PB 41 of 2010
National Health (Emergency Treatment Program) Special Arrangements Instrument 20101
National Health Act 1953
I, LINDA JACKSON, Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make:
(a)   special arrangements under subsection 100 (1) of the National Health Act 1953; and
(b)   a declaration under paragraph 100AA (1) (a) of that Act.
Dated 28 April 2010
 
LINDA JACKSON
Assistant Secretary, Access and Systems Branch, Department of Health and Ageing
Contents
                        1     Name of Instrument                                                                             3
                        2     Commencement                                                                                  3
                        3     Definitions                                                                                           3
                        4     Declaration of special pharmaceutical products                                      3
                        5     Supply of emergency treatment drug by medical practitioner                   3
                        6     Obtaining emergency treatment drugs                                                   4
                        7     Notice to be given by approved medical practitioner                                4
                        8     Supply of emergency treatment drug by approved pharmacist                  5
                        9     Retention of forms                                                                               5
                       10     Payment to approved pharmacist for supply                                           5
                       11     Payment to approved medical practitioner for supply                               6
                       12     Claim for payment for supply                                                                6
                       13     Co‑payment not to be made                                                                 6
Schedule 1             Emergency treatment drugs                                                              7
 
 
1              Name of Instrument
         (1)   This Instrument is the National Health (Emergency Treatment Program) Special Arrangements Instrument 2010.
         (2)   This Instrument may also be cited as Instrument No. PB 41 of 2010.
2              Commencement
                This Instrument commences on 1 May 2010.
3              Definitions
                In this Instrument:
Act means the National Health Act 1953.
approved medical practitioner has the meaning given by subsection 84 (1) of the Act.
approved pharmacist has the meaning given by subsection 84 (1) of the Act.
hospital treatment has the same meaning as in subsection 4 (1) of the Act.
Regulations means the National Health (Pharmaceutical Benefits) Regulations 1960.
4              Declaration of special pharmaceutical products
         (1)   For subsection 100AA (2) of the Act, a drug or medicinal preparation mentioned in Schedule 1 is declared to be a drug or medical preparation to which section 100AA of the Act applies.
Note   A drug or medicinal preparation declared under subsection 100AA (1) of the Act is a special pharmaceutical product for Part VII of the Act.
         (2)   An emergency treatment drug is the drug or medicinal preparation:
                (a)    in a form mentioned for the drug or medicinal preparation in Schedule 1, by reference to strength, type of unit, size of unit or otherwise; and
               (b)    with the manner of administration mentioned in Schedule 1 for the drug or medicinal preparation in that form; and
                (c)    with a brand mentioned in Schedule 1 for the drug or medicinal preparation in that form and with that manner of administration.
5              Supply of emergency treatment drug by medical practitioner
                A medical practitioner may supply an emergency treatment drug as follows:
                (a)    to a person who is entitled to receive pharmaceutical benefits under Part VII of the Act;
               (b)    for emergency medical treatment of the person by the medical practitioner, but only if the treatment is not hospital treatment.
Note   Section 86 of the Act provides for the entitlement by persons to receive pharmaceutical benefits under Part VII of the Act.
6              Obtaining emergency treatment drugs
         (1)   A medical practitioner may obtain, only once in any month, the maximum quantity or number of units of an emergency treatment drug mentioned for the drug in Schedule 1, less the quantity or number of units of the drug that:
                (a)    is still in the medical practitioner’s possession; and
               (b)    was previously obtained by the medical practitioner under the arrangements set out in this Instrument.
Obtaining emergency treatment drugs from approved pharmacist
         (2)   If the medical practitioner is not an approved medical practitioner, the medical practitioner:
                (a)    may obtain an emergency treatment drug only from an approved pharmacist; and
               (b)    must do so in the way described in regulation 16 of the Regulations for obtaining a pharmaceutical benefit for section 93 of the Act.
         (3)   If a medical practitioner obtains an emergency treatment drug as mentioned in subclause (2):
