Poisons Amendment Regulations 2016

Poisons Amendment Regulations 2016

I, the Governor in and over the State of Tasmania and its Dependencies in the Commonwealth of Australia, acting with the advice of the Executive Council, make the following regulations under the Poisons Act 1971 .

25 January 2016

C. Warner

Governor

By Her Excellency's Command,

Michael Darrel Joseph Ferguson

Minister for Health

1.   Short title

These regulations may be cited as the Poisons Amendment Regulations 2016 .

2.   Commencement

These regulations take effect on the day on which their making is notified in the Gazette.

3.   Principal Regulations

In these regulations, the Poisons Regulations 2008 are referred to as the Principal Regulations.

4.    Regulation 3 amended (Interpretation)

Regulation 3(1) of the Principal Regulations is amended by inserting after the definition of primary pack the following definition:

private hospital means a private hospital within the meaning of the Health Service Establishments Act 2006 ;

5.    Regulation 15 amended (Prescribing and supply of narcotic substances)

Regulation 15(7) of the Principal Regulations is amended by inserting after paragraph (a) the following paragraph:

(ab) he or she is not to include in that prescription more than one preparation which is or includes a narcotic substance;

6.    Regulation 21 rescinded

Regulation 21 of the Principal Regulations is rescinded.

7.    Regulation 41 amended (Prescriptions for restricted substances)

Regulation 41(4)(c) of the Principal Regulations is amended as follows:

(a) by inserting in subparagraph (ii) ", private hospital or residential care facility" after "hospital";

(b) by inserting in subparagraph (iii) ", private hospital or residential care facility" after "public hospital";

(c) by inserting in subparagraph (iii) "or residential care facility" after "that hospital".

8.    Regulation 61 rescinded

Regulation 61 of the Principal Regulations is rescinded.

9.    Regulation 62 amended (Ministers authorisation for possession and supply of restricted substance)

Regulation 62 of the Principal Regulations is amended as follows:

(a) by omitting from paragraph (e) "practitioner;" and substituting "practitioner.";

(b) by omitting paragraphs (f) and (g) .

10.    Regulation 62G amended (Interpretation of Division)

Regulation 62G of the Principal Regulations is amended by omitting the definition of relevant person and substituting the following definition:

relevant person means a person who is –

(a) a St John Ambulance member, while he or she is acting in accordance with an agreement by St John Ambulance to provide its services at a particular event or location; or

(b) an employee of Medical Edge Australia (ABN 98 147 076 819), while he or she is acting in accordance with an agreement by Medical Edge Australia to provide its services at a particular event or location;

11.    Regulation 64 amended (Prescribed persons for section 38(1)(i) of Act)

Regulation 64 of the Principal Regulations is amended as follows:

(a) by inserting the following paragraph after paragraph (c) :

(ca) a person –

(i) who is a pharmaceutical chemist; and

(ii) who has completed an educational program approved by the Secretary relating to the administration of vaccines –

may administer to another person, in accordance with a vaccination program approved by the Director of Public Health, a vaccine listed in Schedule 4 to the Poisons List; and

(b) by inserting in paragraph (d) "or midwife" after "a person who is a registered nurse";

(c) by omitting from paragraph (d) "registered nurse who" and substituting "person who is a registered nurse, midwife or pharmaceutical chemist and who";

(d) by omitting from paragraph (d)(ii) "Director." and substituting "Director; and";

(e) by inserting the following paragraph after paragraph (d) :

(e) a person who is a pharmaceutical chemist and who satisfies the requirements of paragraph (ca)(ii) may supervise the administration of a vaccine, listed in Schedule 4 to the Poisons List, in accordance with a vaccination program approved by the Director of Public Health, by another person who is a pharmaceutical chemist and who –

(i) is undertaking an educational program approved by the Secretary relating to the administration of vaccines; or

(ii) has been approved by the Director of Public Health to administer vaccines specified by the Director.

