Alberta on the hook for tens of millions for children’s medication that may never arrive

Open this photo in gallery:

Alberta is unlikely to receive the vast majority of children’s pain-relief medication that Premier Danielle Smith spent nearly $75-million procuring from Turkey, because Health Canada says it won’t approve further shipments at this time after resolving the unprecedented drug shortage.

The United Conservative government announced a deal with Turkish manufacturer Atabay Pharmaceuticals last December after a surge in respiratory infections among children emptied shelves across Canada of pediatric acetaminophen and ibuprofen.

But only 30 per cent of the five million units of medication paid for by the province was ever shipped to Alberta and even less has actually been used.

The first shipment of 250,000 bottles of acetaminophen authorized by Health Canada for hospital use only arrived six weeks after Ms. Smith’s announcement of the deal on Dec. 6, 2022. Alberta Health Services spokesperson Kerry Williamson said that only 9,000 of those units were ever distributed to hospital pharmacies before AHS, in July, ordered its staff to stop using the weaker-strength product because the domestic supply had stabilized.

Meanwhile, despite hope from then-Alberta health minister Jason Copping that pharmacies would be stocked by Christmas, the Atabay medicine authorized for retail was only shipped after the respiratory crisis had subsided. Five shipments, totalling 1.25 million units of Turkish acetaminophen and ibuprofen, arrived between March and May.

A drug supply notice, posted by Health Canada, said the countrywide shortage ended in April.

Health Canada says now it would not consider applications from Alberta to bring in the remaining 3.5 million bottles of foreign medication unless a critical shortage reoccurs.

But Gerry Harrington, senior vice-president of consumer health with Food, Health & Consumer Products of Canada (FHCP), an industry group, said that’s highly unlikely.

“They talk about 100-year storms, this is one of those things,” he said in an interview.

Mr. Williamson said in a statement that $70-million was paid upfront to Atabay for product and approximately $4-million has been spent on freight and distribution costs. Government officials estimated in March that the deal would cost Alberta taxpayers a total of $80-million.

Charlotte Taillon, press secretary to Health Minister Adriana LaGrange, said in a statement that the Health Ministry and AHS are exploring “other options” for the remainder of the continuing contract.

The ministry, for months, has declined to say whether the province was financially protected if the contract was not fulfilled. Ms. Taillon said an update on “next steps” will be provided as it is available.

Ms. Smith said she stands by the decision to import the medication after hearing of parents desperate to find relief at the height of last year’s virus season.

“Although distribution took longer than hoped, we needed to act quickly to ease the burden on kids and families,” she said in a statement. “We stand by the decision made last fall to act and obtain much-needed supply to support families and feel confident that if we find ourselves in a shortage again, Alberta will be prepared.”

The ibuprofen expires in November, 2025, and the acetaminophen in January, 2026.

Atabay did not immediately respond to a request for comment from The Globe and Mail.

Part of the deal made by Alberta was that the province had a minimum purchase order set by the supplier, which greatly exceeded population need. Alberta was banking on reselling the imported medication to other provinces to help offset the cost but has since backed away from that plan “at this time,” according to Ms. Taillon.

The federal government has an established approval process for foreign medications to ensure compliance with Canada’s safety, quality and efficacy requirements. Part of the delay in getting the medication on store shelves was ensuring that childproof caps and labelling conformed to Health Canada standards.

When the medications finally did arrive, additional concerns emerged.

Alberta Blue Cross, in a bulletin posted in March, alerted pharmacists that the Turkish product had a lower dosage concentration and must be kept behind the counter so that parents or guardians are educated on how to use it safely.

The bulletin also said the suggested retail price for the product was $11.99. Alberta paid $14 per bottle.

Health Canada, in a statement, said there are no outstanding proposals from Alberta to import Atabay medications. The department said it would not consider applications for the exceptional importation of acetaminophen or ibuprofen at this time because of current supply.

“We worked closely with provinces and territories, as well as stakeholders, including manufacturers, retailers and health care professionals, to resolve the shortage,” said Health Canada.

More than 16 million units of children’s medication was released into the Canadian market between November, 2022, and September, 2023. The department also authorized the importation of more than four million foreign units, including from Turkey, during that time period.

Mr. Harrington, of FHCP, said the prevalence of respiratory infections – such as RSV, COVID-19 and influenza – paired with intermittent supply problems driven by a sudden surge in demand led to the shortage last fall.

“There was a period of two weeks where demand was four times normal and that completely emptied out the supply chain,” he said. The supply has since rebounded and production remains elevated, said Mr. Harrington, adding that there are “no signs” that Canada will face another collapse of stock any time soon.

“Can it happen again? Sure. I mean, it’s possible,” he said. “But I think the likelihood of those two things coming at us again seems pretty remote.”

A timeline:

• Dec. 6, 2022: Alberta Premier Danielle Smith announces a tentative deal with Turkish company, Atabay Pharmaceuticals and Fine Chemicals, to procure five million bottles of children’s acetaminophen and ibuprofen to address a shortage in pediatric medications while respiratory infections were spiking. Government officials say they are confident the medications will arrive in the coming weeks after Health Canada approval.
• Dec. 30, 2023: Health Canada authorizes the exceptional importation of Atabay liquid paracetamol, more commonly known as acetaminophen. The federal website states the drug will be available to Alberta hospitals, but it does not list community or retail pharmacies where medications are subject to tougher regulations.
• Jan. 18, 2023: The first shipment of 250,000 bottles of liquid acetaminophen arrives in Alberta for hospital use. The province says it is awaiting approval of the remaining 4.75 million bottles for retail sale from Health Canada and notes that child-resistant caps and other regulatory requirements caused delays.
• Jan. 26, 2023: Health Canada authorizes Atabay-produced liquid acetaminophen for Alberta pharmacies but Jason Copping, then-provincial health minister, says final approval on labelling is required before 750,000 bottles of the medication can be shipped. “I’m hopeful it’s in days but I’ve been hopeful for a while,” said Mr. Copping.
• Feb. 10, 2023: Health Canada approves the importation of Atabay Pedifen, more commonly known as ibuprofen, pediatric syrup for Alberta retail and hospital use. Mr. Copping said the supply will be brought in “over the next couple of weeks.” The province confirms Atabay acetaminophen has received final approval but has yet to ship to Alberta.
• March, 2023: An Alberta Blue Cross bulletin for pharmacy service providers says Atabay products have a weaker dosage than found in typical domestic medication. Pharmacists, it says, are required to keep the product behind the counter and provide counselling and education to parents and caregivers on the safe and correct usage of the product.
• March 8, 2023: The cost of the Atabay deal is revealed to be $80-million – $70-million for the medications and $10-million for shipping, waste disposal and other administrative expenses. The province expects a significant portion of the costs will be recovered by selling medication to other provinces and territories and subsidized medication sales.
• March 20, 2023: The first of three shipments, totalling 750,000 units, of Atabay acetaminophen is being distributed to community pharmacies. The shipment arrived on March 2 but had to be kept in quarantine for testing, says the province. Meanwhile, The first shipment of Atabay ibuprofen is clearing the same quarantine process.
• In April, 2023: The countrywide shortage of pediatric ibuprofen and acetaminophen ends, according to Health Canada. “Adult, infant and children acetaminophen and ibuprofen are now widely available across the country and supply is expected to improve even more,” the agency said in a later notice.
• July 10, 2023: Alberta Health Services, in an internal medication posting, orders its staff to stop using Atabay acetaminophen and transition back to the typical, higher-strength products. It said the transition is a result of Canada resolving its shortage of liquid acetaminophen.