June 2, 2011

I. Background: Palliative Care and Pain Treatment

The Need for Palliative Care and Pain Treatment

Palliative care is a compassionate response to the suffering of patients with life-limiting illnesses like cancer or HIV/AIDS. It seeks to improve the quality of life of patients and their families facing life-limiting illness. Unlike curative health care, its purpose is not to cure a patient or extend his or her life, but rather to prevent and relieve pain and other physical, psychosocial, and spiritual problems. As Dame Cicely Saunders, founder of the first modern hospice and a lifelong advocate for palliative care, is widely reported to have said, palliative care is about “adding life to the days, not days to the life.”

The World Health Organization recognizes palliative care to be an integral part of health care for cancer, HIV/AIDS, and various other health conditions, that should be available to those who need it.[4] While palliative care is often associated with cancer, a much wider circle of patients with health conditions that limit their ability to live a normal life can benefit from it, including those with dementia, heart, liver or renal disease, or chronic and debilitating injuries. Palliative care is often provided alongside curative care services.

WHO has emphasized that palliative care is particularly important in developing countries, where the burden of HIV/AIDS is greatest, treatment is not universally available, and many patients with cancer seek medical attention only when the disease is in an advanced stage, beyond cure but causing severe pain.[5]While palliative care providers may offer inpatient services at hospices or hospitals, their focus is frequently on home-based care for people who are terminally ill or have life-limiting conditions, thus reaching people who otherwise might not have any access to healthcare services, including pain management. WHO has urged countries with limited resources to focus on developing home-based palliative care services, which can be provided by a visiting nurse or community health worker under the supervision of a doctor, making them very cost-effective.[6]

Moderate to severe pain is a common symptom of cancer and HIV/AIDS, as well as of many other health conditions.[7] A recent review of pain studies in cancer patients found that more than 50 percent experience pain,[8] and research consistently finds that 60 to 90 percent of patients with advanced cancer experience moderate to severe pain.[9]

Although no population-based studies of AIDS-related pain have been published, multiple studies report that 60 to 80 percent of patients in the last phases of illness experience significant pain.[10] Increasing availability of antiretroviral treatment (ART) in middle and low-income countries is prolonging the lives of many people with HIV. While people receiving ART generally have less pain than people who are not able to obtain it, many continue to experience pain symptoms.[11] ART can itself be a cause of pain, especially neuropathic pain caused by damaged nerves.[12]

The Consequences of Untreated Pain and Lack of Palliative Care

Moderate to severe pain, as well as other physical and psychosocial symptoms, have a profound impact on quality of life. Pain can lead to reduced mobility and consequent loss of strength; compromise the immune system; and interfere with a person’s ability to eat, concentrate, sleep, or interact with others.[13] A WHO study found that people who live with chronic pain are four times more likely to suffer from depression or anxiety.[14] The physical and psychological effects of chronic pain can directly influence the course of disease and also reduce patients’ adherence to treatment.[15]

Pain also has social consequences for patients and their caregivers, including inability to work, care for children or other family members, and participate in social activities.[16] At the end of life, pain can interfere with a patient’s ability to bid farewell to loved ones and make final arrangements.

Impact of Palliative Care and Pain Management

Most suffering caused by pain is avoidable as medicines to treat pain are effective, safe, inexpensive, and generally easy to administer.[17]WHO’s Pain Relief Ladder recommends the use of increasingly potent painkillers as pain becomes more severe, from basic pain medicines (such as acetaminophen, aspirin, or ibuprofen) to strong pain medicines such as morphine.[18]

Like morphine, all strong painkillers are opioids: extracts of the poppy plant or similar synthetic drugs. WHO’s Model List of Essential Medicines includes morphine in oral tablet, oral solution, and injectable formulations.[19] For chronic pain management, WHO recommends oral morphine given at regular intervals around the clock.[20]Patients can easily take oral morphine in their own homes and prescribing it avoids the pain of regular injections, which is especially important for children and patients whose muscle tissue is emaciated by cancer or HIV/AIDS. Similarly, with relatively inexpensive interventions, palliative care providers can treat a variety of other symptoms that are common among people with life-threatening illnesses, including breathlessness, nausea, anxiety, and depression.

