Key Points

• Many prescribers are now undertaking duties and procedures that were previously done by doctors.
• If a non-medical prescriber takes on a task that was previously undertaken by a medical practitioner, then their competence to perform that role needs to be at the level of a medical practitioner.
• Prescribers are accountable to the public through criminal law, their patients through civil law, and their employer and their profession through their contract of employment.
• To ensure that they abide by the law, a prescriber needs to keep their knowledge and skill up to date and to work within their competencies.

This article will give a general overview of the English legal system and describe how it operates in England, Wales, and Northern Ireland with respect to medical liability. Additionally, it will look at how the law would see prescribers in relation to their duties as practitioners and assess the legal ramifications for those working in England, Wales, or Northern Ireland.

Online Prescribing in England

There are several tiers to the English legal system, including criminal law and civil law.

• In criminal law, a person is detained by the police and charged with breaching the law. The Crown Prosecution Service brings the case to court, where the person has to be found ‘guilty beyond reasonable doubt’.
  
• In civil law, a person files a lawsuit against another person or business.. The case is heard in a civil court, and the person may be found guilty on a ‘balance of probability‘, rather than absolutely, as is the case in criminal cases. Because no one may be imprisoned in a civil court, it is easier to establish guilt.
  

Accountability

As a non-medical prescriber, you are accountable to:

• The patient, through civil law
• The public, through criminal law
• The profession, through the professional code of conduct.
• Your employer, through your contract of employment.

Accountability to the patient through civil law

A patient may file a civil lawsuit to recover damages if they were harmed or lost something as a result of your activities, especially if they were rendered unable to work.

The plaintiff (patient) would only have to prove on a ‘balance of probability’ that you were to blame. The practitioner’s professional standards would be used to establish liability, in general, there is often clause pertaining to:

You must be confident in your own evaluation of the patient or client before you can write a prescription for them. This assessment must include obtaining a complete history from them and, if at all feasible, viewing their whole clinical file.

Criminal law

• Criminal law is the system for the state punishment of offences.
• Under criminal law, a person can be imprisoned, have sanctions, such as movement restrictions (electronic tags), imposed against them or can incur financial penalties (fines).
• In a criminal case, the Crown usually brings the prosecution, known as the action, against the defendant.
• An individual may bring a private prosecution, but in practice, these are very rare.
• A criminal case is usually referred to as R v Smith, which is the Regina versus Smith.
• Regina is the official title of a reigning Monarch.
• Because the present monarch approved the laws, the person is breaking the laws endorsed by the Queen, hence R v Smith.
• 95% of all criminal cases are tried by a Magistrates’ Court.
• These courts are composed of justices of the peace (JP), who are laymen or women and not lawyers.
• They have limited powers, in as much as they can only give sentences up to 6 months’ imprisonment and/or a £5,000 fine.
• Magistrates try minor criminal offences, such as petty theft and road traffic offences, in a local courtroom.
• In addition, they hear evidence in relation to more serious criminal offences before committing these cases for trial at the Crown Court.
• In the Crown Court, cases are heard by a judge, usually sitting with a jury of 12 laypersons selected at random from the electoral register in the local community.
• Criminal charges in relation to the care of a patient are rare, but when they do arise they attract considerable publicity, such as the prosecution of Dr Harold Shipman in 2000.

Civil law

• In civil law, the action is brought by a person who has suffered harm or loss — known as the plaintiff — against another person or organisation — known as the defendant.
• The plaintiff seeks a remedy, usually in the form of financial compensation (damages). In addition, the plaintiff may claim an ‘injunction’ to stop a particular type of conduct.
• A civil law case is normally referred to as Bloggs v. Smith, and the legal term for a civil wrong is a tort.
• Examples of torts include negligence, trespass (to property, land or person), nuisance, breach of statutory duty and defamation.
• Civil cases, where the claim is for less than £50,000, are tried in a County Court (which is a local court); thus, county courts deal with 75% of all civil litigation.
• A judge will sit alone to settle these cases; however, cases where the claim is over £50,000 are tried in the High Court, and a jury can be called for these.

