title: An inventory of European data sources for the long-term safety evaluation of methylphenidate.
abstract: To compile an inventory of European healthcare databases with potential to study long-term effects of methylphenidate (MPH) in patients with attention deficit hyperactivity disorder (ADHD). Potential databases were identified through expert opinion, the website of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, and literature search. An online survey was conducted among database providers/coordinators to ascertain the databases' appropriateness for inclusion into the inventory. It included questions about database characteristics, sample size, availability of information on drug exposure, clinical data and accessibility. Forty-two databases from 11 countries were identified and their coordinators invited to participate; responses were obtained for 22 (52.4 %) databases of which 15 record ADHD diagnoses. Eleven had sufficient data on ADHD diagnosis, drug exposure, and at least one type of outcome information (symptoms/clinical events, weight, height, blood pressure, heart rate) to assess MPH safety. These were Aarhus University Prescription Database, Danish National Birth Cohort (Denmark); German Health Interview and Examination Survey for Children and Adolescents; Health Search Database Thales, Italian ADHD Register, Lombardy Region ADHD Database (Italy); Avon Longitudinal Study of Parents and Children, General Practice Research Database, The Health Improvement Network, QResearch (UK) and IMS Disease Analyzer (UK, Germany, France). Of the 20 databases with no responses, information on seven from publications and/or websites was obtained; Pedianet and the Integrated Primary Care Information database were considered suitable. Many European healthcare databases can be used for multinational long-term safety studies of MPH. Methodological research is underway to investigate the feasibility of their pooling and analysis.
authors.affiliation: Centre for Paediatric Pharmacy Research, University College London School of Pharmacy, London, UK, macey.murray@ucl.ac.uk.
authors.forename: Macey L
authors.initials: ML
authors.lastname: Murray
authors.forename: Suppachai
authors.initials: S
authors.lastname: Insuk
authors.forename: Tobias
authors.initials: T
authors.lastname: Banaschewski
authors.forename: Antje C
authors.initials: AC
authors.lastname: Neubert
authors.forename: Suzanne
authors.initials: S
authors.lastname: McCarthy
authors.forename: Jan K
authors.initials: JK
authors.lastname: Buitelaar
authors.forename: David
authors.initials: D
authors.lastname: Coghill
authors.forename: Ralf W
authors.initials: RW
authors.lastname: Dittmann
authors.forename: Kerstin
authors.initials: K
authors.lastname: Konrad
authors.forename: Pietro
authors.initials: P
authors.lastname: Panei
authors.forename: Eric
authors.initials: E
authors.lastname: Rosenthal
authors.forename: Edmund J
authors.initials: EJ
authors.lastname: Sonuga-Barke
authors.forename: Ian C K
authors.initials: IC
authors.lastname: Wong
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003625:Data Collection; D016208:Databases, Factual; D005060:Europe; D006801:Humans; D008774:Methylphenidate / Q000009:adverse effects*; D060735:Pharmacovigilance; D012042:Registries; D012449:Safety
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate