Identifying Food Allergies vs Food Intolerances: Pharmacists Can Play a Critical Role in Education

Patients can experience challenges when distinguishing between food allergies and food intolerances, as the symptoms can be similar, explained Carrie Gatzke, PharmD, CSP, specialty pharmacy manager at the Driscoll Children’s Hospital – Driscoll Health Pharmacy, during Asembia's AXS24 Summit in Las Vegas. As easily accessible health care professionals, pharmacists can help patients identify the differences between each.

“Our ease of access and frequent interactions with patients and their families present many opportunities to provide quality patient education,” said Gatzke during the presentation. “One thing we can do is help families distinguish between food allergies and food intolerances and refer them on for further assessment or treatment if needed. I'm sure many of you have had patients who claimed to have an allergy that was ultimately actually a food intolerance. As pharmacists, we can help clarify some of these ambiguities.”

According to Gatzke, the main difference between food allergies and food intolerances are the acuity of the symptoms. True food allergies can be life threatening medical emergencies, involving swelling of the mouth and throat, hives, and difficulty breathing, which can all occur almost immediately after eating even a small amount of the food allergen.

“If your patient eats a pint of ice cream, and occasionally suffers gastrointestinal consequences later, you're probably dealing with a food intolerance,” Gatzke said. “If that patient accidentally eats one peanut M&M and starts to swell and wheeze, they're most likely dealing with a true food allergy. Hopefully [this] patient has an epinephrine pen readily available. If not, this presents a great opportunity to pharmacists by helping patients and their families gain access to this life-saving medication.”

All patients with known food allergies should have a minimum of 1 pack of emergency epinephrine on hand at all times, explained Gatzke. However, either a brand name or the generic of epinephrine is covered by most insurance plans. For patients with Medicaid, there is often little to no out of pocket expenses. Patients with commercial non-government insurance may be able to take advantage of manufacturer copay cards to reduce costs as well.

Additionally, uninsured or underinsured patients who meet certain financial criteria may be eligible to receive free drug via manufacturer patient assistance programs. To this end, pharmacists can be a valuable resource to help patients find and apply for various savings programs.

For the oral immunotherapy agent peanut allergen powder-dnfp (Palforzia; Aimmune Therapeutics, Inc), pharmacists can not only help patients locate savings opportunities, but can also assist providers with prior authorizations (PAs).

“This is a fairly expensive drug,” Gatzke said. “It's [also] a niche drug [and] a limited distribution drug. All of these make it a likely candidate for [PA]. Although PA criteria will differ from payer to payer, if your patient meets the criteria, you're likely to get a PA approval.”

Gatzke explained that the following are patient criteria that make a patient a likely candidate to receive PA for peanut allergen powder-dnfp:

• Is the patient aged 4 to 17 years?
• Does the patient have a confirmed diagnosis of peanut allergy?
• Did the patient have a positive skin prick or peanut-specific serum immunoglobulin E (IgE) test?
• Has it been prescribed by an allergist or immunologist?
• Are there any previous claims for injectable epinephrine?
• Do they have no history of uncontrolled asthma or eosinophilic esophagitis?
• Can you provide a prescriber attestation that the patient follows a peanut-avoidant diet?

Pharmacists should also be prepared to educate patients about the risk evaluation and mitigation strategy (REMS) program that's associated with this medication. REMS is a safety program required by the FDA for certain medications with serious safety concerns to ensure that their potential benefits outweigh the risks.

“The peanut allergen powder-dnfp REMS was established to reduce the risk of anaphylaxis in patients. It requires that the patient be enrolled in the REMS program, and it requires that the prescriber, the prescriber’s office or health care setting, and the specialty pharmacy all be certified within the REMS program,” Gatzke said. “It's important for families to know that they're not going to be able to pick up this medication at their local drugstore. Only a few certified specialty pharmacies are actually allowed to dispense this drug.”

According to Gatzke, more specialty pharmacies are able to dispense omalizumab (Xolair; Genentech USA, Inc and Novartis Pharmaceuticals Corporation) than peanut allergen powder-dnfp, making omalizumab more accessible for patients. Gatzke explained that the FDA approved omalizumab on February 16, 2024, for IgE-mediated food allergy in adults and children aged 1 year or older. Notably, omalizumab reduces allergic reactions in patients, including the risk of anaphylaxis, that may occur with accidental exposure to the allergen, but does not eliminate allergic reactions. For that reason, patients taking omalizumab would still need to avoid foods they are allergic to. Omalizumab is intended as a preventative therapy to reduce the risk of allergic reactions and is not approved for immediate emergency treatment upon the occurrence of allergic reactions, including anaphylaxis.

