18 June 2018 - Deborah Wilkes
New Zealand's Medicines Classification Committee (MCC) has recommended that modified-release paracetamol medicines be reverse-switched to restricted medicine status.
The move follows an application from the country's regulatory agency Medsafe to reverse-switch modified-release paracetamol medicines from pharmacy-only to restricted status. The latter is also known as a pharmacist-only medicine.
Action in Europe
Medsafe's application follows regulatory action in the European Union to suspend modified-release paracetamol products from the market due to the complexity of managing overdose with such products.
The European Medicines Agency (EMA) said in December 2017 that the medicines would remain suspended unless the companies that held the marketing authorisations could provide “evidence of appropriate and practical European Union-wide measures to help prevent overdose with the products and adequately reduce its risks”.
According to Medsafe, changing the classification of modified-release 665mg paracetamol products to pharmacist-only status would "ensure that consumers are advised of the correct dose of this medicine at the time of sale, thereby reducing the risk of inadvertent overdose".
Medsafe added that pharmacist-only status might reduce the ease of access – relative to immediate-release paracetamol – for intentional overdose, without limiting access to the product for its therapeutic purpose.
The MCC made the recommendation at its meeting on 26 April 2018, the minutes of which have just been released.
Two applications from Bayer rejected
At the April meeting, the MCC turned down an application from Bayer New Zealand to switch Canesten Plus topical cream, a combination of clotrimazole and hydrocortisone, from pharmacist-only to pharmacy-only status.
The MCC also rejected another application from Bayer New Zealand to switch Claratyne (loratadine) from pharmacy-only to general-sale status.
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