BACKGROUND

In 2014, the unmet need for palliative care has been mapped in the “Global atlas of palliative care at the end of life”, published jointly by the World Health Organization (WHO) and the Worldwide Palliative Care Alliance (WPCA). Globally, in 2011, over 29 million people died from diseases requiring palliative care. The estimated number of people in need of palliative care at the end of life was 20.4 million. The biggest proportion, 94%, corresponds to adults of which, 69% are over 60 years of age, and 25% are 15-59-years-old. Only 6% of all people in need of palliative care are children. Based on these estimates, each year in the world, around 377 adults out of 100,000 population over 15-years-old, and 63 children out of 100,000 populations under 15-years-old will require palliative care at the end of life. Globally, great majority of adults in need of palliative care died from cardiovascular diseases (38.5%) and cancer (34%) followed by chronic respiratory diseases (10.3%), HIV/AIDS (5.7%) and diabetes (4.5%). Seventy eight percent of adults and 98% of children in need of palliative care at the end of life belong to low and middle-income countries. According to the 2014 WHO report, India has attained Level 3b integration that is, Generalized Palliative Care Provision with respect to adult palliative care services and with respect to pediatric palliative care provision, India has attained only Level 2 integration which is the Capacity Building Stage.[1]

More than 1 million new cases of cancer occur each year in India with over 80% presenting at stage III and stage IV. Experience from cancer centers from India confirms that two-thirds of patients with cancer are incurable at presentation and need palliative care.[234] Access to oral morphine is one of the indicators of availability of palliative care services. In India, only 0.4% of the patient population has access to oral morphine.[5] In 2008, India used an amount of morphine that was sufficient to treat pain adequately in only about 40,000 patients suffering from moderate to severe pain due to advanced cancer which is approximately 4% of the population needing the same.[6] Hopefully recent ammendment of the NDPS act will improve access and availability of morphine to these patients.

India has about 100 million elderly at present and this is expected to increase to 324 million by 2050, constituting 20% of the total population. It is estimated that 60% of the elderly patients are affected by cancer.[7] Surveillance Epidemiology and End Results (SEER) study of the National Cancer Institute in the USA shows that cancer is 11 times more likely to develop in people over 65 years as compared to their younger counterparts.[8] An Indian Council of Medical Research (ICMR) population-based cancer registry report shows that the prevalence of cancer patients in India above the age of 60 is estimated to reach more than 1 million by 2021.[9]

A report on a study by the Economist Intelligence Unit that was commissioned by Lien Foundation ranked EOLC services in 40 countries (30 OECD countries and 10 select countries), from which data was available. The outcomes of quality of death index showed that India ranked 40 out 40 in EOLC overall score, 37 out of 40 in basic end of life health care environment, 35 out of 40 in availability of EOLC, 39 out of 40 in cost of EOLC, 37 out of 40 in quality of EOLC and scored 2 on a 1-5 scale on public awareness of EOLC where 5 being the highest score.[10] There is an overwhelming need for a national palliative care initiative to bridge these gaps.[11]

A study conducted by Cipla Palliative Care Institute Pune showed that 83% of people in India would prefer to die at home.[12] Palliative care at home is the most cost effective, relevant and practical option in the Indian setting. However, due to lack of awareness among patients and families, and the attitude and lack of knowledge of health care providers about EOLC, significant number of deaths take place in hospitals. Most of the health care expenses are borne by patients and families, and inappropriate and aggressive medical interventions at end of life drain the resources of patients and family.[13] Due to the lack of legal protection, physicians practice defensive medicine, resulting in many inappropriate interventions being done. This ultimately results in holistic suffering instead of holistic care for the dying person and the family. Non-availability of EOLC and rising cost have forced up to 78% of patients to leave hospital against medical advice.[14] The families unilaterally initiate these discharges resulting in these patients not receiving any symptom relief or EOLC measures.

