May 15, 2023
HONG KONG – All COVID-19 oral drugs currently prescribed to confirmed COVID-19 patients in Hong Kong have been tested and confirmed by the drug manufacturers as effective and safe, and they comply with the relevant drug safety regulation.
The Hong Kong Special Administrative Region government said this in response to media inquiries about the two COVID-19 oral drugs’ shelf life extension, saying that such a practice is also an established one in the global pharmaceutical industry.
Since April 2022, the government began providing private doctors with two COVID-19 oral drugs – Paxlovid and Molnupiravir – procured by the Hospital Authority, for free prescription to eligible people who are confirmed COVID-19 patients, a government spokesman said in a statement on Friday.
Generally speaking, subsequent to a pharmaceutical product’s launch, stability testing will continue in order to ensure that it meets the product specification requirement, including the shelf life, set by the manufacturers, said the spokesman.
The government has procured and stockpiled sufficient oral drugs and adjusted the number of courses that private doctors can request each time through the online platform set up by the government, said the spokesman
Moreover, manufacturers can make application to the Pharmacy and Poisons Board of Hong Kong for extending the shelf life once the relevant supporting data is obtained, added the spokesman.
Furthermore, a relevant report and information, including the data on stability tests, requested by the board must be submitted for a review of its safety, efficacy and quality, according to the statement.
Apart from pointing out that the two COVID-19 oral drugs supplied in Hong Kong have been approved as registered pharmaceutical products by the board, the government made it clear that such drugs can only be supplied to healthcare institutions and doctors in the public and private sectors.
“Registration holders of both COVID-19 oral drugs have submitted supporting reports and information on extension of product shelf life after the drugs were marketed. At present, Paxlovid is approved for a shelf life of 24 months while that for Molnupiravir is 30 months,” reads the statement.
Using Paxlovid as an example, the government pointed out that the Hospital Authority earlier received notification from the relevant manufacturer that the US Food and Drug Administration and the board had approved Paxlovid’s shelf life extension.
Based on the relevant information, the authority has arranged for the contractor to affix the label indicating the latest expiry date to the drug’s packaging box, said the spokesman.
This arrangement does not affect the efficacy and safety of the drugs, the government stressed, adding that the HA has also notified the medical staff of public hospitals about the relevant arrangement.
In this connection, the Department of Health also issued letters in December last year and January this year to private doctors who have requested the government to provide Paxlovid via the online platform, informing them of the relevant arrangements.
“The DH reminded private doctors yesterday (Thursday) to pay attention to the label on the packaging box showing the correct expiry date when prescribing drugs, and they should dispense the medicine according to the established ‘first-expired, first-out’ principle,” the spokesman said.
Reiterating that there is currently a sufficient stock of drugs in the public healthcare system for prescription to COVID-19 patients, the government said it will ensure that there are sufficient medical resources to meet local needs.