📋 Tender Overview
Following is a question by the Hon Ginny Man and a written reply by the Secretary for Health Professor Lo Chungmau in the Legislative Council today July 15
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 textonly 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 Cap138 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
2 if no text is prescribed Poison Du Yao and
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 Noncompliance 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 con
