Generic drug switch by Shoppers outrages parents
Complaint filed after autistic son has adverse effects; chain denies wrongdoing
B.C. parents are accusing Shoppers Drug Mart of putting their son’s life at risk by switching his brand-name prescription medication to a generic version, without their knowledge or consent.
“He struggled so much,” said Tiffanie Ujfalusi.
Her 22-year-old son Robert has Asperger’s, an autism spectrum disorder.
“He lost all motivation for everything he was doing. He became severely depressed…and he indicated he was suicidal — more than once,” she said.
Tiffanie and John Ujfalusi have filed a formal complaint with the College of Pharmacists of B.C., alleging pharmacists at a Shoppers location in Victoria made the substitution arbitrarily, despite explicit requests from his doctor and parents not to.
“We did not want any substitutions because he had reacted badly [to generics] in the past,” said Tiffanie. “Every precaution possible had been taken to make sure this would never happen to him.”
“I think Shoppers Drug Mart as a corporation should implement changes to make sure this kind of thing never happens again,” said John.
Records show the switch was made in November 2011. The parents said they didn’t discover what they suspect was the cause of their son’s deterioration, until 17 months later.
“We had no idea that it tied back to this change. During that time, our lives just completely fell apart,” said Tiffanie.
Doctor blames switch for adverse effects
In a recent letter to the College in support of the complaint, Robert’s psychiatrist Dr. Adam Gunn wrote, “This change was done unilaterally by the pharmacy, without informing Robert, his family or myself, despite prior instructions and requests to the contrary… and his past difficulties with generic medications.”
“It is my conclusion that Robert being switched involuntarily to the generic Atomoxetine led to a deterioration in Robert's symptoms and level of functioning.”
Strattera is the brand name of the medication Robert takes to control his behaviour and improve his state of mind. Until two years ago, his parents said it was working well. Their son was enjoying life, had a girlfriend and was starting to live independently.
“It was painstaking progress. And we fought really hard to make all those steps forward,” said his mother.
Although the active and non-active ingredients listed for generic versions of Strattera are the same, doctors say autistic patients can react badly to even a slightly different amount or combination of fillers, used by different manufacturers.
“It is well documented that some individuals will not have as good a response to generic medication,” said Dr. Gunn in his letter.
“This is not an isolated case with Strattera, as I have recently had another case of a patient deteriorating dramatically when switched to generic Atomoxetine.”
In their complaint, the parents allege they specifically told the head pharmacist at Shoppers never to substitute their son’s meds, and were assured it wouldn’t happen.
“I don’t understand how the pharmacy could do this, especially after we asked them not to,” said John.
Records submitted to the College show prescriptions from Robert’s psychiatrist all have “no substitution” printed at the bottom.
The doctor also secured special funding from B.C.’s Pharmacare program, specifically so the brand name medication would be covered for Robert.
“I also remember making the request [by phone] to Robert’s pharmacy at some point before the last year, that he not be placed on generic medications,” Dr. Gunn wrote.
Larger move to generics
After the parents discovered the switch, they said Shoppers told them it was done as part its overall initiative to substitute generics for brand name drugs whenever possible.
Provincial governments have been encouraging all pharmacies to substitute with generics, to cut drug costs.
“Looking at [Robert’s] records it lines up exactly with when he started deteriorating,” said Tiffanie.
His parents said they had no idea the drug had been switched because the pills come in bubble packs and look exactly the same as the brand name.
Because the B.C. government is billed directly for Robert’s drugs, there was no price or drug name on the package the parents picked up from Shoppers. To protect patients' privacy, there is only a bar code on the label attached to the bag.
“We would take the bag home sealed with the blister packs in it and give it to Robert,” said Tiffanie.
As Robert’s state of mind got worse, the parents said they went through months of extreme stress and conflict.
“It’s so upsetting to realize that something that’s been happening that we were blaming him for and getting angry with him about, wasn’t actually his fault,” said Tiffanie.
“It will take a tremendous amount of time to recover and you know to make up for what was lost,” said John.
Patient became suicidal
Robert said he felt like he didn’t want to live anymore and was frustrated because he didn’t know why.
“I lost my girlfriend, which sucked… I lost a lot of friendships. I had trouble coping. I even quit games that I was enjoying,” he said.
“It was terrible. I didn’t really want to do anything.”
His parents said they discovered he was taking generic drugs in April, by chance, when they had to pay for his prescription during a lapse in the coverage from government.
Since then, he’s been back on the brand name Strattera and his parents and doctor said he’s slowly improving.
“I’m still a little anxious and worried about making friends again,” said Robert. “Because, what is the point of friends if you are going to lose them?”
Dr. Wendy Roberts, an autism expert at Toronto’s Hospital for Sick Children told Go Public, while this type of adverse reaction to generics is rare, for autistic patients — including children — it can be serious.
“The construction of some of the non-medicinal parts of the drug may have a way of interacting with the child’s own metabolism to give just a slightly different rate of delivery or amount of delivery,” said Roberts.
Specific to autism cases
“If one little thing gets changed and especially people with autism are exquisitely sensitive to small changes in how they feel, that’s much more likely to have a disruptive effect.”
Seven other cases have been reported to Health Canada of adverse reactions in autistic children and adults, when a generic was substituted for Strattera.
“I do believe that pharmacists should inform patients that the form of the drug has been switched so that if there is any change at all it can be reported quickly,” said Roberts.
B.C.’s College of Pharmacists said it’s not mandatory for pharmacists to tell patients when a brand name drug is switched to generic. However, it is against the rules for a pharmacist to substitute if the patient’s doctor asks them not to.
“The College has a comprehensive policy surrounding both the substitution and adaptation of drugs that pharmacists are required to follow,” said spokesperson Mykle Ludvigsen.
No details from Shoppers
Shoppers Drug Mart refused to answer any questions about this case, citing the formal complaint.
“We want to express our sympathies to the patient and his family for any difficulties they have experienced.
"However, we believe that any allegations of improper conduct being made against Shoppers Drug Mart and/or its associates in this case are without merit and we will vigorously defend this position,” said spokesperson Tammy Smitham.
“Given that the matter is currently before the College of Pharmacists of British Columbia, we are unfortunately not in a position to provide any further details at this time.”
The company didn’t answer questions about what, if any, policies it has in place to make sure other customers are informed of changes like this.
“It’s even more frustrating that no one is saying ‘Oh, we are sorry this happened and we will take steps to make sure it doesn’t happen again,'” said John Ujfalusi.
Pharmacies like Shoppers have received significant rebates from generic drug manufacturers for selling generics — up to an estimated 40 per cent of the checkout price. It’s an incentive they don’t get when they dispense brand-name drugs.
Ontario has banned those rebates because they eat into cost savings. B.C. is dramatically reducing the amount available. However, when Robert’s medication was switched, they were still allowed.
Shoppers didn’t answer questions about how much it receives in rebates from manufacturers of generic versions of Strattera.
“It’s disgusting that they can make that choice to profit off your health care and not let you know that they have done something that could have negative consequences,” said Tiffanie.
Little money saved
Robert’s parents said one month’s supply of the generic drug was only $20 less expensive than the brand name, so there was no significant savings for government.
“The consequences were ours. We’re the ones who suffered here. Robert suffered. The family suffered — and nobody takes any responsibility for any of that,” said Tiffanie.
The College of Pharmacists of B.C. said it is not allowed to say anything specific about this complaint, but indicated it is being looked at.
“Dispensing the wrong medication to the wrong patient could result in very grave consequences. It is a message that cannot be repeated enough and why we take these types of complaints so seriously,” said Ludvigsen.