The wrap-up is designed to provide you with information about medicines that have been listed on the PBS for which full NPS RADAR reviews or brief items are not available.

October 2020 sees an extension to the listing of:

  • apomorphine injection for Parkinson disease (new items and additional clinical criteria)1,2

See the PBS Schedule for complete details.

 

Apomorphine

Apomorphine solution for injection is now listed on the PBS General Schedule (Section 85) as maintenance therapy for the treatment of Parkinson disease, as Authority Required (Streamlined).2

The three new items are:1,2

  • 12142C apomorphine hydrochloride hemihydrate 100 mg/20 mL injection, 5 x 20 mL vials (Apomine Solution for Infusion)
  • 12133N apomorphine hydrochloride hemihydrate 30 mg/3 mL injection, 5 x 3 mL cartridges (Apomine Intermittent)*
  • 12137T apomorphine hydrochloride hemihydrate 30 mg/3 mL injection, 5 x 3 mL pen devices (Movapo Pen)*

*Note that PBS items apomorphine injection 30 mg/3 mL pen devices and apomorphine injection 30 mg/3 mL cartridges are equivalent for the purposes of substitution by pharmacists at the point of dispensing.2

Existing listings for apomorphine solution prescribed for the treatment of Parkinson disease under the Highly Specialised Drugs Program (Private and Public Hospital) have also been altered to include the addition of new clinical criteria.1,2

What is it?

Apomorphine is a direct acting dopamine receptor agonist.3,4

In the treatment of Parkinson disease, apomorphine is believed to directly stimulate postsynaptic D2 receptors. Stimulation of presynaptic D2 dopamine receptors and antagonism of alpha2 adrenergic receptors may also be important.3,4

Apomorphine reduces tremor, rigidity and bradykinesia in patients receiving levodopa – the precursor to dopamine and first line treatment for Parkinson disease.3,4,5

Apomorphine is rapidly and completely absorbed from subcutaneous tissues. This and its rapid clearance contribute to rapid onset and brief duration of action.3,4

Who is it for?

Apomorphine is indicated to reduce the number and severity of ‘off’ phases for patients with Parkinson disease who are severely disabled by fluctuations in motor performance.3,4

PBS clinical criteria for apomorphine require that patients have:2

  • experienced severely disabling motor fluctuations which have not responded to therapy
  • commenced treatment in a specialist unit in a hospital setting.

What does the product information say?

Apomorphine is generally only considered suitable for patients with Parkinson disease who are capable of recognising and anticipating ‘off’ phases in motor performance.3,4

Long term specialist supervision of patients taking apomorphine is advised.

Conventional therapy should be continued during ‘on’ phases.3,4

For more information see the product information for the relevant apomorphine formulation being considered.

Safety issues

Overall, the incidence of adverse events seems to be generally higher in patients receiving continuous subcutaneous apomorphine infusion than in those treated with intermittent injections.6,7

Apomorphine is highly emetogenic and patients should be established on domperidone for at least 48 – 72 hours prior to initiation of therapy to reduce nausea and vomiting.3,4,8

Common adverse effects with apomorphine include:3,4

  • nausea and vomiting (see above)
  • transient sedation
  • somnolence
  • neuropsychiatric disturbances.

Neuropsychiatric disturbances

Hallucinations and confusion may occur with apomorphine.3,4,8

Patients with symptoms and/or a history of serious psychiatric disorders are at increased risk of psychiatric adverse effects such as impulse control disorders from dopamine agonists including apomorphine.3,4,8

Impulse control disorders associated with dopamine agonists including apomorphine can include problem gambling, hypersexuality, compulsive spending or buying, and binge eating.3,4,8

Patients who develop impulse control disorders are at increased risk of dopamine agonist withdrawal syndrome with severe symptoms that may include agitation, anxiety, panic attacks, depression and drug craving.8

Frequency and severity of adverse effects should be monitored carefully at regular intervals with dose adjustments or discontinuation as needed.3,4

See the product information for important steps to follow when starting treatment with apomorphine.

See the PBS Summary of Changes for a complete list of all additions, deletions and alterations.

 

What else should health professionals know?

Changes to prescribing information and processes

Active ingredient prescribing

On 31 October 2019, active ingredient prescribing regulations were introduced by the PBS under the National Health Act 1953. Active ingredient prescribing is part of a wider government strategy to ensure consistent and standardised medicines information.9

Active ingredient prescribing aims to:9

  • ensure the identification of active ingredient names on all PBS prescriptions
  • increase patient understanding of the medicines they are taking
  • promote the uptake of generic and biosimilar medicines.

Under the regulations, prescribers:9

  • are required to include the active ingredient on all PBS prescriptions (excluding handwritten prescriptions, paper-based medication charts in residential aged care settings, and medicines with four or more active ingredients).
  • can include a brand after the active ingredient on a prescription, if the medicine prescribed is likely to pose a patient safety risk if the brand is not specified or to ensure medicine continuance where a patient is familiar with a particular brand of their regular medicine.

A transition period has been arranged to ensure prescribers have sufficient time to update prescribing software to versions which meet the new active ingredient prescribing requirements.

Community level electronic prescriptions

On 31 October 2019, Commonwealth legislation changed to recognise electronic prescriptions as a legal prescription for the purpose of PBS-listed medicine supply. Electronic prescribing is part of a wider government strategy to support safer medicine management and improve the efficiency of the PBS. It will not be mandatory, but provides prescribers and their patients with a safe and secure alternative choice to paper prescriptions.

Electronic prescribing aims to:

  • improve efficiency in prescribing and dispensing medications
  • remove the need for handling and storing a physical paper prescription
  • support digital health services such as telehealth services to ensure continuity of patient care

To support the legislative changes, technical upgrades are currently underway to ensure safe, secure and seamless transmission of information of electronic prescriptions between prescribing and dispensing clinical software and to PBS payment systems.

Once in place, two models will be available to support electronic prescription; Token and Active Script List.

More information about electronic prescriptions is available: