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

被引：0

作者：

Patel J. ^{[1
]}

Desai M. ^{[1
]}

Mishra V. ^{[1
]}

Shah S. ^{[1
]}

机构：

[1] Department of Pharmacology, B. J. Medical College, Ahmedabad, 380016, Gujarat

来源：

Drugs & Therapy Perspectives | 2015年 / 31卷 / 12期

关键词：

Timolol; Ophthalmic Solution; Benzalkonium Chloride; Indian Rupee; Ocular Surface Disorder;

D O I：

10.1007/s40267-015-0244-7

中图分类号：

学科分类号：

摘要：

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. © 2015, Springer International Publishing Switzerland.

引用

页码：448 / 451

页数：3

共 11 条

[1]

Miguel A., Henriques F., Azevedo L.F., Et al., Ophthalmic adverse drug reactions to systemic drugs: a systematic review, Pharmacoepidemiol Drug Saf, 23, 3, pp. 221-233, (2014)

[2]

Bartlett J.D., Jaanus S.D., Clinical Ocular Pharmacology, (2001)

[3]

Wilson F.M., Adverse external ocular effects of topical ophthalmic therapy: an epidemiological laboratory and clinical study, Trans Am Ophthalmol Soc, 81, pp. 854-965, (1983)

[4]

Pisella P.J., Pouliquen P., Baudouin C., Prevalence of ocular symptoms and signs with preserved and preservative-free glaucoma medication, Br J Ophthalmol, 86, 4, pp. 418-423, (2002)

[5]

Shah S.P., Desai M.K., Dikshit R.K., Analysis of cutaneous adverse drug reactions at a tertiary care hospital: a prospective study, Trop J Pharm Res, 10, 4, pp. 517-522, (2011)

[6]

The importance on pharmacovigilance safety monitoring on medicinal products, (2002)

[7]

Naranjo C.A., Busto U., Sellers E.M., Et al., A method for estimating the probability of adverse drug reactions, Clin Pharmacol Ther, 30, 2, pp. 239-245, (1981)

[8]

Hartwig S.C., Siegel J., Schneider P.J., Preventability and severity assessment in reporting adverse drug reactions, Am J Hosp Pharm, 49, 9, pp. 2229-2232, (1992)

[9]

Edwards I.R., Aronson J.K., Adverse drug reactions: definitions, diagnosis, and management, Lancet, 356, pp. 1255-1259, (2000)

[10]

Lau P.M., Stewart K., Dooley M.J., Comment: hospital admissions resulting from preventable adverse drug reactions, Ann Pharmacother, 37, pp. 303-305, (2003)

← 1 2 →