Medication Error Impacts Families in Spain

Medical Mix-Up Leads to Werewolf Syndrome and Possible Serious Long Term Effects in At Least 20 Children

The recent medication mix-up leading to at least 20 small children developing excess body hair calls for stricter policies regarding medical negligence and malpractice

In the past week, the world has been horrified by the drug mix-up that occurred in Spain, which has lead to hypertrichosis, also known as “werewolf syndrome.” This happened after a pharmaceutical company mislabeled drugs used to treat hair loss as drugs used to treat heartburn and acid reflux in children.

The mistake was discovered when parents panicked after 20 infants and toddlers developed a mysterious condition in which their bodies and faces became covered in a thick layer of hair. Upon investigation, it was discovered that all the children who were affected were taking the same medicated formula that was supposed to contain omeprazole, a drug used to treat acid reflux

The Mixup is Discovered

The drug and formula believed to be responsible for the children’s condition was pulled from the shelves to prevent problems from developing in additional children. Further investigation however, revealed a concerning finding. The formula did not contain omeprazole as it should have. Instead, it contained minoxidil, a medication used to stimulate hair growth in adults. This was determined to be due to a labeling error.

Doctors have indicated that the extra hair should fall out in a few months, however, there is a possibility of organ damage as the medicine can widen blood vessels. Parents are extremely worried about this in light of the discovery that one of the children has already sustained liver damage from the drug.

Many are also wondering why the medicine wasn’t recalled until the end of July when concerns were first reported in April. Some of the families have stated that they intend to file a lawsuit against FarmaQuimica Sur, the company said to be responsible for the mix-up. The company has been shut down until the investigation has been completed.

The Question of How to Best Respond to Medical Error

Medical error has been reported to be the third leading cause of death in the U.S. (Makary, & Daniel, 2016). According to a major report commissioned by the British Government, the National Health Service makes hundreds of millions of medical errors a year, more than 230 million of which are due to medication errors alone. These mistakes account for as many as 22,300 deaths annually (Elliott, Camacho, Campbell, Jankovic, St James, Kaltenthaler, & Faria, 2018). Estimates also suggest that over 23 percent of residents of European Union countries have been directly affected by medical error (World Health Organization, 2019).

The greatest barrier to improving health care by decreasing medical error is not technical, but cultural and historical. It is based on our views of medicinal practitioners comprising “the elite” and as such, being deserving of our implicit trust. Up until recently, this has meant following the physicians directives without asking many questions, and for many this mentality is still in place.

That belief system also applies to medical errors. When an error has occurred, we often say, “No one’s perfect. Mistakes will happen.”

While this may be safely applied to things like forgetting to pay a bill, or a siblings birthday, when we are talking about healthcare, mistakes can cause long term suffering or even death. This means the bar that allows such errors to be dismissed without repercussions for the person making the mistake must be set much higher.

Health care providers are often instructed to deny all allegations of medical negligence even when they are aware that they did something wrong. Some of this is due to insurance companies whose business is making money on premiums while paying out as little as possible for claims. They commonly tell their providers to never admit or even suggest they might have been at fault.

In several states in the U.S. there are even “I’m Sorry” laws that permit a health care provider to admit their fault or negligence as part of an apology with their confession being inadmissible as proof of liability in a subsequent lawsuit. These practices and laws allow medical professionals to get away with even major errors that lead to debilitation or death without fear of repercussions. They also put future patients at risk.

If we make a major mistake at work, we are likely to be fired. Children who make the mistake of playing ball too close to a neighbor’s house and break a window are usually made to apologize and they or their parents are responsible for paying for the damage. Shouldn’t those who are responsible for life and death decisions also be held accountable for their mistakes, despite them being accidental?

There are those who are saying that the error that occurred in Spain was an honest mistake and given that there is a good chance that all of the problems that resulted will reverse themselves in time, the families should not seek reparations and certainly shouldn’t pursue criminal charges. Yet just because something is an honest mistake doesn’t mean that there shouldn’t be any repercussions.

Hopefully, all the problems caused by this medical error will, in fact, be reversed. But the mistake could have just as easily involved something that could have lead to permanent disability or even death in these children.

It is important to send a strong statement that just as mistakes aren’t tolerated in other professions, they won’t be tolerated in health care professions either. This means we need to move to a place of greater transparency, oversight, and accountability for health care related services. Laws that require mandatory disclosure of adverse incidents which also set a course for further legal action and possible reparations when warranted should be enacted.

In some places such as the Veterans Administration hospital in Lexington, Ky., and the University of Michigan Health System, they’ve instituted voluntary self-disclosure policies which include an explanation of the error, an apology, and an offer of compensation. These policies have lead to benefits such as a lower number of lengthy lawsuits with a greater number of patients affected by medical errors being compensated and increased trust in medical personnel. Requiring such policies to be universally put in place will go a long way in increasing the safety of medical care for all of us, adults and children alike.

References

Elliott, R., Camacho, E., Campbell, F., Jankovic, D., St James, M. M., Kaltenthaler, E., … & Faria, R. (2018). Prevalence and economic burden of medication errors in the NHS in England. Rapid evidence synthesis and economic analysis of the prevalence and burden of medication error in the UK.

Makary, M. A., & Daniel, M. (2016). Medical error — the third leading cause of death in the US. Bmj, 353, i2139.

World Health Organization, (2019). Patient Safety: Data and Statistics.

Natalie C. Frank has a Ph.D. in Clinical Psychology. She specializes in Pediatric Psychology and Behavioral Medicine.

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