Abstract

Although medicine acceptability is likely to have a significant impact on the patient’s adherence in pediatrics and therefore on therapy success, there is still little data even for common therapeutic areas. For analgesics/antipyretics, healthcare professionals face a wide variety of products and need knowledge to select the best adapted product for each patient. We investigated acceptability of those products most used at the University Children’s Hospital Düsseldorf, Germany. Based on 180 real-life observer reports of medicine intake, we used the acceptability reference framework to score acceptability of six distinct medicines. Both ibuprofen and paracetamol tablets, mainly used in adolescents, were positively accepted. This was not the case for the solution for injection of metamizole sodium. Regarding syrups, mainly used in children under 6 years of age, ibuprofen flavored with strawberry and provided with an oral syringe was positively accepted, while paracetamol flavored with orange and provided with a measuring cup was not. Suppository appeared to be an alternative to oral liquids in infants and toddlers with palatability and administration issues. Differences appeared to be driven by dosage forms and formulations. These findings improve knowledge on acceptability drivers and might help formulating and prescribing better medicines for children.

Highlights

  • In addition to the effectiveness of a drug, the product acceptability plays a decisive role: no matter how potent a drug may be, if the patient refuses to take it, it cannot develop its efficacy

  • The European Medicine Agency’s (EMA) Pediatric Regulation 2007 aimed to increase the availability of pediatric dosage forms and pediatric trials, to improve the safety and compliance of medication administration in childhood [2]

  • Solid oral dosage forms (SODF) that were developed for adults are often used in pediatrics

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Summary

Introduction

In addition to the effectiveness of a drug, the product acceptability plays a decisive role: no matter how potent a drug may be, if the patient refuses to take it, it cannot develop its efficacy. Acceptability, which is the “overall ability and willingness of the patient to use and its care giver to administer the medicine as intended” [1], is an essential criterion for designing and prescribing medicines. This aspect is crucial in patients from the pediatric populations who require special considerations, as they cannot be regarded as small adults nor as a homogeneous group due to physical, metabolic, and psychological development. Solid oral dosage forms (SODF) that were developed for adults are often used in pediatrics. Children’s inability to swallow SODF or inappropriate drug strength result in the crushing of tablets, or the opening of capsules, which may lead to dosing

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