The world of palliative medicine is rapidly becoming a fixture in the paramedic field of practice, and with its proposed inclusion into the UK Ambulance Services Clinical Practice Guidelines (Association of Ambulance Chief Executives (AACE), 2013), it is time for paramedics to inform themselves about the ethics and laws surrounding pain relief for end-of-life patients.
Many healthcare professionals and clinicians working in palliative care believe that failing to address the pain and suffering of terminally ill patients violates two main ethical principles of care. Firstly, the ethical principle of beneficence, whereby failing to relieve a person's pain does not constitute helping the dying patient, and secondly, the ethical principle of non-maleficence, where through the non-treatment of pain, actual harm can be caused to the patient as well as to the loved ones that care for them.
As these patients are, by definition, dying, the principle role to be played here is to reduce any pain and suffering and offer the patient the concept of a ‘good death’. This does, at times, cause conflict between ‘the ethical’ and ‘the legal’, where the fear of litigation forever looms in the shadows should a course of action they choose to undertake shorten the life of the patient. This is a common concern in palliative medicine where research has shown that between 65% and 70% of dying patients experience substantial pain and so need more analgesia, which can ultimately shorten their life (Colvin, 2006).
Health care reforms
The developments that were envisaged by the Department of Health's (2000) healthcare reform plan have placed a wider scope of professional practice on many healthcare workers and have allowed for greater flexibility in treating patients with complex, and very often complicated, medical needs. This is particularly the case with end-of-life patients needing analgesia for moderate to severe pain while at the same time presenting with other serious medical conditions.
The big questions
This need for enhanced analgesia can pose several questions to the paramedics that are called to help the patient in their dying days. For example:
‘Ethically the patient will need stronger pain relief, or at the very least a larger dose of their present pain relief, but am I legally permitted to administer it?’
‘What are the legal consequences if I don't administer effective pain relief?’
‘Do I have a duty of care to relieve the suffering of a patient even if it means placing them at greater risk of dying as a direct result?’
‘Can I give opioid analgesia and not transport the patient to hospital?’
Ethical principles
Ethically, of course, the correct course of action is to treat pain as quickly and as effectively as possible so as to limit any suffering. This is based on the four ethical principles as set out by Beauchamp and Childress (2008), who stated that a person has an ethical right to: autonomy, justice, beneficence and non-maleficence when being cared for, and that, although not written in law, these principles will often dictate a course of action. These ethical dilemma's faced by healthcare professionals can sometimes be in conflict with normal working practice and regimens that are often based on outdated or inflexible best practice guidelines.
The law and the human rights acts
While it is right and proper to endorse ethical principles into practice, it must also be understood that the law is the definitive authority. Where ethics is the science of right and wrong, the European Court of Human Rights (ECHR) is the law by which we are governed. For end-of-life care, the ECHR Articles that are most relevant are Articles 2, 3 and 8.
The ethics of autonomy
The first ethical principle is that of ‘autonomy’, which literally means deliberate self rule, and gives the patient the right to make their own decisions, providing they have capacity to consent, even if the decision the patient makes is not the course of action the healthcare worker themselves would choose (Khan et al, 2002; McLean and Mason, 2003; Beauchamp and Childress, 2008; Dimond, 2008). This is also set out in Article 8 of the ECHR which states that ‘There shall be no interference by a public authority’ into the decisions made by an individual for their own welfare. In practice, however, this can, and continues to, pose challenges when administering strong opioids for end-of-life patients.
Paramedics have a duty of care to provide patients with analgesia consistent with their levels of pain, but patients can then, according to Article 8 of the ECHR, implement their right to refuse transport to hospital once they have received the treatment, even though protocols then say that they must then be transported. This provides the paramedic with an ethical dilemma of either not treating the pain or practising outside local guidelines and protocols (AACE, 2013). This refusal by a patient has been seen in several milestone court cases (Re T [1992]; Re C [1994]; Re B [2002]) and provides a precedent for such actions that need to be considered. In the case of Re T [1992] the refusal of a blood transfusion, following a car crash, led to the premature death of the patient. However, in summing up, Lord Donaldson of Lymington MR concluded that, ‘It is well established that in the ultimate the right of the individual is paramount,’ despite society's interest to preserve life.
The ethics of beneficence and non-maleficence
This brings to the fore the arguments and ethical rights of beneficence and non-maleficence, whereby in the attempt to help a patient we will sometimes risk harm. Such decisions can be made on the balance of probability and by ensuring that each patient ends with a ‘net gain’ in care. The Hippocratic oath, as recited by newly qualified medical doctors, indicates a moral obligation to provide beneficial medical help to the best of their ability, while at the same time causing minimal harm. This can, in many circumstances, be individual to each person. For example, recent genetic advancements have shown that females with a genetic mutation in the BRCA 1 gene show a 60% increased risk of developing breast cancer (Royal Marsden NHS Foundation Trust, 2013). For some women the option to have a mastectomy is straightforward and immediately they opt to undertake the procedure, while for others, the loss of their feminine identity is so psychologically harmful to them that the benefit of potential life extension is not worth the procedure.
