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Abstract:  The problems related to pediatric pharmacotherapeutics and medication management are not unique to any particular country, as drug therapy problems are common causes of emergency department visits. Over the past 20 years, there were only sporadic scientific and commercial efforts to develop unique oral nonsterile dosage forms with a potential for mass production and standardization that would address the needs of pediatric patients under the age of four years with chronic diseases. This article raises awareness of the issues encountered in pharmacy pediatrics practice surrounding compounded nonsterile preparations. Current trends and emerging priorities at the interface between the use of these preparations and patient safety will be discussed. Trends in compounded nonsterile preparations preparation for children include standardization of nomenclature, formulation, dose, re-purposing old medications, reformulating older drugs, increasing federal oversight of pharmacy compounding, and changes to broaden the scope of indications in the product’s label. Among the emerging priorities for safe pediatric compounded nonsterile preparations use include creation of new formulations for expanding pediatric diagnoses, improved quality-control processes described in United States Pharmacopeia Chapter <795>, closing the patient safety gap with changes to the prescription fulfillment systems, and employment of board-certified pediatric pharmacy specialists within the fulfillment process. In particular, an emerging opportunity to close the good clinical practice-good manufacturing practice gap at the pharmacy or point-of-care level with application of reverse-engineering concepts and other novel solutions have the potential to improve a pharmacist’s ability to produce quality pediatric compounded nonsterile preparations. A systems approach (Formulation, Information, Collaboration, and Innovation) to the design of an integrated prescription generation and medication management system for children, including a simulation functionality, would include validation of small batch compounded nonsterile preparations, provision of complete information necessary to verify a prescription order, establishment of models of collaboration between board-certified pediatric clinical pharmacists and pediatricians, and performance of pragmatic clinical trials regarding compounded nonsterile preparation use in children.

Related Keywords: Richard H. Parrish II, BPharm, PhD, FCCP, BCPS, children, infants, drug dosing, drug metabolism, hepatic enzymes, compounded nonsterile preparations, compound safety, formulation errors, medication errors, commercially available, regulatory requirements, standardization

Related Categories: LEGAL, PEDIATRICS, TECHNOLOGY, QUALITY CONTROL, ADVERSE DRUG EVENTS, HOSPITAL PHARMACY

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