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 and bodies appearing to the Minister to be representative of persons likely to be substantially affected by them, and acting on the advice and with the consent of the Executive Council, makes the following regulations.

Regulations

1 Title

These regulations are the Medicines (Standing Order) Regulations 2002.

2 Commencement

These regulations come into force on the 28th day after the date of their notification in the Gazette.

3 Interpretation

(1)

In these regulations,—

Act means the Medicines Act 1981

charted treatment means a written clinical record of a patient’s illness or condition, including the medicine administered or supplied to the patient

controlled drug has the same meaning as in section 2(1) of the Misuse of Drugs Act 1975

countersigning means the issuer signing the charted treatment of a patient to whom medicine has been administered or supplied under a standing order

health provider means a person or organisation who provides, or who arranges the provision of, health or disability services

issuer means—

(a)

an individual practitioner in practice; or

(b)

a practitioner who is an employer of a practitioner or a person permitted to supply or administer a medicine under a standing order; or

(c)

a practitioner who exercises managerial control over a practitioner or a person permitted to supply or administer a medicine under a standing order; or

(d)

a practitioner who is authorised by a group of practitioners or a group of people permitted to supply or administer a medicine under a standing order on their behalf; or

(e)

a nurse practitioner (whether an individual in practice or otherwise); or

(f)

an optometrist (whether an individual in practice or otherwise)

medicine means a prescription medicine or a specified controlled drug

registration authority means a body listed in the Schedule

specified controlled drug means a controlled drug listed in Parts 1 and 3 of Schedule 2 and Parts 2 to 7 of Schedule 3 of the Misuse of Drugs Act 1975.

(2)

Words and expressions defined in the Act and used, but not defined, in these regulations have the same meaning as in the Act.

(3)

The following term is defined in the Act, and its definition is repeated below for ease of reference:

practitioner means a medical practitioner or a dentist.

Regulation 3(1) countersigning: inserted, on 1 August 2011, by regulation 4(1) of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

Regulation 3(1) issuer paragraph (d): amended, on 17 August 2016, by regulation 4(1) of the Medicines (Standing Order) Amendment Regulations 2016 (LI 2016/161).

Regulation 3(1) issuer paragraph (e): inserted, on 17 August 2016, by regulation 4(2) of the Medicines (Standing Order) Amendment Regulations 2016 (LI 2016/161).

Regulation 3(1) issuer paragraph (f): inserted, on 17 August 2016, by regulation 4(2) of the Medicines (Standing Order) Amendment Regulations 2016 (LI 2016/161).

Regulation 3(1) registration authority: substituted, on 1 August 2011, by regulation 4(2) of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

4 Persons permitted to supply and administer medicine under standing order

(1)

An issuer must determine the class of persons permitted to supply or administer a medicine under a standing order and identify that class of persons and the medicine in the standing order.

(2)

A class of persons referred to in subclause (1) must be limited to persons engaged in the delivery of a health service.

5 What standing order must contain

A standing order must—

(a)

be in writing, name the issuer, and be signed and dated by the issuer; and

(b)

explain why the standing order is necessary; and

(c)

describe the class of persons permitted to supply or administer a medicine under the standing order; and

(d)

specify—

(i)

the level of competency required of the class of persons permitted to supply or administer a medicine under a standing order, including any training to be undertaken, in the following circumstances:

(A)

if there is no registration authority for that class of persons; or

(B)

the registration authority for that class of persons has not set any level of competency; or

(ii)

any additional competencies required of the class of persons permitted to supply or administer a medicine under a standing order, including any training to be undertaken, if the registration authority for that class of persons has set levels of competency; and

(e)

identify the class of persons to whom a medicine may be supplied and administered under the standing order; and

(f)

specify either the period for which the standing order applies or, if no period is specified, state that the standing order is to apply until it is replaced by a new standing order covering the same subject matter or until it is cancelled in writing by the issuer; and

(g)

specify the particular circumstances in which the standing order applies; and

(h)

specify the treatments to which the standing order applies; and

(i)

list the medicines that may be supplied or administered under the standing order, the indications for which the medicine is to be administered and the recommended dose or dose range for those indications, the contraindications for the medicine, the validated reference charts for calculation of dose (if required), the method of administration, and the documentation required; and

(j)

specify whether countersigning is required; and

(ja)

if countersigning is required, specify—

(i)

the period within which the issuer must countersign the charted treatment; and

(ii)

any other requirements for countersigning that the issuer considers appropriate; and

(k)

if a policy relating to the standing order exists, attach a copy of that policy, which must have been signed by the issuer, the management of every health provider in which the standing order operates, and every person supplying or administering under the standing order, as applicable; and

(l)

describe the scope of the standing order; and

(m)

define the terms used in the standing order.

Regulation 5(j): substituted, on 1 August 2011, by regulation 5 of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

Regulation 5(ja): inserted, on 1 August 2011, by regulation 5 of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

6 Annual review of competency

If a standing order is required to specify the level of competency or additional competencies of a person permitted to supply and administer a medicine under that standing order then the competency or additional competencies of that person must be reviewed by the issuer at least once a year, commencing from the date on which the standing order was signed by the issuer.

