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

Ukraine, 45,5997,73 population

1. Cancer pain and palliative care

Incidence: number of new cases Incidence (crude rate)363.0 per Mortality: number of new cases85027 Mortality (crude rate)185.7 per Prevalence Cancer epidemiology situation, 2010

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: 1) continue organizing of regional hospices for palliative care, including through the reorganization of health care institution; 2) develop standards for palliative care; 3) 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

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.

WHO method for relief of cancer pain WHO RecommendationUkraine’s Practice Principle 1: Pain medications should be delivered in oral form (tablets or syrup) when possible. Patients receive morphine by injection only. Principle 2: Pain medications should be given every four hours. Most patients receive morphine once or twice per day, in exceptional cases three or four. Principle 3: Morphine should be started when weaker pain medications prove insufficient to control pain. Patients are often started on morphine only when curative treatment is stopped, irrespective of pain levels. Principle 4: Morphine dose should be determined individually. There is no maximum daily dose. Patients are routinely injected with one ampoule of morphine at the time, irrespective of whether this is too little or too much. Many Ukrainian doctors observe a maximum daily dose of 50 mg of injectable morphine, even if it is insufficient to control the patient’s pain. Principle 5: Patients should receive morphine at times convenient to them. Administration of morphine depends on work schedules of nurses.

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 Ivano-Frankiivsk Medical University forty hours of palliative care training, including clinical training in the local hospice

Availability of pain relief and palliative care services in the country Need of palliative careReality 500 thousand of patients and 1,5mlm their relatives, so more than palliative beds and of patients at home 7 hospices and 55 – wards in general or specialized hospitals which have about 985 beds and 6 – mobile visiting team. 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.

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 (Ivano Frankivsc) Mykolayiv regional charitable fund VITA-LITE Charitable organization "Joint union society" (Vinogradiv)

2. HIV/AIDS pain and palliative care

Epidemiology of HIV/AIDS HIV – cases AIDS – cases Deaths, caused by AIDS – cases Incidence, 2011 HIV – new cases (46,2/ population) AIDS – new cases Mortality – 3736 (22 children) Prevalence, January 1 st 2012 HIV – patients (246,3/ population) AIDS – patients (41,2/ population)

Epidemiology of HIV/AIDS

National AIDS policy, plan, or program National program on HIV prevention, treatment, care and support for HIV/AIDS patients for “…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

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”

Availability of pain relief and palliative care services in the country for HIV/AIDS No data available for pediatric palliative care need Need for palliative care for HIV/AIDS Reality patients 5-10% in patient hospice care – 200 beds 70 hospice beds

3. Opioid availability

National Competent Authority State 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

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

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 – yes2006 – yes 2008 – no 2010 – yes 2005 – yes2007 – no 2009 – yes

National essential medicines list WHO Model Essential Medicines list (17th list, 2011)National essential medicines list Codeine, tablet Morphine  Injection  Oral liquid  Tablet  Tablet (prolonged release) Buprenorphine Morphine List of essential medicines for Palliative Care Codeine, tablets Fentanyl, (transdermal patch) Methadone, (immediate release) Morphine  Tablets  Oral solution  Injection  Tablets (sustained release) Oxycodone, tablet Tramadol  immediate release tablets/capsules  oral solution  injection Buprenorphine Morphine

Opioid analgesics approved in the country (ATC N02A) INNManufacture Morphine hydrochloride, inj.1% 1mlZdorovie narody, Ukraine Omnopon (morphine, noskapin, papaverin, codeine, thebain) Zdorovie narody, Ukraine Buprenorfine hydrochloride, injUkraine Butorphanol tartrat 0.2% 1mlUkraine Tramadol hydrochloridum, Sol.inj. 5% 2ml Caps. 50mg Ukraine Hydrorphone hydrochloride sustained tab. 8mg, 16mg, 32mg Janssen, Belgium Fentanil, transdermal patchesSandoz, Slovenia Janssen, Belgium Nycomed, Austria Promedol (trimepedin hydrochlorid)Ukraine Buprenorphine tablet sublinguaval 0.4mg, 2mg, 8mg Rusan Pharma, India Buprenorphine transdermal patches 35 mkg/hour, 52,5 mkg/hour, 70 mkg/hour Grunental, Germany

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

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.

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.

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

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

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

THANK YOU FOR ATTENTION!