Public law

• In some situations, a person may want to challenge a decision of a government body, health authority or other public body.
• They may claim that the public body went beyond the powers given to it by statute or that it has wrongly exercised a discretion granted under statute.
• Such claims against public bodies are called ‘judicial reviews’ and the court determines if the public body has acted legally.
• The Royal Brompton Hospital in London is presently seeking a judicial review in an attempt to block the closure of its children’s heart surgery unit as part of plans for major reorganisations of the NHS.

Accountability to the public through criminal law

If you intended to do harm to your patient and knowingly gave them a drug that would cause harm, the police would investigate and could prosecute you for administering a noxious substance so as to endanger life or inflict grievous bodily harm (GBH). The Offences Against the Persons Act 1861 contains two offences of wounding or causing GBH, under Sections 18 and 20. Section 18 is by far the most serious because it carries a maximum sentence of life imprisonment, whereas the maximum sentence under Section 20 is 5 years. The difference is that the prosecution must prove that you intended to cause serious bodily harm under Section 18, whereas they need to only show that you acted recklessly under Section 20.

Under both sections, an assault that causes grievous bodily harm or wounding is defined as follows: ‘To constitute a wound the whole skin must be broken. It must be more than a scratch, but one drop of blood would be sufficient.’ Grievous bodily harm must be ‘really serious harm’, an obvious example of which would be a broken bone. There is no legal definition of grievous bodily harm, however, and it is ‘a question of fact’, for a jury to decide.

Both offences under Section 18 and Section 20 are arrestable under Section 24 of the Police and Criminal Evidence Act 1984. They would be tried at Crown Court because either offence carries the potential for a lengthy jail term.

If it is shown that your carelessness led to the death of your patient, you may be prosecuted for manslaughter. Criminal charges are uncommon but may generate a lot of media attention.

Coroner’s Court

• The coroner must be a barrister, solicitor or registered medical practitioner with at least 5-years standing.
• The main jurisdictions of the coroner are inquests into the death of a person who appears to have died a violent or unnatural death or where death occurred in a prison or psychiatric hospital.
• The purpose of an inquest is to establish the cause of death.
• A coroner may summon a jury of 7–11 people.

You are responsible for your choice to prescribe, and you may only do so in situations when you are adequately informed about the patient’s health and medical background. You would be held accountable if it could be demonstrated that you fell short of the required standard, for example, by failing to determine whether a patient was allergic to penicillin or by prescribing a prescription that interacts negatively with their current treatment.

Accountability to your employer through disciplinary action

Your employer may discipline you if your acts were work-related, especially if you violated your employment contract by failing to follow the right processes and rules.

Accountability to the profession through the professional governing body

Your professional body can remove your name from their register to stop you from practising as a professional if you do not follow their code of conduct. The Council for Healthcare Regulatory Excellence (CHRE) is an independent, non-departmental public body funded by the Department of Health and answerable to Parliament. It scrutinises and oversees the work of nine regulatory bodies, including the NMC, the General Medical Council (GMC), and the Health Professional Council. If the CHRE considers that the decision by a regulatory body has been unduly lenient, it could refer the case to the High Court for a decision.

Professional indemnity insurance

Most professional organisations now insist that practitioners have their own professional indemnity insurance. Whilst employers have vicarious liability for the negligent acts and/ or omissions of their employees, such cover does not normally extend to activities undertaken outside the registrant’s employment. Independent practice would not be covered by vicarious liability. It is the individual registrant’s responsibility to establish their insurance status and take appropriate action.

In situations where an employer does not have vicarious liability, it is recommended that registrants obtain adequate professional indemnity insurance. If unable to secure professional indemnity insurance, a registrant will need to demonstrate that all their clients and patients
are fully informed of this fact and the implications this might have in the event of a claim for professional negligence.

Role expansion

Role expansion is particularly important to prescribers because many are undertaking duties and procedures that were previously done by doctors. In this new role, the prescribers are signing prescriptions, which was a role formerly done by doctors.

Consider the tasks and duties that you undertake. Which of these were previously done by a doctor?

