Replies to LegCo questions
LCQ19: Misleading label on drugs
Following is a question by the Ir Dr Hon Ho Chung-tai and a written reply by the Secretary for Health, Welfare and Food, Dr York Chow, in the Legislative Council today (November 24):
Question:
It has been reported that some patients mistakenly believe that long-term use of drugs which have the word "poison" printed on their packages will be hazardous to health, and some of them may even decide to cease taking the drugs. In this connection, will the Government inform this Council:
(a) whether patients have indicated to the authorities concerned, over the past three years, that they had ceased taking such drugs in the belief that taking them for a long time would be hazardous to health; if so, of the total number of such cases;
(b) of the existing legislative provisions in respect of the requirement that the word "poison" shall be printed on the packages of some drugs, and whether it plans to amend such provisions; if so, of the details; and
(c) whether it knows if similar provisions are stipulated in the laws of the United Kingdom, the United States of America and Canada?
Reply:
The sale and supply of pharmaceutical products in Hong Kong are regulated through a system of registration and classification provided for under the Pharmacy and Poisons Ordinance (Cap.138). The statutory Pharmacy and Poisons Board is responsible for the registration and classification of pharmaceutical products. Taking into account the toxicity and extent of potential side-effects of the products, as well as the diseases they are to treat, some pharmaceutical products are classified as poisons and placed in the Poisons List under the Poisons List Regulations (Cap.138B). The sale of these products is restricted in terms of the point of sale, the need for the presence of pharmacists at the point of sale and/or the need for doctors' prescription, as the case may be.
As pharmaceutical products on the Poisons List could cause harm to the users if they are not used in accordance with the dosage instructions, it is a statutory requirement for the containers of such products to be labelled with the word "poison", or with a prescribed cautionary statement if the product carries specific risks or side effects which their users should be specifically cautioned against. Such labelling arrangement has been in place since 1970.
(a) According to the Department of Health and Hospital Authority, there had not been recorded complaints in the past three years concerning the cessation of taking drugs with the word 'poison' appearing on drug labels due to the misconception that taking them for a long time would be hazardous to health.
It is important that patients should take pharmaceutical products in accordance with the directions of medical practitioners and where appropriate, those of the pharmacists. In case of doubt, patients should consult their doctors or pharmacists. Public education on this front is an on-going effort of the Department of Health and the Hospital Authority.
(b) Section 27(c) of Cap.138 stipulates that the containers of pharmaceutical products on the Poisons List should be printed with either the word "poison" or such other specific cautionary statements as laid down in the Fifth Schedule of Cap.138A. Such word or statement should be printed clearly in Chinese or English.
The Administration understands that the word 'poison' appearing in the packaging of the drug might cause concern among the users as to the nature of the drug. We are reviewing the relevant provisions in the legislation that has been in place since 1970 to explore options on how the provisions could be improved.
(c) Drugs are not labelled with the word poison in their packages in the UK, USA and Canada. Nonetheless, the regimes governing the classification of drugs in different jurisdictions vary, given the difference in how their systems develop and the needs of their community.
Ends/Wednesday, November 24, 2004
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