A textbook medical error...

[no-see-um]

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Manufacturer creates the same style vials for two different strengths, and patient gets wrong dose... Pharmacists have had to deal with this for years and design systems around this issue to prevent such errors... But it happened again.

This time to the newborns of a high-profile, celebrity- Dennis Quaid. They were administered a heparin dose 1000x greater than indicated. Luckily they are doing fine, but it is interesting to see that Quaid knows enough to sue the manufacturer rather than the hospital/pharmacists. It is good to see that patients are also taking a stand for preventing these types of errors which are more of a result of a manufacturer error in not wanting to spend the extra money to print in a different color of ink and chalk it up to acceptable risk. This has happened over and over again, and it should be mandated that things change on the levels of manufacturing. Perhaps the FDA could step in with regards to unsafe labeling issues and save a few lives.

http://www.chicagotribune.com/busin...-update,0,2143409.story?coll=chi-business-col

Actor Dennis Quaid, wife, sue Baxter in overdose of newborn twins
Suit alleges Deerfield-based health-care products producer was negligent because its packaging contributed to hospital mix-up

By James P. Miller | Tribune staff reporter
4:19 PM CST, December 4, 2007


Actor Dennis Quaid and his wife filed a product-liability lawsuit against Baxter International Inc. Tuesday, alleging the Deerfield-based health-care products producer was negligent because the company's packaging design for a blood thinning product contributed to a hospital mix-up in which their newborn twins were mistakenly given a huge overdose of the drug.

The suit, filed in Cook County Circuit Court in Chicago, notes that Baxter is the maker of the thinner known as Heparin, and that it produced vials of two different strengths, each with a blue background. One strength had a concentration of 10 units of heparin per milliliter, and the other had a concentration of 10,000 units per milliliter.

In mid-November, the suit says, medical personal who were attending the Quaids' new babies were told to receive a treatment that involved the administration of the 10 unit-per-milliliter product. But instead, the complaint says, the staffers at Cedars Sinai Hospital in Los Angeles made a "medical error" and administered the products that is 1,000 times as strong.

Baxter, the suit contends, was negligent because it knew that three infants had died last year as a result of similar Heparin overdosing, but had failed to recall the super-strong product even though it knew of the confusion caused by the similar packaging. It also failed to repackage the product, or to issue an urgent warning to healthcare providers which had purchased the product.

The suit says only that the Quaid twins "suffered and will continue to suffer injuries of a pecuniary nature."

From a health perspective, "Apparently, they're going to be fine," the Quaids' attorney told the Associated Press. The point of the suit, she said, is "to save other children from this fate."

[email protected]

 

[Moxxie]

I've been following this story since it broke. I think that it's amazing that Quaid's babies survived. I was just waiting for him to sue - I'm glad that he's suing the manufacture instead of the hospital, but you really have to question the hospital's SOP - how was this error allowed to happen in the first place?

 

[KUMoose]

That's a cop out. The hospital, manufacturer, pharmacy manager, nursing manager and dispensing agent (RN I think) are all responsible. Even my dead to the world I studied all weekend for a pharmacology examine can tell the difference between the two vials and I'm an 8 color guy. The fact that this STILL happens isn't as much a manufacturing issue as it is LAZY HOSPITAL ADMINISTRATION issue. After (I believe 5 cases now over the last 2-3 years, they start to blend), every hospital pharmacy should have a plan in place for how to deal with this, if they do not it's gross negligence on the hospital's part.

Yes the colors are similar, but let's look at things that could be done (short list):
Manufacture:

• Different colors labels
• Stop making the higher does in that str (i.e. make in 20k rather then 10k)

Hospital

• Segregate the products (and I don't mean next to each other on the same self, different rooms, rows, drawers, etc)
• Regular Medication Safety Error training
• Prevent the 10k from going up on the floor and/or change the check out process
• Evaluate the need for the 10k dose on the ped's/neonats floor (possibly prevent it from going up there/eliminate it from the drug list/pyxis carts, etc)

If the Quiads wants to change the system, don't sue them for money (>$50k in damages plus the P&S they are likely to get), rattle the sabres about medication safety or how hospitals, staff and manufacturers need to work together to promote patient safety and awareness.

 

[no-see-um]

Sure they're all responsible, but one has been negligent (on a systems level) in accepting responsibility with regards to package design. It's about time manufacturers are enjoined as a part of the process to reduce medication errors. It's a processes, after all. These medications aren't manna from heaven- they're created and packaged on a manufacturing level by people and there are steps that could be taken at that level to reduce these mistakes, as well. Without such changes, hospitals are forced to spend extra time and money (still money well spent) to design systems that could negate this negligence at the top, and it forces tired health care professionals to play deadly mind games with labels.

People make mistakes, but systems- both hospital and manufacturing, can work to prevent them. Hospitals have done their share over and over again, and this is a recurring theme in the business. That this has happened over and over again, usually to the youngest of patients, should have been a wakeup call and it shows a lack of remorse in lacking the urge to make necessary changes. There needs to be industry standards and even a small share of profits invested could make a major difference in the betterment of society. If I see a hose has many holes in it, I'd rather stop the flow at the beginning of the hose than perhaps at 20 different places over it's length- only because the probability of errors increases significantly the lower you go.

If they all were sued, which usually is what happens (and I'm amazed they're all not hauled in for this- a good testament to the Quaids in addressing the crux), I'd assign 50% blame to the manufacturer, 30% blame to the hospital, and 20% blame to the pharmacist in charge/Nursing manager/etc. Top-down...

