This article considers some current legal issues regarding non-medical prescribing highlighting some cases where prescribers have fallen foul of the law and the consequences of doing so. It will also review of some of the most recent case laws that have an affect on the delivery of safe, knowledgeable, care. These cases impact all types of prescribers and ignorance of these requirements is no defence in law.
The number of prescriptions dispensed in England in 2012 was 1.1 billion, which equates to 1900 prescriptions per minute. Of these prescriptions, 1.8% (18 million) originated from nurse prescribers and other non-medical prescribers, which showed a 10%, increase from 2011 (Health and Social Care Information Centre (HSCIC), 2013).
There were 232 708 registered doctors on the general Medical Council (GMC) register in 2016, of which 239 were referred to fitness to practise panels (FtP), with 72 of these removed from the medical register (GMC, 2016).
In the 2016/17 period, there were 53 967 registered pharmacists on the General Pharmaceutical Council (GPhC) register. There were a total of 1889 concerns raised and this led to the dismissal of 17 registrants. Several individual cases indicated issues with unsafe practice; poor recording of medicines received or dispensed, including controlled drugs; and incidents of misappropriation of pharmaceuticals, including pharmacists or pharmacy technicians illegally supplying or selling drugs such as fentanyl for recreational use (GPhC, 2017).
The Nursing and Midwifery Council (NMC) 2016/17 annual report states that there were 690 773 nurses and midwives on the register as of 31 March 2017. During that period, there were 5476 reported concerns leading to 1513 hearings regarding nurses and midwives conduct. Of these cases, 126 were concerned with prescribing and medicines management (NMC, 2016). Of the 1513 hearings, 344 nurses (23%) were struck off the register.
In April 2017, a registered nurse was running her own aesthetic and cosmetic business alongside her employment as a health visitor. The nurse had met a doctor on an aesthetics study course and he had signed a blank prescription form that she filled in with Botox for injection. The nurse then photocopied the prescription and submitted a further six copies, which were dispensed by the local pharmacist at a total cost of £3300 to the NHS.
Her behaviour was discovered when the pharmacist contacted the doctor with a query about one of the prescriptions that had been requested. The doctor was surprised to see he had been prescribing to people he did not recognise. The nurse was prosecuted and received an 8 month prison sentence, suspended for 18 months, alongside an order for 200 hours community service. The NMC decided that she should be struck from the NMC register indefinitely for ‘endangering patient's lives’.
In another case, a consultant cardiac care nurse specialist nurse raised suspicions at her hospital when nursing staff became concerned about her erratic prescribing behaviours in the cardiac care unit. She claimed she had been awarded her nurse prescribing qualification at a university that had no record of her ever being registered with them as a student.
The reality was that she had attended 2 study days about prescribing medications and had no formal prescribing qualification at all. She was dismissed by her employers and reported to the NMC.
She was struck from the register indefinitely.
Deciding the appropriate standard of care
Under the English and Welsh law, a patient can seek a remedy if the care given (or not given) is negligent and causes foreseeable harm. The legal remedy is via a process known as the ‘Tort law’ and is generally dealt with in the civil courts. Most cases are settled in the civil court and if found liable, financial damages may be awarded against the health professional; however, if cases of professional negligence are so extreme and seen to be ‘criminally negligent’, they can be tried in criminal court and attract a custodial sentence if it is decided the health professional is guilty of the offence, e.g. manslaughter.
In the case of FB v Princess Alexandra Hospital NHS Trust  following a telephone call to an out-of-hours service, a 13-month-old child was admitted to an emergency department (ED) of a hospital with a history of being unwell, having a pyrexia, erratic breathing and was rolling her eyes. It was the eye rolling that prompted the mother to seek medical advice. The child was admitted at 04:45, to the ED, seen by a triage nurse and then a Senior House Officer (SHO) at 05:20. The doctor gave a physical examination to the child and diagnosed an upper respiratory tract infection. The child was then discharged home at 05:55.
Over the next 12 hours, the child's condition worsened and she was re-admitted to hospital, seen by the paediatric team and given antibiotics. Some time later she was transferred to Great Ormond Street Hospital, where a diagnosis of pneumococcal meningitis with multiple brain infarcts was made resulting in permanent brain damage and deafness.
The SHO had not examined the child properly and her conduct had fallen below the reasonably expected standard of care, which then led to the child not being treated effectively and suffering brain damage as a result.
A key indicator of the child's condition was the occurrence of uncoordinated eye rolling and accompanying lethargy (due to the high level of bacteraemia) that would indicate ‘abnormal state variation’ (ASV) and appear more unwell than if they simply had an upper respiratory tract infection.
The SHO had failed to ask the parents why they had brought the child into hospital. Most health professionals consider that the child's parents know the child much better than anyone else and so signs of unusual behaviour in the child are usually identified by the parents first. These indicators should be taken seriously by the health professional examining the child.
It was argued in court that this type of inquiry about the child's condition was a failure of basic history-taking and fell below the reasonable standard of care that a competent SHO would be expected to provide. In this case, the doctor should be judged by the standard of a reasonably competent SHO in an ED. A proper history-taking and assessment may have reduced the risk that occurred. It was argued that history-taking is a basic skill at which doctors at all levels are expected to possess.
This case sets the standard by which non-medical prescribers will be judged in cases that come before the courts. Healthcare practitioners must display the ability to deliver safe, competent care and when they fail to show these skills they run the risk of not meeting the expected standard of care and may become liable in tort for damages.
