May 12, 2011

VI. A Way Forward: Recommendations for Immediate Implementation

Ukraine is rapidly falling behind its neighbors with palliative care development. On its Western borders, countries like Poland, Hungary, and Romania have all reformed their drug regulations, introduced training for healthcare workers, and developed increasingly well-functioning home-based and institution-based palliative care systems. On its Eastern borders, Georgia and Armenia are also making significant progress. Georgia, which recently introduced oral morphine, has partially reformed drug regulations that had many of the same problems as Ukraine’s, adopted a national palliative care strategy, and is rolling out significant palliative care training for healthcare workers. In Armenia, the introduction of oral morphine is imminent as well.

Ukraine needs to follow the example of these neighbors and move palliative care forward. It needs to urgently formulate and implement a comprehensive strategy for developing palliative care services that includes specific steps to overcome the various policy, regulatory, and educational barriers described in this report. The government should draw on the experiences of its neighbors and the expertise of WHO’s Access to Controlled Medications Programme, the European Association of Palliative Care, and other international palliative care experts. Ukraine should closely examine the Romanian and Georgian experiences with regulatory reform as potential models for its own reform efforts.

The Example of Georgia

With a common history to Ukraine as part of the Soviet Union, Georgia has faced many of the same barriers discussed in this report. Like Ukraine, Georgia did not have oral morphine. Multiple doctors had to sign prescriptions for morphine, which could only be written for patients with a biopsy-proven cancer diagnosis. Patients at home could only get a three day (cities and regional centers) to five day (rural areas) supply of morphine at any time. Health policies did little to support the development of palliative care and pain treatment.

In the last few years the Georgian government has actively sought to address these barriers. In its annual report for 2010 the International Narcotics Control Board praised Georgia for its progress (Para 103, Report of the International Narcotics Control  Board on the Availability of Internationally Controlled Drugs: Ensuring Adequate Access for Medical and Scientific Purposes (E/INCB/2010/1/Supp.1), see: http://incb.org/pdf/annual-report/2010/en/supp/AR10_Supp_E.pdf (accessed March 14, 2011).)

In 2008 the Georgian government amended healthcare laws to incorporate palliative care, providing patients with a right to palliative care on par with preventive, curative, and rehabilitative care. Georgia’s parliament adopted a national palliative care action plan. In 2009 the government introduced oral morphine in the public healthcare system, which is now available for outpatients and increasingly also for inpatients.

In 2008 Georgia amended its drug regulations to eliminate the requirement that multiple doctors sign prescriptions for strong opioid analgesics. In 2010 drug regulations were further amended to allow all trained physicians, as opposed to just oncologists, to prescribe strong opioid analgesics and remove the requirement of a biopsy-confirmed diagnosis for such prescriptions. Patients and their relatives can receive a seven-day take-home supply of morphine and administer the medication themselves.

Georgia has also made instruction in modern pain management available in undergraduate medical programs at state medical universities. At Tbilisi State University, it is a compulsory part of the curriculum; at three other universities it is optional. Instruction in pain management is available in post-graduate medical education in the country. For the last five years palliative care instruction has been available as part of continuing medical education.

Despite this progress, significant barriers remain. Inexpensive instant-release morphine is still unavailable in Georgia; many healthcare workers have yet to have training in palliative care; and patients have to fill prescriptions for morphine at special pharmacies located in police stations which have limited opening hours.

Email correspondence with Dr. Pati Dzotsenidze of the Tbilisi State University, Faculty of Medicine and the Institute for Cancer Prevention and Palliative Medicine, Department of Pain Policy, February 28, 2011.

Below, Human Rights Watch makes two sets of recommendations. The first addresses issues that must be remedied immediately because of their profound negative impact on good patient care. The second group contains recommendations that require a certain amount of time and cannot be implemented overnight. However, we urge the government to move on these recommendations expediently as they are all critical to ensuring good palliative care availability.