6A Periodic audit of charted treatments in certain cases

If a standing order does not require the countersigning of charted treatments, or requires countersigning less frequently than once each month, the issuer must, at least once each month, audit a sample of the charted treatments of patients to whom medicines have been administered or supplied under the standing order.

Regulation 6A: inserted, on 1 August 2011, by regulation 6 of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

7 Annual review of standing orders

(1)

A standing order may be reviewed at any time but must be reviewed by the issuer at least once a year.

(2)

When carrying out a review, the issuer must consider whether the standing order continues to be necessary and whether its terms are appropriate.

(3)

Any material variations, deletions, or additions required to be made to a standing order as a result of a review must be dated and signed by the issuer.

8 Functions of issuer

The issuer has the following functions:

(a)

to ensure that—

(i)

the standing order clearly sets out the expectations of the parties; and

(ii)

the provisions of regulations 5 to 7 are complied with; and

(iii)

if countersigning is required, he or she countersigns the charted treatment within the period specified in the standing order, and in accordance with any other requirements for countersigning specified in the standing order; and

(iv)

in addition to the audit required by regulation 6A and the review required by regulation 7, there is a process in place for monitoring and reviewing the correct operation of the standing order and, in particular, any adverse incidents that occur; and

(v)

the standing order is made available to every person permitted to supply or administer a medicine under the standing order, any person affected by the standing order, and, on request to the issuer, any other person; and

(b)

to impose any requirements for countersigning in the standing order that he or she considers appropriate.

Regulation 8: substituted, on 1 August 2011, by regulation 7 of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

Regulation 8(a)(v): replaced, on 17 August 2016, by regulation 5 of the Medicines (Standing Order) Amendment Regulations 2016 (LI 2016/161).

9 Obligations of person supplying or administering medicine under standing order

A person who administers or supplies a medicine under a standing order must ensure that—

(a)

the medicine is supplied or administered in accordance with the standing order; and

(b)

he or she records or charts the assessment and treatment of the patient (including any adverse reactions) and any monitoring or follow-up of the patient’s treatment, if necessary.

10 Offences

(1)

Every person specified in subclause (2) commits an offence who fails, without reasonable excuse, to comply with a requirement imposed on him or her under any of these regulations.

(2)

The persons referred to in subclause (1) are—

(a)

an issuer:

(b)

a health provider:

(c)

a practitioner who is an employer of a person who is permitted to supply or administer a medicine under a standing order.

(3)

Every person who commits an offence against these regulations is liable on conviction to a fine not exceeding $500.

Regulation 10(3): amended, on 1 July 2013, by section 413 of the Criminal Procedure Act 2011 (2011 No 81).

11 Audit

The Director-General may, from time to time, audit any standing order.

12 Transitional provision for standing orders issued before 1 August 2011

Regulations 5 and 8 as they were in force immediately before 1 August 2011 continue to apply to standing orders issued before that date as if the Medicines (Standing Order) Amendment Regulations 2011 had not been made.

Regulation 12: added, on 1 August 2011, by regulation 8 of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

Schedule Registration authorities

r 3(1)

Schedule 1: substituted, on 1 August 2011, by regulation 9 of the Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246).

Chiropractic Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Dental Council (established by section 114(2) of the Health Practitioners Competence Assurance Act 2003)

Dietitians Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Medical Council of New Zealand (being the Council continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Medical Sciences Council of New Zealand (formerly known as the Medical Laboratory Science Board, which was the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Medical Radiation Technologists Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Midwifery Council (established by section 114(3) of the Health Practitioners Competence Assurance Act 2003)

Nursing Council of New Zealand (being the Council continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Occupational Therapy Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Optometrists and Dispensing Opticians Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Osteopathic Council (established by section 114(4) of the Health Practitioners Competence Assurance Act 2003)

Pharmacy Council (established by section 114(5) of the Health Practitioners Competence Assurance Act 2003)

Physiotherapy Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Podiatrists Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Psychologists Board (being the Board continued by section 114(1) of the Health Practitioners Competence Assurance Act 2003)

Psychotherapists Board (established by the Health Practitioners Competence Assurance (Designation of Psychotherapy Services as Health Profession) Order 2007)

Marie Shroff,
Clerk of the Executive Council.

Issued under the authority of the Legislation Act 2012.

Date of notification in Gazette: 21 November 2002.

Reprints notes

1 General

This is a reprint of the Medicines (Standing Order) Regulations 2002 that incorporates all the amendments to those regulations as at the date of the last amendment to them.

2 Legal status

Reprints are presumed to correctly state, as at the date of the reprint, the law enacted by the principal enactment and by any amendments to that enactment. Section 18 of the Legislation Act 2012 provides that this reprint, published in electronic form, has the status of an official version under section 17 of that Act. A printed version of the reprint produced directly from this official electronic version also has official status.

3 Editorial and format changes

Editorial and format changes to reprints are made using the powers under sections 24 to 26 of the Legislation Act 2012. See also http://www.pco.parliament.govt.nz/editorial-conventions/.

4 Amendments incorporated in this reprint

Medicines (Standing Order) Amendment Regulations 2016 (LI 2016/161)

Criminal Procedure Act 2011 (2011 No 81): section 413

Medicines (Standing Order) Amendment Regulations 2011 (SR 2011/246)

Medicines (Standing Order) Regulations 2002