                (a)    the medical practitioner must give a receipt for the emergency treatment drug to the approved pharmacist; and
               (b)    must do so in the way described in subregulation 16 (3) of the Regulations for receiving a pharmaceutical benefit under section 93 of the Act.
         (4)   An approved medical practitioner must not obtain an emergency treatment drug from an approved pharmacist.
7              Notice to be given by approved medical practitioner
         (1)   An approved medical practitioner who obtains an emergency treatment drug under subclause 6 (1) must give a notice to the Secretary that he or she has obtained the drug.
         (2)   The notice must be:
                (a)    in the form authorised by the Secretary under paragraph 18A (4) (a) of the Regulations, as if the emergency treatment drug were a pharmaceutical benefit obtained for the purpose of section 93 of the Act; and
               (b)    signed and dated by the medical practitioner.
         (3)   The medical practitioner must keep a copy of the notice for at least 1 year after the date on which he or she gives the notice to the Secretary.
8              Supply of emergency treatment drug by approved pharmacist
                If an approved pharmacist supplies an emergency treatment drug to a medical practitioner who is not known to the pharmacist, the pharmacist must:
                (a)    obtain the medical practitioner’s full name, address and medical registration number; and
               (b)    specify those particulars in the order form mentioned in subregulation 16 (1) of the Regulations and lodged for the purpose of obtaining an emergency treatment drug under subclause 6 (2).
9              Retention of forms
                If an approved pharmacist supplies an emergency treatment drug, he or she must:
                (a)    if the drug was supplied under an order lodged in the way described in paragraph 16 (1) (a) of the Regulations — keep the duplicate of the order in his or her possession for at least 1 year after the date of supply; or
               (b)    if the drug was supplied under an order lodged in the way described in paragraph 16 (1) (b) of the Regulations — keep the electronic order form for at least 1 year after the date of supply.
10            Payment to approved pharmacist for supply
         (1)   If an approved pharmacist supplies an emergency treatment drug to a medical practitioner who is not an approved medical practitioner, the pharmacist is entitled to be paid by the Commonwealth for the supply the amount worked out under subclause (2).
         (2)   For subclause (1), the amount is the sum of:
                (a)    the amount agreed between the Minister and the manufacturer of the emergency treatment drug for the sale of the drug; and
               (b)    a mark‑up on the amount that is in accordance with a determination, in force from time to time, made under paragraph 98B (1) (a) of the Act, as if:
                          (i)    the amount agreed under paragraph (2) (a) were the approved price to pharmacists under the determination; and
                         (ii)    the emergency treatment drug were a ready‑prepared pharmaceutical benefit under the determination; and
                (c)    the ready‑prepared dispensing fee mentioned in the determination.
11            Payment to approved medical practitioner for supply
         (1)   An approved medical practitioner who obtains an emergency treatment drug under clause 6, and complies with the requirements in subclause (2), is entitled to be paid by the Commonwealth for the supply the amount worked out under subclause 10 (2) as if the medical practitioner were an approved pharmacist.
         (2)   The requirements are that the approved medical practitioner:
                (a)    gives a notice under subclause 7 (2) to the Secretary about obtaining the emergency treatment drug; and
               (b)    gives the Secretary a claim for the payment under clause 12, in accordance with a form made available by the Secretary to approved medical practitioners under paragraph 18A (7) (c) of the Regulations, as if the emergency treatment drug were a pharmaceutical benefit obtained for the purpose of section 93 of the Act; and
                (c)    completes the claim form in accordance with directions on that form.
12            Claim for payment for supply
         (1)   An approved pharmacist or approved medical practitioner who wants to receive payment from the Commonwealth for the supply of an emergency treatment drug must make a claim for payment to the Secretary.
         (2)   The claim must be made in accordance with section 99AAA of the Act as if an emergency treatment drug were a pharmaceutical benefit that was supplied under section 93 of the Act.
13            Co‑payment not to be made
                A medical practitioner must not demand or receive a payment or other valuable consideration (other than, for an approved medical practitioner, a payment from the Commonwealth) for the supply of an emergency treatment drug to a person under clause 5.
Schedule 1        Emergency treatment drugs
(clause 4)
  
Item
Drug or medicinal preparation
Form (strength, type, size etc)
Manner of administration
Maximum quantity or number of units
Brand

1
Methoxyflurane
Liquid for inhalation 999.9 mg per g, 3 mL (with inhaler)
Inhalation by mouth
1
Penthrox

Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au.