Transcript Слайд 1 - Pain & Policy Studies Group

Country Report for:
UKRAINE
Natallia Datsiuk, MPH
Bogomolets National Medical University
Ukraine, Kyiv
Ukraine,
45,5997,73 population
1. Cancer pain and palliative care
Cancer epidemiology situation, 2010
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
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 Recommendation
Ukraine’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 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
500 thousand of patients and 1,5mlm
their relatives, so more than 3 700
palliative beds and 85 000 of patients
at home
Reality
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
10000
9000
8000
9189
Кількість випадків СНІД
Кількість померлих від хвороб, обумовлених СНІД
7000
5861
6000
4723
5000
4217
4000
2743
1915
3000
2000
647
1353
867
2188 2420
415 473
2507 27142594
3736
3096
1775
1285
1000
0
4573 4386 4446
834
25000
21177
19 84020489
18 963
17 669
16 078
20000
13 770
12491
15000
10 009
8 756
8 913 8 575
10000
5 400
5 827 6 212
7 000
5000
1 490
183
0
Роки
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
Need for palliative care for
HIV/AIDS
2000-3300 patients
5-10% in patient hospice care – 200
beds
Reality
70 hospice beds
• No data available for pediatric palliative care need
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 – 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)
Codeine, tablet
Morphine
Injection
Oral liquid
Tablet
Tablet (prolonged release)
National essential
medicines list
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)
INN
Manufacture
Morphine hydrochloride, inj.1% 1ml
Zdorovie narody, Ukraine
Omnopon (morphine, noskapin, papaverin,
codeine, thebain)
Buprenorfine hydrochloride, inj
Zdorovie narody, Ukraine
Butorphanol tartrat 0.2% 1ml
Ukraine
Tramadol hydrochloridum,
Sol.inj. 5% 2ml
Caps. 50mg
Hydrorphone hydrochloride sustained tab. 8mg,
16mg, 32mg
Fentanil, transdermal patches
Ukraine
Promedol (trimepedin hydrochlorid)
Buprenorphine tablet sublinguaval 0.4mg, 2mg,
8mg
Buprenorphine transdermal patches 35
mkg/hour, 52,5 mkg/hour, 70 mkg/hour
Ukraine
Janssen, Belgium
Sandoz, Slovenia
Janssen, Belgium
Nycomed, Austria
Ukraine
Rusan Pharma, India
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!