To the Ukrainian Government

Immediately:

  • Ensure the availability of oral morphine. Actively engage Zdorovye Narodu and other pharmaceutical companies to introduce oral morphine. The public healthcare system should carry oral morphine at all levels of care.
  • Abolish the requirement that injectable morphine and other injectable strong pain medications be administered by healthcare workers to patients at home. In consultation with medical doctors, the WHO, and other relevant experts, provide new standards for take home medicine to ensure a continuous supply of pain medications.  For example, in areas with a functioning delivery service, healthcare facilities could be allowed to provide patients with at least a seven-day supply to ensure a continuous supply of pain medications. In rural areas, where access to clinics with a narcotics license is problematic, healthcare facilities could be allowed to provide patients with at least a fourteen-day supply.
  • Change licensing requirements for rural clinics. Requirements for narcotics licenses must be such that all rural clinics can obtain such license, including FAPs. In particular, the government should review whether imposing the requirement of a separate storage room on rural clinics is necessary and a proportionate measure to protect against misappropriation and whether a suitable safe would achieve similar results. It should ensure that health clinics can obtain a license with a simple sound and light alarm system rather than a system with a police hookup. If a policy decision is made to leave costly requirements, the state should provide adequate budget allocation for health clinics to meet those costs.
  • Disseminate the WHO pain treatment guideline to all healthcare facilities. The Ministry of Health should urge all doctors to follow the guideline’s recommendations for assessing and treating pain based on accurate pharmacological principles.
  • Provide in-service training on the pain treatment guidelines for doctors throughout the public health system.

The government should also, in conjunction with all relevant stakeholders, including civil society groups, undertake the following steps:

In the Area of Policy

  • Develop a home-based palliative care system. Review staffing structures for healthcare facilities so that hospices and other facilities can provide home-based palliative care; provide funds to hospices to develop such services; reform the current system for delivering strong pain medications through nurse visits to patients’ homes into a palliative care delivery system.
  • Develop palliative care and pain treatment guidelines. The Ministry of Health, medical colleges, palliative care providers, and relevant civil society groups should develop a palliative care and pain treatment guideline based on international best pharmacological and practice evidence. This treatment guideline should be widely disseminated among all relevant healthcare workers and form the basis for training healthcare workers on palliative care and pain management.
  • Ensure palliative care integration into disease control strategies. National cancer and HIV/AIDS control programs and other relevant disease control strategies should have a robust palliative care component, list detailed steps aimed at integrating palliative care into these strategies, and provide for specific and adequate allocations of resources for palliative care development.

In the Area of Education

  • Introduce palliative care instruction into medical and nursing curricula. Establish a clear standard for education in palliative care and pain treatment to ensure that all healthcare providers have at least basic training in the discipline. Healthcare providers who see large numbers of patients in need of palliative care should receive in-depth training and exposure to clinical practice.  
  • Exams for medical and nursing licenses should include questions about palliative care and pain management.
  • Mandate rotations in palliative care. The Ministry of Health should mandate rotations in palliative care units for students of certain postgraduate programs, including oncology, geriatrics and infectious disease, to ensure clinical exposure to palliative care.
  • Develop expert training centers. The Ministry of Health should develop nodal palliative care training centers in Ukraine’s geographic zones, possibly on the basis of existing hospices.
  • Develop training modules. The Ministry of Health should translate key palliative care resources into Ukrainian and develop training modules for doctors, nurses, social workers, counselors, and volunteers, in cooperation with hospices, civil society groups, and international palliative medicine experts.
  • Provide continued medical education. Palliative care and pain management should be included in mandatory continued education programs for all general practitioners, oncologists, infectious disease doctors, anesthesiologists, and geriatrists. Questions about palliative care and pain management should be included in exams for physicians and nurses following these courses.

In the Area of Drug Availability

Using the WHO’s assessment tool, “Ensuring Balance in Controlled Substance Policies,” Ukraine should initiate a thorough review of its drug regulations and amend them so that they ensure adequate availability of strong opioid analgesics, while also being capable of minimizing the risks of misuse that exist in Ukraine. Particular attention should be paid to the following issues:

  • Licensing requirements. These requirements should be as least burdensome as possible, while providing protection against diversion and theft. In rural clinics, the government should consider whether a solid safe would generally be adequate protection for the small amounts of opioid medications they are likely to stock.
  • Take-home medications. It is standard practice in many countries around the world to provide patients with a two-week to one-month take-home supply of morphine.
  • Accounting procedures should be simplified to minimize waste of limited resources.
  • Number of signatures per prescription should be reduced. Doctors in most countries can make individual decisions to prescribe opioid medications.

