88Precautions in prescribing substances capable of producing birth defects

88 Precautions in prescribing substances capable of producing birth defects

(1)  A medical practitioner must not prescribe or supply for use in the treatment of a female patient acitretin, bexarotene, bosentan, etretinate, sitaxentan, isotretinoin for oral use, tretinoin for oral use or thalidomide unless –

(a) the medical practitioner is satisfied that, at that time, the patient is not pregnant; and

(b) the medical practitioner –

(i) is satisfied that the patient is incapable, after that time, of becoming pregnant; or

(ii) warns the patient that, if she is, or becomes, pregnant at any time during the period specified in subregulation (2) , any child of that pregnancy is extremely likely to suffer severe birth defects.

Penalty:  Fine not exceeding 10 penalty units.

(2)  The period referred to in subregulation (1)(b)(ii) is the period –

(a) commencing at the commencement of the period of treatment of the patient with acitretin, bexarotene, bosentan, etretinate, sitaxentan, isotretinoin for oral use, tretinoin for oral use or thalidomide, as the case requires; and

(b) ending –

(i) in the case of treatment with acitretin or etretinate, 2 years after the completion of that treatment; or

(ii) in the case of treatment with bosentan or sitaxentan, 3 months after the completion of that treatment; or

(iii) in the case of treatment with isotretinoin for oral use, tretinoin for oral use, bexarotene or thalidomide, one month after the completion of that treatment.