Department of Health

Medicines and poisons – Secretary approvals

Key messages

  • Some regulations allow for the department Secretary to approve individuals or circumstances that are not included 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 (the Act) and the Drugs, Poisons and Controlled Substances Regulations 2017 (the Regulations).

Some regulations allow for the Secretary of the department 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.

The current Secretary Approvals were published in the following Victoria Government Gazettes:

  • G37 14 September 2017 orthoptists, page 2020.
  • G16 19 April 2018 pp.720-728
    • Australian Ski Patrol Association Inc. qualified ski patroller, page 720
    • dental hygienists, dental therapists or oral health therapists, pp. 720-721
    • any optometrist, page 721
    • any podiatrist, page 722
    • a midwife, page 722
    • cardiac arrest, pp. 723 - 724
    • Victorian Institute of Forensic Medicine – Forensic Nurse Examiner, page 726
    • Victorian Tuberculosis Control Program, page 727
    • criteria for computer-generated prescriptions, pp. 727-728.
  • G40 4 October 2018 dental assistants, page 2123.
  • G49 6 December 2018 Life Saving Victoria lifeguards, page 2720.
  • G51 20 December 2018 on-site emergency response workers at mine sites and power stations, page 2819.
  • G14 9 April 2020 criteria for e-prescriptions, pp. 707-708.
  • S 582 20 October 2021 pp.1-7.
    • nurse immuniser – SARS-CoV-2 (COVID-19) VACCINE pp.1-3.
    • pharmacist immuniser – SARS-CoV-2 (COVID-19) VACCINE pp. 4-7 
  • S 744 23 December 2021 non-emergency patient transport and first aid services licence holders and persons they employ or engage.
  • S 44 1 February 2022 rural and isolated practice registered nurses, pp. 1-5. 
  • G29 21 July 2022 Aboriginal and Torres Strait Islander health practitioners, pp. 3130-3131.
  • S 518 3 October 2022 
    • nurse immunisers pp. 1-3
    • pharmacist immunisers pp. 4-8.
  • S 576 19 October 2022
    • nurse immuniser – SARS-CoV-2 (COVID-19) VACCINE pp.1-3
    • pharmacist immuniser – SARS-CoV-2 (COVID-19) VACCINE pp. 4-7

Pursuant to regulation 160, the Secretary may authorise persons (other than those authorised by the Act) to be in possession of scheduled poisons to the extent specified in regulation 7 or as specified the Secretary.

Nurses and midwives

Nurse immunisers (3 October 2022)

Pursuant to Regulation 161, the Acting Director, Medicines and Poisons Regulation and Delegate of the Secretary, hereby approves:

(1) the Schedule 4 poisons listed in Appendix 1 for possession by a nurse for administration to a patient in that nurse’s care on condition that the nurse meets the requirements of a nurse immuniser as set out below.

(2) the Schedule 4 poisons listed in Appendix 2 for possession by a nurse who meets the requirements of a nurse immuniser for administration to a patient in the nurse’s care; and in addition, on condition that the nurse has satisfactorily completed the Japanese encephalitis eLearning module, as approved by the Deputy Chief Health Officer – Communicable Disease, prior to administering the Japanese encephalitis vaccine.

(3) the Schedule 4 poison listed in Appendix 3 for possession by a nurse who meets the requirements of a nurse immuniser for administration to a patient in the nurse’s care on condition that prior to administering the monkeypox vaccine, the nurse immuniser has satisfactorily completed;

  1. the Monkeypox vaccination eLearning module, as approved by the Deputy Chief Health Officer – Communicable Disease; and
  2. the Intradermal injection – skills and competency assessment1 , if administering intradermal monkeypox vaccinations.

This approval revokes the Secretary Approval  Nurse Immunisers published in the Government Gazette S 244 Thursday 19 May 2022.

1. 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:

  • 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 Victoria2 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)

OR

  • Has satisfactorily completed the assessment of an ‘Immuniser program of study’ recognised by the Chief Health Officer, providing the education provider offers the program to nurses

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

OR

  • Has satisfactorily completed the assessment of an ‘Immuniser program of study’ that meets the curriculum content requirements of the National Immunisation Education Framework for Health Professionals.

Note - For a list of the ‘Immuniser programs of study’ that have been recognised by the Chief Health Officer and links to the Japanese encephalitis eLearning module and Monkeypox vaccination eLearning module that have been approved by the Deputy Chief Health Officer – Communicable Disease see Nurse immuniser study programs.

2. The nurse may possess and administer the following Schedule 4 poisons in order to administer without supervision or instruction:

  1. vaccines listed in Appendix 1
  2. vaccine listed in Appendix 2 where the nurse has completed the Japanese encephalitis eLearning module; and
  3. vaccine listed in Appendix 3 where the nurse has completed the Monkeypox vaccination eLearning module; and
  4. such other Schedule 4 poisons as are necessary for the treatment of anaphylactic reactions to the vaccines

2.1 On the condition that the following circumstances apply:

  1. the nurse is employed, contracted or otherwise engaged 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 clause 2.1 (a) is available to provide advice to the nurse on the use of the specified Scheduled 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 they are employed, contracted or otherwise engaged.
  4. The nurse administers the Schedule 4 poisons in:
    1. the performance of their 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 Handbook3 that is current at the time of the vaccine administration and
    3. accordance with any guidelines issued by the Department of Health such as the 'Approved client groups for immunisation by nurse immunisers'4.

1Included in the Victorian monkeypox vaccination program guidelines.

2This does not include limited registration, provisional registration, non-practising registration, or student registration.

3Current version available online.

4Victorian Department of Health Approved client groups for immunisation by nurse immunisers

5Victorian Department of Health Japanese encephalitis

6Victorian Department of Health, Monkeypox

7Travel medicine is a specialist area that is outside the scope of this approval.

