Question: As allergy practices slowly start to evaluate more patients in person, does the AAAAI COVID-19 Task Force have a recommendation or stance on initiation of FDA-approved peanut oral immunotherapy (Palforzia) in the office? I know the article by Shaker et al on allergy practices during the pandemic discouraged initiation of any form of immunotherapy, but I wanted to know if this has changed given the impending chronicity of the pandemic. Although immunotherapy was deemed to be low risk in the recent AAAAI guidance on resuming allergy practice, I assume this refers to allergen immunotherapy and not food allergen oral immunotherapy.  Thank you.

Answer: Based on the data from the pivotal studies on Palforzia, the up-dosing portion of the protocol would be considered moderate-to-high risk because moderate or severe anaphylaxis can occur.  Systemic reactions in the pivotal studies occurred in 0.7% of 709 patients in the initial dose escalation compared to 0.3% in the placebo group, in 9.1% of patients during an up-dosing visit, compared to 3.5% in the placebo group, and in 8.7% of patients during the maintenance phase compared to 1.7% in the placebo group.  There were 709 patients in the initial dose escalation phase, 693 in the up-dosing phase and 310 in the maintenance phase. All the reactions in the initial dose escalation were mild, most of the reactions in the up-dosing and maintenance phase were mild or moderate, with the rate of severe reactions 0.6% in the up-dosing and 0.3% in the maintenance phase. The individual practitioner should consider this risk, staff safety and PPE availability in deciding to perform any procedure in the office, as well as the fact that we have managed peanut allergy successfully for years with avoidance.  It is the opinion of the Task Force that OIT for peanut allergy should be deferred.


Question: Is there an update regarding the car wait after allergy shots? I thought I had seen a webinar presentation where there was a slide where it was included as acceptable, but someone pointed me to this document (https://education.aaaai.org/immunotherapy_covid-19) where it says this is not recommended. Is there an update in the recommendations to say a car wait is acceptable?

Answer: It is Practice Parameter guidance that patients on immunotherapy be directly observed in the waiting room for 30 minutes after their shot.  It is the consensus of the Task Force and also the opinion of the Work Group Report published in JACI: In Practice that allowing patients to wait in their cars after a shot is not an acceptable practice because of the inability to adequately observe and manage reactions. There is also the question of liability coverage for such a practice.  


Question: In the Work Group Report of the AAAAI Immunotherapy, Allergen Standardization and Allergy Diagnostics (IASAD) Committee it is not recommended to initiate immunotherapy:  “For patients with allergic rhinitis, immunotherapy should ideally not be initiated during the COVID-19 pandemic, unless there are unusual circumstances, such as a patient with unavoidable exposure to a trigger that has resulted in anaphylaxis or asthma-related hospitalization, where no other alternative is feasible for the short-to-intermediate term.”

Intradermal testing is considered low risk. Skin testing is on hold. If all other recommendations are in place, is it still advised not to perform intradermal testing, and to not initiate immunotherapy?

Answer: Last week the AAAAI COVID 19 Task Force issued a message on resuming practice that included information on a variety of procedures considered low, medium, and high risk. You are correct that they have classified skin testing as low risk, although initiating immunotherapy at this time of year could increase the likelihood of a reaction. You can view the entire section on resuming practice here:  https://education.aaaai.org/resources-for-a-i-clinicians/prepare-your-practice_covid-19


Question: I am with an asthma and allergy practice in Minnetonka, Minnesota and have a patient that is a nurse in an assisted care facility. She is working with COVID19 positive patients daily. This patient, currently asymptomatic, receives SCIT and is at maintenance, receiving injections through her primary care clinic every 3 weeks. Is there a contraindication/recommendation regarding receiving allergy injections for this patient (outside of the potential risk to other patients, which is another consideration)?

Answer: There is no medical evidence for a contraindication of SCIT in someone with COVID-19, other than the risk of passing COVID-19 on to others (health care staff, other patients, caregivers, etc.).


Question: Has anyone proposed how we might safely go about resuming allergy shots? There is quite a bit of pressure from patients to resume soon.  We have not administered allergy shots since March 28th.

Answer: We have answered a number of questions related to immunotherapy that can be seen on this page. This is also covered in the workgroup report on allergy practice during the pandemic. Your practice has to have the capability to screen patients before entry into the office, establish requirements for masking patients, have the ability for physical separation in the waiting room and have adequate PPE for your staff. You must also enforce cleaning of the waiting area on a regular basis during the day. If your practice is able to do all these things, they you can make the decision to restart immunotherapy shots.


Question: It’s really hard to ensure the safety of our patients and staff without adequate PPE. I can’t even get N95 masks for my staff, and given a significant percentage of patients are asymptomatic is it safe to continue to administer IT?

Answer: We encourage everyone to read carefully and thoroughly both the AAAAI Immunotherapy workgroup report and the article on COVID-19 Pandemic Contingency Planning for the A/I clinic, which was published in JACI In Practice. While options for providing immunotherapy are discussed, the AAAAI is not recommending whether or not immunotherapy should be continued. Each individual practitioner should make their own decision on providing immunotherapy based on the physical structure of their practice (to allow for physical distancing) the availability of PPE (surgical masks should be sufficient for staff administering shots, and perhaps goggles in some situations), the level of SARS-CoV2 transmission in their community, and the ability to screen patients before having them come into the practice. Every practice needs to continuously evaluate their own situation, and practice decisions may need to change under certain circumstances.


