May 12, 2011

Summary

Patients with life-limiting illnesses need curative treatment, but they also need palliative care, which aims to address pain and improve life quality diminished by debilitating symptoms such as shortness of breath, anxiety, and depression.[6]

Every year almost half a million people in Ukraine may require palliative care services to alleviate the symptoms of life-limiting illnesses.[7] These include circulatory system illnesses such as chronic heart disease (almost 489,000 deaths per year), cancer (100,000), respiratory illnesses (28,000), tuberculosis (10,000), neurological disorders such as Alzheimer’s disease (6,500), and HIV and AIDS (about 2,500).[8]  

Relieving pain is a critical part of palliative care. About 80 percent of patients with advanced cancer develop moderate to severe pain, as do significant numbers of patients with HIV and other life-limiting illnesses. With existing medical knowledge physical pain can be successfully treated in most cases. But while these symptoms are treatable, limitations in Ukraine’s health policy, education, and drug availability; lack of cohesion, urgency, and coordination on the part of the government; unnecessarily onerous drug regulations; inadequate training and a dearth of exposure to palliative care services for Ukrainian healthcare providers mean the country’s public health system offers poor pain treatment and little support for families dealing with life-limiting illnesses.

The country has 9 hospices with a total of about 650 beds, which provide services to inpatients.[9] The government has also assigned palliative care beds in some other public hospitals, and the national cancer control plan envisions a total of 36 hospices by 2016, although it does not allocate a budget for this.[10] Despite this, most patients with life-limiting illnesses in Ukraine die at home; indeed, hospitals are not supposed to admit patients with cancer who are no longer receiving curative treatment. Yet there are no full-fledged home-based palliative care services.[11] Some nongovernmental organizations (NGOs) provide home-based care but cannot offer pain management with opioid analgesics, including morphine, which WHO guidelines for cancer pain emphasize, should be used to treat moderate to severe pain. Most AIDS centers do not offer palliative care services.[12] According to a 2011 International Narcotics Control Board (INCB) report, the amount of opioid analgesics Ukraine uses per year is “very inadequate.”[13]

In 2010 Human Rights Watch—together with the Institute of Legal Research and Strategies in Kharkiv and the Rivne and Kiev branches of the All-Ukrainian Network of People Living with HIV—researched the availability of pain treatment and palliative care in Ukraine. We found that Vlad’s unnecessary suffering was not an unfortunate anomaly. Rather, it was in many ways representative of the fate of patients who endure pain due to life-limiting diseases.

In dozens of interviews, patients, families, doctors, nurses, and government officials painted a picture of a healthcare system that systematically fails patients who are in severe pain because pain treatment is often inaccessible, best practices for palliative care are ignored, and anti-drug abuse regulations hamstring healthcare workers’ ability to deliver evidence-based care. Those healthcare workers who try to provide the most effective pain treatment possible must often operate, as one oncologist said, “on the edge of the law.”[14] These doctors and nurses ignore legal restrictions and provide patients with a take-home supply of strong pain medications or leave the day’s supply with patients to administer themselves. In doing so, these doctors and nurses expose themselves to administrative and criminal charges for putting patients’ well-being first.

The situation is particularly devastating in rural areas—home to about one-third of Ukraine’s population of 46 million—where strong opioid analgesics are often hard to access or simply unavailable.[15] Only central district hospitals have the necessary license to stock and dispense morphine and other strong opioid analgesics, according to doctors in rural districts who said requirements for obtaining such licenses are too onerous and costly for many smaller hospitals and health clinics.[16] As a result, people in rural towns and villages often live far from health centers with strong pain medications.

Distance might be surmountable if healthcare providers could give patients and their families a supply of strong opioid analgesics for at least a week or two. However, under Ukraine’s drug regulations healthcare workers must directly administer injectable strong opioid pain medications to patients, a requirement that is medically unnecessary. As oral morphine is unavailable in Ukraine, a nurse or other healthcare worker must travel to the patient’s home up to six times a day to administer pain medications (the WHO recommends that morphine is administered every four hours). This burden is too great for healthcare workers, leaving patients with severe pain in remote areas “doomed,” according to one nurse.[17]

Patients in urban areas face a different problem. Here, hospitals generally do have the license for strong opioid analgesics, but pain treatment is still often woefully inadequate, as healthcare workers routinely ignore the core principles for effective pain treatment that the World Health Organization has identified.[18] This leaves individuals with inadequate and inconsistent relief from excruciating pain.

