本次审查的目的是概述禁忌症、特别警告和黑框警告，旨在建立一个框架，为一类药物或疾病适应症创建处方安全清单。本研究涵盖生物疾病缓解抗风湿药物 (bDMARD) 和靶向合成 DMARD (tsDMARD)。我们确定了欧洲药品管理局 (EMA) 和美国食品和药物管理局 (FDA) 提供的禁忌症、黑框警告和特别警告。该研究包括批准用于治疗类风湿性关节炎 (RA)、银屑病关节炎 (PsA)、中轴型脊柱关节炎 (SpA) 和幼年特发性关节炎 (JIA) 的药物类别中的抗 CD20、肿瘤坏死因子抑制剂 (TNFi) 的 b/tsDMARD 、白细胞介素 1 抑制剂 (IL-1i)、细胞毒性 T 淋巴细胞相关蛋白 (CTLA) 4、白细胞介素 12/23 抑制剂 (IL-12/23i)、白细胞介素 6 受体抑制剂 (IL-6Ri)、Janus 激酶抑制剂(JAKi)、磷酸二酯酶 4 抑制剂 (PDE4i)、白细胞介素 17 抑制剂 (IL-17i) 和白细胞介素 23 抑制剂 (IL-23i)。除 PDE4i 之外的所有药物类别都有与感染相关的禁忌症和/或警告，包括结核。抗 CD20、IL-1i、IL-6Ri 和 JAKi 列出了有关带状疱疹的警告，而抗 CD20、TNFi、IL-1i、CTLA4-Ig、IL-6Ri、和贾基。除 PDE4i、IL-17i 和 IL-23i 外，所有药物类别都提到了恶性肿瘤风险。其他警告包括脱髓鞘疾病（TNFi、CTLA4-Ig 和 IL-6Ri）、心力衰竭（抗 CD20 和 TNFi）、主要不良心脏事件（JAKi 和 IL-12/23）和静脉血栓栓塞 (JAKi)、高脂血症（ IL-6Ri 和 JAKi）、肝损伤（TNFi、IL-1i、IL-6Ri 和 JAKi）、肾损伤（IL-1i、JAKi 和 PDE4i）、炎症性肠病（IL-17i）、胃肠道穿孔（IL -6Ri、JAKi)、血细胞减少症（抗 CD20、TNFi、IL-1i、IL-6Ri、JAKi）和抑郁症 (PDE4i)。自药物批准以来，禁忌症和警告似乎随着时间的推移而增加。本次审查概述了建立框架的概述，以根据监管医疗机构提供的个人医疗产品处方信息创建易于访问且可操作的处方安全检查表。© 2024。作者获得 Springer Nature Switzerland AG 的独家许可。

The purpose of this review is to provide an overview of the contraindications, special warnings, and boxed warnings with the aim to establish a framework to create a prescription safety checklist for a class of drugs or disease indication. This study covers biologic disease modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs).We identified contraindications, boxed warnings, and special warnings provided by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The study included b/tsDMARDs approved for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA), and juvenile idiopathic arthritis (JIA) within the drug-classes anti-CD20, tumor necrosis factor inhibitors (TNFi), interleukin-1 inhibitors (IL-1i), cytotoxic T-lymphocyte-associated protein (CTLA) 4, interleukin-12/23 inhibitors (IL-12/23i), interleukin 6 receptor inhibitors (IL-6Ri), Janus kinase inhibitors (JAKi), phosphodiesterase 4 inhibitors (PDE4i), interleukin-17 inhibitors (IL-17i), and interleukin-23 inhibitors (IL-23i).All drug classes, except PDE4i, had contraindications and/or warnings related to infections, including tuberculosis. A warning about herpes zoster was listed for anti-CD20, IL-1i, IL-6Ri, and JAKi, while a warning about hepatitis reactivation was listed for anti-CD20, TNFi, IL-1i, CTLA4-Ig, IL-6Ri, and JAKi. Malignancy risk was mentioned for all drug classes except PDE4i, IL-17i, and IL-23i. Other warnings included demyelinating disease (TNFi, CTLA4-Ig, and IL-6Ri), heart failure (anti-CD20 and TNFi), major adverse cardiac events (JAKi and IL-12/23) and venous thromboembolism (JAKi), hyperlipidemia (IL-6Ri and JAKi), liver impairment (TNFi, IL-1i, IL-6Ri, and JAKi), kidney impairment (IL-1i, JAKi, and PDE4i), inflammatory bowel disease (IL-17i), gastrointestinal perforation (IL-6Ri, JAKi), cytopenia (anti-CD20, TNFi, IL-1i, IL-6Ri, JAKi), and depression (PDE4i). Contraindications and warnings appeared to increase with the passage of time since the drug's approval.This review provides an overview to establish the framework to create an easily accessible and actionable prescription safety checklist from individual medical product prescription information provided by regulatory medical authorities.© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.