However, the obligation to provide a net gain for the patient requires the clinician to have a good understanding of the probabilities and risks that may occur as a result of the treatment. In palliative care this may be a grey area, due to the inevitability, and perhaps close proximity, of death, as in the case of Dr Bodkin Adams (R v Adams [1957]). In the case in question, Dr Adams administered high doses of morphia and heroin, claimed to have caused the patient's death, for which the doctor stood trial for murder. The trial judge Patrick Devlin directed the jury by saying: ‘He is entitled to do all that is proper and necessary to relieve pain and suffering even if the measures he takes may incidentally shorten life.’
This is in contrast to the Annie Lindsell case in 1997 where she appealed to the court to allow for her GP to legally administer a large quantity of lethal painkillers, with the intention of ending her life, once her motor neurone disease deteriorated (Dyer, 1997). Annie Lindsell withdrew her case following a conversation and assurances from her GP that he would not let her suffer. Following the Lindsell case the distinction was made between administering pain relief for the good of the patient that may have a secondary effect of shortening the length of life, and the deliberate ending of life through lethal dosages of pain killers. In the context of beneficence and non-maleficence, clinicians look for a low risk of harm in exchange for a high chance of benefit for the patient.
The ethics of justice
The fourth moral principle is that of justice. Justice implies a sense of fairness for the patient, and can be categorised further by highlighting: distributive justice (where a fair distribution of resources is available, especially when those resources are scarce), rights-based justice (which focuses on respect for the individuals rights), and legal justice (that respects the legal and moral laws of the land). The argument regarding what proper justice entails is up for debate, and has been for centuries, with Aristotle arguing that it should be treating equals equally and unequals unequally—the so-called ‘horizontal equity’ and ‘vertical equity’, respectively (McHale and Fox, 2007).
Law and the right to life
Article 2 of the ECHR states that a person has the ‘right to life’, and that this is an ‘absolute right’ that cannot be interfered with. Heavily involved in the Dianne Pretty case (R v Director of Public Prosecutions [2001]), Article 2 is often used for acts of assisted suicide. However, although the Article recognises and protects the rights of an individuals right to self-determine life and death, it draws a line under the involvement of a third party. Thus, a person has a legal right to commit suicide or refuse life-saving medication, but, as most people want to live, it must protect both. Mrs Pretty argued that as she was in no position to commit suicide herself then her wish of being assisted should be recognised. Unfortunately for Mrs Pretty there is no convention authority to support her argument, and so her case was rejected.
For end-of-life care, the significance here is the ability to administer enough pain killing drugs so as to alleviate the pain (or at least considerably ease it) without being an accessory to the deliberate ending of life as a result of the action. This does not follow that in circumstances where death may occur due to the administration of pain relieving drugs that the analgesics should not be given, as in the case of Dr Bodkin Adams (R v Adams [1957]) previously mentioned. Article 3 of the ECHR (the prohibition of torture) also supports the act of easing a person's pain, or refusing to do so, and concerns itself with any treatment against the patient's wishes. Article 3 makes illegal any act that may cause intense physical or mental suffering, whether by doing an action, or potentially by not doing an action. This brings into question any action that causes suffering, especially in cases where the patient is asking for pain relief, which is a liberty protected in Article 8.
The patient's legal right of autonomy (capacity)
Article 8 of the ECHR protects a person's right to personal autonomy and, although sometimes in conflict the desire of Article 2 to protect life, the patient can decide a particular course of action (providing they have capacity). The question of capacity and mental competence is very pertinent in modern medicine. The law states that everyone has capacity until proven otherwise, and then, only after every practicable effort has been made by the clinician. The law of capacity is designed to protect patients from the paternalistic practices of clinicians and third parties claiming to act in the patients best interests (Re F [1990]; Re C [1994]).
In the case of Re C [1994], Judge Lord Thorpe stated three stages to a competent decision: i) to take in and retain treatment information, ii) to believe the information, iii) to be able to balance risk and need. If these three are conformed to, then capacity is proven and a patient has the right to refuse treatment. And if, as in most cases of palliative medicine, capacity is agreed upon, then the issue of consent comes to the fore. Implied consent has often been the argument for paternalistic clinicians, as in the case of Schloendorff v Society of New York State Hospital (Schloendorff v Society of New York State Hospital [1914]) where an operation to remove a tumour was carried out without her consent. Justice Cardozo concluded that:
‘Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages.’
In this case there was no explicit consent, that is to say written documentation, and so the judgement implied that wrong doing was present even though the surgeon was acting in the best interests of the patient.