The GMC defines delegation in their Good Medical Practice (GMC, 2006) guide as

‘…asking a colleague to provide treatment or care on your behalf. Although you will not be accountable for the decisions and actions of those to whom you delegate, you will still be responsible for the overall management of the patient, and accountable for your decision to delegate. When you delegate care or treatment, you must be satisfied that the person to whom you delegate has the qualifications, experience, knowledge and skills to provide the care or treatment involved. You must always pass on enough information about the patient and the treatment they need.’

It can, therefore, be argued that the delegating doctor may be negligent if they fail to follow the guidelines listed above. The boundaries between tasks that are undertaken as part of an expanded role and those that follow from delegation are unclear. The law has no mechanism to find a team negligent; rather, it would find particular individuals negligent and usually this is the person in charge.

To bring a successful claim of negligence it is necessary to prove the following:

• The patient (plaintiff) was owed a duty of care by the defendant (prescriber).
• The defendant (prescriber) breached that duty of care by failing to reach the standard required of them by law.
• That the breach caused harm.
• That the harm is of a type that was foreseeable.

Duty of care

The plaintiff (patient) must first establish that the defendant (prescriber) owed him a legal duty of care. In medical negligence, the existence of a duty owed to the patient is usually regarded as automatic, even if the patient has left the hospital. A duty of care appears to be owed as soon as the patient presents for treatment.

This was established by the case Donoghue v Stephenson (1932), in which the House of Lords held, for the first time in this country, that there could be a liability for negligently causing personal injury (Donoghue v Stephenson [1932] AC 562). A decomposing snail was discovered
in a bottle of ginger beer made by the manufacturer, Stephenson, after Mrs Donoghue had drunk some of it.

The basic concept of the law of negligence is: ‘You must take reasonable care to avoid acts or omissions which you can reasonably foresee which would be likely to injure your neighbour. Who then-in-law is my neighbour? The answer seems to be persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts or omissions which are called in question.’
This clearly would show that a duty of care could be established for anyone to whom you issued a prescription.

Breach of standard

The court will have to decide whether a non-medical prescriber or other healthcare professionals or carers have met the standard that the law expects them to meet.
When a non-medical prescriber performs their usual duties, the standard of practice required is that of the ordinary skilled person in his or her speciality. The Bolam test is currently the standard by which the courts in England and Wales assess doctors’ clinical practice (Bolam v Friern Hospital Management Committee [1957] 2 AllER 118; WLR 528). However, the principles of the Bolam test can be applied to examine the actions of any professional person. Similar standards operate in Scotland and Northern Ireland. ‘The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill at the risk of being found negligent…it is sufficient if he exercises the skill of an ordinary competent man exercising that particular art.’

The key words here are professing and exercising.

• Professing is what you say you are — nurse, pharmacist or physiotherapist — and what level you are in your profession.
• Exercising is what you do, i.e. what task were you actually doing?

Doing your job properly is a defence against accusations of negligence. How- ever, if you are performing an expanded role, then the standard is different. The leading case in this area is Wilsher v Essex Area Health Authority (1986) (Wilsher v Essex Area Health Authority [1986] 3 All ER 801). In this case, the plaintiff, Martin Wilsher, was born about 3 months prematurely. He was in a special care baby unit and he was very ill. An inexperienced junior doctor inserted an arterial line into a vein, rather than into an artery. He asked a senior doctor to check the line, but the registrar failed to notice the mistake; furthermore, when the registrar replaced the line himself, hours later, he made the same mistake. The error resulted in a low blood oxygen measurement being recorded, and the infant was given excess oxygen. This caused retrolental fibroplasia, which left Martin Wilsher blind.

A key issue discussed by the Court of Appeal was the standard of legal care to be exercised by the junior doctor in the case. Lord Mustill stated: ‘In a case such as the present, the standard is not just that of the averagely competent and well-informed junior houseman (or whatever the position of the doctor) but of such a person who fills a post in a unit offering a highly specialised service.’
Lord Glidewell stated: ‘In my view, the law requires the trainee or learner to be judged by the same standard as his more experienced colleagues. If it did not, inexperience would frequently be urged as a defence to an action for professional negligence.’ The case was settled for £116,724.40, and the registrar, but not the house officer, was found to be negligent because the junior had done the reasonable thing and asked his superior for supervision. The key point to be taken from the Wilsher case is that a practitioner is liable to be judged by the professional standard of the post that they are holding at the time. This means that, if the practitioner
is performing an expanded role that was previously carried out by a doctor,
the practitioner would be judged by the standard of a reasonably competent doctor performing that role or in that post. If a practitioner undertakes a task for which they have insufficient training, this in itself may constitute negligence.