“Unlike peanut allergy powder-dnfp, which is indicated for peanuts only, omalizumab is approved to reduce allergic reactions to multiple foods, including peanuts, milk, eggs, wheat, and certain tree nuts,” Gatzke said. “But similar to the peanut allergen powder-dnfp, omalizumab is an expensive medication that will likely require PA.”

Omalizumab is approved to reduce allergic reactions to multiple foods, including peanuts, milk, eggs, wheat, and certain tree nuts. Image Credit: © Irene - stock.adobe.com

The clinical criteria that may need to be documented for PA for omalizumab include the patient being 1 year of age or older, clinical history consistent with IgE-mediated food allergy, a positive food-specific IgE skin prick test or oral food challenge, pretreatment serum level IgE greater than or equal to 30, and body weight greater than or equal to 10 kilos.

“Even if the PA is approved, omalizumab may still be too expensive for some families,” Gatzke said. “Fortunately, there are manufacturing copay cards and patient assistance programs available to qualified patients.”

Besides helping patients and families access these medications, pharmacists can make a significant impact by providing easy to understand education and training. Epinephrine auto injectors come in multiple brand and generic options, according to Gatzke. Because of the options available, it is critical that the injector dose is appropriate for the patient's weight.

“It's also extremely important that patients and caregivers become acquainted with their device well before they would actually need it. During acute anaphylaxis is no time to be messing with how to instructions. Luckily, most, if not all, injector packages come with a training device,” Gatzke said. “It's really important that patients be encouraged to practice with their trainers repeatedly until they're fully comfortable giving the injection. Also, it’s helpful to remind them not to actually carry their trainer with them, so they don't accidentally use it in case of an actual emergency.”

Some epinephrine devices give voice instructions during use, but patients and caregivers should still be encouraged to practice with these training devices as well, Gatzke explained. Regardless of the device, there are some common key counseling points. First, epinephrine should be injected into the outer thigh only, and it can be injected through clothing if needed. Injection into any other area could potentially cause a loss of blood flow to that area.

“If injecting a little one, you want to make sure to hold their leg firmly so you can limit movement during the injection. Parents will want to listen for the click that signals the start of the injection, and they’ll want to hold it in place for 2 to 3 seconds, and that will be specific to the actual device that they're using,” Gatzke said. “After heading to the emergency department right away and getting the patient stabilized, parents should definitely refill their epinephrine as soon as possible. It's so important to have multiple injectors on hand because some patients may actually require a second shot due to ongoing symptoms.”

Most epinephrine auto injectors come in a 2 pack, and patients should make sure to keep a pack on them at all times, according to Gatzke.

“At home, in their purse, in their backpack—wherever they are, the epinephrine should follow,” Gatzke said. “Also, the epinephrine should not be left in the car to melt or freeze. You want to keep it around room temperature. Encourage patients to check the expiration date on their epi pens as well, just to make sure that they're still within date. When in doubt, go ahead and get a refill.”

Also, it's important for pharmacists to monitor and encourage medication adherence for medications prescribed, whether omalizumab or peanut allergen powder-dnfp, according to Gatzke. One study suggested that after 3 to 5 years of maintenance phase dosing of oral immunotherapy, nearly 60% of patients abandoned the treatment.

“Medicine can't do any good if it's not being taken,” Gatzke said. “But these drugs do not cure food allergies, so food avoidance and emergency epinephrine remain the cornerstone of food allergy management.”

According to Gatzke, pharmacists should encourage families to regularly discuss their action plan in case of food allergy emergency. Additionally, Gatzke explained that patients and caregivers should continue active therapy management, especially as the child grows up. More severe allergic reactions have been known to occur during the transition into adolescence and young adulthood, most likely because parents are not always able to monitor food intake as closely during this period, Gatzke explained.

“It's during these times that is particularly important for pharmacists to support patients and their families,” Gatzke said. “Food allergies significantly impact patients’ quality of life across all age groups. It's necessary for effective management strategies to address the associated challenges.”

Additionally, Gatzke explained that ongoing research on immunomodulators and biologic therapies offer promising avenues for improving sensitization and tolerance to food allergens, which could potentially enhance patient outcomes in the future.

“Specialty pharmacists play a vital role in addressing barriers and challenges in food allergy management by staying informed about emerging trends and treatment options,” Gatzke said.

REFERENCE

Gatzke C. Proactive Approaches to Addressing Food Allergy. AXS24 Summit; Las Vegas, NV; April 28-May 2.