What term best describes a patient experiencing anaphylaxis after being prescribed aspirin (acetylsalicylic acid) despite a known allergy, with both the prescriber and pharmacist bypassing allergy alerts?

Medication Error

This event is best described as a medication error (Option C) because both the prescriber and pharmacist bypassed documented allergy alerts, resulting in the administration of a contraindicated medication that caused patient harm. 1

Why This is a Medication Error

This scenario involves multiple system failures in the medication use process:

• The prescriber ignored a documented aspirin allergy when writing the prescription 2
• The pharmacist bypassed the allergy alert during dispensing verification 2
• Both providers failed to act on available safety information that should have prevented drug administration 1

The FDA drug label explicitly warns that "aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), shock" 2. This documented allergy should have been an absolute contraindication to prescribing.

Why the Other Options Don't Apply

Not a Near Miss (Option A):

• A near miss occurs when an error is caught before reaching the patient 1
• In this case, the patient actually received the drug and experienced harm 1
• The anaphylaxis represents actual patient injury, not a prevented event 1

Not Simply an Adverse Drug Reaction (Option B):

• While anaphylaxis is technically an adverse drug reaction (defined by WHO/FDA/EMA as noxious, unintended responses at normal doses), this classification alone misses the critical element 1
• The key distinguishing factor is that this ADR was entirely preventable through proper attention to documented allergies 1, 2
• The anaphylaxis occurred in the context of a known contraindication that was actively bypassed 1

Not a Side Effect (Option D):

• Side effects are expected, known pharmacological consequences of medication use 1
• Anaphylaxis in a patient with documented aspirin allergy is a preventable adverse event, not an anticipated side effect 1

Clinical Context of Aspirin Anaphylaxis

The patient experienced true anaphylaxis, defined as "a severe, life-threatening, generalized or systemic hypersensitivity reaction" 1. Aspirin can cause:

• IgE-mediated allergic anaphylaxis (true immunologic hypersensitivity) 1
• Non-allergic anaphylaxis (anaphylactoid reactions via COX-1 inhibition) 1, 3
• Both presentations are clinically indistinguishable and life-threatening 1

Aspirin hypersensitivity affects up to 9% of the general population and manifests as urticaria-angioedema, bronchospasm, severe rhinitis, or shock within hours of ingestion 4, 5.

Critical Safety Implications

This represents a sentinel event requiring:

• Root cause analysis of why two independent safety checks failed 1
• System review of alert fatigue and override practices 1
• Provider education on the importance of allergy documentation 1, 2
• Patient counseling on absolute avoidance of aspirin and cross-reactive NSAIDs 1, 4

The patient should be referred to an allergist/immunologist for formal evaluation and documentation of the allergy profile 1.