Labbé A, Baudouin C, Ismail D, Amrane M, Garrigue J-S, Leonardi A, Figueiredo F C, Van Setten G, Labetoulle M
Department of Ophthalmology, Quinze-Vingts National Ophthalmology Hospital, Paris, France; Ambroise Paré Hospital, AP-HP, University of Versailles Saint-Quentin-en-Yvelines, Versailles, France.
Department of Ophthalmology, Quinze-Vingts National Ophthalmology Hospital, Paris, France; Ambroise Paré Hospital, AP-HP, University of Versailles Saint-Quentin-en-Yvelines, Versailles, France.
J Fr Ophtalmol. 2017 Mar;40(3):187-195. doi: 10.1016/j.jfo.2016.12.004. Epub 2017 Mar 17.
To assess medical practices surrounding the use of topical ocular cyclosporine A across European Union nations.
Key stakeholders (ophthalmologists, hospital pharmacists, regulatory health authorities) from European Union member states were interviewed by telephone using a semi-structured, open-ended questionnaire. Ophthalmologists responded to questions about practice patterns of cyclosporine A use (prescription frequency, indication, dosage), pharmacists about cyclosporine A formulations (composition, manufacturing process, quality control, distribution), and the regulatory authorities about market authorization and pharmacovigilance for various cyclosporine A products.
Over the years, cyclosporine A use for ophthalmic indications has increased across all European Union nations. Prevalence of cyclosporine A use was heterogeneous, with Belgium, France, Germany, Italy, Portugal, Spain and the United Kingdom reporting the highest frequency. Compounded cyclosporine A formulations and other cyclosporine A products were prescribed through temporary authorization on a compassionate use or named-patient basis. Cyclosporine A was prescribed for dry eye disease, atopic and vernal keratoconjunctivitis, corneal graft rejection, and other autoimmune and inflammatory diseases. Concentrations of prescribed topical cyclosporine A ranged between 0.05-2% and formulations were instilled 1-6 times daily. Interviewed stakeholders expressed concern regarding, (1) paucity of product information, (2) lack of standardized manufacturing processes and quality control of cyclosporine A formulations, and (3) poor regulation and pharmacovigilance of ocular cyclosporine A-based products.
Medical practice surrounding ocular cyclosporine A use in European Union nations differs based on variations in concentration, dosage, prescription indication, formulation, availability and distribution, manufacturing, quality, and regulatory monitoring.
评估欧盟各国局部使用眼部环孢素A的医疗实践情况。
通过电话访谈，使用半结构化、开放式问卷对欧盟成员国的主要利益相关者（眼科医生、医院药剂师、监管卫生当局）进行了调查。眼科医生回答了关于环孢素A使用的实践模式（处方频率、适应症、剂量）的问题，药剂师回答了关于环孢素A制剂（成分、生产工艺、质量控制、分销）的问题，监管当局回答了关于各种环孢素A产品的市场授权和药物警戒问题。
多年来，环孢素A在所有欧盟国家用于眼科适应症的情况都有所增加。环孢素A的使用 prevalence 存在异质性，比利时、法国、德国、意大利、葡萄牙、西班牙和英国报告的使用频率最高。复方环孢素A制剂和其他环孢素A产品通过临时授权以同情用药或指定患者为基础进行处方。环孢素A被用于治疗干眼症、特应性和春季角结膜炎、角膜移植排斥反应以及其他自身免疫性和炎症性疾病。局部使用的环孢素A的处方浓度范围为0.05%-2%，制剂每天滴注1-6次。接受采访的利益相关者表达了对以下方面的担忧：（1）产品信息匮乏；（2）环孢素A制剂缺乏标准化的生产工艺和质量控制；（3）基于眼部环孢素A的产品监管和药物警戒不力。
欧盟各国围绕眼部使用环孢素A的医疗实践因浓度、剂量、处方适应症、制剂、可得性和分销、生产、质量以及监管监测的差异而有所不同。
