Stronger safeguards for risperidone prescribing


Streamlined authority codes for risperidone will change from 1 January 2020, in line with PM’s response to Aged Care Royal Commission’s Interim Report

Commencing 1 January 2020, the PBS listings for risperidone for the treatment of behavioural and psychological symptoms of dementia will change, according to a Department of Health announcement.

This change involves the addition of a new ‘continuing’ listing that is Authority Required (Telephone).

“The listing will allow prescribers to treat Behavioural and Psychological Symptoms of Dementia (BPSD) of the Alzheimer type with risperidone, beyond 12 weeks of ‘initial’ therapy, when appropriate,” says the department.

During the Aged Care Royal Commission’s hearings, several health practitioners were questioned over their decision to prescribe and increase doses of risperidone to people in aged care facilities.

In response to the Commission’s Interim Report, Prime Minister Scott Morrison announced on 25 November that from 1 January 2020, the government would establish stronger safeguards and restrictions for repeat prescriptions of risperidone.

“Doctors will still be able to prescribe it but will be required to apply for additional approval if risperidone is to be prescribed beyond an initial 12-week period,” said Mr Morrison in a media statement.

“These changes have been developed following recommendations from the Pharmaceutical Benefits Advisory Committee, and in collaboration with doctor’s groups and the broader health sector.”

The PBAC had recommended changes to the PBS listing of risperidone for the treatment of BPSD to reduce inappropriate prescribing, specifically beyond 12 weeks of therapy, at the August meeting this year.

It recommended the level of authority for risperidone for the ‘initial’ listing be Authority Required (STREAMLINED) to allow for 12 weeks of PBS-subsidised therapy.

Prescriptions may only be written for 12 weeks initial treatment once every 12 months.

For PBS-subsidised therapy beyond 12 weeks, prescribers will be required to request authority approval from the Department of Human Services (DHS) to prescribe ‘continuing’ PBS subsidised treatment.

Authority can be requested through the Online PBS Authorities System via Health Professional Online Services (HPOS) or by telephone.

The intent of this ‘continuing’ listing is to provide prescribers with the opportunity to trial dose reduction or cessation in their patients, before extended treatment with risperidone.

Patients should not continue PBS-subsidised treatment if they have not responded to an ‘initial’ prescription.

For patients prescribed risperidone prior to 1 January 2020, prescribers will be able to trial a dose reduction or cessation through an Authority Required (STREAMLINED) ‘grandfather’ PBS listing. Prescriptions can only be written under this PBS listing once in a lifetime.

As streamlined authority codes for risperidone will change from 1 January 2020, pharmacists will be required to ensure that any dispensed scripts have a valid streamlined authority code, says the Department of Health.

This code needs to be valid at the date of prescribing.

Existing prescriptions for risperidone dated prior to 1 January 2020 and endorsed with the previous streamlined authority code are valid for PBS supply for the life of the script.

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1 Comment

  1. Mark Coles
    04/12/2019

    The prescribing restrictions on risperidone for the treatment of BPSD is a positive move, but I do have concerns that this will just lead to GPs avoiding the use of risperidone, which still has the greatest evidence of effectiveness in treating BPSD, and in general has a lower risk of side effects, when used in low doses, in the elderly, to more prescribing of other antipsychotics such as olanzapine and quetiapine (off label use) and also conventional antipsychotic therapy with haloperidol. Olanzapine and quetiapine exhibit clinically significant anticholinergic activity and in the elderly are associated with a significantly increased risk of causing anticholinergic side effects, including symptoms that may mimic BPSD, but also loss of visual acuity and dizziness, increasing the risk of falls. Conventional antipsychotic therapy with haloperidol is associated with a significantly increased risk of extrapyramidal side effects (EPSE) in the elderly, including tardive dyskinesia, which may be irreversible. Olanzapine, quetiapine and haloperidol are already being prescribed to treat BPSD, often off label. Will the restriction placed solely on risperidone just lead it to being prescribed less, and the slack taken up with prescribing of other antipsychotics, with a greater risk of adverse reactions?

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