Transcript Ukraine - Pain & Policy Studies Group

Action Plan for:
UKRAINE
Prepared by:
Nataliia Datsiuk
Andrii Shapovalov
Asra Husain
Karen Ryan
10 August 2012
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
1: State the 3-5 problems that lead to inadequate patient access to
opioid analgesics – Be as specific as you can
Problem 1:
Absence of oral morphine
Problem 2:
Strict regulation on prescribing opioids
Problem 3:
Inaccessibility of opioids in rural areas
Problem 4:
Lack of recognition among specialists (top managers, physicians, pharmacists)
that opioids are essential for moderate and severe pain relief
Problem 5:
Domain common society opinion that narcotic drugs is an absolute evil
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
PROBLEM 1
Absence of oral morphine
1.
2.
3.
-
Importers are not interested in importation of morphine due to lack
of profit and bureaucracy of procedure of market authorization
Domestic manufacturer doesn’t want to produce morphine in tab
(lack of profit)
No provision in the national medicines policy that oral morphine is
absolutely necessary
Absence of forms and dosage in List of essential medicine
Absence of special address in National Cancer Program
Misinterpretation of WHO ladder in clinical guidelines
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
B: State the objective(s) that would address the problem. Which
objectives are the top priorities? (What?)
1.
2.
Manufacture or/and import the oral morphine
Provide the provision in the national drug policy that oral
morphine is absolutely necessary
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
C: What action steps are needed to achieve the objectives? (How?)
1. Participate in negotiations with potential importers and domestic
manufacture initiated by Ukrainian League of Hospice and Palliative Care
(League) and IRF
2. Find other potential importers of morphine tablets
3. Identify the main problems of process of market authorization of morphine
tablets
4. Make proposition about:
Essential List of Medicines by adding dosages and forms; special address in National
Cancer Program to opioid availability and promote WHO step ladder; examine the
WHO method proposed in National guidelines
D: List those who have the authority and/or responsibility to take the necessary
action; and with whom they should collaborate. (Who?)
Morphine production: MoH, Domestic manufacture, importers, IRF, League
Market authorization: Pharmaceutical Center of MoH, State Service of Quality Control
National drug policy: MoH, League, AIDS Alliance, Health rights organization
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
E: Timeline for completion of action steps. (When?)
Step
Time
To participate in starting negotiate with potential importers and
domestic manufacture
August - …..
Identify the main problems of process of market authorization of
tab.morphine
September November
Making proposition about changes to national medicines policy
2012
F: What assistance (technical, financial) will be needed to achieve each
objective under part “B”? (How much?)
Experts support in:
import, manufacture, authorization of oral morphine
WHO ladder provision in national guidelines
Opioids availability in national programs (cancer, AIDS)
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
G: Expected outputs, and how measured
1.
2.
3.
4.
Oral morphine available
Oral morphine in National List of Essential medicine
WHO ladder endorsed in right way
Address opioid availability in national programs
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
PROBLEM 2
Strict regulation on prescribing opioids
• Limit the dose prescribing
• Heavy prescribing procedure
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
B: State the objective(s) that would address the problem. Which
objectives are the top priorities? (What?)
1.
2.
3.
4.
Physician must prescribe morphine in dose that is needed for
patient pain relief
Morphine prescription for cancer patient is decision of one
physician
No additional stamps and signs
More days for prescription and for valid prescriptions
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
C: What action steps are needed to achieve the objectives? (How?)
1.
2.
3.
Define what is the main guidelines for physician about dosage
prescribing and promote physician with this information
Identify and revise all prescription barriers
Learn other country experience and create appropriate model for
Ukraine of prescribing morphine(certification of physicians,
duration of prescription ?)
D: List those who have the authority and/or responsibility to take the necessary
action; and with whom they should collaborate. (Who?)
1.
3.
WHO, NICE, Association of oncologists, Institute of Palliative and
Hospice Care, Pharmacological Center of MoH
National Association, Education Institution, Cancer Center
State Service on Drug Control, MoH, Ukrainian League of Palliative Care
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
E: Timeline for completion of action steps. (When?)
Step
Time
Define what is the main guidelines for physician about
dosage prescribing and promote physician with this
information
SeptemberOctober
Identify and revise prescription barriers
2012
Learn other country experience and create appropriate model
for Ukraine of prescribing morphine(certification of
physicians, duration of prescription ?)
2012
F: What assistance (technical, financial) will be needed to achieve each
objective under part “B”? (How much?)
PPSG, Fellows from other countries, State Service on Drug Control
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
G: Expected outputs, and how measured
1.
2.
3.
No prescription dose limit of morphine for pain relief
Simplification prescribing procedure of opioids for pain relief
Long duration of prescription and validity of it
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
PROBLEM 3
Inaccessibility of opioids in rural areas
• Lack of pharmacy/health care sites which has license for handling of
opioids because of vary high costs of ensuring requirements for getting the
license (special equipped room, alarm system) and low profit of morphine
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
B: State the objective(s) that would address the problem. Which
objectives are the top priorities? (What?)
1.
To create a network of pharmacies or heath care sites which has
license for handling opioids
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
C: What action steps are needed to achieve the objectives? (How?)
1.
2.
3.
4.
Identify and revise all barriers of opioids inaccessibility in rural
areas
Learn the system of methadone transportation
Explore how to provide incentives for pharmacy to stock and
dispense morphine
Learn other country experience about distribution system and
create appropriate model for Ukraine
D: List those who have the authority and/or responsibility to take the necessary
action; and with whom they should collaborate. (Who?)
MoH, State Service on Drug Control, National Pharmaceutical
Association, Ukrainian League of Palliative Care
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
E: Timeline for completion of action steps. (When?)
Step
Time
Identify and revise all barriers of opioids inaccessibility 2012-2013
in rural areas
Learn the system of methadone transportation
March 2013
Learn other country experience about distribution
system and create appropriate model for Ukraine
2012-2013
F: What assistance (technical, financial) will be needed to achieve each
objective under part “B”? (How much?)
PPSG, Fellows from other countries, State Service on Drug Control
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
G: Expected outputs, and how measured
1.
2.
Increase numbers of pharmacies in rural areas which have
licenses to handling of opioids
Increase availability of opioids for rural population
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
PROBLEM 4
Lack of recognition among specialists that opioids are
essential for moderate and severe pain relief
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
B: State the objective(s) that would address the problem. Which
objectives are the top priorities? (What?)
1.
2.
3.
Aware top/state health care managers (MoH), pharmaceutical and
physicians community about the problem of opioids availability
Use WHO for pain relief
Include the topics of palliative care, availability of opioids, principle of
“balance” in drug control in education curriculum of medical and
pharmaceutical department
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
C: What action steps are needed to achieve the objectives? (How?)
1.
2.
3.
4.
Promote the MoH with information about availability of opioids,
comparing data of consumption in Ukraine and other countries, experts
opinion
Present the results of research of opioid availability at state conference,
meetings (National Palliative Congress, National Pharmaceutical
Conference, Congress of Oncologists et al.)
Promote the WHO method
Revise medical and pharmaceutical curriculum, give the proposition to
include topics and write methodological base
D: List those who have the authority and/or responsibility to take the necessary
action; and with whom they should collaborate. (Who?)
State Service on Drug Control, Ukrainian League of Palliative Care, Institute of
Palliative and Hospice Care, National medical University, National Pharmaceutical
Academy, IRF (Needs assessment in palliative care – grant from OSF/IRF to Caritas
Ukraine), Ukraine Association of Study Pain et al.
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
E: Timeline for completion of action steps. (When?)
Step
Time
Promote the MoH with information about role and availability of
opioids, comparing data of consumption in Ukraine and other
countries, experts opinion
2012
Present the results of research of opioid availability at state
conference, meetings
2012-2014
Promote the WHO method
2012-2014
Revise medical and pharmaceutical curriculum, give the
proposition to include topics and write methodological base
2012-2013
F: What assistance (technical, financial) will be needed to achieve each
objective under part “B”? (How much?)
1. Technical support: State Service on Drug Control, PPSG, WHO
2,3 Financial support
4. Technical and financial support
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
G: Expected outputs, and how measured
1.
2.
Increase the awareness of professional society of availability of
opioids
Educational curriculum of pharmaceutical and medical
department include the topics of palliative care, availability of
opioids, principle of “balance” in drug control in education
curriculum of medical and pharmaceutical department
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
PROBLEM 5
Domain common society opinion that narcotic drugs is an
absolute evil
Absence of balance approach in policy of drug control
Misinterpretation of “addiction”, “dependence syndrom”
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
B: State the objective(s) that would address the problem. Which
objectives are the top priorities? (What?)
• Approve draft “National Drug Strategy of Ukraine” created by State
Service on Drug Control which ensure the concept of “balance”
• Include in regulatory acts the approach of “balance”
• Include in all activity concern prevention of drug dependence the
statement that opioids is indispensable for pain relief
• Revise regulatory acts concern terminology (“dependence
syndrome”)
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
C: What action steps are needed to achieve the objectives? (How?)
1.
2.
3.
Make proposition about including in regulatory acts the principle
of “balance”
Formulate and include in all activities concern prevention of drug
dependence the statement of the role of opioids in medicine
(preventive drug and alcohol program of MoH targed at pupils,
parents and staff at school)
Identify negative and wrong language concern “dependence
syndrome” and make proposition how to change it
D: List those who have the authority and/or responsibility to take the necessary
action; and with whom they should collaborate. (Who?)
State Service on Drug Control, MoH
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
E: Timeline for completion of action steps. (When?)
Step
Time
Make proposition about including in regulatory acts the
principle of “balance”
2012- March
2013
Formulate and include in all activities concern prevention of
drug dependence the statement of the role of opioids in
medicine
2013-2014
Identify negative and wrong language concern “dependence
syndrome” and make proposition how to change it
2012
F: What assistance (technical, financial) will be needed to achieve each
objective under part “B”? (How much?)
1, 3 Technical support: State Service on Drug Control, PPSG, WHO, UNODC
(regional office in Ukraine)
2. Financial support
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care
G: Expected outputs, and how measured
1.
2.
3.
Concept of “balance” in regulatory acts
Programs of prevention drug and alcohol abuse target to pupils,
school staff and parents include the statement that opioids are
indispensable
Regulatory acts does not include wrong terminology
University of Wisconsin Pain & Policy Studies Group
World Health Organization Collaborating Center for
Pain Policy and Palliative Care