Tag Archives: overdose

Root Cause Analysis

Deadly medication error illustrates danger of discharge period

By ThinkReliability Staff

Medical errors can happen anywhere and at any time. However, these errors may be most likely to occur at transitions, especially the transition from the hospital to home when follow-up care is still required. Says Alicia Arbaje, an assistant professor at the Johns Hopkins School of Medicine, “Poor transitional care is a huge, huge issue for everybody, but especially for older people with complex needs. The most risky transition is from hospital to home with the additional need for home care services, and that’s the one we know the least about.”

The case of a woman’s death from medication errors during that transition period illustrates multiple errors that can occur during this period. We will capture the known details of this issue in a Cause Map, or root cause analysis. The first step in the Cause Mapping process is to capture the what, when, where and impacted goals in a Problem Outline. In this case, the patient passed away October 30, 2013, after discharge from a regional medical center in Missouri, where the patient was treated for congestive heart failure. Organizational goals that were impacted by the patient death (an impact to the patient safety goal), settlements with both the hospital and pharmacy (impacts to both organization’s legal/ financial goals), and the patient being administered a high dose of the wrong medication (an impact to the patient safety goal).

These impacts to the goals become “effects” of cause-and-effect relationships. The Cause Map contains all the cause-and-effect relationships that led to these impacted goals. Causes included in the map are verified with evidence, which can be provided by a variety of sources. Causes can be determined by asking “Why” questions, but more than one cause may be required to produce an effect. In this case, all necessary causes are included and joined with an “AND”.

The patient safety goal was impacted because of a patient’s death due to multiple organ failure when her bone marrow became unable to create blood cells as a result of an overdose of methotrexate. Methotrexate can damage blood cell counts and is primarily used to treat cancer and severe arthritis. The patient was administered a high dose (for methotrexate) of a drug that was not prescribed for her. When the patient left the hospital, the hospital phoned an order for a daily dose of the diuretic metolazone. However, according to court evidence, the order was written down by a pharmacy technician as a daily dose of methotrexate.

Because of the side effects of methotrexate, it is included in a list of eight “high-alert” medications that warrant special safeguards to prevent incorrect dispensing. The typical dose of methotrexate is much lower, usually only once or twice a week. Despite this, the pharmacist missed the error. In a testimony, he was unable to identify a specific reason for this oversight. The pharmacy manager said “there was a breakdown in the system.”

There were more opportunities for this error to be caught before this drug was dispensed to the patient. The patient herself could have noticed the incorrect medication based on the name or information on the enclosed information sheet. However, the patient likely did not fully understand the discharge instructions. Federal data shows that less than half of patients say they’re confident they understand discharge instructions. This patient was also receiving home health care, but neither of the two nurses that saw the patient identified the medication mix-up. Even though a primary purpose of home health care is to develop and follow-up on patient care, a 2013 government report found that more than a third of facilities did not do this properly. Medicare requires that home health agencies verify patient’s medications and check for possible interaction, but inspectors found that nearly a quarter of home health agencies inadequately reviewed or tracked medications for new patients. One of the challenges is that the typical providers of post-discharge patient care (nursing homes, rehabilitation facilities and home health care providers) did not receive any of the funding provided by Congress to upgrade to electronic medical records.

Several systemic issues were identified in this case and actions meant to improve these issues are still ongoing. One reason for increased use of electronic medical records is to avoid delivering prescriptions over the phone, which can result in transcription errors. Ensuring patients better understand their discharge instructions is another goal that could improve patient safety. Lastly, improvements to home health care agencies to ensure their required tasks are being completed effectively is clearly needed, but it has been difficult to determine the most effective way to do this.

To view the Cause Map of this incident, click on “Download PDF” above. Or, click here to read more.

Root Cause

Lack of Available Treatment Leads to Fatal Heroin Overdose

By ThinkReliability Staff

The death of a young man in New Jersey on September 23, 2010 from a heroin overdose was tragic, but part of a trend becoming more and more common.  His death mirrors many of the other fatal heroin overdoses and by examining the issues that led to this fatality, solutions that could reduce the death rates from heroin overdoses across the country (and perhaps beyond) can be developed.

We will examine this particular case in depth by using a Cause Map, or visual root cause analysis. First we capture the particulars of the issue – what, when and where – as well as the impact to the goals.  The fatality is an impact to the patient safety goal, while insufficient help being available is captured as an important difference, and is also an impact to the patient services goal.

