Warnier Miriam J, Holtkamp Frank A, Rutten Frans H, Hoes Arno W, de Boer Anthonius, Mol Peter G M, De Bruin Marie L
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands Department of Clinical Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
Int J Risk Saf Med. 2014;26(2):89-98. doi: 10.3233/JRS-140612.
Information regarding QT-prolongation in the drug label may vary between products. This could lead to suboptimal risk minimization strategies.
To systematically assess the variation in the extent and content of information on QT prolongation in the summary of product characteristics (SPC) of recently approved medicinal products.
Drug labels of products centrally approved in Europe between 2006 and 2012 were screened. Of drugs including the term 'QT' in the SPC, the message on QT-prolongation ('no prolongation'/'unclear drug-QT association'/'possibly QT-prolongation'/'QT-prolongation') and the advice on cautionary measures pertaining to QT-prolongation in the label were examined, as well as their association.
Of the 175 screened products, 44 contained information on QT in the SPC ('no QT-prolongation': 23%, 'unclear drug-QT association': 43%, 'possibly QT-prolongation': 16%, 'QT-prolongation': 18%). 62% contained advices to act with caution in patients with additional risk factors for QT-prolongation. Products that more likely to have QT-prolonging properties according to the SPC provided more information on QT-prolongation in the SPC ('no prolongation': 10% and for the category 'QT-prolongation': 100%).
The extent and content of information on QT-prolongation varies considerably between SPCs, and in almost half of the drugs a clear message on QT-prolongation was lacking in the SPC.
药品标签中关于QT间期延长的信息在不同产品间可能存在差异。这可能导致风险最小化策略不够理想。
系统评估近期获批药品的产品特性摘要（SPC）中QT间期延长信息的范围和内容的差异。
筛选2006年至2012年在欧洲集中获批产品的药品标签。对于SPC中包含“QT”一词的药品，检查其关于QT间期延长的表述（“无延长”/“药物与QT关联不明”/“可能QT间期延长”/“QT间期延长”）以及标签中关于QT间期延长相关警示措施的建议，及其关联性。
在筛选的175种产品中，44种在SPC中包含QT相关信息（“无QT间期延长”：23%，“药物与QT关联不明”：43%，“可能QT间期延长”：16%，“QT间期延长”：18%）。62%包含对有QT间期延长额外风险因素患者需谨慎行事的建议。根据SPC更可能具有QT间期延长特性的产品在SPC中提供了更多关于QT间期延长的信息（“无延长”：10%，“QT间期延长”类别：100%）。
SPC中QT间期延长信息的范围和内容差异很大，且在近半数药品的SPC中缺乏关于QT间期延长的明确表述。
