Pharmacoepidemiology can be a useful tool for evaluating the appropriateness of drug prescriptions and for estimating therapeutic needs. In particular, it can be valuable in the paediatric setting, which is characterized by the availability of only limited information on the safety and effectiveness of drug use. The drug prescription profile varies according to gender and age of the child. Quantitative and qualitative differences exist in the pattern of drug use between and within countries, and the place of residence is one of the main determinants of drug prescription. This may be explained by the different epidemiology of the diseases, by socio-cultural and economic factors related to patients and parents, and by physician attitude. Understanding these differences may be helpful in planning educational interventions, with the aim to improve the rational use of drugs in the paediatric population.