BACKGROUND: Studies carried out in other countries show that drugs are used in children outside the approved conditions, in a context in which investigation, information and authorization of medications in the pediatric population are scarce. OBJECTIVES: To evaluate the conditions of drug use recommended in children and variability in sources of drug information. METHODS: We performed a descriptive, retrospective study. Data on medication consumption in 1997 were obtained from a pediatric university hospital. Information on conditions of drug use in children was analyzed using a Spanish catalog of medications. This information was compared with that of a North American catalog for international reference. RESULTS: Most of the drugs used were of unrestricted (43; 47 %) or restricted (26; 28 %) pediatric use, but drugs that are not recommended (8; 9 %) or those with unspecified conditions of use in children were also used (15; 16 %). Approximately 12 % of the drugs were not identified in the North American catalog; of the remaining drugs, 60 % were of unrestricted pediatric use, 35 % of restricted use and 5 % were not recommended. CONCLUSIONS: A substantial proportion of drugs administered to hospitalized children are not recommended or their possible use in this population is not specified. It is worth encouraging research, having sources of information that help to make decisions, especially in conditions that have not been approved, and adapting regulatory attitudes, as far as possible, to the evidence and therapeutic needs.
BACKGROUND: Studies carried out in other countries show that drugs are used in children outside the approved conditions, in a context in which investigation, information and authorization of medications in the pediatric population are scarce. OBJECTIVES: To evaluate the conditions of drug use recommended in children and variability in sources of drug information. METHODS: We performed a descriptive, retrospective study. Data on medication consumption in 1997 were obtained from a pediatric university hospital. Information on conditions of drug use in children was analyzed using a Spanish catalog of medications. This information was compared with that of a North American catalog for international reference. RESULTS: Most of the drugs used were of unrestricted (43; 47 %) or restricted (26; 28 %) pediatric use, but drugs that are not recommended (8; 9 %) or those with unspecified conditions of use in children were also used (15; 16 %). Approximately 12 % of the drugs were not identified in the North American catalog; of the remaining drugs, 60 % were of unrestricted pediatric use, 35 % of restricted use and 5 % were not recommended. CONCLUSIONS: A substantial proportion of drugs administered to hospitalized children are not recommended or their possible use in this population is not specified. It is worth encouraging research, having sources of information that help to make decisions, especially in conditions that have not been approved, and adapting regulatory attitudes, as far as possible, to the evidence and therapeutic needs.