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Providing Palliative Care at the End of Life: Should Health Professionals Fear Regulation? Lindy Willmott, Ben White, Donella Piper, Patsy Yates, Geoffrey Mitchell and David Currow*

Anecdotal evidence from Australia and abroad suggests that health professionals may fear potential legal and/or professional repercussions if their patient dies after receiving pain relieving medication at the end of life. As a result, patients may be under-medicated and their pain and other symptoms not adequately relieved. The regulatory repercussions from inappropriate administration of medications are potentially broad and include criminal charges, civil negligence claims, coronial investigations and disciplinary proceedings. But despite these potentially serious repercussions, a review of publicly available cases in Australia reveals there has been comparatively little judicial or quasi-judicial scrutiny where over-medication is alleged to have resulted in a patient’s death. In this article, we describe the regulatory framework that governs this field of medical practice and analyse the extent to which the actions of health professionals have been scrutinised, and the consequences of that scrutiny. We identify a number of themes arising from this analysis and conclude that fears of legal or professional repercussions are largely unfounded, and that existing laws and other forms of regulation should not inhibit the prescription and administration of adequate pain and other symptom relief to people at the end of life.

Keywords: doctrine of double effect; Schedule 8 drugs; end of life care; inadequate pain relief; palliative care; end of life law; regulation of pain medication; legal repercussions; disciplinary proceedings

I. INTRODUCTION Advances in medicine mean that people are living longer with chronic conditions.1 However, and in spite of these advances, some patients do not have their pain and symptoms adequately controlled as they approach death.2 This is surprising given that Australia boasts a very high standard of palliative * Lindy Willmott: Professor, Director, Australian Centre for Health Research, Faculty of Law QUT. Ben White: Director, Australian Centre for Health Law Research, Faculty of Law QUT. Dr Donella Piper: Senior Lecturer, Management and Organisational Studies, UNE Business School, University of New England. Patsy Yates: Head of School of Nursing, School of Nursing QUT. Geoffrey Mitchell: Professor of General Practice and Palliative Care, Faculty of Medicine, University of Queensland. David Currow: Professor of Palliative Medicine, Faculty of Health, University of Technology Sydney. Correspondence to: l.willmott@qut.edu.au; bp.white@qut.edu.au; dpiper@une.edu.au; p.yates@qut.edu.au; g.mitchell@uq.edu.au; david.currow@uts.edu.au. 1 C Seale, “Changing Patterns of Death and Dying” (2000) 51 Social Science and Medicine 917; L De Lima and T Pastrana, “Opportunities for Palliative Care in Public Health” (2016) 37 Annual Review of Public Health 357, 360. 2 M Akashi, E Yano and E Aruga, “Under-diagnosis of Pain by Primary Physicians and Late Referral to a Palliative Care Team” (2012) 11 BMC Palliative Care 7; J Menten and J De Lepeleire, “Emergency Hospital Admission for Pain in Palliative Patients: A Crucial Role for General Practitioners” (2006) 12 The European Journal of General Practice 133. See, eg, Australian Commission on Safety and Quality in Health Care, Safety and Quality of End-of-Life Care in Acute Hospitals: A Background Paper (August 2013) 8 <https://www.safetyandquality.gov.au/wp-content/uploads/2013/09/SAQ083_End_of_life_care_V15_FILM_REVISED_TAGGED.pdf>; Pain Australia, who note “[i]n palliative care, inadequate pain relief and symptom management are barriers to quality end-of-life care”, National Pain Strategy (2011) 21 <http://www.painaustralia.org.au/static/uploads/files/national-pain-strategy-2011-wfvjawttsanq.pdf>. The National Pain Strategy is the result of collaborative work of health professionals, consumers and funders, who agreed that an integrated approach was needed to improve care for all types of pain. The National Pain Strategy and the National Pain Summit were led by the Australian and New Zealand College of Anaesthetists, the Faculty of Pain Medicine, the Australian Pain Society and the consumer group Chronic Pain Australia, in collaboration with inaugural supporters, MBF Foundation and the University of Sydney Pain Management Research Institute Pain Australia; NSW Agency for Clinical Innovation Palliative Care Network, Diagnostic

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care,3 and prescribing and administering pain and other symptom relief, most commonly morphine and other opioids, continues to be an important and widely available component of palliative care. The fact that some patients die in pain at the end of life is an undesirable outcome. Inadequate pain and other symptom relief adversely affects the quality of a patient’s life as they face death and can cause unnecessary distress to patients, their families and treating health professionals. There has been considerable research into the barriers that prevent appropriate levels of pain and other symptom relief from being prescribed for patients in the final phases of their illness. These barriers include delay in identifying patients whose deaths could be anticipated,4 access to the right care at the right time, and medical practitioners’, patients’ and families’ fear and denial about facing issues around death and dying.5 What is less well understood in Australia is whether under-treatment of pain and other symptom relief for end-of-life patients occurs, at least in part, because of concerns about possible legal and disciplinary sanction that may result if the patient dies after medication is administered. Studies in both the United States and the United Kingdom point to concern about regulation as a factor in under-treatment of pain and other symptom relief. Some American studies have found that the risk of disciplinary action made clinicians more conservative in prescribing opioids for pain, and some patients therefore suffered from untreated pain.6 Other studies reported similar findings.7 Concerns about potential criminal or administrative liability under drug prescription laws were also reported to be in the minds of health professionals when providing pain relief.8 Studies also demonstrate that there are regulatory concerns about providing adequate pain relief in the United Kingdom.9

Report to Inform the Model for Palliative and End of Life Care Services Provision (February 2014) <https://www.aci.health.nsw.gov.au/__data/assets/pdf_file/0011/208937/ACI_Diagnostic_Report_to_inform_the_Model_for_PEoLC_Service_Provision.pdf>; M Lovell and V Tai, “Pain Relief and the End of Life” (2013) 14 Medicine Today 16, citing G Heading et al, New South Wales Cancer Patient Satisfaction Survey 2007. Interim Report (Cancer Institute NSW, 2008); National Institute of Clinical Studies, Evidence-Practice Gaps Report. Volume 1: A Review of Developments 2004-2007 (2008) 32–36 <https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/nic48_nics_evidence_volume_one_review_2004_2007_150609_0.pdf>. 3 The Economist Intelligence Unit, The 2015 Quality of Death Index: Ranking Palliative Care across the World (6 October 2015) 7, 15, 23, 26 <http://www.eiuperspectives.economist.com/healthcare/2015-quality-death-index>. 4 Clinical Excellence Commission NSW, Care for the Dying (2013) <http://www.cec.health.nsw.gov.au/__data/assets/pdf_file/0010/259309/cec-care-for-the-dying-may-2013.pdf>. 5 Australian Commission on Safety and Quality in Health Care, n 2, 9. 6 FJ Skelly, “Fear of Sanctions Limits Prescribing of Pain Drugs” (1994) 37 American Medical News 19, 19. 7 TE Quill and DE Meier, “The Big Chill – Inserting the DEA into End-of-Life Care” (2006) 354 New England Journal of Medicine 1, 1, citing RA Drayer, J Henderson and M Reidenberg, “Barriers for Better Pain Control in Hospitalized Patients” (1999) 17 Journal of Pain and Symptom Management 440; MZ Wolfert et al, “Opioid Analgesics for Pain Control: Wisconsin Physicians’ Knowledge, Beliefs, Attitudes, and Prescribing Practices” (2010) 11 Pain Medicine 425. 8 MB Kapp, “Treating Medical Charts Near the End of Life: How Legal Anxieties Inhibit Good Patient Deaths” (1996) 28 University of Toledo Law Review 521, 530; MB Kapp, “Legal Anxieties and End-of-Life Care in Nursing Homes” (2003) 19 Issues in Law and Medicine 111, 120; TM Pope, “Physicians and Safe Harbour Legal Immunity” (2012) 21 Annals of Health Law 121, citing R Schwartz, “End-of-Life Care: Doctors’ Complaints and Legal Restraints” (2009) 53 Saint Louis University Law Journal 1155; HS Perkins et al, “Impact of Legal Liability, Family Wishes, and Other ‘External Factors’ on Physicians’ Life-Support Decisions” (1990) 89 The American Journal of Medicine 185; IM Spinello, “End-of-Life Care in ICU: A Practical Guide” (2011) 26 Journal of Intensive Care Medicine 295; M Scanlon, “Providing End-of-Life Care in Connecticut: Should Nurses Fear Liability” (2001) 5 Quinnipiac Health Law Journal 35; K Jablonski and G Duke, “Pain Management in Persons who are Terminally Ill in Rural Acute Care: Barriers and Facilitators” (2012) 14 Journal of Hospice and Palliative Nursing 533. The six identified themes were: (a) knowledge, skills, and experience; (b) judgmentalism; (c) conflicts; (d) time; (e) authoritative boundaries; and (f) fears. 9 In 2010, Nursing Times, the peak industry publication for nurses in the United Kingdom, commissioned an online survey of nurses which explored, among other things, nurses’ experience in relation to the provision of pain relief. Of the 2,311 nurses that completed the survey, 12% indicated that they had restricted a patient’s medication despite the patient’s symptoms as they were concerned about being prosecuted. See <https://www.nursingtimes.net/home/about-nursing-times>. See also M Gott et al, “The Effect of the Shipman Murders on Clinician Attitudes to Prescribing Opiates for Dyspnoea in End-stage Chronic Obstructive Pulmonary Disease in England” (2010) 18 Progress in Palliative Care 79; C Gardiner et al, “Attitudes of Health Care Professionals

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While there is limited empirical research in Australia on the link, if any, between concern about legal and disciplinary sanction and the under-treatment of pain and other symptoms, there is emerging anecdotal evidence that supports such a link.10 The Australian Commission on Safety and Quality in Health Care (the Commission) in 2012–2013 observed that:

Fears held by clinicians about complaints or possible litigation stemming from involvement in end-of-life care … can result in avoidance of dealing with dying patients. 11

In New South Wales, the Agency for Clinical Innovation (ACI) conducted a consultation process in 2013 with over 1,200 stakeholders, including medical practitioners and nurses treating end-of-life patients.12 Evidence provided to ACI suggested that residents of aged care facilities can miss out on pain relief partly due to the reluctance of general practitioners to prescribe Schedule 8 analgesics.13 The Agency also noted that “[p]articularly among some RNs [registered nurses], there is a refusal to give morphine because they believe they are killing the resident”.14 More recently in 2015–2016, the Legislative Council Legal and Social Issues Committee of the Victorian Parliament conducted an inquiry into the need for laws in Victoria to allow citizens to make informed decisions regarding their own end-of-life choices.15 Evidence given at the public hearings by a palliative care specialist observed:

It’s not uncommon for us to have a scenario on the ward where the nursing staff are very fearful that if they give that injection and the patient dies at “X” point in time thereafter, that there will be a repercussion for them.16

In addition:

to Opioid Prescribing in End-of-Life Care: A Qualitative Focus Group Study” (2012) 44 Journal of Pain and Symptoms Management 206. 10 The authors also note that that many strongly dispute the link between the provision of palliative care and death, claiming that appropriately titrated doses of opioids can relieve pain without incidentally hastening death: M Ashby, “The Fallacies of Death Causation in Palliative Care” (1997) 166 Medical Journal of Australia 176; M Bercovitch, A Waller and A Adunsky, “High Dose Morphine Use in the Hospice Setting” (1999) 86 Cancer 871; SA Fohr, “The Double Effect of Pain Medication: Separating Myth from Reality” (1998) 1 Journal of Palliative Medicine 315; R George and C Regnard, “Lethal Opioids or Dangerous Prescribers?” (2007) 21 Palliative Medicine 77; PD Good, PJ Ravenscroft and J Cavenagh, “Effects of Opioids and Sedatives on Survival in an Australian Inpatient Palliative Care Population” (2005) 35 Internal Medicine Journal 512; D Mendelson, “Quill, Glucksberg and Palliative Care: Does Alleviation of Pain Necessarily Hasten Death” (1997) 5 JLM 110; S Minami et al, “Opioids Have No Negative Effect on the Survival Time of Patients with Advanced Lung Cancer in an Acute Care Hospital” (2015) 23 Supportive Care in Cancer 2245; T Morita et al, “Effects of High Dose Opioids and Sedatives on Survival in Terminally Ill Cancer Patients” (2001) 21 Journal of Pain and Symptom Management 282; C Regnard et al, “So, Farewell Then, Doctrine of Double Effect” (2011) 343 British Medical Journal d4512; A Thorns and N Sykes, “Opioid Use in Last Week of Life and Implications for End-of-Life Decision-Making” (2000) 356 The Lancet 398; B White, L Willmott and M Ashby, “Palliative Care, Double Effect and the Law In Australia” (2011) 41 Internal Medicine Journal 485. 11 Australian Commission on Safety and Quality in Health Care, n 2, 12. 12 NSW Agency for Clinical Innovation Palliative Care Network, n 2. 13 NSW Agency for Clinical Innovation Palliative Care Network, n 2, 24. Schedule 8 medications are commonly prescribed and administered to end-of-life patients to treat pain and outer symptoms. See Part III A of this article for more information. 14 NSW Agency for Clinical Innovation Palliative Care Network, n 2, 24. 15 Legislative Council Legal and Social Issues Committee, Parliament of Victoria, Inquiry into End of Life Choices: Final Report (2015) <http://www.parliament.vic.gov.au/lsic/article/2611>. A full list of names of those making submissions is available at pp 243–254 of the Final Report. A full list of the public hearings, briefings, site visits and meetings conducted is available at pp 255–268 of the Final Report. 16 Legislative Council Legal and Social Issues Committee, Parliament of Victoria, Legislative Council Committee Room, Parliament House, 23 July 2015 (Michelle Gold) <https://www.parliament.vic.gov.au/images/stories/committees/SCLSI/Gold-FINAL-23_July_2015.pdf>.

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I’ve had times when GPs don’t prescribe the morphine because they’re worried … that because the patient may die a bit sooner than they would have otherwise, that they’re at risk of prosecution.17

There is also speculation by health professionals in the literature that regulatory concerns may be a factor in the under-treatment of pain and other symptom relief.18 The goal of this article is to explore whether concerns of health professionals about possible legal or professional repercussions when providing pain and other symptom relief are well-founded. Is there evidence in Australia of criminal prosecutions and civil proceedings occurring as a result of “over-medication” of patients? Are coroners making adverse findings against clinicians? Are disciplinary proceedings being brought by regulatory bodies? But before we explore the case law, we will scan the regulatory context in which health professionals practise at the end of life and consider the possible legal or professional sanctions which could be invoked if a health professional acts inappropriately. We conclude the article by making some observations about the implications of the Australian case law for health professionals. At this point, it is important to emphasise that the article does not focus on medical practitioners or nurses who are acting outside the law by willfully over-prescribing and administering medication with a view to deliberately killing or inciting or abetting or assisting patients to die. Nor does it focus on the medications prescribed for patients who are not end-of-life patients.

