Information on the number of prescriptions issued is not available, only on the number of prescription items written and dispensed. Dispensing information is held for England only. The following table provides the number of methylphenidate hydrochloride prescription items written in the United Kingdom and dispensed in the community in England, for each complete calendar year since 1995.

The following table shows the number of prescription items dispensed for the Ritalin brand of methylphenidate hydrochloride has declined in the latest available 10 year period. In the same period prescription items dispensed for all methylphenidate hydrochloride, as listed in British National Formulary section 4.4 ‘CNS stimulants and drugs used for attention deficit hyperactivity disorder’, increased.

The Medicines and Healthcare products Regulatory Agency (MHRA) led a European review of the risks and benefits of methylphenidate that concluded in January 2009. Throughout this review independent scientific expert advice was obtained from the Commission on Human Medicines on the available evidence. This concluded that the benefits of methylphenidate-containing medicines continue to outweigh their risks, when they are used in their approved indication for children aged six years or over and adolescents with attention deficit hyperactivity disorder (ADHD), as part of comprehensive treatment programmes.

As a result of this review the prescribing guidance and information for patients has been updated to ensure it contains clear, comprehensive information about the effects of methylphenidate and the importance of monitoring children and adolescents throughout their treatment. The marketing authorisation holders for methylphenidate

products have also been asked to conduct studies to further characterise the safety of methylphenidate, particularly the long-term safety. The safety of methylphenidate remains under close review and information from the ongoing studies will be evaluated as soon as it becomes available.

NICE published technology appraisal guidance in March 2006 which recommended methylphenidate within its licensed indication as an option for the treatment of ADHD. NICE also published a clinical guideline in September 2008 on the diagnosis and management of ADHD in children, young people and adults which recommends methylphenidate as a treatment option subject to certain criteria.

NICE reviewed the need to update the clinical guideline in October 2011 and decided that it would not be updated at that time. We understand that NICE plans to consider the guideline for an update again in July 2014. Further information is available at:

http://guidance.nice.org.uk/CG72

If an update is made to a drug's marketing authorisation by the regulator, NICE will consider updating its published guidance.

There have been no recent discussions with pharmaceutical companies about publishing the results of clinical trials of antidepressants in children.

NICE is an independent body and any such discussions are a matter for the Institute. As part of its technology appraisal process, NICE asks for full access to all the relevant information that is available to the marketing authorisation holder for the medicine being appraised.

The Secretary of State for Health, the right hon. Member for South West Surrey (Mr Hunt) has not had discussions with his counterparts in the European Union on the matter of pharmaceutical companies publishing all results of the testing of new drugs. However, publishing results from all authorised clinical trials is planned as a development of the current EU Clinical Trials Register later this year and is further being considered as part of the proposed EU clinical trials regulation. The MHRA is leading the discussions on behalf of the United Kingdom and the topic will be considered in the coming months. Also, the MHRA has been involved in discussions on the commitment of the European Medicines Agency to publish clinical trial data that has been submitted as part of applications for a Marketing Authorisation.

Information is not available on the number of people prescribed a particular medicine. Methylphenidate is approved in the European Union for children aged six years or over and adolescents with attention deficit hyperactivity disorder, as part of comprehensive treatment programmes. It is for doctors to decide whether and at what point to review continued treatment.

Information is not available on the number of people prescribed a particular medicine. Methylphenidate is approved in the European Union for children aged six years or over and adolescents with attention deficit hyperactivity disorder, as part of comprehensive treatment programmes. It is for doctors to decide whether and at what point to review continued treatment.