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Are you really allergic to PCN?? Interesting test for PCP's. Easy in office.


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POEMs Research Summaries
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Amoxicillin oral challenge is safe and accessible for removing erroneous penicillin allergy label

Clinical Question

 

Is an amoxicillin oral provocation challenge safe and accessible for distinguishing an erroneous penicillin allergy label from a true one in adults and children?

Bottom Line

 

This study reports the outcome of an amoxicillin oral provocation challenge (OPC) in 99 adults and children who were initially labeled as having a penicillin allergy and were subsequently identified by their history to be at low risk of a true allergy. A total of 96 patients (97%) completed the OPC with no reaction, resulting in removal of the erroneous allergy label. The 3 reactions were all mild and required minimal intervention (no epinephrine). Having primary care clinicians use this method to identify the millions of adults and children who are incorrectly labeled as having a penicillin allergy may result in significant health care savings from the use of less effective, more expensive, and/or less safe alternative antibiotics. 

(LOE = 2b)

Reference

 

Gateman DP, Rumble JE, Protudjer JLP, Kim H. Amoxicillin oral provocation challenge in a primary care clinic: A descriptive analysis. CMAJ Open 2021;9(2):E394-E399.

Study Design: Cohort (retrospective)

Funding: Self-funded or unfunded

Setting: Outpatient (any)

Allocation: Unknown

Synopsis

 

Although approximately 10% of adults and children are labeled as having an allergy to penicillin, less than 20% of those are truly allergic. Referring the millions of adults labeled as allergic to penicillin for testing is not practical. However, an easy rule is available that can identify adults* at low risk of a true allergy. These investigators, using similar criteria as those in the decision tool, identified 99 adults and children, 18 months or older, considered at low risk (< 5%) of having a true penicillin allergy. Clinical settings were equipped with oral diphenhydramine elixir to manage mild reactions and epinephrine to manage anaphylactic reactions. Amoxicillin was given as an oral suspension (250 mg/5 mL) with the first 10% of the challenge dose (50 mg or 4.5 mg/kg if the patient weighed < 10 kg) and the patients were observed for 20 minutes. If there was no reaction, patients received the remaining 90% of the remaining calculated dose (450 mg or 40.5 mg/kg) and were observed for an additional hour. A positive reaction was the development of objective findings, including urticaria, wheezing, or swelling, and did not include subjective symptoms such as pruritus without skin changes or dizziness. Patients were also instructed to report any delayed symptoms of rash, hives, wheezing, or swelling up to a week later. 

Of the 99 eligible patients who completed the protocol, a mild reaction occurred in 3 patients (3%) and required the administration of oral diphenhydramine only. The remaining 96 patients (97%) had the penicillin allergy label removed from their medical record. No delayed reactions were reported.

*Note: Although the adult version is reliably accurate, the same is not true when using the same decision rule for children 12 years or younger. 

David C. Slawson, MD
Professor and Chair of Family Medicine Atrium Health

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Ummm, no thank you.

A skin test suits me just fine.

I could not imagine having a patient sitting in a primary care office and saying "here, swallow this".

Most primary care offices are not remotely prepared to handle an anaphylactic reaction.

What's next - PayDay candy bars to test peanut allergies?

Local allergist had an almond, a SINGLE almond rubbed on the forearm of a kiddo to see if allergy had abated. 

@ventana What are your thoughts or just leaving this here for comment?

P.S. personal hx of severe allergic reactions and no desire to repeat or randomly test in a random place...........................

Edited by Reality Check 2
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I posted for discussion. 
 

I would want to know exactly what inclusion criteria were. 
I keep hearing it over and over (pcn allergy).  It defaults us to using big gun ABX when simple pcn would work so if it is data driven and accepted why not?

 

question to the EM folks.  Does Benadryl, epi and steroids control allergic rxn that spiral down?  
 

 

the inclusion criteria is where rubber meets the road.  Larger better powered study might be in order. 
 

discussion

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11 hours ago, Reality Check 2 said:

P.S. personal hx of severe allergic reactions and no desire to repeat or randomly test in a random place...........................

I too find it difficult to not let my own personal experiences and health history affect my medical practices. But I try so as to not short pts who are not me.

PCPs are not a random place. The article is suggesting PCPs can help with this mislabeled allergy issue, not start taking over the work of allergists or test severe cases.

I think trying to safely correct erroneous allergies is a worthwhile endeavor. 