Indian Society of Critical Care Medicine was instrumental in initiating discussions on EOLC in advanced critically ill patients. Initial work, published in 2005, highlighted on limiting life-prolonging interventions and providing palliative care towards the end of life, in Indian intensive care units (ICU).[15] The consensus ethical position statement on guidelines for end of life and palliative care in Indian intensive care was published in 2012.[16]

END OF LIFE CARE

Principles of a good death

Principles of a good death involve the ability to know when the death is approaching, have physical symptoms well–controlled, patient centered needs met, right to die in a dignified manner at a place of choice and without life needlessly prolonged with artificial means [Table 1].[17]

Table 1 Principles of a good death

Components of good death

Dying well not only involves adequate control of physical symptoms, but also a host of other things such as unambiguous decision-making on the goals of care, preparation for death and a sense of completion [Table 2].[18]

Table 2 Components of good death

Steps involved in providing good end of life care

The process of providing a good EOLC follows a sequential series of steps which involves recognition, decision making, initiation, providing, bereavement support and review of care process [Table 3].[19]

Table 3 Steps involved in providing good end of life care

Recognizing the dying process[20]

Recognition of the dying process is the first step in EOLC provision. The process of dying is usually recognized by the change in physiology, such as, failing vital parameters, decreased movement, decreased spontaneous verbalization, decreased intake of food and fluid and skin changes such as greyish mottling and cooling of peripheries, etc. These could be helpful pointers to suggest poor prognosis and very limited life expectancy. However it is not always easy to predict impending death, and the best approach is to treat a possible reversible cause whilst accepting that the patient might be dying [Table 4].[21]

Table 4 Recognizing that the patient is dying

End of life decision making process

End of life decision-making is a complex process but is vital for good EOLC. The decision makers should always be the primary care givers, in consultation with the palliative care team. Primary care givers are the ones who have longer patient/family contact and therapeutic bonding, which could facilitate better communication and decision-making [Table 5].[23]

Table 5 End of life care decision making process

Open honest communication, shared decision-making and smooth transition of the care process are required to facilitate the process. The key EOLC communication should include prognostication, discussion on resuscitation, advance care planning and end of life symptoms [Figure 1]. Despite many studies and data about prognosis and life expectancy, the best estimates still carry a high degree of uncertainty. This is one of the major limitations of the end of life decision-making process [Figure 2].[22] In India, there is an ongoing debate regarding the legality of advanced directives, and the Supreme Court of India has sought opinion from all the States and stakeholders regarding it.

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Figure 1

Algorithm of end of life care

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Figure 2

Complexities in end of life care decision making

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Initiation of end of life care/end of life care pathway

Initiation of the EOLC in dying patients with advanced life limiting illness is guided by three sets of criteria.

• Clinical criteria reflect on the advanced nature of illness

• Agreement criteria focus on clinician and family consensus and initiation of EOLC

• Symptom control criteria focus on end of life symptoms that prompt the clinician to initiate EOLC. Symptom criteria are a helpful pointer to suggest that the patient might be dying. However it is possible that these things are present and yet the patient may not be dying. Hence these criteria must be considered carefully and applied [Table 6].[24]

Table 6 Initiating end of life care

Process of end of life care[252627]

The process of EOLC provision is based on six principles of ‘Gold Standards Frame Work’[28] which include

• Identification of patients needing EOLC

• Assessment of needs

• Planning of EOLC

• Provision of the EOLC. Ongoing assessment of the process of EOLC

• Reflection on and improvisation of the EOLC process.

The process of EOLC is founded on good communication and ethical principles [Table 7 and Figure 3].

Table 7 Process of end of life care

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Figure 3

Six step process involved in end of life care

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Scope of Palliative care in end of life[2930]

Palliative care at end of life should include measures to improve pain and symptom control, review and optimization of medication charts, stopping of unnecessary medical interventions and providing psychological, spiritual and social support to patients and families [Table 8].

Table 8 Scope of palliative care in end of life care

After death care[31]

The care process does not end with the patient's death. After death, the bereaved family should be dealt sensitively, in a culturally appropriate manner and should be provided all logistical support such that the deceased person is transferred out from the hospital in a timely and dignified manner [Table 9].

