Pan-European survey of the topical ocular use of cyclosporine A.
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.
Department of Ophthalmology, Quinze-Vingts National Ophthalmology Hospital, Paris, France; Ambroise Paré Hospital, AP-HP, University of Versailles Saint-Quentin-en-Yvelines, Versailles, France. Electronic address: dr.antoinelabbe@gmail.com.
A
A
Labbé
Department of Ophthalmology, Quinze-Vingts National Ophthalmology Hospital, Paris, France; Ambroise Paré Hospital, AP-HP, University of Versailles Saint-Quentin-en-Yvelines, Versailles, France.
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Baudouin
Santen SAS, Evry, France.
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D
Ismail
Santen SAS, Evry, France.
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Amrane
Santen SAS, Evry, France.
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JS
Garrigue
Department of Neuroscience, Ophthalmology Unit, University of Padua, Padua, Italy.
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A
Leonardi
Royal Victoria Infirmary, Newcastle University, Newcastle upon Tyne, UK.
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FC
Figueiredo
St. Eriks Eye Hospital, Karolinska Institute, Stockholm, Sweden.
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Van Setten
Ophthalmology Department, South Paris University, Bicêtre Hospital, AP-HP, Kermin-Bicêtre, France.
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M
Labetoulle
D000287:Administration, Topical; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe / Q000453:epidemiology; D005062:European Union / Q000706:statistics & numerical data*; D005128:Eye Diseases / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D060735:Pharmacovigilance; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires
D009883:Ophthalmic Solutions; D016572:Cyclosporine
Ciclosporine A; Cyclosporine A; European Union; Ophtalmologie; Ophthalmology; Physicians’ practice patterns; Standards; Therapeutic use; Topical therapies; Topique; Union européenne; Utilisation pratique