Update information

Update information

April 2018: Footnotes and cautions in the guideline have been added and amended to link to the MHRA's latest advice and resources on sodium valproate. Medicines containing valproate taken in pregnancy can cause malformations in 11% of babies and developmental disorders in 30–40% of children after birth. Valproate treatment must not be used in girls and women including in young girls below the age of puberty, unless alternative treatments are not suitable and unless the terms of the pregnancy prevention programme are met. This programme includes: assessment of patients for the potential of becoming pregnant; pregnancy tests; counselling patients about the risks of valproate treatment; explaining the need for effective contraception throughout treatment; regular (at least annual) reviews of treatment by a specialist, and completion of a risk acknowledgement form. In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation. See the MHRA toolkit to ensure female patients are better informed about the risks of taking valproate during pregnancy.

August 2017: Footnotes were added to recommendations 1.2.3, 1.4.27, 1.4.28 and 1.4.29 with a link to the MHRA toolkit on the risks of valproate medicines in female patients. A crosslink in recommendation 1.8.23 was updated to link to the NICE guideline on violence and aggression. Footnotes were added to recommendations 1.4.17 and 1.9.9 advising people that the UK Drugs in Lactation Advisory is available as an additional resource when seeking advice about specific drugs.

September 2016: The link in recommendation 1.4.25 has been updated.

June 2015: Corrected timescales for GAD-2 in recommendation 1.5.4.

This guideline updates and replaces NICE guideline CG45 (published February 2007).

Recommendations are marked as [2018], [new 2014], [2014] or [2007]:

  • [2018] indicates a recommendation reviewed in 2014 that has had a footnote on sodium valproate added or amended during the April 2018 update

  • [new 2014] indicates that the evidence has been reviewed and the recommendation has been added or updated

  • [2014] indicates that the evidence has been reviewed but no change has been made to the recommended action

  • [2007] indicates that the evidence has not been reviewed since 2007.

Strength of recommendations

Some recommendations can be made with more certainty than others. The Guideline Development Group makes a recommendation based on the trade‑off between the benefits and harms of an intervention, taking into account the quality of the underpinning evidence. For some interventions, the Guideline Development Group is confident that, given the information it has looked at, most patients would choose the intervention. The wording used in the recommendations in this guideline denotes the certainty with which the recommendation is made (the strength of the recommendation).

For all recommendations, NICE expects that there is discussion with the patient about the risks and benefits of the interventions, and their values and preferences. This discussion aims to help them to reach a fully informed decision.

Interventions that must (or must not) be used

We usually use 'must' or 'must not' only if there is a legal duty to apply the recommendation. Occasionally we use 'must' (or 'must not') if the consequences of not following the recommendation could be extremely serious or potentially life threatening.

Interventions that should (or should not) be used – a 'strong' recommendation

We use 'offer' (and similar words such as 'refer' or 'advise') when we are confident that, for the vast majority of patients, an intervention will do more good than harm, and be cost effective. We use similar forms of words (for example, 'Do not offer…') when we are confident that an intervention will not be of benefit for most patients.

Interventions that could be used

We use 'consider' when we are confident that an intervention will do more good than harm for most patients, and be cost effective, but other options may be similarly cost effective. The choice of intervention, and whether or not to have the intervention at all, is more likely to depend on the patient's values and preferences than for a strong recommendation, and so the healthcare professional should spend more time considering and discussing the options with the patient.

Recommendation wording in guideline updates

NICE began using this approach to denote the strength of recommendations in guidelines that started development after publication of the 2009 version of 'The guidelines manual' (January 2009). This does not apply to any recommendations ending [2007] (see 'Update information' above for details about how recommendations are labelled). In particular, for recommendations labelled [2007] the word 'consider' may not necessarily be used to denote the strength of the recommendation.

ISBN: 978-1-4731-0875-2

  • National Institute for Health and Care Excellence (NICE)