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Deregistration of pharmaceutical products containing combination of corticosteroid and NSAID to take effect from January 1, 2014
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     The Department of Health (DH) today (December 2) reminded members of the public that pharmaceutical products containing a combination of corticosteroid and non-steroidal anti-inflammatory drug (NSAID) will be deregistered and will not be available in the market with effect from January 1, 2014.

     After taking into consideration that the risk of gastro-intestinal bleeding and ulceration associated with NSAIDs is increased when it is used in combination with a corticosteroid, the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (the Committee) of the Pharmacy and Poisons Board decided at its meeting on April 30, 2013, to deregister combination products. To allow sufficient time for doctors to review treatment plans and switch to suitable alternative treatments for their patients, the Committee decided that the deregistration will not take effect until January 1, 2014. A press release with a list of the 66 affected products was issued on May 2, 2013 to announce the decision of the Committee. The DH had also notified healthcare professionals on the Committee's decision and related recommendations, as well as requesting the six manufacturers concerned to recall the products from the market.  

     "Patients who are still using the products should contact their doctors for switching to suitable alternative treatments. The DH has issued reminder letters to healthcare professionals and manufacturers on the commencement date of deregistration of the products," a DH spokesman said.
 
     "With effect from January 1, 2014, all drug manufacturers, wholesalers, retailers, and healthcare professionals must stop selling or supplying pharmaceutical products containing the combination of corticosteroid and NSAID. The manufacturers must also recall all concerned products from the market by December 31, 2013, after which the DH will take enforcement action against any illegal possession or sale of these unregistered pharmaceutical products," a DH spokesman said.

     Under the Pharmacy and Poisons Ordinance (Cap. 138), the sale and possession of unregistered pharmaceutical products are both criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.

Ends/Monday, December 2, 2013
Issued at HKT 15:00

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