Table 9 After death care

The multidisciplinary team should review the EOLC provided, as a quality initiative, and attempts should be made to bridge gaps in the care process. The review aims to understand the family's perception of the care provided and satisfaction of the healthcare providers such that there is a continued improvement of the EOLC process [Table 10].

Table 10 Review of care process

Bereavement care support

Bereavement[32] support should begin with identifying high-risk bereavement individuals/families much before the patient's death. Bereavement symptomatology should be identified and addressed, and referral to a psychologist/psychiatrist should be initiated on a need basis [Table 11].

Table 11 Bereavement care support

Infrastructural requirements for good end of life care

Presence of EOLC infrastructure[33] is imperative for providing good EOLC. Infrastructural requirements include an overarching policy, presence of dedicated space and trained staff, access to essential medications for end of life symptom management, necessary documentation to facilitate the process, and access to special requirements such as clinical psychologists, religious leaders, funeral directors etc., [Table 12].

Table 12 Infrastructural requirements for good end of life care

BARRIERS FOR PROVIDING GOOD END OF LIFE CARE IN INDIA

Studies show that physicians in India are reluctant to consider limitation of life support interventions when compared to their western peers. This is primarily due to the lack of a clear legal framework on this issue, rather than prevalent social and cultural customs.[34353637]

A study conducted in Mumbai among ICUs of public and private hospitals shows that limitation of life sustaining treatment was much greater in cancer and public health care institutions when compared to the private health care system.[38] An audit on EOLC practices in a public tertiary Indian cancer hospital showed that at least 39% of patients with advanced metastatic cancer having refractory acute illness staying for >1 day in ICU, receive some form of limitation of life sustaining treatment. In the same setting, withholding of life sustaining treatment was carried out in 73% and withdrawing of life sustaining treatment in 27%of patients.[39] Disparity between EOLC practices between public and private health care is quite glaring, and this disparity is partially due to the lack of a clear legal framework, and possible economic incentives offered to the staff by some hospitals.

The culture of medical practice in India is generally ‘paternalistic’ with little consideration for the patient's autonomy and the respect for the patient's choices. Medical education in India is founded strongly on the ‘acute model of care’, which is assessment and treatment leading to cure. The medical system has not kept pace with the changing pattern of illness and their trajectory. Hence, lack of knowledge of ‘chronic care and palliative care’ has led to treating end of life patients acutely and inappropriately. This, compunded by the lack of a national policy and legal backing, has led to defensive practice of medicine and physicians practicing in the fear of being accused of providing sub-optimal, care or of possible criminal liability of limiting therapies.

Continued unrealistic hope, and the constant search for cure by the patients and families are important barriers for EOLC provision. The prevalent quackery and alternative medicine practitioners making unrealistic promises of cure, often lure the patients and families towards considering incongruous selections. Sometimes these treatment processes are very laborious and painful, depriving these patients, essential and comforting EOLC.

LEGAL PITFALLS IN PROVIDING END OF LIFE CARE

There are no legal framework or policies guiding the clinicians on EOLC or dignified death.[4041] After hearing the public interest litigation on the Aruna Shanbaug case, the Supreme Court of India ruled, “Involuntary passive euthanasia was allowed in principle” but must follow a strict procedure involving clearance by a High Court.

Involuntary passive euthanasia is obsolete medical terminology, which is no longer used.[41] The principles guiding good EOLC involve respecting patient choices, consideration of futility, deliberated consensus decision-making, and moreover, a humane touch. Any comparison drawn between EOLC and involuntary passive euthanasia is foolhardy. The legal standpoint on EOLC remains a dilemma as the highest court in the country has addressed only the issue of euthanasia and is silent about EOLC.