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This is relatively new in the EM literature:

https://www.mdcalc.com/calc/10422/penicillin-allergy-decision-rule-pen-fast

My personal practice is to use 2nd and later generations of cephalosporins in folks who report anything other than anaphylaxis and to use IV meds like zosyn in the ER setting for folks who report a very mild allergy or don't remember what it was as a child. I will grant you that this is in an ER setting where I am fully able to control their airway and give anaphylaxis tx as needed. Same deal for "Iodine allergy" for IV contrast. 

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7 hours ago, SedRate said:

I think trying to safely correct erroneous allergies is a worthwhile endeavor. 

I agree particularly in people who list everything as an allergy. I've had too many patients over the years that list something in every category of antibiotic as an allergy. When I drill down its "it gave me diarrhea" or "it upset my stomach." I tell them.... we have to sort this out. One day you may need one of these to save your life and your provider is going to hesitate.

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I can't see this being appropriate in an outpatient Primary Care.

Observing a patient for 1.5 hours is not feasible. Even 20 min after a vaccine is pushing it - space, personnel, etc 

Many clinics do not have RNs, only MAs who cannot be responsible for an undertaking of this magnitude.

Yes, we need to rule out undue allergy notations.

NO, it is not feasible in the majority of Primary Care settings.

I have sent numerous people to Allergy/Immunology for copious testing of listed allergies to just about every abx there is.

They have the set up, the equipment, the staff and the training.

Primary Care is the dumping ground for everything under the sun. More responsibilities is not the answer.

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22 hours ago, Reality Check 2 said:

I can't see this being appropriate in an outpatient Primary Care.

Observing a patient for 1.5 hours is not feasible. Even 20 min after a vaccine is pushing it - space, personnel, etc 

Many clinics do not have RNs, only MAs who cannot be responsible for an undertaking of this magnitude.

Yes, we need to rule out undue allergy notations.

NO, it is not feasible in the majority of Primary Care settings.

I have sent numerous people to Allergy/Immunology for copious testing of listed allergies to just about every abx there is.

They have the set up, the equipment, the staff and the training.

Primary Care is the dumping ground for everything under the sun. More responsibilities is not the answer.

with 23 years in mostly primary care but also through ER and a few other specialities I gotta disagree.....

 

We have one allergist for 130,000

he works part time

 

If this is verified and supported with the literature it is absolutely reasonable to have this done in a PCP office.  

all it takes is EPI, Steroid, Benadryl and time.... none of which is beyond the scope of a PCP

Time -  that is a creature of the employers trying to squeeze every last darn dime out of pcp clinics.  I think it would be easy enough to bill a level 5 visit, perform the test (with the appropriate screening and informed signed consent from the patient)   Worst case - epi, repeat epi and wait for ambulance to show up.  

 

The point is appropriate screening BEFORE - far to many people are labeled allergic "cause my mommy told me" or some other reason.  A lot of these are not even IgE issue - i.e. the upset tummy augmentin does NOT mean you are PCN allergic!!

 

IF it was proven and with a good screening protocol I would have no problems doing this in a PCP office setting as long as I had a clear treatment algorithm and all appropriate supplies.  (heck I have run codes with a heck of a lot less training, supplies and support)

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2 hours ago, CAAdmission said:

If you want to start messing with epi, that's getting over a FP office's head. Patient should be on a monitor. 

Eh, epi and call for ALS transport is--or should be--within the scope of a PCP office. I keep a vial of epi in my occ med clinic just in case, and I don't ever do anything intentionally that might cause an anaphylactic reaction. This isn't just EMT-trained me talking--I've heard of epi used in one of my prior clinics. The family med doc gave 0.5 ml 1:1000 to an adult for an anaphylactic reaction, which is on the high side, but got the job done. That office, like mine, was less than 1/2 a mile from a fire station staffed with paramedics, and yet having epi around "just in case" seemed like a good idea then and now.

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In the ED, I have no problems asking a patient what their "allergy s/s" are/were.  If it was something of the order of "my mom told me I got a rash when they gave me PCN" I'm willing to try 1 dose and observe.

In the ED, I can manage anaphylaxis, even the cases where epi, benadryl, fluids, steroids, and an IV H2 blocker don't get it.

More importantly, the patient can be put on telemetry for continuous monitoring of pulse, O2 sat, etc. that can be watched from the desk.  No PCP's office, or UC can do that.  They don't even have the staff to do Q5min checks on the patient.

