Monthly Archives: February 2011

Root Cause Analysis

Pregnant Woman Receives Wrong Medication

By ThinkReliability Staff

One of the most exciting moments in a young couples’ relationship is finding out that they are about to start a family.  New moms-to-be will take extra precautions to make sure their child has the best possible start in life – a healthier diet, a regimen on prenatal vitamins, limitations on coffee and so on.  However, that excitement is sometimes tempered with worry about the new baby’s health.

Mareena Silva had just found out she was expecting.  Six weeks pregnant and a bit under the weather, her doctor prescribed Mareena antibiotics to clear up an infection.  She filled the prescription at the local Safeway, and after taking the medicine as directed, became nauseous.  Upon checking the medication label, she made the horrifying discovery that she had been given the wrong medicine.

Instead of the antibiotics she had been prescribed, Mareena had taken a dose of methotrexate.  Methotrexate is a chemotherapy drug which targets rapidly dividing cells, like cancer…or embryos.  Her doctor urged her to vomit whatever medicine she could.  Then an ambulance rushed her to the hospital where she was given charcoal to absorb any medication remaining in her stomach.  Unfortunately, at this point all she can do is wait to see if her unborn child was affected by the unintended medication.  Methotrexate can cause serious birth defects, especially during the critical formative period during the first trimester, and even miscarriage.  Reports state that the baby faces 50-50 odds of developing abnormalities.

How did Mareena end up with a drug sometimes used to abort ectopic pregnancies?  The pharmacy staff dispensing the medication accidentally handed her one intended for patient in her late 50’s with a very similar name.  According to statements released by Safeway, pharmacy staff failed to repeat Silva’s name to her twice and verify her birth date – standard company policy.  The company has said that they are conducting an investigation to see why their procedure was not followed.  They will not be the only ones looking into the incident; the Colorado Pharmacy Board will also be reviewing the case.

Unfortunately mistakes like this are far too common.  No national agency tracks how many prescriptions are incorrectly distributed, and few states track such information either.  However, a 2003 study by Auburn University indicates that the dispensing error rate could conservatively be estimated at 1%.  That’s astonishing considering billions of prescriptions are filled each year.  How might those errors be prevented?  Dispensing medication is more complex than meets the eye, and there are a number of places a mistake can happen.  In this instance, Safeway’s pharmaceutical staff did not follow proper procedures for dispensing medication.  18.3% of dispensing errors were caused by procedures not followed according to U.S. Pharmacopeia’s 2003 study of medication error reports.

While the investigation will unearth further information about what happened behind the counter that day, a detailed Cause Map pictorially lays out how the incident occurred and why.  As the investigation unfolds, more information can be added and solutions can be developed to prevent future incidents like this one from happening.

Root Cause Analysis

A Controversial Approach to the Fight Against AIDS

By Kim Smiley

Not too long ago, the Downtown Eastside neighborhood in Vancouver, British Columbia had the fastest-growing AIDS epidemic in North America.  But that has is no longer true.  Vancouver has succeeded where many cities have failed and has recently seen a decrease in the rate of new AIDS infections.

How did Vancouver do it?  And can it be done elsewhere?

In order to understand how Vancouver has been successful in fighting the AIDS epidemic, we first need to understand why there were such high infection rates to begin with.  This problem can be approached by building a Cause Map, an intuitive visual root cause analysis method that lays out the Causes to a problem.  (Click on the “Download PDF button” to see a high level Cause Map of this example.)

A little research shows that one of the major contributors to this problem is that a significant percentage of the population in this area is engaged in high risk behavior.  The Downtown Eastside area has been called the center of the injection drug epidemic.  Along with rampant drug problems, this area is also home to a thriving sex trade.  Shared needles and unprotected sex significantly contributed to the fast growing rate of new infections in the area.

As many cities have found out, it is difficult to change behavior.  Drug addicts are typically one of the hardest to reach populations.

Vancouver’s approach has been to create a “safe injection site”, called Insite.  At Insite, addicts can inject drugs they bought on the street under the supervisor of nurses.  They are provided clean needles and a safe location.  To make this work, Insite currently has a special exemption from narcotics laws.

Insite also tests for HIV and provides aggressive treatment for those infected.  Aggressive treatment seems to be one of the main factors that has slowed the infection rate in Vancouver.  Antiretroviral medications lower the amount of virus in the blood, which in turn makes a person 90 percent less infective.

Research has shown that the rate at which the AIDS virus is transmitted can be lowered by treating infected people even if they still engage in high risk behavior.

Unfortunately, treatment can be expensive.  One of the reasons that aggressive treatment works in Canada is that the government provides free healthcare.  In the US, the fastest growing epidemics are typically in low income areas where health insurance is limited.

The antiretroviral medication can also have some unpleasant side effects so many doctors don’t prescribe it until there are signs that their patient’s immune system is compromised.

Vancouver’s approach is also obviously controversial.  Using government funds to provide a place for individuals to inject illegal drugs is going to raise a lot of questions.  Insite was created under a more liberal government and the issue is due to be reviewed by the Canadian supreme court this year.

Root Cause

Patient Death from Complications of Liposuction

By ThinkReliability Staff

On July 18, 2008, a young mother of two went in for a routine tummy tuck (abdominoplasty).  Although liposuction was frequently performed along with the surgery, the patient had declined the liposuction option.  Although there were some complications related to low oxygen during the procedure, the patient was released to her husband that evening.  She was sick the remainder of the evening but assumed it was reaction from the anesthesia.  The next morning she woke with a severe headache that worsened until she asked her husband to call an ambulance.  The paramedic consulted with the attending physician and gave the patient morphine for her pain. The patient then went into convulsions and stopped breathing.  The patient was put into a chemically reduced coma to relieve swelling on her brain.  She never recovered and was taken off life support on July 31, 2008.

The medical examiner determined that it was likely that a fat embolism, a rare complication of liposuction, had prevented blood flow to her brain, causing her death. Because the patient had declined liposuction, it’s unclear how she ended up having the procedure.  It appears that the patient may not have known that she had liposuction, and hence, was not aware of the potential complications including fat embolisms, from liposuction.  The nurse who presented the surgical consent form to the patient said she hadn’t brought up liposuction because it was “implied” as part of a tummy tuck.

It is unclear if the outcome would have been different had the patient received treatment more quickly.  The patient was released to her husband the day of the surgery, as it was considered an outpatient procedure, even though there were complications related to low oxygen.  She was not taken to the emergency room until more than 24 hours after the surgery, possibly because of her and her husband’s insufficient understanding of the risks of liposuction.

The public inquiry into improvements to the healthcare system that might reduce the risks of similar incidents occurring (though the risks for fat embolisms causing brain blood flow blockage are very low) ended last week.  When the results of the public inquiry are released, our initial Cause Map can be updated and the potential action items resulting can be added.