The federal government has expanded the PBS to subsidise new ADHD medications in a bid to ease pressure on patients hit by long-running supply shortages.

From July 1, a suite of modified-release methylphenidate tablet forumlations has been added to the Pharmaceutical Benefits Scheme, including several that were previously only available via Section 19A approvals, but without PBS subsidy.

The move is designed to close a cost gap that left some patients paying out of pocket – sometimes hundreds of dollars – for alternative ADHD medications, while others went without treatment during months of disrupted supply.

It comes as the TGA confirmed shortages of long-acting ADHD medications such as Concerta, Teva-XR, Ritalin LA and Rubifen LA are expected to continue through to the end of 2025 [link here].

The PBS has formally listed several methylphenidate hydrochloride modified-release tablets, including brands registered overseas, such as Swiss-manufactured Concerta, which can now be substituted during shortages of locally listed products.

To assist with safe prescribing, GPs have been advised of several PBS restrictions:

• Once-daily dosing is the intended use under PBS subsidy. Split dosing (e.g. 18mg in the morning and 36mg in the evening) is not covered.
  
• Where multiple strengths are sought to support titration, repeats should only be issued for the final, target dose — not each dose used during titration.
  
• Patients may receive only one PBS-subsidised long-acting methylphenidate product at a time.
  
• No increases in maximum quantity or number of repeats can be authorised.
  
• Prescribers must comply with state or territory controlled drug laws.
  
• Authority applications can be made in real time via HPOS, or by phone through Services Australia.

GPs urged to monitor closely as patients switch medications

The TGA has convened a Medicine Shortage Action Group, bringing together stakeholders from the RACGP, AMA, ADHD Foundation and Pharmaceutical Society of Australia to advise on safe switching strategies.

The group advises switching within the same stimulant class where possible, as there is no established dose equivalence between methylphenidate and amphetamine-based medications, and cross-class switching requires new titration.

If switching is unavoidable, prescribers are advised to monitor patients closely for changes in symptom response, appetite, sleep, mood, and cardiovascular health, and to provide appropriate counselling about differences in side effect profiles between medications.

Prescribers should also document the rationale, obtain informed consent, and conduct frequent early reviews to ensure tolerability and effectiveness.

The TGA has warned that the national shortage is likely to increase administrative burden on GPs, with more pharmacists, carers and patients expected to reach out seeking changes to strengths or formulations as stock availability fluctuates.

Antibiotic and contraceptive changes also kick in

In other July PBS changes:

• Azithromycin 500mg tablets manufactured in the US (Precision Dose, USP) can now be substituted during local shortages. No increases in quantity or repeats are allowed under the temporary listing.
• The PBS has also clarified that two Slinda (drospirenone) pack sizes — the 28-tablet and 4 x 28-tablet presentations — are now equivalent for substitution when the full 4-pack quantity is dispensed. The progestin-only pill was added to the PBS earlier this year, and this clarification gives pharmacists more flexibility to maintain supply continuity.
• A new listing for naproxen 750mg modified-release tablets has also been added, giving GPs another option for patients requiring sustained anti-inflammatory therapy.