Country Report for:UKRAINE

Natallia Datsiuk, MPHBogomolets National Medical University

Ukraine, Kyiv

Ukraine, 45,5997,73 population

1. Cancer pain and palliative care

Incidence: number of new cases 166 171

Incidence (crude rate) 363.0 per 100 000

Mortality: number of new cases 85027

Mortality (crude rate) 185.7 per 100 000

Prevalence 1 015 592

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 painWHO Recommendation Ukraine’s Practice

Principle 1: Pain medications shouldbe delivered in oral form (tablets orsyrup) when possible.

Patients receive morphine by injection only.

Principle 2: Pain medications shouldbe given every four hours.

Most patients receive morphine once or twice per day, in exceptionalcases three or four.

Principle 3: Morphine should bestarted when weaker pain medicationsprove insufficient to control pain.

Patients are often started on morphine only when curative treatment isstopped, irrespective of pain levels.

Principle 4: Morphine dose should bedetermined individually. There is nomaximum 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 doctorsobserve a maximum daily dose of 50 mg of injectable morphine, even if it isinsufficient to control the patient’s pain.

Principle 5: Patients should receivemorphine 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 careShchupik 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-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 care Reality

500 thousand of patients and 1,5mlm their relatives, so more than 3 700 palliative beds and 85 000 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• 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)

Epidemiology of HIV/AIDS

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

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

2000-3300 patients5-10% in patient hospice care – 200 beds

70 hospice beds

3. Opioid availability

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

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 – yes 2006 – yes 2008 – no 2010 – yes

2005 – yes 2007 – no 2009 – yes

National essential medicines list

WHO Model Essential Medicines list (17th list, 2011) National essential medicines list

Codeine, tabletMorphineInjectionOral liquidTabletTablet (prolonged release)

Buprenorphine Morphine

List of essential medicines for Palliative Care

Codeine, tabletsFentanyl, (transdermal patch)Methadone, (immediate release)Morphine Tablets Oral solution Injection Tablets (sustained release)Oxycodone, tabletTramadol immediate release tablets/capsules oral solution injection

Buprenorphine Morphine

Opioid analgesics approved in the country (ATC N02A)

INN Manufacture

Morphine hydrochloride, inj.1% 1ml Zdorovie narody, Ukraine

Omnopon (morphine, noskapin, papaverin, codeine, thebain)

Zdorovie narody, Ukraine

Buprenorfine hydrochloride, inj Ukraine

Butorphanol tartrat 0.2% 1ml Ukraine

Tramadol hydrochloridum, Sol.inj. 5% 2mlCaps. 50mg

Ukraine

Hydrorphone hydrochloride sustained tab. 8mg, 16mg, 32mg

Janssen, Belgium

Fentanil, transdermal patches Sandoz, SloveniaJanssen, BelgiumNycomed, 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!