant organisations involving accidental ingestion of medicines containing the substance;
  • the consequences of these incidents (hospital admission or other treatment, serious injury, or death), including the difficulty or complexity of treatment;
  • any special needs of patients who regularly need access to medicines containing the substances, such as older persons or people with a disability;
  • the technical feasibility and practicality of child resistant packaging for medicines containing the substance, taking into account the usual dosage form and presentation; and
  • other such matters as the committee thinks fit.

The 'Introduction' to TGO 80 also advises that a substance will, in general, be considered to be sufficiently toxic to warrant CRP if the amount contained in a maximum prescription quantity (for example under the Pharmaceutical Benefits Scheme) or the largest retail pack quantity, is likely to produce significant harm (i.e. a requirement for hospital treatment, or death) in a child of 11 kg (i.e. a typical weight of an 18 month old child, representative of the age group in which accidental poisoning is most common).

While all stakeholder submissions will be considered, information of most value in the review of Schedule 1 to TGO 80 will be information addressing the criteria specified in the 'Introduction' to TGO 80 and shown above. Factual reports of poisoning incidents and toxicity studies would be of particular value.

Note - the performance requirements specified in TGO 80 for CRP are not currently under review.

Submissions

The closing date for submissions was: Wednesday 23 September 2009.

What will happen to submissions?

Submissions will be provided to the TGC to help inform its review of Schedule 1 to TGO 80.

Recommendations made by the TGC as a result of this review will be published on the TGA website as committee outcomes.

Any recommendations made by the TGC for amendment to TGO 80 as a consequence of these considerations will be subject to full stakeholder consultation, including an assessment of the associated regulatory impact.

Confidentiality

If you wish any information contained in your submission to be treated as confidential, please clearly identify that information and outline the reasons why it is confidential.

Further information

Any questions in relation to this matter should be directed to the Secretary of the Therapeutic Goods Committee on telephone number 02 6232 8661 or by email to standards@tga.gov.au.