12.    Regulation 76 amended (Wholesale dealing)

Regulation 76(3) of the Principal Regulations is amended as follows:

(a) by omitting from paragraph (j) "dental therapist." and substituting "dental therapist;";

(b) by inserting the following paragraph after paragraph (j) :

(k) in respect of the substances specified in regulation 64(b) , a registered nurse or midwife.

13.    Part 4A inserted

After regulation 78 of the Principal Regulations , the following Part is inserted:

PART 4A - Standing orders for administration of restricted substances and narcotic substances

78A.   Interpretation

In this Part –

community health centre means a health centre approved in writing by the Secretary as a community health centre to which this Part applies;

Drugs and Therapeutics Committee means a Drugs and Therapeutics Committee established under regulation 78B(1) or (2) ;

medical intern means a medical school graduate working in an intern position accredited by an authority approved by the Medical Board of Australia;

medical practitioner does not include a medical intern;

pharmaceutical chemist does not include a pharmacy trainee;

standing order means a standing order that complies with regulation 78J and that is –

(a) prepared by the Director of Public Health for the purposes of regulation 78E ; or

(b) prepared by a medical practitioner for the purposes of regulation 78F , 78G , 78H or 78I .

78B.   Drugs and Therapeutics Committee

(1)  The Secretary is to establish a Drugs and Therapeutics Committee for the purpose of considering applications from medical practitioners for authorisations to issue standing orders that are to apply in relation to public hospitals, day-treatment centres or community health centres.

(2)  The governing body of a private hospital or private day-treatment centre is to establish a Drugs and Therapeutics Committee for the purpose of considering applications from medical practitioners for authorisations to issue standing orders that are to apply in relation to the private hospital or private day-treatment centre.

(3)  A Drugs and Therapeutics Committee is to include at least one medical practitioner, one registered nurse and one pharmacist.

(4)  The Secretary, or the governing body of a private hospital or private day-treatment centre, may provide for, in writing, the regulation of the proceedings of a Drugs and Therapeutics Committee.

(5)  Except as provided otherwise by the Secretary, or the governing body of a private hospital or private day-treatment centre, a Drugs and Therapeutics Committee may regulate its own proceedings.

78C.   Application for authorisation of issue of standing order

(1)  A medical practitioner may apply to a Drugs and Therapeutics Committee for an authorisation to issue a standing order.

(2)  An application under subregulation (1) must include the following:

(a) a copy of the standing order that is the subject of the application;

(b) the name of the public hospital, day-treatment centre, community health centre, private hospital or private day-treatment centre in relation to which the standing order is to have effect;

(c) the name of the applicant;

(d) the name of the restricted substance or narcotic substance referred to in the standing order and its form and strength;

(e) the dose and route of administration of the restricted substance or narcotic substance;

(f) if applicable, the frequency of administration of the restricted substance or narcotic substance;

(g) if applicable, the maximum duration for which the restricted substance or narcotic substance is to be administered;

(h) if applicable, the maximum quantity of the restricted substance or narcotic substance that is to be administered;

(i) the clinical circumstances in which the restricted substance or narcotic substance is to be administered;

(j) if applicable, details of the persons to whom, and the clinical circumstances in which, the restricted substance or narcotic substance must not be administered;

(k) if applicable, the clinical area in relation to which the standing order applies;

(l) if applicable, the education and endorsement requirements required for a registered nurse or midwife to whom the standing order applies;

(m) the date the standing order is to take effect;

(n) the reasons for the standing order and how it will improve patient care;

(o) any other information the Secretary considers necessary.

78D.   Determination of application

(1)  After considering an application made under regulation 78C , a Drugs and Therapeutics Committee may –

(a) approve the application and authorise the issue of the standing order; or

(b) refuse to approve the application.

(2)  If a Drugs and Therapeutics Committee approves an application under subregulation (1)(a) , the Committee is to notify the applicant that the issue of the standing order is authorised.

(3)  If a Drugs and Therapeutics Committee refuses to approve an application under subregulation (1)(b) , the Committee is to –

(a) notify the applicant that the application has been refused and the issue of the standing order is not authorised; and

(b) advise the applicant of the reasons for the refusal.