Consent
The ‘concept of therapeutic privilege’ has since become an ever-engaging argument as clinicians endeavour to decide how much information is adequate in order for the patient to make an informed choice. This came to the fore in the case of Chester v Afshar (Chester v Afshar [2004]) where Dr Ashfar failed to warn Ms Chester of a 1–2% unavoidable risk of the surgical procedure on a lumbar disc protrusion. Ms Chester was left partially paralysed as a result and the House of Lords concluded that ‘though the failure to warn was not a direct cause of injury, it did result in negligence.’
In short, patients need to be warned in general terms of any possible risks that may occur so as to make an informed choice without coercion or manipulation. Failure to do so can result in a criminal case for charges of trespassing, battery and assault. However, in the case of pain management a precedence has been set where, even though the three stages of competence has been achieved (Re C [1994]), a clinician can claim diminished capacity due to pain and fear (Re MB [1997]). In the latter case the patient needed a caesarian section but was needle phobic and so panicked and withdrew consent at the last minute. The Court of Appeal upheld the initial judgement of diminished capacity on the grounds that an individual's capacity to make decisions can be temporarily affected by pain, fear, confusion or medication, and that the assessment of of capacity must be ‘time and decision-specific’ (Re MB [1997]). The implication for practice in treating pain in end-of-life patients from the Re MB [1997] case is that this is still a grey area, and a discussion with the multi-disciplinary team may be needed to ascertain the best possible path of treatment.
‘Paramedics have a duty of care, imposed through professional registration, to help a patient to the best of their skill level’
Duty of care
Paramedics have a duty of care, imposed through professional registration, to help a patient to the best of their skill level and onto their ‘neighbour’, as proposed through the Donoghue v Stevenson case (Donoghue v Stevenson [1932]). The ‘neighbour’ tag is based on the proximity of the patient and ‘who’ has that duty of care (Kent v Griffiths [2000]).
Should this not happen, a case of medical malpractice or negligence can arise based upon three principles. Firstly, a duty of care is owed to the patient; secondly, there was a breach of that duty where an inadequate standard of care was provided; and thirdly, harm was caused as a consequence of that breach which, in the eyes of the law, was not so unforeseeable as to be too remote. Hence, to administer pain relief to an end-of-life patient where death occurs as a consequence of that action, it must be apparent that the clinician worked within their scope of practice to the best of their skill level, and that the chance of death occurring as a result of that action be remote (Kent v Griffiths [2000]).
In law, this is often decided through the Bolam test (Bolam v Friern Hospital Management Committee [1957]), from which it must be decided, from a reasonable body of opinion, that the standard of care was all that could be reasonably expected at that moment in time. In addition, it can also be reasonably argued that the ‘but for’ test (Barnett v Chelsea and Kensington Hospital Management Committee [1968]) shows that the patient was so unwell that death may have occurred anyway, and that an attempt to relieve any suffering was the primary aim of the clinician. The causation of events caused through interaction can also be decided with the Bolitho test (Bolitho v City and Hackney Health Authority [1997]), which addresses cases of professional negligence, and follows on from the Bolam test.
Negligence
In tort law (common law), res ipsa loquitur is a doctrine that infers negligence in the absence of direct evidence, but instead by the very nature of the injury caused (Byrne v Boadle, [1863]). There are four elements of res ipsa loquitur: the injury does not occur without negligence, the injury is caused by means exclusively in the control of the clinician, the patient does not contribute to the injury, and the negligent behaviour does not fully explain the injury. In end-of-life care, the patients are, by definition, dying, and an expectation of death cannot be ruled out. Thus, the injury (or death in this scenario) would have occurred without any proposed negligence on behalf of the clinician.
Therefore, with the consent of the patient, the administration of pain killing drugs to treat severe pain, that inadvertently shortens life, does not fall into res ipsa loquitur, and hence a civil case cannot be based upon it.
Implications for practice
The ongoing concerns from healthcare professionals about appropriate pain relief for end-of-life patients in severe pain span both ethical and legal boundaries. Ethically, there is a duty of care to ease pain and suffering for the patient, while also working within their scope of practice; and legally, providing the patient gives consent, the shortening of life as a result of the administration of the pain killers is not an obvious breach of the law.
As the Bolam test can confirm, providing the opinion of the medical profession agrees that the action taken and the standard of care was reasonable for that moment in time, then medical negligence has not been committed. However, for many healthcare professionals the decision to give a drug that can be judged to shorten life, even if it helps to relieve suffering, is still a dilemma that many avoid. Through engagement with the multi-disciplinary team this decision can be made more easily, more consistently, and more efficiently, and with a perceived greater of protection from both a civil law and statutory law standpoint. The precedence from previous case studies show that clinicians acting in the best interest of the patient to reduce suffering are perceived favourably by the law providing, and only providing, it is the patient's best interest that is at heart and all concerned are happy with the actions taken.