Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p1
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 1/381)
Character Range: 11382446–11391951

1  Circumstances, purposes and conditions
  The following table sets out:
 (a) circumstances for circumstances codes, for the purposes of section 13 and 23; and
 (b) purposes for purposes codes, for the purposes of sections 15 and 16; and
 (c) for the purposes of section 19, information relating to how authorisation is obtained when the circumstances or conditions for writing a prescription include an authorisation requirement.

Circumstances Code  Purposes Code  Conditions Code  Listed Drug                                                                                                     Circumstances and Purposes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Authority Requirements (part of Circumstances; or Conditions)

C10020              P10020         CN10020          Risperidone                                                                                                     Behavioural disturbances                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 10020
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be characterised by psychotic symptoms and aggression; AND
                                                                                                                                                                    Patient must have dementia of the Alzheimer type; AND
                                                                                                                                                                    Patient must have failed to respond to non-pharmacological methods of treatment; AND
                                                                                                                                                                    Patient must not receive more than 12 weeks of treatment under this restriction.
                                                                                                                                                                    A patient may only qualify for 12 weeks of PBS-subsidised treatment under this restriction once in a 12 month period.
C10021              P10021         CN10021          Risperidone                                                                                                     Behavioural disturbances                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment, trial of dose reduction or cessation of treatment
                                                                                                                                                                    The condition must be characterised by psychotic symptoms and aggression; AND
                                                                                                                                                                    Patient must have dementia of the Alzheimer type; AND
                                                                                                                                                                    Patient must have responded to an initial course of treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have failed to respond to non-pharmacological methods of treatment; AND
                                                                                                                                                                    The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; or
                                                                                                                                                                    Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND
                                                                                                                                                                    Patient must be optimised on non-pharmacological methods of treatment.
                                                                                                                                                                    The patient's response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.
                                                                                                                                                                    Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.
                                                                                                                                                                    Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.
                                                                                                                                                                    Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.
                                                                                                                                                                    Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.
                                                                                                                                                                    Evidence of patient benefit from therapy, failure