Written Question · S2W-13786 · Session 2
Further to the answer to question S2W-12905 by Mr Andy Kerr on 19 January 2005, whether it is satisfied that adequate clinical trials and r…
The question
To ask the Scottish Executive, further to the answer to question S2W-12905 by Mr Andy Kerr on 19 January 2005, whether it is satisfied that adequate clinical trials and research have been carried out to ensure that prescribing Ritalin to children under 16 is safe.
The answer
Ritalin (methylphenidate hydrochloride) is authorised for use in children aged six years and over for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the assessment of all requests for authorisation to market drugs. Before a new marketing authorisation, or a variation to an existing authorisation, can be granted, data from pre-clinical and clinical trials must be submitted to the MHRA by the applicant.
The agency has advised that Ritalin was assessed for quality, safety and efficacy at the time of authorisation. The product information for Ritalin contains comprehensive information on the recognised side-effects of treatment.
As with all medicines, the safety of Ritalin is continually monitored by the MHRA and the expert independent advisory body the Committee on Safety of Medicines.
More information about the MHRA and the medicines licensing process can be found on:
www.mhra.gov.uk.
The Chief Scientist Office (CSO), within the Scottish Executive Health Department, has responsibility for funding and supporting research into health and healthcare needs in Scotland. The CSO is currently funding research into treatment with methylphenidate in boys with ADHD. The research will investigate whether chronic treatment with methylphenidate leads to tolerance or sensitisation, two processes associated with the development of substance misuse problems.
The National Research Register (NRR), a UK-wide research database, records that there are 11 on-going research projects in the UK on ADHD. Details of these projects are available from the NRR, a copy of which is in the Parliament’s Reference Centre (Bib. number 17404).
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the assessment of all requests for authorisation to market drugs. Before a new marketing authorisation, or a variation to an existing authorisation, can be granted, data from pre-clinical and clinical trials must be submitted to the MHRA by the applicant.
The agency has advised that Ritalin was assessed for quality, safety and efficacy at the time of authorisation. The product information for Ritalin contains comprehensive information on the recognised side-effects of treatment.
As with all medicines, the safety of Ritalin is continually monitored by the MHRA and the expert independent advisory body the Committee on Safety of Medicines.
More information about the MHRA and the medicines licensing process can be found on:
www.mhra.gov.uk.
The Chief Scientist Office (CSO), within the Scottish Executive Health Department, has responsibility for funding and supporting research into health and healthcare needs in Scotland. The CSO is currently funding research into treatment with methylphenidate in boys with ADHD. The research will investigate whether chronic treatment with methylphenidate leads to tolerance or sensitisation, two processes associated with the development of substance misuse problems.
The National Research Register (NRR), a UK-wide research database, records that there are 11 on-going research projects in the UK on ADHD. Details of these projects are available from the NRR, a copy of which is in the Parliament’s Reference Centre (Bib. number 17404).
In the Official Report
No contribution in the Official Report cites S2W-13786 by reference.