Medicines Amendment Regulations 2001

2001/232

Medicines Amendment Regulations 2001


Note

These regulations are administered in the Ministry of Health.


Pursuant to section 105 of the Medicines Act 1981, Her Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations or bodies appearing to the Minister to be representative of persons likely to be substantially affected, and acting on the advice and with the consent of the Executive Council, makes the following regulations.

1 Title
  • (1) These regulations are the Medicines Amendment Regulations 2001.

    (2) In these regulations, the Medicines Regulations 19841 are called the principal regulations.

2 Commencement
  • These regulations come into force on 11 October 2001.

3 Interpretation
  • Regulation 2(1) of the principal regulations is amended by inserting, after the definition of described, the following definition:

    designated prescriber nurse means a nurse authorised to prescribe a prescription medicine by regulations made under the Act.

4 Classification of medicines
  • Regulation 3 of the principal regulations is amended by inserting, after subclause (1), the following subclauses:

    • (1A) All medicines and classes of medicines specified in Part 1A of the First Schedule are specified prescription medicines (as defined in regulation 4 of the Medicines (Designated Prescriber: Nurses Practising in Aged Care and Child Family Health) Regulations 2001), in relation to nurses practising in aged care.

    • (1B) All medicines and classes of medicines specified in Part 1B of the First Schedule are specified prescription medicines (as defined in regulation 4 of the Medicines (Designated Prescriber: Nurses Practising in Aged Care and Child Family Health) Regulations 2001), in relation to nurses practising in child family health.

5 Advertisements to medical professions
  • Regulation 11(2)(a)(ii) of the principal regulations is amended by omitting the expression Drug Tariff 1981*, and substituting the expression pharmaceutical schedule (within the meaning of section 6(1) of the New Zealand Public Health and Disability Act 2000).

6 Consumer information panel
  • Regulation 20(1) of the principal regulations is amended by omitting the words practitioner's prescription, and substituting the words prescription from a practitioner, registered midwife, or designated prescriber nurse.

7 Labels on containers of medicines sold by practitioners, pharmacists, or registered midwives
  • (1) Regulation 23 of the principal regulations is amended by omitting the heading, and substituting the heading Labels on containers of medicines sold by practitioners, registered midwives, designated prescriber nurses, or pharmacists.

    (2) Regulation 23 of the principal regulations is further amended by inserting, after the expression midwife,, the expression a designated prescriber nurse,.

8 Containers for medicines, related products, and cosmetics
  • Regulation 35(8)(b) of the principal regulations is amended by omitting the words or veterinary surgeons, and substituting the words veterinary surgeons, registered midwives, or designated prescriber nurses.

9 Safety containers
  • Regulation 37(2)(a) of the principal regulations is amended—

    • (a) by inserting, after the word practitioner, the expression , registered midwife, or designated prescriber nurse; and

    • (b) by inserting in subparagraph (ii), after the word he, the words or she.

10 Conditions under which practitioners, veterinary surgeons, and registered midwives may prescribe
  • (1) Regulation 39 of the principal regulations is amended by omitting the heading, and substituting the heading Conditions under which practitioners, veterinary surgeons, registered midwives, and designated prescriber nurses may prescribe prescription medicines.

    (2) Regulation 39 of the principal regulations is further amended by adding the following subclause:

    • (7) No designated prescriber nurse may—

      • (a) prescribe any prescription medicine if the nurse is for the time being prohibited by a notice under section 48(1) of the Act from prescribing that prescription medicine or any prescription medicines of a class or description that includes that prescription medicine:

      • (b) prescribe any prescription medicine otherwise than for the treatment of a patient who is under the nurse's care:

      • (c) prescribe for a patient any quantity of any prescription medicine that exceeds,—

        • (i) in the case of an oral contraceptive, 6 months' supply; or

        • (ii) in any other case, 3 months' supply.

11 New regulations 40 and 40A substituted
  • The principal regulations are amended by revoking regulation 40, and substituting the following regulations:

    40 Prescriptions to comply with regulations
    • (1) Except as provided in regulation 40A, every practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse who issues a prescription to a person must comply with regulation 41.

      (2) Subclause (1) applies to a prescription for any medicine (whether a prescription medicine or not).

      (3) Subclause (2) does not prevent the sale by retail, or the supply in circumstances corresponding to retail sale, or the dispensing, of a medicine (other than a prescription medicine) without a prescription.

    40A Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing
    • (1) Where a practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse finds it necessary to do so, he or she may communicate orally to a pharmacist to whom he or she is known personally (whether in the pharmacist's presence or by speaking to the pharmacist on the telephone) a prescription relating to a prescription medicine that the practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse requires urgently.