There is no acceptable reason why Ukraine cannot deliver proper palliative care and pain management to patients with life-limiting illnesses. Although under-resourced, Ukraine has a healthcare system that is able to deliver effective treatment for various other health conditions.

Failure to address barriers to effective pain treatment identified in this report places Ukraine in violation of the right to health guaranteed by the International Covenant on Economic, Social and Cultural Rights (ICESCR), and in possible violation of the prohibition on torture and cruel, inhuman, or degrading treatment. It also ensures that Ukraine continues to remain out of step with its neighbors—including Belarus, Moldova, Russia, and Turkey–which have less restrictive drug regulations and with European countries that all (except for Armenia and Azerbaijan) have oral morphine available for patients.[19] Lack of action also means that Ukraine will continue to deviate fundamentally from World Health Organization recommendations in standard pain treatment practices, that healthcare workers will have to break the law to provide evidence-based care, and that patients will continue to suffer.

All medical students should receive basic instruction on palliative care and pain treatment. Those specializing in disciplines that frequently care for people with life-limiting illnesses should receive detailed instruction and exposure to clinical practice. Ukraine must urgently amend the restrictive and problematic licensing requirements for healthcare institutions and workers to stock, prescribe, or dispense opioid analgesics and must simplify the prescribing procedure that currently creates a barrier to timely treatment with morphine for patients with pain. Problematic dispensing procedures should be revised, and the current complex and wasteful record keeping system improved. Inspections of healthcare institutions that work with opioid analgesics should be conducted so as to minimize their impact on the provision of and access to medical care, and Ukraine’s criminal code should be amended to differentiate between intentional and unintentional violations of the rules of handling opioid medications.

***

Our research found that when strong opioid analgesics are available, they are provided in a way that fundamentally deviates from WHO recommendations, with each of the five core principles it has identified routinely ignored.[20]

Principle 1: Pain medications should be given orally whenever possible. If a patient cannot take medications by mouth, rectal suppositories, or under-the-skin injections should be used.In Ukraine no oral morphine is available. Doctors use only injectable strong opioids for pain treatment. Instead of injecting morphine under the skin, as the WHO recommends, injections are given into muscles. This results in large numbers of unnecessary intramuscular injections, which are unpleasant for patients and carry a risk of infection. Throughout the three years he was on strong pain medications, Vlad received thousands of unnecessary injections with pain medications. His mother compared his bottom, where most of the injections were administered, to a “mine field.”

Principle 2: Pain medications should be given every four hours to ensure continuous pain control.While the WHO recommends that patients receive strong pain medications every four hours, most patients in Ukraine get them only once or twice per day. As the effects of morphine last for four to six hours, this means that such patients are without adequate relief for most of the day. While doctors prescribe weaker pain medicines and other medications for the intervals, these are not potent enough to provide effective relief and expose patients to unnecessary side effects. Our research suggests this practice is largely due to the requirement in Ukrainian law that healthcare providers directly administer injectable strong opioid analgesics to patients. Doctors at various health facilities told us that they do not have the resources for a nurse to visit patients at home six times per day.

Principle 3: The type of pain medication (basic pain reliever, weak opioid, or strong opioid) should depend on severity of pain. If a pain medication stops providing effective relief, a stronger medication should be used. International research suggests that about 80 percent of terminal cancer patients need a strong opioid pain medicine for an average period of 90 days before death.[21] Yet figures we received from various hospitals in Ukraine about the percentage of cancer patients who receive morphine or other strong opioid analgesics and the average number of days patients receive them suggest that many patients are started on strong opioid analgesics late, if at all. In the six hospitals and one polyclinic department of a city hospital for which we received such data, we found that in the best case only about one-third of terminal cancer patients received a strong opioid analgesic—in most cases it was far less—and in some cases for far less than 90 days.

Principle 4: The dose of medication should be determined individually. There is no maximum dose for strong opioid pain medications. While the WHO treatment guideline specifically states there should be no maximum daily dose for morphine, both Ukraine’s Ministry of Health and the Zdorovye Narodu pharmaceutical company, the only manufacturer of morphine in Ukraine, recommend a maximum daily dose of 50 mg of injectable morphine. This dose is far below levels of morphine used safely and effectively for the treatment of severe pain in other countries. We found that many doctors in Ukraine, though not all, adhere to the recommendation and cap the dose even when the patient is still in pain.