Beginning with an impacted goal (in this case, the patient safety goal), we ask why questions to determine the cause-and-effect relationships that led to the impact.  In this case, the death resulted from a heroin overdose.  Overdoses typically result from use of this specific drug, with which overdoses are not uncommon.  Though it is not clear if this played a role in this particular death, heroin overdoses can occur after a user attempts to get clean and relapses.  If the user goes back to the dose from before ending use of the drug, the body (if it has been drug free for some period of time) is unable to handle it, resulting in the overdose.

In order to overdose, heroin use has to begin.  The use of heroin is rapidly increasing, with an estimated 669,000 users by 2012.  First-time users increased from 90,000 in 2006 to 156,000 in 2012.  The reason for the increase is believed to be the comparatively inexpensive cost compared to prescription opiates.  While a gram of heroin might sell for $100, crackdowns against prescription drug “pill mills” have increased the cost of prescription opiates (like OxyContin) to $1,000 a gram.

Once heroin use has begun, quitting is extremely difficult.  While withdrawal symptoms are not life-threatening, they are extremely unpleasant (to use a massive understatement).  Because they are not life-threatening, emergency care is limited (the victim in this case was unable to be admitted to the hospital) and many insurance companies won’t cover treatment, which can be extremely expensive.  In 2012, only 2.5 million of the 23.1 million Americans who needed drug or alcohol treatment received aid at a special facility.

Hope for overdose victims is available in the form of naloxone.  Since 2001, the use of naloxone by emergency responders resulted in reversal of over 10,000 overdoses.  The Affordable Care Act should improve insurance coverage for treatment, though it may take years for this to be in effect and, with the treatment availability shortage, likely means that not everyone will get the help they need.

However, solutions that address the problem of heroin use itself are being developed.  According to Attorney General Eric Holder, “Confronting this crisis will require a combination of enforcement and treatment.  The Justice Department is committed to both.   Since 2011, the DEA has opened more than 4,500 investigations related to heroin.  And as a result of these aggressive enforcement efforts, the amount of heroin seized along America’s southwest border increased by more than 320 percent between 2008 and 2013.   Of course, enforcement alone won’t solve the problem.  That’s why we are enlisting a variety of partners – including doctors, educators, community leaders, and police officials – to increase our support for education, prevention, and treatment.”  With the help of the federal and local governments, as well as dedicated families of users, it is hoped that the tide of heroin use will be turned.  This will be the most effective way to stop overdose deaths.

To view the Outline and Cause Map, please click “Download PDF” above.  Or click here to read more.

Root Cause

Adult Dose of Heparin Delivered to Premature Infants

By ThinkReliability Staff

On September 16, 2006 6 premature newborns in Indianapolis were given adult doses of the blood thinner heparin, used to prevent blood clots that could clog intravenous (IV) tubes.  Adult doses are 1000x more concentrated than infant doses.  Three of the babies died and the other three were in critical condition.  In 2007, in Los Angeles, an overdose was given to three more babies due to the same error.  Luckily none of those babies died.  (Up to 17 babies in Texas also received heparin overdoses in 2008, but these were caused by a mixing error at the hospital pharmacy.)

We can examine this issue in a visual root cause analysis, or Cause Map.  Fully investigating the errors that occurred for these overdoses to happen can lead us to solutions to increase healthcare reliability by decreasing the risk of the same situation recurring.

We begin with the outline, where we capture the what, when and where of the incident, as well as the impact to the organization’s goals.  These medication overdoses impacted the patient safety goal because they resulted in fatalities and serious injury to the babies who received the medications.  Additionally, employees involved in the issue can be affected as a second victim.  Death or serious disability due to a medication error is a “Never Event“, which is an impact to the organization’s compliance goals.  Patient services are impacted due to the incorrect drug dose delivery.

Once we’ve determined the impacts to the goals, we can ask “Why” questions to determine the cause-and-effect relationships that led to the incident.  In this case, 5 opportunities for double-checking the dosage were missed.  The wrong dosage was missed as 1) the bottle was removed from the pharmacy, 2) the bottle was placed in the cabinet, 3) the bottle remained in the cabinet, 4) the bottle was taken from the cabinet, and 5) the drug was administered to the babies.  Some of the reasons that it was missed: there was no effective double check by another staff member, there was no check by a computer and of course due to human error, which was aided by the issue that the adult dosage bottle and the infant dosage bottle looked practically identical (this has since been remedied).

