Manipulation of Medicinal Products for Oral Administration to Paediatric Patients at a German University Hospital: An Observational Study

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.

Development and Evaluation of a Web-Based Paediatric Drug Information System for Germany

“…Nevertheless, prescribers are often unaware of the dosage form, strength, or concentration of the prescribed drugs [ 22 ]. This unawareness may lead to the necessity of manipulations to administer the required dose to the patient [ 23 ]. Simultaneously, manipulations jeopardise patient and medication safety [ 24 ].…”

Manipulations of Oral Medications in Paediatric Neurology and Oncology Care at a Swedish University Hospital: Health Professionals’ Attitudes and Sources of Information

“…Manipulations are more common in younger children and depending on age of the studied group or ward specialisation, numbers could vary greatly. Determined by how extemporaneous compounding is classified also higher figures of manipulations, e.g., 37% are seen [7].…”

“…Furthermore, crushing of tablets is a means of easy administration through nasogastric tube (NGT) or percutaneous endoscopic gastrostomy (PEG). To describe this process, the term manipulation of medications has been defined [4] and further discussed by others [5][6][7][8][9] on the basis of the guidelines from the European Medical Agency Paediatric Committee (PDCO) [10].…”

Evaluation and Comparison of Solid Lipid Nanoparticles (SLNs) and Nanostructured Lipid Carriers (NLCs) as Vectors to Develop Hydrochlorothiazide Effective and Safe Pediatric Oral Liquid Formulations

“…This gives rise to some limitations in its utilization in paediatrics, where the use of oral solid dosage forms is restricted by their rigid dose content and by the difficulty of children to swallow them [ 12 ]. On the other hand, the common practice of caregivers to prepare extemporaneous liquid formulations by crushing of tablets or capsules opening, and then suspending the powder in a suitable liquid, can often lead to loss of accuracy of the dosage, issues with stability, and possible errors due to incorrect manipulation [ 13 , 14 ]. Moreover, excipients present in dosage forms designed for adults could be harmful to children, particularly for neonates and infants [ 15 , 16 ].…”