Appendix 1: Vaccines

Generic name of vaccine

Diphtheria

Measles

Rubella

Haemophilus influenzae type b

Meningococcus

Streptococcus pneumoniae

Hepatitis A

Mumps

Tetanus

Hepatitis B

Pertussis

Varicella/Zoster/Herpes zoster

Human papillomavirus

Polio

 

Influenza

Rotavirus

 

Appendix 2: Vaccine

Generic name of vaccine Additional information
Japanese encephalitis

Approval is limited to people recommended for vaccination as listed on the Victorian Department of Health's Japanese encephalitis in Victoria webpageas amended from time to time.

Approval does not apply to any person seeking vaccination for international travel purposes.

Appendix 3: Vaccine

Generic name of vaccine Additional information
Monkeypox (smallpox/ vaccinia virus)

Approval is limited to people recommended for vaccination as listed on the Victorian Department of Health's Monkeypox webpage6 as amended from time to time.

Approval does not apply to any person seeking vaccination for travel purposes other than those persons recommended for vaccination as listed on the Victorian Department of Health’s Monkeypox webpage7.

This approval takes effect from the date of publication in the Victorian Government Gazette (3 October 2022).

Nurse Immuniser – SARS-CoV-2 (COVID-19) VACCINE (20 October 2022)

Refer to Public Health Emergency Orders and COVID-19 vaccination guidelines:

Information for COVID-19 vaccine providers

Nurses and midwives - cardiac arrest

This approval applies to:

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—

  1. to practise in the nursing and midwifery profession as a nurse (other than as a midwife or as a student); and
  2. 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—

  1. to practise in the nursing and midwifery profession as a midwife (other than as a nurse or student); and
  2. 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.

This approval (19 April 2018) supersedes the approval dated 13 July 2015.

Nurses - Victorian Tuberculosis Program

This approval applies to:

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:

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

The following circumstances apply:

1. the nurse is employed by Melbourne Health to work in the Victorian Tuberculosis Program.
2. 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
3. the nurse administers the Schedule 4 poisons in:

  1. the performance of his or her duties with the Victorian Tuberculosis Program at Melbourne Health,
  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 the Department of Health and Human Services or the medical director of the Victorian Tuberculosis Program at Melbourne Health.

This approval (19 April 2018) supersedes the approval dated 16 June 2014.

Forensic nurse examiners

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 poison 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 poison and
3. the nurse administers the Schedule 4 poison in:

  1. the performance of his or her duties as a forensic nurse examiner
  2. a designated Centre Against Sexual Assault 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 and Human Services.

Note:

Designated Centres Against Sexual Assault are DHHS funded services. See  CASA website for more information.

This approval (19 April 2018) supersedes the approval dated 1 July 2010.

Midwives - pain associated with labour

The Secretary has given approval in general for a registered midwife 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.

This approval (19 April 2018) supersedes the approval dated 1 July 2010.

Rural and isolated practice registered nurses (1 February 2022)

For the purposes of the definition ‘approved registered nurse’ provided in regulation 5 of the Drugs, Poisons and Controlled Substances Regulations 2017 (‘the Regulations’), regulation 159C of the Regulations authorises the Secretary to approve a class of registered nurse.

For the purposes of this approval, the class of approved registered nurse, to be known as the class titled rural and isolated practice registered nurse, is the class of nurses who meet the criteria below.

Competence, education and experience

  1. The class includes nurses:
    1. who are registered by the Nursing and Midwifery Board of Australia as a registered nurse; and
    2. who are assessed by their employer as being competent to obtain, possess, sell, supply and administer Schedule 2, 3, 4 and 8 poisons in accordance with the Health Management Protocols within the Primary Clinical Care Manual that is current at the time; and
    3. who since 1 July 2010, have successfully completed one of the following two courses:
      1. the Rural and Isolated Practice (Scheduled Medicines) Registered Nurse Course at Queensland Health’s the Cunningham Centre or
      2. the Graduate Certificate of Health (Scheduled Medicines) at the University of Southern Queensland; and
    4. have spent a minimum of one year at an average of two shifts per week working as a registered nurse, in one of the following settings
      1. urgent, emergency or critical care setting, or
      2. rural or rural isolated practice setting - That is, within a Monash Modified Model Category MM3 – MM7 (inclusive) location. See the Monash Modified Model, as maintained by the Commonwealth Department of Health: and
    5. who maintain appropriate records as evidence of these competence, education and experience requirements.
  1. Where the registration of a registered nurse was endorsed as qualified to obtain, supply and administer Schedule 2, 3, 4 and 8 medicines for nursing practice under the Nursing and Midwifery Board of Australia Endorsement for scheduled medicines for registered nurses (rural and isolated practice) as at 1 February 2022, the nurse is included in the class titled rural and isolated practice registered nurse if the nurse complies with the requirements set out in paragraphs 1a, 2b and 1e above. 

    A nurse with the relevant endorsement as at 1 February 2022 is not required to comply with the education and experience requirements set out in paragraphs 1c and 1d above.

The locations at which an approved registered nurse practises

  1. In addition to meeting the competence, education and experience requirements set out above, to be included in the class a nurse must be employed or engaged at: 
    1. an urgent care setting at a rural health service that is listed in Schedule 1; 
    2. a non-government organisation that is listed in Schedule 1; or 
    3. the onsite urgent care and emergency stabilisation areas of a bush nursing centre or a bush nursing hospital that is listed in Schedule 1. 

Schedule 1 may be viewed on page 3 of the Government Gazette S44 1 February 2022.

Approved poisons

Regulations 161A, 161B and 161C of the Regulations authorise approved registered nurses to obtain, possess, sell, supply and administer Schedule 2, 3, 4 and 8 poisons that have been approved by the Secretary.

