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.