S.I. No. 225/1998 - Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations, 1998.

S.I. No. 225 of 1998.

MISUSE OF DRUGS (SUPERVISION OF PRESCRIPTION AND SUPPLY OF METHADONE) REGULATIONS, 1998.

I, BRIAN COWEN, T.D., Minister for Health and Children, in exercise of the powers conferred on me by section 5 of the Misuse of Drugs Act, 1977 (No. 12 of 1977), and the Health (Alteration of Name of Department and Title of Minister) Order, 1997 ( S.I. No. 308 of 1997 ), hereby make the following regulations:

1 Commencement

1. (1) These Regulations may be cited as the Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations, 1998.

(2) Save where otherwise expressly provided, these Regulations shall come into operation on the 16th day of July, 1998.

2 Interpretation

2. (1) In these Regulations, unless the context otherwise requires—

"Act of 1977" means the Misuse of Drugs Act, 1977 (No. 12 of 1977);

"Central Treatment List" means the record referred to in Regulation 3(2);

"drug treatment card" means a card which has issued to a person pursuant to Regulation 4;

"Eastern Health Board" means the health board established under Regulation 4 of the Health Boards Regulations, 1970 ( S.I. No. 170 of 1970 );

"health board" means a health board established under section 4 of the Health Act, 1970 (No. 1 of 1970);

"Minister" means the Minister for Health and Children;

"person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons" has the same meaning as in Regulation 3 of the Regulations of 1988 ;

"prescription" means a prescription issued by a registered medical practitioner in compliance with Regulation 13(1) (form of prescriptions) of the Regulations of 1988;

"Regulations of 1988" mean the Misuse of Drugs Regulations, 1988 ( S.I. No. 328 of 1988 );

"specified controlled drug" means a drug specified in the Schedule of these Regulations.

(2) In these Regulations, unless the context otherwise requires—

(a) a reference to a Regulation is a reference to a Regulation of these Regulations,

and

(b) a reference to a paragraph is a reference to a paragraph of the provision in which the reference occurs.

3 Central Treatment List

3. (1) Where a registered medical practitioner intends to prescribe a specified controlled drug for the first time to a person who has presented to the registered medical practitioner for treatment, the registered medical practitioner shall not issue a prescription for the drug until he or she notifies the Eastern Health Board of the name, address and date of birth of the person.

(2) The Eastern Health Board shall maintain a record to be known and in these Regulations referred to as the "Central Treatment List" which shall contain the information notified to it under paragraph (1) and the list may be maintained in electronic form.

(3) Where a notification is made to the Eastern Health Board in accordance with paragraph (1), the Eastern Health Board shall inform the registered medical practitioner as to whether the person has previously been included in the Central Treatment List.

(4) The Eastern Health Board may amend an entry in or delete an entry from the Central Treatment List.

4 Issue of drug treatment card

4. (1) A health board shall issue a drug treatment card in respect of a person participating in a programme of treatment involving the use of a specified controlled drug and in respect of whom the information referred to in Regulation 3(1) has been notified to the Eastern Health Board.

(2) A drug treatment card shall be valid for such period as may be specified on the card but in any case shall not be valid for more than one year from the date of issue.

5 General prohibition on registered medical practitioner

5. (1) A registered medical practitioner shall not issue a prescription for a specified controlled drug other than on a form supplied by or on behalf of the Minister.

(2) From the 1st day of October, 1998, a registered medical practitioner shall not issue a prescription referred to in paragraph (1) other than to a person in respect of whom a drug treatment card has been issued and remains valid.

(3) Notwithstanding Regulation 13 of the Regulations of 1988, it shall be sufficient compliance with requirements of paragraph (1)(f) of that Regulation if the information required to be included on a prescription issued by a registered medical practitioner in accordance with paragraph (1) of this Regulation is impressed upon the prescription from an embossed drug treatment card.

6 General prohibition on person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons

6. (1) Subject to paragraph (3), a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons shall not supply a specified controlled drug on a prescription other than on a prescription issued by a registered medical practitioner in accordance with Regulation 5(1).

(2) From the 1st day of October, 1998, a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons shall not supply a specified controlled drug on a prescription issued by a registered medical practitioner in accordance with Regulation 5(1) other than to a person in respect of whom a drug treatment card has issued and remains valid.

