21 April 2021: OIA response | Discontinuation of methylphenidate sustained release (Ritalin SR)

21 April 2021

Dear [name and contact details withheld] 

REQUEST FOR INFORMATION 

Thank you for your request dated 25 March 2021 under the Official Information Act 1982 (OIA) for information relating to the discontinuation of the methylphenidate sustained-release (Ritalin SR) 20mg tablets. You requested: 

…if PHARMAC raised any concerns with the supplier about the discontinuation. And if so, what the response was from supplier. 

I understand your interest is also around the side effects and learnings of the subsidised brand change of methylphenidate in 2006. I have provided details about the Ritalin SR discontinuation and 2006 brand change within this response. 

PHARMAC staff are just like all New Zealanders; with friends, families and whānau affected by health issues. We take our decision-making responsibility seriously and the wellbeing of New Zealanders is at the heart of our work. However, this change was beyond our control. 

Discontinuation of Ritalin SR

In June 2020, the supplier of Ritalin SR, Novartis, notified PHARMAC of the discontinuation of Ritalin SR. Novartis advised this was due to a closure of the production line for this product globally. 

PHARMAC asked Novartis if it anticipated discontinuations for the remaining strengths of Ritalin. Novartis advised only the Ritalin SR presentation was to be discontinued. This was partly because Ritalin SR was produced in a third-party facility, whilst most other products are made at Novartis facilities. 

It advised that the other Ritalin presentations were more stable than Ritalin SR and that it was prone to issues. Novartis told us that Ritalin SR had not been sold in Australia for a while and that Ritalin SR was only used in around three other markets, and all others had already been discontinued. 

Low demand, manufacturing difficulties, and issues with exporting/importing all factored into Novartis’ decision to discontinue supply of Ritalin SR. 

Following Novartis’ notification to PHARMAC about the discontinuation, we sought clinical advice from our Mental Health Subcommittee. They advised us that Rubifen SR is the most comparable alternative to Ritalin SR. 

Previous change from Ritalin SR to Rubifen SR brand medicine

In June 2006, PHARMAC announced a decision to change the brand of subsidised methylphenidate long-acting 20 mg tablets from Ritalin SR to Rubifen SR, following an invitation to tender. It was notified that from 1 April 2007, Ritalin SR would be delisted from the Pharmaceutical Schedule, with Rubifen SR becoming the sole subsidised brand of methylphenidate long-acting 20 mg tablets. 

In September 2007, PHARMAC agreed to allow funding of Ritalin SR for patients who experienced serious adverse reactions when switching from Ritalin SR to Rubifen SR. This action was taken in response to concerns raised by Medsafe and the Centre for Adverse Reactions Monitoring (CARM). 

In December 2008, PHARMAC announced the decision for Ritalin, Ritalin SR and Ritalin LA to be funded from 1 July 2009. 

Rubifen SR bioequivalence, safety and efficacy

Rubifen SR is approved for use in New Zealand. 

For a medicine to be approved in New Zealand, the supplier must apply to Medsafe. Medsafe is the authority responsible for the regulation of therapeutic products (medicines and medical devices) in New Zealand. It reviews supplier applications for approval and makes a recommendation to the Minister as to whether the medicine is approvable, or otherwise. 

All generic medicines approved in New Zealand have been shown to be bioequivalent to the brand name innovator product. A generic medicine contains the same active ingredient (including different salts), in the same quantity as an innovator medicine (original brand). 

Medsafe’s evaluation and approval process is described on their website: https://www.medsafe.govt.nz/Consumers/Safety-of-Medicines/medsafe-evaluation-process.asp (external link)

At the 131st Medicines Adverse Reactions Committee (MARC) meeting on 13 September 2007(external link), the committee discussed the Rubifen SR brand change and the reports of adverse reactions. 

In September 2007, Medsafe announced that it would conduct its own testing of Rubifen SR so it could determine the likely underlying cause of the increased rate of reporting of serious side-effects. 

Medsafe's Evaluation Team concluded that there was no evidence of a manufacturing or pharmaceutical chemistry fault which could explain the unusual adverse reactions experienced by some patients taking Rubifen SR.

We trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this. 

Yours sincerely 

Rachel Read
Manager, Policy and Government Services