P0319 - A systematic review of the contra-indications in the summary of product characteristics for drugs licensed for ADHD in the UK

Abstract

Background and Aims:

The Summary of Product Characteristics (SPC) specify how to use a medicinal product safely and effectively. They are mandatory documents approved by the regulatory authority (EMEA). The content is compiled based on available evidence and is updated as new information becomes known. The safety of paediatric medicines is of paramount importance and the SPC's specify where a treatment should not be used through the contra-indications section. ADHD is a condition affecting 4-8% of the paediatric population and medicinal treatments are commonly used.

Methods:

A systematic review of the contra-indications for the licensed treatments for ADHD in the UK was undertaken. Data was extracted from the Electronic Medicines Compendium. Categorisation of contra-indications was done using relevant body systems. Where appropriate, language was reported verbatim. Atomoxetine is defined as a non-stimulant, methylphenidate and dexamfetamine as stimulants.

Results:

There are eight licensed treatments (1992-2007) falling into two categories; non-stimulants and stimulants.(1:7) Most SPC's (75%) have been amended from February to July 07.

Numbers of contra-indications; all treatments 3-20, all stimulants 9-20, methylphenidate formulations 10-20. There are inconsistencies in the specific contra-indications between the various formulations of methlyphenidate. The only contra-indication common to all treatments is glaucoma. All forms of methylphenidate are contra-indicated in marked anxiety/tension, diagnosis/family history of Tourettes, severe angina, arrythmias and hyperthyroidism. Atomoxetine is the only treatment with no cardiac or neurological contra-indications.

Conclusions:

The contra-indication section (4.3) of the SPC is a valuable tool when assessing the safety of comparative ADHD medications.