The poison or class of poisons an approved registered nurse who is a member of the class Rural and Isolated Practice Registered Nurse (RIPRN) may obtain, possess, sell, supply and administer.

Approved registered nurses who are members of the class RIPRN are authorised to obtain, possess, sell, supply and administer Schedule 2, 3, 4 or 8 poisons listed in the Health Management Protocols in the Primary Clinical Care Manual that is current at the time, as stated as able to be administered or supplied by an RIPRN.

Pursuant to subregulations 161A(2), 161B(2) and 161C(2) the Secretary considers that:

  • this approval is necessary for the provision of health services. 
  • sections 13 and 14A of the Drugs, Poisons and Controlled Substances Act 1981 do not apply, and that
  • it is within the competence of an approved registered nurse to obtain, possess, sell, supply and administer the poisons without the supervision or instruction of a registered medical practitioner or nurse practitioner.

Approved conditions

The following conditions are necessary for the proper obtaining, possessing, selling, supplying and administering of the Schedule 2, 3, 4 and 8 poisons by an approved registered nurse who is a member of the class rural and isolated practice registered nurse:

The approved registered nurse:

  • appears in the list of approved registered nurses as competent and qualified to obtain, possess, sell, supply or administer Schedule 2, 3, 4 or 8 poisons that is maintained by the health service at which they are located.
  • only obtains, possesses, sells, supplies and administers the Schedule 2, 3, 4 and 8 poisons in the performance of their duties as a rural and isolated practice registered nurse.
  • is able to obtain clinical assistance from a registered medical practitioner or nurse practitioner if it is necessary.
  • obtains, possesses, sells, supplies and administers only the Schedule 2, 3, 4 or 8 poisons obtained under the health services permit held by the health service at which they are located.

Other AHPRA registered health practitioners

Aboriginal and Torres Strait Islander Health Practitioners - Fluoride Varnish

For the purposes of regulation 7 Item 26 and under regulation 160(1)(j) of the Drugs, Poisons and Controlled Substances Regulations 2017, the Secretary has approved the Schedule 4 poison listed below for possession by a registered Aboriginal and Torres Strait Islander health practitioner1 on condition that the registered Aboriginal and Torres Strait Islander health practitioner meets the requirements set out below.

Approved Class of Registered Aboriginal and Torres Strait Islander Health Practitioners

This approval applies to a registered Aboriginal and Health Islander health practitioner who:

  1. holds a Certificate IV in Aboriginal and/or Torres Strait Islander Primary Health Care practice (or qualification/experience considered equivalent by the Aboriginal and Torres Strait Islander Health Practice Board for applications between 1 July 2012 to 30 June 2015);
  2. has successfully completed Certificate IV units of competency relevant to:
    1. applying fluoride varnish;
    2. recognising and responding to oral health issues;
    3. providing or assisting with oral hygiene; and
  3. undergoes refresher training on applying fluoride varnish on an annual basis; and
  4. is employed or engaged by an Aboriginal Community Controlled Organisation located in Victoria that provides a primary health care service.

Schedule 4 poison to which this Approval applies

This approval applies to the following Schedule 4 poison2 that is required for the treatment of a child (aged 3–17 years) who is a patient of the Aboriginal Community Controlled Organisation: 

  • Fluoride varnish (example Duraphat Varnish 5% w/v Sodium Fluoride Varnish tube).

The approval is subject to the following conditions:

  • The registered Aboriginal and Torres Strait Islander health practitioner has been assessed as competent by a registered dental practitioner within a public dental service3 approved under Regulation 160A and undergoes annual re-assessment..
  • The name of the registered Aboriginal and Torres Strait Islander health practitioner appears in the list of registered Aboriginal and Torres Strait Islander health practitioners qualified and competent to administer fluoride varnish maintained by the Aboriginal Community Controlled Organisation where they are employed or engaged and Dental Health Services Victoria.
  • The registered Aboriginal and Torres Strait Islander health practitioner has been assigned the role of administering the fluoride varnish to a child at the Aboriginal Community Controlled Organisation where they are engaged or employed.
  • The registered Aboriginal and Torres Strait Islander health practitioner obtains the fluoride varnish under the procurement practices of the Aboriginal Community Controlled Organisation where they are employed or engaged.

1Registered Aboriginal and Torres Strait Islander health practitioner means a person registered under the Health Practitioner Regulation National Law to practise in the Aboriginal and Torres Strait Islander health practice profession (other than as a student).
2Fluoride varnish is included in Schedule 4 of the Poisons Standard except in preparations for supply to registered dental professionals or by approval of the Secretary for Health.
3A public dental service is an entity wholly or partly funded by the State (whether directly or indirectly) to provide dental services.

Note: Registered Aboriginal and Torres Strait Islander health practitioners who administer fluoride varnish in accordance with this approval are referred to ‘The Use and Application of Tropical Fluoride Clinical Guidelines’, prompt number DHSV0144426 Version 3.0, 11 March 2022, issued by Dental Health Services Victoria.

This approval takes effect from the date it is published in the Victoria Government Gazette 21 July 2022.

Dental hygienists, dental therapists or oral health therapists

In relation to regulation 7, 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.

This approval (19 April 2018) supersedes the approval dated 1 July 2010.

Optometrists

In relation to regulation 7, 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:

  • 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.

This approval (19 April 2018) supersedes the approval dated 1 July 2010.

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). 

Podiatrists

In relation to regulation 7, 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:

  • 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.

This approval (19 April 2018) supersedes the approval dated 1 July 2010.

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.

Pharmacist immunisers (3 October 2022)

Pursuant to Regulation 163, the Acting Director, Medicines and Poisons Regulation and Delegate of the Secretary, hereby approves:

(1) the Schedule 4 poisons listed in Appendix 1 for administration by a pharmacist on condition that the pharmacist meets the requirements of a pharmacist immuniser as set out below.

