Mark S. Smith, 10 May 2015
It is 7 p.m. Saturday evening and I just finished watching “NBC Nightly News” with Lester Holt (Peter Alexander substituting). There was a story that made me very angry and very sad—in much the same way as preventable adverse events do in medical institutions, where patients, who put their trust in the men and women of hospitals and clinics, die or suffer irreparable harm because of medical error.
The story was about Logan Stiner, a graduating high school senior in Ohio, who died of a caffeine overdose. He had ingested pure powdered caffeine, which is available over the counter and as a mail order item. The caffeine powder he ingested, at least according to newspaper reports I read, was sold under the brand name “Hard Rhino” and had been obtained through Amazon.com
The powder is intensely concentrated—one teaspoon of the powder, according to the television report, has the equivalent caffeine load of 25 cups of coffee. The “recommended” dose of this caffeine powder, purportedly to be used as a diet aid, is 1/16th of a teaspoon. That’s the size of a match head. No one has easy access to a measure that small.
The substance is not regulated by the U.S. Food and Drug Administration and is evidently sold freely as a diet aid. The young man’s parents are bringing a wrongful death suit against several companies, including Amazon.com. Their claim is that the safety warnings on the bottle of powdered caffeine were inadequate (the package label says it is a “dietary supplement” and not a stimulant).
But changing the warning label on the bottle will not solve the problem of people inadvertently overdosing. The solution to the problem lies in knowing how people interact with objects, and then designing those objects to minimize or eliminate the possibility of mistakes or errors. This is the science of human factors.
The human factors engineering approach is to “design the problem out of existence.” In the case of powdered caffeine, a simple human factors approach to formulation and packaging could have prevented inadvertent overdosing and death.
Per the autopsy report, the young man had 23 times “normal” post-coffee drinking caffeine levels in his bloodstream. He had probably ingested one or two teaspoons of this terribly concentrated powder. And why not? Most people think that one or two teaspoons of any substance is a safe amount. No one carries around a 1/16th of a teaspoon measure. (One-sixteenth of a teaspoon is 0.31 cc, less than a third of a milliliter).
Why didn’t the manufacturer dilute this powder 16-to-1?
Why wasn’t the caffeine powder mixed with an inert powder in such a way that one full teaspoon of the now diluted powder would contain the same amount of caffeine as 1/16th of a teaspoon of the original formulation? That would make one teaspoon a “normal” dose instead of 1/16th of a teaspoon. Then, even if someone had taken four “normal” doses, at a teaspoon apiece (or even two tablespoons, which would be 6 “normal doses”), it is very unlikely that any harm would have occurred.
Why is the purified caffeine packaged as a powder and not a tablet?
Everyone knows that the standard dose of a tablet medication is one or two tablets at a time (or at most three or four). No one would ever take 26 tablets of a substance at one time unless they were trying to purposely hurt themselves.
We can have an argument as to whether purified caffeine should be sold unregulated, over-the-counter, and available through mail order. (I think it should not). But there can be no argument that the formulation of this substance could and should be changed immediately. And that it should be made more dilute (hopefully diluted 16-fold) and that it should be formulated as a tablet not as a powder.
In its current form, it is a tragedy-in-waiting that could be averted by a simple change in formulation and packaging.
I would go so far as to say that if any manufacturer of powdered caffeine refuses to make these changes after having been presented with this simple logic, those manufacturers (and the distributors and retail outlets that carry the product) will knowingly and irresponsibly be promoting a hazardous substance.
The human factor should always be primary in design.
About the Author
Mark S. Smith, MD, is an Emergency Medicine physician with more than 30 years of clinical experience. He is the Chief Innovation Officer and Director of the MedStar Institute for Innovation (MI2), where he leads a system-wide initiative to catalyze and foster innovation at MedStar Health. MI2 includes the National Center for Human Factors in Health Care, the largest human factors center in a health system in the U.S. In addition, Dr. Smith is professor and chair of Emergency Medicine at the Georgetown University School of Medicine.