Can you ignore guidelines?BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7495.s143-a (Published 09 April 2005) Cite this as: BMJ 2005;330:s143
Sometimes it is not in a patient's best interests for a doctor to follow clinical guidelines. Paul Colbrook, medicolegal adviser at the Medical Defence Union, considers the risk of legal action
Health professionals' adherence to clinical guidelines, particularly those laid down by the National Institute for Clinical Excellence (NICE), are rarely out of the headlines. A recent study by researchers at York University found that implementation of NICE guidance was patchy,1 and another study by Cancer Research UK's Health Behaviour Unit showed a significant minority of general practitioners (GPs) didn't prescribe smoking cessation treatments recommended by NICE.2 Media reports of studies like these often refer to doctors facing legal action for not subscribing to guidelines, but is this really the case?⇓
With the focus on evidence based practice, it is perhaps not surprising that doctors are faced with a plethora of new guidelines. NICE guidelines are perhaps the best known, but many other bodies, such as the royal colleges, NHS screening programmes, and various health charities, also produce them. All aim to help doctors to use the best available evidence when making clinical decisions.
However, the profusion of guidance can occasionally create dilemmas for doctors. The Medical Defence Union (MDU) receives around 30 calls a month from doctors about guidelines. Common questions include whether doctors must follow guidelines and what legal status they have.
Where to adhere to guidelines
Where guidelines carry a weight of authority by virtue of their source (such as NICE guidelines) or where they become widely accepted into everyday practice (such as the British Thoracic Society's guidelines for the management of asthma) then a doctor would be expected to be aware of and follow them unless, in their clinical judgment, it would not be in the patient's best interests to do so. But that is not to say that guidelines need to be adhered to in every case. As the chairman of NICE, Professor Sir Michael Rawlins, said: “No guideline can cover 100 per cent [of patients] because people vary. It's up to the doctor or other health professional to decide when the guideline is no longer applicable and what to do in its place.”3
A patient in his mid 50s with hypertension and type 2 diabetes visits his GP. His total cholesterol is resistant to treatment. The GP assesses the patient's 10 year risk of a coronary event as being unacceptably high and explains that he'd like to prescribe further treatment to reduce his lipid level in line with NICE guidance. Unfortunately, the patient has had side effects with a number of lipid lowering drugs and asks whether he has to have the treatment. The GP is concerned that he may be criticised for not prescribing a lipid lowering drug and wonders if he can act outside the guidance.
The GP rings the MDU for advice and is advised to consider the recommendations made in the guidelines and discuss these with the patient in the light of his history and comorbidities. The doctor would need to give sufficient information about the risks and benefits of each possible choice to allow the patient to reach an informed decision. If the patient refused treatment after this discussion, the GP must respect this decision. The GP is advised to keep detailed records of his discussions with the patient and the reasons for his actions. The MDU adviser also suggests the GP considers offering the patient a referral for a second opinion and recalling the patient at an appropriate time to see if he changes his mind.
Doctors have a legal and ethical duty to act in the best interests of an individual patient, while making efficient use of the resources available to them. They must be able to justify either following the guidelines or acting outside them, on a patient by patient basis. In some cases it will not be in a patient's best interest to follow guidelines. Doctors should use their clinical judgment to decide whether to adhere to the guidelines in relation to an individual patient. But they should bear in mind that they may be asked to justify their decision and should keep a detailed record of their reasoning.
Guidelines in the dock
But how would a doctor who did not follow guidelines fare in the civil courts if the patient later sued the doctor alleging negligence? In a clinical negligence claim the courts use the Bolam principle to establish whether a doctor has acted in accordance with a “responsible body of reasonable medical opinion.” Simply because a doctor did not follow a particular set of guidelines does not prove negligence. Courts rely on expert evidence to determine what is reasonable practice. Experts guide the courts as to whether there is a responsible body of opinion which would reasonably have adopted the same course of action as the doctor concerned, regardless of whether the doctor followed guidelines.
If a doctor clearly documents the reasons for deviating from general guidelines for the management of a condition, and can show that he or she acted in keeping with a responsible body of medical practice in doing so, then he or she should be able successfully to defend an allegation of negligence.
While following widely accepted guidance that is supported by expert opinion can help considerably towards a successful defence, doctors who do not follow guidelines for a justifiable reason supported by experts are not necessarily negligent.
Although guidelines do not establish or replace the Bolam principle, they may shape what is considered reasonable practice, and it may be difficult to show that action outside authoritative guidelines was an appropriate course of action.
All doctors have an ethical obligation to keep up to date throughout their careers, and this includes a requirement to be aware of the latest guidelines.
Guidelines are just that—they provide guidance. They do not and should not imply that doctors must suspend their clinical judgment in order to follow to the letter what has been written down. Because no two clinical situations are exactly the same, it is important for doctors to maintain their freedom to decide on the most appropriate treatment strategy for their patient, taking into consideration individual factors and relevant guidelines. While ignorance of guidelines is a poor defence, a reasoned and justifiable decision to deviate from guidelines in an individual case, backed up by good clinical records made at the time, may be acceptable.
This case is fictitious but is based on cases from MDU files. Doctors with specific concerns are advised to contact their medical defence organisation for advice.