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

Macey L Murray,Ralf W Dittmann,Eric Rosenthal,Tobias Banaschewski,Pietro Panei,David Coghill,Suppachai Insuk,Edmund J Sonuga-Barke,Kerstin Konrad,Ian C K Wong,Antje C Neubert,Jan K Buitelaar,Suzanne Mccarthy

doi:10.1007/s00787-013-0386-x

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.

Highlights

As a first-line pharmacological therapy for attention deficit hyperactivity disorder (ADHD), methylphenidate (MPH) is widely prescribed in children and adolescents and to a lesser extent to adults
A range of different methods were used to identify eligible databases: from those listed on the website of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), a systematic review of the published literature and by nominations from members of the ADDUCE Consortium
Responses were obtained from 22 (52.4 %) database coordinators/providers in seven European countries (Table 1). Seven of these 22 databases did not contain information on ADHD diagnosis; 15 databases were included in the detailed assessment

Summary

Introduction

As a first-line pharmacological therapy for attention deficit hyperactivity disorder (ADHD), methylphenidate (MPH) is widely prescribed in children and adolescents and to a lesser extent to adults. The efficacy of MPH in ADHD has been robustly demonstrated in randomised controlled trials with approximately 70 % of children, adolescents and adults showing a therapeutic response [1]. In order to control the acute and chronic adverse effects of medication, often patients on long-term ([1 year) drug treatment have a structured interruption of treatment (known as a drug holiday). This allows monitoring to ensure medication is still effective, and assessment of whether the balance between adverse effects and therapeutic effects favours the continuation of treatment [3]

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Conclusion