DH and Center for Drug Reevaluation of National Medical Products Administration sign Agreement on Authorizing the Department of Health of the Hong Kong Special Administrative Region to Use VigiLyze - the Uppsala Monitoring Centre Adverse Drug Event Information System
The Department of Health (DH) and the Center for Drug Reevaluation (CDR) of the National Medical Products Administration (NMPA) today (September 13) signed the Agreement on Authorizing the Department of Health of the Hong Kong Special Administrative Region to Use VigiLyze – the Uppsala Monitoring Centre Adverse Drug Event Information System (Agreement). The Agreement authorises the DH to continue making use of the Uppsala Monitoring Centre (UMC) adverse drug event information system, VigiLyze. The Hong Kong Special Administrative Region (HKSAR) Government expresses gratitude to the NMPA for their trust and support to the HKSAR Government in the area of pharmacovigilance activities, which have played a positive role in developing Hong Kong into an international health and medical innovation hub.
Developed and maintained by the UMC for the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM), VigiLyze is a global signal detection and signal management tool for adverse events of medicinal products. It is a web-based platform accessible to national pharmacovigilance centresof member countries of the WHO PIDM. Through its close integration with the WHO global database of adverse event reports for medicines and vaccines, VigiLyze provides member countrieswith global data on adverse events on medicines and vaccines, and access to related investigations. Being a member country of the WHO PIDM enables China to utilise this platform and enhance the national pharmacovigilance system. As a part of China, Hong Kong needs to obtain authorisation from relevant national units in order to use the platform.
The DH signed the Agreement with the NMPA for the first time in 2020. This Agreement played a significant role in the safety monitoring of COVID-19 vaccines during the COVID-19 pandemic. In response to the COVID-19 outbreak, two COVID-19 vaccines were authorised for emergency use in Hong Kong in 2021. The DH has put in place a pharmacovigilance system for COVID-19 vaccination, to detect potential signals of possible side effects of the vaccines. The DH has also established the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation (Expert Committee) to provide independent assessment on potential causal link between adverse events following immunisation (AEFIs) and COVID-19 vaccines used in Hong Kong and to provide expert advice to the Government on safety-related matters. The signing of the Agreement has allowed the DH to use VigiLyze's global adverse drug event data of COVID-19 vaccines to provide the Expert Committee with a reference to assist their causality assessment of AEFIs for COVID-19 vaccines, and also assisted the Expert Committee in identifying potential signs of possible side effects of the vaccines.
The signing of a new Agreement between the NMPA and the DH allows the DH to continue using VigiLyze, which fully demonstrates the country’s recognition of the HKSAR. The DH expresses gratitude to the NMPA for the continuous trust and support to the HKSAR Government in the area of pharmacovigilance activities. The DH hopes to continue collaborating closely with the NMPA and the CDR to ensure all pharmaceutical products used in Hong Kong meet the criteria of safety, quality and efficacy, to effectively safeguard public health.
At the same time, since putting forward in the Chief Executive's 2023 Policy Address the vision of developing Hong Kong into an international health and medical innovation hub, the HKSAR Government has been pushing ahead with multiple initiatives on all fronts to strengthen the HKSAR's capacity of drug evaluation for progressing towards a primary evaluation approach, and has achieved results, including the establishment of the Preparatory Office for the Hong Kong Centre for Medical Products Regulation (CMPR) under the DH on June 5, 2024, to put forward proposals and steps for the formal establishment of the CMPR, and to study the potential restructuring and strengthening of the regulatory and approval regimes for drugs and medical devices. The HKSAR Government will continue to strengthen policies and measures for the regulation of drugs and medical devices, and to build the capacity, recognition and status at different stages to ensure that the eventual approval mechanism of medical products in Hong Kong would be widely recognised internationally and by the Mainland, and develop Hong Kong into an international health and medical innovation hub, striving towards high-quality development.
Source: AI-generated images
CHP reminds public on precautions against cold weather
The Centre for Health Protection (CHP) of the Department of Health (DH) today (December 21) reminded the public, particularly the elderly and people with chronic illnesses, to adopt appropriate measures to protect their health in view of the cold weather.
A spokesman for the CHP said that cold weather can easily trigger or exacerbate diseases, especially among the elderly and persons suffering from heart disease, respiratory illnesses or other chronic illnesses.
"Elderly people have less insulating fat beneath their skin to keep them warm, and their body temperature control mechanisms may be weaker. Their body may not be able to appropriately respond to thecold weather," the spokesman said.
Some senior persons may have decreased mobility, which can impair their ability to generate and conserve body heat. Chronic illnesses, such as hypertension, diabetes and endocrine disorders, may undermine the health of elderly people and lower their metabolic rate, subsequently causing their body to generate less heat. Persons with chronic illnesses, such as chronic respiratory illnesses or heart disease, are vulnerable to disease aggravation due to cold weather.
