Medicines (Designated Prescriber: Nurse Practitioners) Regulations 2005 (SR 2005/266) Pursuant to sections 105 and 105B of the Medicines Act 1981, Her Excellency the GovernorGeneral, acting on the advice of the Min ister 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. Contents Page 1 Title 2 2 Commencement 2 3 Purpose of these regulations 2 4 Interpretation 2 5 Authority to prescribe nurse practitioner medicines 3 6 Requirements for commencing for first time to prescribe 3 7 Other training to be undertaken 3 8 Assessments of competence to be completed 4 9 Gazette notices 4 10 Prohibition on prescribing without meeting requirement 4 11 Conditions under which authorised prescribers and veterinary surgeons may prescribe prescription medicines 5 12 Consequential amendment and revocations 5 13 Saving for existing designated prescriber nurses 5 Schedule 6 Substances that are nurse practitioner medicines if they are prescription medicines Note These regulations are administered in the Ministry of Health. 1
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Pursuant to sections 105 and 105B of the Medicines Act 1981, HerExcellency the GovernorGeneral, acting on the advice of the Minister of Health tendered after consultation with the organisations orbodies appearing to theMinister to be representative of persons likelyto be substantially affected, and acting on the advice and with theconsent of the Executive Council, makes the following regulations.
ContentsPage
1 Title 22 Commencement 23 Purpose of these regulations 24 Interpretation 25 Authority to prescribe nurse practitioner medicines 36 Requirements for commencing for first time to prescribe 37 Other training to be undertaken 38 Assessments of competence to be completed 49 Gazette notices 410 Prohibition on prescribing without meeting requirement 411 Conditions under which authorised prescribers and
veterinary surgeons may prescribe prescription medicines5
12 Consequential amendment and revocations 513 Saving for existing designated prescriber nurses 5
Schedule 6Substances that are nurse practitioner medicines if
they are prescription medicines
NoteThese regulations are administered in the Ministry of Health.
1 TitleThese regulations are the Medicines (Designated Prescriber:Nurse Practitioners) Regulations 2005.
2 CommencementThese regulations come into force on 1 November 2005.
3 Purpose of these regulationsThe purpose of these regulations is to—(a) authorise nurse practitioners who meet specified re
quirements for competency, qualifications, and trainingto prescribe certain prescription medicines; and
(b) specify, and provide for the specification of, the requirements; and
(c) prohibit nurse practitioners who fail to comply with therequirements from prescribing the medicines; and
(d) make contraventions of that prohibition an offence.
4 InterpretationIn these regulations, unless the context otherwise requires,—Act means the Medicines Act 1981nurse practitioner means, in so far as he or she is practisingthe profession of nursing, a health practitioner who—(a) is, or is deemed to be, registered with the Nursing
Council as a practitioner of the profession of nursing(whether or not he or she is, or is deemed to be, registered with another authority established or continuedby the Health Practitioners Competence Assurance Act2003 as a practitioner of, and is practising, anotherhealth profession); and
(b) is permitted to practise within the scope of practice fora nurse practitioner
nurse practitioner medicine—(a) means a substance listed in the Schedule and that is
declared to be a prescription medicine by regulationsunder the Act or by a notice given under section 106 ofthe Act; but
Medicines (Designated Prescriber: NursePractitioners) Regulations 2005 r 7
(b) if the substance is declared to be a prescriptionmedicineonly in 1 or more specified forms or only for 1 or morespecified purposes, does not include the substance inother forms or for other purposes
Nursing Councilmeans the Nursing Council of New Zealandcontinued by section 114(1)(a) of the Health PractitionersCompetence Assurance Act 2003.
5 Authority to prescribe nurse practitioner medicinesA nurse practitioner may prescribe a nurse practitionermedicine if he or she meets—(a) the requirements in regulation 6 for commencing for the
first time to prescribe the medicine; and(b) the additional requirements in regulations 7 and 8 (if
relevant) for prescribing the medicine.
6 Requirements for commencing for first time to prescribeBefore commencing for the first time to prescribe a nurse practitioner medicine, a nurse practitioner must have—(a) obtained a nurse practitioner prescribing qualification
that is specified for the purposes of this paragraph bythe Nursing Council by notice in the Gazette ; and
(b) undertaken the training (if any) that is specified for thepurposes of this paragraph by the Nursing Council bynotice in the Gazette ; and
(c) demonstrated, to the satisfaction of the Nursing Council, that he or she is sufficiently knowledgeable to safelyprescribe all nurse practitioner medicines.
7 Other training to be undertakenTo prescribe a nurse practitioner medicine, a nurse practitionermust have—(a) undertaken successfully the training (if any) that is spe
cified for the purposes of this regulation by the NursingCouncil by notice in the Gazette ; and
(b) done so within the periods, or at the times, specified forthe purpose in the notice, if the training is of an ongoingnature.
8 Assessments of competence to be completedTo prescribe a nurse practitioner medicine, a nurse practitionermust have—(a) completed successfully the assessment (if any) of com
petence to prescribe the medicine that is specified forthe purposes of this regulation by the Nursing Councilby notice in the Gazette ; and
(b) done so within the periods, or at the times, specifiedfor the purpose in the notice, if the assessment is to becompleted at regular intervals.
