S.I. No. 522/2017 - Misuse of Drugs (Supervision of Prescription and Supply of Methadone and Medicinal Products containing Buprenorphine authorised for Opioid Substitution Treatment) Regulations 2017

1. Methadone

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

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

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

5. Any medicinal product containing buprenorphine with a marketing authorisation indicated for substitution treatment for opioid drug dependence.

GIVEN under my hand

22 November 2017.

CATHERINE BYRNE,

Minister of State at the Department of Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations replace the Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations 1998 (

S.I. No 225 of 1998

). The Regulations add certain buprenorphine medicinal products authorised for opioid substitution treatment to the Schedule of products which fall within the scope of these Regulations.

These Regulations also update a number of references and definitions, replace the Minister with the Health Service Executive for the purposes of receiving information and reassign responsibilities relating to maintenance of records from the Minister to the Health Service Executive.

These Regulations may be cited as the Misuse of Drugs (Supervision of Prescription and Supply of Methadone and Medicinal Products containing buprenorphine authorised for Opioid Substitution Treatment) Regulations 2017.

1 OJ No. L 311, 28.11.2001, p. 67.

2 OJ No. L 136, 30.4.2004, p. 1.

6. (1) A person carrying on a retail pharmacy business 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) A person carrying on a retail pharmacy business 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 an opioid substitution treatment card has issued and remains valid.

Information to be furnished to Executive

7. A person carrying on a retail pharmacy business shall forward to the Executive—

(

a

) in respect of each supply of a specified controlled drug on prescription—

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

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

(

b

) in respect of each supply of a specified controlled drug made to a registered medical practitioner pursuant to a requisition referred to in Regulation 14(2) of the Principal Regulations, particulars, including the purpose, of the supply,

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

Executive to maintain a record

8. (1) The Executive shall maintain a record of all prescriptions, statements and particulars received under Regulation 7 and the record may be maintained in an electronic form.

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

(3) Each prescription, statement or particular received by the Executive under Regulation 7 shall be preserved for a period of two years from the date of receipt.

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 carrying on a retail pharmacy business.

(2) Paragraph (1) shall not apply to a person who is the holder of a licence under

section 14

of the

Misuse of Drugs Act 1977

(No. 12 of 1977) to supply a controlled drug, where the licence directs that such supply may be made.

Supply by instalments

10. (1) For the purposes of compliance with Regulation 19(1) of the Principal Regulations, where the supply of a specified 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 19(1) of the Principal Regulations, 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.

Preservation of records

11. Notwithstanding Regulation 22(2) of the Principal Regulations, 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.

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 opioid dependence, or

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

(2) When opioid substitution treatment is initiated in the hospital, the hospital shall notify the Executive of the name, address and date of birth of the person in respect of whom treatment is initiated.

(3) 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.

Exemption: medical consultants

13. (1) Regulations 3, 4, 5(2) and 6(2) shall not apply to a prescription for the treatment of a person for purposes other than for or in connection with opioid 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 medical practitioner in any hospital practice registered in the Specialist Division of the register of medical practitioners established and maintained by the Medical Council under

section 43

of the

Medical Practitioners Act 2007

, who by reason of his or her training, skill and experience in a particular specialty, is consulted by other registered medical practitioners and who has a continuing clinical and professional responsibility for patients under his or her care, or that aspect of their care on which he or she has been consulted.

Transitional provisions

14. (1) A reference in any other enactment to the Regulations of 1998 shall be construed as a reference to these Regulations.

(2) Notwithstanding Regulation 5(2), a registered medical practitioner may issue a prescription for a specified controlled drug to a person in respect of whom an opioid substitution treatment card has not been issued where—

(

a

) a drug treatment card in respect of that person was issued under Regulation 4(1) of the Regulations of 1998 for the use of such specified controlled drug, and

(

b

) the period specified on such card within which that card would remain valid has not expired.

(3) Notwithstanding Regulation 6(1), a person carrying on a retail pharmacy business may 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) where the prescription was issued by a registered medical practitioner in accordance with Regulation 5(1) of the Regulations of 1998.

(4) Notwithstanding the revocation of the Regulations of 1998, a person carrying on a retail pharmacy business may supply a specified controlled drug on a prescription issued by a registered medical practitioner in accordance with Regulation 5(1) of those Regulations where—

(

a

) the prescription was issued to a person in respect of whom a drug treatment card was issued under Regulation 4(1) of those Regulations for the use of such specified controlled drug, and

(

b

) the period specified on such card within which that card would remain valid has not expired.

(5) Notwithstanding the revocation of the Regulations of 1998, the Minister shall preserve any remaining records made in accordance with Regulation 8 of those Regulations for the period specified under paragraph (3) of that Regulation.

SCHEDULE

Regulation 2

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

28

th November

, 2017.

I, CATHERINE BYRNE, Minister of State at the Department of Health, in exercise of the powers conferred on me by section 5 (as amended by

section 15

of the

Misuse of Drugs Act 1984

(No. 18 of 1984) and

section 3

of the

Misuse of Drugs (Amendment) Act 2016

(No. 9 of 2016)) of the

Misuse of Drugs Act 1977

(No. 12 of 1977) and the Health (Delegation of Ministerial Functions) (No. 4) Order 2017 (

S.I. No. 339 of 2017

), hereby make the following regulations

Citation and commencement