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Approved by the Secretary

Page contents: Approvals under the Regulations | Approvals by the Secretary | Regulations 5 & 6 | Regulation 26 | Download documents | Further information

Approvals under the Drugs, Poisons and Controlled Substances Regulations 2006

This section has been prepared to assist those who are regulated by the Drugs, Poisons and Controlled Substances Act 1981 (the Act) and the Drugs, Poisons and Controlled Substances Regulations 2006 (the Regulations).

Approvals granted by the Secretary of the Department of Health

Some regulations allow for the Secretary to approve details that are not contained within the regulations. Approvals are as follows:

Notes:

Regulations 5 and 6

Regulation 5 authorises persons (other than those authorised by the Act) to be in possession of Schedule 4, Schedule 8 or Schedule 9 poisons.  In some cases, the extent of the authorisation is clear.  In others, the extent of the authorisation is set by the approval of the Secretary.

Pursuant to regulation 6, the Secretary has approved the following:

Schedule 4 poisons approved for use by any optometrist

The Secretary has given approval in general for an optometrist registered under the Health Practitioner Regulation National Law and carrying on the lawful practice of his or her profession to be in possession of, and administer, the following Schedule 4 poisons for use in the eyes of patients in the practice of his or her profession:

Note: Pursuant to section 13(1)(c) of the Drugs, Poisons and Controlled Substances Act 1981, the Minister for Health has approved a registered optometrist, whose registration is endorsed under section 94 of the Health Practitioner Regulation National Law (Victoria) Act 2009, to obtain and have in his or her possession and to use, sell or supply any Schedule 2, 3 or 4 poison that is in the form of a preparation for the topical use in the eye (Victoria Government Gazette G26 1 July 2010 p 1384).

Schedule 4 poisons approved for use by any podiatrist

The Secretary has given approval in general for a podiatrist registered under the Health Practitioner Regulation National Law and carrying on the lawful practice of his or her profession to be in possession of, and administer, the following Schedule 4 poisons in the practice of his or her profession for the treatment of conditions of the human foot:

Note: Pursuant to section 13(1)(ca) of the Drugs, Poisons and Controlled Substances Act 1981, the Minister for Health has approved a registered podiatrist, whose registration is endorsed under section 94 of the Health Practitioner Regulation National Law (Victoria) Act 2009, to obtain and have in his or her possession and to use, sell or supply any Schedule 2, 3 or 4 poison listed in the tables as published in the Victoria Government Gazette G26 1 July 2010 pp 1381-1383.

Schedule 4 poisons approved for use by an Australian Ski Patrol Association Inc. qualified ski patroller

The Secretary has given approval in general for an Australian Ski Patrol Association Inc. qualified ski patroller to be in possession of the following Schedule 4 Poisons and administer them to persons in the performance of his or her duties for the treatment of emergencies

Schedule 4 poisons approved for use by dental hygienists, dental therapists or oral health therapists (1 July 2010)

The Secretary has given approval in general for a dental hygienist, dental therapist or oral health therapist registered under Health Practitioner Regulation National Law to have in his or her possession the Schedule 4 poisons listed in Appendix 1 that are required for the provision of dental care by the registered dental hygienist, dental therapist or oral health therapist.

Appendix 1: dental hygienists, dental therapists or oral health therapists

Regulation 5(3)

The Secretary may approve the possession and administration of a Schedule 4, Schedule 8 or Schedule 9 poison by a nurse or class of nurses if the Secretary considers that the possession and administration —

Pursuant to regulation 5(3), the Secretary has approved the following:

A midwife

The Secretary has given approval in general for a midwife registered under Health Practitioner Regulation National Law employed at a hospital to possess and administer to a pregnant woman in labour, in an emergency if unable to contact a medical practitioner, a single dose of morphine or pethidine if such practice is in accordance with the written instructions of the medical practitioner under whose care the patient is, provided that the practice has been approved by the governing body of the hospital concerned or a committee to which the responsibility has been delegated by the governing body.

Tuberculosis control section

The Secretary has given approval in general for a nurse who is approved by the Assistant Director, Communicable Diseases Section, in vaccine and skin testing administration and technique and as having satisfactorily completed a course in the management of acute reactions associated with vaccination, may possess and administer the Schedule 4 poisons:

under the following circumstances:

Nurse Immunisers – Approval from 28 March 2012

Approval under regulation 5(3) Drugs, Poisons and Controlled Substances Regulations 2006

The approval applies to:

A nurse who is registered in Division 1 of the Nursing and Midwifery Board of Australia register who provides evidence to the employer of currency of competence and ongoing professional development in immunisation and who:

Or

Or

Note 1 - For the nurse immuniser programs recognised by the Chief Health Officer see Nurse Immuniser information

The nurse may possess and administer the following Schedule 4 poisons:

  1. vaccines listed in Appendix 1 and
  2. such other Schedule 4 poisons as are necessary for the treatment of anaphylactic reactions to the vaccines.

