A mother who has ADHD says she has no option but to give her own branded medication to her teenage son, who has the same condition but no free access to the drug.

A psychiatrist has recommended both Rachel Spiteri and her 18-year-old son to take Concerta, a branded version of methylphenidate, to treat the neurodevelopmental disorder.

But whereas Spiteri gets the branded drug free through the Pharmacy of Your Choice (POYC) scheme, a long-running supply issue means her son does not and she would have to pay at least €130 a month to buy it for him.

“I’m doing what’s best for my son,” said Spiteri, who took the measure despite the impact on her own health.

She is speaking out in the hope the government resolves the issue that has been going on for four years despite the Ombudsman finding in her favour and the recommendations of a UK specialist.

The issue arose after the tender for Concerta expired and since then, Xenidate and other generic versions, which are a lower cost to the health service, have been offered instead.

According to policy, only those who were on Concerta before the tender expired are entitled to get it for free under POYC.

He was not doing well on generics. His behaviour was changing

Spiteri said her son was diagnosed with ADHD when he was six years old and over the years was placed on various medications but none had the desired effect.

“He was not doing well on generics. His behaviour was changing. He was irritable, angry and impulsive. He went through a difficult patch,” she said.

In 2016, their psychiatrist recommended putting her son on Concerta and it gave him relief – he could focus and his challenging behaviour calmed down.

‘Playing with our mental health’

Spiteri admits she is struggling to cope.

“They are playing with people’s mental health when they change medications offered by the government because they are not all the same,” she said.

“I am suffering for my son. I really want to work but I’m scared I will not be able to hold down a job. Part of the condition comes with impulsivity and I am struggling with that a lot at the moment. I struggle, for example, with budgeting and managing money,” she said.

ADHD is the most diagnosed mental disorder in children and is characterised by, among other things, difficulty in sustaining attention and emotion regulation, excessive activity and difficulty in controlling behaviour.

Concerta, Xenidate and the generics that followed are long-acting drugs that essentially do the same thing. They contain the stimulant methylphenidate which works by releasing neurotransmitters (chemical messengers) called norepinephrine and dopamine into the brain. Increasing these neurotransmitter levels helps to stimulate the brain, which can improve the symptoms of ADHD.

I am suffering for my son. I really want to work but I’m scared I will not be able to hold down a job

Generics are clinically less effective than branded medicines and are effective for a shorter time.

In November 2015, the government made the ADHD medicine Concerta available for free until 2018 when it was swapped for a cheaper generic one.

Some ADHD sufferers reported their condition had regressed. Psychiatrists warned that changes in medication provided by the government were having a detrimental effect on children and adults. The side effects were having an impact on sleeping patterns, appetite, aggression and anxiety, among others.

That was when the government commissioned a UK expert to look into the matter and decided that previous Concerta patients would be given the medicine.

But problems continued, explains Pamela Muscat, president of ADHD Malta. The case of Spiteri and her son was not unique, she said as many were struggling since Concerta was removed from the formulary.

While not all patients on generics are reporting adverse symptoms, Muscat is urging the government to allow people to switch to Concerta on the recommendation of their doctor.

She noted that some patients were so desperate that they were paying for Concerta themselves, forking out up to €200 a month depending on the dosage. Another option worth exploring, she said, was allowing patients to pay the difference between the drugs.

“What the government is not seeing is that this is going to end up costing more in the long run. Research has shown that if ADHD goes untreated, patients can become a burden to society as they might not hold down a job, be prone to addictions, cause more accidents and even end up in prison,” she said.

‘The policy stands’

Spiteri lodged a complaint with the Ombudsman in December 2021 because her son was not given Concerta as part of his ADHD treatment.

Last May, Commissioner for Health Raymond Galea ruled that her son should be given Concerta after hearing how he was started on Xenidate but this did not control his behaviour and was detrimental to him.

Galea heard how the boy’s psychiatrist said he improved on Concerta.

He referred to the 2019 report commissioned by the Department of Health and drawn up by Doctor Ramzi Nasir, a consultant paediatrician at the Royal Free London NHS Foundation Trust. Nasir looked into the problems reported by patients who moved from Concerta to Xenidate.

He concluded that, while not all patients warranted a change back to Concerta, this should be a clinical decision made jointly by the clinical physician and the patient.

He said “the brand name Concerta should be made available in cases where it is deemed clinically necessary”. 

The health authorities maintained that, according to policy, new patients are not entitled to Concerta. The Ombudsman report said it was “not acceptable” to quote policy and recommended the setting up of an adequate structure to deal with cases that suffered adverse reactions.

Questions sent to the health authorities remained unanswered by the time of writing.