Move to generic methadone raises concerns

Ontario’s move to a generic methadone product has sparked concerns the switch could negatively impact those who rely on the drug. As of Sept. 29, two generic formulations of the name brand Methadose, or methadone hydrochloride, a synthetic opioid used for pain management and to treat opioid dependence, will be added to the formulary.

Once the patent for a drug expires, Health Canada is responsible for evaluating and approving generic products for drug alternatives. The Ontario Drug Benefit (ODB) formulary updates its list of interchangeable medications monthly. When a generic drug becomes available, provincial health plans typically only cover the cost of the generic.

“It’s a way for them to manage their budgets as best they can,” says Tara Gomes, scientist at Unity Health and lead of the Ontario Drug Policy Research Network. Gomes says that in the case of Methadose, the province has recently decided to list both the brand name and the new generic at the same price. This means that pharmacies will not be incentivized to stop supplying the brand name entirely.  But given the liquid dispensation required for methadone,  most pharmacies will likely transition to either supplying only the generic or the brand name as soon as their current supplies have run out, rather than offer multiple options for patients.

Although the Ontario Ministry of Health told Healthy Debate that there is “no difference in the taste/appearance of the generic products compared to the brand product,” Gomes says she worries that users could still be caught off guard by the change and hopes that pharmacists have conversations with patients as the switch takes place. She has taken to Twitter to spread word on the change.

“My hope is that this isn’t going to be too disruptive for people,” Gomes says. “Pharmacologically, in terms of people going into withdrawal or feeling dope sick, that likely won’t happen.

“But we also know that this population has so little power when it comes to their treatment, and there’s already so much regulation and restriction around how they access their methadone. When people get a product at a dose that they feel works for them, any sort of real or perceived disruption can be really challenging.”

People on methadone maintenance treatment (MMT) have reason to be wary of formulary changes. In 2014, British Columbia forced the roughly 15,000 on MMT in the province to transition from a liquid compound orange-flavoured methadone to a 10 times more concentrated cherry-flavoured version of brand name Methadose. The difference in taste and smaller amounts in people’s cups was a big shift for those used to the old formula. One study cited that the worse taste was associated with increasing dosage, more dope sickness, worsening pain and supplementing with other opioids. Drug-user groups blame an increase in fatal overdoses on the change.

A 2022 study found a 63 per cent increase in days off the drug following the regulatory change and signalled the need “for greater client involvement in the planning and implementation of regulatory changes.”

“It’s best practice to include the affected people in policymaking. Otherwise, you risk messing it up.”

Board member of the British Columbia Association of People on Methadone Garth Mullins says that supportive gestures following formulary changes aren’t enough. “If a decision has been made… there’s very little a pharmacist or a doctor can do. What if you say ‘No, I don’t want this, I want to stick with a thing I know that works.’ The answer then was ‘You can’t.’”

Mullins says B.C.’s changes to methadone products have ruined the program’s reputation. “People don’t stay on the program. (Methadone’s) got one job – to make you not dope sick. And if you’re dope sick after 12 hours, you’re just like, what’s the point of this thing?”

Gomes says Ontario’s move to include a new generic methadone should go smoother than B.C.’s change. “They’re supposed to have the same viscosity, the same colour, the same lack of flavour.”

But, Gomes adds, when vulnerable populations aren’t given the opportunity to take part in major changes in a product they depend on, this can have real effects. “Even if technically the product doesn’t have pharmacologically based differences, because of the trauma that they’ve already experienced around access and treatment in the past, there can still be negative impacts.”

Mullins says that even if the product is the same, he fears that a phenomenon known as “change intolerance,” in which patients do not feel beneficial effects after a change in their medication, will still impact 12 to 14 per cent of users. One study found that up to 25 per cent of methadone users were change intolerant following formulary changes. “What about them?” Mullins asks. “I’ve been through this a lot. I’ve lost a lot of friends and buried a lot of people because of (methadone changes).”

Gomes says she hopes that pharmacists and Opioid Agonist Treatment clinicians will have conversations with their patients as the switch takes place. “I’d just really like to see that pharmacies are communicating proactively with their patients and not just saying ‘Well, today it’s a new product.’ ”

In an emailed statement, the College of Pharmacists wrote: “The Ministry shares information about ODBP policy changes directly with pharmacies and encourages pharmacy professionals to discuss these changes with patients and prescribers.”

For Mullins, when provinces task pharmacists with discussing changes with MMT patients, that effort is “next door to doing nothing.” He says the buy-in of affected groups needs to happen before these changes get made.

“We should have the right to determine what happens to our lives. But it’s also just good policy. In public policymaking in all areas, it is known that it’s a best practice to include the affected people in that policymaking,” says Mullins. “Otherwise, you risk messing it up.”