Pediatric Drugs and Labeling

683 Words2 Pages

Historically, pediatric drugs have been used without the adequate research done for pediatric formulation and dosage information for children usage. There have been difficulties and lack of pediatric trials done on drugs and children received unapproved therapeutic uses based on adult formulation, which have caused harmful results in children. There is a profound need for pharmaceutical tests to be approved for safety and effective for use by children. Only few drugs have adequate labeling information and approved indication for dosage, frequency, and route of administration. However, over the recent years, implementation of pediatric regulations and legislations have been initiated and review committees have been established to renew this issue. #2 In order to improve the health of children, both FDA and EMA established several regulations to ensure the safety and efficacy of pediatric medicines. The FDA established the Pediatric Labeling Rule in 1994 and later finalized into the Pediatric Rule in 1997 to ensure adequate pediatric labeling and to require manufacturers of new drugs to submit safety and effectiveness information for approval. Under, the Food and Drug Administration Modernization Act (FDAMA), FDA also issues a Written Request (WR) to pharmaceutical companies for pediatric studies of certain drugs with incentives. Through the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), FDA continue to request pediatric studies and the data to be presented one year after the study conduct. The EMA established its pediatric regulations in 2006. It includes the Paediatric Committee to help oversee the pediatric medicines. EMA’s regulation requires new products and certain changes... ... middle of paper ... ...e forms for children lags behind that of their adult counterparts. The main challenges are solubility, stability, taste masking, and appropriate selections of excipients and packaging material. For example, a problem rests in the use of tablets and capsules that lack dosing flexibility. Tablets and capsules are usually not created or dosed for children and thus adult tablets and capsules are modified by compounding. However by grinding the tablet and sprinkling it into fluid or a food vehicle usually results in dosing variability from one administration to the next. Taste is also a major problem for pediatrics. Alot of the time children do not like the taste of non-masked formulations. There are many physiological and pharmacokinetic differences between adults and children. As technology advances, it will become easier to research and create pediatric formulations.

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