 

[tussionex]

That's a cop out. The hospital, manufacturer, pharmacy manager, nursing manager and dispensing agent (RN I think) are all responsible. Even my dead to the world I studied all weekend for a pharmacology examine can tell the difference between the two vials and I'm an 8 color guy. The fact that this STILL happens isn't as much a manufacturing issue as it is LAZY HOSPITAL ADMINISTRATION issue. After (I believe 5 cases now over the last 2-3 years, they start to blend), every hospital pharmacy should have a plan in place for how to deal with this, if they do not it's gross negligence on the hospital's part.

Yes the colors are similar, but let's look at things that could be done (short list):
Manufacture:

• Different colors labels
• Stop making the higher does in that str (i.e. make in 20k rather then 10k)

Hospital

• Segregate the products (and I don't mean next to each other on the same self, different rooms, rows, drawers, etc)
• Regular Medication Safety Error training
• Prevent the 10k from going up on the floor and/or change the check out process
• Evaluate the need for the 10k dose on the ped's/neonats floor (possibly prevent it from going up there/eliminate it from the drug list/pyxis carts, etc)

If the Quiads wants to change the system, don't sue them for money (>$50k in damages plus the P&S they are likely to get), rattle the sabres about medication safety or how hospitals, staff and manufacturers need to work together to promote patient safety and awareness.

you're a student and you have this many ideas on systems improvements? you do have valid points.

i'm truly pleased that someone is finally placing the onus on the manufacturer for a change. it's very refreshing! yes, the pharmacist and the nurse and the hospital should have systems in place and are responsible, but look alike drugs are not a new issue and there are many many more besides heparin!

my problem with this case is that all of a sudden it's news because it's a celebrity's kid. there are thousands of kids [and adults!] hurt by errors from look alike drugs/packaging...why is this suddenly such a huge deal because it's dennis quaid's kid? what about everyone else?

 

[KUMoose]

Here's the bigget flaw in your argument NoCUm, The Quaids are suing for negligence and product liability, had they gotten together with other parents of kids that received the same overdose and started a class action lawsuit, their motives would be a lot better. Right now they have to prove the following two components.

First to prove negligence generally (from what I've read and talking to the 1st and 2nd year law students, I am NOT a law student nor am I a lawyer so my interpretaions may be off) must prove that the company didn't apply a minimal amount of expected/ordinal care in designing the package. The suit fails at this, for the following three reasons:

• Different vial colors
• Different names on the vial
• Clearly posted dose strengths
• Different NDCs

Now the product liability part is a little trickier, it's about proving a product defect (either in design or manufacturing) AND not warning consumers (in this case medical staff because they are the end user) about the defect. Now one could argue that the labels consist of a defect, but it would be hard to prove, especially if what I'm reading about dosing strengths is true (i.e. there's not a good reason to keep Hep10k on a peds floor because the only time it's used is in a 24hr ifn (F&C)). The standard peds prophylaxis dose is 50units/kg IVB or 100units/kg IV Q4.

Had this been given as part of an ER mistake, I'd be more forgiving of the hospital, those are hectic areas and the mash of adults and ped meds can be crazy. However given to new borns as part of a NICU or birthing floor, I still don't see a valid reason to have Hep10k on the floor and from what little I've been able to glean it was pulled from a floor stock not sent up by the pharmacy (specifically), however until (or if I should say) full disclosure is made, it's impossile to pinpoint the exact problem.

And ultimately here's my biggest problem with your theory that Baxter is 50% responsible NoCUm, when it comes down to it, the person that made the syringe has the ultimate responsibility to check the orders and the vial. The fact they had to place the vial in one hand to draw out some of the solution, makes it really hard to hold Baxter to a greater blame then anyone else. Because I'm a big proponent of personal accountability, I tend to think the actual blame is 70% syringe maker, 20% hospital and 10% Baxter. As long as Hospitals keep feeding Hep10k to peds area, I'll keep believing they need to be smacked around a bit.

My suggestion to Baxter would be to hold the course, because in changing the labels now it's a de facto admission that they are in the wrong. That will bring all sorts of crazy lawsuits out of the woodwork. Six months down the road I'd change the color of the labels (something I still have my doubts will be that effective if the person can't distinguish between Heparin and HepLock).

 

[njac]

my problem with this case is that all of a sudden it's news because it's a celebrity's kid. there are thousands of kids [and adults!] hurt by errors from look alike drugs/packaging...why is this suddenly such a huge deal because it's dennis quaid's kid? what about everyone else?

last year this happened in Indiana (?) to a bunch of noncelebrity neonates and it got quite a bit of national exposure. I think a couple of those babies died.

KUMoose is on the money. my stepfather is in hospital administration and we've discussed these things quite a bit over the dinner table. I forget what their literature says, but he follows rules that say "x number of people must eff up for a drug error to reach a patient" - from the buyer to the stocker to the tech and down the administering nurse. The nurses give the orrect product every day and should notice a difference.

and for that reason I thank every nurse who calls with a question, ie: "The Dr ordered 1g of Unasyn why does the bag say 1.5g?" etc. Because in the end they're the last one to prevent the error.

my personal beef with this case is that the mass e-mail our dept head sent out was full of articles from tmz.com rather than a reputable news organization or even a pharmacy organization.