II. REGULATION OF PRESCRIBING AND ADMINISTERING MEDICATION Parts II and III of this article consider the broad regulatory framework that governs medical practice at the end of life, especially in the context of the provision of medication that could also (possibly) have the effect of accelerating death. Pain and other symptom relief for patients at the end of life is regulated by a complex interplay of legislation and regulations, therapeutic standards, national, State, Territory and facility-level policies and procedures, professional codes of ethics and conduct in clinical practice, and guidelines of learned colleges and health professionals’ associations. Each of these regulatory instruments cuts across different dimensions of the prescription, dispensing and administration of medications for pain and other symptom relief generally, as well as for patients at the end of life. It is outside the scope of this article to review all of these forms of regulation. However, this section provides an overview of the specific regulation of the drugs used for pain and other symptom relief.19 Part III is broader in scope and considers the various causes of action and proceedings that may be relevant if a health professional is alleged to have acted inappropriately.

A. Legislation Governing “Schedule 8” Drugs

17 Legislative Council Legal and Social Issues Committee, Parliament of Victoria, Legislative Council Committee Room, Parliament House, 23 July 2015 (William Silvester) <https://www.parliament.vic.gov.au/images/stories/committees/SCLSI/Silvester-FINAL-23_July_2015.pdf>. 18 KM Hillman and M Cardona-Morrell, “The Ten Barriers to Appropriate Management of Patients at the End of Their Life” (2015) 41 Intensive Care Medicine 1700. Similarly, in a survey with follow-on focus groups aimed at identifying New Zealand intensive care nurses experience of and attitudes towards end-of-life care, found that fear of litigation and breaking the law was ranked 6/9 in terms of important criteria for making end-of-life decision by intensive care nurses in New Zealand, with 20.7% of the sample ranking fear of litigation or breaking the law as important and 15.8% ranking it as very important. (NB 23.6% of the sample were not sure it this was an issue, 18.7% ranked it as quite important and 21.2% ranked it as not important): M Coombs et al, “Certainty and Uncertainty about End of Life Care Nursing Practices in New Zealand Intensive Care Units: A Mixed Methods Study” (2015) 28 Australian Critical Care 82; R Syme, “Necessity to Palliate Pain and Suffering as a Defence to Medical Homicide”‘ (2009) 12 JLM 439, 442; P Hudson et al, “Legalizing Physician-assisted Suicide and/or Euthanasia: Pragmatic Implications” (2015) 13 Palliative and Supportive Care 1399, 1400. 19 The authors note the existence of new legal regimes that permit medicinal cannabis to be used as pain relief in limited circumstances, including palliative care. Parts II and III of this article do not discuss the regulation or use of medicinal cannabis because it is not one of the medications considered to potentially accelerate death in an end-of-life context. For more information on the legal regime for medicinal cannabis in Australia see: I Freckelton, “Medicinal Cannabis Law Reform in Australia” (2016) 23 JLM 497.

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The usual type of pain-relieving drug prescribed to end-of-life patients is known as a “Schedule 8” drug. Schedule 8 drugs are generally opioids such as morphine, oxycodone or fentanyl.20 All States and Territories have legislation to regulate the prescription and administration of these drugs.21 The Acts and Regulations that govern Schedule 8 drugs have been described by Mendelson as an “intricate statutory framework”,22 evolved from the early Poisons Acts.23 The intent behind the legislation is to prevent improper use and to protect the public’s health and safety by preventing lay people from treating themselves with dangerous drugs and health professionals from abusing or supplying drugs to addicts and others for non-therapeutic uses. The legislation seeks to control and restrict access and supply of Schedule 8 drugs by setting out procedural requirements in relation to access, supply, possession, administration, prescription, storage, dispensing, record keeping and destruction of such drugs. The legislation sets out a very general requirement about prescription, dispensing and administration of these drugs. One particular population for whom they are frequently prescribed is patients at the end-of-life patients. For example, in New South Wales, “authorised practitioners” may possess and prescribe Schedule 8 drugs for the “the lawful practice of his or her profession”.24 Under reg 78 of the Poisons and Therapeutic Goods Regulation 2008 (NSW):

A medical practitioner must not issue a prescription for a drug of addiction otherwise than for medical treatment; and a nurse practitioner must not issue a prescription for a drug of addiction otherwise than in the course of practising as a nurse practitioner.

The quantity and purpose of prescriptions must be “appropriate”, meaning the quantity and purpose must accord with “the recognised therapeutic standard of what is appropriate in the circumstances”.25 Health professionals must look elsewhere for clinical guidance on what is “appropriate”. This guidance is provided by therapeutic and other guidelines and policies which are considered further below.

B. Therapeutic and Other Guidance on Schedule 8 Drugs Guidance on the appropriate therapeutic and medical use or purpose for which a health professional may prescribe or administer Schedule 8 drugs is set out in the consensus-based Therapeutic Guidelines Palliative Care Version 4.26 The Therapeutic Guidelines cover a broad range of issues and provide a number of resources to guide those who treat patients at the end of life. Like all clinical guidelines, the Therapeutic Guidelines are not binding, but are intended to guide clinical practice.27 In relation to pain management in palliative care, the Therapeutic Guidelines state: “For palliative care patients, opioids usually provide the best relief for most pain; they are predictable in their effect and the dose can be

20 Drugs are classified as Schedule 1–9 drugs as set out in the Therapeutic Goods Act 1989 (Cth) by virtue of s 52D(2)(b) of that Act. Drugs are listed on each of the nine schedules based on a number of factors including toxicity, purpose of use, potential for abuse, safety in use and the need for the substance. There is a higher degree of control required as the schedule number increases. 21 Poisons and Therapeutic Goods Act 1966 (NSW); Poisons and Therapeutic Goods Regulation 2008 (NSW); Health (Drugs and Poisons) Regulation 1996 (Qld); Medicines, Poisons and Therapeutic Goods Act 2008 (ACT); Medicines, Poisons and Therapeutic Goods Regulations 2008 (ACT); Medicines, Poisons, and Therapeutic Goods Act 2012 (NT); Controlled Substances Act 1984 (SA); Controlled Substances (Poisons) Regulations 2011 (SA); Poisons Act 1971 (Tas); Poisons Regulations 1965 (WA); Drug Poisons and Controlled Substances Act 1981 (Vic); Drugs, Poisons and Controlled Substances Regulations 2006 (Vic). 22 D Mendelson, “Opioid Regulation: Time to Reconsider the Nomenclature and Approach” (2013) 21 JLM 27, 27. See too AC Hua, F Shen and X Ge, “State-based Legal Requirements for Schedule 8 Prescriptions: Why So Complicated?” (2015) 203(2) The Medical Journal of Australia 64. 23 Mendelson, n 22, 28. 24 Poisons and Therapeutic Goods Regulation 2008 (NSW) reg 101(3). 25 Poisons and Therapeutic Goods Regulation 2008 (NSW) regs 79, 109. A maximum penalty of 20 penalty units or imprisonment for six months, or both is imposed for breach of this regulation under reg 79. 26 Therapeutic Guidelines Limited Palliative Care Expert Group, Palliative Care (Version 4, 2016) <https://tgldcdp.tg.org.au/guideLine?guidelinePage=Palliative+Care&frompage=etgcomplete>. 27 F McDonald, “The Legal System and the Legitimacy of Clinical Guidelines” (2017) 24 JLM 821.

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adjusted precisely.”28 They also provide guidance, in general terms, on an approach when starting a patient on opioid therapy.29 The Therapeutic Guidelines also set out the acceptable dosage range for opioid naïve patients30 and for patients already receiving opioids.31 The Guidelines include further information, including opioid dose adjustment if the patient is older or frail, or has kidney or liver impairment, using different routes for administration of opioids, changing to a different opioid, combining opioids, opioids used and not routinely used in palliative care and adverse opioid effects in palliative care patients and alternative therapies.32 The Therapeutic Guidelines also provide guidance specifically in relation to care in the last days of life.33 In relation to pain management at this time, the Therapeutic Guidelines state: “Opioids are frequently used for pain in the terminal phase. Morphine is the opioid of choice for the majority of opioid-naive patients in the last days of life.”34 In the same way guidance is provided for palliative care patients, specific guidance on dosage, for both opioid naïve patients as well as those who have previously been administered opioids, is provided for patients in the terminal stages of their illness, including guidance on anticipatory prescribing and alternative medications.35 Further procedural guidance is provided to frontline health professionals by State and Territory health departments, private and public institutions and colleges, in the form of policies, procedures and forms governing Schedule 8 medications.36 A plethora of other policies, guidelines, protocols and standing orders exist in relation to various contextual and procedural aspects relating to Schedule 8 medications, regardless of clinical setting.37 28 Therapeutic Guidelines Limited Palliative Care Expert Group, n 26. 29 “The initiation of an opioid requires cautious adjustment and frequent review because individuals vary markedly in their response. Best practice in starting opioid therapy is to start with a low dose and slowly adjust the dose until it controls the patient’s pain. The initial opioid dose is determined by the previous medication used and the severity of the pain”: Therapeutic Guidelines Limited Palliative Care Expert Group, n 26. 30 Therapeutic Guidelines Limited Palliative Care Expert Group, n 26: “immediate-release 2 to 5 mg orally, 1-hourly as required. Maximum 3 consecutive hourly doses or 6 doses in a 24-hour period”. 31 Therapeutic Guidelines Limited Palliative Care Expert Group, n 26: “Calculate the total amount of opioid taken in the previous 24 hours and give that amount as modified-release opioid; give either the total 24-hour dose once daily or half the total 24-hour dose twice daily, depending on the formulation. The pharmacokinetic properties of modified-release opioid formulations can differ significantly – they should not be used interchangeably. An alternative regimen is to continue the immediate-release opioid. Calculate one-sixth of the total amount of opioid taken in the previous 24 hours and give that amount 4-hourly as a regular immediate-release opioid dose. For ongoing opioid therapy, prescribe regular and breakthrough doses of opioids. In addition to the regular opioid dose (modified-release or immediate-release), prescribe breakthrough doses of immediate-release opioid to be taken as required (see Breakthrough pain) for information on calculating opioid doses for breakthrough pain.” 32 Therapeutic Guidelines Limited Palliative Care Expert Group, n 26. 33 Therapeutic Guidelines Limited Palliative Care Expert Group, n 26. 34 Therapeutic Guidelines Limited Palliative Care Expert Group, n 26. 35 Therapeutic Guidelines Limited Palliative Care Expert Group, n 26. 36 For example, in New South Wales, the NSW Department of Health’s Policy Guide to Poisons and Therapeutic Goods Legislation for Medical, Nursing and Midwife Practitioners and Dentists summarises the prescription requirements of the Act and Regulations for that jurisdiction as follows: “A prescription for the supply of a drug of addiction may be issued only for use in the course of medical treatment”: NSW Department of Health, Policy Guide to Poisons and Therapeutic Goods Legislation for Medical, Nursing and Midwife Practitioners and Dentists (February 2014) C4 <http://www.health.nsw.gov.au/pharmaceutical/Documents/guide-medprac-nurse-dentist.pdf>. A drug of addiction is a Schedule 8 drug. 37 In New South Wales alone the following relevant polices and guidelines have been identified: NSW Department of Health, NSW Health High Risk Medications Policy (12 August 2015) <http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2015_029.pdf>; NSW Department of Health, Summary of Controls on the Prescribing and Handling of Drugs of Dependence by Medical, Nurse and Midwife Practitioners (February 2014) <http://www.health.nsw.gov.au/pharmaceutical/Documents/drugsofdependence-controls.pdf>; NSW Department of Health, Requirements for an Authority to Prescribe Drugs of Addiction in New South Wales (March 2016)

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C. Policies and Guidelines Specifically for Pain and Symptom Relief for End-of-Life Care

A number of policies and guidelines exist in all Australian jurisdictions for pain and other symptom relief specifically for patients at the end of life. Guidance ranges from a general statement about the importance of managing pain and other symptoms through to statements about members’ responsibility to uphold the law. Many of these policies note that the appropriate administration of pain relief is lawful and does not constitute euthanasia. For example, at a national level, the Australian Commission on Safety and Quality in Health Care released a National Consensus Statement: Essential Elements for Safe and High-quality End-of-Life Care.38 The statement provides broad policy-level guidance, citing “the prevention and relief of suffering” as being “of paramount importance”,39 couching pain and other symptom relief in terms of a patient “right”.40 Some professional associations also provide overarching guidance to their members in terms of pain and other symptom relief for people in the terminal stages of their illness. For example, the codes of conduct and ethics for medical practitioners set out such guiding principles.41 Guiding principles on the importance of pain management and organisations’ positions on euthanasia are also provided by Learned Colleges and professional associations. By way of summary, most couch adequate pain relief as a “right”; some offer reassurance that the appropriate use of pain relief will not shorten a patient’s life and reinforce the proposition that appropriate pain relief does not constitute euthanasia, an illegal activity in Australia.42 Only one association, the Royal Australian College of General Practitioners, specifically <http://www.health.nsw.gov.au/pharmaceutical/Documents/section28-requirements.pdf>; NSW Department of Health, Medication Handling in NSW Public Health Facilities (27 November 2013) <http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2013_043.pdf>; NSW Department of Health, Criteria for Issuing Non-handwritten (Computer Generated) Prescriptions (November 2015) <http://www.health.nsw.gov.au/pharmaceutical/Documents/prescriptions-nonhandwritten.pdf>. In terms of aged care facilities, national policies are relevant. See, eg, Department of Health and Ageing (Cth), Guiding Principles for Medication Management in Residential Aged Care Facilities (October 2012) <http://www.health.gov.au/internet/main/publishing.nsf/content/nmp-pdf-resguide-cnt.htm>; Australian Pharmaceutical Advisory Council, Guiding Principles for Medication Management in the Community (June 2006) <https://www.health.gov.au/internet/main/publishing.nsf/Content/0A434BB6C6456749CA257BF0001A9578/$File/booklet.pdf>. 38 Australian Commission on Safety and Quality in Health Care, National Consensus Statement: Essential Elements for Safe and High-quality End-of-Life Care (2015) <https://www.safetyandquality.gov.au/wp-content/uploads/2015/05/National-Consensus-Statement-Essential-Elements-forsafe-high-quality-end-of-life-care.pdf>. 39 Australian Commission on Safety and Quality in Health Care, n 2, 19. 40 “All patients, including people with chronic or severe mental illness, intellectual disability or cognitive impairment, have the right to adequate pain relief and symptom control, and to the prevention and relief of suffering. Physical symptoms should be managed in alignment with the patient’s wishes, and treatment reviewed regularly”: Australian Commission on Safety and Quality in Health Care, n 2, 16. 41 See, eg, the Medical Board of Australia, Good Medical Practice: A Code of Conduct for Doctors in Australia (March 2014) [3.12.1] <http://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of-conduct.aspx>, which states “Doctors have a vital role in assisting the community to deal with the reality of death and its consequences. In caring for patients towards the end of their life, good medical practice involves. … Taking steps to manage a patient’s symptoms and concerns in a manner consistent with their values and wishes”. 42 See, eg, Australian Medical Association, Position Statement on Euthanasia and Physician Assisted Suicide (24 November 2016) [1.4], [2.2], [3.1], [3.6] <https://ama.com.au/position-statement/euthanasia-and-physician-assisted-suicide-2016>; Australian Medical Association, The Role of the Medical Practitioner in End of Life Care (2014) [10.3], [10.5], [10.7], [10.8] <https://ama.com.au/sites/default/files/documents/ps_on_the_role_of_the_medical_practitioner_in_end_of_life_care_2007_amended_2014_0.pdf>; Australian Medical Association, Position Statement on End of Life Care and Advance Care Planning (5 September 2015) [1.1], [1.4], [3.5] <https://ama.com.au/position-statement/end-life-care-and-advance-care-planning-2014>; Royal Australasian College of Physicians, Improving Care at the End of Life: Our Roles and Responsibilities (May 2016) 5–6 <https://www.racp.edu.au/docs/default-source/advocacy-library/pa-pos-end-of-life-position-statement.pdf>; Royal Australian College of Physicians, Decision Making at the End of Life in Infants, Children and Adolescents (2008) 10 <https://www.racp.edu.au/docs/default-source/advocacy-library/decision-making-at-the-end-of-life-in-infants-children-and-adolescents.pdf?sfvrsn=8>; Royal Australian College of Surgeons, Position Paper End of Life Care (October 2016) 1 <https://www.surgeons.org/media/24971463/2017-07-28_pos_fes-pst-057_end_of_life_care.pdf>; Royal Australian College of General Practitioners, Medical Care of Older Persons in Residential Aged Care Facilities (4th ed, 2006) 17–20

