National Institiue for Health and Clinical Excellence

Annual Review - 2012/2013

Support for medicines and prescribing from NICE

NICE provides a comprehensive suite of advice and support products to help the NHS deliver quality, safety, and efficiency in the use of medicines.

We provides support for medicines and prescribing through:

  • Good practice guidance to support best practice in medicines management and use
  • Advice on medicines optimisation including support for QIPP[PM1] .
  • Specific medicines advice, for example on unlicensed and off-label drugs.
  • Formulary information, through provision of the British National Formulary (BNF)

This year, NICE launched a range of products and services providing medicines advice.

Evidence summaries: new medicines

These products aim to provide high quality information to the NHS in England about the best available evidence for selected new medicines, or for existing medicines with new indications.

The summaries are aimed at commissioners, budget holders and groups such as Area Prescribing Committees.

In 2012/13, 18 summaries were produced covering topics such as lixisenatide for type 2 diabetes, lurasidone for schizophrenia, and lisdexamfetamine dimesylate for attention deficit hyperactive disorder in children and young people.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE which oversees this work, said: "Our Evidence summaries for new medicines take the process a step beyond the regulatory requirements needed for a new drug to be able to be prescribed.

“So as well as considering the strengths and limitations of the available evidence of the drug's safety and efficacy, they also consider the context of the new drug in terms of what other treatments are available for the condition and their cost, as well as the likely place of the new drug in local prescribing and its estimated cost impact for the NHS.”

He added: “Where there is no technology appraisal from NICE, these summaries help to ensure consistent access to evidence for decision-makers."

Visit our website for a full list of published new medicines summaries.

Evidence summaries: Unlicensed and off-label medicines

Unlicensed and off-label medicines have a valuable role in the care of certain patients when there are no suitable licensed medicines available which meet their needs. Yet, it can be difficult to find information on whether these medicines are safe and effective, and when they are most likely to yield good patient outcomes. This is particularly the case for certain rare diseases, where there are often not enough patients to enlist on the clinical trials that are needed to develop a drug.

‘Evidence summaries: unlicensed and off-label medicines’ summarise the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS where there are no clinically appropriate alternatives.

This year, we published seven summaries that cover topics such as tranexamic acid for significant haemorrhage following trauma and metformin in women not planning pregnancy for polycystic ovary syndrome.

Professor Mark Baker said: “Up until now there has been a lack of nationally available, good quality information about using unlicensed and off-label medicines.

“This new resource from NICE, while not formal guidance, will help to ensure that the decisions of clinicians and the choices made by patients are properly informed and made on the basis of the best available evidence.”

He added: “It will also help avoid potential duplication of effort where, as happens currently, different NHS organisations undertake their own analyses of the evidence - NICE will save them the trouble by doing it once.”

A full list of published unlicensed and off-label medicines summaries is available from our website.

Good Practice Guidance

Good practice guidance provides advice and guides good practice for those involved in handling, prescribing, commissioning and decision-making about medicines. The outputs have a wide range of audiences across both health and social care environments.

In December 2012, we published our first piece of good practice guidance on developing and updating local formularies. The guide provides recommendations for the systems and processes needed to ensure NHS organisations develop and update local formularies effectively and in accordance with statutory requirements, to support the managed introduction, utilisation or withdrawal of healthcare treatments.


Over the past year, we have hosted a number of free events and workshops for medicines managers and providers, which offer face-face advice and training.

We held workshops on the safe and effective use of controlled drugs, support for prescribing in the digital age, and managing medicines in care homes.

Melatonin to treat sleep disorders in children with attention deficit hyperactivity disorder (ADHD)

In January 2013, NICE produced an evidence summary on the unlicensed and off-label use of melatonin to treat sleep disorders in children and young people with ADHD.

Up to 3 per cent of all children and young people have ADHD, making it one of the most common behavioural disorders among younger people.

Common symptoms include an inability to concentrate for very long or finish a task, hyperactivity and a tendency towards being impulsive. Between 50 and 60 per cent of children with ADHD also experience sleep disorders, which include problems with getting to sleep or staying asleep.

NICE’s evidence summary examined the evidence for the use of melatonin to help promote sleep among children with ADHD. Melatonin is a naturally occurring hormone, which is involved in coordinating the body’s sleep-wake cycle and helping to regulate sleep.

Although one melatonin product – Circadin (Circadin®Flynn Pharma Ltd) – is licensed for use in treating sleep disorders in the UK, it is not licensed for use in people aged under 55. Its use in children and young people is therefore known as ‘off-label’.

Other melatonin products are available from specialist suppliers and on the internet. These are not licensed for use in any patient group in the UK and so are known as ‘unlicensed'.

NICE found that melatonin appeared to improve sleep, and was relatively safe in the short term (using it for up to 4 weeks) and medium term (using it for up to 18 months), based on the small amount of evidence available.

NICE added that since the studies were small, infrequent side effects may not have been detected. It also found that while unlicensed melatonin appeared safe in the short-term, safety in the long-term in children and young people with ADHD is unclear.

Our Evidence summaries for new medicines take the process a step beyond the regulatory requirements needed for a new drug to be able to be prescribed