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Development of a best practice guideline on non-reclosable packaging

Consultation

14 March 2008

This consultation closed on 14 March 2008.

The Therapeutic Goods Administration (TGA) invited submissions from interested parties to help inform the development of a best practice guideline on non-reclosable packaging.

The guideline is intended to assist sponsors of therapeutic goods improve the effectiveness of blister or foil strip packaging as a barrier to children and thereby reduce the potential for accidental childhood poisoning from medicines packaged in this way.

Background

During the consideration of standards for child-resistant packaging (CRP) to be applied by the proposed Australia New Zealand Therapeutic Products Authority (establishment of which has now been postponed), the Therapeutic Goods Committee (TGC) noted that various injury prevention authorities were concerned with the performance of non-reclosable forms of packaging such as blisters and foil strips and the reported failure of this packaging to prevent children accessing medicines.

These concerns were supported by the continuing presentation of children to hospital after accidental ingestion of medicines packaged in this way and a small number of studies that were claimed to demonstrate that conventional blister packs were not child-resistant.

The data available however did not allow determination of the true contribution to the overall incidence of poisoning events of products in blister packs. Other published studies, albeit somewhat older, did clearly show that a reduction in child poisoning rates had occurred following the introduction of blister packaging to the market.

A key consideration was whether requiring non-reclosable packaging, when used to provide a child barrier, to comply with the recently published British Standard BS EN 14375:2003 Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing or the similar Canadian Standard or US Code of Federal Regulations requirements, should be introduced. These Standards all require performance testing involving both child and adult panels.

The apparently conflicting information on the effectiveness of current forms of non-reclosable packaging as a child barrier, and advice that requiring compliance in the short term with any of the currently available Standards for non-reclosable packaging, may be counter-productive (ie result in less protective forms of packaging being used) and may have other profound implications for the pharmaceutical industry, led to the recommendation for development of a best practice guideline as a practical alternative. The TGC recommended that this work be undertaken by the new joint Australia New Zealand standards committee once ANZTPA had commenced operation.

At its 31st meeting held in November 2007 the TGC noted that, in view of establishment of ANZTPA being postponed, development of the best practice guideline on non-reclosable packaging could not proceed as originally recommended. The TGC reinforced its previous recommendation for the development of the best practice guideline and agreed that the work should now be undertaken under its direction, commencing as soon as possible. A specialist subcommittee of the TGC is being established to progress this work.

Information sought

The best practice guideline is intended to present information on accidental poisoning in children, and packaging solutions and options that can reasonably be expected to deliver benefits in terms of reducing the incidence of this accidental poisoning. Packaging solutions that are practical, technically simple and would result in minimal additional cost, but would not affect the ability of adults to access their medicines are needed.

Development of the best practice guideline will necessitate a critical appraisal of available information on the effectiveness of current forms of blister and foil strip packaging in preventing accidental poisoning in children, and an assessment of the different approaches to package design or materials which may be used to reduce accessibility to children.

In order to inform this process, information (with supporting data where possible) on the following matters is being sought:

  • the number and proportion of accidental poisonings in children which result from medicines packaged in blister or foil strip packs (compared with reclosable containers, whether child-resistant or not);
  • the proportion of medicines packaged in blister or foil strip packaging compared with reclosable containers and the relative cost of blister or foil strip packaging compared to reclosable forms of child-resistant packaging;
  • the extent to which existing and/or new formats of blister/strip packaging provide protection for children;
  • established risk factors for accidental poisoning in childhood;
  • the attributes of packaging or presentation that may deter children or act to deflect a child's interest in the product;
  • any relationship between the physical characteristics of packaging and its accessibility to children;
  • features of blister or foil strip packaging that can increase the resistance of this packaging to opening by children;
  • the effectiveness in reducing the rate of accidental poisoning in children of the newly introduced requirement in the United Kingdom (UK) for non-reclosable packaging, when used for medicines containing aspirin, paracetamol or more than 24 mg of elemental iron, to comply with child and adult panel test requirements of the applicable British Standard;
  • the impact in the UK on industry of this new requirement;
  • technical information relating to blister or foil strip packaging and formats/enhancements that may provide additional protection for children;
  • the consequential effect of packaging enhancements on the accessibility of the product for adults, particularly the elderly and those less able;
  • the potential impact for industry of requiring child and adult panel testing of non-reclosable packaging, including comment on the practicalities of the test requirements and the necessary processes and costs of upgrading packaging/packaging equipment to achieve compliance; and
  • any other information considered relevant to the subject.

What will happen to submissions?

Submissions will be used by the TGC and its specialist subcommittee to inform discussion and the content of the best practice guideline.

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 telephone number 02 6232 8661 or by email to standards@tga.gov.au.