Program safely removes penicillin allergy labels for patients with COVID-19 in ICU
Click Here to Manage Email Alerts
Patients with COVID-19 in the ICU safely and effectively received direct oral challenges for low-risk and unverified penicillin allergies, according to a study published in The Journal of Allergy and Clinical Immunology: In Practice.
These challenges could clear patients to receive more effective antibiotics against ventilator-associated pneumonia and other common bacterial superinfections among patients with COVID-19 in the ICU, the researchers said.
“Many critically ill patients with COVID-19 have high severity of illness and prolonged ICU and hospital lengths of stay, resulting in the development of bacterial superinfections,” Joanna L. Stollings, PharmD, medical ICU clinical pharmacy specialist in the department of pharmaceutical services in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center in Nashville, told Healio.
“The drug of choice for many of these superinfections is frequently limited by an allergy to penicillin or another beta lactam,” Stollings continued. “We had previously conducted a study showing that direct oral challenge with amoxicillin is a safe and effective means to remove penicillin allergy labels in patients with low-risk penicillin allergies.”
Study findings
An ongoing pharmacist-driven program identified 24 patients (median age, 62 years; 37.5% women; 70.8% white) with stabilized COVID-19 and a low-risk penicillin allergy label in the medical ICU at Vanderbilt between April 2020 and February 2022.
The researchers’ low-risk category included patients with urticaria more than 5 years ago, remote childhood reactions with limited details, family histories of penicillin allergy without their own reaction, known tolerance of a penicillin and other indications.
The 19 patients (79.2%) who agreed to participate in an oral amoxicillin challenge successfully passed it and subsequently had their penicillin allergy label removed.
Six of these patients (31.5%) then had an indication for antibiotics and received a penicillin in the hospital, including five who received piperacillin-tazobactam and one who received amoxicillin-clavulanate. Two patients (10.5%) received additional penicillin antibiotics for a median duration of 10 days, given at a median of 10 days after hospital discharge.
These patients did not experience any adverse events secondary to the administration of penicillin, and none of them were re-labeled with a penicillin allergy after their challenge or during subsequent treatment.
The five patients who did not participate in an oral amoxicillin challenge experienced infections that complicated their hospitalization for COVID-19, the researchers said, and they typically received cefepime and vancomycin instead of piperacillin-tazobactam.
The safety of this program appeared similar to the safety experienced by other patients in their routine penicillin allergy de-labeling program, the researchers added.
Incorporating de-labeling programs elsewhere
Additionally, the researchers suggested that these challenges may benefit patients with penicillin allergy labels who are hospitalized for COVID-19 but who are less critically ill as well.
“The next step in this process is to develop protocols to remove other common low-risk allergies such as cephalosporins or sulfa to enable patients to receive the most appropriate antimicrobial therapy,” Stollings said.
The researchers also said that other practices and clinics can establish similar programs.
“There is increasing knowledge available about different ways to take the history of a penicillin reaction and identify patients who have a low-risk penicillin allergy, which is called risk-stratified management,” Cosby A. Stone Jr., MD, MPH, assistant professor in allergy/immunology, VUMC Drug Allergy Research of Vanderbilt University Medical Center, told Healio.
Risk-stratification schemes such as PEN-FAST and the system developed at Vanderbilt are gaining traction because they are increasingly well validated for safely identifying patients with low-risk penicillin allergies and who only have an approximately 0.5% chance for a rash, Stone said.
“For someone who wants to do this in their setting, I try to break it down into its component steps. Asking questions of patients and giving a dose of amoxicillin under observation to disprove such a low-risk penicillin allergy is fairly cheap in terms of time and materials,” Stone explained.
Clinicians also would need to be able to contextualize the known risks of testing to patients, explain their options, and educate patients when they either pass the test or develop a rash, Stone said. Discussing the patient’s history, explaining the risks and getting an informed procedural consent form signed takes about 15 minutes, he continued.
Next, Stone advised, clinicians need a safe place where patients can be observed after their allergy has been challenged.
“We check on our patients with vital signs and a check-in at baseline, and then every 30 minutes for an hour, just to make sure we don’t miss any warning signs for anaphylaxis,” he said. “But we still haven’t seen it in these low-risk history patients. We keep an epinephrine injection at the bedside but, again, we haven’t needed to use it.”
What comes next
After patients pass these challenges, providers tell patients that their allergy can be removed from their chart. Patients also can receive a letter and a card indicating the removal of their allergy that they can show to other providers.
“They can use these written proofs to demonstrate to others that they have had the relevant penicillin allergy testing via an oral challenge,” Stone said. “All those things are routinely available in almost any clinical setting.”
Stone also cited how he and his colleagues have collaborated with their facility’s informatics team to help identify which patients have penicillin allergies and to document their risk assessments and challenge outcomes.
“We created informatics-enabled lists that import the patients with penicillin allergies, and then we walk folks through the step-by-step process of risk assessment, challenge and removal of the allergy,” he said. “Maybe these extra resources are unnecessary in a lot of settings, but it seems to help in ours by making the workflow clear and straightforward.”
Additionally, Stone explained that he is considering how he and his colleagues can integrate an easily performed penicillin allergy assessment into other routine clinical workflows where they know patients might benefit, such as ordering antibiotics to protect patients from infections after surgery.
“We have always wanted to make it as easy as possible for non-allergists to do these risk assessments, knowing that allergists like me are in short supply in general,” he said.
Finally, Stone said that an “all-hands-on-deck” approach will be needed if the health care system will ever really tackle the problems presented by 10% to 15% of patients in the U.S. reporting untested penicillin allergies.
“Lots of people need to know how to do this,” Stone said. “I’ll teach anyone who wants to learn.”
For more information:
Joanna L. Stollings, PharmD, can be reached at joanna.stollings@vumc.org.
Cosby A. Stone Jr., MD, MPH, can be reached at cosby.a.stone@vumc.org.
Perspective
Back to Top
I think these results are not surprising, but they are significant to show the spectrum of patients who are able to undergo direct challenges to penicillin-based antibiotics.
We have a similar ongoing initiative in our ICU to de-label penicillin allergy, and we have had the same experience that patients tolerate these challenges. However, the ICU patients are quite ill, so many do pass away from their illnesses that brought them to the ICU in the first place, COVID-19 or otherwise.
Before doctors can replicate this program in their own practices and departments, they would need clear guidelines for low-risk reaction histories, which are nicely outlined in this paper. I also think pharmacist-led protocols have shown significant success. Pharmacists have a significantly greater presence in hospitals than allergists and have the expertise in a drug allergy history.
Future research should include larger numbers of patients, which are always helpful. Also, outcomes research should examine how de-labeling these patients impacts future care. Sick patients who end up in the ICU have an overall high risk for mortality, and it’s not clear yet whether taking away penicillin allergy labels would impact these risks.
Collapse
Read more about
Click Here to Manage Email Alerts