其 他 安 全 警 示
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| Australia: TGA makes final decision to reduce paracetamol pack sizes (English only) |
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The Therapeutic Goods Administration (TGA) announces its final decision to reduce the maximum size of packs for various paracetamol products.
Each year in Australia around 225 people are hospitalised and 50 Australians die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults. This decision aims to reduce the harm from intentional overdose.
From 1 Feb 2025, new restrictions on paracetamol will:
- reduce the maximum size of packs available for general sale (e.g. supermarkets and convenience stores) from 20 to 16 tablets or capsules.
- reduce the maximum size of packs available in pharmacies without the supervision of a pharmacist (i.e. ‘Pharmacy Only’ packs) from 100 to 50 tablets or capsules.
- make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist (‘Pharmacist Only’ medicines).
Paracetamol tablets and capsules for both general and Pharmacy Only sale will also be required to be in blister packaging. The maximum size of Pharmacy Only packs of individually wrapped powders or sachets of granules containing paracetamol will also be reduced in line with tablet and capsule packs.
Access to liquid, modified-release and Prescription Only paracetamol is not affected by this decision.
The decision takes into account:
- An independent expert report commissioned by the TGA that examined the incidence of serious injury and death from intentional paracetamol overdose.
- Advice received from the Advisory Committee on Medicines Scheduling.
- Submissions from two rounds of consultation from individuals, and organisations representing consumers, healthcare practitioners and industry.
To further minimise the harm from paracetamol overdose, the TGA is encouraging retailers such as supermarkets to restrict sales to a single pack at a time. The TGA is also encouraging consumers not to stockpile paracetamol in their home and to appropriately store paracetamol and other medicines. To allow manufacturers and retail outlets sufficient time to adjust, the decision takes effect from 1 Feb 2025.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/media-releases/tga-makes-final-decision-reduce-paracetamol-pack-sizes
In Hong Kong, there are 746 registered pharmaceutical products containing paracetamol. So far, the Department of Health (DH) has received 50 cases of adverse drug reaction related to paracetamol, of which 11 cases were related to overdose/intentional misuse in dosing frequency.
Currently, the sales pack label of locally registered paracetamol-containing products should include advice against using more than the recommended dose and against using more than one product containing paracetamol.
The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, May 3, 2023
Issued at HKT 15:00
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