30 June 2000
I write to draw your attention to the recent amendments to the Dangerous Drugs Ordinance (Cap 134) in which 2 substances are to be added to Part I of the First Schedule of the Ordinance with effect from 1 September 2000, namely,
As the Dangerous Drugs Ordinance confers authority on some persons, including registered doctors, to possess, supply or use dangerous drugs in the course of their duties, they are also required to comply with the provisions in the Ordinance in respect of the storage and record-keeping of dangerous drugs in Part I of the First Schedule.
Copies of the guidance notes on the requirements of the law relating to the storage and record-keeping of dangerous drugs, the Form of Register and additional information on the above two dangerous drugs are enclosed herewith. The same information will also be posted on the Department of Health's Homepage.
Thank you for your attention.
(Dr S P Mak)
for Director of Health
Guidance Notes on the Storage and Record-keeping of Dangerous Drugs
The Dangerous Drugs Ordinance (Cap. 134) confers authority on the following persons to possess, supply or use dangerous drugs in the course of their duties:
registered doctors, dentists and veterinary surgeons;
registered pharmacists or approved persons employed at prescribed hospitals (i.e. a list of hospitals specified in the Second Schedule to the Dangerous Drugs Ordinance);
persons in charge of certain laboratories.
These guidance notes have been drawn up for the above persons. They must not be treated as a complete or an authoritative statement of the law. Copies of the Dangerous Drugs Ordinance and Regulations should be purchased from the Government Publications Centre and consulted when necessary.
Dangerous drugs should be kept in a locked receptacle which can only be opened by the person authorised under the Dangerous Drugs Ordinance to possess them.
Every one of the above persons in possession of dangerous drugs must keep a "Dangerous Drugs Register" in which all transactions of dangerous drugs must be recorded. The format of this Register is fixed by the Ordinance. A copy is attached to these notes.
A separate Dangerous Drugs Register, or a different page of the same Register, should be used for each dangerous drug. The name of the dangerous drug preparation and (where applicable) the strength or concentration of the preparation should be written at the head of each page of the Register.
Every receipt or supply of a dangerous drug must be recorded, in indelible ink, on the day of the transaction or, if this is not practicable, on the following day. No cancellation or alteration of any record is permitted: corrections must be made by means of a marginal note or footnote and must be dated.
If a registered doctor, dentist or veterinary surgeon practises in more than one clinic from which dangerous drugs are supplied, a separate set of registers must be kept and used in each clinic. All used registers must be kept in the clinic for two years from the date on which the last entry was made. It is advisable that all supporting documents such as invoices should also be kept for two years.
Department of Health
|Date of receipt/ supply||Name and address of person* or firm from whom received/to whom supplied||Patient's identity card number#||Amount||Invoice No.||Balance|
|*||Cross reference of the person to whom supplied may be made in which case only the reference number of the person's treatment record needs to be given.|
|#||For a patient who is not resident in Hong Kong, the reference number of any proof of identity, other than an identity card, specified in section 17B(1) of the Immigration Ordinance (Cap. 115) shall be inserted.|
Products registered in Hong Kong as at 1.6.2000
|Remifentanil||Ultiva Injection 1mg||HK-43301|
|Ultiva Injection 2mg||HK-43302|
|Ultiva Injection 5mg||HK-43303|