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sets out a care pathway (The Liverpool Care of the Dying Pathway) for end-of-life patients in aged care facilities.43 State and Territory health departments provide another layer of guidance in the form of specific end-of-life policies and procedures.44 Like the associations’ guidelines, the policies reinforce the need to provide pain relief, and the fact that such relief does not constitute euthanasia. Unlike the associations’ guidelines, the policies highlight the importance of the health professional’s “intention” when providing pain relief. For example, Guidelines for the End-of-Life Care and Decision-Making (the relevant New South Wales policy) provides as follows:

Analgesia and sedation should be provided by whatever route is necessary for relief, in proportion with clinical need, and with the primary goal of relieving pain or other unwanted symptoms. Such administration will not be unlawful provided the intention of the medical practitioner is the relief of symptoms, even if the medical practitioner is aware that the administration of the drug might also hasten death.45

The next part of this article explores the potential sources of legal and professional challenge for alleged over-medication of a patient at the end of life.

III. POTENTIAL SOURCES OF LEGAL AND PROFESSIONAL CHALLENGE If a patient dies and there is an allegation that the death was a result of the over-prescription and/or administration of a Schedule 8 drug, a number of possible legal and professional repercussions may flow. Before exploring them further below, we remind the reader that the scope of this article is to examine this issue in the context of health professionals who intend to provide appropriate end-of-life

<http://www.racgp.org.au/your-practice/guidelines/silverbook/>; Australasian College of Rural and Remote Medicine, Position Statement on End-of-Life and Advance Care Planning for Rural and Remote Communities (November 2015) 1, 2 <http://www.acrrm.org.au/docs/default-source/documents/the-college-at-work/end-of-life-care---nov-2015.pdf>; Australian and New Zealand Society of Palliative Medicine, Guidance Document on Palliative Sedation Therapy (18 July 2017) [4] <http://www.anzspm.org.au/c/anzspm?a=da&did=1005077>; Australian and New Zealand Society of Palliative Medicine, Position Statement: The Practice of Euthanasia and Assisted Suicide (31 March 2017) 1, 2, 6–9 <http://www.anzspm.org.au/c/anzspm?a=da&did=1005077>; Australian and New Zealand Society of Palliative Medicine, Position Statement on Quality End-of-Life Care (February 2017) 1 <http://www.anzspm.org.au/c/anzspm?a=da&did=1005077>; Australian Nursing Federation, Position Statement on Voluntary Euthanasia/Assisted Suicide (May 2012) [1]–[3], [6], [10], [12] <http://anf.org.au/documents/policies/PS_Voluntary_euthanasia.pdf>; Australian Nursing and Midwifery Federation, Position Statement on Assisted Dying (November 2016) [2], [6], [7], [12] <http://anmf.org.au/documents/policies/PS_Assisted_Dying.pdf>. 43 The Royal Australian College of General Practitioners, n 42, 16–19. Note however the criticisms of this Pathway in the United Kingdom: see, eg, Department of Health. More care, less pathway: a review of the Liverpool Care Pathway. July 2013. <https://www.gov.uk/government/publications/review-of-liverpool-care-pathway-for-dying-patients>. 44 For example, in Queensland, see: Queensland Health, State-Wide Strategy for End of Life Care (May 2015) <https://www.health.qld.gov.au/publications/portal/health-strategies/end-of-life-strategy-full.pdf>; Queensland Health, Clinical Guidance for the Dying Patient (August 2014) <https://www.health.qld.gov.au/caru/pathways/docs/pway-guid-dyng.pdf>; Queensland Health, Clinical Guidance for the Dying Patient: Ongoing Assessment (August 2014) <https://www.health.qld.gov.au/caru/pathways/docs/pway-guid-dyng-ong.pdf>; Queensland Health, Clinical Guidance for the Dying Patient: Clinical Events/Variances (August 2014) <https://www.health.qld.gov.au/caru/pathways/docs/pway-guid-dyng-var.pdf>; Brisbane South Palliative Care Collaborative, Guide to the Pharmacological Management of End of Life (Terminal) Symptoms in Residential Aged Care Residents (2013) <https://www.caresearch.com.au/caresearch/tabid/3588/Default.aspx>. 45 NSW Department of Health, End-of-Life Care and Decision-Making – Guidelines (22 March 2005) [7.3] <http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/GL2005_057.pdf>. NB this policy applies the Area Health Services/Chief Executive Governed Statutory Health Corporation, Board Governed Statutory Health Corporations, Affiliate Health Organisations Affiliated Health Organisations – Declared, Divisions of General Practice, NSW Ambulance Service, Private Hospitals and Day Procedure Centres, Public Hospitals (this includes aged care and nursing homes). Similar assurance is provided by the NSW Ministry of Health’s Advance Planning for Quality Care at End of Life Action Plan 2013-18 (2013) <http://www.health.nsw.gov.au/patients/acp/Publications/acp-plan-2013-2018.pdf> which states: “There is ongoing concern in the community and among some health professionals about what is, or is not, assisted dying (or euthanasia). In NSW it is illegal to aid or abet the suicide or attempted suicide of another person. However, this does not include: Giving doses of necessary pain relief, including opioids, commensurate with a person’s clinical need. Good pain management in skilled hands neither under- nor over-doses the patient.”

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care, rather than to operate intentionally outside legal parameters, for example by deliberately ending the life of their patients or assisting patients to end their own lives. The possible avenues for legal or professional redress include criminal charges, ranging from murder and manslaughter through to criminal negligence, civil negligence claims, performance and conduct hearings, coronial investigations, and internal reporting and investigation processes.

A. Criminal Proceedings Criminal proceedings in relation to a health professional (here, referred to as the defendant) causing a patient’s death requires that there has been an unlawful killing. The most serious charge involving unlawful killing is murder. Broadly speaking, as the criminal law across Australian States varies – most notably depending on whether it is a common law or Code jurisdiction, murder will be proven only when two limbs can be proved beyond reasonable doubt. First, the defendant must cause the death of the patient, and here that would be through the provision of pain or other symptom relief.46 Second, the defendant must have the requisite intent. This could be an actual intention to bring about the patient’s death, or to cause serious bodily harm, or that the defendant knew or believed that death or serious bodily harm would be a probable consequence of his or her actions.47 In the context of the provision of medication, however, there is an important defence known as the doctrine of double effect which is likely to form part of the common law in Australia.48 This doctrine provides a defence to a criminal charge and will be available if the primary intention of the person administering palliative care is to relieve pain, and not to cause death. In such a case, the person will not be criminally responsible for a death that might follow, even if that death is foreseen. That is, the defence is available even if it is proven that the medication may have caused or hastened the patient’s death.49 Health professionals intending to provide appropriate pain and other symptom relief to their patients would therefore be able to rely on this defence. If, however, the defendant intended to relieve pain by killing the patient, the doctrine of double effect would not apply, and the defendant would be regarded as having criminal intent.50 Compassionate motives or the patient’s consent are irrelevant in Australia.51 In three Australian States, the doctrine of double effect has been incorporated into statute.52 In these jurisdictions, it is likely that having the appropriate intention (to reduce suffering) is necessary but not sufficient to trigger the protection provided by these statutory excuses. Each of these provisions, in different ways, also require that the medication must be given in a manner that is consistent with good

46 We note the literature which argues that carefully titrated levels of opioids will not cause the death of the patient: see, references mentioned in n 10. However, as evidenced in Parts IV B2 and IV B3 of this article, in some cases inappropriate amounts of medication or inappropriate means of providing medication can result in the death of a patient. 47 B White, F McDonald and L Willmott (eds), Health Law in Australia (Thomson Reuters, 2nd ed, 2014) 508–509. 48 According to White, McDonald and Willmott, n 47, [15.10]: “This doctrine had its origins in moral theology and its essence is that an act performed with good intent can still be moral even if it has bad side effects. Applying the doctrine to palliative care, it argues that medication may be administered to a patient to relieve pain (the good effect), even if it hastens death (the bad effect) when four conditions are met: the nature of the act, namely administering palliative medication, is morally good (because it relieves pain); the medication is administered with the intention of relieving pain, not with the intention of hastening the patient’s death (although that may be foreseen); the medication does not achieve the relief of pain through hastening the patient’s death; and proportionally, the need to relive pain is such that it outweighs the negative consequences of hastening death.” The doctrine is recognised by the common law and the operation of the doctrine is illustrated by R v Adams (Unreported, Central Criminal Court, Devlin J, 9 April 1957), reported at H Palmer, “Dr Adams’ Trial for Murder” [1957] Criminal Law Review 365, and R v Cox (1992) 12 BMLR 38. For an explanation and analysis of these cases see White, McDonald and Willmott, n 47, [15.20]. 49White, McDonald and Willmott, n 47, [15.20]. 50 Although note the particular interpretation given to double effect in Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150: see further discussed below. 51 White, McDonald and Willmott, n 47, [13.60]. 52 South Australia: Consent to Medical Treatment and Palliative Care Act 1995 (SA) s 17; Queensland: Criminal Code Act 1899 (Qld) s 282A; Western Australia: Criminal Code Act Compilation Act 1913 (WA) s 259. For a detailed discussion of these provisions, see White, McDonald and Willmott, n 47, [15.30]–[15.110].

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practice. For example, in Western Australia, s 259 of the Criminal Code Act Compilation Act 1913 (WA) (Criminal Code 1913) provides that a person is not criminally responsible for administering palliative care if to do so “is reasonable, having regard to the patient’s state at the time and to all the circumstances of the case”.53 If there is an unlawful killing but it falls short of murder, it may be that a charge of manslaughter is available. This may arise, for example, where a health professional has been criminally negligent. For a conviction to be sustained for criminal negligence, there must have been a falling short of the standard of care which a reasonable person would have exercised and the conduct involved such a high risk that death or grievous bodily harm that the doing of the act merited criminal punishment.54 It is unlikely that the doctrine of double effect would operate as a defence in such cases.55 A final category of offences that each Australian jurisdiction has are those related to assisted suicide.56 Again, the scope and wording of these provisions vary by jurisdiction but refer to whether the defendant intended to either aid, abet, assist, incite or instigate suicide.57

B. Civil Negligence Health professionals have a legal duty to take reasonable care to ensure that the right drug and dose is given to the right patients at the right time in the right way.58 If they fail in this duty, they may be liable in civil negligence. Questions as to professional culpability for negligent services are now increasingly governed by the provisions of the relevant civil liability legislation in each jurisdiction.59 By way of summary and example, a health professional would not incur liability in negligence in New South Wales if it is established that they acted in a manner that, at the time the service was provided, was widely accepted in Australia by peer professional opinion as competent professional practice.60

C. Performance and Conduct Proceedings A health professional who prescribes or administers too much medication may be the subject of performance and conduct reviews for practising below the requisite standard of care. The relevant entity will conduct a preliminary assessment and may investigate whether the health professional engaged in misconduct or unprofessional or unsatisfactory conduct.61 Relevant entities may take no further action

53 See Part IV B of this article for a description of a case that considered this provision. 54 Nydam v The Queen [1977] VR 430, 445 which the High Court approved in R v Lavender (2005) 222 CLR 67, [17], [60], [72], [136]; [2005] HCA 37; Burns v The Queen (2012) 246 CLR 334, [19] (French CJ); [2012] HCA 35. 55 BP White and L Willmott, “The Edge of Palliative Care: Certainty, But at What Price?” (2004) 7 Flinders Journal of Law Reform 225. Also White, McDonald and Willmott, n 47, [15.70]. 56 White, McDonald and Willmott, n 47, [13.130]–[13.170]. 57 White, McDonald and Willmott, n 47, [13.110]–[13.160]. 58 CCH Australia Limited, Australian Health and Medical Law Reporter (29 August 2017) ¶23-540. 59 See discussion in White, McDonald and Willmott, n 47, Ch 8. 60 Civil Liability Act 2002 (NSW) s 5O which states: “Standard of care for professionals: (1) A person practising a profession (‘a professional’) does not incur a liability in negligence arising from the provision of a professional service if it is established that the professional acted in a manner that (at the time the service was provided) was widely accepted in Australia by peer professional opinion as competent professional practice. (2) However, peer professional opinion cannot be relied on for the purposes of this section if the court considers that the opinion is irrational. (3) The fact that there are differing peer professional opinions widely accepted in Australia concerning a matter does not prevent any one or more (or all) of those opinions being relied on for the purposes of this section. (4) Peer professional opinion does not have to be universally accepted to be considered widely accepted.” See also: Wrongs Act 1958 (Vic) s 59; Civil Liability Act 2003 (Qld) s 22; Civil Liability Act 1936 (SA) s 41; Civil Liability Act 2002 (WA) s 5PB (which applies to health care professionals only); and Civil Liability Act 2002 (Tas) s 22. 61 The National Law is set out in the Health Practitioner Regulation National Law Act 2009 (Qld) Sch s 36 establishes National Boards for each regulated heath profession (including but not limited to medical practitioners (The Medical Board of Australia) and nurses and midwifes (The Nursing and Midwifery Board of Australia), overseen by the Australian Health Practitioner Regulation Agency. One of the functions of the National Boards is to establish panels to conduct hearings in respect of performance

