Posted on 10/22/2016 8:32:21 AM PDT by rickmichaels
On a Saturday night this past March, Melissa Sheldrick gave her eight-year-old son Andrew his usual liquid medication for his REM sleep disorder and then tucked him into bed.
When she went to wake him in the morning, her little boy was dead.
It’s a nightmare almost too painful to even imagine. It would take almost five months before she and her husband, Alan, learned what killed their only son: The coroner sat them down and told them their healthy child had died from a lethal dose of baclofen, a powerful muscle relaxant usually used to treat adults with MS.
Andrew hadn’t been prescribed baclofen.
Floradale Medical Pharmacy in Mississauga had refilled their son’s prescription the day before for his usual tryptophan. But according to the family’s $4-million lawsuit filed this week, “an analysis of the tryptophan medication compounded by Floradale revealed that it contained 135 mg of baclofen and no trace of tryptophan. This indicates that baclofen was substituted for tryptophan at Floradale in error.”
A request for comment from Floradale owner Amit Shah was not returned. No statement of defence has yet been filed and the family’s allegations have not been tested in court.
In their grief, the Sheldricks have launched more than just a lawsuit. They’ve started a petition calling on Queen’s Park to force pharmacies to report any medication errors so they can be tracked not only for consumers, but so any trends can be identified and corrected.
Shockingly, as it stands right now, any mistake can be kept quiet. Incorrect dosages, inadvertent medication substitutions, misread prescriptions — the Ontario College of Pharmacists doesn’t require their members to report any of them. Only Nova Scotia makes it mandatory to report all medication errors and near-misses to the Institute for Safe Medication Practices (ISMP) Canada — in its first three years, the province had a frightening 75,000 reported incidents.
According to the ISMP, dispensing slip-ups are rare — yet the non-profit group, which depends mostly on voluntary reports, admits it has no official data for this country. In the U.S., the accuracy rate is estimated at 98.3%. “Canadian researchers have estimated that extrapolating this data to Canada would have resulted in 7 million medication errors in 2009, based on 453 million prescriptions dispensed in Canada in 2008,” says spokesman Julie Greenall.
That’s a stunning number of errors. The ISMP estimates that only 1% of the cases reported to them have resulted in patient harm. For Sheldrick, that harm saw her family of four tragically reduced to three. “He was a light and this has left a huge, gaping hole in our lives,” his mother says.
Like most of us, Sheldrick never imagined such a medication mix-up could even occur. When her son had trouble swallowing his pills, they were referred to a compound pharmacy that would produce a mixture instead. For 18 months, there had been no problems — until that fatal refill.
When the coroner told them the cause of their son’s death, they were stunned — and then they were furious. What made it worse was realizing that no one would learn from their excruciating experience — not the public and not other pharmacies.
“How does this happen?” demands his mother. “This is so unbelievable and so unacceptable. We don’t want anyone to have to go through what we have. Pharmacies have to be accountable for their errors.”
She has garnered more than 2,000 signatures on her petition: “Nothing can bring Andrew back to us, however, in his caring spirit we want the laws to protect all people, and so we are asking that Ontario create a law to enforce the use of error tracking tools for dispensaries,” Sheldrick wrote on the change.org site.
“Thousands of pharmacy errors are made annually, but there is no law in Ontario requiring such errors to be reported or tracked. A reporting system would help put in place a vehicle to examine errors and see how training and procedures can be improved to reduce the number and types of errors.”
For a family left broken, such a law is the only good they can imagine coming from their loss.
They needed George Bailey.
I wonder what the mother will get.
Some countries put a ceiling on the maximum $$ that a suit can hold.
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Attorneys are required because folks simply cannot settle their own differences.
By the way, “Queen’s Park” is this article is a demonym referring to the capitol (not capital) of Ontario.
You beat me to it!
Good to see Freepers are still on their toes.
I agree their health system sucks but dont really see how it correlates to an article about a pharmacy screwing up.
It happens in the US way too much also.
Have a relative with permanent brain damage from contra indicated meds.
I thought the same thing.
Lack of funds for oversight (and thereby enforcement) moved them to a "cost recovery program". Drug, medical device, cosmetic, 'health products' , submission costs, did not generate the desired revenue. Focus was placed on the federal level, with provinces - local compounding pharmacies- not a priority.
Not that, that is a problem in and of itself, but the "compounding" can obviate all the federal level controls/oversight that is built into the final product (cGMP compliance for finished drug products).
BTW: the U.S. treated compound pharmacies the same on on the Fed level but for many reasons, there was better state control/oversight. Not to pick on people but the most egregious crimes & mistakes by U.S. compounding pharmacies were committed by pearsons with names not seen in your highschool year book...
I do believe US pharmacies have addressed these type errors over the years so this kind of thing is less likely here. That said, humans make mistakes. Remember the shuttle Columbia was designed and built by our best minds.
They really do make an effort to distribute similar sounding or spelled names in packaging that is as different as possible.
““How does this happen?” demands his mother. “This is so unbelievable and so unacceptable.”
I am not minimizing the pain of the parents but mistakes DO happen in life.
I certainly agree that pharmacy mistakes should be thoroughly tracked.
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It’s easy to make sure pills have been filled correctly, not so with liquids.
If you have a prescription filled for a ‘liquid’ medicine, be very careful that it is filled correctly. Pills you can check the identity of online. Liquids cannot be, and are usually dispensed from a larger bottle.
My guess is that this was not filled by the pharmacist, but probably someone the pharmacist designated to fill it. If you aren't a pharmacist and someone says “tryptophan” and you are looking at bottles and you weren't sure what was said to you, but you see a bottle labeled “baclofen”, you might mistake them (3 syllables, similar sounding ending). No one should make that mistake, pharmacist or not, but if it were up to me I would make it punishable by imprisonment, no exceptions, for anyone but a pharmacist to fill a liquid prescription. To be honest, they should probably require that all liquid prescriptions are pre-bottled and sealed.
As a more general comment, you should never put blind faith in the medical care you receive. As a patient you are a crucial part of the process that prevents errors from being made. No one has a bigger stake in the outcome than you.
Good advice. Many docs simply read instructions and are too busy to do "root cause analysis" and investigate the source of complex healthcare problems. It's good for the patient to engage in finding the solution, medicines, etc.
Really sad for this family....I cannot imagine what they have been through.
But, it was built by the low bidder!!!!
My first thought too
Baclofen and other muscle relaxants are very dangerous drugs, and not just as an obvious overdose. I had a very scary event with Baclofen myself and it wasn’t an issue of taking too many pills, but having been prescribed both Baclofen and high strenght pain killers. They DO NOT MIX WELL!! and it doesn’t take much to get in trouble.
Be thankful that we are not that pharmacist.
So sorrowful, all the way around.
A govt. pharmacy?
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