Extemporaneous product use in paediatric patients: a systematic review

This is the authors' abstract. We don't add key points for this paper.

Objective To identify the relative extent of extemporaneous product use reported in the paediatric population and the implications for pharmacy practice. Method A systematic literature review was undertaken to identify the prevalence of extemporaneous product use in paediatric patients including those studies examining both ‘off-label’ and unlicensed medicine use from which extemporaneous products were separately identified and compared to licensed drug use. Key findings Twenty studies were identified and evaluated in which extemporaneous products prepared by a pharmacy or licensed manufacturer could be identified. Although prescribing of unlicensed drugs and licensed drugs used ‘off-label’ occurs more frequently in younger children and for more serious conditions, the use of extemporaneous products is consistent across all age groups and therapeutic areas. Studies using pharmacy dispensing records identified details of extemporaneous products more accurately than studies using prescribing records. Despite efforts to improve the availability of suitable licensed medicine products for children, extemporaneously prepared products are still needed to ensure that optimal drug therapy is available to children in accurate and effective doses and dosage forms. Conclusions Paediatric patients have a continuing need for extemporaneously prepared medicines when suitable dose forms are unavailable from manufacturers. Pharmacists require access to stability, compatibility and formulation information, as well as appropriate training to ensure patients are supplied with high-quality, safe and effective preparations.