Margulis A, Houben E, Olesen M, Hallas J, Overbeek J, Pottegard A, Ye W, Villegas D, Perez-Gutthann S, Arana A. Drug utilization study: evaluation of the use of nepafenac in the Netherlands and Denmark. Poster presented at the 32nd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):225.

BACKGROUND: Nevanac 1 mg/ml and Nevanac 3 mg/ml are available in the EU for prevention and treatment of postoperative pain and inflammation after cataract surgery, for the first 2 weeks of the postoperative period. Treatment can be extended to the first 3 weeks of the postoperative period as directed by the clinician. In 2011, Nevanac 1 mg/ml was approved for reduction in risk of postoperative macular edema associated with cataract surgery in adult patients with diabetes, for up to 60 days after surgery. This study aimed to address the European Medicines Agency concern about potential offlabel use.

OBJECTIVES: To quantify and describe use of nepafenac with reference to the approved indications.

METHODS: Using data from the PHARMO Database Network (The Netherlands, 2008 to 2013) and the National Health Databases (Denmark, 2008 to 2014), we created cohorts of nepafenac users starting with the first prescription. Some underrecording of cataract surgery is present in both databases.

RESULTS: The Netherlands contributed 9,530 users (12,691 therapy episodes); mean age, 71 years; 60% women; 17% diabetic. Of all episodes, 79% did not have recorded cataract surgery; 19% of these had cataract diagnoses. Of 2,266 episodes in adult nondiabetic patients with cataract surgery, 40% had more than one bottle dispensed (greater than 21 days). Of 441 episodes in adult diabetic patients with cataract surgery, 10% had more than two bottles dispensed (greater than 60 days) Denmark had 60,403 nepafenac users (73,648 therapy episodes); mean age, 72 years; 58% women; 59% did not have recorded cataract surgery. Of 26,649 nepafenac episodes in adult nondiabetic patients with cataract surgery, 8% had more than one bottle dispensed (greater than 21 days). Of 3,458 episodes in adult diabetic patients with cataract surgery, 0.2% had more than two bottles dispensed (greater than 60 days) Pediatric use was 0.3% in both populations.

CONCLUSIONS: Nepafenac use in pediatric patients was minimal. In adults, more than half of therapy episodes were not related to cataract surgery, and around 10% were for longer use than approved. Underrecording of ophthalmic conditions and procedures challenges research in this area and can result in overestimation of this offlabel use.