The TGA alert highlights some overseas-registered methylphenidate alternatives for use and provides guidance on cross-class switching
Shortages of long-acting methylphenidate medications are expected to continue until the end of December, including Concerta and Teva-XR modified-release tablets and Ritalin LA and Rubifen LA capsules.
Ritalin 10mg immediate-release tablet shortages are expected to begin in July but Artige 10mg immediate-release tablets are still available, according to an alert from the TGA.
The regulator has approved overseas-registered substitute capsules in multiple strengths until the end of January 2026. However, these are not PBS-subsidised and TGA advice does not indicate price or availability.
To address the issue, the regulator convened a Medicine Shortage Action Group (MSAG), with input from nearly a dozen groups including the RACGP, AMA, ADHD Foundation and the Pharmaceutical Society of Australia.
The methylphenidate MSAG is advising prescribers to consider ongoing shortages of these products and be aware of the availability of other ADHD medicines. These can be found on the section 19A approvals database and currently include alternatives from Switzerland, Sweden, Denmark and the US.
If possible, switching within the same stimulant class is preferred. There is no established dose equivalence between methylphenidate and amphetamine-based stimulants and cross-class switching requires new titration.
Following medication change, it advises monitoring patients carefully and documenting changes in symptom response, appetite, sleep, mood and cardiovascular health. Patients should be warned that people experience different responses and side effect profiles from different formulations, particularly around sleep and appetite, according to the advice.
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Prescribers should record rationale, informed consent, treatment plans and monitoring outcomes for all adjustments. Initial frequent reviews are recommended following a substitution to ensure effectiveness and tolerability.
These shortages are affecting multiple countries and are reported to be due to manufacturing issues and increased demand.
The TGA warns that pharmacists, patients and carers may contact prescribers to authorise use of alternative strengths or formulations of methylphenidate substitute medicines.
“We acknowledge the difficulties involved in the prescribing of controlled medicines and the extra administrative workload these shortages cause. We understand that knowing about shortages early enables you to review and change prescriptions and treatment for patients if needed,” the TGA said.
Dexamfetamine IR and lisdexamfetamine are currently still available.
Clinical resources are available which cover switching from long acting to short acting methylphenidate, cross-class switching to amphetamine-based stimulants, dosage transitions and more.
The dose equivalence tables are only relevant to within-class switching but are an easy reference guide which break down exactly how to prescribe short-acting products to substitute long-acting brands and doses.
