Eight-year-old Andrew Sheldrick went to bed on Saturday, March 12, after his mom gave him what she thought was his usual dose of medication for a sleep disorder. When his dad went to wake him in the morning, he found the boy dead.
“They did let us know that there was no amount of intervention that could have saved him. He had been gone for several hours by the time we found him,” Andrew’s mom, Melissa Sheldrick told Go Public.
For four and a half months, the family didn’t know what caused Andrew’s death.
Then in late July, a coroner’s report concluded Andrew had not taken Tryptophan, the sleep medication he’d been prescribed, but Baclofen, a muscle relaxant drug used to treat muscle spasms caused by conditions such as multiple sclerosis.
Boy had nearly 3 times the toxic dose in his system
The coroner found the boy had almost three times the dose of Baclofen in his system that would be toxic to an adult, and no trace of the sleep drug Tryptophan.
A report by Ontario’s Office of the Chief Coroner concluded an independent compounding pharmacy in Mississauga had made a mistake and substituted one drug for the other. Andrew died after getting just one dose of the Baclofen.
A compounding pharmacy prepares personalized medications for patients by mixing individual ingredients together in the exact strength and dosage form required by the patient.
According to the report:
“Analysis of the Tryptophan medication that Andrew was prescribed for parasomnia from a compounding pharmacy revealed that it contained approximately 135 mg/L of Baclofen and no trace of Tryptophan. This would be consistent with the pharmacy mixing the amount of power that would generate 150 mg/ml concentration of Trypyophan, but substituting Baclofen powder.”
Andrew’s mom says the family had no indication there was a problem with the medication.
“The liquid that was in the bottle, it looked the same as Andrew’s medication, and he didn’t say that it tasted any different,” Sheldrick said.
“Unfortunately there was no way of knowing that it was anything different than what he was supposed to have.”
Boy used sleep medication for years
Otherwise a healthy boy, Andrew suffered from a REM sleep disorder called parasomnia that caused him to enter his sleep cycle twice as fast as normal, leading him to wake up as many as five times during the night. A sleep specialist prescribed Tryptophan at bedtime.
He had trouble swallowing pills, so his sleep specialist prescribed a liquid dose in October 2014. That’s when the family began using the liquid compound from Floradale Medical Pharmacy Ltd.
For years, Andrew had no issues with the medication.
Family launches lawsuit
Floradale Medical Pharmacy Ltd. and Amit Shah, its owner and manager, are named in a multi-million dollar lawsuit. The family’s lawyer filed the statement of claim in Ontario Supreme Court this week.
According to that claim, the pharmacy failed to dispense proper medication, failed to keep accurate records and didn’t adhere to pharmacy laws and regulations.
To date, no statement of defence has been filed.
The lawsuit also names “Jane/John Doe” referring to the unknown pharmacist or lab technician who prepared the compound.
Pharmacy says ‘the matter is being addressed’
Go Public contacted Floradale Medical Pharmacy. We received a brief response from owner and manager Amit Shah.
“At this time we have no comment. The family has retained counsel. The matter is being addressed,” he wrote in an email.
Mom launches petition for change
Lack of information and accountability is why Andrew’s mom Melissa Sheldrick says she’s now campaigning to ask Ontario’s Health Minister to have medication error reporting made mandatory. So far her petition has more than 1,000 signatures.
To date, there is no requirement to report errors to a formal body unless a pharmacy is inspected by its governing college. Typically, each Ontario pharmacy is inspected every two to four years and error reports are not public.
“To me it’s a form of negligence that is being overlooked in the pharmacies and nobody is holding them accountable or responsible, and that’s unacceptable,” Sheldrick said.
As Go Public reported, Nova Scotia is the only province that requires pharmacists to report all errors to The Institute for Safe Medication Practices (ISMP) Canada.
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All other provinces allow community and retail pharmacies to investigate their own errors and deal with the issues internally.
Melissa Sheldrick wants Ontario Health Minister Dr. Eric Hoskins to implement legislation that would force pharmacies to be more transparent about medication errors.
“Practices have to change, people have to be held accountable,” Sheldrick said.
“The rest of our country has no idea about how many pharmacist errors are being made in a day, in a week, in a month, in a year, and there are many … I think that when there is transparency, training can happen, review of policy and procedures can happen, intervention that can happen.”
Ontario working to ‘increase transparency’
In a statement to Go Public, Ontario’s health minister says his heart goes out to Andrew’s family, but Hoskins made no mention of supporting the changes the family is proposing.
“This is a tragic situation and my heart goes out to this family as they come to terms with their terrible loss,” he wrote.
“Our government is committed to working with our partners to improve safety for patients… We will continue to work with the Ontario College of Pharmacists and patient groups to improve the monitoring and reporting of medication incidents, as well as working with all of our colleges to increase transparency for the public.”
ISMP Canada is now investigating what happened in Andrew Sheldrick’s case. Its report should be complete in the next couple of weeks.
The report’s findings will be used to improve the system, according to Julie Greenall, ISMP Canada’s Director of Projects and Education.
“Preparing a medication that is not available in a ready-to-use form is a complex process. We anticipate the learning from this tragedy will be widely shared.”
She says once the report is complete, ISMP Canada will give it to the Ontario Coroner’s Office, which will determine if the findings will be made public.
ISMP Canada has no power to force change or discipline those responsible.
That is the job of the Ontario College of Pharmacists. Andrew’s family is now in the process of filing a complaint with the college.
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Article source: http://www.cbc.ca/news/canada/toronto/go-public-sleep-medication-accidentally-switched-1.3811972?cmp=rss