Principle 5: Pain treatment should be delivered according to the patient’s needs. Because nurses have to come to patients’ homes to administer morphine injections, it is not the patient’s schedule but that of the healthcare worker that determines when the patient receives his medications. As a result, patients wait in agony for nurses to arrive or do not need the medicine when the nurse is present.

While our research focused mostly on the plight of cancer patients, we also documented a number of cases of people who had severe pain due to other diseases or health conditions. We found that these patients face even greater challenges in getting access to good pain treatment. General practitioners and other specialists are rarely trained in treating pain and often worry about prescribing strong opioid medications to non-cancer patients. Several patients with non-cancer pain told us that their doctors ignored their complaints about pain or told them it would simply go away by itself once the cause had been treated.

***

Three areas—health policy, education, and drug availability—contribute to the limited availability of palliative care and pain treatment in Ukraine. The World Health Organization sees each of these three areas as fundamental to the development of palliative care and pain management services and has urged countries to take action in each, observing that measures in each area cost little but can significantly impact the availability of palliative care.[22]

Health Policy The WHO has recognized palliative care as an integral and essential part of comprehensive care for cancer, HIV/AIDS, and other health conditions and recommends that countries establish a national palliative care policy or program.[23] While the Ukrainian government has established the Institute of Palliative and Hospice Medicine in the Ministry of Health and created a number of hospices and palliative care beds, no national palliative care policy exists at this time and the government has not undertaken a coordinated effort to address barriers to palliative care. The government’s failure to address critical issues like the lack of oral morphine and the need to develop home-based palliative care are particularly problematic.

Education The World Health Organization recommends that countries adequately instruct healthcare workers on palliative care and pain treatment.[24] Yet in Ukraine official curricula for undergraduate and postgraduate medical studies do not provide any specific education on palliative care and pain management. The WHO cancer pain treatment guideline is barely taught in medical or nursing schools, if it is taught at all. Many healthcare workers interviewed did not understand the basic principles of pain management and palliative care.

Drug availability The WHO recommends that countries establish a rational drug policy that ensures availability and accessibility of essential medicines, including morphine. Under the UN drug conventions countries must ensure adequate availability of opioids for medical purposes while also preventing their misuse.[25] However, Ukraine’s primary focus has been to prevent misuse of these medications. Human Rights Watch recognizes that such prevention is particularly important in countries that, like Ukraine, face major problems with illicit drug use—the country is home to an estimated 230,000 to 360,000 injecting drug users—and corruption in the healthcare sector.[26] But these efforts should not interfere with adequate availability of controlled substances for legitimate, medical purposes.

Ukraine’s drug regulations are far more restrictive than required under the UN drug conventions and contain numerous provisions that directly interfere with the delivery of good pain care, discourage doctors from prescribing opioid medications due to excessively burdensome bureaucratic requirements, and generate fear among doctors of the legal repercussions of prescribing these medications.

To its credit, Ukraine’s government recognizes the need for reform to ensure effective pain treatment and palliative care services. It has established the Institute of Palliative and Hospice Medicines in the Ministry of health, created hundreds of hospice beds, and removed some problematic provisions from its drug regulations in 2010.[27] In an October 2010 meeting with Human Rights Watch the then head of the National Drug Control Committee expressed concern about the lack of narcotics licenses at pharmacies in rural areas and said his committee was exploring solutions.[28]

***

Under the International Covenant on Economic, Social and Cultural Rights, the Ukrainian government is obligated to take steps “to the maximum of its available resources” to progressively realize the right to health. In keeping with this, the government should formulate a plan for the development and implementation of palliative care services, ensure the availability and accessibility of morphine and other medications that the World Health Organization considers essential, and ensure that healthcare providers receive training in palliative care. The Ukrainian government’s failure to do so violates the right to health.

Under the prohibition of torture and ill-treatment, the Ukrainian government has an obligation to take steps to protect people under its jurisdiction from inhuman or degrading treatment, such as unnecessary suffering from extreme pain. As the UN special rapporteur on torture and other cruel, inhuman or degrading treatment or punishment has noted, “failure of governments to take reasonable measures to ensure accessibility of pain treatment … raises questions whether they have adequately discharged this obligation.”[29] The fact that public healthcare facilities in Ukraine offer pain treatment in a way that fundamentally deviates from well-established international best practices and that the government has not taken steps to change this calls into question whether the government has fulfilled this obligation. It may thus be liable under the prohibition of torture and cruel, inhuman, or degrading treatment.