The reasonable standard of care expected by a junior doctor was considered in the case of Wilsher v Essex AHA  where it was held that the level of care should be that of the post or position the doctor was covering for. Hence, if a junior was acting up to the level of a consultant, for example, the standard by which they are judged should be that of a consultant in that post, not the junior level.
The case of Wilsher v Essex AHA  reinforced Nettleship v Weston  where an inexperienced driver, involved in an accident, claimed because she was a learner driver, she should not be judged by the same standard as a qualified driver, rather, that a lower standard should apply. The case was settled against her with the precedent being set that the same standard of care applied to inexperienced as to experienced drivers. The application of this finding in non-medical prescribing is that an inexperienced prescriber cannot claim that the standard of care they deliver can be of a lower standard than a more experienced prescriber, simply because they are learning how to prescribe medications.
Patient autonomy, consent and information sharing
The law regarding patient consent and refusal along with a patient's right to autonomy was considered in Montgomery v Lanarkshire Health Board . Mrs Montgomery was expecting her first child and was under the care of an obstetric consultant. Mrs Montgomery had insulin-dependent diabetes and a small pelvis. These factors combined to increase the risk of a difficult delivery, as babies from mothers with diabetes can have more weight distributed around their shoulder area, which can cause the shoulder to get stuck in the pelvis at delivery, causing shoulder dystocia and oxygen deprivation. The risk is estimated around 9–10%. The consultant did not discuss this situation at all with Mrs Montgomery because she felt the risk was very small and as she stated in her defence, ‘if she was to say to every diabetic mother, that there was a small chance of the baby dying in labour, everyone would ask for a caesarean section, and it's not in the maternal interests to have a caesarean section’.
The baby's delivery was difficult and between his head appearing and delivery, his shoulder became impacted in the pelvis for around 12 minutes, occluding the umbilical cord and depriving him of oxygen. As a result, the baby was born with severe disabilities. The case was decided in Mrs Montgomery's favour and the consultant was found liable for damages (£5.2 million).
The importance of this decision is that the courts recognise that patients have the right to make choices about their treatment, the risks involved and the availability of other treatment options (including refusal of treatment) and that paternalistic attitudes are no longer acceptable. It is the health professionals’ duty to inform and advise, and the patient's right to decide.
With prescribed medications, the rationale for their use should be explained and any material risks, e.g. side effects, or other variant treatments should be offered, as this is all part of good medicines management and therapeutic patient care.
It is important for all prescribers to be aware of their limitations when assuming roles and responsibilities in the course of their work. The prescribers' competence will be measured against the reasonable expectations of that job role. The law and professional bodies require registrants to provide safe, knowledgeable, competent care to patients who expect appropriate advice that enables them to decide the treatment that is best for them. Standards of professional behaviour have to be maintained in and outside the work setting and if these are found to be inappropriate, professional bodies will investigate allegations of illegal or disreputable behaviours. If these are found to be proven, the consequences can be severe leading to loss of registration and loss of career.
This article was originally published in Nurse Prescribing
Mark Gagan, Senior academic, Bournemouth University, Faculty of Health and Social Sciences
- All registered medical and non-medical prescribers are accountable to their professional bodies who can require explanations regarding professional conduct and competence
- The autonomy of patients has to be respected particularly when deciding to accept or decline treatments suggested or recommended by health professionals
- The standard of explanation or information giving to a patients is centred on what a reasonably prudent person would wish to know about the risks and benefits of undertaking treatment, and not what the health professional thinks or decides the person should know
- All health professionals should be able to demonstrate a reasonable understanding of the laws and professional bodies' expectations that affect their practice and interaction with clients, patients and their families
CPD reflective questions
- How do I evidence that my patients receive the appropriate amount of information to enable them to make choices about the treatment they receive?
- Which communication strategies do I employ to ascertain that the clients/patients I interact with are fully engaged with the treatment plan offered to them? How do I evaluate these strategies?
- How do I keep up-to-date in order to remain compliant with legal and professional requirements that ensure safe, knowledgeable effective delivery of patient care? What evidence would I offer to prove this?
FB v Princess Alexandra NHS Trust  EWCA Civ 334
General Medical Council. Annual statistics for fitness to practice 2015. 2016. www.gmc.org/DC9491 07
Fitness to Practice_Annual_Statistics_Report_2015 (accessed 15 March 2018) General Medical Council. Fitness to practise statistics, 2016. 2016. https://www.gmc-uk.org/2016_fitness_ to_practise_annual_statistics.pdf_71779372.pdf (accessed 19 March 2018)
General Pharmaceutical Council. Annual fitness to practise report. 2016/17. 2017 https://www.pharmacyregulation.org/sites/default/files/pdf/ gphc_annual_report_2016-17.pdf (accessed 20 March 2018)
Health and Social Care Information Centre. Prescriptions Dispensed in the Community: England 2002-2012. 2013. file:///Users/sophie. gardner/Downloads/pres-disp-com-eng-2002-12- rep.pdf (accessed 15 March 2018)
Montgomery v Lanarkshire Health Board (Scotland)  UKSC 11 Nettleship v Weston  3WLR 370
Nursing and Midwifery Council. Annual Report and Accounts 2016–2017 and Strategic Plan 2017– 2018. 2017. https://www.nmc.org.uk/globalassets/ sitedocuments/annual_reports_and_accounts/ annual-report-and-accounts-2016-2017.pdf (accessed 15 March 2018)
Wilsher v Essex AHA  1QB 730