Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p43
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 43/161)
Character Range: 14076745–14082348

Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                   Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
                                                                                   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.
C13293              P13293         CN13293          Mecasermin                     Severe growth failure with primary insulin-like growth factor-1 deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must have a bone age of less than 13.5 years (females); or
                                                                                   Patient must have a bone age of less than 15.5 years (males); AND
                                                                                   The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND
                                                                                   The condition must be responsive to this drug treatment as evidenced by each of:
                                                                                    (i) patient is showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (ii) patient has a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this continuing authority application; or
                                                                                   The condition must be yet to respond to this drug treatment only for the reason of sub-optimal dosing; AND
                                                                                   Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or
                                                                                   Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician;
                                                                                   Patient must be aged from 2 years up until their 18th birthday.
                                                                                   The continuing treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include
                                                                                   (1) The patient's height (cm);
                                                                                   (2) Where this authority application seeks to continue treatment where there has been an inadequate response to treatment due to sub-optimal dosing, state each of
                                                                                   (i) the most recently prescribed dose (mg/kg) that resulted in an inadequate response;
                                                                                   (ii) the dose (mg/kg) (between 0.04 to 0.12) that was/will be subsequently prescribed to address the inadequate response;
                                                                                   (3) The patient's weight (kg);
                                                                                   (4) The patient's growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment);
                                                                                   (5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity