People have the right to be able to make informed decisions about their care. Our guidance should be taken into account when making decisions with them.
We're working with other leading health organisations to encourage shared decision making between the people receiving and delivering care.
When we recommend medicines we expect that healthcare professionals will prescribe or advise their use within the terms of their UK marketing authorisations, as described in manufacturers' summaries of product characteristics (SPCs). SPCs for most medicines can be found in the electronic medicines compendium.
Healthcare professionals should take note of the contraindications, warnings, safety recommendations and any monitoring requirements for the medicine. These are explained in the SPC for the medicine, the British National Formulary (BNF) or British National Formulary for Children (BNFC).
Off-label or unlicensed use
Sometimes we recommend a medicine for a particular condition or patient group when this is not within the medicine's marketing authorisation, or by a route that is not within the marketing authorisation. This is known as ‘off-label’ or ‘unlicensed’ use.
We do this only if there is enough evidence or experience to support it and we make it clear in our guidance when we do so. Healthcare professionals should follow relevant professional guidance. They should take full responsibility for the decision when prescribing or advising the use of off-label or unlicensed medicines. This includes considering the contraindications, warnings, monitoring requirements and other safety recommendations for the medicine.
You can find more information on this at:
- General Medical Council's prescribing guidance: prescribing unlicensed medicines
- Medicines and Healthcare products Regulatory Agency's drug safety update for off-label or unlicensed use of medicines.
- NHS medicines information.
Our recommendations are based on:
- the trade-off between the benefits and harms of an intervention
- the quality of the underpinning evidence.
Some recommendations are made with more certainty than others. We word our recommendations to reflect this. Where there is clear and strong evidence of benefit, we will use the word 'offer'. Where the benefit is less certain we use the word 'consider'.
For more information take a look at our developing NICE guidelines: the manual.
Remember that abuse and neglect:
- is common
- may also exist alongside other health problems or social care needs
- can happen anywhere, including in emergency departments and primary care.
Consider or suspect abuse as a contributory factor or cause of an injury in adults or children at risk.
Our guidance and quality standards on safeguarding will provide you with more information.
Professional guidelines, standards and laws
There are laws and professional standards that should be followed when making decisions. We have complied a list of organisations and key information which may help you.
- Care Act 2014.
- Care Quality Commission.
- Code of practice that accompanies the Mental Capacity Act for when people do not have the capacity to make decisions.
- Department for Education's guidance on working together to safeguard children.
- Department of Health and Social Care's advice on getting consent, including advice on consent, children and young people under 16.
- GMC's decision making and consent guidance: Decision making and consent - GMC.
- Health and Social Care Act (2012)
- Montgomery v Lanarkshire Health Board  UKSC 11 - Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (PDF)
- NHS England's Accessible Information Standard.
- NHS Constitution for England.
- NICE guidance on what people should expect from care in the NHS and social care.
- OFSTED.Public health outcomes framework for England 2016 to 2019.