9 Gazette notices(1) For the purposes of these regulations, a notice in theGazette—
(a) comes into force on the 28th day after the date of publication or on a later date specified for the purpose in thenotice; and
(b) may provide that it expires, if not sooner revoked, withthe close of a specified day.
(2) Within 5 working days after the date of publication of a noticein the Gazette for the purposes of these regulations, and whilethe notice remains in force, the Nursing Council must ensurethat an uptodate version of the notice is—(a) available on the Internet; and(b) available at the office of the Nursing Council during
business hours, so that members of the public may—(i) inspect the notice free of charge; or(ii) obtain a photocopy of the notice for a reasonable
fee.
10 Prohibition on prescribing without meeting requirement(1) A nurse practitioner must not prescribe a nurse practitioner
medicine if he or she fails to comply with a requirement inregulation 6, 7, or 8 relating to the medicine.
(2) A person commits an offence if he or she contravenes or failsto comply with subclause (1).
(3) The offence is punishable on summary conviction by a fine notexceeding $500.
4
Reprinted as at4 September 2007
Medicines (Designated Prescriber: NursePractitioners) Regulations 2005 r 13
11 Conditions under which authorised prescribers andveterinary surgeons may prescribe prescription medicinesRegulation 39(7) of the Medicines Regulations 1984 isamended by inserting, after paragraph (a), the followingparagraph:
“(ab) prescribe any prescription medicine otherwise than for usewithin, and in accordance with all conditions (if any) statedin, his or her scope of practice, as determined by an authorisation granted under section 21 of the Health Practitioners Competence Assurance Act 2003 by the Nursing Council of NewZealand:”.
12 Consequential amendment and revocations(1) The Medicines (Designated Prescriber: Nurses Practising in
Aged Care and Child Family Health) Regulations 2001 (SR2001/230) are consequentially revoked.
(2) The Medicines Regulations 1984 are consequentiallyamended by—(a) revoking regulation 3(1A) and (1B) and Parts 1A and
1B of Schedule 1; and(b) inserting in regulation 64(1)(a), after the expression
“39(5),”, the expression “39(7),” ; and(c) inserting in Schedule 1, after the Part 1 heading, the
following note: “Amending or replacing this Part mayaffect designated prescriber regulations under section105(1)(q) of the Act.”
13 Saving for existing designated prescriber nurses(1) An existing designated prescriber nurse must, during the 3
years beginning with 1 November 2005, and despite the revocations effected by regulation 12, be treated as authorised bythe former regulations to prescribe a specified prescriptionmedicine if the nurse meets the requirements in the formerregulations, and those imposed by the Nursing Council underthose regulations before their revocation,—(a) for commencing for the first time to prescribe the
medicine; and(b) (if relevant) for prescribing the medicine.
existing designated prescriber nurse means a person who,immediately before 1 November 2005, was authorised bythe former regulations to prescribe a specified prescriptionmedicineformer regulationsmeans the regulations revoked by regulation 12(1)specified prescription medicine means a prescriptionmedicine specified in Part 1A or Part 1B of Schedule 1 of theMedicines Regulations 1984 (as those Parts existed immediately before 1 November 2005).
(3) Nothing in this regulation prevents an existing designated prescriber nurse from becoming, during the period specified insubclause (1), a nurse practitioner authorised by these regulations to prescribe a nurse practitioner medicine.
Schedule r 4
Substances that are nurse practitionermedicines if they are prescription
medicinesSubstances listed in this schedule are nurse practitioner medicinesonly if, and only in the forms and for the purposes that, they aredeclared to be prescription medicines by—
These regulations come into force on 1 November 2005.They authorise nurse practitioners registered with the Nursing Council of New Zealand to prescribe certain prescription medicines if thenurse practitioners meet certain requirements relating to competence,qualifications, and training. The details ofmost of those requirementswill be specified by the Council by notice in the Gazette.Nurse practitioners who do not meet those requirements—•• must not prescribe prescription medicines; and•• commit an offence if they do.These regulations also—•• amend the Medicines Regulations 1984 so that they prohibit
prescribing of prescription medicines by authorised nursepractitioners for use outside, or contrary to a condition statedin, their personal scopes of practice determined by the Councilunder the Health Practitioners Competence Assurance Act2003; and
•• revoke and replace the Medicines (Designated Prescriber:Nurses Practising in Aged Care and Child Family Health)Regulations 2001; and
•• make consequential amendments to the MedicinesRegulations 1984; and
•• continue, for a 3year transitional period, and if those nursesmeet specified requirements, existing designated prescribernurses’ authority under the revoked regulations to prescribespecified prescription medicines.
Designated prescriber nurses are also authorised, in certain circumstances, to prescribe certain controlled drugs: see section 8(2A)(a) ofthe Misuse of Drugs Act 1975 and regulations 12A and 21(4B) of theMisuse of Drugs Regulations 1977. (Those regulations also regulatethe issue by those nurses of prescriptions for the supply of controlleddrugs.)
Issued under the authority of the Acts and Regulations Publication Act 1989.Date of notification in Gazette: 15 September 2005.