LCQ20:Enhancement in relation to drug labels
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Question:
In accordance with the existing requirements in Hong Kong, all medicines dispensed by a pharmacy or medical practitioner should be labelled, and pharmaceutical products should have information printed on their packaging boxes to indicate important details such as the name of medicine, dosage and route of administration of the medicine, thereby enabling patients to take their medication according to the instructions set out on the labels. There are views that the current font size of information on the drug labels is too small for the elderly to read, which will likely cause problems of failure to take medication as prescribed or taking expired medication by mistake. In this connection, will the Government inform this Council:
(1) whether it has studied the formulation of guidelines relating to the font size of information on drug labels to ensure that the labels can be read clearly by the elderly; if so, of the details;
(2) given that drug labels primarily provide text-only information at present, whether the Government will consider requiring drug labels to include standardised pharmaceutical symbols, such as those reminding patients of the scheduled time for medication, instructions to take medication before or after meals and so on, as supplementary information to reduce the risk of taking wrong medication by mistake among the elderly and the ethnic minorities; and
(3) whether it has studied if the relevant gerontechnology is available in the market to assist the elderly in medication management; if so, of the details; whether the Government has plans to subsidise the elderly to use the related technologies?
Reply:
President,
The consolidated reply, in consultation with the Department of Health and the Labour and Welfare Bureau, to the question raised by the Hon Ginny Man is as follows:
(1) and (2) Labelling requirements of pharmaceutical products
Pharmaceutical products are regulated under the Pharmacy and Poisons Ordinance (Cap.138) (PPO). Labelling requirements for poisons and pharmaceutical products are stipulated under the PPO. Furthermore, based on the PPO, the Pharmacy and Poisons Board of Hong Kong (the Board) promulgated the Guidelines on the Labelling of Pharmaceutical Products to set out the labelling requirements in respect of pharmaceutical products for the trade to comply.
In accordance with the labelling requirements of the Pharmacy and Poisons Regulations (Cap. 138A) (PPR), all pharmaceutical products (whether or not they are poisons specified in the Poisons List) must be labelled with the name of the product, name and quantity of each active ingredient, name and address of the manufacturer, Hong Kong registration number, batch number, expiry date, product pack size and unit of quantity, as well as storage conditions.
In addition to the labelling requirements applicable to all pharmaceutical products described above, all poisons specified in the Poisons List of the PPR (Note 1) must be labelled with:
(i) the name of the poison;
(ii) in the case of a preparation of which one or more of the ingredients is a poison, particulars as to the proportion each poison bears to the total of the ingredients in the preparation;
(iii) for a medicine, the text prescribed in respect of the medicine or the class to which the medicine belongs;
(iv) for a substance or mixture of substances that is not a medicine :
- the text prescribed in respect of the substance or mixture or the class to which the substance or mixture belongs; or
(v) the name of the seller of the poison and the address of the premises in which it was sold.
For pharmaceutical product that is not included in Part 1 of the Poisons List of the PPR or in the Schedule to the Antibiotics Regulations (Cap. 137A), PPR stipulated that it shall be labelled with particulars printed so as to be clearly legible in English and Chinese, as to dosage and the route and frequency of administration.
Requirements of the Code of Practice for Authorized Seller of Poisons
The Code of Practice for Authorized Seller of Poisons (ASP), commonly known as pharmacy, issued by the Board stipulates the mandatory requirements for labelling of dispensed medicines. Non-compliance with the Code of Practice may lead to disciplinary actions which include revocation or suspension of licences. Unless otherwise specified in the Code of Practice (Note 2), the labels of all pharmaceutical products that are dispensed against prescriptions and other pharmaceutical products that are dispensed by registered pharmacist (Note 3) should be labelled with the following important information:
(i) name of patient;
(ii) date of dispensing;
(iii) name and address of the dispensary;
(iv) trade name or pharmacological name of the medicine;
(v) dosage per unit;
(vi) method and dosage of administration; and
(vii) precautions where applicable.
The label affixed to the pharmaceutical products must be clear and legible in English or Chinese. The Code of Practice also specifically states that the special needs of certain patients such as those with poor eyesight must be accommodated as far as possible. Furthermore, if pharmaceutical products are supplied in their original packing, the label must be affixed in such a manner that any statements appearing on the original packing that are important to the patient (Note 4) are left visible.
Pharmaceutical products vary in dosage form, strength and pack size due to factors such as different storage requirements and usage needs, and the effectiveness of pictograms in facilitating understanding also varies accordingly. The Board will continue to monitor relevant international developments and research, review the relevant labelling requirements from time to time, and, having regard to the abovementioned factors and striking a balance between practical needs and feasibility, consider optimising the relevant codes of practice and guidelines with a view to facilitating users' access to the necessary information to the greatest extent possible.
Note 1: The relevant labelling requirements for poisons are not applicable to pharmaceutical products containing poison that are supplied by or pharmaceutical products dispensed at the registered premises of an ASP and pharmaceutical products supplied by registered medical practitioner for the purposes of medical treatment. However, such pharmaceutical product is still required to distinctly labelled with the name and address of the person by whom it is supplied or dispensed.
Note 2: Exempted if the patients' consulting doctors/dentists have so specified in the prescriptions.
Note 3: Except those supplied in their original and properly labelled packaging.
Note 4: Including the batch number of the medicines, the storage conditions, the expiry date, and the name and strength of the medicines.
(3) The Government set up the Innovation and Technology Fund for Application in Elderly and Rehabilitation Care in 2018 to subsidise eligible elderly and rehabilitation service units to procure, rent and try out technology products, including smart information management systems that assist in managing drug information (e.g. the types of medicines, drug records and time slots for drug dispensation). As at end June 2026, the Fund had allocated a total of about $1 billion, subsidising about 2 200 service units to procure or rent over 30 000 technology products, including drug dispensing machines and drug management systems. The Government will continue to utilise the Fund to improve the quality of life of service users as well as reduce the burden and pressure of care staff and carers.
Under the five-year eHealth+ programme, the Government has launched the eMedication function, which aims to integrate medication records and related healthcare services from different healthcare providers, and support medication management processes such as prescribing and dispensing through data connectivity with the eHealth platform, thereby enhancing medication safety and convenience. Currently, elderly and their carers can access allergy and adverse drug reaction records, as well as prescription records, stored in their eHealth accounts through the eHealth Mobile App, covering key information such as drug names, dosage and directions for use, to assist in managing their medication. The App offers a "Lite Mode" which incorporates larger fonts, clear icons and a streamlined layout to better address the needs of the elderly and other users who require such accessibility features.
In addition, since 2024, the Government and the Hospital Authority (HA) have partnered with the Logistics and Supply Chain MultiTech R&D Centre to implement the eMedication (Residential Care Home) project, supporting residential care homes for the elderly (RCHEs) and their electronic medication management system vendors in connecting to eHealth. Through eHealth, RCHEs can obtain residents' electronic medication information, thereby reducing manual transcription of medication information, streamlining the medication distribution and management process, and enhancing the efficiency of medication dispensing and monitoring at RCHEs, thereby reducing the risk of adverse drug events.
eHealth will also support the Government's Community Pharmacy Programme, which is planned to be rolled out in phases starting from 2026/27, so as to promote the synergistic development of future community pharmacies and primary healthcare services by consolidating medication records from HA and different healthcare providers and facilitating their sharing, and to support medication management processes such as prescribing and dispensing.
Ends/Wednesday, July 15, 2026
Issued at HKT 16:55
Issued at HKT 16:55
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