South Australian Current Regulations

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CONTROLLED SUBSTANCES (POISONS) REGULATIONS 2011 - REG 19

19—Regulation of prescription drugs—prescription of certain S4 drugs by medical practitioners (section 18(2) of Act)

        (1)         For the purposes of section 18(2) of the Act—

            (a)         each of the S4 drugs listed in column 1 of the table below, when used for the purpose set out in column 2, is a prescribed prescription drug; and

            (b)         the qualifications and requirements specified in that table alongside a drug or list of drugs in column 3 are prescribed qualifications and requirements.



Prescription drug

Use

Qualifications and requirements

1

Clomiphene

Cyclofenil

Follitropin alpha (recombinant human follicle stimulating hormone)

Follitropin beta (recombinant human follicle stimulating hormone)

Luteinising hormone

Urofollitrophin (follicle stimulating hormone)

Human use

Medical practitioner who—

            (a)         is registered in the specialty of endocrinology or obstetrics and gynaecology; or

            (b)         provides services to a fertility unit, an endocrinology unit or obstetrics and gynaecology unit of a teaching hospital in South Australia.

2

Acitretin

Bexarotene

Etretinate

Human use

Medical practitioner who—

            (a)         is registered in the specialty of dermatology, oncology or haematology; or

            (b)         is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or

            (c)         is registered in some other specialty and is authorised by the Minister to prescribe such drugs.

3

Isotretinoin

Human internal use

Medical practitioner who—

            (a)         is registered in the specialty of dermatology, oncology or haematology; or

            (b)         is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or

            (c)         is registered in some other speciality and is authorised by the Minister to prescribe such drugs.

4

Tretinoin

Human internal use

Medical practitioner who—

            (a)         is registered in the specialty of oncology or haematology; or

            (b)         is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or

            (c)         is registered in some other speciality and is authorised by the Minister to prescribe such drugs.

5

Lenalidomide

Pomalidomide

Thalidomide

Human use

A medical practitioner who—

            (a)         is registered in the specialty of oncology or haematology; or

            (b)         is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or

            (c)         is authorised by the Minister to prescribe such drugs.

6

Ambrisentan

Bosentan

Macitentan

Sitaxentan

Human use

A medical practitioner who—

            (a)         is registered as a specialist; or

            (b)         is a medical registrar who is working under the supervision of a medical practitioner referred to in paragraph (a); or

            (c)         is authorised by the Minister to prescribe such drugs.

7

Enzalutamide

Human use

A medical practitioner who—

            (a)         is registered as a specialist; or

            (b)         is a medical registrar who is working under the supervision of a medical practitioner referred to in paragraph (a); or

            (c)         is authorised by the Minister to prescribe such drugs.

8

Riociguat

Human use

A medical practitioner who—

            (a)         is registered as a specialist; or

            (b)         is a medical registrar who is working under the supervision of a medical practitioner referred to in paragraph (a); or

            (c)         is authorised by the Minister to prescribe such drugs.

        (2)         A medical practitioner who prescribes an S4 drug listed in the table in subregulation (1) (other than in item 1) must—

            (a)         inform the patient of the name of the drug and that the drug may cause birth defects; and

            (b)         provide the patient with written information about the drug and its potential side effects; and

            (c)         inform the patient of the dangers should the patient unlawfully supply the drug to another person; and

            (d)         if the patient is a female of child-bearing age—

                  (i)         ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and

                  (ii)         inform her that she must not become pregnant during treatment or within the prescribed period after completion of treatment; and

            (e)         obtain written consent for the treatment from the patient.

Maximum penalty: $5 000.

        (3)         In this regulation—

"prescribed period" means—

            (a)         in the case of treatment with a drug listed in item 2 of the table in subregulation (1) (other than bexarotene)—24 months;

            (b)         in the case of treatment with bexarotene or a drug listed in item 3, 4, 5 or 8 of that table—1 month;

            (c)         in the case of treatment with a drug listed in item 6 or 7 of that table—3 months.



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