title: [Medicines for children and "off-label use" 5 years after implementation of the Paediatric Regulation (EC) No 1901/2006. An interim analyis].
abstract: Regulation EC 1901/2006, better known as the "Paediatric Regulation," targets the challenging aim of improving the supply of pharmaceutical products for children and adolescents living in Europe. In order to counteract the much-debated and long-standing problem of "off-label" use within paediatrics, the Paediatric Regulation established two new paediatric procedures in order to increase the number of medicines licensed for children in future. This article reports on the outcomes of these procedures, covering the period from 2007 to the present. The aim was to find out how many substances underwent the paediatric procedures and how many medicinal products have been approved explicitly for children as a result. In the second part, a prioritized off-label analysis was conducted focusing on the top 100 substances most frequently prescribed to children and adolescents in Germany in 2011. The top 100 substances consist of the respective top 20 substances of five therapeutic areas. The prescription scores are based on the GAmSi project of the National Association of the Statutory Health Insurance of Germany. The rankings refer to outpatient care and cover the statutory health-insured paediatric population of Germany below 18 years of age, divided into two age groups, children and adolescents. In order to investigate whether the most frequently prescribed substances are labelled for paediatric use, 200 SmPCs were screened and evaluated (cut-off date: 31 December 2012). In a final step, the relation between the top 100 substances and the Paediatric Regulation was examined. For this purpose, it was investigated whether the listed substances are or have been subject to the paediatric procedures in order to identify potential positive impacts of the Paediatric Regulation.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland, anna.afentaki@bfarm.de.
authors.forename: A
authors.initials: A
authors.lastname: Afentaki
mesh_terms: D000293:Adolescent; D017677:Age Distribution; D002648:Child; D002675:Child, Preschool; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D017723:Drug Utilization Review; D005260:Female; D005858:Germany; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007880:Legislation, Drug; D008297:Male; D056687:Off-Label Use / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D010372:Pediatrics / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data* / Q000639:trends; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data / Q000639:trends