Pearse Doherty (Donegal South West, Sinn Fein)
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Question 158: To ask the Minister for Health the legislation, regulations and guidelines currently in place pertaining to the use of psychiatric, psycho stimulant psychotropic drugs such as ritalin and prozac on minors; if he is satisfied that these regulations ensure that only drugs which have been adequately and independently tested in clinical trials are prescribed; and if he will make a statement on the matter. [28725/12]

Róisín Shortall (Dublin North West, Labour)
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Medicines must be authorised by the Irish Medicines Board or at European level, by the European Commission, before they are marketed in Ireland. A company wishing to market a medicine, makes an application including clinical trial safety, efficacy and pharmaceutical quality data. These data are reviewed by the competent authority and if the risk/benefit balance of the medicine is considered positive, the medicine receives a marketing authorisation.

There is substantial EU legislation and guidelines on the content and format of applications and specific legislation covering medicines intended for use in children including information on the clinical trial data required.

In addition to being controlled as a prescription medicine, Ritalin (methylphenidate) is controlled under the Misuse of Drugs Regulations 1988. As a controlled drug, it is an offence to supply or possess methylphenidate except in accordance with a prescription, licence or other authority.

Ritalin is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and over when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood and/or adolescent behavioural disorders. Patients should be evaluated at commencement of treatment and be continuously monitored.

Prozac (fluoxetine) is controlled under the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended) and is indicated for the treatment of moderate to severe depression in children and adolescents aged 8 years and above that are unresponsive to psychological therapy. Treatment should be initiated and monitored under specialist supervision.

The safety and efficacy of Prozac was reviewed by IMB in consultation with the scientific committee of the European Medicines Agency in 2006. The safety and efficacy in the approved indications was considered positive and the currently authorised product information reflects these data.

The IMB continues to review the safety of authorised medicines and takes appropriate regulatory action when necessary. The authorised product information for Ritalin, Prozac and other medicines is available from the IMB website: www.imb.ie .