Of the tasks you undertake that were previously performed by a doctor, do you think you reach the same standard as a doctor? Many new posts have been created, such as transplant clinician’s assistants and cardiac surgeons’ assistants, and many different healthcare professionals can occupy these posts. How would you judge their standard of care?

The courts would have difficulty in assessing the appropriate standard of care for a professional if only one or two posts exist in the country. The court could look at the nature of the tasks performed and determine who normally performs those tasks. If doctors normally undertake these tasks, then a medical standard of care and skill will be expected. Some useful criteria that a court might take into account when determining the standard of care in an expanded role case, could include:

• The nature of the task.
• The way the practitioner ‘holds themself’ to patients.

If the prescriber takes on a task that was previously undertaken by a medical practitioner, then their competence to perform that role needs to be at the level of the medical practitioner. The courts may be looking for the non-medical prescriber to exercise and maintain medical knowledge, and if the non-medical prescriber does not reach the correct standard of competence to do that task, they could be found negligent and in breach of their professional code of conduct.

Inexperience is not a defence to a negligence action. It is very important that prescribers closely adhere to the principles of their professional code of conduct and, in particular, take steps to remedy any deficits in their knowledge. If you are, for example, a physiotherapist performing a task done solely by physiotherapists, and the patient sees you as a physiotherapist and not as another practitioner, you would be judged under the Bolam test. Hence it is important that the patient knows your profession. Alternatively, if the patient had good reason to believe you were a doctor (you were not wearing a uniform or the patient saw you in a GP’s surgery), you might be judged under the standard of care seen in the Wilsher case (i.e. as a doctor).

Causation

The claimant must now demonstrate that the negligent act or omission caused the injury complained of once the duty of care and failure to reach the requisite level of care has been established. The criteria used to determine causality have changed throughout time. If the defendant hadn’t acted or failed to act negligently, would the plaintiff have been injured? That is the first issue the court would require an answer for. This test is known as the “but for” test.

According to civil law, the court must be convinced that the negligent act or omission caused the injury on a balance of probability. It must be demonstrated that there is at least a 50% chance that it was the cause. In complicated medical situations, this is especially challenging.

Foreseeability

Only those harms that are foreseeable can be recovered. In Roe v. Ministry of Health and Others, Woolley v Same (1954), two patients had operations. Before both operations, a spinal anaesthetic consisting of Nupercaine® was administered to the patients by lumbar puncture. The plaintiffs were permanently paralysed from the waist down. The injuries were caused by the Nupercaine® being contaminated by phenol; the ampoules had been immersed in phenol, which had percolated through the glass. Because it was an unforeseeable occurrence, the defendant was not legally expected to anticipate the danger (Roe v Ministry of Health and Others, Woolley v Same [1954] 2 All ER 131).

Lord Denning stated ‘Every surgical operation is attended by risks. We cannot take the benefits without taking the risks. Every advance in technology is also attended by risks. Doctors, like the rest of us, have to learn by experience, and experience often teaches the hard way. Something goes wrong and shows up as a weakness, and then it is put right.

Summary

To bring a successful negligence claim it is necessary to prove the following:

• The plaintiff (patient) was owed a duty of care by the defendant (prescriber).
• The defendant (prescriber) breached that duty of care by failing to reach the standard required of them by law.
• That the breach caused harm.
• That the harm is of a type that was foreseeable.

The defence for a prescriber against negligence is that the prescriber is aware of the standard of care expected for the position they hold and that they have the necessary competencies to maintain that standard of care. To ensure defence, a registered prescriber needs to keep up to date in the knowledge and skills required for the position and work within their competencies. They must also ensure that any deficiencies in their knowledge or skills are corrected before they start prescribing in a particular area.