So, I'm with Reality Check on this.  The Rev is right, keeping epi around to respond to an unexpected anaphylactic reaction is wise.  Testing for it in the PCP or UC setting is not wise.

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It is not practical to test millions of people [in an allergist's office] for these essentially erroneous allergies. As is continuing to modify treatment plans for said listed erroneous allergies. 

And as it also states, they are testing people with a low risk (less than 5% chance) of a true allergy based on a set of guidelines. Not high risk individuals. 

 

-Just thoughts from someone who encounters pts with "allergies" to commonly used drugs and has had to figure out fourth- and fifth-line oral drugs for bacterial infections. 

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3 hours ago, thinkertdm said:

No ones mentioned the wrath of the practice manager and other bean counters.  While this person is taking up an exam room, that’s an exam room not being used, people having to wait, upset patients, metrics flying right out the window…

Someone’s gonna get a stern talking to if you keep on doing medical stuff.  

Haha, no kidding. But yes, that would be inefficient and a waste of resources. I would expect these pts would be in the waiting room for the 1.5 hours, not alone in an exam room. 

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On 10/18/2023 at 1:34 PM, EMEDPA said:

This is relatively new in the EM literature:

https://www.mdcalc.com/calc/10422/penicillin-allergy-decision-rule-pen-fast

My personal practice is to use 2nd and later generations of cephalosporins in folks who report anything other than anaphylaxis and to use IV meds like zosyn in the ER setting for folks who report a very mild allergy or don't remember what it was as a child. I will grant you that this is in an ER setting where I am fully able to control their airway and give anaphylaxis tx as needed. Same deal for "Iodine allergy" for IV contrast. 

We deal with iodine allergies all the time for heart caths, etc. Starting the day before with prednisone and diphenhydramine seems to do the trick.

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On 10/19/2023 at 10:53 PM, CAAdmission said:

If you want to start messing with epi, that's getting over a FP office's head. Patient should be on a monitor. 

UGH - did you read the initial post - these are very low possible true allergies - out of 100 people NONE had anaphylaxis.  

On 10/20/2023 at 9:15 AM, SedRate said:

It is not practical to test millions of people [in an allergist's office] for these essentially erroneous allergies. As is continuing to modify treatment plans for said listed erroneous allergies. 

And as it also states, they are testing people with a low risk (less than 5% chance) of a true allergy based on a set of guidelines. Not high risk individuals. 

 

-Just thoughts from someone who encounters pts with "allergies" to commonly used drugs and has had to figure out fourth- and fifth-line oral drugs for bacterial infections. 

BINGO

8 hours ago, thinkertdm said:

No ones mentioned the wrath of the practice manager and other bean counters.  While this person is taking up an exam room, that’s an exam room not being used, people having to wait, upset patients, metrics flying right out the window…

Someone’s gonna get a stern talking to if you keep on doing medical stuff.  

Yup - that is likely where this would be push back 

 

 

The big picture issue

These false allergies create big problems with choosing an ABX
there is likely 10% of people labeled as allergic (that is 33 MILLION people) in this county
There is not the capacity in allegist to treat 33 MILLION people - no way no how

Only those with LOW likelihood of having true allergy get tested (the devil is in this one step - you need the pretest probability of being allergic as low as possible)

 

This is totally reasonable and possible in the PCP realm - IF it pans out in the literature.

EPI is absolutely in the realm of a PCP - I find is slightly professionally insulting to hear a fellow PA state that it is not.  Lets not get on the "everyone needs a specialist" bandwagon.

 

 

It is great to see people debate this.  It is a great exercise is looking at the global problem, developing a reasonable, reliabel, reproducible, scientifically verified method - then rolling it out and doing it.  Hats off to those that can look at this as a population based problem and offer a population based solution.

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6 hours ago, ventana said:

UGH - did you read the initial post - these are very low possible true allergies - out of 100 people NONE had anaphylaxis.  

Great. Let me know how it works out for the one who eventually does. You'll be what legal types refer to as the "test case."

Epi in a primary care office belongs in a code box to help with unanticipated emergencies. That's very different from doing stuff that could iatrogenicly provoke a reaction. 

 

On 10/20/2023 at 1:50 AM, rev ronin said:

I don't ever do anything intentionally that might cause an anaphylactic reaction.

Yep, that's the key

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