(235) Drug utilization in children at a German university hospital – Are evidence-based (off-label) dosing recommendations available?

Background: Monitoring prescribing patterns is important in order to continuously improve the rational use of medicines and thus the safety of drug therapy in pediatrics. Due to the frequent off-label use of medicines in children, specific information such as age-appropriate dosages is not regularly available. The German pediatric drug formulary (Kinderformularium.DE) is an evidence-based drug information system freely available in Germany since 2021.

Objectives: Our aim was to examine the pattern of drug utilization in our general pediatric hospital admissions. For the medications used, we investigated the extent to which there is easy access to dose recommendations in Kinderformularium.DE. In addition, we determined the proportion of off-label therapies.

Methods: We retrospectively analyzed drug utilization patterns on a pediatric general ward of a German tertiary teaching hospital during a 6-year period (2014-2019) using electronic medical records (VMobil) from pediatric inpatients < 18 years. Prescribed drugs were classified according to the availability of on- or (partially) off-label dosing information in Kinderformularium.DE as of 04/2023. In addition, we analyzed to which extent the different classes were used in our pediatric hospital.

Results: A total of 13976 hospital admissions involving 58062 drug prescriptions (698 different ATC-Codes) were documented in the database. The median number of medications per patient was 3 (min=1; max=64; IQR [2;5]). Analgesic drugs (metamizole, ibuprofen, paracetamol) were most commonly prescribed followed by antibiotics and drugs for the respiratory system.
For 42% of the drug prescriptions, on-label dosing recommendations were available in the German pediatric formulary. 7% had off-label dosing recommendations and 42% had recommendations that were partly on/off-label. No information was provided for 9% of prescriptions. The percentage of off-label prescriptions was similar in all age groups, with a slight increase in younger age groups (infants: 8%, neonates: 11%). The number of admissions with at least one off-label prescription was highest in children (>6 years) (24%) and adolescents (>12) (25%) as compared to younger age groups (19%-21%); (p>0.05).

Conclusions: Providing information for the majority (93%) of drug prescriptions in a pediatric tertiary hospital Kinderformularium.DE is an important information source for pediatric drug therapy in Germany.