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, in order to do good, medical interventions and treatments can often carry a risk of harm and therefore require justification. Non‐maleficence means that by our actions, we should do others no harm. The principle of non‐maleficence therefore cannot be absolute and must be balanced against beneficence. For example, when treating patients with cytotoxic chemotherapy drugs for cancer, we balance beneficence (the potential to do good and eradicate the cancer) against non‐maleficence and the risk of the chemotherapy itself to cause the patient's condition to deteriorate, possibly leading to death.
It is also generally believed that people should have the right to make decisions about what is right for them, provided they have sufficient capacity or understanding to do so. This principle is a respect for the autonomy of the individual and relates to enabling patients to make self‐determined decisions regarding their care. Consent to treatment is a fundamental component of ethical patient care in addition to a legal requirement. It involves a genuine agreement (verbal or written) to receive treatment under circumstances where the patient has been assessed as competent, has been fully informed and where there is no undue pressure exerted (Herring, 2018). Beauchamp and Childress (1957) have argued that no decision can be truly autonomous, as patients rarely have the relevant knowledge to hold a full understanding of treatment options and, as such, are vulnerable to the coercion of health professionals who feel that they are best placed to make decisions in the interests of their patients (paternalism). However, increasingly patient groups have sought to increase autonomy for patients through changes in policies and practices which decrease the potential for coercion and increase patients’ freedom to act (Williamson, 2010). An example of this has been seen in recent years, as a greater emphasis has been placed on models of shared decision‐making between health professionals and patients. The shared decision‐making approach seeks a balance between paternalistic care and the informed consent approach. Paternalistic care is where decisions about care are made by health professionals (predominantly doctors) and patients passively receive the care prescribed. This model does not factor in patients' own values and beliefs and can lead to patients feeling greater distress where there is a negative outcome (Stewart and Brown, 2001). The informed consent approach offers patients greater responsibility and will often involve health professionals offering patients all of the information required and then leaving them to make the decision unsupported. This can lead to patients feeling abandoned and unsure, creating anxiety and distrust (Corrigan, 2003; Deber et al., 2007). The shared decision‐making approach involves health professionals and patients working together to devise a plan of care that is in line with the best available evidence as well as the values and beliefs of the individual patient, aligning to the principle of true autonomy.
Clinical considerations
A shared decision‐making approach to care has been shown to benefit patients in terms of their active engagement in the treatment plan or taking the prescribed medications (Edwards and Elwyn, 2009). As such, it is an ethical approach to care which has also been shown to reduce the incidences of medico‐legal claims where there is a negative outcome (Studdert et al., 2005). As health professionals, we should always aim to fully involve patients in decisions about drug treatments to maximise engagement and increase the potential for success.
Health professionals also abide by the principle of justice, which is the belief that people should be treated fairly, equally and reasonably. At its heart, justice is about equality; but how equality is determined can be ambiguous and problematic in healthcare. An example of the difficulties posed within this principle is often seen in relation to the fair and equal distribution of resources: ‘distributive justice’. A drug for a specific condition may be available within one healthcare trust but the same drug is not available to patients with the same or similar condition in another trust. Sometimes colloquially labelled the ‘postcode lottery’, this occurs as a result of differing priorities for resources among those who make difficult commissioning decisions about resources on a local level.
Health professionals should also be honest and tell the truth to enable someone to have the full information relevant to them in order to make full rational choices about their care. This is known as veracity and involves conveying accurate and objective information to the patient. Giving patients full information regarding treatment options is the most common application of the veracity principle. Disclosures of medication errors are also an obvious example of veracity, and the recent introduction of the ‘Duty of Candour’ guidance for health professionals (NMC and GMC, 2015) highlights the importance of the veracity principle. Informing patients when something has gone wrong, apologising, and offering a remedy are measures that are advised by Sir Robert Francis in his report on the failings of the Mid‐Staffordshire Health Trust (2013). Francis (2013) stated that candour and transparency are key components of a safe and effective culture for patient care. However, in reality, true veracity is a complex notion. Returning to the example of the drug that is available in one health trust and not another, health professionals engage in such rationing ‘inconspicuously’ (Williamson, 2010, p. 201) without necessarily informing patients that they are being denied something that could benefit them. Aside from the greater ethical issues concerned with who makes the decisions and how they are implemented, there is the more immediate concern relating to veracity and the decision on whether to inform patients.
Finally, the principle of fidelity requires the act of loyalty and trustworthiness; it involves keeping our promises, performing our duties and doing what is expected of us within our relationships with patients. This principle can be conflicted where the health professional's loyalty or obligation may be torn between their patients and colleagues