Evaluation of the Use of Nepafenac in Selected European Populations

This study is a drug utilization study to evaluate the use of nepafenac (Nevanac), an ophthalmic non-steroidal agent, in two selected European populations from Denmark and The Netherlands. In Europe, nepafenac has been approved for (1) prevention and treatment of postoperative pain and inflammation associated with cataract surgery in adults (approval in 2007) and (2) to reduce the risk of macular edema after cataract surgery in diabetic patients (approval in 2011). The aim of this study is describe the use of nepafenac.This will be a cohort study including new users of nepafenac and new users of other selected ophthalmic NSAIDs. The study will be conducted in the network of databases from the National Health Databases in Denmark and the PHARMO Record Linkage System database in the Netherlands. Patients will become eligible for cohort entry after 6 months of enrolment in the databases.The exposure will be based on dispensed prescriptions, medical condition concomitant to the exposure will be derived from diagnoses and procedures around the prescription dispensing date. Target conditions for this evaluation are cataract surgery, refractive procedures, other ophthalmic procedures, two or more ophthalmic surgeries or procedures, dry eye/Sjögren syndrome, uveitis/iritis, ophthalmic manifestations of allergy, ocular pain, macular edema, vitreous-related disorders.The study will report the frequency of the demographic characteristics of nepafenac users and users of other selected individual ophthalmic NSAIDs. The potential off-label use of nepafenac will be characterized as, a) use not preceded by cataract surgery b) use preceded by cataract but longer than 21 days in patients without diabetes or longer than 60 days in patients with diabetes c) use in individuals aged less than 19 years.