Medicines (Standing Order) Amendment Regulations 2011

2011/246

Coat of Arms of New Zealand

Medicines (Standing Order) Amendment Regulations 2011

Anand Satyanand, Governor-General

Order in Council

At Wellington this 11th day of July 2011

Present:
The Right Hon John Key presiding in Council

Pursuant to section 105 of the Medicines Act 1981, His 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, 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) Amendment Regulations 2011.

2  Commencement
  • These regulations come into force on 1 August 2011.

3  Principal regulations amended
4  Interpretation
  • (1) Regulation 3(1) is amended by inserting the following definition in its appropriate alphabetical order:

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

    (2) Regulation 3(1) is amended by revoking the definition of registration authority and substituting the following definition:

    registration authority means a body listed in the Schedule.

5  What standing order must contain
  • Regulation 5 is amended by revoking paragraph (j) and substituting the following paragraphs:

    • (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.

6  New regulation 6A inserted
  • The following regulation is inserted after regulation 6:

    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.

7  Obligations of issuer
  • Regulation 8 is revoked and the following regulation substituted:

    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, an employer of any practitioner or practitioner who is not an issuer, any person affected by the standing order, and, on request to the Director-General or any person authorised by the Director-General, any member of the public; and

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

8  New regulation 12 added
  • The following regulation is added:

    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.

9  New Schedule substituted
  • Schedule 1 is revoked and the Schedule set out in the Schedule of these regulations substituted.


Schedule
New Schedule substituted

r 9

Schedule
Registration authorities

r 3(1)

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)

Rebecca Kitteridge,
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 come into force on 1 August 2011.

These regulations amend the Medicines (Standing Order) Regulations 2002, which set minimum requirements for the content, development, and use of standing orders. The amendments—

  • require a standing order to specify whether countersigning of a charted treatment is required and, if so, the requirements for countersigning; and

  • provide that, if countersigning is not required, or is required less frequently than once each month, the issuer must carry out a monthly audit of a sample of charted treatments; and

  • substitute a new Schedule with an updated list of registration authorities, appointed by or under the Health Practitioners Competence Assurance Act 2003.


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

Date of notification in Gazette: 14 July 2011.

These regulations are administered by the Ministry of Health.