Pharmaceutical formulation needs assessment to limit the use of inappropriate drugs in paediatric intensive care and continuing care units

Introduction
Medicines may be inappropriate for the paediatric population due to a dosage form unsuitable for their administration, or the presence of excipients with known effects (EKE). Prescribing these drugs may put the child at iatrogenic risk. The aim of this study is to identify the use of inappropriate medicines in a paediatric intensive care unit in order to propose alternatives.

Material/Methods
At first, we reviewed all the medicines used in the paediatric units over a 6-month period and noticed the presence of EKE in their compounding. Then, we conducted a quick audit of practices (3 days to 1 week apart) in order to analyze the drug delivery procedures in the paediatric intensive care unit. The collection included: demographic data, dosage form, drug delivery method, and the presence of EKE.

Results
The drug repository included 56.9% (426/748) of medications containing at least one EKE. Of these, 21.1% (158/748) contained an excipient with a proven know effect or potentially toxic. Among the oral solutions 19.3% (22/114) mentioned the presence of ethanol. The audit allowed us to collect 49 prescriptions for 32 patients (18 premature babies, 8 children < 1 year old, 1 child 1-6 years old, 5 children > 6 years old). More than 50% of the prescriptions (170/338) were about 9 drugs, including folic acid and epoetin beta. Within injectable drugs (222/338), 56.8% (126/222) were diluted outside of the manufacturer’s recommendations and 1/3 (44/126) of the solutions were double diluted. Regarding oral treatments (104/338), oral solutions accounted for 63% of the administrations. The use of monolithic forms (39/104) requiring dispersion was common with the use of folic acid tablets (20/39). Alternative and more accurate medical devices were used for 6.8% of administrations. About 50% of the prescriptions included a drug containing at least EKE. The excipients that can lead to irritation or allergies were the most represented with 18 medications. Regarding the presence of EKE for premature babies or newborns, there are 8 drugs including epoetin beta. Alcohol-containing drugs accounted for 0.59% (2/338) of the prescriptions.

Discussion/Conclusions
The lack of suitable pharmaceutical formulations for the paediatric population has led to iatrogenic risk behaviors. To limit these risks when there is no alternative, develop paediatric formulations and support medical teams on the use of medicines, appear to us to be necessary. This study allowed us to prioritize our research projects by highlighting the most important needs in our paediatric units: oral solutions of folic acid, and furosemide without ethanol.

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