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Clinical law
Friday 03 March 2023


A recent judgement considered the case of John Berry, a patient who suffered ototoxicity after receiving gentamicin whilst dependent on haemodialysis. He was seventy when he was admitted with myocardial infarction and rapid clinical decline, the latter possibly resulting from a hospital-acquired pneumonia. Following previous surgery for renal cancer, he had for some time undergone haemodialysis for end-stage renal failure and was immunosuppressed with steroids to provide symptom relief for his rheumatoid arthritis. His deteriorating condition raised the spectre of forthcoming sepsis, and on clinical grounds it was decided to give him 400 mgm of gentamicin. This is a drug excreted by the kidney, thus gentamicin toxicity in patients with renal failure is foreseeable.

One of the questions for the court was whether the prescription of 400 mgm gentamicin (which was in accordance with the local intensive care guideline but inconsistent with national guidelines, and others in use at the hospital) equated to substandard care. The court concluded after a lengthy narrative that in this particular patient’s clinical circumstances, the prescription was reasonable. But the judge ‘earnestly hoped’ that the hospital concerned would review and revise its relevant guideline urgently: ‘Clinical guidelines are very important clinical tools and should be considered and written to reflect best practice…”

While guidelines may be applicable to a clinical situation, the court found that what ultimately matters is that clinical management is reasonable, in the sense that (i) it conforms with practice accepted as proper by a responsible body of practitioners in that field; and that (ii) the practice accepted as proper by the responsible body can withstand independent forensic scrutiny, in the form of logical analysis.

Guidelines are neither a substitute for clinical judgment in an individual case, nor a shortcut for the approaches taken in (i) & (ii). This is made clear by NICE, the GMC and the Courts. Nevertheless, clinicians acting reasonably will consider whether clinical guidelines, either local or national, may be applicable to the patient in front of them.

National guidelines may provide reassurance that a responsible body of practitioners consider that a particular aspect of clinical management is reasonable. Alternatively, if the national guideline is unsatisfactory because it is flawed or incomplete or incoherent, then variance from it may not require detailed explanation. However, a clinician needs to pause and reflect before preferring an ‘in-house’ guideline, particularly if he or she contributed to its creation. The reassurance given by a national guideline is that there is less risk that one is marking one’s own homework. Nevertheless, in highly specialised practice, where your unit may be a source of national standards, ‘independent’ logical analysis of proposed treatment plans and their inherent disadvantages may be forthcoming from peer reviewed publications, and multidisciplinary and multi professional debate.

Departure from a national guideline is not necessarily indicative of substandard care. But it is likely to call for explanation. That explanation will most probably be based on the unusual facts presented by the patient concerned. It is foreseeable that the diversity of patient characteristics will occasionally render even the ‘best‘ guideline inapplicable. The court considered that Mr Berry's co-morbidities of cardiac and renal failure and immunosuppression, together with the fear of impending sepsis provided a diversity of characteristics that rendered the application of the existing gentamicin guidelines inapplicable. The departure from national guidelines was justified by good logical cogent reasons.

In general, guidelines relating to frequently performed clinical activities in patients who fall close to the centre of the normal distribution curve in their clinical characteristics are likely to be reliably applicable. By contrast, clinicians seeking guidance in a rare clinical encounter with a patient whose clinical presentation or phenotype is unusual are more likely to find difficulty in adhering to guidelines, local or national, designed for patients representing the majority of the population. In this latter situation, clinical judgment based upon a balancing exercise between the risks and benefits related to clinical management of that particular patient on that particular day may be the safest approach.

Dr Robert Wheeler
Department of clinical law