Poisons Amendment Regulations (No. 3) 2021
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 .
13 December 2021B. BAKER
Governor
By Her Excellency's Command,
JEREMY ROCKLIFF
Minister for Health
These regulations may be cited as the Poisons Amendment Regulations (No. 3) 2021 .
These regulations take effect on 17 December 2021.
In these regulations, the Poisons Regulations 2018 are referred to as the Principal Regulations.
4. Regulation 53A rescinded
Regulation 53A of the Principal Regulations is rescinded.
5. Part 4A inserted
After regulation 95 of the Principal Regulations , the following is inserted:PART 4A - Monitored Medicines DatabaseIn this Part –dispensing information includes the following information in relation to the dispensing of a monitored medicine:(a) the date on which the monitored medicine is dispensed;(b) the name, residential address and date of birth of the person to whom the monitored medicine is dispensed;(c) the healthcare identifier that is assigned to the person to whom the monitored medicine is dispensed;(d) the name, form, strength and quantity of the monitored medicine that is dispensed;(e) the directions in relation to the use of the monitored medicine that is dispensed;(f) the name, business address and telephone number of the dispenser of the monitored medicine;(g) the healthcare identifier that is assigned to the dispenser of the monitored medicine;(h) the healthcare identifier that is assigned to the healthcare provider organisation relevant to the dispenser of the monitored medicine;healthcare identifier means healthcare identifier within the meaning of the Healthcare Identifiers Act 2010 of the Commonwealth;prescription information includes the following information in relation to the issue of a prescription for the supply of a monitored medicine:(a) the date on which the prescription is issued;(b) the name, residential address and date of birth of the person to whom the prescription is issued;(c) the healthcare identifier that is assigned to the person to whom the prescription is issued;(d) the name, form, strength and quantity of the monitored medicine to be supplied;(e) the number of repeats for the supply of the monitored medicine;(f) the directions specified on the prescription in relation to the use of the monitored medicine;(g) the name, business address and telephone number of the prescriber;(i) the healthcare identifier that is assigned to the prescriber;(h) the healthcare identifier that is assigned to the healthcare provider organisation relevant to the prescriber;sale and supply information includes the following information in relation to the sale, or to the supply, of a monitored medicine otherwise than on and in accordance with a prescription:(a) the date on which the monitored medicine is sold or supplied;(b) the name, residential address and date of birth of the person to whom the monitored medicine is sold or supplied;(c) the healthcare identifier that is assigned to the person to whom the monitored medicine is sold or supplied;(d) the name, form, strength and quantity of the monitored medicine that is sold or supplied;(e) the directions in relation to the use of the monitored medicine that is sold or supplied;(f) the name, business address and telephone number of the seller, or or supplier, of the monitored medicine;(g) the healthcare identifier that is assigned to the seller, or supplier, of the monitored medicine;(h) the healthcare identifier that is assigned to the healthcare provider organisation relevant to the sale, or supply, of the monitored medicine.95B. Prescribed monitored medicines
For the purposes of paragraph (b) of the definition of monitored medicines in section 3(1) of the Act, the following are prescribed monitored medicines:(a) codeine (S4);(b) tramadol;(c) dextropropoxyphene.For the purposes of paragraph (b) of the definition of dispenser in section 38A of the Act, the following persons are prescribed as a dispenser:(a) a medical practitioner;(b) a dentist;(c) a nurse practitioner;(d) an endorsed midwife;(e) an authorised health professional;(f) a pharmacy trainee.For the purposes of paragraph (c) of the definition of prescriber in section 38A of the Act, the following persons are prescribed as a prescriber:(a) an authorised health professional;(b) a nurse practitioner;(c) an endorsed midwife.95E. Prescribed manner and prescribed form of providing information to monitored medicines database
For the purposes of paragraph (c) of section 38C(1) of the Act, a data source entity is to provide information to the monitored medicines database in an electronic form and in an electronic manner.95F. Prescribed information provided to, or collected and stored in, the monitored medicines database
For the purposes of section 38D(1) of the Act the following information must be provided to, or collected and stored in, the monitored medicines database:(a) any personal information within the meaning of the Right to Information Act 2009 ;(b) any information obtained under a law of another jurisdiction for a purpose specified in section 38B(2) of the Act;(c) any prescription information that is obtained in relation to the issue of a prescription in Tasmania for the supply of a monitored medicine to –(i) a person who resides in Tasmania; or(ii) a person who resides in another State or a Territory;(d) any prescription information that is obtained in relation to the issue of a prescription in another State or a Territory for the supply of a monitored medicine to a person who resides in Tasmania;(e) any dispensing information that is obtained in relation to the dispensing of a monitored medicine in Tasmania to –(i) a person who resides in Tasmania; or(ii) a person who resides in another State or a Territory;(f) any dispensing information that is obtained in relation to the dispensing of a monitored medicine in another State or a Territory to a person who resides in Tasmania;(g) any sale and supply information that is obtained in relation to the sale and supply of a monitored medicine in Tasmania, otherwise than on and in accordance with a prescription, to –(i) a person who resides in Tasmania; or(ii) a person who resides in another State or a Territory;(h) any sale and supply information that is obtained in relation to the sale and supply of a monitored medicine in another State or a Territory to a person who resides in Tasmania, otherwise than on and in accordance with a prescription.
6. Schedule 8 amended (Infringement Notice Offences)
Schedule 8 to the Principal Regulations is amended by omitting item 19 from in Part 1 and substituting:
19.
Section 37(2)
4
19A
Section 38G
2
19B
Section 38H
2
19C
Section 38I(1)
2
19D
Section 38I(2)
2
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 14 December 2021
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 to –(a) prescribe certain substances that are prescribed to be monitored medicines; and(b) prescribe certain persons who are prescribed as a dispenser; and(c) prescribe certain persons who are prescribed as a prescriber; and(d) prescribe the manner, and the form, in which a data source entity is to provide information to the monitored medicines database; and(e) prescribe certain information that is to be provided to, or collected and stored in, the monitored medicines database; and(f) prescribe certain offences as offences for which an infringement notice may be issued; and(g) rescind a provision of the regulations, for the sale or supply of certain restricted substances, that is no longer required.