Systems in Place to Prevent These Medication Errors? Seems Not…
A few weeks ago, I saw a horrific story about a retail pharmacy error in the article “Pharmacy Mistakenly Gives Pregnant Woman Abortion Pill.” Mareena Silva was mistakenly given the wrong drug by her Safeway pharmacy, which means she might lose her unborn child, as a result.
When tragic events like this happen, leaders should go to the “gemba” (the actual workplace). We don't have that luxury here on the blog, but we can look at statements in news reports to see what cautionary lessons we might draw that could be of use in other settings.
From the article:
Silva said the pharmacist at the Ft. Lupton Safeway gave her the prescription of methotrexate. Methotrexate is used in chemotherapy regimens to treat cancer, but it is also used to terminate early-stage pregnancies.
After she took it, Silva was nauseated.
“I came back and I looked at the bottle and it wasn't my name,” she said.
The methotrexate was intended for a 59-year-old woman with the exact same last name as Silva's and a similar first name.
She called the pharmacist and was given an immediate countermeasure – to try to vomit up the medication. She was rushed to a hospital so they could give her charcoal to try to absorb the medication.
The other immediate countermeasure, at the pharmacy, should have been an immediate root cause investigation, looking for what happened (or didn't) and WHY, rather than just looking for an individual to blame (as so often happens in these events).
It's often interesting to look at a company or hospital's reaction and statements after an error like this, to see how much blaming or denial is taking place. There's often chest-beating about how errors like that are unacceptable and people will be disciplined.
We are also very concerned about how this happened and we are conducting a full and complete investigation. Safeway has pharmacy systems and processes in place to prevent this kind of occurrence. We have a well-earned reputation for reliably and safely filling prescriptions, and we will continue to work diligently to ensure our procedures and policies are being followed at each of our pharmacies.”
Whatever the systems and processes were – they failed in this case, they failed Ms. Silva and her baby.
Again, from the article:
7NEWS checked and it is common practice at Walgreens and other pharmacies to ask for your address when issuing prescription medication just in case names are similar.
I know this happens when I pick up medications. It's certainly a good practice to, as the patient, check to make sure the name on your package is correct. It's also worth checking that the bottle is correct (could be the wrong bottle in the right bag). It's also worth confirming to see if the pills look correct (could be the wrong pill in the right bottle). The pharmacy I use puts a diagram on the paperwork so you can physically inspect what shape, size, and color the pills are and what should be printed on the pill.
Again, we're forced to speculate — but was a standard process NOT followed in this case? Was the pharmacy swamped and busy, leading somebody to skip a step? Or did they just forget?
In another article, from a few days later (“Procedure not followed in abortion pill error“) – well, the headline gives it away. The pills given to Mareena Silva were intended for another woman with the same last name.
From this article:
Safeway says procedures meant to reduce prescription errors were not followed at its pharmacy when a pregnant woman was given the wrong prescription.
But they aren't any more specific than that.
So systems were in place, except the system wasn't being followed here – what kind of system is that?
This different article says:
All pharmacy personnel are trained and instructed to confirm verbally the patient's full name and date of birth before retrieving a medication from the “will call” area. This procedure includes getting a verbal acknowledgment and confirmation from the customer. Had that procedure been followed, this regrettable error could have been avoided,” Safeway said in a statement
I'd argue that instead of asking WHO didn't follow the procedure, Safeway (and its customers) would be far better off if they started asking WHY?
Why were procedures not followed?
Was this an isolated case?
We're taught in the Lean methodology that “standardized work” is not just a matter of writing procedures. We need a culture and an environment where standardized work is actively managed. How do supervisors and managers confirm that standardized work is being followed? Are leaders providing the right support in the case that there are barriers to following standardized work (such as being too busy or having broken equipment)?
How often are procedures and policies NOT followed? It's got to be more than just this one time.
