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The only pharmaceutical company in Australia which supplies a critical ADHD drug in the grips of a global shortage will not be allowed to ramp up production after US drug officials, who control the key ingredient, refused to raise manufacturing limits.
The drug Vyvanse is used to treat adults and children with Attention-Deficit/Hyperactivity Disorder (ADHD) but from August last year, patients on certain strengths of the medication have struggled to fill prescriptions.
Since then, the situation has worsened, with the Therapeutic Goods Administration advising Australians there are now four different strengths in shortage — 30mg, 40mg, 50mg and 60mg.
The shortage is further complicated because Vyvanse contains an active ingredient called lisdexamfetamine.
Lisdexamfetamine is made in the United States and is tightly controlled because of its potential for abuse, with the Drug Enforcement Administration (DEA) setting limits on how much the industry can make.
In Australia, buying generic lisdexamfetamine medication is not available because Takeda Pharmaceuticals still owns Vyvanse under patent.
Plea to increase manufacturing denied
The severe shortage of Vyvanse prompted multiple Australian groups to write to the US DEA, pleading with the officials to lift production limits of lisdexamfetamine to ease the pressure on patients.
A letter obtained by the ABC also reveals that late last year, the Royal Australian and New Zealand College of Psychiatrists asked for an urgent meeting with the administration in the hopes of shoring up medication supply.
The president of the college, Dr Elizabeth Moore, said the DEA controlled how much Vyvanse was allotted to Australia and New Zealand.
"We've written to the DEA to seek advice from them as to whether or not they can in fact increase the amount that is coming to Australia and New Zealand," Dr Moore said.
"This is a crisis currently and we need to work together to solve this crisis, because people are suffering.
"People who are on Vyvanse that have found it a really useful medication and are living lives to the full are now faced with a period of uncertainty, anxiety, and a return to the lives that they did not want to live."
But in January the DEA dashed any hopes of a supply-side solution, quietly publishing a notice on a US federal government website denying pleas to increase manufacturing quotas of the drug.
"The quantities which will be produced in 2024 will be sufficient to meet the growing medical usage in domestic and foreign markets," the DEA said.
The DEA has previously said drug manufacturers have not made the maximum amount of ADHD medication they were allowed to produce.
"Resulting in a shortfall of 1 billion doses that could have been produced but were not made or shipped — and the data for 2023 has shown a similar trend," DEA administrator Anne Milgram said.
But the only company which brings Vyvanse into Australia, Takeda Pharmaceuticals, revealed it has been manufacturing at full capacity.
"Takeda utilised its full DEA-allotted lisdexamfetamine quota for 2022 and 2023 production," a spokesman told the ABC.
"We are working to resolve these interruptions as quickly as possible and expect normal supply of impacted strengths to resume between March and April 2024.
"Takeda understands the importance of maintaining consistent treatment with Vyvanse … and have communicated with the DEA regarding global prescription volumes for Vyvanse as part of the normal quota process."
The Royal Australian and New Zealand College of Psychiatrists is still waiting for the DEA to respond to its request for an urgent meeting.
"I think it's really important … they need to understand the effects that it's having on people in Australia and New Zealand, and we're certainly very willing to work with them," said its president, Dr Moore.
Father with ADHD says uncertain months ahead 'frightening'
In Australia, an estimated 5 per cent of children have ADHD while the figure is between 2 and 6 per cent for adults.
There has been a steady increase in the use of ADHD medication in the last five years.
In 2022, a health department briefing released under Freedom Of Information laws revealed that 413,747 patients were prescribed ADHD medication with more than 3.17 million scripts issued.
It marks a significant rise from 2018 when there were 186,423 patients who had 1.36 million scripts.
Vyvanse was the second most-prescribed medication for ADHD.
The severe shortage of Vyvanse has left patients across Australia anxious that their lives, punctuated with order and control after the medication, will now slide back into chaos.
For years Mark McCudden, 42, struggled with undiagnosed ADHD, bouncing between schools and then professions.
"I nearly lost all my family, I lost a lot of friends. I was just making poor decision after poor decision, after poor decision," he said.
"I'd sunk myself into the most ridiculous hole financially and imposed that on my family … I was making stupid decisions at work."
He only discovered he had ADHD after his son was also diagnosed with the condition and was put on Vyvanse, which made a profound difference.
After a lifetime of inattention, Mr McCudden said he was finally able to focus and dedicate himself to a job he loved.
"There's no way on earth, without the medication, that I would have achieved what I've achieved in this role and there's so many people with so many former employers that can attest to that," he said.
The prospect of a shortage being stretched out has left him reeling.
"I've got some medications still until it runs out but there are people out there that haven't," he said.
"It's like one day waking up and trying to come in and do the same role and provide for my family and my kids and be the same person.
"I don't know what that's going to look like and that's frightening."
Parents face issues 'on a daily basis'
While Vyvanse shortages are nominally expected to end in March or April, parents of children with ADHD are facing an anxious wait with the start of the school year just weeks away.
The drug works by decreasing a student's distractibility and increases attention span and concentration, which is essential for students in class.
Simon Clarke is a Sydney-based paediatrician and said the shortage had already become a serious problem for parents.
He said since August last year, when dosages stopped becoming available, doctors were left to teach patients how to reduce or double their doses with different strengths of the medication.
"I'm dealing with it on a daily basis," Professor Clarke said.
"I've done one of those, two of those today already."
Professor Clarke has had some success in putting patients on other medications while they wait for Vyvanse to be restocked.
"They were medications that we had tried before, they didn't seem to be as effective as Vyvanse … I went back to the previous medication, which will suffice in the short term," Professor Clarke said.
As the shortage rolls on, the Royal Australian and New Zealand College of Psychiatrists has proposed a suite of measures including for drugs like Vyvanse to placed on the Pharmaceutical Benefits Scheme, which would give patients a cheap alternative.
But this poses its own challenges — as the rules around ADHD medication in Australia require adult patients to make an appointment with a psychiatrist which, due to another serious shortage, could take months and cost hundreds of dollars.
There are also calls for the federal government to get generic versions of Vyvanse from other manufacturers.
The federal health department told the ABC the government was spending $117 million between 2022-25 for 205 psychiatry training positions per year.
"In addition, the Australian Government has committed an additional $40.5 million over four years … to increase the psychiatry workforce, particularly in rural Australia," a spokesman said.
The department said Vyvanse was expected to be in normal supply between March and April.