(2) the Schedule 4 poison listed in Appendix 2 for administration by a pharmacist who meets the requirements of a pharmacist immuniser, and in addition on condition that the pharmacist has satisfactorily completed the Japanese encephalitis eLearning module, as approved by the Deputy Chief Health Officer – Communicable Disease, prior to administering the Japanese encephalitis vaccine.

(3) the Schedule 4 poison listed in Appendix 3 for administration by a pharmacist who meets the requirements of a pharmacist immuniser on condition that prior to administering the monkeypox vaccine, the pharmacist immuniser has satisfactorily completed;

  1. the Monkeypox vaccination eLearning module, as approved by the Deputy Chief Health Officer – Communicable Disease; and
  2. the Intradermal injection – skills and competency assessment1, if administering intradermal monkeypox vaccinations.

This approval revokes the Secretary Approval Pharmacist Immuniser published in the Government Gazette S 244 Thursday 19 May 2022.

1. This approval applies to a pharmacist who at the time of the administration of the Schedule 4 poisons2 holds general registration with the Pharmacy Board of Australia3 and:

(a) Has satisfactorily completed the assessment of an ‘Immuniser program of study’ recognised by the Chief Health Officer (see Note);

OR

(b) Has satisfactorily completed the assessment of an ‘Immuniser program of study’ that meets the curriculum content requirements of the National Immunisation Education Framework for Health Professionals; and

(c) Has recency of practice and continuing professional development in immunisation (as defined from time to time by the Pharmacy Board of Australia);

OR

(d) Is currently completing clinical practice in a hospital, pharmacy, pharmacy depot, general practice or immunisation clinic as part of an ‘Immuniser program of study’ recognised by the Chief Health Officer under the direct supervision of a:
(i) medical practitioner;
(ii) nurse practitioner;
(iii) ‘Nurse Immuniser’4 that is compliant with regulation 8(1) of the Drugs, Poisons and Controlled Substance Regulations 2017; or
(iv) Pharmacist that is compliant with regulation 99(c) of the Drugs, Poisons and Controlled Substances Regulations 2017;

AND

(e) Holds a current first aid certificate (to be updated every three years); and
(f) Holds a current cardiopulmonary resuscitation certificate (to be updated annually).

Note – For a list of the immuniser programs of study that have been recognised by the Chief Health Officer and links to the Japanese encephalitis eLearning module and Monkeypox vaccination eLearning module that have been approved by the Deputy Chief Health Officer – Communicable Disease see Programs of Study.

2. The pharmacist may administer the following Schedule 4 poisons:

(a) vaccines listed in Appendix 1 to persons set out in the corresponding entry in Column 2 , subject to the corresponding exclusions in column 3.
(b) vaccine listed in Appendix 2 where the pharmacist has completed the Japanese encephalitis eLearning module, to persons listed in column 2, subject to the exclusions in column 3.
(c) vaccine listed in Appendix 3 where the pharmacist has completed the Monkeypox vaccination eLearning module, to persons listed in column 2, subject to the exclusions in column 3.

3. On the condition that the following circumstances apply:
(a) The premises on which a pharmacist administers the Schedule 4 poisons must:

(i) be one of the following premises:
(I) A hospital; or
(II) A pharmacy as defined in the Pharmacy Regulation Act 2010; or
(III) A pharmacy depot, as defined in the Pharmacy Regulation Act 2010, that is a stand-alone business in premises owned or leased by the licensee of the related pharmacy; or
(IV) Be a mobile or outreach service of one of the premises referred to in paragraphs 3(a)(i)(I), (II) or (III) because the pharmacist administering the vaccines owns, is employed or otherwise engaged by the business referred to in paragraphs 3(a)(i)(I), (II) or (III) and sources the vaccines from those premises. 

(b) Any premises referred to in paragraphs 3(a)(i)(I), (II) or (III) on which a pharmacist administers a Schedule 4 vaccine must meet the guidelines for facilities for immunisation services described in the Victorian Pharmacy Authority Guidelines that are current at the time of the administration.

(c) All pharmacists administering the Schedule 4 poisons:

(i) must do so in accordance with:
I. The edition of the Australian Immunisation Handbook5 that is current at the time of the administration; and
II. The edition of the National Vaccine Storage Guidelines: Strive for 55 that is current at the time of the administration; and

(ii) Must ensure that at least one other staff member that holds a current first aid and cardiopulmonary resuscitation certificate is on duty in the pharmacy when the Schedule 4 poisons are administered and for a minimum period of 15 minutes afterwards, where administering on premises defined in paragraphs 3(a)(i)(I), (II) or (III).

NOTE: Pharmacists who administer Schedule 4 poisons, as listed in Appendices 1, 2 and 3, are referred to the edition of the Victorian Pharmacist-Administered Vaccination Program Guidelines current at the time of administration and issued by the Department of Health, which apply to the administration of all government-funded vaccines by pharmacists. These guidelines contain best practice guidance for the administration of all vaccines listed in Appendices 1, 2 and 3 (whether government funded or not) by pharmacists.

NOTE: Pharmacists are permitted to possess and administer Schedule 3 poisons pursuant to Regulation 141 of the Regulations. Accordingly, pharmacists are permitted to possess and administer Schedule 3 poisons that are necessary for the treatment of anaphylactic reactions to the vaccine. Those Schedule 3 poisons should be kept on hand and utilised should they be required at the time the vaccine is administered.
 

Appendix 1

Column 1:

Generic name

Column 2:

Approval for pharmacists to vaccinate with this vaccine applies to

Column 3:

Approval for pharmacists to vaccinate with this vaccine excludes

Influenza

  • Vaccination of people aged 5 years and older, excluding those circumstances listed in Column 3.
  • Vaccination for travel purposes 6;
  • Vaccination of people aged 4 years and younger;
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook 5.

