Volume 75, Issue 7 , Pages 419-429, July 2004
Pediatric use of topical ophthalmic drugs
Article Outline
Background
Changes in the policies of the Food and Drug Administration (FDA) have resulted in a rapid increase in the number of drugs now labeled for pediatric use. In topical ophthalmic drugs, there are Pharmaceuticals approved for use in children in the treatment of allergy, inflammation, and bacterial and viral infection. Clinicians should anticipate that this trend will continue into the future.
Overview
This article reviews the history of FDA oversight of drugs used to treat children. Recent shifts in policies and approach are emphasized. Pediatric issues associated with ophthalmic drug use are discussed, including important differences regarding dosage, instillation, distribution, systemic toxicity, and metabolism. A summary of topical ophthalmic drugs approved for pediatric use, including age considerations, is provided.
Conclusions
Clinicians should be aware of the increasing number of topical ophthalmic drugs that are approved for pediatric use. Social, regulatory, and economic factors suggest this trend will continue. When prescribing these drugs for use in children, clinicians should remember to refer to details of labeling for Pediatric Use, including the age of the child for whom the drug is approved.
Key Words: Children, Food and Drug Administration (FDA), pediatric, topical ophthalmic drugs, treatment
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References
- . Adverse drug reactions and the package insert. Acta Paediatr. 1999;88:925–927
- Nahata MC. (May 1997) Licensing of medicines for children in the USA. Paediatric and Perinatal Drug Therapy 1997. http://www.Priory.com/pharmol/lomfcitu.html. Last accessed April 3, 2002.
- . Topical therapies and medications in the pediatric patient. Pediatr Clin North Am. 2000;47(4):867–876
- Shelton DL. (June 12, 2000). Pace picks up in pediatric studies. Amednews.com. http://www.ama-assn.org/sci-pubs/amnews/pick_00/hlsa0612.html. Last accessed April 3, 2003.
- Modern regulatory environment shaped by pediatric pharmacology. Cited from Brown University Child and Adolescent Psychopharmacology Update 2002;4(5):l, 2-3. Medscape. http://www.medscape.com/viewarticle/433244_print. Last accessed April 4, 2003).
- . Challenges in providing pharmaceutical care to pediatric patients. Am J Hosp Pharm. 1994;51:688–694
- . Drug research and children. FDA Consum. 2003;37(2):36
- . The FDA drug approval process: focus on pediatric labeling [Letter to the editor]. Science. 2002;296(5573):1609–1610
- . An update on the therapeutic orphan. Pediatrics. 1999;104:585–590
- Paediatric labelling requirements: implications for pharmakinetic studies. Clin Pharmacokinet. 1994;24:308–325
- Unlicensed and off label drug use in paediatric wards: prospective study. Br Med J. 1998;316:343–345
- Buck ML. (2000). The FDA Modernization Act of 1997: Impact on pediatric medicine. Cited from Pediatr Pharm 2000; 6(12):2000. Medscape. http://www.medscape.com/viewarticle/410910. Last accessed September 27, 2003.
- . Pediatric study of medicines becomes mandatory. Nat Med. 2000;6:1069
- Pediatric clinical trials are on the rise as new law goes into effect. (August 9, 2000). Medscape Medical News. http://www.medscape.com/viewarticle/412078. Last accessed September 28, 2003.
- . Pediatric Drug Studies. FDA Consum. 1999;33(4):23–28
- . The pediatric pharmacology research unit (PPRU) network and its role in meeting pediatric labeling needs. Pediatrics. 1999;104:644–645
- . Pediatric testing of prescription drugs: the Food and Drug Administration's carrot and stick for the pharmaceutical industry. Am Univ Law Rev. 2000;49:739–772
- FDA draft sets 50,000 pediatric prescription mentions/year threshold for research list. FDC Reports “The Pink Sheet”1998;60(12):11-2.
- FDA mandatory pediatric labeling rule would apply to first indication for NMEs, marketed products with wide use or important benefits in children. FDC Reports “The Pink Sheet” 1997;59(33):3-4.
- HHS Identifies drugs for pediatric testing and announces FY 2003 and FY 2004 funding. News release (January 21, 2003) Health and Human Services, Washington, D.C. http://www.hhs.gov/news. Last accessed October 27, 2003.
- . FDA in a quandary over Pediatric Rule. Nat Med. 2002;8(6):541–542
- Safety-related labeling for pediatric drugs. Cited from Drug Benefit Trends 1999;11(1):11. Medscape. http://www.medscape.com/viewarticle/416823. Last accessed September 29, 2003.
- Otto A. Industry heeds FDA call to add pediatric info to drug labels. Cited from Pharmacy Today 2001. 7(2). Medscape. http://www.medscape.com/viewarticle/4066801. Last accessed September 29, 2003.
- Plummer J. (May 2000). FDA's Pediatric Rule restricts access to medicine. Consumers’ Research Magazine. www.consumeralert.org/pubs/research/CRMayOO.html. Last accessed April 3, 2003.