78E.   Standing orders issued by Director of Public Health in public health emergencies or for treatment of notifiable diseases

(1)  If the Director of Public Health makes a declaration under section 14(1) of the Public Health Act 1997 that a public health emergency exists, the Director of Public Health may also issue a standing order in relation to the administration of a restricted substance, by a registered nurse or midwife, to persons affected by the public health emergency.

(2)  If, in relation to a notifiable disease, the Director of Public Health issues –

(a) a notice under section 42 of the Public Health Act 1997 ; or

(b) an order under section 53 of the Public Health Act 1997  –

the Director of Public Health may also issue a standing order in relation to the administration of a restricted substance, by a registered nurse or midwife, to persons for the purpose of treating that notifiable disease.

78F.   Standing orders issued by medical practitioners for persons treated in public hospitals or day-treatment centres

(1)  A medical practitioner may issue a standing order in relation to the administration of a restricted substance or narcotic substance, by a registered nurse or midwife, or a registered nurse and midwife, to persons being treated in a public hospital or day-treatment centre.

(2)  Subregulation (1) only applies in relation to the issue of a standing order by a medical practitioner if –

(a) the medical practitioner has made an application, under regulation 78C , to the Drugs and Therapeutics Committee for authorisation to issue the standing order; and

(b) the medical practitioner has received notification, under regulation 78D(2) , that the application has been approved and the issue of the standing order is authorised.

78G.   Standing orders issued by medical practitioner for patients of medical practitioner treated in private hospitals or private day-treatment centres

(1)  A medical practitioner may issue a standing order in relation to the administration of a restricted substance or narcotic substance, by a registered nurse or midwife, or a registered nurse and midwife, to a patient of the medical practitioner who is being treated in a private hospital or private day-treatment centre.

(2)  Subregulation (1) only applies in relation to the issue of a standing order by a medical practitioner if –

(a) the medical practitioner has made an application, under regulation 78C , to the Drugs and Therapeutics Committee at the private hospital or private day-treatment centre for authorisation to issue the standing order; and

(b) the medical practitioner has received notification, under regulation 78D(2) , that the application has been approved and the issue of the standing order is authorised.

78H.   Standing orders issued by medical practitioners for persons treated in community health centres

(1)  A medical practitioner may issue a standing order in relation to the administration of a restricted substance or narcotic substance, by a registered nurse employed at a community health centre, to persons being treated in the community health centre.

(2)  Subregulation (1) only applies in relation to the issue of a standing order by a medical practitioner if –

(a) the medical practitioner has made an application, under regulation 78C , to the Drugs and Therapeutics Committee for authorisation to issue the standing order; and

(b) the medical practitioner has received notification, under regulation 78D(2) , that the application has been approved and the issue of the standing order is authorised.

78I.   Standing orders issued by medical practitioners for persons treated in remote areas

(1)  A medical practitioner may issue a standing order in relation to the administration of a restricted substance or narcotic substance, by a registered nurse or midwife who attends an emergency in a remote area, to persons who require urgent treatment, if it is not practicable for a medical practitioner to be present to administer the restricted substance or narcotic substance to the person requiring urgent treatment.

(2)  Subregulation (1) only applies in relation to the issue of a standing order by a medical practitioner if –

(a) the medical practitioner has made an application, under regulation 78C , to the Drugs and Therapeutics Committee for authorisation to issue the standing order; and

(b) the medical practitioner has received notification, under regulation 78D(2) , that the application has been approved and the issue of the standing order is authorised.

