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Director of Health Dr Lam Ping-yan has attributed the fungal contamination of Europharm-produced Allopurinol to undue delay in tableting during the drug's production.
The Secretary for Food & Health Dr York Chow said he has asked the Department of Health to find out whether other drugs produced by Europharm had fungus contamination and to announce the results and follow-up measures as early as possible.
"The results can serve as references to private doctors and hospitals for taking appropriate measures correspondingly," he said.
The Department of Health has asked Europharm to recall all Allopurinol tablets from the market and is investigating the production of all pharmaceutical products it manufactures.
Further management of other drug items will be considered depending on the result of laboratory tests which will be available later this week.
Cause of contamination
Briefing the media on the investigation progress today, Dr Lam said the concerned drug granules were found to have been stored at 25 degrees Celsius for five to 14 days before they were turned into tablets.
When storing these granules under a non-fully-sterilised environment for such a long period, mould can grow, Dr Lam said.
The affected four batches of drug were manufactured from April to November last year. Laboratory tests confirmed they were contaminated by the Rhizopus microsporus fungus, and exceeded the permitted level by 10 times or more.
More checks
Dr Lam said more than 1,000 drug samples have been collected from the factory for testing, with priority given to those drugs the Hospital Authority uses. Results will be available this week.
As there is so far no evidence showing the concerned manufacturer's other drugs have the same irregularity, the Government cannot recklessly request a recall of all its products which would affect hundreds of thousands of patients, Dr Lam noted.
Hospital Authority Director (Cluster Services) Dr Cheung Wai-lun said besides the drug-replacement arrangement that began yesterday, hospitals will stop prescribing Europharm drugs if there are alternatives. The company supplies 41 types of drugs to the authority.
The authority will also contact immunocompromised patients to ensure they stop taking Europharm drugs.
Dr Chow has also instructed the Department of Health to comprehensively review and improve the drug-manufacturing monitoring mechanism, and refer to overseas experience to prevent a recurrence of similar incidents.
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