Tag Archives: Prescription error

The July Effect

By ThinkReliability Staff

No one ever looks forward to a trip to the hospital, and a new study suggests that you might be particularly wary during the coming weeks.  A new study shows a 10% spike in patient fatalities during the month of July.  Many in the medical profession have been aware of “the July Effect” anecdotally for years, but researchers in the University of California at San Diego study combed through over 62 million death certificates dating back to 1976 to prove its existence.

Why the spike?  Sociologist Dr. David Phillips, who conducted the study, believes it is because new doctors begin their residencies in July each year.  The phenomenon is limited to fatal medical errors, and is not evident in surgical or “general” error rates.  Consistent with the study’s “New Resident Hypothesis”, fatalities are even higher in counties with higher concentrations of teaching hospitals, in which there would be more resident doctors.  It is clear there is a link between higher rates of medication errors and the presence of brand new doctors.

The study is one of the first to demonstrate the linkage though.  Multiple smaller studies have failed to show any correlation between time of year and death rates.  Researchers point out that the new study focused on a much longer time range and broader geographic area than any previous study however.

Although the study raises some interesting questions, it stops short of providing solutions.  Doctors already face a rigorous course of study to prepare for their residencies, which of course are designed to provide the experience needed.  New doctors are also generally well supervised.  And to some extent there will always be risk associated with inexperience when it comes to teaching hospitals.

A Cause Map can illuminate areas that might benefit from further research.  The study narrowed down one of the contributing factors to medication administration.  Why just in that area though?  Are new residents better supervised in the OR?  Do new doctors have the capability of prescribing and administering medication during their first month?  What types of errors do they make when doing this?  Do they prescribe the wrong medication completely?  The wrong dosage?  Or do they overlook adverse interactions with other medications?

More research is needed to accurately determine why the July Effect occurs, but patients can be prepared.  Experts agree that patients should ask plenty of questions and bring along an advocate for support.  For more information, the study, “A July Spike in Fatal Medication Errors: A Possible Effect of New Medical Residents”, is available here.

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.

Errors in Translated Medication Instructions

By ThinkReliability Staff

It’s well known that instructions on medication (both prescription and otherwise) can be confusing and lead to potentially lethal consequences.  (See our previous blog on the topic.)  Now imagine how much more danger there is if you don’t speak the language in which the instructions are printed.

A recent study published in the American Academy of Pediatrics Journal “evaluated the accuracy of translated Spanish-language medicine labels among pharmacies in a borough with a large Spanish-speaking population. ”  The study found significant issues with label accuracy with a popular language in an area with a large population of speakers of that language.  You can imagine how these results could get even worse for an area that had a smaller number of Spanish speakers, or for patients who speak a less common language.

One of the most striking examples was a man who received heart medication that was to be taken once daily.  The instructions were only partially translated and “once” (which means 11 in Spanish) was left on the instructions.  The patient took 11 pills (instead of 1) a day.

The study found an overall error rate of the prescription instructions that had been translated into Spanish by computer of 50%.  (86% of the pharmacies surveyed translated their prescriptions with a computer program.)  It is likely that patients with the incorrectly translated prescription instructions took the medicine incorrectly, resulting in the potential for serious harm, or even death.  This is an impact to the patient safety goal.  The rate of errors made by the computer means more work for pharmacists and translators due to the corrections that must be (or should be) made.  (Obviously this is not always happening.)  Patients receiving instructions they do not understand can be considered an impact to the patient services, compliance, and organizational goals.  (The study was performed in the Bronx, New York.  It is a law in New York City for pharmacy chains to provide translated labels for the top seven foreign languages in the area.)

Patients do not understand the directions because the patients do not speak English and the instructions are either not translated, or are translated incorrectly.  The instructions may be translated incorrectly because the computer program translates them incorrectly and there is an inadequate verification of the computer translation, because the pharmacist does not speak the language and/or there is no translator available (likely due to lack of funds or an uncommon language).   The instructions may not be translated if the pharmacy has no translating capabilities, also likely due to cost or an uncommon language.

An obvious suggestion is to improve the accuracy of the computer programs that do the translating, perhaps standardizing the translations among the different programs that do the job.  Pharmacists could also be provided with a guidebook of translations for standard pharmacy terms (such as take orally).  Additionally, translation software could be added to the computer programs currently used by pharmacists.

I have a simpler suggestion that I borrowed from the aviation industry.  I noticed the last time I flew that instead of having translations of the safety instructions in a dozen different languages, there were practically no words at all.  Instead, the airline used picture instructions.  I suggest doing something similar with medications.  (See my example of a picture for “take orally” on the PDF.  View the root cause analysis investigation and my picture by clicking “Download PDF” above.)

Because of the risk involved, it’s clear something needs to be done.  Prescription instructions are hard enough to understand in English, much less poorly translated into another language.  I’m sure suggestions will keep coming in, and surely some smart folks out there will come up with a way to reduce the potential for confusion and injury.