Question: With the epidemic of COVID-19, I am concerned about the potential exposure to my patients who are in a waiting room for 30 minutes after an allergy injection. I understand the rationale for a 30 minute observation, but should we reduce the waiting time to 15 minutes if we prescribe an EpiPen for the patient and the patient agrees to leave earlier?

Answer: Social distancing is an essential public health measure to slow the spread of COVID-19 and flatten the curve. Consideration should be given to delaying elective healthcare system interactions whenever possible. Those essential healthcare activities that are performed should still be done in the safest manner possible. It is NOT recommended to reduce the waiting time to 15 minutes after subcutaneous immunotherapy.

The better approach is to limit the number of IT patients you have and the times when they are getting shots (consider off hours, and other ways to lessen the number of patients in the waiting room at any one time). There is also a thought that it would make sense to stretch out the interval of IT to also limit the number of patients coming for IT. 


Question: Given concerns about infectious disease during the current COVID-19 outbreak, there has been discussion in some quarters about changing allergy immunotherapy protocols using glycerinated/aqueous extracts to a standard maintenance interval of six weeks or more. The discussion stems from proposed efforts to reduce patient visits to physician offices to reduce potential waiting room exposures among patients.

Would we expect a recommended interval of six weeks to be both safe and effective for most patients? Are there thoughts about waiting room transmissibility of common respiratory pathogens incorporated in the existing guidelines?

Answer: Please refer to the current CDC guidelines on COVID-19 mitigation in healthcare settings for the most up to date information. 

One will still need to consider the overall risks and benefits of administering immunotherapy on an individual basis for each patient. 

Given the current concerns about COVID-19, recommendations to practice social distancing, and the need to minimize elective encounters, this is a very valid question and the resulting actions may help mitigate risks of infectious disease transmission in this pandemic. The current practice parameters do say that maintenance IT can be given every 2-6 weeks, customized to the patient. Thus, for most patients, (and again, it should be tailored to the patient) the frequency of subcutaneous aeroallergen immunotherapy during maintenance, can safely be extended temporarily to meet that time frame. Of course during build up phase, this may not be the same, as the safety of building up doses with longer intervals is not usually recommended. However, as with pregnant patients on build up, it may be okay to not increase IT dose but increase the interval (i.e., decrease the frequency) temporarily until they deliver or in this case, until the concern about infectious transmission abates.


Question: I’m an allergist in Texas and it’s unclear to us whether we can still see follow ups, new patients, or urgent patients. Also, I assume biologics and venom immunotherapy may be considered essential procedures, but what about environmental allergen immunotherapy? Is there an overall consensus to halt these or is it OK just to continue spacing out and limit waiting room (ie parking lot shots) exposure?

Answer: We cannot address state-specific rules, but encourage you to reach out to the Texas Medical Board regarding your concerns. Many allergists are converting all visits to virtual visits, whereas some are only seeing sick patients virtually.  If you do see patients in-person, make sure that everyone on the staff is aware of the risks, and that your policies for sick employees and return to work policies are consistent with recommendations from the CDC.  Virtual or telemedicine visits will reduce the risk for you and your staff, are now being paid by most major commercial carriers, and reimbursement from Medicare is generally the same as for in-person visits.  The rules for payment vary by state for Medicaid and by carrier for commercial insurance.  We will continue to post updates on these issues to the AAAAI COVID-19 Resource page on the AAAAI website.

We have heard from practices utilizing varying practices for immunotherapy. Many are continuing to provide venom, environmental and biologic therapy in the office, with adjustments in schedule, as noted in the Special Article: COVID-19: Pandemic Contingency Planning for the Allergy and Immunology Clinic. Most offices are screening patients before or at arrival for fever or symptoms, rearranging their waiting rooms to allow for appropriate social distancing, limiting the number of patients in the waiting room by techniques such as using empty exam rooms or having patients wait in their car before getting the shot, to be summoned when there is safe space in the waiting room for them before their shot.  


Question: I am nearly 69 years old and have contact with extensive volume with patients, administering 200+ injections per day. Please let me know what our staff should be doing to protect our patients and ourselves.

Answer: Any medical professional in the high-risk category, including advanced age, should take proactive precautions now to limit potential exposure to COVID-19, which is currently widespread in many communities. It appears that the majority of people infected with COVID-19 are either asymptomatic or have mild symptoms. As such, even a bare minimum screening of every patient who visits the office each day, which should be mandatory at this time, will miss potential exposures. Offices such as this need to consider safety not only for any staff, but for all patients as well. More than 200 injections a day makes it almost impossible to properly screen each patient and visitor, practice social distancing, and allow for proper cleaning/disinfecting of the registration and waiting areas as well as exam rooms. This is a prime example of why changes need to be implemented now, including telehealth for nonessential office visits to decompress the resources needed for seeing regular patients. The AAAAI also has recommendations regarding patients receiving immunotherapy to consider holding/spacing the current dosing, scheduling office visits, or instituting new rules surrounding wait times/areas after each injection.

Some practices may allow older employees to stay home assuming they have adequate staff to cover the practice. The office should have policies in place for leave for employees during this pandemic.  Changes in waiting room space need to be made, proper precautions and PPE are vital for the safety of all. 

 

Some answers have been updated to reflect changing circumstances and information since the individuals submitting the questions were originally provided with a response. While we’re working on keeping answers updated as best we can, information continues to evolve rapidly. Please email us at practicematters@aaaai.org with concerns or additional questions.