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or refer the matter to a number of different forums such as the police. Potential repercussions for the health professional may include a caution or reprimand, the suspension of registration, the imposition of conditions imposed upon registration or disqualification to practise.62

D. Coronial Investigations In the health care context, coroners are mandated to investigate certain kinds of deaths including “reportable deaths”.63 A “reportable death” includes a “healthcare-related death” or where the death occurred “in care”. In New South Wales, for example, a “healthcare-related death” will be investigated, if the death was not a reasonably expected outcome of the health-related procedure carried out on the person.64 A death in care in New South Wales, will be investigated, for example, if a patient is at a facility for the purpose of receiving care, treatment or assistance under mental health legislation or suffers a disability and is living in specified types of residential services.65 While the role of the coroner is to ascertain cause of death rather than attribute blame, repercussions for health professionals include possible referral to other forums such as the Director of Public Prosecutions or relevant disciplinary entities.66

E. Internal Reporting and Investigations The death of a patient in a public health organisation, as well as most private organisations, as a result of an “incident”, (as defined in each jurisdiction’s Incident Management Policy),67 triggers a number of reporting and investigative processes. If the patient dies, an “incident” will be logged on the incident management reporting system.68 Depending upon the incident type and severity, this will trigger a number of notification requirements to the patient’s family and carers (an “Open Disclosure”), as well as to the relevant Department of Health and associated entities such as safety and quality bodies and the Director-General of Health.69 A number of different types of internal investigative processes may also commence. All such processes focus on ascertaining the system-based cause(s) of the incident, and how such incidents may be prevented in the future.

issues and professional standards. For a summary of the relevant law in Australia, see White, McDonald and Willmott, n 47, Ch 16. 62 White, McDonald and Willmott, n 47, [16.250]–[16.290]. 63 “Reportable deaths” are defined in each jurisdiction’s Coroners Act. See, eg, Coroners Act 2003 (Qld) s 8; Coroners Act 2009 (NSW) s 6. 64 See, eg, Coroners Act 2009 (NSW) s 6(1)(e). For an example of a slightly different statutory requirement, see Coroners Act 2003 (Qld) s 10AA. 65 Death in “care” in New South Wales, for example, includes a patient at a facility for the purpose of receiving care, treatment or assistance under the Mental Health Act 2007 (NSW) or Mental Health (Forensic Provisions) Act 1990 (NSW): see Coroners Act 2009 (NSW) s 6(1)(f). In Queensland, a death in care includes a person with a disability living in specific types of residential services: Coroners Act 2003 (Qld) s 9(1)(a). 66 See, eg, Coroners Act 2003 (Qld) s 48; Coroners Act 2009 (NSW) s 82(2)(b). 67See, eg, Clinical Excellence Commission NSW, Incident Management Policy PD2014_004 (10 February 2014) <http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2014_004.pdf>; Queensland Health, Guideline: QH-HSDGDL-032-2 Health Service Directive Patient Safety Guideline for Clinical Incident Management (1 August 2013) <https://www.health.qld.gov.au/__data/assets/pdf_file/0018/155016/qh-hsdgdl-032-2.pdf>. An “incident” is defined in the NSW Incident Management Policy as “[a]ny unplanned event resulting in, or with the potential for, injury, damage or other loss including a near miss” at [3]. The Queensland Clinical Incident Guideline defines incident as “[a]ny event or circumstance which has actually or could potentially lead to unintended and/or unnecessary mental or physical harm to a patient” at [4]. 68 For example, PRIME in Queensland, or IIMS in New South Wales. 69 In New South Wales, this may mean the submission of a Reportable Incident Brief (RIB) as set out in Health Administration Act 1982 (NSW) Div 6C s 20L due to a national sentinel event relating to “[m]edication error leading to the death of a patient reasonably believed to be due to the incorrect administration of drugs”. In Queensland, local facilities are required to have similar processes in place under Queensland Health, n 67; Queensland Health, Health Service Directive: Patient Safety (13 November 2014) <https://www.health.qld.gov.au/__data/assets/pdf_file/0020/150734/qh-hsd-032.pdf>.

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In the case of an incident resulting in death or serious injury, a Root Cause Analysis (RCA) will be conducted.70 A finding that an incident may involve an individual’s standard of care, rather than system issues, will trigger a referral in relation to that individual, possibly having legal or professional consequences considered earlier in this section.

IV. AUSTRALIAN CASE LAW – FINDINGS OF REVIEW The foregoing reveals the highly regulated context in which health professionals working in the end-of-life field operate. In this part of the article, we examine the extent to which health professionals in fact fall foul of regulation and are, as a result, called upon to account for their actions. We will consider cases where there have been concerns about the amount of medication provided, the method for providing the medication, or other irregularities leading to a review of the medical treatment preceding a patient’s death. We also review cases in which direction has been expressly sought from the courts regarding the lawfulness of proposed action regarding the administration of medication which may also accelerate death. But first we describe the search strategy to locate relevant cases.

A. Search Method and Cases Located The primary databases searched were AustLII, Caselaw, and the websites of Coroners Courts in all jurisdictions as at 30 June 2017. While date ranges were not restricted (we searched all databases across all available dates), a limitation of our method is the lack of uniformity across jurisdictions in terms of the date ranges for courts and other entities. A further limitation is that there is a lack of availability of nursing and medical performance and conduct proceedings in most jurisdictions prior to 2010. The focus of the article is on cases that involve judicial or quasi-judicial consideration that are publicly reported and available in the databases listed above. Internal investigations including RCA reports (which are not generally in the public domain), are therefore outside the scope of this review. The following terms were searched individually and in combination across all listed databases: • “doctrine of double effect” • “end-of-life” • “end-of-life care” • “morphine toxicity” • “pain relief” • “palliative sedation” • “palliative care” • “Schedule 8 drugs” • “terminal sedation” To ensure all publicly available cases were retrieved, further searches for “palliative care”, “end-of-life care”, and “pain relief” (the terms most effective in the above searches) were additionally performed across all LexisNexis online databases. This search of these further databases did not reveal any new cases. Finally, to ensure location of all cases that considered the relevant statutory provisions that embody the doctrine of double effect in relevant jurisdictions (South Australia, Queensland, Western Australia), searches were also conducted using AustLII’s Noteup function as well as via LexisNexis Casebase.71

70 RCA is a method used to investigate and analyse incidents to identify the root causes and factors that contributed to the incident. The process yields recommended actions directed at the prevention of a similar occurrence (Clinical Excellence Commission NSW, n 67, 4). The purpose, functions, and release of reports produced during an RCA are governed by Hospital and Health Service Boards Act 2011 (Qld) Pt 6 Div 2 and Health Administration Act 1992 (NSW) Div 6C. Similar provisions exist for private facilities in New South Wales: See Private Health Facilities Act 2007 (NSW) Pt 4. 71 For completeness, these searches also included Medical Treatment (Health Directions) Act 2006 (ACT) s 17; Powers of Attorney Act 2006 (ACT) s 86: both provisions refer to a right to pain relief although the authors are of the view that these provisions either do not change or disturb the common law (White, McDonald and Willmott, n 47, [15.30]) and so are not considered further.

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These searches revealed a modest number of cases: only 15 across Australia. Twelve of these specifically considered over-medication of end-of-life patients. Of these twelve, 10 were coronial investigations (across six jurisdictions), one was a civil negligence action (in New South Wales) and one was a professional conduct proceeding (in New South Wales). These cases involved a range of clinicians: seven nurses, three palliative care specialists or teams, one general practitioner and a variety of other specialist medical practitioners. The cases also spanned a range of clinical settings: three in aged care facilities, eight in acute care settings and one in a hospice.72 Three were in rural and nine were in urban settings. Out of these 12 cases, in only two cases were adverse findings made which required further action: the disciplinary hearing, and a coronial decision to refer the matter to the Nursing Council to determine whether disciplinary action should be taken. In all other actions, there were either no adverse findings made, or findings that identified systems issues rather than issues at the clinician level. A summary of these cases appears in Appendix 1. Of the remaining three of 15 cases, two involved applications for declaratory relief in the Supreme Court and Family Court respectively about the lawfulness of certain proposed conduct involving the provision of palliative care. Although these cases did not review past conduct of health professionals, the courts provided helpful obiter dicta comment about relevant aspects of the law that relate to the provision of medication that may also result in a patient’s death. The final case is a recent decision of the Victorian Civil and Administrative Tribunal (Review and Regulation List) reviewing a decision of the Medical Board of Australia to impose a condition on the registration of Dr Rodney Syme. The Tribunal also commented on the doctrine of double effect, so will be briefly considered.73

B. Coronial Investigations The 10 coronial investigations cut across the majority of Australian States and Territories,74 and involve both doctors and nurses from a variety of clinical settings ranging from palliative care, through to aged care and acute care settings, in both urban and rural locations. These coronial cases fall into one of three categories: the coroner found that the facts did not raise any concerning legal or professional standards issues (four cases); the coroner found that errors occurred, which raised systems issues rather than legal or professional standards issues for the individual clinician (five cases); and the coroner found that an error occurred which required further investigation into the clinician’s actions by the relevant disciplinary body (one case). Each of these categories is explored further below.

1. Cases Where No Legal or Professional Standards Issues Arose In the four cases considered in this section, the coroner found there to be no questions to be answered regarding medication administered to the deceased person. This was despite the fact that high levels of medication were found to be given in two cases, and allegations of the same in the other two cases. Inquest into the Death of Sybil Zimmerman:75 As a result of allegations of wrongdoing made by the deceased’s daughters,76 there was close scrutiny of the medical treatment provided to the deceased by a number of agencies. Mrs Zimmerman was an 84-year-old woman suffering from multiple comorbidities. Her daughters alleged that Mrs Zimmerman was overdosed with morphine by nurses at the rural aged care facility at which she resided.77 Shortly before her death, one of Mrs Zimmerman’s daughters called 72 Five of the eight patients who died in acute settings were receiving palliative care and the remaining three acute patients were admitted for other reasons and deteriorated quickly; an additional four patients were receiving palliative care in non-acute settings (one in a hospice and three in aged care facilities). 73 Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150. 74 Northern Territory (1), Western Australia (1), Queensland (1), Tasmania (2), New South Wales (3) and South Australia (2). 75 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491. 76 Her daughters alleged that Mrs Zimmerman died as a result of gross negligence or had been involuntarily euthanised: Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [2]. 77 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [4].

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Crimestoppers claiming that her mother had been given a narcotic overdose which had caused her to lapse into a coma.78 Mrs Zimmerman was taken to hospital where she remained comatose until she died later the same night.79 An autopsy found that the most likely cause of death was coronary artery thrombosis and that cerebrovascular disease with recent and remote infarcts and dementia were contributory causes. Mrs Zimmerman was suffering from pneumonia and this was also a possible cause of death.80 The autopsy report stated that if she had received an excessive dose of morphine, this may have depressed her respiratory system and brought on the pneumonia. However, the pneumonia may have been entirely coincidental. According to the autopsy report, it was not possible to be certain as to the role that morphine played in Mrs Zimmerman’s death.81 Following her death, Mrs Zimmerman’s daughters made complaints to the Aged Care Complaints Investigation Scheme (a Commonwealth Government agency) and the Health Care Complaints Commission (HCCC) (a New South Wales Government agency).82 They alleged that 10mg of morphine was administered rather than the 5mg recorded in the medical records. Neither agency found the claim that Mrs Zimmerman died of an overdose to be made out. After further representations from the Zimmermans and their lawyer, the then State Coroner ordered that an inquest be conducted.83 At the inquest, the Coroner relied on contemporaneous records, namely the Schedule 8 drug register and medications chart, to find that 5mg of morphine was administered subcutaneously. The balance check of the Schedule 8 drug register confirmed this conclusion.84 The Coroner continued that, even if he was wrong and 10mg rather than 5mg had been given, the independent pharmacological advice and medical evidence did not support the claim that this caused or contributed to Mrs Zimmerman’s death.85 The Court relied on the expert evidence of a consultant physician, geriatrician and pharmacologist in reaching this conclusion. The emergency doctor from the hospital to which Mrs Zimmerman was taken also gave evidence that she was not displaying any signs of morphine overdose. The Coroner confirmed and accepted the cause of death as outlined in the autopsy. There were no adverse findings made against the nurses who had administered the morphine, the general practitioner who had prescribed it while Mrs Zimmerman was at the aged care facility, or the treating doctors in the emergency department to which she was taken prior to her death. Record of Investigation into Death (without Inquest) of Steven Paul Jones:86 In a similar vein, a Tasmanian Coroner in this case found that treatment provided to Mr Jones did not warrant further investigation. Mr Jones suffered bowel cancer and pain from chronic conditions and was receiving care at the palliative care unit at St Luke’s hospital. Upon leaving hospital, Mr Jones self-administered and accidentally overdosed on drugs prescribed for pain relief. Mr Jones’ wife gave evidence that she had been concerned about the level of medication prescribed for Mr Jones for some time. She had expressed concerns about this to his general practitioner approximately six months before Mr Jones’s death. Mrs Jones stated that Mr Jones’s admission to the palliative care unit in March 2012 was at her instigation because of her concern about the level of medication. The Coroner found the cause of death to be “toxicity arising from the medication being taken by Mr Jones, in particular, the opiates, oxycodone and methadone”. Despite this finding, the coroner did not hold an inquest, based largely on expert evidence that the prescribed medication fell within

78 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [19]. 79 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [19]. 80 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [22]. 81 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [23]. 82 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [24]. 83 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [26]. 84 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [33]–[56], [64]–[75]. 85 Inquest into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491, [57]. 86 Record of Investigation into Death (without Inquest) of Steven Paul Jones [2014] TASCD 238.