Diphtheria-tetanus-pertussis vaccines

  • Vaccination of people aged 12 years and older, excluding those circumstances listed in Column 3.
  • Vaccination for travel purposes 6;
  • Vaccination of people aged 11 years and younger;
  • Vaccination for the express purpose of post-exposure prophylaxis in people with a tetanus prone wound7;
  • Vaccination of people that are contacts in the event of a case of pertussis, unless directed by the Department of Health8; or
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook 5.

Human papillomavirus (HPV) 

  • Vaccination of people aged 12 years and older, excluding those circumstances listed in Column 3.
  • Vaccination for travel purposes6;
  • Vaccination of people aged 11 years and younger;
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook5

 

 

Measles-mumps-rubella vaccine (MMR)

  • Vaccination of people aged 15 years and older, excluding those circumstances listed in Column 3.
  • Vaccination for travel purposes6;
  • Vaccination of people aged 14 years and younger;
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook5

Meningococcal ACWY

  • Vaccination of people aged 15 years and older, excluding those circumstances listed in Column 3.
  • Vaccination for travel purposes6;
  • Vaccination of people aged 14 years and younger;
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook5
Pneumococcal
  • Vaccination of people aged 50 years and older, excluding those circumstances listed in Column 3.
  • Vaccination for travel purposes6;
  • Vaccination of people aged 49 years and younger; 
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook5
Herpes zoster/varicella zoster
  • Vaccination of people aged 50 years and older, excluding those circumstances listed in Column 3.
  • Vaccination for travel purposes6;
  • Vaccination of people aged 49 years and younger; 
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook5

Appendix 2

Japanese encephalitis vaccine
  • Vaccination of people aged 5 years and older that are recommended for vaccination as listed on the Victorian Department of Health's Japanese encephalitis in Victoria webpage9 as amended from time to time.
  • Vaccination for people not recommended for vaccination;
  • Vaccination for travel purposes6;
  • Vaccination for people aged 4 and younger;
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook5

Appendix 3

Monkeypox/smallpox/
vaccinia virus
  • Vaccination of people aged 5 years and older that are recommended for vaccination as listed on the Victorian Department of Health's Monkeypox webpage10 as amended from time to time.
  • Vaccination for people not recommended for vaccination;
  • Vaccination for travel purposes6,10
  • Vaccination for people aged 4 and younger;
  • Vaccination of people with contraindications defined in the current edition of the Australian Immunisation Handbook (or current recommendations issued by the Australian Technical Advisory Group on Immunisation (ATAGI)) 5.

1Included in the Victorian monkeypox vaccination program guidelines

2 Included in Schedule 4 of the Poisons Standard.

This does not include limited registration, provisional registration, non-practising registration, or student registration.

4 ‘Nurse Immuniser’ is a nurse acting in accordance with a Secretary Approval to administer certain vaccines.

5 Current version available online.

6 Travel medicine is a specialist area that is outside the scope of this approval.

7 Pertussis vaccine is only available in Australia in combination with diphtheria and tetanus, or diphtheria, tetanus and poliomyelitis. 

A case of this vaccine-preventable disease is notifiable to the Department of Health under the Public Health and Wellbeing Regulations 2019. The Department of Health will advise on management of the case and contacts.

Victorian Department of Health Japanese encephalitis virus

10 Victorian Department of Health, Monkeypox

The Gazette Notice and related requirements for pharmacists are described in Pharmacist immunisers.

Pharmacist Immuniser – SARS-CoV-2 (COVID-19) VACCINE (20 October 2022)

Refer to Public Health Emergency Orders and COVID-19 vaccination guidelines:

Information for COVID-19 vaccine providers

Other professions

Dental assistants

In relation to regulation 7, this approval (15 October 2018) applies to a dental assistant who:

  • holds a qualification approved by the Secretary under regulation 159A and has completed a course approved by the Secretary under regulation 159A; and
  • is employed or engaged by an entity declared to be a public dental service by the Secretary under regulation 160A

to possess the following Schedule 4 poison1 that is required for the treatment of a person whose name is specified in an instruction written by a registered dental practitioner and given to the dental assistant:

  • Fluoride varnish (example Duraphat Varnish 5% w/v Sodium Fluoride Varnish tube).

Conditions

  1. The dental assistant has been assessed as competent by a registered dental practitioner within the declared public dental service.
  2. The name of the dental assistant appears in the list of dental assistants qualified and competent to administer fluoride varnish maintained by the declared public dental service and Dental Health Services Victoria.
  3. The dental assistant has been allocated the task of administering the fluoride varnish to a child in the Victorian child fluoride varnish program within the Department of Health and Human Services public dental program by a registered dental practitioner.  The registered dental practitioner remains responsible for assessment and care planning.
  4. The dental assistant administers the fluoride varnish to children in the Victorian child fluoride varnish program within the Department of Health and Human Services public dental program. The dental assistant administers the fluoride varnish within a declared public dental service or as an outreach service of that declared public dental service.
  5. The dental assistant obtains the fluoride varnish under the procurement practices of the declared public dental service or from a registered dental practitioner employed at the declared public dental service.
  6. The dental assistant will be supervised on the use of the fluoride varnish by a registered dental practitioner.  Supervision may be direct, indirect or remote and may occur frequently, regularly or intermittently based on the assessment of the registered dental practitioner.
  7. The dental assistant administers the fluoride varnish in accordance with any guidelines issued by the Department of Health and Human Services or Dental Health Services Victoria for the Victorian child fluoride dental program.

1Fluoride varnish is included in Schedule 4 of the Poisons Standard except in preparations for supply to registered dental professionals or by approval of the Secretary for Health and Human Services.

Orthoptists

In relation to regulation 7, the Secretary has approved 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 G37 14 September 2017.

