Osemeke U. Osokogu
Erasmus Medical Center, Netherlands
Title: Impact of pediatric drug legislations on methods development for post-marketing safety surveillance: Opportunities and challenges
Biography
Biography: Osemeke U. Osokogu
Abstract
In order to generate pediatric-specific drug safety (and efficacy) evidence, the US Pediatric Research Equity Act (PREA) and the EU Pediatric Regulation were passed in 2003 and 2007 respectively. While some safety evidence may be generated from pre-marketing studies, important evidence regarding rare and delayed-onset adverse effects may be missed. Analysis of spontaneous reporting systems is the most common method for post-marketing drug safety surveillance, but unlike the general population, little research effort has focused on improving surveillance in the pediatric population specifically. Yet unlicensed and off-label drug use; and organ maturation and changing hormonal levels, both of which impact drug pharmacokinetics and Pharmacodynamics, predisposes this vulnerable population to adverse drug reactions. Available data may be used for pediatric drug safety monitoring but pediatric-specific methods are not available. Methods that have been applied to the general population may be tailored to the specific needs of the pediatric age group, however a pediatric-specific reference set of drug-adverse event associations is required. Osokogu et al. 2015 reported on the creation of such a reference set; currently it is being applied to evaluate the performance of selected signal detection methods. Preliminary results are promising, however there are challenges. Time is crucial to the definition and application of a reference set when such is used for methods’ evaluation. Yet, the confirmation of adverse drug events is country-specific. Age may impact methods’ performance. These (and other) challenges must be overcome if we are to improve drug safety monitoring in the pediatric population.