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applicable guidelines. Interestingly, the Coroner noted that toxicity is a risk with all drugs and that pain medication is an active area of medical research. The circumstances surrounding death were reviewed in the final two cases below because the death occurred “in care”, not because the deaths were suspicious. Inquest into the Death of Bill Portelli:87 Mr Portelli was 64-years-old and an involuntary patient under the Mental Health Act 1996 (WA) at the time of his death.88 He was receiving palliative care for terminal carcinoma of the rectum at Fremantle Hospital. Toxicological analysis showed a “very high level” of the opioid Fentanyl (the level not being cited in the findings).89 However, despite these high levels, the Coroner accepted the expert medical evidence and found that Mr Portelli died from natural causes. His Honour described the medication as “not unusual in end-stage palliative care where pain-killers are increased to reduce suffering”,90 and Mr Portelli’s care as “exemplary”.91 Inquest into the Death of Damien Hughes:92 The circumstances of death were reviewed in this case because Mr Hughes died in custody.93 Mr Hughes was receiving end-of-life treatment for metastatic lung cancer and the Coroner found that he died from bronchopneumonia.94 Post-mortem results identified six legally prescribed drugs, all within therapeutic range except for hydromorphone.95 In finding the death from natural causes, despite the dosage for one drug being outside therapeutic guidelines, the Coroner accepted expert medical opinion from Mr Hughes’s palliative care doctor, the toxicologist who conducted the toxicology screening and the pathologist who conducted the autopsy, that a patient may build tolerance to drugs at the end of life.96 He concluded by stating that “no criticism” could be made of the staff who prescribed and administered the pain relief to Mr Hughes.97

2. Cases Where Errors Occurred, But No Recommendation of Further Action against Clinician Five coronial cases fell into this category: one in Tasmania; two in New South Wales; and two in South Australia. In these cases, despite adverse findings regarding the conduct of clinicians, there were no recommendations or referrals made by the Coroners for further investigation or review of those clinicians, nor any reported subsequent investigations by disciplinary and conduct entities. Re Inquest Touching the Death of Stanley Valentine Whiley:98 This case involved the death of a terminally ill patient in an aged care facility who accidentally received a dose of morphine five times greater than the maximum prescribed and 10 times greater than the amount the nurse intended to administer. The morphine was administered by a registered nurse, Ms Lord, who had only recently graduated. The Coroner framed the issue in terms of causation, complexity, clinical setting and professional experience. Turning first to causation, the Coroner did not find a causal connection between the dosage error and death, despite the dosage being five times the maximum prescribed and the patient dying only five hours

87 Inquest into the Death of Bill Portelli [2014] CCWA Ref 3/14. 88 Coroners Act 1996 (WA) s 22(1)(a) provides that a coroner who has jurisdiction to investigate a death must hold an inquest if the death appears to be a Western Australian death and the deceased was immediately before death a person held in care. In this case, Mr Portelli was “a person held in care” under Coroners Act 1996 s 3. 89 Inquest into the Death of Bill Portelli [2014] CCWA Ref 3/14, [27]. 90 Inquest into the Death of Bill Portelli [2014] CCWA Ref 3/14, [27]. 91 Inquest into the Death of Bill Portelli [2014] CCWA Ref 3/14, [96]. 92 Inquest into the Death of Damien Hughes [2013] NTMC 022. 93 Coroners Act 1993 (NT) s 12. 94 Inquest into the Death of Damien Hughes [2013] NTMC 022, [38]. 95 Inquest into the Death of Damien Hughes [2013] NTMC 022, [34]. 96 Inquest into the Death of Damien Hughes [2013] NTMC 022, [34]. 97 Inquest into the Death of Damien Hughes [2013] NTMC 022, [34]. 98 Re Inquest Touching the Death of Stanley Valentine Whiley [2013] TASCD 144.

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later, and the autopsy report stating “toxicology reveals a blood morphine level of 0.2mg/L which is at the lower end of the lethal range”.99 The Coroner concluded that death was a result of the underlying natural disease rather than the morphine overdose. In coming to this conclusion, he noted the complexity of the patient’s condition given his comorbidities and the fact that his life expectancy at the time he received the medication was “measurable in hours rather than days”.100 Despite this finding, the Coroner proceeded to comment on the invidious position in which the administering nurse was placed. He made specific mention of her lack of experience and training, and he was critical of the failure to support her at such an early point in her career. The Coroner recommended a number of systemic changes relating to staff education, training and orientation regarding medication to ensure a similar incident could not happen again.101 Inquest in to the Death of Audrey MacGregor:102 This case also involved the death of a palliative care patient who accidentally received a greater dose of medication than intended. The drug involved was hydromorphone and two registered nurses administered a dose 10 times greater than the maximum prescribed. The nurses were not familiar with hydromorphone and mistakenly gave the dose in millilitres instead of milligrams. Despite toxicology results indicating that the hydromorphone concentration was within the normal therapeutic range, in the circumstances of the case, the Coroner found the cause of death was the combined effect of an overdose of hydromorphone and complications of pneumonia against a background of heart disease and lung disease. The Coroner identified a number of systemic issues and made recommendations to the Minster for Health in relation to ensuring hydromorphone was more clearly distinguished from morphine. Despite the finding that the overdose had a causal connection to the death, the Coroner made no recommendations in relation to the individual nurses responsible. Inquest into the Death of Michael Nelson:103 In this case, Mr Nelson was given 2.5mg of midazolam intravenously rather than through an intramuscular injection. This mistake occurred as a result of a miscommunication between the doctor and nurse. He died four hours later. The Coroner found that although midazolam may have contributed to Mr Nelson’s death, it was not the “direct cause”104 as it was “within the clinically appropriate limit”.105 She noted the expert evidence that Mr Nelson’s reaction was “very unusual and unpredictable”.106 The Coroner acknowledged the expertise and experience of the doctor and nurse and, while noting that the miscommunication was “unfortunate”,107 considered no recommendations to be warranted. The next two South Australian cases involved dosage errors by nurses, and a consideration of whether the statutory enactment of the doctrine of double effect could apply in such circumstances. As noted earlier,108 at common law, the doctrine can provide protection to a health professional who prescribes or administers medication to a patient and that medication causes death as well as relieves suffering, provided the intention was the relief of suffering. This defence was incorporated into s 17 of the Consent to Medical Treatment and Palliative Care Act 1995 (SA), but will operate only when the medical

99 Re Inquest Touching the Death of Stanley Valentine Whiley [2013] TASCD 144, [28]. 100 Re Inquest Touching the Death of Stanley Valentine Whiley [2013] TASCD 144, [34]. 101 Re Inquest Touching the Death of Stanley Valentine Whiley [2013] TASCD 144, [42]–[43]. 102 Inquest into the Death of Audrey MacGregor [2016] SCCNSW 2013/322168. 103 Inquest into the Death of Michael Nelson [2015] SCCNSW 2014/134742. 104 Inquest into the Death of Michael Nelson [2015] SCCNSW 2014/134742, [42]. 105 Inquest into the Death of Michael Nelson [2015] SCCNSW 2014/134742, [39]. 106 Inquest into the Death of Michael Nelson [2015] SCCNSW 2014/134742, [43]. 107 Inquest into the Death of Michael Nelson [2015] SCCNSW 2014/134742, [47]. 108 See Part III A of this article.

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treatment is delivered “without negligence and in accordance with proper professional standards of palliative care”.109 Inquest into the Death of Brian Russell:110 In this case, Mr Russell was suffering from terminal liver disease among other conditions.111 He received an “abnormally large” dose in a short time as a result of an infusion pump being set incorrectly by nursing staff. Despite attempts to correct the error, Mr Russell died 20 minutes later.112 The Coroner found the primary cause of death to be bronchopneumonia complicated by morphine toxicity. The overdose complicated that condition by adding to respiratory depression.113 Section 17(1) of the Consent to Medical Treatment and Palliative Care Act 1995 (SA) did not provide protection to the nurse in this case because the requirements of the provision were not satisfied, the Coroner finding that treatment was not in accordance with proper professional standards of palliative care:

I am of the opinion that the evidence is so clear that the treatment that Mr Russell received, an overdose of potentially lethal medication, delivered through a machine which was in a bad state of repair, by a nurse who had no real understanding of how the machine worked, who failed to check with an experienced nurse or with the procedural manual, and failed to attempt to properly verify the correct operation of the machine in any other way, could not be considered to be in accordance with such standards. Accordingly, I find that s 17(3) … does not apply and I will include the words “complicated by morphine toxicity” in the cause of death.114

Despite this finding, no reported disciplinary or civil proceedings were brought against the nurse involved. However, the Coroner made a number of systems-level recommendations including staff training and regular servicing of equipment. Inquest into the Death of Cynthia Joy Pauley:115 Mrs Pauley had cancer and was in the terminal phase of her illness.116 She was admitted to a rural hospital after she fell and suffered a pelvic fracture.117 An intrathecal line for pain management was established and documented in the clinical record.118 Mrs Pauley’s palliative care specialist knew she had an intrathecal port, however by error, he ordered spinal analgesia of a bolus dose of 5mg of morphine and 3ml of bupivacaine to be delivered twice daily to the “epidural portal”.119 It was delivered through an intrathecal port. This dose may have been appropriate for administration through an epidural port but was excessive if through an intrathecal port. Mrs Pauley died four hours later. Her death was reported to the Coroner as there was concern that the method of delivery of the analgesic may have contributed to her death. After hearing all of the evidence, the Coroner found that the cause of death was intrathecal toxicity of bupivacaine and morphine,120 and that “a bolus dose of such medication was inappropriate and excessive

109 Note that there are other conditions that must be satisfied to receive the protection of s 17. For further consideration of this statutory provision, see White, McDonald and Willmott, n 47, [15.30]–[15.110]. Table 15.1 at [15.110] provides a comparison of the common law doctrine with the legislative provisions in South Australia, as well as Western Australia and Queensland. 110 Inquest into the Death of Brian Russell [2000] SACC 11/2000. 111 Inquest into the Death of Brian Russell [2000] SACC 11/2000, [1.1]. 112 Inquest into the Death of Brian Russell [2000] SACC 11/2000, [1.1]. 113 Inquest into the Death of Brian Russell [2000] SACC 11/2000, [4.1]–[4.2]. The Coroner further found that the effects of the dosage would have been higher due to impairment of liver and kidney functions. 114 Inquest into the Death of Brian Russell [2000] SACC 11/2000, [4.6]. 115 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010). 116 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [3.4]. 117 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [1.3]. 118 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [4.6]. 119 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [4.9]–[4.13]. 120 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [1.1].

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if administered by way of an intrathecal portal”.121 Despite this error, the Coroner observed that it was not a result of “lack of knowledge or expertise” by the specialist.122 Rather, it was “simply, and tragically, a case of [the specialist], at the crucial moment, not realising that Mrs Pauley had an intrathecal line in place”.123 In considering the actions of the nurse administering the medication, the Coroner was prepared to consider the context in which the health care was provided. He made specific mention of the rural context and the skill level of the nurse who administered the dosage without question. The Coroner noted that while nursing staff in a dedicated pain management unit “might have picked up the error”,124 the nurse in question would not necessarily have sufficient expertise to do so. Importantly, the Coroner also found that the nurse was unable to rely on the s 17 protection. It was inapplicable here because the requisite standard of care as set out in the provision (and outlined above) had not been met. Accordingly, on the facts of this case, the Coroner was unable to find that it was the underlying illness rather than the medication that caused the death.125 As no criminal action was taken against the nurse, however, the inability to rely on s 17 did not have adverse legal consequences for the nurse. Finally, despite finding that there was an error in the administration of the medication and this resulted in the death of the patient, the coroner’s only recommendation in relation to drug administration was a systems one. The coroner recommended that the general manager of the facility “draw to the attention of all clinical staff the need to closely monitor vital signs of a patient to whom such analgesia has been administered”.126

3. Case Where Error Occurred, and Further Action Recommended There is only one case of those reviewed where the Coroner recommended further action be taken against the clinician as a result of the error that occurred. Given the significance of the case, the complexity of facts and their potential criminal implications, the facts will be outlined in some detail. Inquest into the Death of John Walter Hedges127 involved a 76-year-old man, Mr Hedges, who died in Greenslopes Private Hospital. Mr Hedges had advanced malignancy in his vertebra, stomach, pancreas, ribs and lung. He was not expected to live long and was receiving palliative care at the time of his death.128 For the final month of his life, Mr Hedges had two sites for the administration of morphine. Neither was labelled.129 Nurse Empen administered morphine to the wrong site. This meant that Mr Hedges received a bolus dose of 5mg of morphine into his intrathecal space rather than the prescribed 0.1mg per hour. For reasons she could not explain, Nurse Empen then injected the 5mg remaining in the syringe into the subcutaneous port, even though she knew she had already given Mr Hedges too much morphine via the wrong route.130 After some delay, a pain management doctor was consulted and he authorised 0.1mg of Narcan to reverse the effects of the overdose, as often as required. Despite this, Mr Hedges died that afternoon.131

121 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [14.2]. 122 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [4.13]. 123 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [4.13]. 124 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [4.14]. 125 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [5.10]–[5.11]. 126 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [7.4]. 127 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02. 128 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 1. 129 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 6. 130 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 7–8. 131 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 8–9.

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The death was reported to the police132 who reported it to the Coroner. An autopsy was conducted, and the report considered at the inquest. In his autopsy report, the pathologist, Dr Naylor, expressed the view that the 0.85 mg/kg morphine level in Mr Hedge’s blood was near the middle of the fatal range but cautioned that “such levels are not uncommon in patients with terminal malignancy who are on high continuous doses of morphine and in whom a degree of tolerance has developed”.133 Nevertheless, in view of the death occurring so soon after the overdose of morphine, Dr Naylor stated that the circumstances “suggest at least a contribution from morphine toxicity”.134 His autopsy report listed the primary cause of death as “carcinomatosis (the widespread of cancer throughout the body) and possible morphine toxicity”. The Coroner also relied on a report from a forensic toxicologist, Dr Olaf Drummer. He confirmed that a tolerance develops in patients repeatedly receiving morphine which means that such patients can safely receive doses that would otherwise be fatal.135 Dr Drummer stated that there was no blood concentration that is definitively therapeutic or toxic: that is, it cannot be established with certainty what dose would necessarily be toxic and cause Mr Hedges to die.136 Dr Drummer stated in evidence: “It’s hard to be certain that the morphine necessarily killed Mr Hedges. It may well have – and it possibly contributed to his death.”137 And later in his evidence “It’s hard to sort of be totally emphatic that the morphine was the final cause of his death”.138 In weighing up the expert evidence, the Coroner stated:

Both experts stressed that Mr Hedges was terminally ill, near death when the overdose was given and that it was therefore impossible to rule out the possibility that one of his various co-morbidities or a combination of them caused the death. However, both also accepted that having regard to the temporal connection between the overdose and the death and the symptoms observed after the morphine was given, it was likely that the morphine caused or at least contributed to the death.139

The Coroner concluded that the cause of death was morphine toxicity and carcinomatosis.140 Particularly relevant to his findings was the proximity to death to the provision of medication.141 Having established a causal link between the provision of medication and death Magistrate Barnes, the then Queensland State Coroner, was required to consider whether anyone should be charged with murder or manslaughter.142 The State Coroner observed that in administering the medication, Nurse Empen was intending to ease the patient’s pain rather than cause death. Accordingly, the requisite intention for an offence of murder did not exist.143 The State Coroner then considered whether there could be a charge of manslaughter by way of criminal negligence. Under the relevant provision of the Criminal Code Act 1899 (Qld) (Criminal Code),144 the State Coroner noted that the prosecution would need to demonstrate the following elements:

132 This was a “reportable death” because it was unnatural or suspicious within the terms of Coroners Act 2003 (Qld) s 7(1)(a)(i)(iii). 133 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 9. 134 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 9. 135 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 9. 136 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 9. 137 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 10. 138 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 10. 139 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 10. 140 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 11. 141 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 10. 142 Under Coroner’s Act 2003 (Qld) s 43(2)(b). 143 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 11. 144 Criminal Code Act 1899 (Qld) ss 291, 293, 296, 300, 303, 288, para 11.

