[Analysis of the new active principles sold in Spain (1992-2002)]. / Análisis de los nuevos principios activos comercializados en España (1992-2002).

OBJECTIVES: To describe the active principles (AP) marketed in Spain from 1992 to 2002, to determine their characteristics, and to find whether they supposed genuine therapeutic advances (TA). DESIGN: Transversal, descriptive study. MAIN MEASUREMENTS: The degree of TA in the AP analysed was studied with the classification used by the FDA (A*: exceptional therapeutic novelty; A: important therapeutic novelty; B: modest therapeutic improvement; C: null or very little therapeutic improvement, corresponding to "me-too" drugs; and D: not classified), the context of use and the price. RESULTS: 369 new AP were marketed. 3.5% were in group A*, 11.9% in A, 30.1% in B, 49.3% in C, and 5.1% in D. 42.3% corresponded to AP used in hospitals for therapy or diagnosis. Significant differences were found (P<.05) on comparing the degree of TA and the context of use, such that more AP in the A/A* (32.6%) and B (44.0%) groups were found in AP used in hospital therapy and diagnosis than in AP used in primary care and generally (5.3% in the A/A* groups and 23.4% in group B). Only 11 AP of the A/A* groups were used in primary care. The cost per defined daily dose was 17.6 euros; and the new AP in group C were dearer than already existing alternatives in 93.4% of cases. CONCLUSIONS: Real TA are few in number and preferentially used in hospitals. Almost all the new AP are "me-too" drugs and are dearer than already existing alternatives.

Análisis de los nuevos principios activos comercializados en España (1992-2002) / Anañysis of the new active principles sold in Spain (1992-2002)

Objetivo. Describir los principios activos (PA) comercializados en España en el período 1992-2002 para determinar sus características y si suponen verdaderos avances terapéuticos (AT). Diseño. Estudio descriptivo, transversal. Mediciones principales. Se estudiaron el grado de AT de los PA analizados con la clasificación de la Food and Drug Administration (A*: novedad terapéutica excepcional, A: importante mejora terapéutica, B: modesta mejora terapéutica, C: nula o muy pequeña mejora terapéutica correspondiente a los fármacos me-too y D: sin calificación), el ámbito de uso y el precio. Resultados. Se comercializaron 369 nuevos PA. El 3,5% era del grupo A*, el 11,9% del A, el 30,1% del B, el 49,3% del C y el 5,1% del D. El 42,3% correspondió a PA de uso o diagnóstico hospitalario. Se hallaron diferencias significativas (p < 0,05) al comparar el grado de AT y el ámbito de uso, de manera que la proporción de PA de los grupos A/A* (32,6%) y B (44,0%) fue superior en los PA de uso o diagnóstico hospitalario respecto a los de uso general y atención primaria (5,3% del grupo A/A* y 23,4% del grupo B). Sólo 11 PA del grupo A/A* fueron de uso en atención primaria. El coste por dosis diaria definida fue de 17,6 e y los nuevos PA del grupo C fueron en el 93,4% de los casos más caros que las alternativas ya disponibles. Conclusiones. Los verdaderos AT son escasos en número y su uso es preferentemente hospitalario. Casi todos los nuevos PA son fármacos me-too y más caros que las alternativas ya disponibles

Objectives. To describe the active principles (AP) marketed in Spain from 1992 to 2002, to determine their characteristics, and to find whether they supposed genuine therapeutic advances (TA). Design. Transversal, descriptive study. Main measurements. The degree of TA in the AP analysed was studied with the classification used by the FDA (A*: exceptional therapeutic novelty; A: important therapeutic novelty; B: modest therapeutic improvement; C: null or very little therapeutic improvement, corresponding to "me-too" drugs; and D: not classified), the context of use and the price. Results. 369 new AP were marketed. 3.5% were in group A*, 11.9% in A, 30.1% in B, 49.3% in C, and 5.1% in D. 42.3% corresponded to AP used in hospitals for therapy or diagnosis. Significant differences were found (P<.05) on comparing the degree of TA and the context of use, such that more AP in the A/A* (32.6%) and B (44.0%) groups were found in AP used in hospital therapy and diagnosis than in AP used in primary care and generally (5.3% in the A/A* groups and 23.4% in group B). Only 11 AP of the A/A* groups were used in primary care. The cost per defined daily dose was 17.6 euros; and the new AP in group C were dearer than already existing alternatives in 93.4% of cases. Conclusions. Real TA are few in number and preferentially used in hospitals. Almost all the new AP are "me-too" drugs and are dearer than already existing alternatives

El gasto sanitario en atención primaria: además de la Cenicienta, el Patito Feo del cuento / Health costs in primary care: as well as Cinderella, the Ugly Duckling

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