Poisons Amendment (Miscellaneous) Regulations 2020

Poisons Amendment (Miscellaneous) Regulations 2020

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 .

30 March 2020

C. WARNER

Governor

By Her Excellency's Command,

S. Courtney

Minister for Health

1.   Short title

These regulations may be cited as the Poisons Amendment (Miscellaneous) Regulations 2020 .

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 2018 are referred to as the Principal Regulations.

4.    Regulation 3 amended (Interpretation)

Regulation 3(1) of the Principal Regulations is amended by omitting paragraph (a) from the definition of medication chart and substituting:

(a) a medication chart in a format formulated by the Australian Commission on Safety and Quality in Health Care established under section 8 of the National Health Reform Act 2011 of the Commonwealth; and

5.    Regulation 20 amended (Prescribing and supplying narcotic substances)

Regulation 20(8) of the Principal Regulations is amended by omitting paragraph (b) and substituting the following paragraph:

(b) the prescription is issued on a medication chart and the following fields have been completed legibly in ink by a medical practitioner, authorised nurse practitioner or authorised health professional:

(i) the name, form and strength of the narcotic substance;

(ii) the date of prescribing the narcotic substance;

(iii) the dose of the narcotic substance;

(iv) the frequency of administration of the narcotic substance;

(v) the route of administration of the narcotic substance;

(vi) the signature of the person prescribing the narcotic substance; and

6.    Regulation 45 amended (Prescriptions for restricted substances)

Regulation 45 of the Principal Regulations is amended by omitting subregulation (7) and substituting the following subregulation:

(7)  A prescription is to be taken, for the purposes of these regulations, to have been issued in accordance with subregulation (5) if –

(a) the prescription is issued in respect of a patient who is an admitted patient of a medical institution; and

(b) the prescription is issued on a medication chart and the following fields have been completed legibly in ink by a medical practitioner, endorsed midwife, authorised nurse practitioner or authorised health professional:

(i) the name, form and strength of the restricted substance;

(ii) the date of prescribing the restricted substance;

(iii) the dose of the restricted substance;

(iv) the frequency of administration or a notation to the effect that the restricted substance is to be used as directed;

(v) the route of administration of the restricted substance;

(vi) the signature of the person prescribing the restricted substance.

7.    Regulation 48 amended (Continued dispensing without prescription in specified circumstances)

Regulation 48 of the Principal Regulations is amended as follows:

(a) by omitting from subregulation (1) "maximum single Pharmaceutical Benefit Listed quantity" and substituting "PBS maximum quantity";

(b) by omitting the definition of maximum single Pharmaceutical Benefit Listed quantity from subregulation (2) ;

(c) by omitting "time." from the definition of National Health (Continued Dispensing) Determination in subregulation (2) and substituting "time;";

(d) by inserting the following definitions after the definition of National Health (Continued Dispensing) Determination in subregulation (2) :

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 means the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 made under the National Health Act 1953 of the Commonwealth, as amended from time to time;

PBS maximum quantity, in respect of an eligible restricted substance, means the maximum quantity specified for that substance in Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

8.    Regulation 53A inserted

After regulation 53 of the Principal Regulations , the following regulation is inserted in Division 2:

53A.   Sale or supply of restricted substances other than specified psychotropic substances without prescription

(1)  Regulation 51 does not apply in respect of a restricted substance, other than a specified psychotropic substance, if the restricted substance is sold or supplied –

(a) by a pharmaceutical chemist in accordance with an order made by the Director of Public Health under section 53 of the Public Health Act 1997 specifying the restricted substance and that it may be sold or supplied without a prescription; and

(b) while the order is in force under that Act.

(2)  Regulation 51 does not apply in respect of a restricted substance, other than a specified psychotropic substance –

(a) if –

(i) the exercise of emergency powers has been authorised under sections 40 , 41A or 45 of the Emergency Management Act 2006 in respect of an emergency; or

(ii) an emergency declaration has been made under section 14 of the Public Health Act 1997 ; and

(b) the restricted substance is sold or supplied by a pharmaceutical chemist; and

(c) the pharmaceutical chemist is satisfied on reasonable grounds that the person seeking the sale or supply of the restricted substance –

(i) has a valid prescription for the restricted substance to be sold or supplied but is unable to provide the prescription to the pharmaceutical chemist due to the emergency, to which the authorisation, or declaration, referred to in paragraph (a) relates; or

(ii) requires provision of the restricted substance and has previously had a valid prescription for the restricted substance to be sold or supplied but is unable to be issued with a new prescription for the restricted substance due to the emergency, to which the authorisation, or declaration, referred to in paragraph (a) relates.

(3)  If a restricted substance is sold or supplied in accordance with subregulation (1) or (2)  –

(a) the maximum quantity of that substance that may be sold or supplied to a person under those subregulations is –

(i) if the substance is a PBS restricted substance, the PBS maximum quantity; and

(ii) if the substance is not a PBS restricted substance, the quantity contained in the smallest package in which the substance is generally available; and

(b) the restricted substance must be labelled in accordance with regulation 53(c) ; and

(c) the pharmaceutical chemist must make an entry into in the approved recording system relating to the pharmacy at which that supply is effected in accordance with regulation 53(d) .

(4)  For the purposes of subregulation (3)  –

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 means the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 made under the National Health Act 1953 of the Commonwealth, as amended from time to time;

PBS maximum quantity, in respect of a PBS restricted substance, means the maximum quantity specified for that substance in Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012;

PBS restricted substance means a restricted substance specified in Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

9.    Regulation 58 amended (Supply of potent substances by pharmaceutical chemists)

Regulation 58 of the Principal Regulations is amended by inserting after subregulation (7) the following subregulation:

(8)  Notwithstanding this regulation, a pharmaceutical chemist may supply naloxone (S3) for the treatment of opioid toxicity to a certified person within the meaning of section 56A of the Public Health Act 1997 .