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• by injecting the morphine into the intrathecal port Nurse Empen failed to use reasonable care within the terms of s 288 of the Criminal Code; and

• the injecting of the morphine into that port caused the death.145 The State Coroner found that a properly instructed jury could be satisfied that the medication caused the death of Mr Hedges (the second limb). However, in relation to the first limb, the State Coroner found that while there was:

[A]mple evidence that the conduct of Nurse Empen fell short of the standard of care that a reasonable person in her position could be expected to exercise. [The only issue was…] whether the departure from this standard of care was of such magnitude as to amount to gross negligence such as would warrant societal condemnation and punishment. … Although her actions were clearly poor practice, in view of the ease with which the mistake could be made and having regard to the short duration of her departure from the expected standard of care, I consider Nurse Empen’s conduct can better be described as inadvertence rather than reckless disregard and that it would be unreasonable for a jury to conclude otherwise. Accordingly, I find that no one should be committed to stand trial in connection with the death.146

The State Coroner stated that the Queensland Nursing Council investigation into the conduct of Nurse Empen was “the more appropriate forum in which to address the shortcomings she displayed on the day in question”.147 As a final point, the Queensland State Coroner noted that a number of systems-level changes had been implemented at the hospital to prevent a reoccurrence, and he was not in a position to recommend any further changes.148

C. Disciplinary Proceedings The only disciplinary proceeding149 revealed by our searches was the case of Health Care Complaints Commission v Osborne150 before the New South Wales Civil and Administrative Tribunal (the Tribunal). The complaint of unsatisfactory professional conduct and professional misconduct151 was brought by HCCC against Dr Lamorna Osborne, a general practitioner, who was caring for two elderly nursing home residents (Patients A and B) in the final stages of their lives. These patients had been treated by Dr Osborne for a number of years. The main particulars of the complaint were that Dr Osborne administered increasing doses of morphine to Patients A and B in a quantity in excess of recognised therapeutic standards.152 Peer review evidence was provided to the Tribunal by Dr Lake that morphine was clinically indicated for Patient A, and initial doses were appropriate for an opioid naïve patient. However, Dr Lake was strongly critical of Dr Osborne’s ongoing larger doses because of her failure to follow recommended guidelines. Dr Lake considered it inappropriate and unnecessary to administer 60mg two hourly as this was in excess of that recommended by the guidelines, and not clinically indicated. Dr Lake was also critical of the means of administration for the final dose of morphine. In Dr Lake’s opinion, this injection could have hastened Patient A’s death.

145 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 12. 146 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 14–15. 147 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 15. 148 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02, 16. 149 For the purposes of our analysis, we have not included Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150 as a “disciplinary case” despite it giving rise to questions under the Health Practitioner Regulation National Law (Victoria) Act 2009 (Vic). This case falls outside the criteria that we outlined in the introduction. Given the extensive discussion of the principle of double effect in the case, we have included it in Part IV E dealing with the criminal law. 150 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118. 151 For meaning of “unsatisfactory professional conduct” and “professional misconduct”, see Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW) ss 139B, 139E. 152 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118, [1]–[10].

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Dr Lake gave evidence that morphine was clinically indicated for Patient B. However, given her increasing renal failure (as clearly indicted in the medical record), morphine should have been used less frequently and replaced with another drug. Dr Lake considered the dose and method of administration inappropriate and could have hastened Patient B’s death.153 Dr Osborne “admitted without qualification” all of the particulars of the complaints relating to both patients.154 The explanation for her conduct was that she was suffering from an undiagnosed major depressive disorder at the time of treating the patients.155 The Tribunal found Dr Osborne guilty of unsatisfactory professional conduct and professional misconduct. Accepting the evidence of Dr Lake, the Tribunal noted Dr Osborne’s failure to check the Therapeutic Guidelines to ensure that she was prescribing morphine in quantities that were appropriate to palliative care and to the particular needs of Patients A and B. This failure demonstrated a lack of skill and judgment.156 The Tribunal suspended Dr Osborne’s registration for six months, made an costs order against her and imposed a number of conditions on her licence to practise after that period.157 The Tribunal acknowledged that Dr Osborne was suffering an impairment from a major depressive disorder, but deemed that not to be the sole cause of the serious error made.158 Our searches revealed no civil or criminal proceedings against Dr Osborne relating to this matter.

D. Civil Negligence Claim Our searches revealed only one civil claim brought in any Australian jurisdiction that related to an alleged over-medication resulting in a patient’s death. In D Lane v Northern NSW Local Health District,159 two adult children brought action against the Northern NSW Local Health District claiming psychiatric injury (nervous shock) as a result of their mother’s death in hospital. The plaintiffs alleged that their mother’s death was caused by her negligent treatment while a patient in two rural hospitals and that the defendant “allowed, in reality forced, (Mrs Lane) to die”160 and that the defendant was recklessly indifferent to Mrs Lane’s life “having the intent to cause her death”.161 In relation to the provision of medication, it was alleged that the defendant administered or continued to administer morphine when: it was apparent that the deceased was having an adverse reaction to the drug; such drug impeded the deceased’s ability to communicate her wishes in respect to treatment; and such drug was having an adverse effect upon the deceased and her wellbeing.162 Based on the evidence of the expert and treating doctors, Williams DCJ found the defendant was not negligent.163 In relation to the pain medication, the Court found that the dosage of morphine was so low that it was unlikely to have affected Mrs Lane’s overall situation:

The maximum dosage ever prescribed was 5mg subcutaneously over a number of hours which is a very low dose and was, according to the medical evidence, unlikely to have caused any deterioration in her condition despite Mrs Lane’s size and weight. The purpose of giving morphine is both for pain relief and patient comfort. This was not the situation one sees in terminally ill persons in great pain who are prescribed increasingly larger doses of morphine to a stage that the morphine begins to affect the ability

153 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118, [28]–[40]. 154 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118, [41]. 155 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118, [44]. 156 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118, [87], [90]–[91]. 157 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118, [131]. 158 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118, [66]–[68]. 159 D Lane v Northern NSW Local Health District [2013] NSWDC 12. 160 D Lane v Northern NSW Local Health District [2013] NSWDC 12, [9] (emphasis not added). 161 D Lane v Northern NSW Local Health District [2013] NSWDC 12, [9]. 162 D Lane v Northern NSW Local Health District [2013] NSWDC 12, [17]. 163 D Lane v Northern NSW Local Health District [2013] NSWDC 12, [324].

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of other organs of the body to function appropriately. In fact there is no expert evidence to suggest that the prescription and amount given of morphine to Mrs Lane was either inappropriate, incorrect, negligent or hastened her ultimate demise.164

The plaintiffs unsuccessfully appealed the decision.165

E. Potential Engagement of Criminal Law and Defence of Double Effect The nature and role played by the doctrine of double effect was described earlier. It also featured in two of the coronial cases that considered the provision of medication which allegedly accelerated the death of the deceased. The possible reach of the criminal law in cases of this kind is also considered in the cases below, outside of the coronial context, as well as the possible role played by the double effect doctrine. In the first two cases, declaratory relief was sought from the Supreme Court and Family Court respectively to obtain a ruling about the lawfulness of certain proposed medical action including the provision of medication that might accelerate death. The third case was a review by the Victorian Civil and Administrative Tribunal of a decision of the Medical Board of Australia to impose a condition on the registration of Dr Rodney Syme and involved detailed consideration of the principle of double effect. Brightwater Care Group (inc) v Rossiter:166 In this case, a quadriplegic patient, Mr Rossiter, requested his care facility (Brightwater) to discontinue his artificial nutrition and hydration. He also sought the prescription of analgesics for the purposes of sedation and pain relief as he approached death. Mr Rossiter was not terminally ill, although he would die from the cessation of nutrition and hydration. Both Brightwater and Mr Rossiter sought declaratory relief from the Western Australian Supreme Court about whether it was lawful to discontinue artificial nutrition and hydration, and to provide necessary pain relief in the knowledge that the latter may accelerate death. The lawfulness of discontinuing artificial nutrition and hydration is beyond the scope of this article.167 In relation to the provision of medication to address Mr Rossiter’s pain, the treating doctor expressed concern that he might face criminal prosecution in the event that he prescribed medication, specifically, analgesics for the purpose of sedation and pain relief, as Mr Rossiter approached the end of his life. As set out in Part III A, a form of the doctrine of double effect has been recognised in three states including Western Australia. The Western Australian provision is embodied in s 259 of the Criminal Code 1913. Relevantly, that section provides that a person is not criminally responsible for administering palliative care if to do so “is reasonable, having regard to the patient’s state at the time and to all the circumstances of the case”. In interpreting that provision, Martin CJ noted that, as a general principle, it is unlawful for any person, including any health professional, to administer medication for the purpose of causing or hastening the death of another person.168 However, Martin CJ noted that contextual factors may have impacted on the provision of palliative care to Mr Rossiter. His Honour observed the possibility of pain relief incidentally hastening death, and stated that the applicability of the protection afforded by s 259(1) “might well provide a defence to any criminal charge brought in such a circumstance”.169 In other words, provided the conduct in question falls within the scope of the statutory 164 D Lane v Northern NSW Local Health District [2013] NSWDC 12, [132]. 165 Lane v Northern NSW Local Health District (No 3) [2015] Aust Torts Reports 82-194; [2014] NSWCA 233. On 11 December 2014 the High Court refused to grant special leave to appeal in the matter of Lane v Northern NSW Local Health District [2014] HCASL 240. The High Court described the application as “misconceived”. The matter otherwise gave rise to no question of principle and had insufficient prospects of success. 166 Brightwater Care Group (Inc) v Rossiter (2009) 40 WAR 84; [2009] WASC 229. 167 On this point, the Court held that Brightwater was required to comply with a competent (and informed) decision by Mr Rossiter to cease artificial nutrition and hydration. For a more detailed discussion of this point, see B White, L Willmott and J Allen, “Withholding and Withdrawing Life-sustaining Treatment: Criminal Responsibility for Established Medical Practice?” (2010) 17 JLM 849. 168 Brightwater Care Group (Inc) v Rossiter (2009) 40 WAR 84, [54]; [2009] WASC 229. 169 Brightwater Care Group (inc) v Rossiter (2009) 40 WAR 84, [55]; [2009] WASC 229. See too H Ltd v J (2010) 107 SASR 352; [2010] SASC 176. The First defendant, a resident in a high care unit of plaintiff’s facilities in South Australia, informed the plaintiff of his intention to end his life by ceasing to take any food, water or medical treatment necessary for the particular

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protection, the excuse is capable of applying where medication is administered to relieve pain rather than to bring about death. Re Baby D (No 2):170 The second case concerned Baby D, a twin born at 27 weeks gestation, who required intubation and mechanical ventilation. Baby D suffered widespread and severe injury to the brain, and the treating medical team and parents considered it to be in Baby D’s best interests to cease ventilation by removing the endotracheal tube. The treating team and the parents were concerned that removing the tube may cause distress as Baby D struggled to breathe. At such time, the team would want to provide palliative care to Baby D in the form of administering sedation or other medication as it considered necessary and proper to relieve pain or distress. The parents sought declaratory relief from the Family Court regarding the lawfulness of both the withdrawal of the ventilation and the provision of palliative care to address any pain or distress of Baby D. Again, the lawfulness of the withdrawal of ventilation is beyond the scope of this article. However, the Family Court declared that the parents had the authority (ie it was lawful) to consent to the removal of the breathing tube as well as the provision of palliative care to address any respiratory distress that Baby D may suffer as a result of the removal of the tube. In the course of the judgment, the Court noted that the only way to relieve Baby D’s distress may have been to suppress the desire to breathe. Implicit in that observation is that the treatment to relieve the distress would also result in Baby D’s death. Dr Y, the physician with overall responsibility for the conduct of the neonatal intensive care unit and the special care nursery at the hospital at which Baby D was being treated, identified the problem in the following way:

The dilemma that I think we may face with Baby D is that the source – the very source of her distress will be likely to be that desire to breathe. And whilst one would hope in that setting that it is possible to give her sufficient morphine to relieve the distress, but not to remove her desire to breathe, it is also possible in that setting that the two may prove to be inseparable.171

Similarly, Dr W, a consultant neonatologist who was not involved in Baby D’s care, provided expert evidence that:

This is a classical “double effect” situation, which in medical logic turns on the intent of the sedation. It is very clear to me … that the intent is entirely to relieve distress and that enormous thought has gone into the issues surrounding this…It would be good, normal medical practice to use sedation and analgesia in this situation. It would be medically unacceptable to fail to do so.172

Although the Court recognised that the sedation may result in the baby’s death, it declared that it would be lawful for the treating team to provide such palliative care as it considered necessary and proper. Although this falls short of explicit endorsement of double effect, this does suggest it is part of Australian law as the Court’s conclusion about lawfulness was based on the medical evidence which was couched in terms of the principle of double effect.173 Syme v Medical Board of Australia (Review and Regulation):174 This is the third case that considered the doctrine of double effect. This case involved Dr Rodney Syme, a euthanasia advocate, who had a condition placed on his registration by the Medical Board of Australia, as a result of prescribing

conditions suffered. The first defendant proposed to give the plaintiff direction not to provide nutrition, hydration and insulin and the plaintiff sought declarations which will allow it to determine the extent to which it can lawfully comply with direction of first defendant to be given to achieve stated intention. While focusing on withholding treatment, interestingly the declaration, specifically mentions pain medication only in terms of default hydration via “mouth swabs to palliate pain and discomfort”. Unlike Brightwater, there is no mention of the prescription and administration of pain relief. 170 Re Baby D (No 2) (2011) 258 FLR 290; [2011] FamCA 176. 171 Re Baby D (No 2) (2011) 258 FLR 290, [95]; [2011] FamCA 176. 172 Re Baby D (No 2) (2011) 258 FLR 290, [139]; [2011] FamCA 176. 173 White, McDonald and Willmott, n 47, [15.20]. 174 Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150.

