PJ Online | News: Child-resistant blister packs for aspirin, paracetamol and iron to be brought in
The Pharmaceutical Journal
Child-resistant blister packs for aspirin, paracetamol and iron to be brought in
Blister packs of paracetamol, aspirin and iron preparations will have to conform to the British Standard for non-reclosable packaging from next year.
Under proposals from the Medicines Control Agency, all packaging for solid dosage forms of aspirin and paracetamol will have to comply with BS8404, which was introduced at the end of 2001 (PJ, 19 January, p48). In addition, preparations containing more than 24mg of elemental iron per unit dose and liquid paracetamol preparations will also have to meet requirements for child-resistant packaging. BS8404 sets out what defines child resistance. It is up to manufacturers to decide how to meet this.
Speaking during a visit to Great Ormond Street Children's Hospital, London, on 26 November, Lord Hunt, Parliamentary Under-Secretary of State for Health, said: "Most parents realise the potential danger and take adequate precautions with medicines in the home. While the first line of defence must always be to keep medicines out of the sight and reach of children, child-resistant packaging represents an important additional safeguard."
The Committee on Safety of Medicines has recommended that iron preparations should also meet the new standard because they can be toxic to young children in small quantities. As few as six tablets may contain enough iron to cause death in a one-year-old child. And, because they are commonly taken by mothers following child birth, they are more likely to be found in homes with toddlers.
The British Standards Institution has recommended that the use of child-resistant closures should be confined to those products that are potentially hazardous, since if they were used in other circumstances there would be confusion over the degree of hazard posed by the product. Once new regulations are in place, probably from the middle of next year, it will be an offence to supply these paracetamol, aspirin or iron products outside hospitals without such packaging unless a customer makes a request in person for non-child-resistant closures. Products already on the market will be able to be sold until their shelf-life expires.
The Proprietary Association of Great Britain said that its members would be consulting with the MCA to find a workable and effective way of bringing in new packaging. The PAGB said that accidental poisoning incidents involving children have declined markedly over the past two decades as the use of blister packs has increased. The overall number of incidents fell from around 61,000 in 1982 to around 41,000 in 1998, and the number involving children under five years fell by more than half. Only one child fatality from iron ingestion has been reported in the past decade and no deaths due to aspirin or paracetamol.
Following the announcement by Lord Hunt, the MCA issued consultation letter MLX 291 on draft Medicines (Child Safety) Regulations 2003. Copies of the letter can be found here (Microsoft Word document). The consultation period runs until 18 February 2003.
Citation: The Pharmaceutical Journal URI: 20008278
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