University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care Action Plan for: ALBANIA Prepared by: Kristo Huta Sokol Morina Snezana Bosnjak Jody Moen 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: Unavailability of IR morphine and low range of doses of SR morphine Lack of knowledge and negative attitudes about opioids Unbalanced policies exist for prescribing, dispensing and reimbursement.

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care A: State the problem that leads to inadequate patient access to opioid analgesics (What?) – Be as specific as you can in stating one problem Unbalanced policies exist for prescribing, dispensing and reimbursement. –Limits to duration of therapy per prescription (7 days) –The amount of money allocated medications restricts the number or amount of prescriptions to patients, consequently creating a barrier to treatment –Limits to diagnosis/stage of disease: only cancer patients in the terminal phase can receive opioids (HIV/AIDS are excluded) –Restrictions to maximum daily dose of morphine that may be prescribed by a GP(100 mg/day) –Restricted authority to prescribe opioids to specifically licensed physicians –Few pharmacies stock opioids(only one per region) a special license is required to dispense opioids Cost-related factors Fear of theft / diversion –The range of reimbursed opioids is limited (Tramadol, transdermal Fentanyl, Methadone not reimbursed) PROBLEM 1

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.To amend the law and change the regulations in accordance with the principle of balance 2.Achieve access to cancer pain management for patients regardless of the stage of their disease 3.Negotiate with the Health Insurance Fund to increase the reimbursement allocation to physicians, thereby educating them on the need 4.Negotiate with the MOH to increase the number of pharmacies that dispense 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?) –Based on the National Cancer Control Program and the Palliative Care Strategy, the Palliative Care working group will: propose to the MOH to amend the law from 7 up to 28 days in treatment duration propose to the MOH to change the regulation to allow opioid prescription for non cancer patients with moderate to severe pain propose to the Health Insurance Institute to remove the limit daily dose of morphine that may be prescribed propose to the MOH to increase the number of physicians allowed to acquire a license to prescribe (after appropriate education and training in effective and safe prescribing) Implement a survey to pharmacists regarding their knowledge and attitudes on stocking opioids, collect the results, and then share them with the MoH (No need to create a survey! Use the one prepared by PPSG, Aaron proposed that in the discussion) Jody will share this propose to the MOH an increase in the number of licensed pharmacies and then obligate those pharmacies to dispense opioids.(one in each town) propose to the Health Insurance Fund to cover the cost of morphine as an Essential WHO medication,with reference to pain relief as a human rights issue (provide 2008 Letter to CND from Special UN Rapporteurs) 1.Palliative Care working group 2.MOH – Directory of Pharmacy 3.Health Insurance Institute 4.Pharmacy Association 5.IPPF mentors 6.Members of Health Parliamentary Commission 7.PPSG for survey for pharmacists 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.One year (end of August 2014) 1.Attendance of IPPF mentor Stephen Connor at meetings with MoH and HII (pending financial support) 2.Collaboration with Chief of Oncology Dept in University Center in Tirana 3.Local WHO representative 4.Resources from PPSG and IEC 5.Commitment from Palliative Care working group 6.Seek funds from SOROS, to implement objectives F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?)

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Survey to pharmacies and results 2.Letters and proposals to MoH, HII, and pharmacies 3.Report summaries from each meeting 4.Parliament passes the law G: Expected outputs, and how measured

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care A: State the problem that leads to inadequate patient access to opioid analgesics (What?) – Be as specific as you can in stating one problem 1.Unavailability of IR morphine and low range of doses of SR morphine –Only 10mg SR morphine is available, 30mg and 60mg SR morphine are needed PROBLEM 2

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Register 10 mg IR Morphine 2.Register 30mg and 60mg SR Morphine 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.Inform decision-makers that oral IR Morphine is indispensable for treatment of cancer pain 2.Raise interest Albtrade Pharma company to register IR Morphine and other dosage forms of SR Morphine 3.Explore options to import morphine tablets 4.Calculate the need for IR and SR Morphine for a 3-year time period 1.MOH 2.Pharmaceutical company (Albtrade Pharma) 3.Drug Control Agency 4.Health Insurance Institute 5.Local WHO office 6.Members of Health Parliamentary Commission 7.Addiction office 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?) 1.2 years 1.Collaboration with International Expert – IPPF mentor Stephen Connor 2.Advice from Martha Maurer in how to calculate estimate 3.Palliative Care working group 4.Sign and use Morphine Manifesto as an advocacy tool (PC members) 5.Working group of Palliative Care new law F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?)

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Oral IR and SR morphine available and accessible for cancer pain and palliative care 2.Calculation of the need for oral morphine for cancer pain treatment 3.Calculation of the need for IR and SR morphine 4.Report to the MOH about the need for IR and SR (30mg and 60mg) based on the WHO Essential Medicines list. G: Expected outputs, and how measured

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care A: State the problem that leads to inadequate patient access to opioid analgesics (What?) – Be as specific as you can in stating one problem 1.Lack of knowledge and negative attitudes among health care professionals about opioids. PROBLEM 3

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Educate health care professionals about the indispensability, efficacy and safety of morphine for moderate and severe cancer pain and palliative care 2.Change negative/wrong attitudes 3.Educate pharmacies on the obligation to ensure adequate availability of 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.Translate and adapt international clinical practice guidelines (CPGs) on cancer pain management in collaboration with QKSCA 2.Organize and conduct lectures, professional meetings, round table discussions, etc on cancer pain management and palliative care 3.Disseminate translated guidelines to health care professionals at the above-mentioned events 4.Prepare pre- and post-tests to evaluate knowledge acquired 5.To present to guidelines to all stakeholders 1.MoH (pharmaceutical dept. and drug issues dept.) 2.Health Insurance Institute 3.Palliative Care working group 4.GPs 5.Oncology associations 6.Albanian Association for Pain 7.Albanian Association for Palliative Care 8.Potential funding organizations 9.Members of Health Parliamentary Commission 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.Ongoing throughout 2 year period 1.Translation services 2.Publication costs 3.Dissemination costs 4.Cost of meeting,workshops, round tables F: What assistance (technical, financial) will be needed to achieve each objective under part “B”? (How much?)

University of Wisconsin Pain & Policy Studies Group World Health Organization Collaborating Center for Pain Policy and Palliative Care 1.Translated/published guideline 2.Prepared slide presentations from various meetings, lectures, discussions, etc 3.Number of meetings 4.Number of meeting participants 5.Pre- and post-test results G: Expected outputs, and how measured