An inventory of European data sources for the long-term safety evaluation of methylphenidate
Year: 2013
Type: article
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.
Institutions: UCL School of Pharmacy, University College London, Heidelberg University, Central Institute of Mental Health, Universitätsklinikum Erlangen, University College Cork, Cork University Hospital, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, University of Dundee, Universitätsklinikum Aachen, Istituto Superiore di Sanità, St Thomas' Hospital, Evelina London Children's Healthcare, Ghent University, University of Southampton, University of Hong Kong
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,372
Funders: Eli Lilly and Company, University of Dundee, London School of Hygiene and Tropical Medicine, Università degli Studi di Cagliari, Bundesinstitut für Arzneimittel und Medizinprodukte, University of Southampton, King's College London, University College London, European Commission, University College Cork, Deutsche Forschungsgemeinschaft, Universität Heidelberg, Institut National de la Santé et de la Recherche Médicale, Radboud Universiteit, Bundesministerium für Bildung und Forschung, Istituto Superiore di Sanità, Servier, Lilly Deutschland, School of Pharmacy, University College London, National Institute of Mental Health, UCB Pharma, Cilag
OpenAlex ID: W1963955527