10.    Regulation 70 amended (Possession and supply of nitrous oxide at workplace)

Regulation 70 of the Principal Regulations is amended as follows:

(a) by omitting from paragraph (b) "or paramedic";

(b) by omitting from paragraph (c) "or paramedic";

(c) by omitting from paragraph (d) "or paramedic".

11.    Regulation 71 amended (Possession and supply of methoxyflurane at workplace)

Regulation 71 of the Principal Regulations is amended as follows:

(a) by omitting from paragraph (b) "or paramedic";

(b) by omitting from paragraph (c) "or paramedic";

(c) by omitting from paragraph (d) "or paramedic".

12.    Regulation 74 amended (Possession, &c., of nitrous oxide by relevant first-aiders)

Regulation 74 of the Principal Regulations is amended as follows:

(a) by omitting from paragraph (b) "or paramedic";

(b) by omitting from paragraph (c) "or paramedic";

(c) by omitting from paragraph (d) "or paramedic".

13.    Regulation 75 amended (Possession, &c., of methoxyflurane by relevant first-aiders)

Regulation 75 of the Principal Regulations is amended as follows:

(a) by omitting from paragraph (b) "or paramedic";

(b) by omitting from paragraph (c) "or paramedic";

(c) by omitting from paragraph (d) "or paramedic".

14.    Part 4, Division 8A inserted

After regulation 79 of the Principal Regulations , the following Division is inserted in Part 4:

Division 8A - Possession and supply of naloxone by needle and syringe services

79A.   Interpretation of Division

In this Division –

certified person has the same meaning as in section 56A of the Public Health Act 1997 ;

needle and syringe service has the same meaning as in section 56A of the Public Health Act 1997 ;

permitted premises has the same meaning as in section 56A of the Public Health Act 1997 .

79B.   Possession, &c., of naloxone by certified person at permitted premises

(1)  Subject to subregulation (2) , a certified person may, at permitted premises –

(a) possess naloxone; and

(b) if the certified person believes that a person is at considerable risk of opioid toxicity, administer it, or supply it for administration, to the person with or without instruction from a prescriber.

(2)  If a certified person supplies naloxone to a person for administration in accordance with subregulation (1) , the certified person is to also supply to the person an information sheet containing information regarding the use of naloxone for the treatment of opioid toxicity.

79C.   Records of possession, supply and administration to be kept

(1)  If naloxone comes into the possession of, or is supplied or administered by, a certified person under this Division, the certified person must make and keep a written record of that possession, administration or supply.

(2)  A written record required under subregulation (1) is to include the name of the certified person and the address of the permitted premises and, if relevant, the name of a prescriber on whose instructions the substance was supplied.

15.   Regulation 82 amended (Prescribed persons for section 38(1)(i) of Act)

Regulation 82 of the Principal Regulations is amended as follows:

(a) by renumbering the text of the regulation as subregulation (1);

(b) by omitting from paragraph (c) "a vaccination" and substituting "an immunisation";

(c) by omitting from paragraph (d) "a vaccination" and substituting "an immunisation";

(d) by omitting from paragraph (e) "a vaccination" and substituting "an immunisation";

(e) by omitting from paragraph (e) "midwife or pharmaceutical chemist" and substituting "midwife, pharmaceutical chemist or pharmaceutical chemist who holds provisional registration with AHRPA";

(f) by omitting from paragraph (f) "a vaccination" and substituting "an immunisation";

(g) by omitting from paragraph (f) "pharmaceutical chemist" second occurring and substituting "pharmaceutical chemist or pharmaceutical chemist who holds provisional registration with AHPRA";

(h) by inserting the following subregulation after subregulation (1) :

(2)  In this regulation –

AHPRA means the Australian Health Practitioner Regulation Agency, established under section 23 of the Health Practitioner Regulation National Law (Tasmania).

16.    Regulation 87 amended (Prescription, &c., of certain substances prohibited, unless authorised by Secretary)

Regulation 87(1) of the Principal Regulations is amended by inserting after paragraph (o) the following paragraph:

(oa) hydroxychloroquine;

17.    Regulation 127 amended (Administration of certain substances by disability service workers)

Regulation 127(1) of the Principal Regulations is amended by omitting paragraph (b) from the definition of specified narcotic substance and substituting:

(b) methylphenidate; or

(c) lisdexamphetamine.

18.    Schedule 8 amended (Infringement Notice Offences)

Schedule 8 to the Principal Regulations is amended by inserting after item 52A in Part 1 the following item:

52B.

Section 86G(4)

10

19.   Regulations rescinded

These regulations are rescinded on the first anniversary of the day on which they take effect.

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

Notified in the Gazette on 31 March 2020

These regulations are administered in the Department of Health.

EXPLANATORY NOTE

(This note is not part of the regulation)

These regulations amend the Poisons Regulations 2018 by –

(a) providing for supply of restricted substances by pharmacists without a prescription in certain circumstances; and

(b) providing for naloxone to be possessed, supplied and administered in certain circumstances by needle and syringe program providers; and

(c) including lisdexamphetamine as a specified narcotic substance that is able to be administered, or made available for self-administration by, disability service workers; and

(d) providing that instructions to supply certain substances are only to be issued by medical practitioners; and

(e) providing that pharmacists with provisional registration are able to administer vaccines; and

(f) updating the requirements for prescriptions issued on a medication chart; and

(g) updating terminology relating to immunisation programs; and

(h) including an offence relating to the seizure of ice pipes in the list of infringement notice offences.