Pan-European survey of the topical ocular use of cyclosporine A
| Autor: | Jean-Sebastien Garrigue, Andrea Leonardi, Francisco C Figueiredo, Antoine Labbé, Dahlia Ismail, Mourad Amrane, Marc Labetoulle, C. Baudouin, G B van Setten |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Eye Diseases Administration Topical Pharmacovigilance 03 medical and health sciences 0302 clinical medicine Pan european Surveys and Questionnaires Ophthalmology polycyclic compounds Humans media_common.cataloged_instance Medicine European Union Practice Patterns Physicians' European union Medical prescription media_common Corneal graft rejection business.industry Member states Authorization Medical practice Europe Family medicine Cyclosporine 030221 ophthalmology & optometry Ophthalmic Solutions business 030217 neurology & neurosurgery |
| Zdroj: | Journal Français d'Ophtalmologie. 40:187-195 |
| ISSN: | 0181-5512 |
| DOI: | 10.1016/j.jfo.2016.12.004 |
| Popis: | Summary 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. |
| Databáze: | OpenAIRE |
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