This report focuses specifically on the poor availability of palliative care services in Ukraine. Human Rights Watch fully recognizes the problems that exist with availability and accessibility of other health services in Ukraine. The fact that this report focuses on a specific area of healthcare does not suggest that government authorities in Ukraine do not have an obligation under international human rights law to take reasonable steps to address problems in other parts of the healthcare system.

Key Recommendations

To the Government of Ukraine:

  • Ensure the availability of oral morphine throughout the public healthcare system.
  • Amend licensing provisions of drug regulations to ensure that all rural healthcare clinics and hospitals can obtain licenses for strong opioid analgesics.
  • Amend drug regulations to ensure that patients or their relatives can receive a reasonable take-home supply of strong opioid analgesics that realistically enables them to enjoy continuous pain relief.
  • Disseminate WHO pain treatment guidelines to all healthcare facilities and roll out in-service training for all oncologists and other relevant healthcare workers.

In consultation with all relevant stakeholders, develop an action plan to ensure access to palliative care and pain management nationwide that provides for:

  • Developing a national palliative care and pain treatment guideline, consistent with international best practices.
  • Introducing instruction on internationally recognized pain treatment best practices in all medical and nursing schools and as part of continued medical education programs.
  • A review process for Ukraine’s drug regulations aimed at ensuring adequate availability and accessibility of strong opioid medications for medical use while preventing their misuse.

To the Zdorovye Narodu Pharmaceutical Company:

  • Amend product information for injectable morphine to bring it in line with available evidence.
  • Start manufacturing oral morphine.

To the International Community:

  • Raise concern with the government of Ukraine about the limited availability of quality palliative care and pain treatment services.
  • Offer technical and financial assistance to implement the recommendations contained in this report.

[6] While palliative care is often associated with terminal illness, it can benefit patients with a much broader group of illnesses or health conditions. Palliative care advocates use the term “life-limiting” illness or health condition to delineate the group of patients who would benefit from the services provided by palliative care, including symptom control, pain treatment, psychosocial and spiritual support and others. A life-limiting illness or health condition is a chronic condition that limits or has the potential to limit the patient’s ability to lead a normal life and includes, among others, cancer, HIV/AIDS, dementia, heart, renal, and liver disease, and permanent serious injury.

[7] The WHO estimates that on average about 60 percent of people who die would benefit from palliative care before death. See Stjernsward and Clark, “Palliative Medicine: A Global Perspective” in Doyle et al, eds., Oxford Textbook of Palliative Medicine, 3rd edition. In Ukraine, with a population of 45.4 million and a death rate of 15.7 per 1,000 this translates to an estimated 428 thousand individuals each year who could benefit from palliative care. (US Central Intelligence Agency, The World Fact Book, 2010, https://www.cia.gov/library/publications/the-world-factbook/geos/up.html (accessed January 3, 2011)

[8] WHO Regional Office for Europe, European Mortality Database, 2005, http://apps.who.int/whosis/database/mort/table1_process.cfm (accessed February 24, 2011).

[9] Press service of the Ministry of Health of Ukraine, “Minzdrav: Sozdana Vseukrainskaia obshestvennaia organizatsia ‘Ukrainskaia liga  sodeistvia razvitiu palliativnoi I khospisnoi pomoshchi (Ministry of Health: The Al-Ukrainian League for the Development of Palliative and Hospice Care Created), December 21, 2010, http://www.kmu.gov.ua/control/ru/publish/article;jsessionid=CA13DDA8611EF7B8E83F12CEC812FD47?art_id=243933605&cat_id=33695 (accessed March 29, 2011). See also:  Institute of Palliative and Hospice Medicine, “Development of Palliative Care in Ukraine in 2008.” See http://www.eurochaplains.org/ukraine_pal_developm ent_08.pdf (accessed March 14, 2011).

[10] National Program for the Battle against Oncological Diseases of 2009, on file with Human Rights Watch.

[11] The European Association for Palliative Care reports that in 2005, 85 percent of patients in the Donetsk region died at home. EAPC Task Force on the development of Palliative Care in Europe, http://www.eapcnet.org/download/forPolicy/CountriesRep/Ukraine.pdf (accessed February 28, 2011). Similarly, 82 percent of cancer deaths and 86 percent of cardiovascular deaths in Ukraine occur at home.  Mykhalskyy, V, “Palliative Care in Ukraine,” http://www.eapcnet.org/download/forEAPC-East/PCinUkraineReport-2002.pdf (accessed February 28, 2011).  

