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LCQ15: Shelf life of drugs

     Following is a question by the Dr Hon Priscilla Leung and a written reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (February 4):


     It has been reported that the Department of Health (DH) and Hospital Authority (HA) had extended for two years the expiry dates of about 20 million doses of antiviral drugs for influenza stockpiled by them, and the expiry dates of some of the drugs have been extended for the second time. In the connection, will the Government inform this Council:

(a) among the drugs stockpiled by DH and HA, how many doses have had their expiry dates extended since 2004, together with a breakdown by the type of drugs;

(b) whether the authorities have specified the maximum number of times that the expiry dates of various types of drugs may be extended;

(c) what testing mechanism is presently adopted by the authorities for ensuring that drugs with extended expiry dates are still potent and will not produce unexpected side effects;

(d) whether, over the past five years, there were cases of patients feeling sick or experiencing unexpected side effects after taking drugs with extended expiry dates, and whether the authorities have received complaints from patients about the falsification of the expiry dates of drugs; if there were such cases and complaints, of their respective numbers; and

(e) whether it knows if hospitals in overseas places extend the expiry dates of their drugs?



     The shelf life of a drug is set by its manufacturer. Under specific circumstances, the manufacturer may apply to the Department of Health (DH) for extension of the expiry date of the drug. The drug manufacturer must carry out tests on the drug and provide to DH with the relevant test data to prove that its expiry date can be extended. DH will then consider approving the application after detailed examination of the relevant test data. The replies to the various parts of the question are set out at Annex.

(a) DH has granted approval for the drug manufactories to extend the expiry dates of the Tamiflu capsule and Relenza spray after detailed examination of the test data provided by the drug manufactories. The expiry dates of 17,375,140 doses of Tamiflu capsule and 1,769,990 doses of Relenza spray stockpiled by DH have been extended by three years and two years respectively. As regards the Hospital Authority (HA), extension of expiry dates as approved by DH upon application by the relevant drug manufacturers has been recorded for 11 types of drugs since April 2006 when it took over the procurement of drugs from the Government Logistics Department. Details of the drugs are provided at Annex.

(b) & (c) As mentioned above, drug manufacturers are required to make prior application to DH each time when they intend to extend the expiry dates of their drugs. Drug manufacturers are also required to furnish test data on the drugs concerned to prove that their expiry dates can be extended for the purpose of seeking approval of DH. DH regularly reviews the expiry dates of drugs to ensure their potency. HA also puts in place a drug quality surveillance mechanism and monitors the reports on adverse drug reaction and incidents relating to the use of drug for the purpose of quality assurance and risk management.

(d) Over the past five years, neither DH nor HA has received any complaint about or report of adverse drug reaction caused by a change or extension of the shelf life of drugs.

(e) Similar mechanism as mentioned above has largely been adopted by drug administration agencies in advanced countries to assess the applications made by drug manufacturers for extension of the expiry date of individual drugs.

Ends/Wednesday, February 4, 2009
Issued at HKT 14:33


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