Health Canada has approved the importation of children’s acetaminophen from a Turkish manufacturer for Alberta pharmacies after weeks of delays, while the province’s proposal for pediatric ibuprofen remains undecided.
The approval was granted nearly two months after Premier Danielle Smith announced a deal with Atabay Pharmaceuticals and Fine Chemicals to bring five million bottles of children’s pain medications to local shelves. The announcement was in response to a shortage driven by a spike in respiratory illnesses. Last Thursday, the federal agency authorized liquid paracetamol, more commonly known as acetaminophen, for children 2 to 11 for retail pharmacies.
It is the same medication approved for Alberta hospitals in January, but was subject to additional requirements by Health Canada for public purchase. Ms. Smith has said packaging issues were to blame for the delay.
Health Minister Jason Copping said on Thursday the approval is a “positive step forward” but the government is still awaiting final approval on labelling for the pharmacy-bound medications to be shipped to Alberta. He said they will have a better idea of timelines once they are given the green light.
“I’m hopeful it’s in days but I’ve been hopeful for a while,” Mr. Copping said. “There still is a shortage here, so we are quite comfortable that Alberta will still need the shipments and, again, the shelf life on this is two years, so it’s not just about this season. It’s about next season as well. In addition, we’re continuing to work with other provinces should they have need.”
Anne Génier, a spokesperson for Health Canada, said in a statement that a thorough review and discussions with Atabay and the Alberta government took place before acetaminophen with child-resistant packaging was approved for distribution and sale in pharmacies. She said the agency continues to review the ibuprofen proposal.
“Timelines for review depend on multiple factors, including the completeness of the proposal and supply chain details, the speed at which information is made available to Health Canada, and how similar the product is to a Canadian-authorized product,” said Ms. Génier.
In early December, the Alberta government said it was hopeful the pain relief medications would arrive by Christmas. Ms. Smith billed the deal as a way to address medication shortages and pediatric respiratory infections, which were spiking at the time.
Alberta is paying a “small premium” over the planned retail price and was required to purchase the minimum amount of product set by the supplier. There are plans to share excess supply with other provinces and territories.
The Ministry of Health did not respond to requests for comment on Thursday about the total cost of the deal or how many bottles are still in flux.
The first shipment, of 250,000 bottles for hospital-use only, arrived on Jan. 18. Ms. Génier said that approval included the requirement for “a strong health product risk communication informing health care professionals how to safely administer the foreign product within the Canadian hospital setting.”
James Wood, a spokesperson with Alberta Health Services, said hospitals will distribute the liquid acetaminophen as needed to nursing units and programs.
More than two million units of children’s pain and fever-reducing medications have been imported into Canada for hospital, pharmacy and retail use, in addition to domestic supply.