A person who holds a non-emergency patient transport service licence (23 December 2021)

For the purposes of Item 24 of regulation 7 of the Drugs, Poisons and Controlled Substances Regulations 2017 (‘the Regulations’), under regulation 160(1)(ha) of the Regulations the Secretary approves a person who holds a non-emergency patient transport service licence issued under the Non-Emergency Patient Transport and First Aid Services Act 2003 to possess the following Schedule 4 poisons.

The licence holder must take all reasonable steps to ensure that the administration of scheduled poisons possessed under this approval is in accordance with guidelines approved by the Victorian Department of Health.
The licence holder must ensure that any loss, theft or misappropriation of a Schedule 4 poison is reported to Victoria Police, and reported in writing to the Victorian Department of Health.

Schedule 4 poisons

  • Amiodarone
  • Ipratropium
  • Methoxyflurane
  • Ondansetron
  • Salbutamol

This Secretary Approval takes effect from 23 December 2021, the day it is published in the Government Gazette S 744 23 December 2021.

A person (including a nurse) employed or engaged by the holder of a non-emergency patient transport service licence (23 December 2021)

For the purposes of Item 24A of regulation 7 of the Drugs, Poisons and Controlled Substances Regulations 2017 (‘the Regulations’), under regulation 160(1)(hb) of the Regulations the Secretary approves a person (including a nurse) employed or engaged by the holder of a non-emergency patient transport service licence issued under the Non-Emergency Patient Transport and First Aid Services Act 2003 to possess the following Schedule 4 poisons.

A person administering a Schedule 4 poison possessed under this approval must do so in accordance with guidelines approved by the Victorian Department of Health and must only possess and administer Schedule 4 poisons obtained by the licence holder by whom they are employed or engaged.

  • Schedule 4 poisons
  • Amiodarone
  • Ipratropium
  • Methoxyflurane
  • Ondansetron
  • Salbutamol

This Secretary Approval takes effect from 23 December 2021, the day it is published in the Government Gazette S 744 23 December 2021.

Other professions - emergency response

A person who holds a first aid service licence to operate an intermediate first aid service or an advanced first aid service (23 December 2021)

Intermediate first-aid service licence holders

For the purposes of Item 24B of regulation 7 of the Drugs, Poisons and Controlled Substances Regulations 2017 (‘the Regulations’), under regulation 160(1)(hc) of the Regulations the Secretary approves a person who holds a first aid service licence to operate an intermediate first aid service issued under the Non-Emergency Patient Transport and First Aid Services Act 2003 to possess the following Schedule 4 poisons.

A licence holder must only possess those Schedule 4 poisons for which the licence holder has Clinical Practice Protocols (‘Guidelines’) that are approved by the Victorian Department of Health.

The licence holder must take all reasonable steps to ensure that the administration of any scheduled poison possessed under this approval is in accordance with the approved Clinical Practice Protocol (‘Guideline’) held by the licence holder.

The licence holder must ensure that any loss, theft or misappropriation of a Schedule 4 poison is reported to Victoria Police, and reported in writing to the Victorian Department of Health.

Schedule 4 poisons

  • Ipratropium
  • Methoxyflurane
  • Nitrous oxide
  • Ondansetron
  • Salbutamol

Advanced first-aid service licence holders

For the purposes of Item 24B of regulation 7 of the Regulations, under regulation 160(1)(hc) of the Regulations the Secretary approves a person who holds a first aid service licence to operate an advanced first aid service issued under the Non-Emergency Patient Transport and First Aid Services Act 2003 to possess the following Schedule 4 poisons.

The licence holder must only possess those Schedule 4 poisons for which the licence holder has Clinical Practice Protocols (‘Guidelines’) that are approved by the Victorian Department of Health.

The licence holder must take all reasonable steps to ensure that the administration of any scheduled poison possessed under this approval is in accordance with the approved Clinical Practice Protocol (‘Guideline’) held by the licence holder.

The licence holder must ensure that any loss, theft or misappropriation of a Schedule 4 poison is reported to Victoria Police, and reported in writing to the Victorian Department of Health.

Schedule 4 poisons1

Schedule 4 poisons that are not Drugs of Dependence and Schedule 4 poisons within a therapeutic class, excluding any Schedule 4 poison that is a Drug of Dependence2

  • Adrenal steroid hormones
  • Adrenergic stimulants, vasopressor agents
  • Agents acting on the uterus
  • Aminoglycosides
  • Anaesthetics - local and general (includes Nitrous oxide)
  • Antiangina agents
  • Antiarrhythmic agents
  • Anticoagulants, antithrombotics
  • Anticonvulsants
  • Antidiarrhoeals
  • Antihypertensive agents
  • Antiemetics, antinauseants (includes Ondansetron)
  • Antihistamines
  • Antipsychotic agents
  • Antispasmodics and motility agents
  • Atropine
  • Beta-adrenergic blocking agents
  • Bronchodilator aerosols and inhalations (includes Ipratropium and Salbutamol)
  • Cephalosporins
  • Cholinergic and anticholinergic agents
  • Combined oral contraceptive agents
  • Combination simple analgesics
  • Detoxifying agents, antidotes
  • Diuretics
  • Fibrinolytic agents
  • Haemostatic agents
  • Hyperacidity, reflux and ulcers
  • Immunoglobulins
  • Insulin preparations
  • Macrolides
  • Movement disorders
  • Muscle relaxants
  • Neuromuscular agents
  • Neuromuscular blocking agents
  • Nonsteroidal anti-inflammatory agents
  • Ocular decongestants, anaesthetics, anti-inflammatories
  • Oral and parenteral electrolytes
  • Other antibiotics and anti-infectives
  • Penicillins
  • Progestogen only contraceptive agents
  • Quinolones
  • Simple analgesic and antipyretics (includes Methoxyflurane)
  • Tetracyclines
  • Tramadol

Schedule 4 poisons that are drugs of dependence
•    Diazepam
•    Midazolam

This Secretary Approval takes effect from 23 December 2021, the day it is published in the Government Gazette S 744 23 December 2021.

