Title An inventory of European data sources for the long-term safetyevaluation of methylphenidate

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 On behalf of the Attention deficit hyperactivity disorder drugs use chronic effects (ADDUCE) project, European Community’s 7th framework programme project number 260576. M. L. Murray (&) S. Insuk A. C. Neubert I. C. K. Wong Centre for Paediatric Pharmacy Research, University College London School of Pharmacy, London, UK e-mail: macey.murray@ucl.ac.uk T. Banaschewski R. W. Dittmann Department of Child and Adolescent Psychiatry, Medical Faculty Mannheim, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany e-mail: tobias.banaschewski@zi-mannheim.de R. W. Dittmann e-mail: ralf.dittmann@zi-mannheim.de A. C. Neubert Department of Paediatric and Adolescent Medicine, University Hospital Erlangen, Erlangen, Germany e-mail: antje.neubert@uk-erlangen.de S. McCarthy School of Pharmacy, University College Cork, Cork, Ireland e-mail: S.McCarthy@ucc.ie S. McCarthy Pharmacy Department, Cork University Hospital, Cork, Ireland J. K. Buitelaar Department of Cognitive Neuroscience, Radboud University Nijmegen Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands e-mail: JB@psy.umcn.nl D. Coghill Division of Neuroscience, Medical Research Institute, University of Dundee, Dundee, UK e-mail: d.r.coghill@dundee.ac.uk K. Konrad Section of Child Neuropsychology, Department of Child and Adolescent Psychiatry, University Hospital Aachen, Aachen, Germany e-mail: kkonrad@ukaachen.de P. Panei Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy e-mail: pietro.panei@iss.it 123 Eur Child Adolesc Psychiatry (2013) 22:605–618 DOI 10.1007/s00787-013-0386-x 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.