      (2) Within 7 days after a communication made by a practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse to a pharmacist under subclause (1), the practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse must forward to the pharmacist a written prescription confirming the oral communication.

12 Dispensing of prescription medicines
  • (1) Regulation 42 of the principal regulations is amended by revoking subclause (1), and substituting the following subclause:

    • (1) Except as provided in subclause (2), no person other than a practitioner, veterinary surgeon, registered midwife, designated prescriber nurse, pharmacist, pharmacy graduate, or dispensary technician may dispense a prescription medicine.

    (2) Regulation 42(3) of the principal regulations is amended by revoking paragraph (f), and substituting the following paragraph:

    • (f) if the prescription has been communicated orally pursuant to regulation 40A(1), the prescription must not be dispensed on more than 1 occasion before the pharmacist has received the written confirmation of the prescription, as required by regulation 40A(2):.

    (3) Regulation 42(3) of the principal regulations is further amended—

    • (a) by omitting the expression 40(2) of these regulations where it appears in paragraphs (g), (j), and (k), and substituting in each case the expression 40A; and

    • (b) by revoking subparagraph (i) of paragraph (l).

    (4) Regulation 42(4) of the principal regulations is amended by omitting the words or registered midwife or veterinary surgeon in both places where they appear, and substituting in each case the expression , veterinary surgeon, registered midwife, or designated prescriber nurse.

13 Prescriptions not required in certain cases
  • (1) The heading to regulation 44 of the principal regulations is amended by inserting, after the word Prescriptions, the words for prescription medicines.

    (2) Regulation 44(d) of the principal regulations is amended by omitting the expression Drug Tariff 1981*, and substituting the expression pharmaceutical schedule (within the meaning of section 6(1) of that Act).

    (3) Regulation 44 of the principal regulations is amended by inserting, after paragraph (fa), the following paragraph:

    • (fb) a designated prescriber nurse; or.

    (4) Regulation 44(g) of the principal regulations is amended by inserting, after the word his, the words or her.

    (5) Regulation 44 of the principal regulations is further amended by inserting, after paragraph (ga), the following paragraph:

    • (gb) a patient under his or her care by a designated prescriber nurse; or.

    (6) Regulation 44 of the principal regulations is further amended by inserting, after paragraph (ha), the following paragraph:

    • (hb) a patient under the care of a designated prescriber nurse for administration to that patient pursuant to the instructions of the designated prescriber nurse; or.

    (7) Regulation 44(m) of the principal regulations is amended by omitting the words or registered midwife, and substituting the expression , registered midwife, or designated prescriber nurse.

14 Administration of vaccines in approved immunisation programmes
  • Regulation 44A(2)(a) of the principal regulations is amended by omitting the word anaphlaxis, and substituting the word anaphylaxis.

15 Duty to supply information
  • (1) Regulation 44B(1) of the principal regulations is amended—

    • (a) by omitting the words or registered midwife, and substituting the expression , registered midwife, or designated prescriber nurse; and

    • (b) by omitting the words or midwife, and substituting the expression , registered midwife, or designated prescriber nurse.

    (2) Regulation 44B(4) of the principal regulations is amended by omitting the words or registered midwife, and substituting the expression , registered midwife, or designated prescriber nurse.

16 Offences
  • Regulation 64(1)(a) of the principal regulations is amended by omitting the expression 40(3), and substituting the expression 40A(2).

17 Schedule 1 amended
  • [Revoked]

    Regulation 17 was revoked, as from 30 June 2002, by regulation 3(2)(b) Medicines Amendment Regulations 2002 (SR 2002/134).


Schedule
New Parts 1A and 1B inserted in Schedule 1 of principal regulations

r 17

[Revoked]

  • This Schedule was revoked, as from 30 June 2002, by regulation 3(2)(b) Medicines Amendment Regulations 2002 (SR 2002/134).

Marie Shroff,

Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations, which come into force on 11 October 2001, amend the Medicines Regulations 1984. Most of the amendments are consequential upon the making of the Medicines (Designated Prescriber: Nurses Practising in Aged Care and Child Family Health) Regulations 2001, and regulate the issue by designated prescriber nurses of prescriptions for medicines. The amendments also include the insertion, in Schedule 1 of the Regulations, of new Parts 1A and 1B, which list prescription medicines that nurses practising in particular areas of nursing practice may be authorised to prescribe. The rest of the amendments are to correct minor technical defects and drafting errors.


Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notification in Gazette: 13 September 2001.


  • 1 SR 1984/143