To Zdorovye Narodu

  • Amend the product information for injectable morphine to bring it in line with available evidence. The maximum daily dose recommendation and inaccurate information on the risk of psychological dependence should be removed as out of line with international standards.
  • Start manufacturing oral morphine. Oral morphine can be introduced through a so-called bio-waver, as no clinical trial or other costly procedures are required for its introduction.[220] Ukraine’s essential medicines list and list of medications that can be bought from state funds include morphine—without specifying the formulation—so oral morphine could be distributed through the public healthcare system.[221]

To the International Community

To the International Narcotics Control Board

  • Consistently report in the annual report on the availability of controlled substances for medical and scientific purposes in countries, including on specific barriers that impede such availability.
  • Raise concern about the problems with availability of opioid analgesics raised in this report in follow-up efforts to its 2008 mission to Ukraine. In particular, the INCB should request information from the government about its efforts to ensure adequate availability of controlled substances for medical and scientific purposes and about remaining barriers. Information on this correspondence should be included in subsequent annual reports.
  • Establish regular contact with key palliative care leaders to ensure the INCB receives information on opioid availability barriers directly from healthcare providers.
  • Offer technical support to Ukraine in reviewing and amending current drug regulations.

To the World Health Organization and UN Office on Drugs and Crime

  • Raise concerns with the Ukrainian government about the problems with availability and accessibility of controlled medications identified in this report.
  • Urge the government to use the WHO tool for assessing drug policies to review its regulations and offer technical assistance.
  • The WHO Access to Controlled Medications Programme should offer technical assistance to the Ukrainian government on drug regulatory reform and educational barriers.
  • Urge the government to implement resolution 53/4 of the Commission on Narcotic Drugs.

To the European Union

  • Raise concerns about the limited availability of palliative care and pain treatment in Ukraine as part of its structured human rights dialogue and other relevant bilateral and multilateral dialogues with the Ukrainian government, including in the context of the Association Agreement preparatory process currently underway. Ensuring adequate availability of palliative care and pain treatment should feature among the benchmarks articulated for Ukraine.
  • Offer financial and technical assistance to the government of Ukraine to review and amend drug regulations, develop palliative care policies, and introduce palliative care instruction for healthcare workers. Consider involving partners in the EU-funded Access to Opioid Medication in Europe (ATOME) in this assistance.[222]
  • Offer funding and technical assistance for the development of Ukrainian palliative care and pain treatment guidelines.

To the Council of Europe

The Council of Europe has recommended that member states ensure the availability of palliative care.[223] However, its recommendations have, to date, not adequately addressed the significant problems that exist in Council of Europe states with regard to availability of opioid medications. To address this shortcoming:

  • The Commissioner for Human Rights should take up the issue of access to pain treatment medications and palliative care more generally, as part of his work, including specifically in Ukraine.
  • The Parliamentary Assembly of the Council of Europe should appoint a rapporteur to look into the question of availability of pain treatment medications and relevant laws in the Council of Europe region, including in Ukraine.
  • The Committee of Ministers should encourage all Council of Europe countries to review their drug regulations using the tool WHO has developed for this purpose.[224]

To International Donors, in particular the Global Fund against AIDS, Tuberculosis and Malaria, the US and EU Governments

  • Ensure that palliative care and pain management are an integral part of any programs that are funded to provide care and treatment services to people living with HIV and AIDS.
  • Require that supported healthcare institutions obtain a license for morphine and other opioid analgesics and maintain an adequate stock of these medications.
  • Financially support training of healthcare workers at AIDS centers and community care centers on palliative care and pain management.

[220] Human Rights Watch interview with Olga Baulia, State Expert Center of the Ministry of Health, October 21, 2010.

[221] Cabinet of Ministers Order 333 of March 25, 2009.

[222] For a description of the ATOME project, see: http://www.atome-project.eu/project.php (accessed February 25, 2011).

[223]Recommendation Rec (2003)24 of the Committee of Ministers to member states on the organisation of palliative care, Adopted November 12, 2003, http://www.coe.int/t/dg3/health/Source/Rec(2003)24_en.pdf (accessed February 25, 2011); Recommendation 1418 (1999) on the protection of the human rights and dignity of the terminally ill and the dying, Adopted June 25, 1999, http://assembly.coe.int/documents/adoptedtext/ta99/erec1418.htm (accessed February 25, 2011); and Parliamentary Assembly of the Council of Europe, Social, Health and Family Affairs Committee, “Palliative care: a model for innovative health and social policies,” Doc. 11758, November 4, 2008, http://assembly.coe.int/Documents/WorkingDocs/Doc08/EDOC11758.pdf (accessed February 25, 2011).

[224] WHO, WHO Policy Guidelines Ensuring Balance in National Policies on Controlled Substances, Guidance for Availability and Accessibility for Controlled Medicines, 2011, http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html (accessed March 29, 2011).