Country Report for: UKRAINE Natallia Datsiuk, MPH Bogomolets National Medical University

1. Country Report for: UKRAINE Natallia Datsiuk, MPH Bogomolets National Medical University Ukraine, Kyiv

2. Ukraine, 45,5997,73 population

3. 1. Cancer pain and palliative care

4. Cancer epidemiology situation, 2010

6. National cancer program • In 2009 the National Program to prevent cancer was adopted. • The authority of charge is Ministry of Health and others • “3. Improving palliative care for cancer patients: • continue organizing of regional hospices for palliative care, including through the reorganization of health care institution; • develop standards for palliative care; • development analgesics therapy cabinets and mobile team in outpatient facilities to assist in patient and home based cancer patients” • In this plan there is no address to the availability of opioids

7. WHO method for relief of cancer pain • In April, 2012 was adopted Clinical protocols “Palliative care of chronic pain syndrome”, which includes description of WHO three step ladder. • While the WHO pain relief ladder is briefly mentioned, it is not studied in any detail or used in practice. • In pharmacology, students learn about the pharmacological characteristics of morphine rather than its use in clinical practice.

8. WHO method for relief of cancer pain

9. Training programs in cancer pain relief, palliative care and the medical use of opioid analgesics The mandatory undergraduate curriculum in medical schools • does not include any specific instruction on palliative care • classes about pain treatment focus primarily on acute pain rather than chronic or cancer pain. Continuing medical education courses in palliative care Shchupik National Medical Academy for Post-Graduate • In 2010 the department of palliative care started offering one and two-week courses for oncologists, general practitioners, and nurses. • The department of gerontology has organized palliative care courses since December 2009. Ivano-FrankiivskMedical University • forty hours of palliative care training, including clinical training in the local hospice  

10. Availability of pain relief and palliative care services in the country • 10% of patients in end-stage disease cover with palliative and hospice care • “opioid analgesics are often hard to access or simply unavailable” (Human Rights Watch) • Preliminary results showed that only in one region in Ukraine morphine consumption is more than 10% of the estimated need, others (23 regions) – less than 10% and two – even more than 2%. • The palliative care for children at present is absent in Ukraine. Real estimation the need of palliative care for children has not been done.

11. Non-governmental organizations that have a focus on pain relief and palliative care • International Renaissance Foundation   • Ukrainian League for Palliative and Hospice Care Development • Palliative Care Association • Ukrainian Association of Study Pain – representative of IASP in Ukraine • Regional organizations: «Mother Theresa» Charitable Fund for incurably sick people support (IvanoFrankivsc) Mykolayiv regional charitable fund VITA-LITE Charitable organization "Joint union society" (Vinogradiv)

12. 2. HIV/AIDS pain and palliative care

13. Epidemiology of HIV/AIDS • 1987-2011 • HIV – 202 787 cases • AIDS – 46 300 cases • Deaths, caused by AIDS – 24 626 cases • Incidence, 2011 • HIV – 21 177 new cases (46,2/100 000 population) • AIDS – 9 189 new cases • Mortality – 3736 (22 children) • Prevalence, January 1st 2012 • HIV – 120 148 patients (246,3/ 100 000 population) • AIDS – 18 751 patients (41,2/ 100 000 population)

14. Epidemiology of HIV/AIDS

15. National AIDS policy, plan, or program • National program on HIV prevention, treatment, care and support for HIV/AIDS patients for 2009-2012 “…Measures of care and support are:Palliative care to HIV-infected and AIDS patients …” “…Tasks of care and support:to promote implementation of palliate and hospice care for AIDS patients with ensuring pain relief medicines by the usage of narcotic drugs…” • The authority of charge is Ministry of Health and others

16. WHO method for relief of HIV/AIDS pain • Clinical protocol of palliative care, symptomatic and pathogenetic therapy of HIV infection (2007) • WHO method introduce only one concept “by ladder”

17. Availability of pain relief and palliative care services in the country for HIV/AIDS • No data available for pediatric palliative care need

