A Labbé1, C Baudouin2, D Ismail3, M Amrane3, J-S Garrigue3, A Leonardi4, F C Figueiredo5, G Van Setten6, M Labetoulle7. 1. 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. 2. Department of Ophthalmology, Quinze-Vingts National Ophthalmology Hospital, Paris, France; Ambroise Paré Hospital, AP-HP, University of Versailles Saint-Quentin-en-Yvelines, Versailles, France. 3. Santen SAS, Evry, France. 4. Department of Neuroscience, Ophthalmology Unit, University of Padua, Padua, Italy. 5. Royal Victoria Infirmary, Newcastle University, Newcastle upon Tyne, UK. 6. St. Eriks Eye Hospital, Karolinska Institute, Stockholm, Sweden. 7. Ophthalmology Department, South Paris University, Bicêtre Hospital, AP-HP, Kermin-Bicêtre, France.
Abstract
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.
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.
Authors: Andrea Leonardi; Elisabeth M Messmer; Marc Labetoulle; Mourad Amrane; Jean-Sébastien Garrigue; Dahlia Ismail; Maite Sainz-de-la-Maza; Francisco C Figueiredo; Christophe Baudouin Journal: Br J Ophthalmol Date: 2018-03-15 Impact factor: 4.638