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News — Here’s the scene. Your child appears to be sick. You take their temperature. Fever is over 100. Their throat hurts. You immediately wonder if this could be some type of infection. Urgent care test results determine it is indeed strep throat, and the provider prescribes penicillin as the treatment. The child takes the drug and eventually develops a rash. You take them to the pediatrician to explain the symptoms. The doctor confirms that your child could be allergic to penicillin and makes a note on the child’s medical chart. From then on, you tell everyone that your child is allergic, and they can never be prescribed penicillin or amoxicillin products again, ever.

The child is now deemed to be penicillin allergic. But what if that diagnosis was wrong?

, approximately 10% of patients report an allergy to penicillin. However, the majority of those patients may not truly be allergic.

“A lot of kids get penicillin or amoxicillin when they get sick because that is the normal tendency to treat respiratory infections,” said Mildred Kwan, MD, PhD, assistant professor of medicine at the UNC School of Medicine. “The problem is that children can get rashes with infections, especially viral infections, even without treatment with antibiotics. But if they got a penicillin to treat the infection, the practitioner attributes the rash to the use of the penicillin. One major issue is that many providers have a misperception about what is considered to be a drug allergy,” said Kwan, who is also director of Quality Improvement in the UNC Division of Rheumatology, Allergy, and Immunology, UNC Department of Medicine.

Most children with a penicillin allergy history are found not to be truly allergic when they are formally tested. Rashes can often develop when an infection appears, and this can lead to a penicillin allergy misdiagnosis. A true penicillin allergy can look quite different with a full range of symptoms.

“When a child is having an allergic reaction to a penicillin, the symptoms may be consistent with either anaphylaxis (severe allergic reaction) that is an immediate onset of symptoms following the ingestion of the penicillin that can be life threatening or a severe cutaneous adverse reaction that may result on oral and other mucosal ulcers, skin peeling off, and/or other severe symptoms,” said Kwan. “Rash or hives only or fever, joint pain/swelling alone are not true allergic reactions to penicillins,” she said.

The most effective antibiotics for common infections like ear infections, strep throat, and skin infections are penicillin and its derivatives. When a penicillin allergy is reported, second-line antibiotics are prescribed. However, along with that second choice comes a host of other complications.

“Alternate treatments may not be as effective to eliminate the infection,” said Kwan. “It may also increase the amount of antibiotic resistance to other antibiotics particularly by that bacteria. It may increase costs in other antibiotics compared to penicillin because penicillins are the oldest class. They’re the least expensive class too,” she said.

Penicillin side effects like nausea, vomiting, diarrhea and rash can lead to the misinterpretation of an allergic reaction now placed on medical records. This label can cause serious healthcare effects, such as fewer efficacious antibiotic choices, more costly antibiotics, and potentially life-threatening situations. To recognize and identify who really has a penicillin allergy, and to delabel those who don’t, investigators at the UNC School of Medicine and Cincinnati Children’s developed an innovative, patient-initiated online platform to take the initial steps to delabel.

Combining Efforts to Delabel

Andrew Winslow, MD, assistant professor in the Division of Allergy and Immunology at Cincinnati Children’s was a UNC School of Medicine Allergy & Immunology fellow in 2020. He and Dr. Kwan had overlapping clinical experiences in penicillin allergy.

“We both were interested in finding ways to bolster penicillin allergy delabeling within the pediatric populations at UNC,” said Winslow.

Dr. Kwan along with Dr. Renae Boerneke and her pharmacy resident, Dr. Ashlyn Norris, worked on a pilot project back in 2020 where they were involved in a pharmacist-led initiative in the emergency department at UNC. The pilot involved Dr. Norris screening patients in the ED who had a penicillin allergy on their record.

“She found that up to 23-24% of patients could have their penicillin allergy label removed by this evaluation and medication record review (documentation of previous penicillin use with tolerance) without even needing to have testing or an amoxicillin challenge with an allergist,” said Kwan.

That experience sparked a realization that much more needed to be done to recognize a penicillin allergy. The importance of knowing a patient’s true allergy history while offering tools and ideas to help create awareness throughout healthcare offices, facilities, and communities became the foundation of Dr. Winslow and Dr. Kwan’s new partnership in building an online platform called PADME.

“We got together to amplify the history-taking element by doing a lot of the work that needed to be asked in clinic through a virtual resource to help find patients that could be delabeled from penicillin allergy,” said Winslow.

After obtaining a two-year grant application in November 2022 from Pfizer,  was introduced. It is a novel patient-facing resource that helps to delabel misdiagnosed penicillin allergies. The program targets rural, underserved pediatric patients through a mobile-enabled virtual platform.

“Access to an allergist in the rural communities is far less likely than in places like the Raleigh-Durham-Chapel Hill area of North Carolina,” said Kwan. “Part of the project is to gather more details about the practices that exist within these areas and demand for such delabeling services. This platform can be moved to rural locations, and that has been a priority of ours – to extend the program to those communities.”

PADME collects information about drug allergy reactions. A risk assessment survey will pop up on-screen asking the patient questions such as: what was the reaction after taking penicillin, was there a rash only, were there other symptoms, how long has it been since the reaction occurred, etc. After all questions are answered, PADME will use a decision support algorithm to generate a risk certificate.

“After you take the survey, the patient will receive a certificate and they’ll bring that certificate either to their primary care doctor or to an allergy doctor that can help them perform the next steps of delabeling,” Winslow said.

The goal of the program is to improve patient and caregiver education about the penicillin allergy delabeling process. It will also empower parents of penicillin-allergic patients to seek delabeling care. The safe and easy process will help guide next steps in evaluating the penicillin allergy and connect patients with a medical professional to help remove the label off medical records.

“If the patient feels empowered to take this issue on themselves through the use of PADME, we are hopeful that more people will try to address this problem,” said Dr. Kwan.

And, the good news is that the tool is already available at UNC Hospitals and Cincinnati Children’s affiliated specialty clinics and primary care sites. Correctly identifying those who are not actually allergic can improve antibiotic prescribing, combat bacteria resistance, and shorten hospital stays, thus, equating to overall better healthcare.

Media Contact: Brittany T. Phillips, Communications Specialist, UNC Health | UNC School of Medicine