Topical Therapeutics for the Pediatric Patient

Ida Chung, OD, FAAO

COPE #18495-PH

Expires April 1, 2010

2 credits, $49

Section: Pediatrics and Special Populations

Introduction:

The efficacy and safety of more than half of commonly prescribed ophthalmic medications have not been well studied in pediatric patients.(1) There is a particular paucity of information on pediatric use safety profiles for anti-inflammatory agents and glaucoma medications. Lack of pediatric labeling does not mean drugs are necessarily harmful, ineffective, or contraindicated in children, but simply that the clinical trials that satisfy the Food and Drug Administration (FDA) requirements for labeling have not been conducted in children. Lacking this information, doctors may be reluctant to prescribe certain medications for their pediatric patients, or they may prescribe medications based on information from limited clinical observations rather than from comprehensive multi-centered clinical trials conducted in the pediatric population. To circumvent at least some of the problems associated with pediatric drug labeling, the FDA passed a ruling in 1995 to recognize methods of establishing substantive evidence to support pediatric labeling claims other than from adequate and well-controlled studies in the pediatric population.(2) For example, products may be labeled for pediatric use based on adequate and well-controlled studies in adults, together with other information supporting pediatric use including pharmacokinetic and pharmacodynamic data. Just as with adult drug testing, there are problems associated with testing drugs in the pediatric population, which include obtaining informed consent for tests not of direct benefit to the child, and the use of placebo controls in a vulnerable population.

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