Grieving mother urges more oversight for pharmacies that make errors
As she had done so many times before, Melissa Sheldrick helped her 8-year-old son Andrew get ready for bed one Saturday evening last March.
Andrew, who was diagnosed by a doctor with a sleeping disorder, was on a regular prescription for tryptophan, a drug that helped regulate his sleep cycle. After taking his usual dosage, Andrew went to bed at 9:30 p.m.
He never woke up.
“The next morning, we found him in his bed. He was gone,” his mother said. “We were frantic. We called 911 and the paramedics came and said there was nothing, any kind of medical intervention they could do. It was like something out of a nightmare.”
Andrew was mischievous, caring and funny, his family recalls. He loved sports, playing video games on his Xbox, and above all, his family and friends.
Until July, his family didn’t know why he died. Sheldrick, her husband Alan and 14-year-old daughter Samantha found out through a coroner’s report that Andrew died of a toxic overdose of baclofen, a muscle relaxant drug.
The coroner’s report concluded that the bottle of medication Sheldrick had picked up for her son at the pharmacy that same Saturday, March 12, contained no traces of the sleeping drug he had been prescribed.
“Logic would dictate that baclofen was substituted for tryptophan at the compounding pharmacy in error,” the report states. Peel Regional Police are “addressing this issue” with Floradale Medical Pharmacy in Mississauga, where Sheldrick had received the drug for her son, according to the report.
Andrew had consumed about three times the amount of baclofen considered toxic in an adult, according to the coroner’s report.
The family is also asking Ontario Health Minister Dr. Eric Hoskins to implement a law that would increase oversight and tracking upon pharmacies that make errors.
With the hope of effecting change so that no other families face a similar tragedy, Sheldrick is in the process of requesting a coroner’s inquiry, which could produce recommendations for how pharmacies can reduce the risk of human error.
Andrew had taken tryptophan for two years. The only reason Sheldrick had gone to Floradale was because it is a compounding pharmacy, meaning it could take the pill form of Andrew’s medication, which he had trouble ingesting, and make it into a liquid.
The statement of claim names Floradale and its owner and manager Amit Shah as defendants, as well as a “Jane/John Doe pharmacist” who allegedly made the error. The family has been unable to identify who had prepared the medication.
“As a result of the negligence of the Defendants, which includes but is not limited to, their failure to properly compound the prescribed medication, Andrew died,” reads the statement of claim.
After several calls to pharmacies operated by Shah, he did not respond to requests for comment, but told the CBC News in an email “at this time we have no comment.”
“The family has retained counsel. The matter is being addressed,” he stated.
The lawsuit alleges the pharmacy permitted “unqualified and incompetent staff” to attend to patients and failed to keep accurate records.
Sheldrick is in the process of filing a complaint with the Ontario College of Pharmacists, the regulatory body for pharmacy practice in the province.
“There has to be a body that oversees this,” Sheldrick said.
Hoskins told reporters on Thursday he would look into the request along with the Ontario College of Pharmacists.
“I will be looking specifically, in light of this tragic situation, to see if there’s more that can be done in a transparent and accountable way,” he said. “Certainly if there are any allegations or complaints or suggestions of misconduct or errors that have been made, I would encourage Ontarians to report that to the college. It’s their responsibility to investigate.”
In Nova Scotia, pharmacists must report all errors to the Institute for Safe Medication Practices Canada. It’s the only province in the country that requires such reporting and Hoskins said he would look to Nova Scotia to determine if it’s the right approach.
Julie Greenall, the institute’s projects and education director, said she’d like to see Ontario adopt the same process.
“I think that would be helpful, particularly for critical incidents,” she said. “I think the more information we have about errors that are happening means the more we can learn about how to prevent them in the future.”
The institute is co-ordinating with the Ontario Coroner’s Office to investigate Andrew’s case to determine contributing factors and how to prevent future harm in pharmacies across the country. A report will be delivered to the coroner’s office in the coming weeks.
“This is a terrible situation,” Greenall said.
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