Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p209
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 209/381)
Character Range: 12918572–12925226

and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                                                                                                    In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C12704              P12704         CN12704          Somatropin                                                                                                      Short stature due to short stature homeobox (SHOX) gene disorders                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or
                                                                                                                                                                    Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
                                                                                                                                                                    Patient must have a current height at or below the 1st percentile for age and sex; AND
                                                                                                                                                                    Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or
                                                                                                                                                                    Patient must have an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or
                                                                                                                                                                    Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
                                                                                                                                                                    Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
                                                                                                                                                                    Patient must not have an active tumour or evidence of tumour growth or activity; AND
                                                                                                                                                                    Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
                                                                                                                                                                    Patient must be male and must not have a height greater than or equal to 167.7cm; or
                                                                                                                                                                    Patient must be female and must not have a height greater than or equal to 155.0cm; AND
                                                                                                                                                                    Patient must be male and must not have a bone age of 15.5 years or more; or
                                                                                                                                                                    Patient must be female and must not have a bone age of 13.5 years or more; AND
                                                                                                                                                                    Must be treated by a specialist or consultant physician in paediatric endocrinology.  or
                                                                                                                                                                    Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
                                                                                                                                                                    An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or