An article in The Journal of Pediatric Pharmacology and Therapeutics states, “As frequently occurs, all of these heparin-associated medication errors happened when a number of system failures occurred simultaneously. System failures included: 1) failure to carefully and accurately read the label on the medication vial prior to administering the drug to the patient; 2) inaccurate filling of automated drug-dispensing cabinets; 3) non-distinct “look-alike” labels on the heparin vials; 4) similar size of the heparin vials as both were 1-mL vials; and 5) “factor of ten” dosing errors.”

Many solutions to this type of error (such as requiring double checks by staff members and using a computerized prescription dispensation system) were suggested as a result of this and other heparin overdoses over the past several years and are already being implemented at hospitals across the nation.

To view the Outline, Cause Map and potential solutions please click “Download PDF” above.  Or click here to read more.

Root Cause

Lack of Care After Overdose Led to Patient Death

by ThinkReliability Staff


An inquest into the death of a patient in a Milton Keynes hospital was completed on May 17, 2013 by the local coroner.  The coroner found that the staff failed to take and report appropriate observations and render effective treatment.  Diagramming the cause-and-effect relationships identified in the inquest in a visual root cause analysis, or Cause Map, allows identification of lessons learned and possible solutions to reduce the risk of this type of incident happening again.

We begin with the impacts to the goals.  In this case, the patient safety goal is impacted due to the patient death.   It was suggested that nursing shortages may have been related to the issues that occurred.  If this is the case, the shortages would impact employees.  The inquest that resulted due to the patient death can be considered an impact to the compliance and organization goals.  Last but not least, the insufficient patient treatment is an impact to the patient services goal.

Beginning with these impacted goals, we can ask Why questions to determine the cause-and-effect relationships that resulted in the patient death.  In this case, the patient death was due to respiratory arrest caused by an obstructed airway.  The patient being placed on her back while unconscious (though sources differ on whether the patient was placed on her back or her side) due to a drug overdose.   The patient overdose was due to a self-administered overdose and not being administered the antidote for the drugs on which she had overdosed.

The patient was not given an antidote for the drugs on which she overdosed.  The family of the patient, who had a history of mental illness and frequented the hospital, believes that the staff believed she was faking her symptoms.

Through the patient’s eleven hours within the hospital’s Accident & Emergency (A&E) Department, only 2 formal observations were recorded.  One set of observations was recorded on a glove, which was later lost.  Abnormal results from these observations were not passed along from the healthcare aid who was responsible for the patient, likely due to nursing shortages.

Once all of the causes related to the incident have been recorded within the Cause Map, solutions can be brainstormed and recommended for implementation.  The coroner involved in the case has requested the Secretary of State for Health implement changes that would require seriously ill patients to be observed by nurses rather than healthcare assistants. The hospital has stated that they “have conducted an investigation to ensure lessons are learned” and “will be continuing to improve our service in regard to emergency patients”.  The hospital has commissioned training for their healthcare assistances to improve their skills.

To view the Outline and Cause Map, please click “Download PDF” above.

Root Cause Analysis

The Number of Accidental Child Poisoning from Medication is Increasing

By Kim Smiley

A recent study in The Journal of Pediatrics revealed that the number of accidental drug overdoses by children is increasing in the United States.  An investigation of hundreds of thousands of patient records showed that the number of accidental drug poisonings among children under 5 years of age increased 22% from 2001 to 2008.

In 95% of the cases, the overdose occurred because the child self-ingested the drugs, as opposed to a labeling or dosing error.

Why?  How are so many young children finding and consuming medication? And more importantly, what could be done to prevent these accidental overdoses?

This incident can be built into a Cause Map, an intuitive visual method for root cause analyses.  Better understanding the causes that contribute to a problem can lead to finding better solutions.

According to the study, one of the causes contributing to the increase in accidental overdoses is that there is simply more medication in homes with small children.  As lifestyles change, the population is facing more health problems.  Obesity and metabolic syndromes are more common at younger ages than in the past and more homes of small children now contain medication associated with these illnesses as well as a variety of other medications.

Changes in drug technology have also affected the severity of overdoses, if not the number of occurrences.  More sustained-release medications are being prescribed and they can result in more severe poisoning.

The study also suggests that there is a possibility that people are being less strict about storing drugs safely, but it’s difficult to prove.  There is also the issue that people may not be aware of how dangerous their prescription and OTC medications are.

One thing we know is that the current safety precautions are ineffective.  Children are findings ways to open child proof caps and warning labels aren’t sufficiently motivating adults to safely store medications in locked or inaccessible locations.

Changing medication packaging is one of the potential solutions being considered for this problem.  New packaging that would be more difficult to open or would only dispense limited amounts of medication.  Bottles can be designed to dispense one pill at a time or restrict the flow of liquid.