ETHICS OF END OF LIFE CARE

Patient autonomy, or respecting the patient's choices, is the cornerstone of end of life decision-making. The patient has the right to consent or refuse, and in the event the patient has diminished decision making capacity, surrogates acting on the patient's behalf can communicate the patient's previously expressed wishes.[4344]

Beneficence is to do what is in the best interest of the patient. In the context of an advanced progressive illness with no scope for reversal, the best interests of the patient are controlling the patient's pain and symptoms, and reducing the sufferings of the patient and his family, providing emotional support and protecting the family from financial ruin.[42]

Therefore, withholding and withdrawing of the life support, in this context, is a humane approach of ‘allowing natural death,’ that is, allowing the patient to die of the underlying illness, with symptoms well–controlled, in a dignified manner, in the presence of his family and loved ones and this in no way amounts to euthanasia.

Euthanasia is a voluntary act where an intervention is performed to hasten the dying process.[45] Non-malfeasance in this context is not instituting or escalating aggressive medical interventions in a futile condition. Futility as defined by the American Thoracic Society is “A life-sustaining intervention is futile if reasoning and experience indicate that the intervention would be highly unlikely to result in a meaningful survival for that patient”.[46] Hence, instituting a futile intervention after fully understanding the irreversible nature of illness, amounts to harm and assault. Understanding the futility will prompt the medical practitioners to initiate discussions on EOLC.[47] Distributive justice will enable the medical practitioners to allocate optimally, the medical, technical, human and financial resources.[48]

The ethical basis of EOLC can be best explained by four principles of the doctrine of double effect.

• The act itself must be morally permissible. Good EOLC is providing the most appropriate and humane care at the terminal phase of life in a patient with advanced irreversible illness where the physical, emotional and psychological issues are dealt with, and families and caregivers are supported through this transition. This amounts to the highest degree of care and is morally and ethically permissible

• The ill effect, while foreseen, must be unintended. EOLC is strongly founded on principles of palliative care, where it affirms life and does not hasten the dying process nor needlessly prolongs the dying by artificial means in a futile situation. All the medications and interventions carried out in this context are to relieve symptoms and maximise comfort. Hence, if there is an inadvertent shortening of life, it is unintentional

• The ill effect must not be disproportionate to the good effect. During EOLC symptom management, all medications are carefully titrated and used. In palliative sedation the doses of sedatives are titrated such that the minimum possible dose is used to alleviate the symptom distress

• The ill effect is not the means by which the good effect is achieved. The core principle and intent of palliation in EOLC is ‘killing the symptom and not the patient’. Hastening death is not a means to attain symptom relief in EOLC. By careful and persistent attention to details, one can ensure that all patient directed interventions are based on clinical evidence, ethical and moral principles, and humane touch.[49]

However, the current evidence suggests that the doctrine of double effect may come in the way of good EOLC as justification needs to provided about ill effects, and good death is not an ill effect but a desired effect.[50]

RECOMMENDATIONS OF INDIAN ASSOCIATION OF PALLIATIVE CARE

CONCLUSION

IAPC will make continued efforts to improve the EOLC provided to patients and families/caregivers.

This position paper is an effort to achieve this goal by developing a nationwide uniform EOLC policy, creating an appropriate environment for its provision and encouraging the participation of all the stake holders such that a common goal is attained. The position paper is envisaged to support and facilitate those health care providers who aim to make a difference in lives of the patients who are dying.

IAPC hopes that a nationwide EOLC policy would pave the way for clinical excellence in care for the dying, facilitates standard and scientific care processes, research and development and, above all, provide the human touch to patients in the very crucial phase of theirs life's journey.

FUTURE

IAPC proposes to create guidelines, algorithms, manuals, toolkits, standard forms to ensure quality care is provided for all at end of life.

• EOLC user manual and tool kit

• Standard EOLC pathway appropriate to Indian socio-cultural context

• Algorithms for management of end of life symptoms

• EOLC training module

• Framework for application of standard format of ethics in EOLC

• Framework for surrogate decision-making in EOLC

• Framework for documentation of EOLC

• Standard formats for documenting not for resuscitation, allowing natural death and withholding/withdrawing inappropriate life sustaining treatment

• Standard format for EOLC Informed Consent

• Current legal/Indian Penal Code provisions protecting the practitioner adopting/practicing EOLC

• Frequently Asked Questions (FAQs) for both health care provider and patient/caregiver.