[Use of antibiotics in Spain and regulatory framework for clinical development in the European Union].

The high use of antibiotics in the community is closely related to the increase in resistance to antibiotics. Monitoring antibiotic use is a key step to understanding whether trends are changing, and in this way efforts towards more prudent use can be implemented. Over the last 9 years, available active ingredients have decreased in Spain while at the same time the number of antibiotic offerings has increased. Presentations of generic pharmaceutical specialties account for almost 50% of the most frequently used subgroups. The use of antibiotics remains stable or shows a slight decrease depending on the unit of measure (DID or PIM) used. These differences are explained mainly by amoxicillin-clavulanate, since in recent years packages with greater concentrations and greater number of pharmaceutical formulations per package have been used. Ten active ingredients constitute 80% of antibiotic use. Throughout the study period, more than 50% of total antibiotic use was due to amoxicillin-clavulanate and amoxicillin. There is significant seasonal variation in the use of antibiotics. Peaks in influenza incidence are correlated with the maximum consumption of antibiotics. The criteria on which the marketing authorization for medication, including antibiotics, is based are quality, safety and effectiveness, regardless of the registration procedure used. The criteria that dictate the use of these antibiotics in clinical practice go beyond the purely regulatory framework. For this reason, it would be useful to have clinical practice guidelines based on broad consensus that incorporate criteria for a more rational use of antibiotics, such as the local prevalence of resistance.