Prescribing and supply changes introduced on 1 July 2015

Changes to PBS S100 prescribing arrangements for HIV antiretroviral therapy, hepatitis B medicines and clozapine have been introduced from 1 July 2015 to acknowledge that many people who take these medicines are being managed in the community setting.1

Prescriptions written before 1 July 2015, and their repeats, are to be dispensed according to the current (hospital-based) arrangement.1 , 2

HIV antiretroviral therapy (ART)

From 1 July 2015 the following changes were introduced:1

  • authorised prescribers no longer need to be affiliated with a hospital when prescribing
  • patients can be dispensed these medicines at a hospital or community pharmacy of their choice.

It is important to inform patients that community pharmacies are not required to supply HIV medicines within the usual 24 hours.3 The Australasian Society for HIV Medicine has strongly recommended that prescribers advise patients to lodge their prescriptions with community pharmacies 1 week before their current prescription runs out.3

Hepatitis B medicines

From 1 July 2015 the following changes were introduced:1

  • authorised prescribers no longer need to be affiliated with a hospital when prescribing
  • patients can be dispensed these medicines at a hospital or community pharmacy of their choice.

Clozapine for schizophrenia, maintenance therapy only

From 1 July 2015 the following changes were introduced for clozapine maintenance therapy only (not when starting treatment):2

  • registered prescribers no longer need to be affiliated with a hospital when prescribing
  • patients can be dispensed these medicines at a hospital or community pharmacy of their choice.

Prescribing clozapine in the community

PBS eligibility requirements for community-based management of people taking clozapine are:2

  • previous initial treatment under a psychiatrist for a period of no less than 18 weeks AND
  • the treating psychiatrist agrees the patient is suitable for community-based management and prescribing AND
  • the patient’s clozapine dosage is considered stable by the treating psychiatrist AND
  • treatment is under the supervision and direction of the psychiatrist reviewing the patient at regular intervals.

Careful monitoring of people taking clozapine is required

People taking clozapine need to be regularly assessed and questioned about any adverse events, and must be monitored for the development of granulocytopenia and agranulocytosis.4

It is mandatory that white blood cell count (WBC) and absolute neutrophil count (ANC) be assessed weekly for the first 18 weeks of treatment, at least monthly throughout treatment, and for 1 month after complete discontinuation of clozapine.5, 6

Prescribers must order and review blood test results before each occasion of prescribing.2 Because of this requirement for regular blood tests it is recommended that prescribers request a quantity sufficient for up to 1 month’s supply only, rather than the full PBS maximum quantity.2

Mandatory use of clozapine patient monitoring databases

Treatment centres and individual patients, prescribers, and pharmacists must be registered with the appropriate patient monitoring system before clozapine can be prescribed or dispensed.2 The two monitoring systems can be accessed at:

Prescribers and pharmacists must first register with Novartis or Hospira and obtain a protocol for prescribing clozapine; see monitoring system pages for contact details.

After starting clozapine, patients should be maintained on the same brand of medicine to facilitate safety monitoring by the manufacturer’s patient monitoring systems.2

All prescribers will be required to use the Streamlined authority approval process when prescribing clozapine.2

Before clozapine is dispensed, the patient’s pathology results (WBC, ANC) must be checked and the details entered into the relevant brand-specific clozapine patient monitoring database.2

Staged supply based on current blood results (WBC, ANC) may be necessary to improve quality use of medicines in some patients.2