The CHP reminded the public, in particular the elderly and persons with chronic illnesses, to adopt the following preventive measures:
Take note of the weather forecast. Wear warm clothing, including hats, scarves, gloves and socks, accordingly;
Consume sufficient food to ensure adequate calorie intake;
Perform regular exercise to facilitate blood circulation and heat production;
Stay in a warm environment and avoid prolonged outdoor exposure;
Use heaters with care and maintain adequate indoor ventilation; and
Seek medical advice if feeling unwell.
In addition, the public should avoid alcoholic beverages.
"Drinking alcohol cannot keep you warm. Alcohol accelerates the loss of body heat through dilated blood vessels, resulting in chilling instead," the spokesman said.
"Parents should ensure that babies are sufficiently warm, but it is also important to keep babies relatively lightly clothed to avoid overheating them," the spokesman added.
Parents should observe the following safety measures when putting their children to bed:
Keep the room well ventilated and at a comfortable temperature;
Always place babies on their backs to sleep. Leave their heads, faces and arms uncovered during sleep;
Babies do not need pillows. Place babies on a firm and well-fitted mattress to sleep. Avoid soft objects, pillows and loose bedding;
Let babies sleep in a cot placed near their parents' bed; and
Maintain a smoke-free environment.
In addition, many respiratory pathogens, including influenza and SARS-CoV-2, may have increasing activity and community transmission during winter. Seasonal influenza vaccination is recommended for all persons aged 6 months or above, except those with known contraindications. Persons at higher risk of getting influenza and its complications, including the elderly and children, should receive seasonal influenza vaccinations early. Please see details of the vaccination schemes on theCHP's website.
A person who gets influenza and COVID-19 at the same time may be more seriously ill and would have a higher risk of death. It is important for elderly persons, especially those residing in residential care homes, to receive both a seasonal influenza vaccination and a COVID-19 vaccination. They should also receive an additional booster against COVID-19 according to recommendations as soon as possible. The public should also maintain good personal and environmental hygiene against respiratory illnesses and note the following:
Surgical masks can prevent transmission of respiratory viruses from ill persons. It is essential for persons who are symptomatic (even if having mild symptoms) to wear a surgical mask;
Wear a surgical mask when taking public transport or staying in crowded places. It is important to wear a mask properly, including performing hand hygiene before wearing and after removing a mask;
Avoid touching one's eyes, mouth and nose;
Wash hands with liquid soap and water properly whenever possibly contaminated;
When hands are not visibly soiled, clean them with 70 to 80 per cent alcohol-based handrub;
Cover the mouth and nose with tissue paper when sneezing or coughing. Dispose of soiled tissue paper properly into a lidded rubbish bin and wash hands thoroughly afterwards;
Maintain good indoor ventilation;
When having respiratory symptoms, wear a surgical mask, refrain from work or attending classes at school, avoid going to crowded places and seek medical advice promptly; and
Maintain a balanced diet, exercise regularly, take adequate rest, do not smoke and avoid overstress.
Food-borne diseases, particularly those linked to hotpot cuisine, are also common in cold weather. The following preventive measures should be taken:
Wash hands before handling and consuming food;
Do not patronise unlicensed vendors or those with poor hygienic standards while selecting food;
Wash and cook all food thoroughly;
Vegetables should be washed thoroughly in clean running water before cooking and consumption. When appropriate, scrub vegetables with hard surfaces with a clean brush to remove dirt and substances, including pesticide residues and contaminants, from surfaces and crevices;
Shrimps should be fully cooked until the shells turn red and the flesh turns white and opaque;
For shellfish such as scallops and geoduck, scrub the shells thoroughly and remove internal organs;
Do not eat any undercooked freshwater aquatic products. To ensure that the food is thoroughly cooked, the centre of the food should reach a temperature of at least 75 degrees Celsius so as to destroy pathogen;
Most hotpot ingredients should be stored in a refrigerator at 4 degrees C or below, while frozen food should be stored in a freezer at -18 degrees C or below;
Never use raw eggs as a dipping sauce for hotpot; and
Use different sets of chopsticks to handle raw and cooked food to avoid cross-contamination.
In addition, when using fuel-burning appliances, especially in indoor areas, the public should ensure adequate ventilation to avoid harmful exposure to carbon monoxide (CO) and prevent CO poisoning.
For more health information, the public may call the DH's Health Education Infoline (2833 0111) or visit theCHP's websiteandFacebook Fanpage.
The public may also call Dial-a-Weather (1878 200) or visit thewebsite of the Hong Kong Observatoryfor the latest weather information and forecasts, or itspage on Weather Information for Senior Citizens.
