The EpiPen shortage: A perfect pharmaceutical storm

Any parent of school-aged children knows summer is not all about vacations and fun. One of the big back-to-school activities is the well-child check and completion of school-specific paperwork.

Pediatricians’ clinics prepare well in advance for the onslaught. School nurses are set up to receive the paperwork and medications specific to children with medical needs. If a child has potentially life-threatening allergic reactions, he or she needs to have the immediate treatment available at the school.

The most common form of treatment for severe allergic reactions is the EpiPen, a self-injectable epinephrine pen made by Mylan, a pharmaceuticals company. Mylan’s scruples were highlighted in 2016 by sharply increasing the price of EpiPens to over $600, coincidentally around the start of school.

There are a few other brands of self-injectable systems with a smaller market share priced in a similar range. The Food and Drug Administration (FDA) recently announced approval to fast-track a generic form of EpiPens produced by Teva Pharmaceuticals.

Let’s be clear. Shortages aren’t a new thing and there is nothing particularly extraordinary about this one. For the past decade, we’ve had limited drug supplies in all types of pharmaceuticals because of manufacturing and distribution problems. The current list of drugs in shortage can be found on the FDA’s website.

However, public awareness of shortages is fleeting. My clinic has managed patients through shortages of chemotherapy, antibiotics, basic nutrients, and other issues. I am not pointing a finger at Mylan or their collaborator, Pfizer pharmaceuticals, or calling them out as poor performers in the pharmaceutical industry.

What I want to point out is the down-stream effect of these shortages. Evidence-based medicine is discussed in all forums as a way to improve outcomes. As medical providers, we can only do that if the drugs are actually available. There is a growing body of literature that patients treated during shortages have worse outcomes.

If a child who needs epinephrine does not get it, there is a chance of death. These reasons alone should force a more intensive look at the policies and markets that result in shortages.

Drug shortages also add a burden on the healthcare system and patients. When a shortage occurs, we spend countless administrative hours addressing the issues instead of doing something else – such as actually improving healthcare.

The EpiPen shortage will end. In the meantime, families can take the extra step of calling Mylan for help. After the shortage ends, somehow the healthcare system, the educational system, and families will have to catch up. These may seem minor issues in the grand scheme of our society, but are massive issues for those involved.

-By Dr. Heidi Voelker Russell, associate professor of pediatrics-hematology and oncology and member of the Center for Medical Ethics and Health Policy at Baylor College of Medicine

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