1Note: MIMS Class terminology is used to define therapeutic class 
2‘Drug of dependence’ is defined in the Drugs, Poisons and Controlled Substances Act 1981 section 4, and refers to those substances listed in Schedule Eleven to that Act. 

A person (including a nurse) employed or engaged by the holder of a first aid service licence to operate an intermediate first aid service or an advanced first aid service (23 December 2021)

Intermediate first-aid service

For the purposes of Item 24C of regulation 7 of the Drugs, Poisons and Controlled Substances Regulations 2017 (‘the Regulations’), under regulation 160(1)(hd) of the Regulations the Secretary approves a person (including a nurse) employed or engaged by the holder of a licence issued under the Non-Emergency Patient Transport and First Aid Services Act 2003 to operate an intermediate first aid service to possess the following Schedule 4 poisons.

A person employed or engaged by the licence holder must only possess those Schedule 4 poisons for which the licence holder has Clinical Practice Protocols (‘Guidelines’) approved by the Victorian Department of Health. 

A person administering a Schedule 4 poison possessed under this approval must do so in accordance with a Clinical Practice Protocol (‘Guideline’) approved by the Victorian Department of Health and must only possess and administer Schedule 4 poisons obtained by the licence holder by whom they are employed or engaged.

Schedule 4 poisons:

  • Ipratropium
  • Methoxyflurane
  • Nitrous oxide
  • Ondansetron
  • Salbutamol

Advanced first-aid service

For the purposes of Item 24C of regulation 7 of the Regulations, under regulation 160(1)(hd) of the Regulations the Secretary approves a person (including a nurse) employed or engaged by the holder of a licence issued under the Non-Emergency Patient Transport and First Aid Services Act 2003 to operate an advanced first aid service to possess the following Schedule 4 poisons. 

A person employed or engaged by the licence holder must only possess those Schedule 4 poisons for which the licence holder has Clinical Practice Protocols (‘Guidelines’) approved by the Victorian Department of Health. 

A person administering a Schedule 4 poison possessed under this approval must do so in accordance with a Clinical Practice Protocol (‘Guideline’) approved by the Victorian Department of Health and must only possess and administer Schedule 4 poisons obtained by the licence holder by whom they are employed or engaged.

Schedule 4 poisons3

Schedule 4 poisons that are not Drugs of Dependence and Schedule 4 poisons within a therapeutic class, excluding any Schedule 4 poison that is a Drug of Dependence4

  • Adrenal steroid hormones
  • Adrenergic stimulants, vasopressor agents
  • Agents acting on the uterus
  • Aminoglycosides
  • Anaesthetics - local and general (includes Nitrous oxide)
  • Antiangina agents
  • Antiarrhythmic agents
  • Anticoagulants, antithrombotics
  • Anticonvulsants
  • Antidiarrhoeals
  • Antihypertensive agents
  • Antiemetics, antinauseants (includes Ondansetron)
  • Antihistamines
  • Antipsychotic agents
  • Antispasmodics and motility agents
  • Atropine
  • Beta-adrenergic blocking agents
  • Bronchodilator aerosols and inhalations (includes Ipratropium and Salbutamol) 
  • Cephalosporins
  • Cholinergic and anticholinergic agents
  • Combined oral contraceptive agents
  • Combination simple analgesics
  • Detoxifying agents, antidotes
  • Diuretics
  • Fibrinolytic agents
  • Haemostatic agents
  • Hyperacidity, reflux and ulcers
  • Immunoglobulins
  • Insulin preparations
  • Macrolides
  • Movement disorders
  • Muscle relaxants
  • Neuromuscular agents
  • Neuromuscular blocking agents
  • Nonsteroidal anti-inflammatory agents
  • Ocular decongestants, anaesthetics, anti-inflammatories
  • Oral and parenteral electrolytes
  • Other antibiotics and anti-infectives
  • Penicillins
  • Progestogen only contraceptive agents
  • Quinolones
  • Simple analgesic and antipyretics (includes Methoxyflurane)
  • Tetracyclines
  • Tramadol

Schedule 4 poisons that are drugs of dependence

  • Diazepam
  • Midazolam

This Secretary Approval takes effect from 23 December 2021, the day it is published in the Government Gazette S 744 23 December 2021.

3Note: MIMS Class terminology is used to define therapeutic class
4‘Drug of dependence’ is defined in the Drugs, Poisons and Controlled Substances Act 1981 section 4, and refers to those substances listed in Schedule Eleven to that Act. 

Life Saving Victoria lifeguards

In relation to regulation 7, the Secretary has given approval (6 December 2018) for a person employed or engaged as a lifeguard (on a paid or unpaid basis) by Life Saving Victoria Limited to be in possession of the following Schedule 4 poison to the extent that it is required in the performance of his or her duties for the treatment of emergencies:

  • Methoxyflurane

Conditions

This Approval is subject to the following conditions:

  1. The Schedule 4 poison is purchased or obtained under a Health Services Permit issued under section 19 of the Drugs, Poisons and Controlled Substances Act 1981 to Life Saving Victoria Limited.
  2. The Life Saving Victoria lifeguard is qualified with a current Surf Life Saving Australia Pain Management Certificate or unit of competency PUAEME005A or equivalent qualification.
  3. The Life Saving Victoria lifeguard is assessed as competent in administration of the Schedule 4 poison by Life Saving Victoria Limited.
     

Qualified ski patrollers

In relation to regulation 7, 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.

This approval (19 April 2018) supersedes the approval dated 30 July 2010.

