Drug-related problems in ophthalmic practice: is product quality a contributing factor?

Abstract

Eye drops are the most common medication in ophthalmic practice, and ensuring product quality is vital to effective treatment and minimizing health risks. This cross-sectional study investigated whether reported drugrelated problems in ophthalmic products were linked to quality deviations. Quality control tests were performed on products seized by the Post-marketing Surveillance Service – one containing travoprost and two containing tropicamide. Issues included irregular drop dispensing, adverse drug reaction, and therapeutic failure. For travoprost, tests assessed drip and drop size, while for tropicamide, tests focused on composition (identification, assay, and pH). Travoprost met drip (94.3 drops; specification: 80–110 drops) and drop size (27.1µL; specification: 20–70µL) standards. Tropicamide met identification (positive, positive; specification: positive), assay (101%, 101%; specification: 95–105%), and pH (5.0, 5.3; specification: 4.0–5.8) standards. The findings suggested that reported adverse events were unrelated to product quality, highlighting the need for further investigation into other contributing factors.