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epipen Photo courtesy of Mylan

How to create a guideline for EpiPen use

More states are drafting legislation that covers the public use of injectors that can stop severe food allergy reactions

California has joined a growing number of states that allow restaurants and other businesses to take customer service to a new level: potentially saving a guest’s life.

The legislation in California, which went into effect on Jan. 1, allows businesses or other public entities to keep epinephrine auto-injectors, commonly known as EpiPens, on hand for emergency use. Thirty states across the country now have what are called “entity laws” allowing the practice, and similar bills have been proposed in six more states. 

The injectors deliver shots of epinephrine that can stop severe allergic reactions to foods, which is the stuff of nightmares for restaurant operators. 

While most people with severe allergies would likely carry the injectors with them when they eat out, there’s always a chance it could be left at home, or that a guest could be unaware of an allergy if exposed to new ingredients.

According to Food Allergy Research and Education, an estimated 15 million Americans have food allergies, and a severe reaction sends patients to the emergency room about every three minutes. Food allergies account for 30 percent of anaphylaxis, according to the Allergy & Asthma Network, and about 150 to 200 people die of food allergies every year. 

Most states allow, and some require, auto-injectors to be available in schools. Entity laws expand on that access with the goal of making the injectors more broadly available in public places.

Not surprisingly, drug maker Mylan, maker of the EpiPen, is a backer of entity laws. Mylan came under fire last year for price gouging after the EpiPen topped $600 for a two-pack, up from less than $100 a few years ago. Responding to critics, in December Mylan released a generic version of the same medication, priced at $300 for a two pack.

The injectors are getting even more affordable: In January, CVS Pharmacies unveiled a separate generic called Adrenaclick priced at $110 per two-pack.

So should restaurants keep an auto-injector on the premises in case of emergency?

The decision is best discussed with legal counsel and your insurance company’s risk management specialist, said attorney Nancy Stagg, a partner with Kilpatrick Townsend & Stockton LP in San Diego. State laws may vary.

“Obviously, you could save someone’s life by having it,” Stagg said. “It’s not just for your customers, but your employees eat at the worksite too. Years ago, we didn’t think anyone could use defibrillators, but now lots of people are trained to use them in public places.”

If a restaurant operator chooses to stock an EpiPen or generic, there are clear rules about compliance that offer civil liability protections, Stagg said.

In California, for example, “lay rescuers” who administer the injection to someone who appears to be experiencing a severe allergic reaction are protected from liability, so long as the injection is given in good faith and not for compensation.

However, the rescuer must also have complied with specific certification and training requirements, which must be updated every two years. The Adrenaclick, however, has a different set of instructions than the EpiPen, so businesses should make sure training is specific to the product.

Here are steps restaurants in California should take if keeping an auto-injector on premises:

  • Create a written plan for the use and upkeep of the auto-injector. Make sure the plan is readily available on site.
  • The plan should includes the name and contact number for the authorized healthcare provider who prescribed the injector and the names of designated employees that have been trained to administer the injections.
  • The designated employees must be recertified every two years, and restaurants should document the process. 
  • The plan should also include specific information on where and how the injector should be stored, as well as the procedure for inspecting the injector’s expiration date, and the process for disposal of expired injectors. 
  • Records related to the injector plan should be kept for three years. 
  • If the injector is used, the restaurant must also call 911. “It’s hard to imagine that people wouldn’t, but you can’t use the injector and then let the person walk out if they say they want to go to the hospital on their own,” Stagg said.
  • If the injector is used, the restaurant operator must also report it to authorities. Check with local legal counsel for guidance on where the reports must go.

Contact Lisa Jennings at [email protected]

Follow her on Twitter: @livetodineout

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