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Prospective Multiregional Evaluation of Protocol-Based Penicillin Allergy Delabeling in China: Real-World Outcomes
Philip H Li1, Feng Xu2, Weihong Shi3
1Division of Rheumatology and Clinical Immunology, Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, China; Department of Medicine, University of Hong Kong- Shenzhen Hospital, Shenzhen, China.
Background:
Penicillin allergy is frequently mislabeled, leading to the unnecessary use of second-line antibiotics and contributing to antimicrobial resistance. Preemptive penicillin skin tests (PST) remain mandatory in mainland China and is associated with high false-positive rates. In contrast, Hong Kong follows evidence-based, standardized allergy assessment protocols under the Hong Kong Drug Allergy Delabelling Initiative (HK-DADI).
Objective:
To evaluate longitudinal outcomes of protocol-based penicillin delabeling in real-world clinical practice across mainland China and Hong Kong.
Methods:
This prospective, multiregional study included 514 patients (206 from mainland China and 308 from Hong Kong) who underwent allergy evaluation between September 2023 and January 2025. All centers followed the HK-DADI protocol, including structured history-taking, skin testing, and drug provocation testing. Longitudinal outcomes included delabeling rates, penicillin reuse, and health-related quality of life.
Results:
The overall delabeling rate was 90.3%, with significantly higher rates among patients previously labeled owing to preemptive PSTs. Among this subgroup, 98.2% had negative skin tests and 99.4% had subsequent negative drug provocation testing. One-quarter of delabeled patients reused penicillin within 6 months (without allergic reactions), with fourfold higher rates in mainland China (45.5% vs 12.0%; P < .001). Sustained health-related quality of life improvements were observed at 12 months, particularly among those previously mislabeled by PSTs.
Conclusions:
This study demonstrates the effectiveness of HK-DADI in correcting widespread mislabeling in China and highlights the potential for implementing protocol-based delabeling initiatives across diverse regions. The high rate of mislabeling underscores the urgent need for reform of PST practices and supports global efforts to combat antimicrobial resistance with protocol-based delabeling initiatives.
