Justine Saffir, director at the Sunnymont-Westside nursery school in San Jose, keeps in her classroom a spare EpiPen to treat potentially life-threatening allergic reactions, even though she is not allowed to use it.
And in her 22 years at the school, she hasn’t had to.
“We’ve been lucky,” she said. But in case of an emergency, she wouldn’t hesitate to use it, even if that meant legal consequences for the nursery.
Earlier this month, Gov. Jerry Brown signed legislation that would allow nurseries like Sunnymont-Westside and many other organizations and businesses — including youth sports leagues, colleges and restaurants — to stock up on epinephrine auto-injectors, commonly referred to as EpiPens, the most popular model. Many parents, advocates and health care professionals applaud the new law, calling it a potentially life-saving move.
But the new law, which takes effect Jan. 1, is not a requirement, and whether businesses and organizations would want to stock the medication remains to be seen. Some may not want the responsibility or expense.
The law permits doctors to prescribe epinephrine injectors to businesses and organizations and permits pharmacies to fill those prescriptions. Before this legislation, prescriptions were only allowed for individuals and K-12 schools.
Organizations wanting prescriptions must meet training requirements on how to properly administer epinephrine. The bill also protects an entity from liability for damages, which offers reassurance to groups, supporters of the bill have said.
“It does provide relief,” Saffir said. “For us, it’s been a question of: How much risk are we putting ourselves in?”
For the most part, auto-injectors are easy and safe to use, said Dr. Bradley Chipps, an allergist and pediatric pulmonologist based in Sacramento. The issue is in knowing a person’s medical history. A patient with an irregular heartbeat, or some type of heart disease, for example, could become worse with epinephrine, he said. If the person is healthy, epinephrine poses no real danger, he said.
“But again, an event that is emotionally charged can masquerade as anaphylaxis,” a serious allergic reaction, Chipps said. “Sometimes it is even hard for me to be 100 percent sure at first glance.”
So it is not rational for a layperson to be expected to know what they’re dealing with, he said.
This is why the training and education component is so important, Chipps said. He would recommend that directions on how to work an auto-injector always be attached to the device, despite the assumption that someone was trained to use it.
Some colleges and universities are evaluating whether to purchase auto-injectors and how to distribute them across campus. Janet Dumonchelle, the pharmacist in charge at Sacramento State’s student health center, said that current protocol for such situations calls for paramedics or other first responders to assist and take a student to the health center where they can be stabilized.
Having an injector in every classroom or common area is unrealistic, so it is a matter of discussing who will carry and be responsible for these spare injectors if the school decides to participate under the new law, Dumonchelle said.
The Sunnymont-Westside nursery in San Jose cares for children from 15 months old to right before they enter kindergarten — a critical age for discovering allergies in children, Saffir said.
“Having one [injector] onsite along with a first-aid kit makes sense,” she said. As a nonprofit nursery school, her concern now is being able to afford the expensive auto-injectors. One two-dose package costs about $600, significantly higher than in any other wealthy country, according to a recent survey by the consumer group Public Citizen.
The legislation was sponsored by Mylan, the manufacturer that acquired the rights to the EpiPen in 2007. While this particular bill received no official opposition, Mylan has been heavily criticized for its dramatic price increases and government lobbying.
While the law only calls for an auto-injector, not specifying Mylan’s EpiPen, the company has a patent on the auto-injector model until 2025, and it is the only such device that’s widely available. Mylan announced that it plans to create a lower-cost generic version of the EpiPen.
Mylan’s CEO, Heather Bresch, appeared before the U.S. House Committee on Oversight last week to defend the company’s increasing prices.
In signing AB 1386, Gov. Brown denounced Mylan for its perceived price gouging.
“We acknowledge the fact that EpiPens are life-saving for a person suffering a severe allergic reaction, Brown wrote in a letter to congressional leaders. “But Mylan’s arbitrary manner of pricing and their utter lack of transparency put those in need of the drug at a terrible disadvantage.”
California’s new law builds on legislation passed in 2014 that required California schools to stock up on auto-injectors. Forty-eight states now have laws that either allow or mandate schools to stock injectors.
But allergic reactions are not restricted to schools, which is why this new law is important, said Connie Green, co-founder of the California Advocates for Food Allergies.
Being able to stock injectors and receive the necessary training helps fill in knowledge gaps around anaphylaxis, Green said.
“Anyone can develop allergies to any food, even to foods they have eaten for many years,” Green said. “You can’t be prepared, so you want them everywhere just in case.”
Green expects this legislation to be most helpful for places where children and young adults gather, including preschools, universities, summer camps and theme parks.
“Many organizations are concerned about liability giving epinephrine,” Green said, “and legislation such as this will give them more confidence that this medication is safe.”