Abstract
BackgroundMany ocular medications are prescribed for paediatric patients, but the evidence for their rational use is very scant. This study was planned to compare the availability and the licensing status of ocular medications marketed in Italy, the United Kingdom (UK), and the United States of America (USA) related to the amount of published and un-published RCTs testing these drugs in the paediatric population.MethodsA quantitative analysis was performed to evaluate the number of ocular medications with a paediatric license in Italy, the UK, and the USA. A literature search was also performed in MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) on ophthalmic pharmacological therapy in children aged < 18 years, published up to December 2010. A search in the international clinical trial registries, the list of paediatric investigation plans (PIPs) approved by European Medicines Agency (EMA), and the table of medicines with new paediatric information approved by Food and Drug Administration (FDA) was also performed.ResultsIn all, of 197 drugs identified, 68 (35%) single drugs are licensed for paediatric use at least in one considered country, while 23 (12%) were marketed in all three countries. More specifically, in Italy 43 single drugs (48% of those marketed) had a paediatric license, while 39 (64%) did in the UK and 22 (54%) did in the USA. Only 13 drugs were marketed with a paediatric license in all countries.The percentage of drugs licensed for paediatric use and for which at least one RCT had been performed ranged between 51% in Italy and 55% in the USA. No published RCTs were found for 11 (48%) drugs licensed for paediatric use in all three countries. In all, 74 (35%) of the retrieved RCTs involved mydriatic/cycloplegic medications.A total of 62 RCTs (56% completed) on 46 drugs were found in the international clinical trial registries. Cyclosporin and bevacizumab were being studied in many ongoing trials. Twenty-six drugs had new paediatric information approved by FDA based on new paediatric clinical trials, while only 4 PIPs were approved by EMA.ConclusionsThere is a pressing need for further research and clinical development in the pediatric ophthalmic area, where effective up-to-date treatments, and additional research and education on use in children, remain priorities.
Highlights
Many ocular medications are prescribed for paediatric patients, but the evidence for their rational use is very scant
A study was planned to compare the availability and the licensing status of ocular medications marketed in Italy, the United Kingdom (UK), and the United States of America (USA) related to the amount of published and un-published randomized controlled trials (RCTs) testing these drugs in the paediatric population
Data on the licensing status of individual drugs were obtained by consulting national formularies: Italy’s Repertorio Farmaceutico Italiano (Refi) [11], the UK’s British National Formulary (BNF) [12], and the USA’s Physicians’ Desk Reference® (PDR®) [13]
Summary
Many ocular medications are prescribed for paediatric patients, but the evidence for their rational use is very scant. Despite the prevalence of eye disease in early childhood (in the United Kingdom, by 3 years of age 5.7% of children had had ≥ 1 eye condition, 0.24% of which associated with visual impairment) [2] more than in other paediatric areas, evidence for the rational use of ocular medicines in these patients is very scant. Many ocular medications are used in children to treat common bacterial and viral infections, inflammation and allergy, uveitis and glaucoma, as well as other conditions including myopia, amblyopia, and strabismus [3], even if data regarding their safety and effectiveness in the paediatric population are sparse. Without adequate paediatric labelling information, practitioners treating eye disease in children may be forced to prescribe ocular medications in an “off-label” manner, placing their paediatric patients at risk for serious adverse reactions [5,6]
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