Several vials of a powerful heart drug found inside a package of injectable morphine were properly labelled, although they had been put in the box in error and could have posed a serious threat to patients, Health Canada said Thursday.
The federal department warned hospitals across the country late Wednesday to "quarantine" a specific batch of morphine made by Sandoz Canada after the drug packaging mix-up was discovered by an unidentified Toronto hospital.
But only one 10-vial package of 2 mg/ml injectable morphine sulfate appears to have been affected by the packaging error, said Dr. Robert Cushman, head of Health Canada's biologic and genetic therapies directorate.
"We're just talking about a single package that to date has been identified. We haven't had a report of any others," Dr. Cushman said Thursday from Ottawa.
The cellphone-sized box contained six vials of the painkiller and four vials of 0.2 mg/ml isoproterenol hydrochloride — a powerful adrenalin drug used in cardiac arrest patients to help restart the heart.
Each vial was properly labelled, and the labels for the two drugs have different colouring and wording, he said.
"Two drugs got into one package that was labelled morphine. It's been confirmed that the morphine was in the morphine vial and the isoproterenol was in the isoproterenol vial."
Dr. Cushman said there have been no reports of harm to patients as a result of the drug mix-up, which he suggested could have occurred when workers packaging the drugs at the company's Boucherville, Que., plant switched from morphine to isoproterenol.
Sandoz had shipped 57,000 vials of the morphine product in 10-ampule packs to hospitals, pharmacies and long-term care facilities across the country, said Steve Outhouse, spokesman for federal Health Minister Leona Aglukkaq. Another 103,000 vials are in its warehouse.
A spokesman for Sandoz Canada was not able to provide any information on how such a packaging mix-up could occur, but he said the company was preparing a statement on the incident.
Inadvertent use of isoproterenol hydrochloride instead of morphine could result in serious health effects.
Not only would patients not receive the intended dose of the potent painkiller, but isoproterenol hydrochloride is associated with a risk of life-threatening abnormal heart rhythms.
Isoproterenol hydrochloride, which has physiological effects similar to those of the stimulating hormone epinephrine, is a powerful cardiac drug that could seriously harm or prove fatal if given by accident to a patient with an underlying heart condition.
"I think what this has also called attention to is that people really look at these packages," Dr. Cushman said. "Due diligence and precaution requires that the hospitals and the pharmacies and the clinicians look at this very closely."
Health Canada said it was contacting the provinces and territories with the updated information on the packaging mistake and would be informing hospitals when the do-not-use order is lifted.
Sandoz Canada, which supplies the majority of injectable medications used in Canada – among them painkillers, anti-nausea medications and antibiotics – is at the centre of a national drug shortage caused by quality-control problems at its Boucherville, Que., plant.