Background: In December 2006, the European Commission issued the Regulation 1901/2006 with the aim to improve the development of medicines for children, because currently many of the pediatric drugs are used outside their authorization. The aim of the present study was to establish a status quo of the medical prescriptions to patients admitted to a neonatal intensive care unit.
Method: The records of all patients admitted during a three-month period were analyzed retrospectively. Study endpoints were all prescribed medications, including dosage, route and form of administration. Medications were categorized in three groups: licenced, unlicenced and off-label medications.
Results: A total of 81 patients with a total of 84 admissions (3 re-admissions) had a median length of stay of 6 days (range: 1-101 days) in the intensive care unit. Of the 84 admissions, 20 were attributable to heart surgery conditions and 11 to extremely low birth weight (less than 1 000 g). A total of 748 prescriptions of 82 different medications were registered with an average of 6 (range: 1-38) different drugs per stay. 364 prescriptions (49%) were licenced, 250 (34%) were off-label, and 134 (18%) were unlicenced. During 77% of all 84 admissions, we used at least one off-label or unlicenced drug.
Conclusion: The data of our study demonstrate that the availability of licenced drugs for neonates is greatly limited. The results are consistent with studies in other European countries. This study underlines once more the need of adequate testing of medicines in children to assess their safety and efficacy. Whether the new European regulation will achieve this goal remains to be seen.