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Nembutal to a patient.175 Dr Syme brought an application to the Victorian Civil and Administrative Tribunal to overturn the imposition of this condition. The Medical Board imposed the condition because it believed that Dr Syme provided the Nembutal with the primary purpose of enabling the patient to use it to end their life. Dr Syme argued, among other things, that his intention in providing the Nembutal was not to end the life of his patient, but “the relief or palliation, of the psychological and existential suffering being experienced by his patients”176 and that “the palliation occurs because patients feel an increased sense of control and certainty about how their life will end”.177 Dr Syme relied on the application of the doctrine of double effect, among other things, to support his argument that he did not intend to bring about death by providing Nembutal and, therefore, could not be regarded as causing death if the Nembutal was later consumed by a patient. The Tribunal was persuaded by the relevance of the doctrine in the context of the case:

[A]lthough not a classic instance of double effect, the process by which some patients who are given Nembutal choose to die by ingesting it, is analogous to the process of terminal sedation, where a mixture of opioids and sedatives are used. In each case, the intended and established purpose of treatment is palliation of suffering. The fact that the treatment also has the effect of providing an opportunity for the patient to later ingest Nembutal is not intended by Dr Syme and can be seen as a secondary but unintended consequence178 … there is a logical analogy between the principle of double effect used in palliative care; and the prospect that the patient may elect to ingest Nembutal, the later representing the same kind of secondary effect as the hastening of death … when terminal sedation is used. The only real difference is one of timing.179

For this and other reasons, the Tribunal set aside the condition imposed on Dr Syme’s registration. In our view, the application of the doctrine of double effect, as expressed by the Tribunal in this case, is surprising and controversial.180 However, we note that the prescription of Nembutal does not constitute standard palliative care practice and so the relevance of this case to liability for mainstream medical practice is limited.

V. IMPLICATIONS OF CASE LAW FOR CLINICIANS An analysis of the publicly available decisions, as undertaken in the previous part, enables us to make the following observations which we believe may provide comfort to health professionals who practise in the end-of-life field.

A. Infrequency of Regulatory Scrutiny The first observation is the small number of cases in which the prescription or administration of medication provided to patients at the end of their lives has received scrutiny by courts, tribunals, coroners or disciplinary bodies. The provision of pain and symptom relief at the end of life is a mainstream part of medical practice for many health professionals. The administration of a last dose of medication and death frequently occur in close temporal proximity. Each year there would be tens of thousands of instances in which death follows the provision of pain or other symptom relief. Yet, our searches revealed only fifteen cases in which actions of health professionals or health services have been formally reviewed in this way. This number of cases is extremely small when viewed in this context. In 175 The condition was imposed as a form of immediate action under Health Practitioner Regulation National Law (Victoria) Act 2009 (Vic) s 156 by the Medical Board of Australia. The condition was that Dr Syme not engage in the provision of any form of medical care, or any professional conduct in his capacity as a medical practitioner that had the primary purpose of ending a person’s life. 176 Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150, [130(a)]. 177 Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150, [130(b)]. 178 Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150, [147(i)]. 179 Syme v Medical Board of Australia (Review and Regulation) [2016] VCAT 2150, [148]. 180 R Magnusson, “Dr Rodney Syme and Nembutal” on Sydney Health Law (15 February 2017) <https://sydneyhealthlaw.com/2017/02/15/dr-rodney-syme-and-nembutal/>.

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relative terms, the evidence indicates that this field of medical practice is not one that should cause concern to regulators of health professions.

B. Regulatory Bodies Are Not Seeking to Blame The second point emerging from the examined cases is that the regulators of the health professions and coroners are not seeking to sheet home blame, particularly to individual health care professionals. They do not appear to be driven by a desire to make a particular person or health service responsible for a patient’s death, but rather a desire to improve the provision of health care at a systemic level. We make this claim for a number of reasons. First, these bodies recognise the complexity of clinical practice at the end of life, and that a person may die following the provision of medication for pain relief without anyone acting unlawfully or breaching professional standards of practice. For example, they understand the difficulty in predicting the precise amount of medication that will relieve pain but not result in the patient’s death. Post-mortem results in Hughes’s case identified six different medications in the deceased’s system, five of the six being within therapeutic range. The Coroner accepted the doctors’ submission that “in the context of significant pain occurring as death approaches, toxicity levels cannot be stated with any precision and would be professionally balanced with the pain level experienced by the patient”.181 The Coroner concluded that there could be no criticism of the staff administering pain relief to the patient. Another example of this complexity is the difficulty in attributing cause of death to patients at the end of life. Patients who are receiving medication at the end of life can be very medically compromised and may have built up a tolerance to pain-relieving medication. Emerging research on the complexity of the pharmacokinetics of morphine and other drugs used for symptom control in palliative care patients suggests the effects may be altered in these patients as a result of physiological changes that occur at the end stage of life. That is, the pharmacokinetics of these patients differ from the average population because of the effects of terminal illness on absorption, distribution, metabolism and elimination.182 As such, at least in some cases, it may be difficult, if not impossible, to attribute death to the provision of medication rather than the underlying illness. Zimmerman’s case is illustrative of this point. Despite allegations by Mrs Zimmerman’s daughters, the Coroner adopted the findings in the autopsy report that it was not possible to be certain as to the possible role morphine played in her death. The most likely cause of death was coronary artery thrombosis. The medical team therefore had no case to answer. Other cases reviewed above also demonstrated the reluctance of the Coroner to find that the medication caused death.183 Of course, this does not mean that a finding of causation will never be made. As noted earlier, the dosage error was found by the Coroner to have caused death in Inquest into the Death of Cynthia Joy Pauley:184

The events that almost immediately followed the administration of the medication in and of themselves are strongly suggestive of a connection between that administration and Mrs Pauley’s collapse. In particular, her unresponsiveness and drop in blood pressure … and her rallying to the administration of naxolone suggest that at least morphine had been at work as far as Mrs Pauley’s suddenly deteriorating presentation was concerned. Furthermore, the fact that Dr Gilbert found no anatomical features to explain

181 Inquest into the Death of Damien Hughes [2013] NTMC 022, [34]. 182 LG Franken et al, “Pharmacokinetic Considerations and Recommendations in Palliative Care, with Focus on Morphine, Midazolam and Haloperidol” (2016) 12 Expert Opinion on Drug Metabolism and Toxicology 669. 183 See also Inquest into the Death of Bill Portelli [2014] CCWA Ref 3/14; Inquest into the Death of Damien Hughes [2013] NTMC 022; Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02 where there was found to be no causal link between the provision of medication and death; and Record of Investigation into Death (without Inquest) of Steven Paul Jones [2014] TASCD 238 where the Coroner noted the expert evidence that medication for pain relief for end-of-life patients is not an exact science: “toxicity is a risk with all drugs and that pain medication is an active area of medical research.” 184 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013.

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a sudden death notwithstanding Mrs Pauley’s widely disseminated metastatic cancer is also strongly suggestive that the medication administered had a significant role to play.185

The difficulty in establishing causation also has implications for any civil suit brought by the families of deceased persons. In Lane’s case, for example, one reason the family was unsuccessful in their claim for psychiatric injury caused by the mother’s death was that they could not demonstrate a causal link between the medical treatment and death. Second, and perhaps surprisingly given the finding in the Pauley’s case, coroners have generally not recommended prosecution or disciplinary action despite errors in the administration of medication. There is a preparedness on the part of coroners to consider all the circumstances of the case including what led to the error. In Pauley’s case, where the quantity of medication was excessive having regard to its mode of administration, and notwithstanding a finding that the medication caused the patient’s death, the coroner took into account the skill level of the nurse as well as the rural setting. In Whiley’s case, where a five times greater dose of morphine than the maximum prescribed and 10 times greater than what the nurse intended to administer was accidentally administered, the Coroner observed that the nurse only recently graduated and accepted that she was inappropriately charged with the responsibility of too many patients for her skill and experience level. In neither case was further action taken in relation to the health professionals involved. Finally, and following on from the above point, the primary goal of coronial reviews is to address systemic issues that may have resulted in death, rather than attributing blame to an individual person. In the Whiley and Pauley cases, for example, the Coroner made recommendations to avoid any future occurrence of inexperienced staff having sole responsibility for high need patients. In Russell’s case, the Coroner did find death to be complicated by morphine toxicity and found treatment not in accordance with professional standards. However, only systems level recommendations were made and there are no reported disciplinary or civil proceedings arising from the case. Of course, this does not mean that more adverse recommendations cannot be made by a coroner in an appropriate case. And in an appropriate case, they will be made. As we saw in Hedges case, where an error in the administration of medication resulted in the patient’s death, the Coroner made a number of systems-level recommendations and also observed that Queensland Nursing Council investigation into the conduct would be appropriate.186

C. Regulatory Bodies Rely Heavily on Expert Clinical Evidence and Therapeutic Guidelines

In determining whether there is potentially unlawful or professionally questionable conduct, regulatory bodies will seek guidance from within the health disciplines. This expertise is gathered in two ways: through obtaining evidence from expert witnesses, generally doctors; and by reference to therapeutic guidelines. Reliance on expert evidence from medical practitioners occurs across the board, namely in coronial hearings as well as in the civil and disciplinary proceedings.187 The regulatory bodies recognise that, for the most part, details about the amount and type of medication and mode of administration, and circumstances around the clinical setting in which the patient was being cared for, are within the realm of expertise of health professionals working within the field. Of course, the medical evidence presented is not always consistent. If this occurs, the relevant adjudicating body will need to make a decision about

185 Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013, [5.4]–[5.5]. 186 Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02. 187 For example, in Inquest into the Death of Sybil Zimmerman ([2014] SCCNSW 2011/00389491), expert evidence was presented from a physician/geriatrician and pharmacologist; in Health Care Complaints Commission v Osborne ([2014] NSWCATOD 118) (disciplinary matter heard in the New South Wales Civil and Administrative Tribunal), peer review evidence was presented from a medical doctor (although the reasons for decision did not specify the specialty). In D Lane v Northern NSW Local Health District ([2013] NSWDC 12) (civil negligence case heard in the NSW District Court), evidence was presented from a medico-legal psychiatrist, a medico-legal expert; a geriatrician; an emergency medical specialist as well as a number of other medical practitioners and health care professionals.

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which evidence to accept and must justify its choice. In D Lane v Northern NSW Local Health District,188 for example, the New South Wales District Court had to decide between two opposing medical opinions. In making a choice, Williams DCJ noted that the Court would prefer widely held peer opinion over one peer opinion.189 Our review of cases also revealed the importance of therapeutic guidelines in assessing the appropriateness of conduct of health professionals. Again, this was the case in the three different kinds of reviews: coronial,190 civil191 and disciplinary.192 There are two important points to make here. The first is that if the dose of medication and route of administration fall within therapeutic guidelines, it is unlikely that there would be a finding that the medication caused the deceased’s death.193 But second, even if the medication administered (dose or route) was outside therapeutic guidelines, a finding that the medication caused the death would not necessarily follow. The adjudicating body will consider the circumstances of the individual case to determine whether treatment was reasonable despite not being within recommended dosage parameters. In Hughes’s case, for example, the conduct of the medical staff was found to be acceptable even though one drug did not fall within therapeutic guidelines. In relation to this, the Coroner commented as follows:

Furthermore, the doctors added that in the context of significant pain occurring as death approaches, toxicity levels cannot be stated with any precision and would be professionally balanced with the pain level experienced by the patient. Therefore, the 0.1mg/litre estimate [in the guidelines], would appear to be a rough guide and nothing more. I so find.194

As a final (and related, but separate) point, as demonstrated in Zimmerman’s case, compliance with the procedural safeguards contained within legislation that regulates Schedule 8 drugs can assist health professionals where allegations of administration of excessive doses of medication are levelled. In that case, the doctor was able to refute the factual allegations of Mrs Zimmerman’s family about the dose of morphine by balancing the quantity of the drug contained in the Schedule 8 register.

D. Significance of “Intention” and “Good Practice Standards” As we have seen, compliance with standards of good practice is important for health professionals where their treatment of a patient is being reviewed. If a coroner is satisfied that medication has been prescribed and administered in accordance with accepted practice, no further scrutiny is likely to be recommended.

188 D Lane v Northern NSW Local Health District [2013] NSWDC 12. 189 D Lane v Northern NSW Local Health District [2013] NSWDC 12, [235]. See also Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010), [5.18], where the Coroner “found it difficult to decide which of the evidence … should be preferred” as “[b]oth witnesses were of similar expertise in almost identical fields of medicine”. 190 Record of Investigation into Death (Without Inquest) of Steven Paul Jones [2014] TASCD 238 “I accept Dr Bell’s opinion that Mr Jones’s treatment was appropriate and within applicable guidelines. He notes that toxicity is a risk with all drugs and that pain medication is an active area of medical research”. 191 D Lane v Northern NSW Local Health District [2013] NSWDC 12, [131]–[132], [324]. 192 Health Care Complaints Commission v Osborne [2014] NSWCATOD 118 “the evidence established that the practitioner lacked knowledge and skill concerning the prescription and administration of morphine in a palliative care setting and that she failed to consult readily available guidelines to determine recognised therapeutic standards” at [87]. “The errors made by the practitioner were serious and significant to the extent that the Tribunal accepted that they could have hastened the deaths of patients A and B. Of particular concern was the practitioner’s failure to check against accepted therapeutic guidelines that she was prescribing morphine in quantities that were appropriate to palliative care and to the particular needs of patients A and B. Her failure to do so was the result of her failure to exercise skill and judgment in checking her understanding of appropriate therapeutic doses against the guidelines” at [90]. 193 See, eg, D Lane v Northern NSW Local Health District [2013] NSWDC 12; Record of Investigation into Death (without Inquest) of Steven Paul Jones [2014] TASCD 238. 194 Inquest into the Death of Damien Hughes [2013] NTMC 022, [34]. See too Inquest into the Death of Bill Portelli [2014] CCWA Ref 3/14 where toxicological analysis showed a “very high level” of the opioid Fentanyl. The Coroner found that Mr Portelli died from natural causes despite the high levels of Fentanyl, which his Honour described in terms of an issue of tolerance to the medication as “not unusual in end-stage palliative care where pain-killers are increased to reduce suffering”, at [27].

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Similarly, a civil claim by a bereaved relative for damages following the death of a loved one will be unsuccessful if the medical treatment leading up to the death satisfied the relevant standards of care. But it is in circumstances when the Crown is contemplating criminal charges that the issue around standards of practice becomes more complicated, and probably even more critical given the consequences of a guilty verdict. As a reminder, we are dealing with the situation where a health professional is practising in good faith and without intention to end the patient’s life. If the Crown is able to prove that the provision of medication has resulted in the death of the patient, then theoretically the clinician may be at risk of a charge of murder or manslaughter. At common law, the doctrine of double effect provides a health professional with a defence against such a charge if his or her intention, when providing medication, was to relieve pain, rather than to end the patient’s life. Such conduct would not attract criminal liability at common law even if the medical treatment provided fell short of good medical practice. As observed earlier in this article, however, in Queensland, South Australia and Western Australia, a form of this common law defence has been incorporated into statute.195 In those States, to rely on the statutory defence of double effect, the health professional must also act in accordance with good medical practice (expressed in various ways in the different jurisdictions) in providing the medical treatment. To rely on the statutory excuse, it is not enough to demonstrate an intention only to relieve pain rather than cause death, as at the common law. The health professional must demonstrate that he or she has discharged the requisite standard of care. This makes the defence a more onerous one to make out in those States.196 While the scope and operation of the statutory defences in South Australia, Queensland and Western Australia are yet to be tested in any criminal action against a health professional, meeting the standards of good practice may be a requirement to rely on the statutory defence. It will be insufficient to simply have an appropriate intention (to relieve pain and not to kill) which is the relevant test at common law.

