Introduction
This section will introduce readers to fundamental ethical principles relating to nursing and healthcare, as well as some of the key legal concepts with which healthcare professionals should become familiar in order to ensure that decisions around pharmacology have a legal and ethical basis.
Any decisions made about pharmacology require consideration of various issues: what you are legally obliged to do, what you are professionally guided to do and what is in the best interests of the person within the situation. In practice, the three usually exist together; but before considering them as a whole, let's start with the fundamentals and look at them separately.
This chapter will consider the three components that underpin high‐quality decision‐making in pharmacology:
the law
ethical principles and theories
regulatory bodies.
The law
Laws exist to protect patients and the public. Recent years have seen changes in the culture within healthcare in the United Kingdom (UK), with a notable rise in litigation. Unlike some countries, where there is a ‘no‐blame’ process for medico‐legal cases, the UK system operates a ‘fault criterion’ whereby fault has to be established for the complainant to prove a case. Clinical negligence claims quadrupled between 2007 and 2017 (National Health Service Improvement (NHSI), 2019) leading to an exponential growth in the number of cases involving healthcare professionals who are forced to defend their practice in a court setting. Failing to monitor a particular drug therapy, failure to recognise the prescription of a contraindicated drug, failure to warn patients of adverse effects and neglecting to protect a patient from harm are all examples of pharmacology cases whereby blame could be laid. As our professional remit grows, so does the legal expectation. Given the amount of resources and information health professionals have access to, the defence of lack of knowledge is wholly insufficient.
Laws originate from two sources: Common Law, sometimes referred to as ‘Case’ Law, and Statute Law known as ‘Acts of Parliament’.
Common Law or Case Law refers to cases that are tried in courts of law, whereby a judge will give rule to a set of legal precedents. Common Law is constantly changing due to the ways in which judges interpret the law and use their knowledge of legal precedent and common sense as well as applying the facts of the case. Common Law safeguards that the law remains common throughout the land, and can be divided into either Criminal or Civil Law.
Statute Law or Acts of Parliament is law which is written down and codified into law. Acts begin as bills which then become Acts once the bills have been heard and possibly amended in the House of Commons and House of Lords before receiving ‘Royal Assent’. The Acts can either be private or public. Private Acts may apply to detailed locations within the UK or they may grant specific powers to public bodies, such as local authorities. Public Acts are the laws that affect the whole of the UK or one or more of its constituent countries: England, Wales, Scotland and Northern Ireland.
Healthcare and the law in the UK are strongly entwined. The laws created to protect the health of an individual can be seen when under the care of the hospital and its medical team, through to public health and the legal requirements of health and safety. Across the UK, the laws and charters that exist have been created to ensure that the rights and health interests of the individual are protected throughout the duration of their medical care. Healthcare professionals therefore have a legal duty to act with reasonable care when providing services. This ‘Duty of Care’ is defined as a ‘legal obligation imposed on individuals or organisations that they take reasonable care in the conduct of acts that could foreseeably result in actionable harm to another’ (Samanta and Samanta, 2011, p. 89). This includes prescribing drug therapy and drug administration, as well as consent, negligence and confidentiality – to name but a few. Failure to act with reasonable care could result in healthcare staff being held responsible in both criminal and civil courts.
Clinical considerations: The Bolam test
The majority of litigation in relation to medical malpractice comes under the category of negligence.
When considering cases of clinical negligence, courts will assess whether the health professional or organisation in question acted in line with the practice accepted as proper by a body of health professionals specialising in the specific field under scrutiny. This is known as the ‘Bolam’ test. The case (Bolam v Friern Hospital Management Committee, 1957), involved a patient who had suffered a fractured hip during electroconvulsive therapy (ECT). No relaxant or other restraint had been given to the patient in preparation for the treatment. The case explored this, along with the information the patient had been offered. The question was asked of a group of similar professionals and it was assessed that the practitioner had not been negligent as he had acted in accordance with accepted practice at that time. This set the standard and the Bolam test is now utilised in cases of negligence as a benchmark for whether the professional concerned acted in a reasonable manner. However, a judge can still make the assessment that the body of opinion is not reasonable.
There are several Acts or Laws that affect the provision of medicines which are illustrated on this timeline (see Figure 3.1).
Figure 3.1 Acts or laws affecting the provision of medicines.
Ethical principles and theories
Making ethical decisions is about deciding on the right way to act in a given situation; this is underpinned by the moral values held by an individual or group. In 1979, Beauchamp and Childress (1957) developed a four‐point theoretical framework to be used as a method of analysing ethical dilemmas in clinical medicine. The framework included beneficence, non‐maleficence, autonomy and justice. These principles remain in healthcare along with the addition of a further two principles. Today the following ethical principles apply:
beneficence
non‐maleficence
autonomy
justice
veracity
fidelity.
The principles outlined here are commonly felt to underpin judgments that health professionals believe to be right. First, beneficence, whereby we should endeavour to do good. This extends to protecting others and defending their rights, preventing harm and helping others. It is argued by some, such as Pellegrino (1988), that beneficence is the only fundamental principle within healthcare ethics and that the sole purpose of medicine should be to heal. By this assumption, medicines such as contraception, and treatments for conditions such as infertility, erectile dysfunction or aesthetics, could fall beyond its purpose. However, the notion of ‘healing’ is complex and dynamic, referring to more than just the rectifying of an immediate physical ailment or condition. Contraception, fertility treatment and plastic surgery support health and wellbeing in a myriad of direct and indirect ways, physically as well as psychologically, which is why the endeavour of beneficence is not as straight forward as it would first appear.
In practice,
