Government’s response on arrangement of extending shelf life of COVID-19 oral drugs

     â€‹In response to media enquiries on the arrangement of extending the shelf life of COVID-19 oral drugs, a Government spokesman today (May 12) stressed that 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 comply with the relevant drug safety regulation. The practice of shelf life extension of the two COVID-19 oral drugs is also an established practice in the global pharmaceutical industry. The spokesman reiterated that the COVID-19 oral drugs is safe and effective while the local supply is sufficient. The Government will ensure that there are sufficient medical resources to meet local needs.

     The Government has started providing private doctors with two COVID-19 oral drugs, Paxlovid and Molnupiravir, procured by the Hospital Authority (HA), for free prescription to "Eligible Persons" who are confirmed COVID-19 patients, since April 2022. Private doctors who have registered under the Electronic Health Record Sharing System (eHRSS) can make requests for provision of the two COVID-19 oral drugs via the dedicated online platform. The drug distributor will distribute the drugs concerned to their selected practice address among those they have registered with the eHRSS.

     Generally speaking, subsequent to the launch of a pharmaceutical product, stability testing will continue in order to ensure that it meets the product specification requirement (including the shelf life) set by the manufacturers. Manufacturers can make application to the Pharmacy and Poisons Board of Hong Kong (the Board) for an extension of the shelf life once relevant supporting data is obtained, but relevant report and information (including the data on stability tests) requested by the Board must be submitted for reviewing its safety, efficacy and quality. Relevant procedures can be found at "Guidance Notes on Change of Registered Particulars of Registered Pharmaceutical Products/Substances" stipulated by the Board.

     The two COVID-19 oral drugs supplied in Hong Kong, Paxlovid (registration number: HK67360 and HK67683) and Molnupiravir (registration number: HK67385), have been approved as registered pharmaceutical products by the Board. They could only be supplied to healthcare institutions and doctors in 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.

     Take the COVID-19 oral drug Paxlovid as an example, the HA earlier received notification from the relevant manufacturer that the U.S. Food and Drug Administration and the Boardhad approved the extension of shelf life of Paxlovid. Based on the relevant information, the HA has arranged for the contractor to affix the label indicating the latest expiry date to the drug packaging box. This arrangement does not affect the efficacy and safety of the drugs. The HA has also notified the medical staff of public hospitals about the relevant arrangement. In this connection, the Department of Health (DH) has 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 extension of shelf life of Paxlovid, and the procedures for the drug distributor to replace the label with an extended shelf life. The DH reminded private doctors yesterday (May 11) 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 emphasised that both types of COVID-19 oral drugs are new and were developed within a short period of time. Applications for shelf life extension were submitted by relevant registration holders with scientific evidence and test data to confirm the effectiveness of the relevant drugs, which is also an established practice in the global pharmaceutical industry.

     According to the Pharmacy and Poisons Ordinance (Chapter 138), all pharmaceutical products must satisfy the criteria of safety, efficacy and quality and be registered with the Pharmacy and Poisons Board (the Board) before they can be sold in Hong Kong. However, the Ordinance allows the import of unregistered pharmaceutical product to be possessed or used for the purpose of treatment of a particular patient by a registered medical practitioner or conduct clinical trials. The DH provides administrative and professional support in respect of registration of pharmaceutical product for the Board and its subsidiary committees. Guidelines, fact sheets on the use of the COVID-19 oral drugs as well as other points to note formulated by the HA are available for download on the online platform. Private doctors must follow the treatment guidelines set out by the HA to prescribe the COVID-19 oral drugs to suitable patients. Besides, registered medical practitioners should abide by the relevant laws and the Code of Professional Conduct for the Guidance of Registered Medical Practitioners at all times when prescribing drugs, including COVID-19 oral drugs.

     â€‹The spokesman reiterated that there is currently sufficient stock of drugs in the public healthcare system for prescription to COVID-19 patients, and the Government will ensure that there are sufficient medical resources to meet local needs. The Government has also procured and stockpiled sufficient oral drugs and adjusted, in a timely manner and according to actual needs, the number of courses that private doctors can request each time through the online platform set up by the Government, so as to cope with the changing situation of the COVID-19 epidemic.




