An inventory of European data sources for the long-term safety evaluation of methylphenidate

• Published in: European child & adolescent psychiatry Vol. 22; no. 10; pp. 605 - 618
• Main Authors: Murray, Macey L., Insuk, Suppachai, Banaschewski, Tobias, Neubert, Antje C., McCarthy, Suzanne, Buitelaar, Jan K., Coghill, David, Dittmann, Ralf W., Konrad, Kerstin, Panei, Pietro, Rosenthal, Eric, Sonuga-Barke, Edmund J., Wong, Ian C. K.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-10-2013; Springer Nature B.V
• Subjects: Adolescent; Adverse Drug Reaction Reporting Systems; Attention Deficit Disorder with Hyperactivity - drug therapy; Attention deficit hyperactivity disorder; Blood pressure; Cardiovascular system; Central Nervous System Stimulants - adverse effects; Central Nervous System Stimulants - therapeutic use; Child; Child & adolescent psychiatry; Child and Adolescent Psychiatry; Child, Preschool; Children; Children & youth; Data Collection; Databases, Factual; Europe; Health; Hospitals; Humans; Hyperactivity; Italy; Medicine; Medicine & Public Health; Methylphenidate - adverse effects; Neurosciences; Original Contribution; Patients; Pediatrics; Pharmacovigilance; Pharmacy; Product safety; Psychiatry; Registries; Research methodology; Safety; Teenagers; Young adults; Europe; United Kingdom > UK; Aachen Germany; Germany; Database(s); Paediatric; Attention deficit hyperactivity disorder (ADHD); Drug safety; Methylphenidate
• ISSN: 1018-8827; 1435-165X
• DOI: 10.1007/s00787-013-0386-x

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.