VI. CONCLUSION Every day, thousands of health professionals provide medical treatment to Australians as they approach the end of their lives. An important component of that medical treatment is provision of medication to alleviate pain and other symptoms. So that patients can experience the best possible medical care at the end of life, it is critical that medical treatment can be provided by health professionals who are not constrained by ill-informed concerns about potential or even likely legal or disciplinary consequences of providing pain and symptom relief that may incidentally hasten a patient’s death. The available anecdotal evidence in Australia suggests that under-medication of patients may be happening because of concern about potential regulatory repercussions of providing that treatment. But these concerns are not warranted. Despite a rigorous search of publicly available legal databases, the authors have been able to identify only a handful of cases where the provision of medication at the end of life has been scrutinised by judicial or quasi-judicial bodies. This, of course, does not purport to represent the number of cases of adverse consequences arising from inappropriate practice. There may be an under-reporting of such practice by families who lack the confidence, knowledge or motivation to raise their concerns. Nevertheless, these bare figures alone point to the fact that, in reality, the myriad of health professionals who work with patients at the end of life are extremely unlikely to experience any formal review of their practice by a regulatory body as a result of the provision of pain and symptom medication. And, even if their actions do come under scrutiny, they have no reason for concern if treatment has been provided in accordance with good practice. Indeed, even if conduct falls short of

195 South Australia: Consent to Medical Treatment and Palliative Care Act 1995 (SA) s 17; Queensland: Criminal Code Act 1899 (Qld) s 282A; Western Australia: Criminal Code Act Compilation Act 1913 (WA) s 259. For a comparison and analysis of these provisions in tabular form see White, McDonald and Willmott, n 47, [15.110]. 196 See, eg, the coronial cases of Inquest into the Death of Cynthia Joy [2013] SACC 2/2013 (1454/2010) and Inquest into the Death of Brian Russell [2000] SACC 11/2000. In both cases, the conduct of the nursing staff fell short of the appropriate standards for the provision of palliative care, so fell outside the scope of the relevant statutory provision.

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good practice standards, the focus of the regulatory bodies is on improving the provision of care at a system level to avoid further issues in the future rather than on sheeting home blame to individual health professionals. We do acknowledge, though, that our review has only identified legal cases and there may be other less formal review mechanisms, such as the making of a complaint to the institution, the relevant professionals’ regulatory body or the Health Care Complaints Commission (or equivalent) which are not pursued, and this can still be stressful for health professionals. The “shadow of the law” remains present in these decisions even if formal engagement with the legal system happens only very rarely.197 We also acknowledge that even if the conduct of a health professional is vindicated by the courts, being the subject of review (particularly a criminal investigation) is very stressful.198 The goal of this article was to determine if concerns of health professionals about potential regulatory repercussions when they care for patients in accordance with good practice standards are well-founded. For the reasons articulated, we believe that they are not. We hope that this may provide reassurance for health professionals and supports them to provide sufficient medication to their patients to alleviate pain and symptom as they approach the end of their lives. This may point to the need for better education about the true nature of the regulatory risk so health professionals can practise palliative care with confidence. This should include education that takes account of the differences in regulation of pain relief in the various Australian jurisdictions.199 In decisions about withholding and withdrawing treatment, there is research which links a lack of knowledge to defensive medicine (in that setting, leading to overtreatment at the end of life).200 It may be that education is needed here to avoid a defensive approach, which here involves the under-treatment of pain and other symptoms. POSTSCRIPT: The authors note that since finalising the manuscript, there has been a media report of multiple deaths at a Townsville nursing home which resulted in the sacking of nurses and the reporting of a doctor to the Queensland Health Ombudsman: http://www.abc.net.au/news/2018-02-21/five-deaths-at-townsville-nursing-home-prompt-nurse-sackings/9469598 (accessed 31 August 2018). Publicly available searches have not revealed information on the progress of investigations.

197 TM Pope and EA Waldman, “Mediation at the End of Life: Getting Beyond the Limits of the Talking Cure” (2007) 23 Ohio State Journal on Dispute Resolution 143. 198 L Cohen et al, “Accusations of Murder and Euthanasia in End-of-Life Care” (2005) 8 Journal of Palliative Medicine 1096; CD Kollas, B Boyer-Kollas and JW Kollas, “Criminal Prosecutions of Physicians Providing Palliative or End-of-Life Care” (2008) 11 Journal of Palliative Medicine 233. 199 BP White, L Willmott and M Ashby, “Palliative Care, Double Effect and the Law in Australia” (2011) 41 Internal Medicine Journal 485. 200 SV McCrary et al, “Treatment Decisions for Terminally Ill Patients: Physicians’ Legal Defensiveness and Knowledge of Medical Law” (1992) 20 Law, Medicine & Health Care 364; SV McCrary and JW Swanson, “Physicians’ Legal Defensiveness and Knowledge of Medical Law: Comparing Denmark and the USA” (1999) 27 Scandinavian Journal of Public Health 18. See also on doctors’ knowledge of the law in this area: B White et al, “Doctors’ Knowledge of the Law on Withholding and Withdrawing Life-Sustaining Medical Treatment” (2014) 201 Medical Journal of Australia 229.

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Appendix 1: Summary of Cases CASE HEALTH

PRACTITIONER & CLINICAL

SETTING

FACTS OUTCOME

Coronial Findings Inquest into the Death of Brian Russell [2000] SACC 11/2000 (12 April 2000)

Nurse Acute facility Palliative care

Mr Russell was suffering from terminal liver disease and was receiving palliative care at the time of his death. He received an unusually large dose of morphine in a short time as a result of an infusion pump being set incorrectly, followed by a further subsequent dose of morphine. The matter was investigated by the Coroner because the death was a reportable death under s 12(1)(a) of the Coroners Act 1975 (SA).

Coroner found that Mr Russell’s death was complicated by morphine toxicity. Section 17 of the Consent to Medical Treatment and Palliative Care Act 1995 (SA) was not applicable because Mr Russell’s treatment was not in accordance with professional standards of palliative care. Coroner made a number of systems-level recommendations and a recommendation for review by the Attorney-General of the interaction of s 17(3) of the Consent to Medical Treatment and Palliative Care Act 1995 (SA) and s 26(3) of the Coroners Act 1975 (SA).

Inquest into the Death of John Walter Hedges [2006] QCC Cor153/02 (15 June 2006)

Nurse Private acute facility Palliative care

Mr Hedges died from a morphine overdose. He had advanced cancer and was receiving palliative care. Morphine was administered by a nurse to the wrong site, resulting in an overdose. Because the hospital staff recognised that the death of Mr Hedges was unnatural or suspicious within the terms of s 7(1)(a)(i)(iii) of the Coroners Act 2003 (Qld), they reported the death to police who were obliged by s 12(1) to report it to a coroner.

Coroner found that it was likely that the morphine caused or at least contributed to the death given the temporal connection between the overdose and the death and the symptoms observed after the morphine was given. Coroner considered whether nurse should be charged with manslaughter and ruled against this due to lack of intention to harm. Coroner then considered manslaughter by way of criminal negligence, finding the nurses actions were inadvertence rather than reckless disregard. Coroner noted that the nurse was being investigated by the Nursing Council and considered this to be “the more appropriate forum”. Coroner identified systems

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issues noting they had been addressed by the hospital.

Inquest into the Death of Cynthia Joy Pauley [2013] SACC 2/2013 (1454/2010) (8 March 2013)

Nurse Acute facility (rural) Palliative care

Mrs Pauley was in the terminal phase of advanced cancer. Her palliative care specialist knew she had an intrathecal line, however when he later came to write the order for spinal analgesia he wrote it for administration via an epidural line, in mistake. Significantly less analgesic medication is required when an intrathecal line is utilised. A nurse administered the dose written for epidural administration via the intrathecal line. Mrs Pauley’s death was reported to the coroner following an independent clinical overview of the circumstances of Mrs Pauly’s death and two post-mortem reports in the belief that the analgesic being delivered by way of spinal line may have played some part in her death.

Coroner found that the cause of death was intrathecal toxicity of bupivacaine and morphine. Coroner noted nurse should not be criticised for not questioning dosages or mode of delivery as ordered by the doctor stating a nurse in a dedicated pain management unit might have picked up on the error but a nurse in the current clinical setting would not necessarily have possessed sufficient expertise to do so. Coroner found that s 17 of the Consent to Medical Treatment and Palliative Care Act 1995 (SA) was not applicable and made a systems only recommendation.

Re Inquest Touching the Death of Stanley Valentine Whiley [2013] TASCD 144 (18 July 2013)

Nurse Aged care facility Palliative care

Mr Whiley was s receiving palliative care in an aged care facility. A nurse administered a dosage of morphine five times greater than the maximum prescribed and 10 times greater than the dose she intended to administer. The matter came before the Coroner to determine cause of death under s 28(1)(c) of the Coroners Act 1995 (Tas).

Coroner found the death was from natural causes and no person contributed to the cause of death. Coroner made systems recommendations and referred the matter to the aged care accrediting agency.

Inquest into the Death of Damien Hughes [2013] NTMC 022 (30 September 2013)

Palliative care doctor Hospice attached to acute facility

Mr Hughes was receiving end-of-life treatment for cancer. Post-mortem results revealed six legally prescribed drugs in his blood. Quantities of each drug were within therapeutic range, except for one. An inquest was held because Mr Hughes was a prisoner at the time of his diagnosis and death and his death was classified as a death in custody necessitating inquest under s 12 of the Coroners Act.

Coroner found that no criticism could be made of the care, supervision and treatment of Mr Hughes.

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Investigation into the Death of Sybil Zimmerman [2014] SCCNSW 2011/00389491 (14 March 2014)

Nurses Aged care facility (rural)

Mrs Zimmerman, an 84-year-old woman with multiple comorbidities, died in hospital. Her family alleged her death resulted from gross negligence or she had been involuntarily euthanised by nursing home staff. Following representations from the Zimmermans’ and their lawyer, the then State Coroner ordered that an inquest be conducted.

Coroner reviewed the conduct of the nursing staff in the aged care facility and found there was no case to answer.

Inquest into the Death of Bill Portelli [2014] CCWA Ref 3/14 (11 April 2014)

None specified Mental health facility attached to acute facility Palliative care

Mr Portelli was receiving palliative care for cancer. Toxicological analysis showed a “very high level” of the opioid Fentanyl (the level was not cited in the findings). As he was an involuntary patient under the Mental Health Act 1996 (WA), an inquest to inquire into the death was mandatory under s 22 (1)(a) of the Coroners Act 1996 (WA).

Coroner found death from natural causes. Coroner made specific comment on Mr Portelli’s care, describing it as “exemplary”.

Record of Investigation into Death (Without Inquest) of Steven Paul Jones [2014] TASCD 238 (18 July 2014)

Palliative care specialists Private acute Palliative Care

Mr Jones suffered bowel cancer and was receiving care at a palliative care unit at a hospital. There had been a number of attempts to rationalise his pain medication. After leaving hospital, Mr Jones self-administered and overdosed on prescription drugs. The record of investigation does not state why a coronial investigation was conducted.

Coroner found the provision of medication was within applicable guidelines and decided not to hold an inquest to further investigate the circumstances surrounding death.

Inquest into the Death of Michael Nelson [2015] SCCNSW 2014/134742 (28 October 2015)

Doctor (Emergency Medicine) Nurse Public acute

Mr Nelson had been suffering from early onset dementia and Parkinson’s disease for some time and was living in a Nursing home and a not for resuscitation order was in place. He was admitted to the Emergency Department of Westmead Hospital as he was unable to eat or lift his head. He became increasingly agitated. He was mistakenly given 2.5mg of midazolam by way of intravenous as opposed to intramuscular injection because of a miscommunication

Coroner found the overdose was still within the clinically appropriate limit and death and that the reaction of Mr Nelson was very unusual and unpredictable and not the direct cause of his death. Cause of death was a result of multiple comorbidities caused by neck dystonia and possible intravenous midazolam.

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between the doctor and nurse, and died four hours later. The matter came before the Coroner to determine cause of death under s 81 of the Coroners Act 1989 (NSW).

Inquest into the Death of Audrey MacGregor [2016] SCCNSW 2013/322168 (26 October 2016)

Doctor (Registrar) Doctor (Cardiologist) Nurses Private acute

Mrs MacGregor had several underlying health problems and was admitted to hospital suffering pneumonia and clostridium difficile colitis. She was being assessed for a transcatheter aortic transplant procedure however this could not proceed due to the colitis. She developed renal and respiratory failure and deteriorated. She was documented as not for resuscitation. The registrar prescribed a small dose of hydromorphone for respiratory distress. Mrs MacGregor was incorrectly administered a dose 10 times the actual dose prescribed because the administering nurses mistook 0.5mg as 0.5mls, believing hydromorphone to be relatively the same as morphine. The matter came before the Coroner to determine cause of death under s 81 of the Coroners Act 1989 (NSW).

Despite toxicology results indicating that the hydromorphone concentration was within the normal therapeutic range, given the proximity of the overdose to the death, the Coroner found the cause of death was the combined effect of an overdose of hydromorphone and complications of pneumonia (following treatment for chronic clostridium difficile colitis) against a background of heart disease and lung disease. Coroner identified systems issues and make recommendations to the Mister for Health in relation to those issues.

Professional Conduct Proceedings Health Care Complaints Commission v Osborne [2014] NSWCATOD 118 (20 October 2014)

General Practitioner Aged care facility

The allegations were that the doctor administered increasing doses of morphine, contrary to clinical guidelines in a quantity in excess of recognised Therapeutic Standards, to two patients. The HCCC complained that the standard of treatment was such that the practitioner was guilty of unsatisfactory professional conduct and professional misconduct within the meaning of ss 139B and 139E of the National Law. The matter came to the attention of the Commission via a complaint by

The doctor was found guilty of unsatisfactory professional conduct and professional misconduct. Tribunal noted its particular concern over the doctor’s failure to check against accepted Therapeutic Guidelines. Tribunal suspended the doctor’s registration for six months, made an adverse costs order against her and imposed a number of conditions on her licence.

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a nurse from the aged care facility where the patients were residents.

Negligence (Civil) D Lane v Northern NSW Local Health District [2013] NSWDC 12 (15 February 2013)

Local Health District Acute facility (rural) Doctors

Proceedings in civil negligence were brought against the Northern NSW Local Health District (LHD) by two adult children claiming psychiatric injury (nervous shock) as a result of their elderly (and deteriorating) mother’s death. The adult children alleged that their mother’s death was caused by her negligent treatment while a patient in two of the LHD’s rural hospitals, after experiencing some sort of cerebral incident.

The defendant was found not to be negligent. Appeals were also dismissed.