Dr Gerard Panting examines the legal position of those writing or acting upon recommendations in a guideline that later prove to be inappropriate
In a recent letter to the Journal of the Royal Society of Medicine, a consultant psychiatrist suggested that "in time, all guidelines will be shown to be partly or wholly wrong".1
It is clearly true that most, if not all, guidelines will become outdated as they are superseded by developments in clinical care. The most recent version of the Department of Health guidelines, Drug Misuse and Dependence Guidelines on Clinical Management ,2 acknowledges this.The foreword explains that "substantial changes in the extent and patterns of misuse and developments in treatment have required a revision of the guidelines and a new approach to their structure and content" and that "these guidelines will be subject to future review as appropriate".
However, the guidelines also state that "any doctor not fulfilling the standards and quality of care in the appropriate treatment of drug misusers that are set out in these clinical guidelines will have this taken into account if, for any reason, consideration of their performance in this clinical area is undertaken", a thinly veiled threat that those who do not follow the guidelines could find themselves struggling to defend their position.
So what if the authors of a guideline turn out to be wrong? Do they bear any liability if a patient comes to harm as a result of receiving substandard care that complies with a guideline that is outdated or simply incorrect?
It is extremely unlikely that a clinical negligence claim could be brought against the authors of a deficient guideline. First, the authors owe no duty of care to individual patients. A duty of care is essential in any negligence claim and without it there can be no recovery of compensation.
Furthermore, the authors will claim that their guidelines amount to no more than guidance for the treating clinician, who does have a duty of care requiring him to treat the patient in accordance with accepted medical practice.
They will argue that while the guidelines might set out the standard approach, deviation from it may be necessary to cater for the idiosyncrasies of a particular patient. The treating doctor is in a position to evaluate these and must take them into account when determining clinical management. The authors of the guidelines on the other hand, will not be aware of relevant individual factors and so cannot be prescriptive about the management of specific individuals.
A treating clinician may refer to authoritative guidelines in his or her defence. Provided they are applicable to the claimant and there is no reason for the doctor to believe that they were superseded or out of date, those guidelines will usually provide a sound basis for the defence, even if the guidelines themselves do not in retrospect enjoy the support of experts in the field.
It would be up to the claimant to prove that in the circumstances the doctor should have acted differently, notwithstanding the existence of the guidelines. That would depend upon clear expert evidence that the doctor knew, or should have known, that the management set out in the guidelines was not appropriate for that patient.
So does this mean that the authors of guidelines are unaccountable for the consequences of what they write?
Doctors who write guidelines are accountable to the General Medical Council for this area of their practice as for any other. Just as experts have been criticised for giving evidence adjudged illfounded in one recent case resulting in erasure from the Medical Register with immediate effect so guideline authors can expect severe censure if it is proved that in writing their guidelines they lacked the requisite degree of attention to available evidence on current best practice.
The GMC publication Good Medical Practice does not make any express reference to guidelines. However, its section on probity emphasises that before signing any documents,doctors should take reasonable steps to verify the content, and that they should not write or sign documents that are false or misleading.
The booklet's final paragraph states clearly that it "is not exhaustive. It cannot cover all forms of professional practice or misconduct which may bring your registration into question. You must therefore always be prepared to explain and justify your actions and decisions."
In preparing guidelines, authors must take all reasonable steps to ensure that their guidance reflects current practice as supported by the available evidence.
It is prudent to include a general statement that the guidelines cannot anticipate all possible circumstances and exist only to provide general guidance on clinical management to clinicians. All guidelines should be clearly dated and, where possible, active review dates should be set so that they can be revised before they become partly or wholly wrong.
- Marjot J. Legal considerations of clinical guidelines. J R Soc Med 2004; 97: 97.
- Department of Health, The Scottish Office Department of Health, Welsh Office, Department of Health and Social Services, Northern Ireland. Drug Misuse and Dependence Guidelines on Clinical Management. London:The Stationery Office, 1999.
- General Medical Council. Good Medical Practice. London: GMC, May 2001.