Here is a news video about the case (no longer available) – my sympathies and prayers go out to Ms. Silva, you can see the mental anguish on her face. It's unclear yet if there will be any harm to her baby – if the baby will miscarried or be born with severe birth defects.
There haven't been any news updates since February 10.
There have been a rash of medication and pharmacy error stories in the news recently. Not to single out Safeway, but there was another error, this time involving meds for a dog (“Another Safeway Pharmacy Error: A Near Fatal Overdose Of Family Dog“). It says:
Susan Stoltz, sister to movie actor Eric Stoltz, had a prescription filled for her beloved Jack Russell Terrier who suffered from severe allergies. She went home and gave her pooch one pill. Sharkey soon collapsed on the floor and had to be rushed to the animal emergency clinic, where Stoltz learned that each pill contained 10x the amount of medication prescribed by the vet.
And in what might go down in the Annals of Horrible Customer Relations:
Safeway pharmacy has not even offered Stoltz an apology. After first denying that any mistake occurred, the pharmacist eventually acknowledged the error, and then rudely blurted out, “The dog is alive today isn't she, so it hardly matters.”
The article mentions that the pharmacist was not disciplined or held accountable. What problem solving and prevention is taking place? That's a more critical issue to me. I'm not interested in throwing people in jail for human error – I'm more interesting in designing systems where errors are less likely to occur, if not impossible.
And it's not just Safeway – another recent case at a Walgreens had a woman receiving the wrong medications.
Again, to recap the main thought – having policies or procedures or “standardized work” isn't worth much of that process is not being followed. Far too often, I see managers wanting to blame the individuals involved, instead of looking for more systemic causes.
And the ultimate final thought – as the customer, you must play the role of “final inspector.” It's a real shame when you have put your customer in that position. Does Toyota or GM ask customers to double check that the lugnuts are tightened properly on a new car, so that the wheels don't come flying off? That type of error could be brushed off as “human error,” but maybe the automakers have been processes in place than these pharmacies, to prevent errors and defects from getting to the end customer?
What do you think? Please scroll down (or click) to post a comment. Or please share the post with your thoughts on LinkedIn.
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Here is a related editorial on preventable medical errors from Pittsburgh:
Hospitals are still killing patients with needless mistakes
And it’s inexcusable because we know how to prevent them, complains health care advocate KAREN WOLK FEINSTEIN
Read more: http://www.post-gazette.com/pg/11058/1127982-109.stm?cmpid=newspanel#ixzz1FIDAyLJg
When doing root cause with people new on the Lean journey, I am surprised how many people stop once they reach “human error”. There are deeper causes for why human error occurs (some you listed above).
I once worked with an upstream process where they said it was the downstream person’s job to inspect before giving it to the patient. I coached to say the downstream inspection may be needed but it is the upstream’s responsibility to ensure it is not passing down defects for the downstream to catch! Luckily, this coaching hit home and a better quality system was put in place.
I think this thiking goes with the customer is responsible for inspecting too. While it is in a patient’s best interest to look before taking a medication, the pharmacy should have systems in place that the patient NEVER finds an error.
Thanks for the addition, Brian.
I agree that the customer inspection I’m advocating is not ideal. To me, it’s part of a necessary containment strategy that is necessary until the supplier (the pharmacy) can demonstrate perfect quality.
I completely agree that the healthcare system as a whole needs a very close inspection. Too many mistakes are being made. A recent study estimated that 15,000 Medicare patients die a month from human error: http://www.usatoday.com/yourlife/health/healthcare/2010-11-16-medicare_N.htm Steps need to be taken to avoid these tragic deaths.
Great post. You are exactly right that you must have good processes that are FOLLOWED. Having good process that are sometimes followed is better than not having them at all, but in general I see that both the process is in need of substantial improvement AND standardization is needed. Poor management requires people to constantly make exceptions to actually get things done. This is bad in most organization and potentially catastrophic in some (like health care). http://management.curiouscatblog.net/2007/11/28/arbitrary-rules-dont-work/