Pan-European survey of the topical ocular use of cyclosporine A

被引：13

作者：

Labbe, A. ^{[1
,2
]}

Baudouin, C. ^{[1
,2
]}

Ismail, D. ^{[3
]}

Amrane, M. ^{[3
]}

Garrigue, J. -S. ^{[3
]}

Leonardi, A. ^{[4
]}

Figueiredo, F. C. ^{[5
]}

Van Setten, G. ^{[6
]}

Labetoulle, M. ^{[7
]}

机构：

[1] Quinze Vingts Natl Ophthalmol Hosp, Dept Ophthalmol, Paris, France

[2] Univ Versailles St Quentin En Yvelines, Ambroise Pare Hosp, AP HP, Versailles, France

[3] Santen SAS, Evry, France

[4] Univ Padua, Dept Neurosci, Ophthalmol Unit, Padua, Italy

[5] Newcastle Univ, Royal Victoria Infirm, Newcastle Upon Tyne, Tyne & Wear, England

[6] Karolinska Inst, St Eriks Eye Hosp, Stockholm, Sweden

[7] South Paris Univ, Bicetre Hosp, AP HP, Ophthalmol Dept, Kermin Bicetre, France

来源：

JOURNAL FRANCAIS D OPHTALMOLOGIE | 2017年 / 40卷 / 03期

关键词：

Cyclosporine A; Ophthalmology; Physicians' practice; patterns; Standards; Therapeutic use; Topical therapies; European Union; DRY EYE SYNDROME; VERNAL KERATOCONJUNCTIVITIS; 0.05-PERCENT CYCLOSPORINE; DISEASE; METAANALYSIS; DROPS; OPHTHALMOLOGISTS; REJECTION; 1-PERCENT; EYEDROPS;

D O I：

10.1016/j.jfo.2016.12.004

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

Objective. - To assess medical practices surrounding the use of topical ocular cyclosporine A across European Union nations. Methods. - 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. Results. - 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. Conclusions. - 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. (C) 2017 Elsevier Masson SAS. All rights reserved.

引用

页码：187 / 195

页数：9