BACKGROUND The safety of paediatric medications is paramount and contraindications provide clear pragmatic advice. Further advice may be accessed through Summaries of Product Characteristics (SPCs) and relevant national guidelines. The SPC can be considered the ultimate independent guideline and is regularly updated. In 2008, the authors undertook a systematic review of the SPC contraindications of medications licensed in the United Kingdom (UK) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). At that time, there were fewer contraindications reported in the SPC for atomoxetine than methylphenidate and the specific contraindications varied considerably amongst methylphenidate formulations. In 2009, the European Medicines Agency (EMA) mandated harmonisation of methylphenidate SPCs. Between September and November 2011, there were three changes to the atomoxetine SPC that resulted in revised prescribing information. In addition, Clinical Guidance has also been produced by the National Institute for Health and Clinical Excellence (NICE) (2008), the Scottish Intercollegiate Guidelines Network (SIGN) (2009) and the British National Formulary for Children (BNFC). METHODS An updated systematic review of the Contraindications sections of the SPCs of all medications currently licensed for treatment of ADHD in the UK was undertaken and independent statements regarding contraindications and relevant warnings and precautions were then compared with UK national guidance with the aim of assessing any disparity and potential areas of confusion for prescribers. RESULTS As of November 2011, there were seven medications available in the UK for the treatment of ADHD. There are 15 contraindications for most formulations of methylphenidate, 14 for dexamfetamine and 5 for atomoxetine. Significant differences exist between the SPCs and national guidance part due to the ongoing reactive process of amending the former as new information becomes known. In addition, recommendations are made outside UK SPC licensed indications and a significant contraindication for methylphenidate (suicidal behaviours) is missing from both the NICE and SIGN guidelines. Particular disparity exists relating to monitoring for suicidal and psychiatric side effects. The BNFC has not yet been updated in line with the European Union (EU) Directive on methylphenidate; it does not include any contraindications for atomoxetine but describes contraindications for methylphenidate that are no longer in the SPC. CONCLUSION Clinicians seeking prescribing advice from critical independent sources of data, such as SPCs and national guidelines, may be confused by the disparity that exists. There are major differences between guidelines and SPCs and neither should be referred to in isolation. The SPC represents the most relevant source of safety data to aid prescribing of medications for ADHD as they present the most current safety data in line with increased exposure. National guidelines may need more regular updates.

中文翻译：

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对在英国获得许可的注意力缺陷多动障碍药物的产品特性摘要中包含的安全性信息的系统评价。安全处方建议与国家指导相比如何？

背景 儿科药物的安全性至关重要，禁忌症提供了明确的实用建议。可以通过产品特性摘要 (SPC) 和相关的国家指南获得进一步的建议。SPC 可被视为最终的独立指南，并会定期更新。2008 年，作者对在英国 (UK) 获得许可用于治疗注意力缺陷多动障碍 (ADHD) 的药物的 SPC 禁忌症进行了系统审查。当时，托莫西汀的 SPC 中报告的禁忌症比哌醋甲酯少，而且哌甲酯制剂之间的具体禁忌症差异很大。2009 年，欧洲药品管理局 (EMA) 要求统一哌醋甲酯 SPC。2011 年 9 月至 11 月期间，对托莫西汀 SPC 进行了三处更改，导致对处方信息进行了修订。此外，国家健康与临床卓越研究所 (NICE) (2008)、苏格兰校际指南网络 (SIGN) (2009) 和英国国家儿童处方集 (BNFC) 还制定了临床指南。方法 对目前在英国获得许可用于治疗 ADHD 的所有药物的 SPC 的禁忌症部分进行了更新的系统审查，然后将关于禁忌症和相关警告和预防措施的独立声明与英国国家指南进行比较，目的是评估任何差异以及处方者可能感到困惑的领域。结果 截至 2011 年 11 月，英国有七种药物可用于治疗多动症。大多数哌醋甲酯制剂有 15 种禁忌症，右旋苯丙胺有 14 种禁忌症，托莫西汀有 5 种禁忌症。SPC 和国家指导部分之间存在显着差异，这是因为随着新信息的出现，对前者进行修订的反应过程正在进行中。此外，在英国 SPC 许可的适应症之外提出了建议，并且 NICE 和 SIGN 指南中都缺少哌醋甲酯（自杀行为）的重要禁忌症。在监测自杀和精神病副作用方面存在特殊差异。BNFC 尚未根据欧盟 (EU) 哌甲酯指令进行更新；它不包括托莫西汀的任何禁忌症，但描述了不再在 SPC 中的哌醋甲酯的禁忌症。结论 从关键的独立数据来源（例如 SPC 和国家指南）寻求处方建议的临床医生可能会因存在的差异而感到困惑。指南和 SPC 之间存在重大差异，不应单独提及两者。SPC 代表了最相关的安全数据来源，以帮助为 ADHD 开具药物处方，因为它们提供了与暴露增加相一致的最新安全数据。国家指南可能需要更定期的更新。SPC 代表了最相关的安全数据来源，以帮助为 ADHD 开具药物处方，因为它们提供了与暴露增加相一致的最新安全数据。国家指南可能需要更定期的更新。SPC 代表了最相关的安全数据来源，以帮助为 ADHD 开具药物处方，因为它们提供了与暴露增加相一致的最新安全数据。国家指南可能需要更定期更新。