18. 3. Opioid availability

19. National Competent AuthorityState Service of Ukraine on Drugs control was established in April 2011 as a central body of executive power coordinated by the Cabinet of Ministers of Ukraine • development and implementation of national policy on narcotic drugs, psychotropic substances and precursors and prevention illegal traffic • state regulation and control of narcotic drugs, psychotropic substances and precursors • coordination of executive bodies in the field of narcotic drugs, psychotropic substances and precursors and prevention illegal traffic

20. Draft National Drug Strategy of Ukraine (until the 2020) • “The priority should be to ensure an optimum balance between upholding the law to prevent diversion of controlled substances into illicit traffic and at the same time - to ensure their availability for medical, scientific and other purposes.” Among the strategic directions of implementations of National Drugs Policy: • Ensuring the availability of narcotic drugs • Promoting palliative care • Production, procurement, supply, storage and sale of drugs

21. National Competent Authority calculating and submitting the annual estimate • State Service of Ukraine on Drugs control submit the estimate of medical requirements for narcotic drugs on the basis of data given be Ministry of Health. • Ministry of Heath gathers the information from regional department of heath. • As a rule, it is consumption in previous year and not address actual need for opioid analgesics Reporting annual statistics on the consumption of opioid analgesics to the INCB 2004 – yes 2006 – yes 2008 – no 2010 – yes 2005 – yes 2007 – no 2009 – yes

22. National essential medicines list

23. Opioid analgesics approved in the country (ATC N02A)

24. Availability of opioids in the places where cancer patients are treated • In general, physicians do not write prescriptions for strong opioid analgesics for patients to fill at pharmacies and patients receive morphine from hospital stock. • There is no evidence about “stock-outs” of opioids in hospitals, where they used. • Healthcare workers routinely ignore the core principles for effective pain treatment that the World Health Organization has identified (HRW) • Significant problem - the lack of licensed health facilities in rural areas

25. Basic requirements for a physician to prescribe an opioid such as morphine • Prescriptions for opiods should be done by physician of health care facilities according to medical evidence. In general, prescriptions are carried out by doctors of health institutions which has license to stock and dispense narcotic drugs. Doctors do not write prescriptions for strong opioid analgesics for patients to fill at pharmacies. Instead, patients receive morphine from hospital stock. • Decision to prescribe narcotic drugs for more than 3 days must make the commission of medical institutions which approved by the chief physician.

26. Prescription forms required for opioids • Special Form-3 for narcotics drugs and their compositions. • This forms additionally must be signed by the chief of health institution or vice-chief and certified by stamp of institution • All this make prescription procedure complex and burdensome. • They are ordered by heath facilities Special training • No special training is required for opioid prescribing • Prescribing is not limited to only certain types of doctors, but as a rule for pain relief it is prescribed by oncologists.

27. Other requirements for writing a prescription for an opioid such as morphine • Maximum amounts that can be prescribed in one receipt are – 0,1g (10 tabs 10mg or 10 ampoules 0,1% ) • There is no a maximum length of time that patient can receive opioids. • Prescription form-3 (narcotic drugs) is valid 5 days • Prescribing regulation does not exclude patient populations or diagnoses • Injection may be carried out only by medical personal (either at hospital or at home) Other forms - by himself according prescription at home or in medical personal presence at health care institutions • Illegal prescription or violation of regulation – from penalty to arrestment for three years • National law or regulation don’t require reporting names of patients who receive opioid prescriptions to the government, but receipts with names muat be stored for 5 years

28. Changes which have been made in laws • Permission to get narcotic license to all medical institution, not only state (from 2008) • Permission to get narcotic license not only to  juridical entity (company, organization) but to private person

29. Cost of medications as a barrier to patient accessibility to opioid analgesics • Injection opioids is free for patients if received from hospital stock • Transdermal fentanyl in most cases is unaffordable for population

30. THANK YOU FOR ATTENTION!