Case study You are working in an emergency department as an advanced clinical practitioner (ACP). It is very busy, there is a long wait and very little space to see new patients. You assess Kamal, a 65-year-old male with a 2-week history of productive cough with purulent sputum. There are coarse crackles left midzone to base and a chest X-ray demonstrates left lower lobe consolidation consistent with community acquired pneumonia. Full blood count shows raised white cells and neutrophils, and his renal function is unremarkable. You calculate the CURB-65 score as 1, based on age (Lim et al, 2009). Kamal knows he is taking ‘something for the heart’ but can’t remember exactly what, and is allergic to penicillin. Following local guidelines, you prescribe clarithromycin 500 mg tablets twice daily for 5 days and reassure him that things should clear up, but he will need a follow-up chest X-ray in 6 weeks.
After the 5 days, Kamal is brought to hospital by his daughter following a 2-day history of dark stool and a collapse at home. He is haemodynamically unstable with low haemoglobin and is treated for an upper gastrointestinal haemorrhage with admission for urgent endoscopy.
Looking back at Kamal’s notes, you realise that in your haste to assess and discharge you overlooked his drug history: Kamal takes aspirin 75mg daily plus ticagrelor 90mg twice daily following a non-ST elevation myocardial infarction 6 months ago. You also review the local Microguide and the British National Formulary, and realise that concurrent use of ticagrelor and clarithromycin is contraindicated, because as a CYP3A4 inhibitor, clarithromycin will increase exposure to ticagrelor, resulting in a significant increase in bleeding risk ( Joint Formulary Committee, 2020; Milpharm Ltd, 2021).
What are the legal issues? There are two decisions to be scrutinised in Kamal’s case—firstly, whether the decision to prescribe clarithromycin concurrently with ticagrelor constitutes clinical negligence; and secondly, whether failure to disclose possible side effects of the treatment constitutes negligence. Clarithromycin is a licensed medicine indicated for mild-tomoderate community-acquired pneumonia ( Joint Formulary Committee, 2020; Milpharm Ltd, 2021). Therefore, there is no question about the legitimacy of the prescription itself.
Did Kamal give informed consent to the treatment prescribed? In an accompanying article in this series considering patient autonomy, Nordoff (2021) argues that if a patient is not told about likely side effects, they cannot make an informed choice about whether to follow a course of treatment or take a prescribed medicine. This is an important point about patient autonomy; however, in this case, failure by a clinician to provide sufficient information, for example, about the risks of treatment remains a claim of negligence, rather than a claim that consent to treatment was invalid (Herring, 2020).
Law on negligence While criminal action can be brought for gross negligence manslaughter, the majority of litigation against healthcare professionals is in civil cases of negligence. A claimant must establish (i) that the professional being sued owed a duty of care; (ii) that the duty of care was breached; and (iii) that breach of the duty caused the claimant’s loss (Herring, 2020).
It is widely accepted that health professionals owe their patients a duty of care, after which establishing breach of duty requires application of the Bolam test (Bolam v Friern Hospital Management Committee, 1957) which seeks to establish whether the defendant’s actions were above the minimal acceptable practice and consistent with a reasonable body of medical opinion (Herring, 2020). If there is breach of duty, it must be shown that your negligent act caused the injury (causation) using the ‘but for’ test (Turton, 2016). Can the claimant show that ‘but for’ the action of the defendant, they would not have suffered harm? Put simply, did your negligent act make a difference?
The law applied to Kamal’s case Duty of care As the assessing clinician who has prescribed medication, it is conceivable that you could injure Kamal. There is a sufficiently close relationship between you as clinician and the patient, and there is no public policy overriding duty of care. This establishes that you owe a duty of care to Kamal.
Breach of duty of care The Bolam test applies to clinical decisions involving medical skill, including consideration of appropriate treatments (Herring, 2020). Applying the test to the decision to prescribe clarithromycin, the standard of care that a professional must exercise is that of a standard practitioner in the specialty (Wilsher v Essex Area Health Authority, 1974). Therefore, one might expect an advanced paramedic or ACP working in an emergency department to be assessed against the standard of other ACPs performing a similar role, rather than directly compared to a doctor, who might previously have been the only professional undertaking elements of this role such as clinical assessment and prescription of medicines.
Journal of Paramedic Practice • Vol 13 No 10