Key messages

  • Some regulations allow for the department Secretary to approve details that are not included in the Drugs, Poisons and Controlled Substances Regulations 2017.
  • The Secretary approvals under the Drugs, Poisons and Controlled Substance Regulations 2006 continue under transitional provisions in the Drugs, Poisons and Controlled Substances Regulations 2017.
  • The Secretary approvals are in place to ensure that health practitioners and others can possess and use certain medicines and poisons.

Registered health practitioners are regulated by the Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 2017.

Some regulations allow for the department Secretary to approve details that are not included in the Regulations.

Note: Details of matters that are ‘approved by the Secretary' may change from time to time, so be sure to refer to the current version. 


Regulation 7 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 160, the Secretary has approved the following:

Schedule 4 poisons approved for use by any optometrist (1 July 2010)

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

  • Anaesthetics Local – being synthetic cocaine substitutes – when prepared and packed in the form of eye drops containing 0.5 per cent or less of such anaesthetics local
  • Tropicamide when prepared and packed in the form of eye drops containing 1 per cent or less of tropicamide
  • Cyclopentolate hydrochloride when prepared and packed in the form of eye drops containing 1 per cent or less of cyclopentolate hydrochloride
  • Pilocarpine nitrate when prepared and packed in the form of eye drops containing 2 per cent or less of pilocarpine nitrate and
  • Physostigmine salicylate when prepared and packed in the form of eye drops containing 0.5 per cent or less of physostigmine salicylate.

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 (1 July 2010)

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

  • Anaesthetics Local – the following only – lignocaine hydrochloride in preparations containing 2 per cent or less of lignocaine hydrochloride
  • Prilocaine hydrochloride in preparations containing 2 per cent or less of prilocaine hydrochloride.

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 (30 July 2010)

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:

  • Methoxyflurane
  • Nitrous oxide.

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

  • Adrenaline
  • Articaine
  • Demeclocycline and triamcinolone in combination for topical endodontic use
  • Felypressin
  • Lignocaine
  • Mepivacaine
  • Mercury (metallic) for human therapeutic use
  • Prilocaine.

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 —

  • is necessary for the provision of health services and
  • is within the competence of a nurse to do so without the direct supervision of a medical practitioner, dentist, nurse practitioner or authorised optometrist (as the case requires).

Pursuant to regulation 162, the Secretary has approved the following:

Approval for a midwife (1 July 2010)

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.

Schedule 4 poisons approved for use in the Victorian Tuberculosis Program (16 June 2014)

A nurse who is registered in Division 1 of the Nursing and Midwifery Board of Australia register and who is approved by the medical director of the Victorian Tuberculosis Program at Melbourne Health in vaccine and skin testing administration and technique and as having satisfactorily completed a course in the management of acute reactions associated with vaccination.

The nurse may possess and administer the Schedule 4 poisons:

  • Bacillus Calmette-Guerin (BCG) vaccine for administration as recommended in the Australian Immunisation Handbook published by the Commonwealth Department of Health.
  • Purified Protein Derivative (PPD) Human, for Tuberculin Skin Testing.
  • Adrenaline for the treatment of anaphylactic reactions to the BCG vaccine and PPD.

The following circumstances apply:

  • the nurse is employed by Melbourne Health to work in the Victorian Tuberculosis Program.
  • the Victorian Tuberculosis Program medical director or designated Melbourne Health medical officer is available to provide advice to the nurse on the use of the Schedule 4 poisons, and
  • the nurse administers the Schedule 4 poisons in:
    • the performance of his or her duties with the Victorian Tuberculosis Program at Melbourne Health,
    • accordance with the edition of the Australian Immunisation Handbook that is current at the time of the administration, and
    • accordance with any guidelines issued by the Department of Health or the medical director of the Victorian Tuberculosis Program at Melbourne Health.

This approval supersedes any previous approval for Tuberculosis program nurses.

Schedule 4 poisons approved for use by nurse immunisers (28 March 2012)

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:

  • On 30 June 2010 was registered in division 1 of the register of nurses endorsed under section 27A of the Health Professions Registration Act 2005 by the Nurses Board of Victoria in the approved area of practice – Immunisation
Or
  • Has satisfactorily completed the assessment of a nurse immuniser program recognised by the Chief Health Officer (see Note 1)
Or
  • Has satisfactorily completed a nurse immuniser program not recognised by the Chief Health Officer and has written confirmation from the program provider that at the time the program was completed, it was of equivalent standard to a program currently recognised by the Chief Health Officer.