Numerous studies have shown that patients who receive palliative care enjoy greater quality of life, have fewer distressing physical symptoms, and a lower incidence of depression or anxiety. A recent study published in the New England Journal of Medicine found that, in addition to improving quality of life, when palliative care was started shortly after diagnosis in patients with metastatic lung cancer, they actually lived an average of three months longer than patients that did not have access to palliative care.[21]

The Palliative Care and Pain Treatment Gap

WHO and the INCB have repeatedly drawn attention to the enormous unmet need for pain treatment and called for countries to meet this need through low-cost palliative care services. WHO estimates that tens of millions of people each year suffer untreated moderate to severe pain, including 5.5 million terminal cancer patients and 1 million patients in the last phases of HIV/AIDS. The president of the INCB has stated that access to morphine and other strong pain medicines is “virtually non-existent in over 150 countries.”[22]

In 2006 the International Observatory on End of Life Care published a study that found that no palliative care activity could be identified in 78 of 234 countries reviewed; in 41 countries it found some preparation for palliative care delivery but no actual services; and in 80 countries it found “localized provision” of palliative care by a small number of isolated services. In only 35 countries did the study find that palliative care was “approaching integration” into health services.[23]

Barriers to Palliative Care and Pain Treatment

There is no lack of information about the reasons why so many people who suffer from life-limiting illnesses do not have access to adequate pain treatment and palliative care. In dozens of publications spanning several decades, WHO, INCB, health care providers, academics and others have chronicled the barriers in great detail.[24] A common theme of many of these publications is the failure of many governments around the world to take reasonable steps to improve access to pain treatment and palliative care services.

Barriers can be divided into three areas: lack of health policies in support of palliative care development; lack of relevant training for healthcare workers; and poor availability of essential palliative care drugs. Within this latter category, there are a number of different common barriers, including the failure of states to put in place functioning drug supply systems, existence of unnecessarily restrictive drug control regulations and practices, fear among healthcare workers of legal sanctions for legitimate prescribing of opioid medications, and the unnecessarily high cost of pain medications. A more detailed discussion of these barriers can be found in Human Rights Watch’s March 2009 report, “Please do not make us suffer anymore…”: Access to Pain Treatment as a Human Right.

[4]WHO, “National Cancer Control Programmes: Policies and Managerial Guidelines, second edition,” pp. 86-87.

[5] World Health Organization, “National Cancer Control Programs: Policies and Managerial Guidelines,” 2002, http://www.who.int/cancer/media/en/408.pdf (accessed August 6, 2010) pp. 85-86.

[6] Ibid., pp. 85, 91.

[7] Pain is also a symptom in various other diseases and chronic conditions and acute pain is often a side effect of medical procedures. This paper, however, focuses primarily on chronic pain.

[8] M. van den Beuken-van Everdingen et al., “Prevalence of Pain in Patients with Cancer: A Systematic Review of the Past 40 Years,” Annals of Oncology,vol. 18, no. 9 (2007) pp. 1437-1499.

[9]Charles S. Cleeland et al., “Multidimensional Measurement of Cancer Pain: Comparisons of U.S. and Vietnamese Patients,” Journal of Pain and Symptom Management vol. 3, no. 1 (1988); Charles S. Cleeland et al., “Dimensions of the Impact of Cancer Pain in a Four Country Sample: New Information from Multidimensional Scaling,”Pain, vol. 67, no. 2-3 (1996) pp. 267-73; Randall L. Daut & Charles S. Cleeland, “The Prevalence and Severity of Pain in Cancer,” Cancer vol. 50, no. 9 (1982) p. 1913; Kathleen M. Foley, Pain Syndromes in Patients with Cancer, in Kathleen M. Foley et al., eds., Advances in Pain Research and Therapy (1979) pp. 59-75;Kathleen M. Foley, “Pain Assessment and Cancer Pain Syndromes,” in Derek Doyle, Geoffrey W.C. Hanks and Neil MacDonald, Oxford Textbook of Palliative Medicine (Oxford: Oxford University Press, 2nd ed., 1999), pp. 310-331; J. Stjernsward & D. Clark, Palliative Medicine: A Global Perspective, in Derek Doyle et al., eds., Oxford Textbook of Palliative Medicine (Oxford: Oxford University Press, 3rd ed., 2003) pp. 1199-1222.

[10]K. Green, Evaluating the Delivery of HIV Palliative Care Services in Out-Patient Clinics in Viet Nam, Upgrading Document, London School of Hygiene and Tropical Medicine (2008); Kathleen M. Foley et al., “Pain Control for People with Cancer and AIDS,” in Dean T Jamison et al., Disease Control Priorities in Developing Countries (Washington: World Bank Publications, 2nd ed. 2003), pp. 981-994; Francois Larue et al., “Underestimation and Under-Treatment of Pain in HIV Disease: A Multicentre Study,” British Medical Journal, vol. 314 (1997) http://www.bmj.com/cgi/content/full/314/7073/23 (accessed August 6, 2010) p. 23; J. Schofferman & R. Brody, Pain in Far Advanced AIDS, in K. M. Foley et al., eds., Advances in Pain Research and Therapy (1990) pp. 379-386; E. J. Singer et al., “Painful Symptoms Reported by Ambulatory HIV-Infected Men in a Longitudinal Study," Pain, vol. 54 (1993) pp. 15-19.

