Advance your institution’s AMS goals by implementing penicillin allergy skin testing with PRE-PEN^®

PRE-PEN^® (benzylpenicilloyl polylysine injection USP) is the only FDA-approved skin test antigen reagent for the diagnosis of penicillin allergy.^1,2

Penicillin allergy skin testing may be a way to reduce use of broad-spectrum antibiotics and could have a significant and immediate impact on antibiotic usage³

The National Quality Partners’ Antibiotic Stewardship Action Team recommends penicillin allergy skin testing as a component of a comprehensive antibiotic stewardship program⁴

Penicillin allergy skin testing frequently allows for administration of less expensive agents that would have been avoided due to a reported allergy^3,5

Performing penicillin allergy skin testing as soon as possible after admission allows clinicians more time to select the best antibiotic therapy and can reduce the time to first antibiotic dose.⁶

Testing supplies

Gather the testing supplies that you will need to perform one penicillin allergy skin test.

Testing steps overview

Perform penicillin allergy skin testing with PRE-PEN^® by following these 3 steps.

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IF PRICK/PUNCTURE TEST IS NEGATIVE...

IF INTRADERMAL TESTING IN STEP 2 IS NEGATIVE...

References: 1. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. Accessed October 3, 2021. 2. PRE-PEN. Prescribing information. ALK-Abelló, Inc.; 2013. 3. Heil EL, Bork JT, Schmalzle SA, et al. Implementation of an infectious disease fellow-managed penicillin allergy skin testing service. Open Forum Infect Dis. 2016;3(3):ofw155. doi:10.1093/ofid/ofw155 4. National Quality Forum. National Quality Partners Playbook: Antibiotic Stewardship in Acute Care. Published May 2016. Accessed July 13, 2021. www.qualityforum.org 5. King EA, Challa S, Curtin P, Bielory L. Penicillin skin testing in hospitalized patients with β-lactam allergies: effect on antibiotic selection and cost. Ann Allergy Asthma Immunol. 2016;117(1):67-71. doi:10.1016/j.anai.2016.04.021 6. Conway EL, Lin K, Sellick JA, et al. Impact of penicillin allergy on time to first dose of antimicrobial therapy and clinical outcomes. Clin Ther. 2017;39(11):2276-2283. doi:10.1016/j.clinthera.2017.09.012 7. Chen JR, Tarver SA, Alvarez KS, Tran T, Khan DA. A proactive approach to penicillin allergy testing in hospitalized patients. J Allergy Clin Immunol Pract. 2017;5(3):686-693. doi:10.1016/j.jaip.2016.09.045

INDICATION

PRE-PEN is indicated for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity. A negative skin test to PRE-PEN is associated with an incidence of immediate allergic reactions of less than 5% after the administration of therapeutic penicillin, whereas the incidence may be more than 50% in a history-positive patient with a positive skin test to PRE-PEN. These allergic reactions are predominantly dermatologic. Whether a negative skin test to PRE-PEN predicts a lower risk of anaphylaxis is not established. Similarly, when deciding the risk of proposed penicillin treatment, there are not enough data at present to permit relative weighing in individual cases of a history of clinical penicillin hypersensitivity as compared to positive skin tests to PRE-PEN and/or minor penicillin determinants.

IMPORTANT SAFETY INFORMATION

The risk of sensitization to repeated skin testing with PRE-PEN is not established. Rarely, a systemic allergic reaction including anaphylaxis (see below) may follow a skin test with PRE-PEN. To decrease the risk of a systemic allergic reaction, puncture skin testing should be performed first. Intradermal skin testing should be performed only if the puncture test is entirely negative.

PRE-PEN is contraindicated in those patients who have exhibited either a systemic or marked local reaction to its previous administration. Patients known to be extremely hypersensitive to penicillin should not be skin tested.

No reagent, test, or combination of tests will completely assure that a reaction to penicillin therapy will not occur. The value of the PRE-PEN skin test alone as a means of assessing the risk of administering therapeutic penicillin (when penicillin is the preferred drug of choice) in the following situations is not established:

• Adult patients who give no history of clinical penicillin hypersensitivity.
• Pediatric patients.

In addition, the clinical value of PRE-PEN where exposure to penicillin is suspected as a cause of a current drug reaction or in patients who are undergoing routine allergy evaluation is not known. Likewise, the clinical value of PRE-PEN skin tests alone in determining the risk of administering semisynthetic penicillins (phenoxymethylpenicillin, ampicillin, carbenicillin, dicloxacillin, methicillin, nafcillin, oxacillin, amoxicillin), cephalosporin-derived antibiotics, and penem antibiotics is not known.

In addition to the results of the PRE-PEN skin test, the decision to administer or not administer penicillin should take into account individual patient factors. Healthcare professionals should keep in mind the following:

• A serious allergic reaction to therapeutic penicillin may occur in a patient with a negative skin test to PRE-PEN.
• It is possible for a patient to have an anaphylactic reaction to therapeutic penicillin in the presence of a negative PRE-PEN skin test and a negative history of clinical penicillin hypersensitivity.
• If penicillin is the drug of choice for a life-threatening infection, successful desensitization with therapeutic penicillin may be possible irrespective of a positive skin test and/or a positive history of clinical penicillin hypersensitivity.

Occasionally, patients may develop an intense local inflammatory response at the skin test site. Rarely, patients will develop a systemic allergic reaction, manifested by generalized erythema, pruritus, angioedema, urticaria, dyspnea, hypotension, and anaphylaxis. The usual methods of treating a skin test antigen-induced reaction—the applications of a venous occlusion tourniquet proximal to the skin test site and administration of epinephrine—are recommended. The patient should be kept under observation for several hours.

Pregnancy Category C: Animal reproduction studies have not been conducted with PRE-PEN. It is not known whether PRE-PEN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The hazards of skin testing in such patients should be weighed against the hazard of penicillin therapy without skin testing.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information for additional Important Safety Information.