78J.   Form of standing orders

(1)  A standing order must –

(a) in the case of a standing order issued by a medical practitioner, specify the name of that medical practitioner; and

(b) contain a unique number for the standing order; and

(c) if applicable, specify that the Director of Public Health is issuing the standing order and describe the notifiable disease or public health emergency to which the standing order relates; and

(d) if applicable, specify the public hospital, day-treatment centre, private hospital, private day-treatment centre or community health centre in relation to which the standing order applies; and

(e) if applicable, specify the remote area in relation to which the standing order applies; and

(f) specify the date on which the standing order is to take effect; and

(g) specify the date, not more than 2 years after the specified date on which the standing order took effect, on which the standing order will cease to have effect; and

(h) if applicable, specify the clinical area to which the standing order applies; and

(i) specify the clinical circumstances in which the restricted substance or narcotic substance may be administered; and

(j) describe the people to whom the restricted substance or narcotic substance may be administered; and

(k) if applicable, describe the people, if any, to whom the restricted substance or narcotic substance must not be administered; and

(l) specify the Australian Approved Name of the restricted substance or narcotic substance and, if applicable, its brand name; and

(m) if applicable, specify the form and strength of the restricted substance or narcotic substance; and

(n) specify the dose and route of administration of the restricted substance or narcotic substance; and

(o) if applicable, specify the frequency of the administration of the restricted substance or narcotic substance; and

(p) if applicable, specify the maximum duration for which the restricted substance or narcotic substance is to be administered; and

(q) if applicable, specify the maximum quantity of the restricted substance or narcotic substance to be administered; and

(r) if applicable, specify the educational and endorsement requirements necessary for a registered nurse or midwife to whom the standing order applies; and

(s) be signed by the medical practitioner issuing the standing order.

(2)  In this regulation –

Australian Approved Name means the name approved by the Therapeutic Goods Association.

78K.   Authorisation by standing orders

A standing order authorises a registered nurse or midwife to whom the standing order applies to possess, and administer, in accordance with the standing order, a restricted substance or narcotic substance.

78L.   Offences relating to standing orders

A person must not issue a standing order for a restricted substance or narcotic substance if the person is not authorised under these regulations to issue the standing order.

Penalty:  Fine not exceeding 10 penalty units.

78M.   Revocation of standing orders

(1)  The Drugs and Therapeutics Committee, by notice in writing given to the medical practitioner who issued a standing order, may revoke the standing order –

(a) if requested to do so by that medical practitioner; or

(b) if the Committee considers it appropriate to do so.

(2)  The Drugs and Therapeutics Committee is to specify in the notice referred to in subregulation (1) the day on which a revocation takes effect.

14.    Regulation 96A inserted

After regulation 96 of the Principal Regulations , the following regulation is inserted in Part 6:

96A.   Administration of certain substances to animals

(1)  A veterinary surgeon may issue a written order to a veterinary nurse, employed by the veterinary surgeon in the course of his or her practice or business –

(a) authorising the veterinary nurse to administer a substance specified in Schedule 4 to the Poisons List, and also specified in the order, to an animal for the purpose of the treatment of that animal; and

(b) setting out instructions for the administration by the veterinary nurse of that substance.

(2)  A veterinary nurse may administer a substance specified in Schedule 4 to the Poisons List to an animal for the purpose of treating that animal if –

(a) the veterinary nurse is authorised by a veterinary surgeon, in accordance with subregulation (1) , to administer the substance to the animal; and

(b) the substance has been lawfully prescribed and supplied for the animal to whom it is being administered; and

(c) the administration is in accordance with the instructions of that veterinary surgeon.

Displayed and numbered in accordance with the Rules Publication Act 1953.

Notified in the Gazette on 3 February 2016

These regulations are administered in the Department of Health and Human Services.

EXPLANATORY NOTE

(This note is not part of the regulation)

These regulations amend the Poisons Regulations 2008 to –

(a) enable the Director of Public Health and medical practitioners to issue standing orders for the administration of restricted substances and narcotic substances by certain health professionals in certain circumstances; and

(b) alter the conditions that certain medical practitioners must comply with on issuing a prescription; and

(c) prescribe certain persons who are pharmaceutical chemists, midwives and registered nurses as persons who may administer to another person a vaccine listed in Schedule 4 to the Poisons List and the circumstances in which that administration is to occur; and

(d) make provision in relation to certain other miscellaneous matters under the Act.