The following circumstances apply:

  1. the nurse is employed or contracted by:
    1. a medical practitioner
    2. municipal council which employs, contracts or ensures access to a medical practitioner or
    3. health services permit holder who employs, contracts or ensures access to a medical practitioner.
  2. The medical practitioner referred in paragraph (a) is available to provide advice to the nurse on the use of the Schedule 4 poisons when needed.
  3. The nurse possesses and administers only the Schedule 4 poisons obtained by the medical practitioner, municipal council or health services permit holder by whom he or she is employed or contracted.
  4. The nurse administers the Schedule 4 poisons in:
    1. the performance of his or her duties with the medical practitioner, municipal council or health services permit holder (as the case requires)
    2. accordance with the edition of the Australian Immunisation Handbook that is current at the time of the administration and
    3. accordance with any guidelines issued by Department of Health such as the 'Approved client groups for immunisation by nurse immunisers'.

Appendix 1: Vaccines

Diphtheria Measles Rubella
Haemophilus influenzae type b Meningococcus Streptococcus pneumoniae
Hepatitis A Mumps Tetanus
Hepatitis B Pertussis Varicella
Human papillomavirus Polio  
Influenza Rotavirus  

Victorian Institute of Forensic Medicine - Forensic Nurse Examiner (1 July 2010)

A nurse registered in Division 1 of the Nursing and Midwifery Board of Australia register may possess and administer a single oral dose of the Schedule 4 drug azithromycin under the following circumstances:

  1. the nurse is employed or contracted by Victorian Institute of Forensic Medicine (VIFM) to undertake forensic medical examinations
  2. a medical practitioner employed or contracted by VIFM is available to provide advice to the nurse on the use of the Schedule 4 drug and
  3. the nurse administers the Schedule 4 drug in:
    1. the performance of his or her duties as a forensic nurse examiner
    2. a designated Centre Against Sexual Assault (Note 2) Crisis Care Unit providing services to adults
    3. accordance with a treatment protocol approved by VIFM, and
    4. accordance with any guideline issued by the Department of Health or Department of Human Service.

Note 2
Designated Centres Against Sexual Assault are DHS funded services. See Victorian Centres Against Sexual Assault

Regulation 26

The Secretary has given approval in general for a person referred to in regulation 25 to issue computer-generated prescriptions under circumstances which satisfy the criteria set out below.

Criteria for computer-generated prescriptions
  1. The computer program will restrict access to the prescription-printing module to authorised persons.
  2. Prescriptions will be generated only by authorised persons.
  3. The prescription will be either printed with the prescriber's name, address and contact telephone number or with the address and contact telephone number of the practice.
  4. The prescription will be personalised to the prescriber by the addition at the time of printing of the name of the prescriber below the last prescribed item when the prescription is being generated.
  5. The prescriber will sign, in his or her own handwriting, the prescription form beneath and as near as practicable to the last item prescribed on the form.
  6. The prescription will not be pre-signed.
  7. The total number of items prescribed on the prescription will be either stated on the prescription or the area on the prescription below the prescriber's signature will be scored, hatched or otherwise marked in some way to prevent any other item being printed in that area.
  8. The particulars of any prescription issued will be included in the clinical or medication record of the person or animal for whom the prescription was generated.
  9. The clinical or medication record of the person or animal for whom the prescription was issued will be preserved for at least one year from the date on which the prescription was generated and will be capable of being accessed when required.
  10. Alterations will not be made to printed prescriptions. Where alteration is required a new printed prescription will be generated and the other prescription will be immediately destroyed.

    Drugs of dependence
    In addition, in the case of drugs of dependence (which includes all Schedule 8 poisons and some Schedule 4 poisons):

  11. In addition to the printed particulars on the prescription, the prescriber will in his/her own handwriting write all of the particulars required under the Regulations (other than the date and the patient's or animal owner's name and address), namely:
        • the name of the substance or the proprietary product containing it
        • the strength where more than one strength is available
        • the quantity being prescribed (in both words and figures)
        • adequate directions for use
        • the number of repeats authorised (in both words and figures).

The software program will automatically indicate that such handwriting is required.

Notes:

Last updated: 29 March 2012

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Approved by the Secretary

Further information

Submissions for approval by the Secretary for access to drugs are considered by the department's Health Professions Drug Access Committee. For information see Health Professions Drug Access Committee.

For further explanation or clarification of any aspect of the Regulations, phone 1300 364 545.