Lack of patient epinephrine access, education creates need for outreach
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LOUISVILLE, Ky. — Only about half of all adults with food allergies have immediate access to epinephrine, according to a study presented at the American College of Asthma & Immunology Annual Scientific Meeting.
Also, about one-third of the respondents believed that epinephrine autoinjectors (EAIs) could cause life-threatening side effects, the researchers wrote, adding that these gaps in access and education indicate a need for study and outreach.
“This study is the result of the combined effort of the Food Allergy Collaborative, an alliance of advocacy organizations working to improve the lives of those living with food allergy through patient-centered initiatives, research and care,” Erin Malawer, cofounder of the Food Allergy Collaborative, told Healio.
In September 2021, the organization hosted the Externally-Led Patient-Focused Drug Development (PFDD) Meeting for Food Allergy for the FDA, where the study was conceived.
“Having read through studies related to the burden of food allergy, we identified gaps in our community’s knowledge and crafted the survey to expand our understanding of the patient experience,” said Malawer, who also is CEO at AllergyHealth.
Survey results
The online survey polled 1,006 adults with food allergy in May 2022, with 61% identifying as white; 16% as Black; 15% as Hispanic; and 7% as Asian, Native American or other.
Specifically, only 52% of adults reported that they had ever been prescribed an EAI. The most common responses explaining these gaps in prescriptions included “my doctor did not indicate it was really needed,” and “I don’t believe I need it.”
“There were several additional reasons why patients did not have an EAI,” Malawer said. “Broadly, these reasons had to do with insurance, time to obtain a prescription from their doctor or go to the pharmacy, cost of EAIs, and fear of the EAI and epinephrine itself.”
Respondents with private insurance, including 59% of those with insurance through an employer and 68% who had purchased their own insurance, reported the most coverage with EAIs. Patients with Medicare (48%) and Medicaid (51%) had the least coverage.
Out-of-pocket costs for EAIs averaged $476 (standard deviation, $971) over the previous year. Also, only 33% of respondents had an unexpired EAI, and only 25% reported always having access to EAIs.
“There are several EAIs on the market, and ideally more competition should have driven down the cost,” Malawer said. “One way to offset patient costs would be to extend the shelf life of epinephrine.”
EAIs currently have a 12-month expiration date, which forces patients to replace one or more sets annually, Malawer said.
“Studies have shown that epinephrine is 90% effective 30 months after expiration, which falls well within the FDA’s efficacy standards,” Malawer said. “That would help by spreading patient costs over several years.”
Patient fears
Meanwhile, 36% of the respondents said they believed that EAIs could cause life-threatening side effects.
“Misconceptions related to epinephrine, including the one that suggests it can be harmful, have existed for quite some time,” Malawer said.
Although the survey did not explore the origin of this mistaken belief, Malawer said, the researchers believed three factors may drive these fears.
“One explanation may be borne out of the fear of using it incorrectly or of the size of the needle. This is particularly true for caregivers of very young patients with food allergies where the use of a needle feels even more challenging and the risk of laceration exists,” Malawer said.
During the Externally-Led PFDD Meeting for Food Allergy, patients testified that they have hesitated in using EAIs because of fears about the needle.
“I know the most stressful and traumatizing part of this all is having to use an [EAI] because it’s not simply just ‘using’ it,” one patient said, according to Malawer. “During the most stressful couple of minutes, you then have to find someone to jab a needle into you. And as a child, that is terrifying.”
Malawer also indicated that the delayed administration of epinephrine has been associated with negative outcomes, which allows symptoms to worsen, could require additional medication and may lead to longer recovery time.
Another reason behind these fears may be the outdated belief that Benadryl (diphenhydramine; Johnson & Johnson), which is a first-generation antihistamine, is the appropriate first-line treatment for an allergic reaction.
“Benadryl is known, affordable and has been on pharmacy shelves and in medicine cabinets for decades,” Malawer said. “In comparison, injectable epinephrine appears to be an extreme treatment.”
The third factor the researchers cited is the expense of EAIs, even though epinephrine itself is not expensive.
“The high cost of EAIs and the inconvenience of carrying them give patients just enough reason to justify their fears and leave their prescriptions unfilled,” Malawer said.
Next steps
Malawer said that providers can improve these attitudes through patient education.
“Health care providers can begin by asking if patients have a current, unexpired prescription filled and review EAI use, including training on administration, the need for temperature control and strategizing best ways to carry it at all times,” she said.
Providers must underscore the safety and efficacy of epinephrine as a medication to alleviate fears as well as emphasize its use as soon as the first symptom of anaphylaxis appears, Malawer continued, which gives patients and caregivers permission to use it when they suspect they are having a reaction.
Also, Malawer emphasized the need for communication, as many people do not manage their food allergy at an allergist’s office, preferring to see their pediatrician, primary care provider, dermatologist and other physicians.
“In addition to the patient education that occurs in the doctor’s office, we hope that this survey encourages allergists to work with health care providers in the other specialties that sometimes diagnose and manage food allergies,” she said.
“We’d like to see these providers brought up to speed on best practices for prescribing and educating patients about EAIs,” she continued. “It will be a collective effort to ensure patients are armed with the knowledge and epinephrine that could protect them in the event of a severe reaction.”