There is a vast amount of guidance for GPs covering clinical decision-making, legal and ethical practice, and local policies and procedures. The primary purpose of guidelines is to improve the quality and safety of care provided to patients. They're an invaluable tool for promoting efficient healthcare delivery and ensuring this is done consistently throughout healthcare settings.
However, despite the benefits of clinical guidelines, they can also have their limitations and potentially be harmful if inflexible, by preventing clinicians to tailor care to individual patients.
In circumstances where guidance conflicts with individual clinical judgement, it is important to know the legal status of guidance and how to apply it to the specific situation.
In the latest version of Good medical practice (2024), the GMC states that "you must keep up to date with guidelines and developments that affect your work [and] follow the law, our guidance on professional standards, and other regulations relevant to your work."
When providing clinical care, the GMC also expects you to "propose, provide or prescribe effective treatment based on the best available evidence."
Therefore, the starting point is to be aware of the relevant guidance, which includes:
- national organisations such as the Royal Colleges, NICE and the Scottish Intercollegiate Guidelines Network (SIGN)
- regulators such as the GMC and CQC
- local organisations such as your Integrated Care Board (ICB) or health board.
Departing from guidelines
Guidelines inform clinical practice and promote consistent application of standards. However, they do not replace clinicians’ knowledge and skills or override patients' wishes.
Clinicians can make a conscious and justifiable decision to depart from guidelines in specific situations when they consider it best serves the patient’s needs, and after discussion with the patient. NICE says that while "health and social care professionals are actively encouraged to follow our recommendations to help them deliver the highest quality care…our recommendations are not intended to replace the professional expertise and clinical judgement of health professionals, as they discuss treatment options with their patients".
In seeking consent from the patient (or their legal representative), the decision to depart from the relevant guidelines should be explained to the patient, outlining the alternatives and possible outcomes. In line with the GMC guidance on consent and the Montgomery judgement, they must be provided with information about all material risks; including any risk where a reasonable person in the patient's position would attach significance.
The discussion should be recorded along with the reasons for departing from guidance and the patient’s consent in their clinical records. Clinicians must be prepared to explain and justify their decisions and actions.
Degrees of certainty
In some cases, it will be more difficult to depart from established guidance, particularly when it has been produced by a nationally recognised body or regulator or reinforces legislation. For example, the CQC has produced extensive guidance for providers on how they can meet their legal obligations under the Health and Social Care Act 2008. Failure to adhere to its guidance could lead to enforcement action.
Some organisations acknowledge that not all guidance will be appropriate in every situation and doctors will need to use their clinical judgement to determine the best way forward. Both the GMC and NICE have developed their own terminology to reflect this.
The GMC's guidance, including Good medical practice (2024), uses the following terms:
- 'you should’, for duties or principles that either:
- may not apply to you or to the situation you’re currently in, or
- you may not be able to comply with because of factors outside your control.
- 'you must’, which reflects "a legal or ethical duty you’re expected to meet (or be able to justify why you didn’t)".
NICE says "some recommendations can be made with more certainty than others" and uses the following terms:
- 'offer’, 'advise’, 'ask about’ or similar directive terms, where an intervention should (or should not) be used
- 'consider', to reflect an intervention where there is a closer balance between benefits and harms
- 'must’ and 'must not’, where there is a legal duty to follow a recommendation, or the consequences of not doing so are extremely serious.
Medico-legal consequences
Doctors are right to be concerned about what might happen if there is a clinical negligence claim following treatment where it was necessary to depart from guidelines.
It can help build a successful defence of a claim if you can demonstrate you followed widely accepted guidance, supported by expert opinion. However, it is equally possible to mount a successful defence of a GP who has not followed guidelines because it is not clinically appropriate for that patient, especially if this involves the patient’s informed consent and there is a clear and contemporaneous record of the steps that took place.
It's advisable to talk to your medical defence organisation or a senior colleague if you're considering departing from current guidance. Discussing the specific situation should help you clarify the issues and ensure your decision is justifiable.
This article was originally published in GPonline on 8 September 2023.
This page was correct at publication on 11/09/2023. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.
by Dr Ellie Mein Medico-legal adviser
MB ChB MRCOphth GDL LLM
Ellie joined the MDU as a medico-legal adviser in 2013. Prior to this she worked as an ophthalmologist before completing her Graduate Diploma in Law in Birmingham.