Kan Andy Ka Chun, Chiang Valerie, Saha Chinmoy, Au Elaine Y L, Li Philip Hei
Division of Rheumatology and Clinical Immunology, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, Hong Kong SAR, China.
Division of Clinical Immunology, Department of Pathology, Queen Mary Hospital, Hong Kong, Hong Kong SAR, China.
Front Allergy. 2024 Jan 16;4:1331036. doi: 10.3389/falgy.2023.1331036. eCollection 2023.
Excipient allergy is a rare, but potentially lethal, form of drug allergy. Diagnosing excipient allergy remains difficult in regions without mandatory drug ingredient disclosure and is a significant barrier to drug safety.
To investigate the feasibility of a drug allergy registry-based excipient database to identify potential excipient culprits in patients with history of drug allergy, using polyethylene glycol (PEG) as an example.
An excipient registry was created by compiling the excipient lists pertaining to all available formulations of the top 50 most reported drug allergy culprits in Hong Kong. Availability of excipient information, and its relationship with total number of formulations of individual drugs were analysed. All formulations were checked for the presence or absence of PEG.
Complete excipient information was available for 36.5% (729/2,000) of all formulations of the top 50 reported drug allergy culprits in Hong Kong. The number of formulations for each drug was associated with proportion of available excipient information ( = 0.466, = 0.001). Out of 729 formulations, 109 (15.0%) and 620 (85.0%) were confirmed to contain and not contain PEG, respectively. Excipient information was not available for the other 1,271 (63.6%) formulations. We were unable to confirm the presence or absence of PEG in any of the top 50 drug allergy culprits in Hong Kong.
In countries without mandatory drug ingredient disclosure, excipient databases are unlikely able to identify potential excipient allergy in drug allergy patients. Legislations to enforce mandatory and universal ingredient disclosure are urgently needed.
辅料过敏是药物过敏中一种罕见但可能致命的形式。在没有强制披露药物成分的地区，诊断辅料过敏仍然困难，这是药物安全的一个重大障碍。
以聚乙二醇（PEG）为例，研究基于药物过敏登记处的辅料数据库在有药物过敏史患者中识别潜在辅料罪魁祸首的可行性。
通过汇编与香港报告最多的50种药物过敏罪魁祸首的所有可用制剂相关的辅料清单，创建了一个辅料登记处。分析了辅料信息的可用性及其与个别药物制剂总数的关系。检查所有制剂中是否存在PEG。
香港报告最多的50种药物过敏罪魁祸首的所有制剂中，36.5%（729/2000）有完整的辅料信息。每种药物的制剂数量与可用辅料信息的比例相关（r = 0.466，P = 0.001）。在729种制剂中，分别有109种（15.0%）和620种（85.0%）被确认含有和不含有PEG。其他1271种（63.6%）制剂没有辅料信息。我们无法确认香港50种药物过敏罪魁祸首中任何一种是否存在PEG。
在没有强制披露药物成分的国家，辅料数据库不太可能识别药物过敏患者中的潜在辅料过敏。迫切需要实施强制和全面成分披露的立法。
