New Use for Old Drug May Save Lives

By ThinkReliability Staff

An off-label use for an existing drug, tranexamic acid, has been shown in recent studies to reduce bleeding – and so risk of death – from trauma.  The drug is believed to slow bleeding by slowing the dissolution of blood clots  by  blocking plasmin, which aids in the dissolution of blood clots.  A recent trial shows that 128,000 lives could be saved thanks to the use of tranexamic acid, an existing, cheap generic.  The drug slows bleeding in trauma patients and is being used on the battlefield, in Britain . . . and just about nowhere else.

How does the drug help trauma patients and why isn’t it being used? We can look at both of these issues in a Cause Map, or visual root cause analysis.  We begin the Cause Map with the outline, which captures the basic information about the issue and the impacts to the goals.  Here, we are looking at the use of tranexamic acid to slow bleeding in trauma patients.  Currently, it’s being used primarily on battlefields and in trauma centers, mainly by Britain.  Use of the drug impacts the patient safety goal by potentially reducing the risk of death from trauma, and the patient services goal by slowing bleeding.

We begin with these impacted goals and ask “Why” questions to add detail to the Cause Map.  In this case, the potential for the reduced risk of death  results from having 400,000 people die of trauma in hospitals every year, and  the potential for slowed bleeding.    The potential for slowed bleeding is due to a drug that has been shown to slow bleeding, and the fact that that drug is not commonly used for trauma.  The drug is believed to slow bleeding by  blocking plasmin, which aids in the dissolution of blood clots.  The drug is not commonly used  for trauma, in part because it has not been FDA approved for this use.  (It can still be prescribed “off label” by doctors.)  The leader of the trial showing the potential benefits of the drug in trauma believes that the lack of use is due to inertia.  Because the drug is inexpensive, it doesn’t provide a large profit for drug companies, and so they are less likely to advertise the benefits.  Additionally, since the FDA hasn’t approved it for trauma, the drug companies aren’t allowed to advertise the drug for this use.

It’s unclear if manufacturers are attempting to  obtain FDA approval for trauma use.  However, publication of these studies, and sharing information between healthcare facilities may help increase the use of this drug, potentially saving lives.   It’s been added to the World Health Organization’s essential drugs, and is finding use on battlefields aiding wounded soldiers.  Hopefully in time, it will be used in healthcare facilities as well.

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