- Arshagouni P. (December 23, 2002). Federal court invalidates the FDA Pediatric Rule: AAPS v. FDA. http://www.law.uh.edu/healthlawperspectives/Children/021223Federal.html. Last accessed April 3, 2003.
- Association of American Physicians and Surgeons, Inc. v. U.S. Food and Drug Administration, 2002, U.S. Dist LEXIS 19689 http://www/law.uh.edu/healthlawperspectives (D.D.C., October 17, 2002).
- Barclay L. (November 6, 2002). Court overturns FDA Pediatric Rule: an expert interview with Philip Watson, M.D. Medscape Medical News, http://medscape.com/viewarticle/444180. Last accessed April 3, 2003.
- (2003). Recent court decision invalidating FDA's Pediatric Rule. Biotechnology Industry Organization, http://www.bio.org/reg/pedrule.asp. Last accessed April 3, 2003.
- . Challenge to FDA's authority may end up giving it more. Science. 2002;296:820–821
- Best Pharmaceuticals for Children Act. Public Law 107–109. pll5 Stat. 1408.
- . Am J Hosp Pharm. 1991;48:2475–2477
- . Tenfold errors in administration of drug doses: a neglected iatrogenic disease in pediatrics. Pediatrics. 1986;177:848–849
- . Pediatric pharmacology. In: Rosenbloom AA, Morgan MW editor. Principles and practice of pediatric optometry. Philadelphia: JB Lippincott Co; 1990;p. 293–312
- Mitchell A. (2001) Challenges in pediatric pharmacology: minimizing medication errors. Medscape Pharmacists 2 (10). http://www.medscape.com/viewarticle/421220. Last accessed September 28, 2003.
- The eye in childhood. Chicago: Yearbook Medical Publishers, Inc, 1967.
- In: Liebman SD, Gellis SS editor. Pediatric ophthalmology. St Louis: CV Mosby Co; 1966;
- . How safe are ocular drugs in pediatrics?. Ophthalmology. 1984;91:1361–1363
- . Pediatric considerations in ophthalmology. J Pediatr Ophthalmol. 1976;13:171–178
- . Ocular pharmacology. 4th ed. St Louis: CV Mosby; 1978;218-61
- . How to prescribe for the smallest sufferers. Rev Ophthalmol. 1999;6(2):101–103
- . Extraocular fluid dynamics: how best to apply topical ocular medication. Trans Am Ophthalmol Soc. 1976;74:457–487
- Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102:551–553
- Efficacy of a pediatric cycloplegic administration as a spray. J AM OPTOM ASSOC. 1993;64:617–621
- . A comparison of drop instillation and spray application of 1% cyclopentolate. Optom Vis Sci. 1994;71:235–241
- . Efficacy of a mydriatic spray in the pediatric population. Optom Vis Sci. 1997;74:160–163
- . Pilocarpine spray: an alternative delivery method. J Ocul Pharmacol Ther. 1998;14:1–4
- . Comparison of mydriatic efficacy of spray instillation and drop instillation of tropicamide 1%. Eye. 1999;13:653–655
- . Plasma timolol in glaucoma patients. Ophthalmology. 1984;91:1361–1363
- . Pharmacokinetics of instilled drugs in the human eye. Int Ophthalmol Clin. 1980;20(3):33–49
- . Factors influencing the penetration of topically applied drugs in the human eye. Int Ophthalmol Clin. 1980;20:21–32
- . Pharmacokinetics of topically applied ophthalmic drugs. Surv Ophthalmol. 1982;26:207–218
- Lacrimal and instilled fluid dynamics in rabbit eyes. J Pharm Sci. 1973;62:1112–1121
- . Creating smaller eyedrops by reducing eyedropper tip dimensions. Am J Ophthalmol. 1985;99:460–464
- Improving the therapeutic index of topical phenylephrine by reducing drop volume. Ophthalmology. 1987;94(7):847–850
- Reduction of phenylephrine size in infants achieves equal dilation with decreased systemic absorption. Arch Ophthalmol. 1987;105:1364–1365
- . Reduction in mydriatic drop size in premature infants. Br J Ophthalmol. 1993;77:364–365
- . Principles of drug prescribing in infants and children. A practical guide. Drugs. 1993;46(2):281–288
- . A look at the future of pediatric therapeutics: an investigator's perspective of the new pediatric rule. Pediatrics. 1999;104(3):610–613
- Wilson RP. Lee DA, Netland PA, eds. The changing face of pediatric glaucomas. Rev Ophthalmol 2002;9(10):97-106.
PII: S1529-1839(04)70157-8
doi:10.1016/S1529-1839(04)70157-8
© 2004 American Optometric Association. Published by Elsevier Inc. All rights reserved.
Volume 75, Issue 7 , Pages 419-429, July 2004
