PORTSMOUTH, Virg.  –   Antibiotics are one of the most frequently prescribed medications in the world today. And among all antibiotics, penicillin and related beta-lactam antibiotics have proven to be the safest and most effective at eradicating common bacterial infections since their discovery in the early 20th century.

Unfortunately, today, many U.S. patients are incorrectly labeled as having a penicillin allergy, which limits their access to essential medications and makes them vulnerable to complications associated with broad-spectrum antibiotic treatments.

According to the Centers for Disease Control and Prevention (CDC), 10 percent of the U.S. population reports having a penicillin allergy. However, less than one percent of the whole population is truly allergic.

As part of the Defense Health Agency Tidewater Market's approach to optimize and improve the military healthcare system, U.S. Navy Cmdr. (Dr.) Taylor Banks, the market's allergy and immunology product line leader, is leading an effort to "de-label" patients who are incorrectly identified as having a penicillin allergy.

Banks, who also serves as the Navy Allergy Specialty Leader at Naval Medical Center Portsmouth, says there are countless benefits to de-labeling, especially since the process is safe and it allows patients to access such an important treatment.

"At the patient level, patients (once correctly labeled) have access to what are often the best antibiotic agents in penicillin or beta-lactam antibiotics, with fewer side effects associated with broad-spectrum antibiotic treatments," he said. "There's a reduction in hospital days for inpatients and a reduction in resistant bacterial infections overall.

"From a provider perspective, we can now actively implement best practices, evidence-based medicine, and have confidence in safety and the care plan. It really liberates providers to prescribe what they think is the right treatment.

"From the health care system perspective, it's a priority to have effective antimicrobial stewardship (improve how antibiotics are prescribed by clinicians and used by patients) and really be thoughtful about our antibiotic practices. But if 10 percent of your patients can't access the first-line agent, that's a huge impediment to that effort," said Banks.

Since having a penicillin allergy label often means patients are prescribed alternative antibiotics for treatment, it is also associated with increased healthcare costs. Conversely, de-labeling has the potential to save money.

A 2018 Military Medicine article cited a study that showed a savings of $2,000 in healthcare expenses per patient, per year, in both inpatient and outpatient settings, with the de-labeling of reported penicillin allergies.

Since beginning their efforts, the Tidewater Market has successfully de-labled 250 patients—equating to $500,000 in annual cost savings (using the study mentioned as model).

The Process of De-labeling

The gold standard to know whether a patient is truly allergic to penicillin is through direct exposure. But before providers take this step, they first work to identify patients as being low risk by having them answer the following series of questions about their prior history:

- Following the reaction, has your child since taken and tolerated a penicillin or a penicillin derivative (such as Amoxicillin, Augmentin, etc.)?
- Did your reaction occur within the past year?
- Did your reaction involve any systemic symptoms other than a rash or other skin symptoms? If unknown, mark NO.
- Was your reaction life-threatening (i.e., severe anaphylaxis requiring epinephrine, Emergency Room visit, hospitalization, or intubation)?
- Did your reaction involve blistering, ulceration, sloughing of your skin or lining of your mouth, eyes, or genitals - OR - being diagnosed with Stevens Johnson Syndrome or Toxic Epidermal Necrolysis?
- Did your reaction involve any organ dysfunction/failure - OR - were you diagnosed with serum sickness, drug reaction with eosinophilia and systemic symptoms (DRESS/DIHS) syndrome, or acute interstitial nephritis?

Once the patients answer the questionnaire and a provider determines them to be at low risk, the provider then administers a single tablet or oral solution of amoxicillin, at which time the patient remains under observation in a controlled environment for one hour.

"[In the event that a patient does have a reaction] We have any of the various treatments to include epinephrine to treat anaphylaxis," said Banks. "Fortunately, in this low-risk group – even in the less than one percent that does have symptoms – the literature, and our experience, has shown that we see hives only."

With 10 percent of the U.S. population reporting a penicillin allergy, the number of labeled patients across the country could be approximately 30 million. To reach as many patients as possible in the Tidewater Market, Banks and his team are enlisting the help of their primary and pediatric care colleagues at military treatment facilities in Hampton Roads, and they have teamed with ships at the Norfolk waterfront to reach active-duty service members as well.

"No matter what perspective you look at it from, this is the kind of initiative where everyone sees it's just the right thing to do," said Banks. "My experience has been that this is a great example of us working together to marshal resources across the market to get a shared win."

The Tidewater Market is the nation's second largest Military Health System market, established to manage military medical treatment facilities that support the delivery of integrated, high-quality health services for more than 390,000 eligible beneficiaries. Tidewater military treatment facilities include Naval Medical Center Portsmouth, McDonald Army Health Center, the 633d Medical Group at Joint Base Langley-Eustis, U. S. Naval Hospital Guantanamo Bay, Cuba, and 14 other clinics in Hampton Roads.