Thousands of patients in Newfoundland and Labrador could have received tampered eye medications without their knowledge for several years, documents obtained by CBC News reveal.
The drugs in question are injectable doses of Eylea and Lucentis, used to treat age-related macular degeneration. More than two million CanadiansThe drugs come in single-use pristine vials directly from the manufacturer, but a whistleblower has uncovered evidence that the vials were being tampered with to create multiple doses.
Bayer's product monograph for Eylea states that each vial is to be used for only one procedure, and any overfill left in the vial must be discarded. It issued a directive in 2022 reiterating that vial-splitting its medication is strictly prohibited. Meanwhile Bayer, the manufacturer of Eylea, notes under its standard terms and conditions of sale that "under no circumstances may a customer multi-dose, compound or vial-split any Bayer product."
"You're taking one product and creating four or five doses out of that one product," Dicks said, adding that there is no reason to interfere with the optimal product manufactured by the drug companies. In addition to the risk of infection, Dicks is concerned about whether dose-split eye injections effectively treat the patient's condition.Over the past eight years, Dicks has taken his concerns to Health Canada, the provincial government in Newfoundland and Labrador, including the premier and the minister of health, the National Association of Pharmacy Regulatory Authorities and the Newfoundland and Labrador Pharmacy Board , but has not been satisfied by their responses.
"It was glaring," said Dicks. "It's in a one-to-one relationship with a procedure. It was easy enough to … research how many procedures are being done. And then the question became … where are the products to match those procedures?" Three weeks later, Ontario-based Advanced Care Specialty Pharmacy presented a 67-page proposal in response to the RFP. It outlined pre-existing experience with splitting vials, a list of qualified personnel on staff and its logistical storage and delivery capabilities.
"We know that it's been distributed throughout the province without patient contact…. We know these things have occurred," said Morgan. "What actually happened in the distribution is out of sight. But what we do know is that the billings occurred were heavily concentrated at one pharmacy," Dicks said.
"They reviewed it and found that it was sterile and destroyed the sample, destroyed the product that we provided to them…. I was flabbergasted," said Morgan.Dicks was shocked that Health Canada didn't check if the medication was contaminated."If I or any pharmacist in Canada received insulin in a polybag, marked insulin … without any product parameters on it on a label, would they dispense that? No. No chance…. They'd have no idea what they were getting.
"I remember when these drugs were first proposed as therapy and I thought that this was really not going to fly," said Cruess. "But they've been a real game changer in the treatment of age-related macular degeneration, diabetic retinopathy and vascular obstruction in the eye.""Microbiological risks could be hazardous, you know, obviously, and … if the dosing isn't correct, then we might not see … an ideal outcome as we would expect.
Contained in a sealed, tinted bag, was a nondescript glass syringe with a single drop of clear liquid, and no other markings. Dicks and Morgan say Health Canada took the item and destroyed it. Patten encourages "anyone who has concerns about a specific pharmacy or pharmacy professional to share that information with NLPB so that any potential patient safety issues can be assessed and addressed using our scope as outlined in the Pharmacy Act, 2012," she wrote.The billing discrepancies that dose-splitting creates could be substantial, but exactly who along the distribution chain is directly pocketing the extra money is not clear."It is a national issue.
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