SCS grieves over passing of Field Assistant

     The Secretary for the Civil Service, Mrs Ingrid Yeung, today (May 12) expressed deep sorrow over the passing of Field Assistant of the Agriculture, Fisheries and Conservation Department (AFCD) Mr Ng Kwok-pui during his work at Chi Ma Wan Peninsula, Lantau South Country Park. She extended her deepest condolences to Mr Ng's family.
 
     Mr Ng had served the AFCD for more than four decades and then worked in the department under the Post-retirement Service Contract Scheme. The Civil Service Bureau is in contact with the AFCD to make every effort to help the family during this sad and difficult period.




CHP investigates outbreak of acute gastroenteritis at kindergarten-cum-child care centre in Wan Chai

     The Centre for Health Protection (CHP) of the Department of Health (DH) is today (May 12) investigating an outbreak of acute gastroenteritis (AGE) at a kindergarten-cum-child care centre in Wan Chai, and hence reminded the public and management of institutions to maintain personal and environmental hygiene against AGE.

     The outbreak involves 20 pupils comprising nine males and 11 females aged 2 to 6. Ten of them sought medical attention and one required hospitalisation. All patients are in stable condition.
 
     According to the CHP's epidemiological investigation, one of the students had an onset of a symptom (vomiting in a classroom) earliest on May 10. Other students developed symptoms including vomiting and diarrhoea from May 11. The investigation results revealed that there was an outbreak of AGE in the affected kindergarten-cum-child care centre, with a higher chance of person-to-person transmission or environmental contamination. The chance of involving food poisoning is relatively low. For the sake of prudence, officers of the CHP have conducted a site visit this afternoon together with officers of the Centre for Food Safety of the Food and Environmental Hygiene Department, and no unusual situation was found in the food production environment hygiene of the school during the preliminary assessment.
     
     Officers of the CHP have provided health advice to the staff of the school concerning proper and thorough disinfection, proper disposal of vomitus, and personal and environmental hygiene. The school has been put under medical surveillance.

     Investigations are ongoing.

     A spokesman for the CHP advised members of the public to take heed of the following preventive measures against gastroenteritis:
 

  • Ensure proper personal hygiene;
  • Wash hands thoroughly before handling food and eating, after using the toilet or after changing diapers;
  • Wear gloves when disposing of vomitus or faecal matter, and wash hands afterwards;
  • Clean and disinfect contaminated areas or items promptly and thoroughly with diluted household bleach (by adding one part of bleach containing 5.25 per cent sodium hypochlorite to 49 parts of water). Wash hands thoroughly afterwards;
  • As alcohol does not effectively kill some viruses e.g. norovirus, alcohol-based handrub should not substitute hand hygiene with liquid soap and water;
  • Maintain good indoor ventilation;
  • Pay attention to food hygiene;
  • Use separate utensils to handle raw and cooked food;
  • Avoid food that is not thoroughly cooked;
  • Drink boiled water; and
  • Do not patronise unlicensed food premises or food stalls.

          
     â€‹The public may visit the CHP's website (www.chp.gov.hk) or call the DH's Health Education Infoline (2833 0111) for more information.




Missing woman in Sha Tin located

     A woman who went missing in Sha Tin has been located.

     Du Le-vien, aged 70, went missing after she was last seen at a shopping mall on Sha Tin Centre Street on May 10 afternoon. Her family made a report to Police on the same day.

     The woman was located on Hai Tan Street, Sham Shui Po this afternoon (May 12). She sustained no injuries and no suspicious circumstances were detected.




LegCo Member to attend Parliamentarian Workshop on International Trade 2023 in Singapore

The following is issued on behalf of the Legislative Council Secretariat:
 
     Legislative Council (LegCo) Member Mr Edward Leung will attend the Parliamentarian Workshop on International Trade 2023 organised by the S Rajaratnam School of International Studies and the World Trade Organization (WTO) to be held between May 15 and 17 in Singapore.
 
     The workshop aims to increase the capacity of regional legislators to engage in international trade issues. The programme includes topics on fostering deeper understanding of the WTO, and current and future negotiating issues in international trade.
 
     Up to 40 parliamentarians from the Association of Southeast Asian Nations, Asia and the Pacific Island economies are expected to take part in the workshop. This is also the 11th year the LegCo has been invited to join the event.
 
     Mr Leung was nominated by the LegCo Panel on Commerce, Industry, Innovation and Technology to attend the workshop and the House Committee endorsed the nomination.