4 Introduction

(1) The objective of this Order is to set particular requirements for the packaging of medicines that may present a significant risk of toxicity to children if accidentally ingested. These requirements relate to child‑resistant packaging — that is, packaging that is designed to be resistant to opening by young children.

(2) Child‑resistant packaging is not child‑proof. While it has an important role in reducing the incidence and public health burden of accidental poisoning in children and the associated morbidity and mortality, it provides only one safeguard in that it delays the time taken by a child to open a package and access multiple units, thereby increasing the probability of adult intervention before the contents are fully accessible and can be ingested.

(3) Compliance of packaging with the national or international Standards for child‑resistance referred to in this Order only establishes a packaging system as child‑resistant, not child‑proof.

(4) The criteria used by the committee advising on requirements for child‑resistant packaging are:

(a) the toxicity of the substance contained in the medicine, and risk of harm if it is accidentally ingested by a young child; and

(b) the extent and patterns of availability in the community of medicines containing the substance; and

(c) the number and type of incidents reported to Poisons Information Centres and other relevant organisations involving accidental ingestion of medicines containing the substance; and

(d) the consequences of these incidents (hospital admission or other treatment, serious injury, or death), including the difficulty or complexity of treatment; and

(e) any special needs of patients who regularly need access to medicines containing the substances, such as older persons or people with a disability; and

(f) the technical feasibility and practicality of child‑resistant packaging for medicines containing the substance, taking into account the usual dosage form and presentation; and

(g) other such matters as the committee thinks fit.

(5) A substance will, in general, be considered to be sufficiently toxic to warrant child‑resistant packaging 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).

(6) While the criteria set out in subsection 4(4) and the guideline set out in subsection 4(5) relate to toxicity only from ingestion, if a medicine presents a hazard in terms of potential to cause serious harm to young children through inadvertent contact with the eyes, the skin or mucous membranes, then these medicines will also be considered for child‑resistant packaging.