Abstract
Pharmacotherapy in children requires medicinal products in age-appropriate dosage forms and flexible dose strengths. Healthcare professionals often encounter a lack of licensed and commercially available formulations, which results in the need for manipulation. This study aimed to investigate the nature, frequency and preventability of the manipulation of medicinal products before oral drug administration to paediatric inpatients in Germany. A prospective, direct observational approach was used. Two thousand and three medication preparation processes (MPP) in 193 patients were included in the analysis. Medicines were manipulated in 37% of oral administrations, affecting 57% of the patients. The percentage of manipulations was highest in infants/toddlers (42%) and lowest in adolescents (31%). Antiepileptics were most frequently manipulated (27%), followed by vitamins (20%) and drugs for acid-related disorders (13%). Fifty-six per cent of all manipulations were off-label. In 71% of these, no alternative appropriate medicinal product was commercially available. These results demonstrate that the manipulation of medicinal products before oral administration is common in paediatric wards in Germany. About half of the manipulations were off-label, indicating that no suitable formulation was available. Evidence-based guidelines for manipulations are required, with the overall aim of improving the safety of paediatric drug therapy.
Highlights
Adequate and safe pharmacotherapy in children requires evidence-based dosing guidelines as well as licensed medicinal products in age-appropriate dosage forms and flexible dose strengths [1,2,3]
The paediatric population is characterised by continuous growth and developmental changes [4]
The manipulation of medicinal products to extract a part of the whole dosage form, to facilitate administration or to improve acceptability is common practice in paediatric drug therapy [8,9,10,11,12,13]
Summary
Adequate and safe pharmacotherapy in children requires evidence-based dosing guidelines as well as licensed medicinal products in age-appropriate dosage forms and flexible dose strengths [1,2,3]. In addition to the correct dose, the acceptability of the dosage form and taste, and the individual’s ability to handle a medicine are important points to consider when prescribing a drug to a child. Healthcare professionals and caregivers often face a lack of commercially available, age-appropriate formulations in the required dose strength. The manipulation of medicinal products to extract a part of the whole dosage form, to facilitate administration or to improve acceptability is common practice in paediatric drug therapy [8,9,10,11,12,13]
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