Program safely removes penicillin allergy labels for COVID-19 patients in intensive care
October 14, 2022
4 minute read
Stollings and Stone report no relevant financial information. Please see the study for relevant financial information from all other authors.
According to a study published in The Journal of Allergy and Clinical Immunology: In Practice.
These challenges could allow patients to receive more effective antibiotics for ventilator-associated pneumonia and other bacterial superinfections common in patients with COVID-19 in intensive care, the researchers said.
“Many critically ill patients with COVID-19 have high disease severity and prolonged ICU and hospital lengths of stay, leading to the development of bacterial superinfections,” Joanna L. Stollings, PharmD, medical critical care 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, Healio told Healio.
Joanna L. Stollings
“The drug of choice for many of these superinfections is often limited by an allergy to penicillin or another beta-lactam,” Stollings continued. “We previously conducted a study showing that direct oral challenge with amoxicillin is a safe and effective way to remove penicillin allergy tags in patients with low-risk penicillin allergies.”
An ongoing pharmacist-led program has identified 24 patients (median age, 62 years; 37.5% female; 70.8% Caucasian) with stabilized COVID-19 and a penicillin allergy tag at low risk in Vanderbilt Medical ICU between April 2020 and February 2022.
The researchers’ low-risk category included patients with hives more than 5 years ago, distant childhood reactions with limited details, family history of penicillin allergy without their own reaction, known tolerance to a penicillin and other indications.
All 19 patients (79.2%) who agreed to participate in an amoxicillin oral challenge test passed and subsequently had their penicillin allergy label removed.
Six of these patients (31.5%) then had an indication for antibiotics and received penicillin in hospital, including five who received piperacillin-tazobactam and one who received amoxicillin-clavulanic acid. Two patients (10.5%) received additional penicillin antibiotics for a median of 10 days, administered at a median of 10 days after hospital discharge.
These patients had no adverse events secondary to penicillin administration and none of them were relabeled with 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 generally received cefepime and vancomycin instead of piperacillin-tazobactam.
The safety of this program appears similar to the safety experienced by other patients in their routine penicillin allergy unlabeling program, the researchers added.
Incorporate delabeling programs elsewhere
Additionally, the researchers suggested that these challenges could benefit patients with penicillin allergy tags who are hospitalized with COVID-19 but are also less severely ill.
“The next step in this process is to develop protocols to eliminate other common low-risk allergies such as cephalosporins or sulfonamides to allow patients to receive the most appropriate antimicrobial therapy,” Stollings said.
The researchers also said other practices and clinics may establish similar programs.
“There is a growing body of knowledge available on the different ways to take the history of a penicillin reaction and identify patients who have a low-risk penicillin allergy, known as risk-stratified management”, Cosby A. Stone Jr., MD, MPH, assistant professor of allergy/immunology, VUMC Drug Allergy Research at Vanderbilt University Medical Center, Healio told Healio.
Risk stratification schemes such as PEN-FAST and the system developed at Vanderbilt are gaining traction as they are increasingly well validated for safely identifying patients with low-risk penicillin allergies who do not have only about a 0.5% chance of getting a rash, Stone said.
Cosby A.Stone Jr.
“For someone who wants to do this in their environment, I try to break it down into its component steps. Asking patients questions and administering a dose of amoxicillin under observation to refute such a low-risk penicillin allergy is pretty cheap in terms of time and materials,” Stone explained.
Clinicians should also be able to contextualize the known risks of the tests to patients, explain their options, and educate patients when they pass the test or develop a rash, Stone said. Discussing the patient’s story, 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 our patients with vital signs and check-up initially, then every 30 minutes for an hour, just to make sure we don’t miss any warning signs of anaphylaxis,” he said. “But we still haven’t seen it in these low-risk patients. We keep an epinephrine injection at the bedside but, again, we didn’t need to use it.
What happens after
Once patients have passed these challenges, providers notify patients that their allergy can be removed from their records. Patients may also receive a letter and card stating their allergy has been removed which they can show to other providers.
“They can use this written evidence to demonstrate to others that they have had the relevant penicillin allergy test via an oral test,” Stone said. “All of these things are routinely available in almost every clinical setting.”
Stone also cited how he and his colleagues worked with their institution’s IT team to help identify patients with penicillin allergies and to document their risk assessments and challenge results.
“We’ve created computer lists that import penicillin-allergic patients, and then walk people through the step-by-step process of risk assessment, challenge, and allergy removal,” he said. declared. “Perhaps these additional resources aren’t necessary in many contexts, but it seems to help in ours by making the workflow clear and simple.”
Additionally, Stone explained that he is considering how he and his colleagues could integrate easy penicillin allergy assessment into other routine clinical workflows that they know patients could benefit from, such as ordering antibiotics to protect patients against infection after surgery.
“We’ve always wanted to make it as easy as possible for non-allergists to do these risk assessments, knowing that allergists like me are generally rare,” he said.
Finally, Stone said an “everyone on deck” approach will be needed if the healthcare system ever truly addresses the issues presented by the 10% to 15% of patients in the United States reporting allergies to penicillin not tested.
“A lot of people need to know how to do this,” Stone said. “I will teach anyone who wants to learn.”
For more information:
Joanna L. Stollings, PharmD, can be contacted at [email protected]
Cosby A. Stone Jr., MD, MPH, can be reached at [email protected]