Replies to LegCo questions
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):
Question:
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?
Reply:
President,
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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Annex to LCQ15