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Letter to Doctors on
Amendments to the Dangerous Drugs Ordinance (Cap 134) - Ketamine

27 November 2000

Dear Doctor

I write to draw your attention to the recent gazetting on 24 November 2000 of the Dangerous Drugs Ordinance (Amendment of First Schedule)(No. 2) Order 2000 in which Ketamine is to be added to Part I of the First Schedule of the Ordinance with effect from 15 December 2000.

As the Dangerous Drugs Ordinance confers authority on some persons, including registered doctors and dentists, 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 dangerous drug are enclosed herewith. The same information will also be posted on the Department of Health's Homepage.

Thank you for your attention.

    Yours faithfully



(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:

  1. registered doctors, dentists and veterinary surgeons;

  2. 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);

  3. 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.

Storage

Dangerous drugs should be kept in a locked receptable which can only be opened by the person authorised under the Dangerous Drugs Ordinance to possess them.

Record-keeping

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 practices 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
January, 1999


FIRST SCHEDULE

FORM OF REGISTER

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
received supplied
             

* 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.

Additional Information

Name Products registered in
Hong Kong as at 1.11.2000
Registration No.
Ketamine Ketalar Injection 100 mg/ml HK-07196
Ketalar Injection 50 mg/ml HK-07197
Ketalar Injection 10 mg/ml HK-07901
Ketamine Injection 10% (Vet) HK-37715
Ketaset Injection 10% (Vet) HK-40568
  Last Revision Date : 11 Jan 2013