Note - 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:

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

The following circumstances apply:

  • the nurse is employed or contracted by:
    • a medical practitioner
    • municipal council which employs, contracts or ensures access to a medical practitioner or
    • health services permit holder who employs, contracts or ensures access to a medical practitioner.
  • 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.
  • 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.
  • The nurse administers the Schedule 4 poisons in:
    • the performance of his or her duties with the medical practitioner, municipal council or health services permit holder (as the case requires)
    • accordance with the edition of the Australian Immunisation Handbook that is current at the time of the administration and
    • 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

Schedule 4 poison approved for use in forensic nurse examinations (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:

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

Note

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

Schedule 4 poisons approved for use by nurses and midwives for cardiac arrest (13 July 2015) 

A nurse(1) or midwife(2) who is registered by the Nursing and Midwifery Board of Australia and is employed (engaged or contracted) at a health service organisation(3) in Victoria.

The approval allows the nurse or midwife to possess and administer the following Schedule 4 poisons:

  • adrenaline
  • amiodarone

The approval is granted under the following circumstances:

The nurse or midwife is providing Advanced Life Support(4) in the event of cardiac arrest.

The nurse or midwife has satisfactorily completed a course that conforms to the Australian Resuscitation Council Guidelines(5) and is either:

  • delivered by the Australian Resuscitation Council(6);
  • credentialed by a relevant professional group or college and delivered by a registered training organisation;
  • delivered by a higher education provider as part of a postgraduate qualification; or
  • delivered by health service staff who have Basic Life Support, Advanced Life Support and adult learning qualifications.

The nurse or midwife administers the Schedule 4 poisons in accordance with the current Australian Resuscitation Council Guidelines for cardiac arrest, in particular, the ARC Basic Life Support, ARC Adult Cardiorespiratory Arrest and ARC Paediatric Cardiorespiratory Arrest flow charts.

The nurse or midwife administers the Schedule 4 poisons in the course of his/her employment (engaged or contracted) at a Victorian health service organisation.

The nurse or midwife possesses and administers only those Schedule 4 poisons obtained from the Victorian health service organisation at which he/she is employed (including being engaged or contracted).

The nurse or midwife has been assessed, through annual refresher training, to be competent to administer the Schedule 4 poisons for the purpose of providing Advanced Life Support and keeps a record of that assessment.

The refresher training will conform to the Australian Resuscitation Council Guidelines and be either:

  • delivered by the Australian Resuscitation Council;
  • credentialed by a relevant professional group or college and delivered by a registered training organisation;
  • delivered by a higher education provider as part of a postgraduate qualification; or
  • delivered by health service staff who have Basic Life Support, Advanced Life Support and adult learning qualifications.

Definitions

1. For the purpose of this approval a nurse means a person registered under the Health Practitioner Regulation National Law

a. to practise in the nursing and midwifery profession as a nurse (other than as a midwife or as a student); and

b. in the registered nurses division of that profession.

2. For the purpose of this approval a midwife means a person registered under the Health Practitioner Regulation National Law—

a. to practise in the nursing and midwifery profession as a midwife (other than as a nurse or student); and

b. in the register of midwives kept for that profession.

3. Health service organisation: A separately constituted health service that is responsible for the clinical governance, administration and financial management of a service unit(s) providing health care. A service unit involves a grouping of clinicians and others working in a systematic way to deliver health care to patients and can be in any location or setting, including pharmacies, clinics, outpatient facilities, hospitals, patients’ homes, community settings, practices and clinicians’ rooms (National Safety and Quality Health Service Standards 2012).

4. Advanced Life Support - the provision of effective airway management, ventilation of the lungs and production of a circulation by means of techniques additional to those of Basic Life Support. These techniques may include, but not be limited to, advanced airway management, tracheal intubation, intravenous access/drug therapy and defibrillation.

