University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 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: Problem 2: Problem 3: Problem 4: Problem 5: Domain common society opinion that narcotic drugs is an absolute evil Strict regulation on prescribing opioids Absence of oral morphine Lack of recognition among specialists (top managers, physicians, pharmacists) that opioids are essential for moderate and severe pain relief Inaccessibility of opioids in rural areas

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Importers are not interested in importation of morphine due to lack of profit and bureaucracy of procedure of market authorization 2.Domestic manufacturer doesn’t want to produce morphine in tab (lack of profit) 3.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 PROBLEM 1 Absence of oral morphine

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Manufacture or/and import the oral morphine 2.Provide the provision in the national drug policy that oral morphine is absolutely necessary B: State the objective(s) that would address the problem. Which objectives are the top priorities? (What?)

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 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 D: List those who have the authority and/or responsibility to take the necessary action; and with whom they should collaborate. (Who?)

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?) Experts support in: - import, manufacture, authorization of oral morphine -WHO ladder provision in national guidelines -Opioids availability in national programs (cancer, AIDS) F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?) StepTime 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

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Oral morphine available 2.Oral morphine in National List of Essential medicine 3.WHO ladder endorsed in right way 4. Address opioid availability in national programs G: Expected outputs, and how measured

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care Limit the dose prescribing Heavy prescribing procedure PROBLEM 2 Strict regulation on prescribing opioids

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Physician must prescribe morphine in dose that is needed for patient pain relief 2.Morphine prescription for cancer patient is decision of one physician 3.No additional stamps and signs 4.More days for prescription and for valid prescriptions B: State the objective(s) that would address the problem. Which objectives are the top priorities? (What?)

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.Define what is the main guidelines for physician about dosage prescribing and promote physician with this information 2.Identify and revise all prescription barriers 3.Learn other country experience and create appropriate model for Ukraine of prescribing morphine(certification of physicians, duration of prescription ?) 1.WHO, NICE, Association of oncologists, Institute of Palliative and Hospice Care, Pharmacological Center of MoH National Association, Education Institution, Cancer Center 3. State Service on Drug Control, MoH, Ukrainian League of Palliative Care D: List those who have the authority and/or responsibility to take the necessary action; and with whom they should collaborate. (Who?)

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?) PPSG, Fellows from other countries, State Service on Drug Control F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?) StepTime Define what is the main guidelines for physician about dosage prescribing and promote physician with this information September- October 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

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.No prescription dose limit of morphine for pain relief 2.Simplification prescribing procedure of opioids for pain relief 3.Long duration of prescription and validity of it G: Expected outputs, and how measured

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 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 PROBLEM 3 Inaccessibility of opioids in rural areas

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.To create a network of pharmacies or heath care sites which has license for handling opioids B: State the objective(s) that would address the problem. Which objectives are the top priorities? (What?)

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.Identify and revise all barriers of opioids inaccessibility in rural areas 2.Learn the system of methadone transportation 3.Explore how to provide incentives for pharmacy to stock and dispense morphine 4.Learn other country experience about distribution system and create appropriate model for Ukraine MoH, State Service on Drug Control, National Pharmaceutical Association, Ukrainian League of Palliative Care D: List those who have the authority and/or responsibility to take the necessary action; and with whom they should collaborate. (Who?)

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?) PPSG, Fellows from other countries, State Service on Drug Control F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?) StepTime Identify and revise all barriers of opioids inaccessibility in rural areas Learn the system of methadone transportationMarch 2013 Learn other country experience about distribution system and create appropriate model for Ukraine

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Increase numbers of pharmacies in rural areas which have licenses to handling of opioids 2.Increase availability of opioids for rural population G: Expected outputs, and how measured

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 1.Aware top/state health care managers (MoH), pharmaceutical and physicians community about the problem of opioids availability 2.Use WHO for pain relief 3.Include the topics of palliative care, availability of opioids, principle of “balance” in drug control in education curriculum of medical and pharmaceutical department B: State the objective(s) that would address the problem. Which objectives are the top priorities? (What?)

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.Promote the MoH with information about availability of opioids, comparing data of consumption in Ukraine and other countries, experts opinion 2.Present the results of research of opioid availability at state conference, meetings (National Palliative Congress, National Pharmaceutical Conference, Congress of Oncologists et al.) 3.Promote the WHO method 4.Revise medical and pharmaceutical curriculum, give the proposition to include topics and write methodological base 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. D: List those who have the authority and/or responsibility to take the necessary action; and with whom they should collaborate. (Who?)

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?) 1.Technical support: State Service on Drug Control, PPSG, WHO 2,3 Financial support 4. Technical and financial support F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?) StepTime 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 Promote the WHO method Revise medical and pharmaceutical curriculum, give the proposition to include topics and write methodological base

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Increase the awareness of professional society of availability of opioids 2.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 G: Expected outputs, and how measured

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 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”) B: State the objective(s) that would address the problem. Which objectives are the top priorities? (What?)

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.Make proposition about including in regulatory acts the principle of “balance” 2.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) 3.Identify negative and wrong language concern “dependence syndrome” and make proposition how to change it State Service on Drug Control, MoH D: List those who have the authority and/or responsibility to take the necessary action; and with whom they should collaborate. (Who?)

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?) 1, 3 Technical support: State Service on Drug Control, PPSG, WHO, UNODC (regional office in Ukraine) 2.Financial support F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?) StepTime Make proposition about including in regulatory acts the principle of “balance” March 2013 Formulate and include in all activities concern prevention of drug dependence the statement of the role of opioids in medicine Identify negative and wrong language concern “dependence syndrome” and make proposition how to change it 2012

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Concept of “balance” in regulatory acts 2.Programs of prevention drug and alcohol abuse target to pupils, school staff and parents include the statement that opioids are indispensable 3.Regulatory acts does not include wrong terminology G: Expected outputs, and how measured