[12]A 2010 report by the Ministry of Health for UNAIDS found neither “home-based care” nor “palliative care and treatment of common HIV-related infections” available to the majority of people in need. Ministry of Health of Ukraine, “Ukraine: National Report on Monitoring Progress towards the UNGASS Declaration of Commitment on HIV/AIDS,” 2010, p. 103, http://data.unaids.org/pub/Report/2010/ukraine_2010_country_progress_report_en.pdf (accessed February 28, 2011).  

[13] International Narcotics Control Board, “Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes,” 2010, http://incb.org/pdf/annual-report/2010/en/supp/AR10_Supp_E.pdf (accessed March 29, 2011).

[14] All-Ukrainian Network of People Living with HIV, Rivne branch, interview with chief doctor in district 5, May 12, 2010.

[15] State Statistics Committee of Ukraine, "General results of the census", 2002, http://2001.ukrcensus.gov.ua/eng/results/general (access February 24, 2011).

[16] In Ukraine, three strong opioid analgesics are used to treat moderate to severe pain: morphine, omnopon and promedol. Omnopon is a cocktail of morphine, codeine and several other substances. Promedol is a synthetic opioid. Both omnopon and prodemol are weaker than morphine.

[17] Human Rights Watch and Institute of Legal Research and Strategies interview with nurse in district 1, April 16, 2010.

[18] WHO, “Cancer Pain Relief, Second Edition, With a guide to opioid availability,” 1996.

[19] Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in Europe: a report from the ESMO/EAPC Opioid Policy Initiative, N. I. Cherny, J. Baselga, F. de Conno and L. Radbruch, Annals of Oncology Volume 21, Issue 3 Pp. 615-626. This survey covered all European countries with the exception of Armenia, Azerbaijan, Malta and San Marino. It did not cover most Central Asian countries. Like Ukraine, Armenia and Azerbaijan do not have any oral morphine;

Several of Ukraine’s neighbors have taken active steps to develop palliative care services, including Romania, which in 2005 overhauled and replaced its restrictive drug regulations with ones that ensure good accessibility to pain medications, and Georgia, which in 2010 adopted a national palliative care policy, introduced oral morphine, and removed several key obstacles to strong opioid analgesics availability from its drug regulations. See: Reform of drug control policy for palliative care in Romania, Daniela Mosoiu MD,Karen M Ryan MA,David E Joranson MSSW,Jody P Garthwaite BA The Lancet , June 24, 2006 ( Vol. 367, Issue 9528, Pages 2110-2117 ) DOI: 10.1016/S0140-6736(06)68482-1, see at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(06)68482-1/abstract (accessed February 24, 2011).

[20] WHO, “Cancer Pain Relief, Second Edition, With a guide to opioid availability,” 1996.

[21] Kathleen M. Foley, et al., "Pain Control for People with Cancer and AIDS," in Disease Control Priorities in Developing Countries, 2nd ed., (New York: Oxford University Press, 2003), pp. 981-994.

[22] WHO, “Cancer Pain Relief, Second Edition, With a guide to opioid availability,” 1996, p. 3.

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

[24] WHO, “Cancer Pain Relief, Second Edition, With a guide to opioid availability,” 1996, p. 3.

[25] 1961 Single Convention on Narcotic Drugs, http://www.incb.org/pdf/e/conv/convention_1961_en.pdf; 1971 Convention on Psychotropic Substances, http://www.incb.org/pdf/e/conv/convention_1971_en.pdf, and the 1988 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, http://www.unodc.org/pdf/convention_1988_en.pdf (accessed February 24, 2011).

[26] International HIV/AIDS Alliance in Ukraine, “ANALYTICAL REPORT based on sociological study results Estimation of the Size of Populations Most-at-Risk for HIV Infection in Ukraine in 2009,” Kiev, 2010, p. 12. http://www.aidsalliance.org.ua/ru/library/our/monitoring/pdf/indd_en.pdf (accessed March 30, 2011).

[27] Order 11 of 2010 of the Ministry of Health on the procedure of handling narcotic drugs, psychotropic substances and precursors at healthcare facilities of Ukraine.

[28]Human Rights Watch meeting with Volodymyr Tymoshenko, head of the National Drug Control Committee, Kiev, October 22, 2010.

[29]Joint letter by the UN special rapporteur on the prevention of torture and cruel, inhuman or degrading treatment or punishment, Manfred Nowak, and the UN special rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, to the Commission on Narcotic Drugs, December 2008. A copy of the letter is available at http://www.ihra.net/Assets/1384/1/SpecialRapporteursLettertoCND012009.pdf (accessed January 16, 2009).