RESUMEN
OBJECTIVE: To determine the status of drug use in Neonatology units regarding: 1. Frequency of use for drugs unauthorised by DirecciA(3)n General de Farmacia y Productos Sanitarios. 2. Suitability of commercial presentations regarding actual needs of patients. METHOD: Two cut-off points were established for 100% of patients admitted to Neonatology Units in 6 Spanish hospitals. Data on demography and therapeutic drug profile were collected, as well as on whether doses were or not prepared by Pharmacy departments. Approval for each drug regarding indication, age range, dosage and administration route was assessed. RESULTS: The number of patients included was 346. In all, 17.6% of patients were under treatment with unauthorised drugs, the reason being age in 78.7% and indication in 21.3%. Master formula preparation was needed for 22% of patients because of a lack of commercial preparations suited for paediatric age. Pharmacy departments prepared 25% of prescribed drugs. CONCLUSIONS: The use of unauthorised drugs in Neonatology is a common fact. Pharmacy departments are actively involved in Neonatology-related drug therapies: counselling and/or processing for compassionate unauthorised drug use, master formula preparation, intravenous mixtures, etc. Therapeutics in Neonatology benefits from specialised pharmaceutical involvement.