Tag Archives: medication error

Root Cause Analysis

Working Towards Solutions for Medication Errors

By ThinkReliability Staff

It’s no surprise that we’ve written frequently about medication errors.  It is estimated that medication errors harm approximately 1.5 million people annually in the U.S.  We’ve outlined some of the many causes that contribute to medical errors at medical facilities, as well as some of the things that the public can do to reduce their risk of medication errors.

Some of the more common issues that lead to medication errors include confusion on the label of the medication.  It is estimated that almost half of Americans don’t understand the dosing instructions on their medication, leading to the potential for medication dosing errors.  It’s no wonder, when “take one pill a day,” can be written in 44 different ways according to Dr. Ruth Parker.   Additionally, many patients receive medication instructions that are either not in their primary language, or contain errors in the translation (see our previous blog about errors in translated medication instructions.)

It’s obvious that if almost half of people receiving medication instructions don’t understand them that something should be changed.  An expert panel appointed by the US Pharmacopeial Convention (USP) has created national labeling standards in order to reduce medication errors caused by patient confusion with medication instructions.  It is hoped that a final version of these rules is published by May 2012 and will then be implemented nationally.  (Additionally, Canada is considering these standards as well.)

The proposed standards attempt to cover some of the most common errors in label decoding that lead to medication errors, including use of unfamiliar terms (such as Latin terms or jargon) and pictures instead of text (such as a picture of a crossed off alcohol bottle rather than “do not take with alcohol”).  Additionally, medication instructions would be provided in the preferred language of the patient (and hopefully national standards will reduce the translation errors currently found on many medication bottles) in clearer font, with the information important to the medication found larger and on top and other information (such as the provider and pharmacy names) below and less emphasized.

Coming up with process improvements, such as these, with an expert panel allows consideration of many issues and points of view.  When you’re looking at improvements in your organization, you already have an expert panel – it’s the people who do the work processes day in and day out.  Additionally, information released by other organizations can be leveraged to provide solutions relevant to your organization.  Take advantage of the expertise found in your organization when you are looking to improve processes – it will save time and money, and may even save lives.

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

Drug Shortages

By ThinkReliability Staff

Shortages of commonly used medications are beginning to impact patient safety.  The Institute for Safe Medicine  Practices (ISMP)recently asked healthcare workers to participate in a survey regarding drug shortages.  One out of three respondents said that shortages caused medication errors that could have caused harm to patients.  One out of four respondents said mistakes with medication reached patients, and one in five said that patients were harmed by the medication errors.  In addition, patient care has been impacted by the unavailability of some commonly used medications.  There have been reports of patients who woke up during surgery because sedative was being conserved.

Although the U.S. Food and Drug Administration (FDA) requires manufacturers to notify them when there are drug shortages that have no alternatives, there are no sanctions if they do not.  Because many of these drugs have alternatives, the manufacturers are not required to notify the FDA, and healthcare providers are oftentimes not aware of shortages until they run out of needed medication, causing last-minute scrambles and potentially leading to medication errors, such as when an alternative drug has a lower dosage than the drug being replaced.  Because healthcare providers are so accustomed to the dose of the replaced drug, medication errors can result amidst the confusion.

The FDA estimates that approximately 40% of the shortages are due to manufacturing problems, including safety issues identified in inspections, 20% of the shortages are due to production delays, and another 20% occur when manufacturers stop making drugs.  Although drug manufacturers will not confirm, it is assumed that as insurance companies start covering fewer and fewer brand names and generic prices continue to undercut brand-name prices, it isn’t profitable to make some medications.  The FDA does not have authority to require manufacturers to make medication.  Also contributing to the shortages are increased demand, and shortages of parts and raw materials required to manufacture the medications.

Trying to address these issues and come up with some solutions to the drug shortages is going to take more work than just identifying the issues.  To that end, groups representing doctors, anesthesiologists, pharmacists and safety advocates have invited the FDA, health experts, supply chain representatives and drug manufacturers to attempt to work through a solution earlier this month.  Hopefully they’re able to come up with some actions that will prevent further deaths and medication errors due to this shortage

Root Cause Analysis

Hospital Working Hard to Prevent Recurrence of Medication Errors

By ThinkReliability Staff

Experts believe that most medical errors go unreported, due to a combination of lax reporting laws, strict patient privacy laws, and ambiguous definitions of these medical errors.  However, Seattle Children’s Hospital is making an attempt to be forthright and accountable with not only its mistakes, but its plan for improvements.  Seattle Children’s made the news recently when it published the serious reportable events that had occurred there from 2004-2010, including two deaths resulting from medication errors.

Additionally, a third child died after a medication error in September 2010, but it has not been determined if the medication error contributed to the death and an adult patient was given the wrong medication but recovered at around the same time.

In response to these errors, Seattle Children’s is performing a root cause analysis by independent experts to determine the causes.  In the meantime, Seattle Children’s is making specific process improvements, such as allowing only pharmacists and anesthesiologists to administer calcium chloride (an overdose of which led to one of the deaths), as well as general training and reminders for staff.  The hospital held a patient safety day on Saturday, October 30th, 2010, where over 550 staff members participated in training and simulations designed to improve patient safety, with a focus on medication safety.

Although the root cause analysis of the various medication errors has not been completed, Seattle Children’s has identified some specific causes that may contribute to medication errors and is launching improvements to try and reduce the impact of these causes.  For example, interruptions to nurses when they are in the process of ordering, preparing or administering medications can lead to medication errors.  During the training, the staff discussed the types of interruptions that occur and what can be done to reduce them.

Medication errors are estimated to kill 1.5 million people per year, so Seattle Children’s is not the only medical facility that will find itself reeling after the deaths of several patients.  These other facilities should take Seattle Children’s lead and begin a serious attempt to reduce these errors, and deaths.

Want to learn more?  See our webpage about medication errors in medical facilities or watch the video.