[11] P. Selwyn & M. Forstein, “Overcoming the False Dichotomy of Curative vs. Palliative Care for Late-Stage HIV/AIDS,” Journal of the American Medical Association, vol. 290 (2003) pp. 806-814.

[12] M. C. Dalakas, “Peripheral Neuropathy and Antiretroviral Drugs”, Journal of the Peripheral Nervous System, vol. 6, no. 1 (2001) pp. 14-20; Several studies have found that between 29 and 74 percent of people who receive antiretroviral treatment experience pain symptoms: K. Green, Evaluating the Delivery of HIV Palliative Care Services in Out-Patient Clinics in Viet Nam, Upgrading Document, London School of Hygiene and Tropical Medicine (2008).

[13] F. Brennan, D.B. Carr and M. Cousins, “Pain Management: A Fundamental Human Right,” Anesthesia & Analgesia, vol. 105 (2007) pp. 205-221.

[14] O. Gureje et al., “Persistent Pain and Well-Being: A World Health Organization Study in Primary Care”, Journal of the American Medical Association, vol. 280(1998) pp. 147-51. See also: B. Rosenfeld et al., “Pain in Ambulatory AIDS Patients. II: Impact of Pain on Psychological Functioning and Quality of Life,"Pain, vol. 68, no. 2-3 (1996) pp. 323–28.

[15]B. Rosenfeld et al., “Pain in Ambulatory AIDS Patients. II: Impact of Pain on Psychological Functioning and Quality of Life,”Pain, pp. 323 – 28.

[16] R. L. Daut et al., “Developmentof the Wisconsin Brief Pain Questionnaire to Assess Pain in Cancer and Other Diseases,” Pain, vol. 17, no. 2 (1983) pp. 197 – 210.

[17] World Health Organization, “Achieving Balance in National Opioid Control Policy,” 2000, http://apps.who.int/medicinedocs/en/d/Jwhozip39e/ (accessed August 6, 2010).

[18] World Health Organization, “WHO’s Pain Ladder,” 2010, http://www.who.int/cancer/palliative/painladder/en/ (accessed August 6, 2010). This has been developed for cancer but is also referred to for other conditions.

[19] World Health Organization, “Model List of Essential Medicines - 16th List,” March 2009, http://www.who.int/selection_medicines/committees/expert/17/sixteenth_adult_list_en.pdf (accessed 6 August 2010).

[20] World Health Organization, Cancer Pain Relief: a Guide To Opioid Availability 14 (2nd ed. 1996).

[21] Jennifer S. Temel, M.D., Joseph A. Greer, Ph.D., Alona Muzikansky, M.A., Emily R. Gallagher, R.N., Sonal Admane, M.B., B.S., M.P.H., Vicki A. Jackson, M.D., M.P.H., Constance M. Dahlin, A.P.N., Craig D. Blinderman, M.D., Juliet Jacobsen, M.D., William F. Pirl, M.D., M.P.H., J. Andrew Billings, M.D., and Thomas J. Lynch, M.D., Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer N Engl J Med 2010; 363:733-742, August 19, 2010

[22]“Briefing Note: Access to Controlled Medicines Program,” World Health Organisation Briefing Note, February 2009, http://www.who.int/medicines/areas/quality_safety/ACMP_BrNoteGenrl_EN_Feb09.pdf (accessed August 6, 2010);Sevil Atasoy, Statement by Professor Sevil Atasoy President of the International Narcotics Control Board (2009) http://www.incb.org/documents/President_statements_09/2009_ECOSOC_Substantive_Session_published.pdf p. 2; World Health Organization, “Model List of Essential Medicines - 16th List,” March 2009, http://www.who.int/selection_medicines/committees/expert/17/sixteenth_adult_list_en.pdf (accessed August 6, 2010).

[23]Michael Wright and others, “Mapping levels of palliative care development: a global view,” International Observatory on End of Life Care, Lancaster University, November 2006, www.eolc-observatory.net/global/pdr/world_map.pdf (accessed February 10, 2011).

[24] Human Rights Watch, “Please, do not make us suffer any more…”:Access to Pain Treatment as Human Right, March 2009, http://www.hrw.org/sites/default/files/reports/health0309web_1.pdf.