Basic Life Support - the preservation of life by the initial establishment of, and/or maintenance of, airway, breathing, circulation and related emergency care, including use of an automated external defibrillator (Australian Resuscitation Council, accessed May 2015).

5. Australian Resuscitation Council Guidelines - guidelines produced by the Australian Resuscitation Council to meet its objectives in fostering uniformity and simplicity in resuscitation techniques and terminology. Guidelines are produced after consideration of all available scientific and published material and are only issued after acceptance by all member organisations.

6. Australian Resuscitation Council - a voluntary co-ordinating body which represents all major groups involved in the teaching and practice of resuscitation. The Australian Resuscitation Council is sponsored by the Royal Australasian College of Surgeons and the Australian and New Zealand College of Anaesthetists.

Criteria for computer-generated prescriptions (20 August 2009)

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.

  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):

1. 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:

  • A computer-generated prescription must also comply with the requirements of regulations 26(3), 26(4), 26(5) and 26(6).
  • The criteria for computer-generated prescriptions may vary in different states. Medical practitioners, veterinary practitioners, dentists, nurse practitioners and authorised optometrists are strongly advised to seek, prior to purchase, verification from the software supplier that their software enables compliance with the specified criteria.

Criteria for e-Prescriptions (27 September 2013)

1. The software issuing electronic prescriptions will have the relevant roles defined, with access rights, that will only allow authorised persons to generate electronic prescriptions for all medications.

2. The digital signature of the authorised prescriber must be included in the electronic prescription content. The generation of the digital signature for an electronic prescription must follow the following criteria:

  • The prescriber must possess a credential (private key) that asserts the identity of the prescriber.
  • The prescribing software must display the prescription and obtain a final approval from the prescriber prior to generating a prescription for electronic distribution.
  • The prescribing software must re-authenticate the prescriber’s credentials at the point at which an electronic prescription for any medication, including drugs of dependence (which includes all Schedule 8 poisons and some Schedule 4 poisons), is generated.

3. Electronic prescriptions generated by the prescription software will produce the script information in an electronic format that is aligned with national medications messaging standards or related Australian Technical Specifications. The standards must include secure messaging (such as encryption), and application level acknowledgement, indicating positive or negative receipt of this information.

4. The electronic transfer of a prescription (e-Prescribing) must use national standards for clinical information, terminology and medications in both prescribing and dispensing organisations. The exchange of electronic prescription detail should include the following capabilities:

  • It will provide an indirect communication path between the prescriber and the dispenser(s) in which the dispenser(s) can be selected by the individual (or their agent) at any time after the prescription is created.
  • It will provide a single point of control for each prescription that allows the prescriber to electronically cancel an electronic prescription. From the time of cancellation, the dispenser(s) system will inactivate the dispensing of any prescription items that have not been actioned.
  • It will manage the security of the electronic prescription records that are distributed, including taking reasonable measures to apply current and future principles to:
    • Prevent the disclosure of information in the prescription record to unauthorised parties.
    • Ensure that the view of the prescription in both the prescribing and dispensing systems is consistent.
    • Protect against fraudulent electronic prescriptions.

5. The particulars of any electronic prescription issued will be included in the clinical or medication record of the person or animal for whom the electronic prescription was generated.

6. 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.

Last updated: 16 June 2014 

Approval for a pharmacist immuniser (6 May 2016)

The conditions of the Secretary Approval and related requirements for pharmacists are described in Pharmacist immunisers

Approval for an orthoptist (14 September 2017)

This Secretary Approval continues the authorisation for an orthoptist previously given under regulation 5 of the Drugs, Poisons and Controlled Substances Regulations 2006.

It takes effect from 14 September 2017, the date of publication in the Government Gazette.

Approval under Regulation 160 of the Drugs, Poisons and Controlled Substances Regulations 2017

Under Regulation 160(1)(g) of the Drugs, Poisons and Controlled Substances Regulations 2017 (the regulations) the Delegate of the Secretary for Health has approved for the purpose of regulation 7(1) Item 22 of the regulations:

An orthoptist practising under the direction of a registered medical practitioner or an authorised optometrist

To obtain or possess

Schedule 4 poisons that are local anaesthetics and cycloplegics in topical ophthalmic preparations for the purpose of use in the eyes of patients.

See page 2030 in the Victoria Government Gazette.

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