Emergency response workers at mine sites and power stations

In relation to regulation 7, the Secretary has given approval (20 December 2018) for an on-site emergency response worker1 trained in Advanced First Aid at mine sites2 and power stations3 to be in possession of the following Schedule 4 poison to the extent that it is required in the performance of his or her emergency response duties for treatment in emergencies:

  • Methoxyflurane

Conditions

The Approval is subject to the following conditions.

The on-site emergency response worker:

  1. is a member of the on-site emergency response team
  2. is qualified in Advanced First Aid that includes Unit PUAEME005A Provide Pain Management (or an equivalent qualification) provided by a Registered Training Organisation and undergoes refresher training on an annual basis
  3. undergoes on-site training in emergency procedures, including annual refresher training, relevant to the possession and administration of methoxyflurane under the supervision of the site Emergency Response Coordinator4 (or equivalent)
  4. is included on a list of on-site emergency response workers who are assessed as competent by the Emergency Response Coordinator and authorised by the Site Senior Responsible Person (General Manager or equivalent) and is identifiable as such to other workers
  5. operates only when the site emergency plan that is signed off by the Site Senior Responsible Person incorporates the capacity for these workers to administer methoxyflurane in an emergency
  6. only administers methoxyflurane in circumstances where emergency ambulance or the employer's contracted medical or health service provider has been called and hands over care to that person/service
  7. administers no Schedule 4 poison other than methoxyflurane; and
  8. possesses methoxyflurane in accordance with guidelines, if any, prepared by the Department of Health and Human Services.

1An on-site emergency response worker is a member of the site emergency response team who has been trained in emergency response procedures and systems relevant to that particular mine site or power station.
2A mine site is where minerals (such as coal or gold) are extracted for their chemical properties; a quarry is not a mine.  
3A power station is a facility generating electricity.
4An Emergency Response Coordinator or equivalent position is designated as responsible by the Site Senior Responsible Person for management of the on-site emergency response team. The role is held by persons with extensive emergency management experience and appropriate competencies in emergency response, including Advanced First Aid with Unit PUAEME005A and a formal training qualification or extensive experience in training and coaching staff.  They coordinate the emergency response team, including training and documentation relating to the team.

Guideline for managing methoxyflurane at mine sites and power stations and Minerals Council of Australia - Victoria submission

Prescribing

Criteria for other than handwritten prescriptions

Pursuant to regulation 162, the Secretary may approve specifications for prescriptions, issued under regulation 24, to be issued other that in the handwriting of the prescriber.

Criteria for electronic prescriptions (9 April 2020)

For the purposes of this approval, a person who issues an electronic prescription must comply with the Criteria for Electronic Prescriptions, listed below in addition to any requirements under the National Health (Pharmaceutical Benefits) Regulations 2017 (Commonwealth Regulations), the Drugs, Poisons and Controlled Substances Act 1981 and the Regulations.

1. The software used to issue or receive the prescription must be listed on the Register of Conformance by the Australian Digital Health Agency with a current conformance identifier, and must comply with the current version of the Australian Digital Health Agency Electronic Prescribing Participating Software Conformance Profile.
2. The digital prescription message for each prescription must include:

  • the Healthcare Provider Identifier – Organisation (HPI-O) of the practice or organisation from which the prescription is issued (Electronic Prescribing Conformance Profile requirement PRES-18), and
  • the Healthcare Provider Identifier – Individual (HPI-I) (Electronic Prescribing Conformance Profile requirement PRES-19) or for an electronic prescription that is transmitted within a hospital a unique identifier that is managed and audited by that hospital, and
  • a unique prescription number (Electronic Prescribing Conformance Profile requirement PRES-18), and
  • the conformance identifier, except those electronic prescriptions that are transmitted within a hospital.

3. The electronic prescription must include information that confirms the identity of the authorised prescriber.
4. The software used to issue the prescription must:

  • manage defined roles with access rights that will only allow authorised persons to issue or receive electronic prescriptions for all medications, and
  • display the prescription and obtain a final approval from the prescriber prior to issuing a prescription for electronic distribution, and
  • utilise Electronic Prescribing Conformance Profile requirements to protect against fraud.

5. The software audit requirements (Electronic Prescribing Conformance Profile requirements PRES-10, PRES-38, PRES-39) will be capable of being accessed when required and must be produced on demand to an authorised officer.
6. The electronic prescription must comply with other requirements of the Drugs, Poisons and Controlled Substances Regulations 2017.

Criteria for computer-generated prescriptions (19 April 2018)

The Secretary has given approval in general for a person referred to in regulation 24(1) 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 persons authorised to issue prescriptions.
  2. Prescriptions will be generated only by persons authorised to issue prescriptions.
  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):

  • In addition to the printed particulars on the prescription, the prescriber will include in his/her own handwriting, the following particulars:
    • 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 for Schedule 8 poisons)
    • the number of repeats authorised (in both words and figures for Schedule 8 poisons).

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

Notes:

  • A computer-generated prescription must comply with the requirements of regulations 18(2)(e), 24(1A), 24(2), 24(3), 24(6) and 24(7).
  • The criteria for computer-generated prescriptions may vary in different states. Medical practitioners, veterinary practitioners, dentists, nurse practitioners, authorised midwives, authorised optometrists and authorised podiatrists are strongly advised to seek, prior to purchase, verification from the software supplier that their software enables compliance with the specified criteria.

As of 20 August 2009, it is no longer a criterion that only one item appears on a prescription for a drug of dependence.

This approval supersedes the approval dated 20 August 2009

Reviewed 26 October 2022

Health.vic

Contact details

Postal address: Medicines and Poisons Regulation Department of Health GPO Box 4057 Melbourne VIC 3001

Medicines and Poisons Regulation Department of Health Department of Health

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