Evaluation of ophthalmic adverse drug reactions at a tertiary-care hospital.

Objective: The aim of this study was to evaluate the clinical spectrum and drugs responsible for ophthalmic adverse drug reactions (ADRs) in a tertiary-care hospital and to establish their causality, severity and preventability. Materials and methods: A prospective, observational study was conducted in the department of ophthalmology of a tertiary-care hospital from September 2012 to February 2014. Demographic details, clinical pattern and causal drug groups were recorded on a case-record form. Ophthalmic ADRs were assessed for causality, severity, preventability and economic impact. Results: A total of 114 ophthalmic ADRs were reported, of which 86 were associated with topical drug instillation and 28 with systemic administration. The most commonly suspected drug group was antiglaucoma agents, followed by mydriatics and corticosteroids, and the most frequently suspected causal drugs were topical timolol and oral acetazolamide. Clinical presentations of ophthalmic ADRs included burning sensations in eyes, eyelid oedema, eye pain, conjunctival hyperemia and reduced visual acuity due to cataract. The majority of ophthalmic ADRs started within 1 week of therapy, were probably associated with the suspected causal drug, and were mild to moderate in nature, but none of the ADRs were preventable. From a patient's perspective, the mean cost per ophthalmic ADR was 319.07 Indian rupees (US$5.19). Conclusion: Ophthalmic ADRs can occur as a result of the active ingredient and/or preservatives in ophthalmic solutions. Although the incidence of ophthalmic ADRs is low, mild to moderate ADRs can result into substantial functional impairment. Increasing the general awareness of clinicians and patients regarding ophthalmic ADRs would go a long way towards preventing and identifying these reactions. [ABSTRACT FROM AUTHOR]