(3) Paragraph (1) shall not apply to a prescription issued by a registered medical practitioner before the coming into operation of that paragraph.

7 Information to be furnished to Minister

7. (1) Subject to paragraph (2), a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons shall forward to the Minister—

(a) in respect of each supply of a specified controlled drug—

(i) the orginal prescription on which the supply of the specified controlled drug was made, and

(ii) in respect of the prescription, a statement which confirms or clarifies the identity of the person to whom the prescription was issued, if the information given on the prescription is inadequate, illegible or misleading,

and

(b) particulars of each supply of a specified controlled drug made to a registered medical practitioner pursuant to a requisition referred to in Regulation 12(2) (documents to be obtained by a supplier) of the Regulations of 1988,

not later than 14 days after the last day of the calendar month in which the supply of the specified controlled drug made on that prescription was completed or when no further supply may be made on that prescription.

(2) Paragraph (1) shall not apply to a prescription issued by a registered medical practitioner before the coming into operation of this Regulation.

8 Minister to maintain a record

8. (1) The Minister shall maintain a record of all prescriptions received by him or her under Regulation 7 and the record may be maintained in electronic form.

(2) Subject to paragraph (3), the Minister may amend an entry in or delete an entry from the record referred to in paragraph (1).

(3) Each prescription received by the Minister under Regulation 7 shall be preserved for a period. of two years from the date of receipt of that prescription.

9 Prohibition on supply

9. (1) A person shall not supply a specified controlled drug to a registered medical practitioner unless that person is a person keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons.

(2) Paragraph (1) shall not apply to a person who is the holder of a licence under section 14 of the Act of 1977 to supply a controlled drug, where the licence directs that such supply may be made.

10 Supply by instalments

10. (1) From the 1st day of October, 1998, for the purposes of compliance with Regulation 16(1) (keeping of registers) of the Regulations of 1988, where the supply of a controlled drug on a prescription issued by a registered medical practitioner in accordance with Regulation 5(1) is to be dispensed in instalments—

(a) the information in relation to each supply may be entered on the prescription, and

(b) the total amount supplied on the prescription, when the dispensing of that prescription has been completed or when no further supply may be made on that prescription, may be entered, in the register referred to in Regulation 16(1) of the Regulations of 1988, as the amount supplied.

(2) For the purposes of an entry in a register to be made under paragraph (1), the date to be entered in the register shall be the date on which the last supply was made on the prescription concerned.

11 Preservation of registers

11. Notwithstanding Regulation 19(2) (preservation of registers) of the Regulations of 1988, the preservation of a copy of a prescription issued by a registered medical practitioner in accordance with Regulation 5(1), made by a registered medical practitioner at the time of writing the original prescription, shall be treated as if it were the preservation of the original prescription.

12 Exemption: hospitals

12. (1) These Regulations shall not apply to a prescription issued in respect of a specified controlled drug where the prescription has been issued in a hospital

(a) for administration in the hospital, to the person to whom the prescription relates, or

(b) for supply in the hospital, in exceptional circumstances, to the person to whom the prescription relates and who has attended the hospital—

(i) for the treatment of opiate dependence, or

(ii) as an in-patient who is opiate dependent.

(2) In this Regulation "hospital" means a hospital, nursing home or clinic which is wholly or mainly maintained by a public authority out of public funds, by a charity or by voluntary subscriptions.

13 Exemption: medical consultants

13. (1) Regulations 3, 4, 5(2) and 6(2) shall not apply to a prescription issued for the treatment of a person for purposes other than for or in connection with opiate dependence provided that—

(a) the prescription has been initiated, for issue by a registered medical practitioner, by a medical consultant whose name and address is included on the prescription, or

(b) the prescription is issued by the medical consultant.

(2) In this Regulation "medical consultant" means a registered medical practitioner in any hospital practice who by reason of his or her training, skill and experience in a particular speciality, is consulted by other registered medical practitioners.

SCHEDULE

Regulation 2

1. Methadone.

2. Any steroisomeric form of a substance specified in paragraph (1).

3. Any salt of a substance specified in paragraph 1 or 2.

4. Any preparation or other product containing any proportion of a substance or product specified in paragraphs 1, 2 or 3.

GIVEN under the Official Seal of the Minister for Health and Children, this 1st day of July, 1998.

BRIAN COWEN, T.D.,

Minister for Health and Children.