The new listings 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.
February 2021 sees changes to the listing of:
- methylphenidate (new clinical criteria and administrative advice)
See the PBS Schedule for complete details
Long-acting (modified release) methylphenidate for the treatment of attention deficit hyperactivity disorder (ADHD) is now listed on the PBS General Schedule (Section 85) with additions of new clinical criteria and administrative advice.1,2
The new clinical criteria are:1,2
- ‘The treatment must not exceed a maximum daily dose of 72 mg with this drug’ for methylphenidate hydrochloride 18 mg (2387P), 27 mg (2172H), 36 mg (2388Q) and 54 mg (2432B) modified release tablets (Concerta)
- ‘The treatment must not exceed a maximum daily dose of 80 mg with this drug’ for methylphenidate hydrochloride 10 mg (3440C), 20 mg (2276T), 30 mg (2280B), 40 mg (2283E) and 60 mg (12116Q) modified release capsules (Ritalin LA).
The new administrative advice for the above medicines is the addition of the following notes:1,2
- In accordance with the Therapeutic Goods Administration (TGA)-approved Product Information, this PBS listing currently intends for once-daily dosing only. Divided dosing is not intended (eg for Concerta, 18 mg in the mornings, 36 mg in the evenings or for Ritalin LA, 20 mg in the mornings, 30 mg in the evenings).
- No increase in the maximum quantity or number of units may be authorised.
- No increase in the maximum number of repeats may be authorised.
The new clinical criteria and administrative advice make the listings consistent with the Product Information (PI) of the medicines3,4 and also with the listing changes made on 1 February 2021 to another long-acting ADHD medicine, lisdexamfetamine.2
What is it?
Methylphenidate is a central nervous system (CNS) psychostimulant.5
The therapeutic activity of methylphenidate in ADHD is not fully established but is thought to be due to its ability to block the reuptake of noradrenaline and dopamine into presynaptic neurons, which can reduce persistent inattention and/or hyperactivity/impulsivity symptoms.3-6
Who is it for?
Methylphenidate is indicated for the treatment of ADHD as part of a comprehensive treatment program. Patients must be or have been diagnosed with ADHD, between the ages of 6 and 18 years of age inclusive.1
As with other psychostimulants, common adverse effects can include:3-5
- nausea, diarrhoea, abdominal pain
- loss of appetite, weight loss
- insomnia, headaches, irritability and anxiety.
For information about reporting adverse reactions see the TGA website.
What else should health professionals know?
Guidance on methylphenidate includes:3-6
- use with caution for people who have psychiatric comorbidities and/or substance use disorders
- use with caution if the patient has structural cardiac abnormalities, as sudden death has been reported with psychostimulant medicines
- assess cardiovascular function before starting treatment, and monitor blood pressure and heart rate regularly throughout treatment
- monitor weight and height in children and adolescents – while some growth retardation is possible during treatment, this is usually followed by a period of catch-up growth once the medicine is discontinued.
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.7
Active ingredient prescribing aims to:7
- 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:7
- 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:
- Pharmaceutical Benefits Scheme. Methylphenidate. Canberra: Australian Government Department of Health, 2021 (accessed 4 February 2021).
- Pharmaceutical Benefits Scheme. PBS Schedule: Summary of changes (February 2021). Canberra: Australian Government Department of Health, 2021 (accessed 4 February 2021).
- Janssen-Cilag Pty Ltd. Australian Product Information Concerta (methylphenidate hydrochloride) extended release tablets. Macquarie Park: Janssen-Cilag Pty Ltd, 2020 (accessed 4 February 2021).
- Novartis Pharmaceuticals Australia Pty Ltd. Australian Product Information Ritalin 10/Ritalin LA (methylphenidate). West Ryde: Novartis Pty Ltd, 2020 (accessed 4 February 2021).
- Australian Medicines Handbook. Drugs for attention deficit hyperactivity disorder. Adelaide: AMH Pty Ltd, 2020 (accessed 4 February 2021).
- Psychotropic Expert Group. Therapeutic Guidelines: Attention deficit hyperactivity disorder. West Melbourne: Therapeutic Guidelines Pty Ltd, 2019 (accessed 4 February 2021).
- Australian Government Minister for Health. National health (Pharmaceutical Benefits) amendment (Active Ingredient Prescribing) Regulations 2019. Canberra: Australian Government Department of Health, 2019 (accessed 15 February 2021).