Expert consensus on physician–pharmacist co-management model and standardized application of anti-IgE monoclonal antibody therapy for allergic asthma

This consensus establishes a physician‑pharmacist co‑management model to standardize omalizumab use for allergic asthma. Using GRADE evidence grading and the Delphi method (agreement >80% on 12 recommendations), it provides frameworks for joint and pharmacist‑led clinics, clinical pathways (dosing, 60‑min observation, quarterly follow‑up), hierarchical referral, and pharmacist training. The model aims to improve adherence, asthma control, and cost‑effectiveness.

Introduction
Allergic asthma affects ~45.7 million adults in China. Omalizumab (anti‑IgE) reduces exacerbations and improves lung function but faces inappropriate use, dosing errors, and poor pharmacist involvement. This consensus promotes physician‑pharmacist co‑management to optimize therapy.

Consensus Formulation
A multidisciplinary panel (48 experts) used systematic literature review, GRADE evidence grading (I–IV for quality; A–C for recommendation strength), and two‑round Delphi. Consensus defined as >80% agreement. Twelve recommendations were finalized.

Co-management Workflows

• Joint clinic: Physician diagnoses/prescribes; pharmacist reviews, educates, monitors adverse events.

• Pharmacist‑led clinic: For stable patients (≥4 months), pharmacists manage follow‑up (ACT, pulmonary function every 3 months) with protocol‑based refills. Refer back to physician if exacerbation occurs.

Key Recommendations (12 items)

1. Co‑management improves adherence, asthma control, and quality of life (II, B).

2. Use cautiously if total IgE <30 or >1,500 U/mL, or weight <20 or >150 kg. Evaluate indications, dose (75–600 mg q2–4w based on weight/IgE), control, and biomarkers (II, A/B).

3. Observe 60 min after first three injections (II, A). Pharmacists provide pre‑injection guidance (II, B).

4. Evaluate every 3 months; responders treat ≥12 months. Dose reduction possible if well‑controlled on medium‑dose ICS+LABA (≥6 months between adjustments) (II, A/B). Pharmacists monitor drug interactions (III, C).

5. Pharmacists provide family education (disease, vaccination – 2‑week interval with routine vaccines, lifestyle) (II, B).

6. Hierarchical referral: primary → higher‑level for diagnosis; stable patients referred back; two‑way referral as needed (III, C).

7. Pharmacists must complete training and pass assessments before co‑management (III, C).

Clinical Pathway

• Dosing: Age ≥6 years, weight 20–150 kg, IgE 30–1,500 U/mL. Dose 75–600 mg q2–4w.

• Injection: Subcutaneous (deltoid, thigh, abdomen). Lyophilized powder reconstituted in 15–20 min; pre‑filled syringes used within 4 h.

• Observation: 60 min after first three injections for anaphylaxis (~0.2%). Mild reactions (headache, redness) symptomatic; severe (shock, laryngeal edema) emergency transfer.

• Follow‑up: ACT, MMAS‑8, AQLQ, pulmonary function every 3 months. Responders continue ≥12 months. Dose reduction possible with stable control on medium‑dose ICS+LABA (≥6 months between adjustments).

Special Populations

• Pediatric (≥6y): Similar safety; monitor closely.

• Elderly: Monitor comorbidities; assess bleeding/infection risks with anticoagulants/immunosuppressants.

• Pregnancy/lactation: No significant increased risk; mid‑pregnancy preferred; monitor infant if breastfeeding.

Benefits and Prospects

• Benefits: Optimizes treatment, reduces exacerbations, lowers rehospitalization, improves quality of life. Cost‑effective (ICER below GDP per capita threshold).

• Prospects: AI‑driven decision support, pharmacogenomics, integration with payment reforms.

Limitations
Based on expert opinion (Delphi) and low‑to‑moderate evidence for some recommendations. Requires multicenter prospective validation.

Conclusions
This consensus standardizes physician‑pharmacist co‑management of omalizumab for allergic asthma, covering screening, treatment, monitoring, follow‑up, and referral. It clarifies roles and collaboration pathways to rationalize drug use, improve outcomes, and optimize resource allocation. Recommendations should be adapted locally and refined with emerging evidence.

Full text

https://www.xiahepublishing.com/2572-5505/JERP-2025-00062

The study was recently published in the Journal of Exploratory Research in Pharmacology.

Journal of Exploratory Research in Pharmacology (JERP) publishes original innovative exploratory research articles, state-of-the-art reviews, editorials, short communications that focus on novel findings and the most recent advances in basic and clinical pharmacology, covering topics from drug research, drug development, clinical trials and application.

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