“Improving opioid availability through advocacy” Experience from Serbia
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Transcript of “Improving opioid availability through advocacy” Experience from Serbia
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“Improving opioid availability through advocacy”
Experience from Serbia
“Improving opioid availability through advocacy”
Experience from Serbia
Snežana Bošnjak
International Pain Policy Fellow (2006-2010)
Institute for Oncology and Radiology of Serbia: National center for palliative care development
Snežana Bošnjak
International Pain Policy Fellow (2006-2010)
Institute for Oncology and Radiology of Serbia: National center for palliative care development
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EURO Regional Morphine consumption (2004)
EURO Regional Morphine consumption (2004)
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(Un)available opioids: 2006(Un)available opioids: 2006
Drug Dosage Form
Oral/Rectal Parenteral Transdermal
Tramadol 50 mg caps.10 ml drops (100 mg / 1 ml)100 mg tbl. SR100 mg supp
50 mg IV100 mg IV
x
Methadone IR 10 ml drops (10 mg / 1 ml)
Not available x
Morphine NOT AVAILABLE 20 mg vial x
Fentanyl TDS 25-100 ugr/h
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International Pain Policy Fellowship (IPPF) Univ of Wisconsin Pain & Policy Studies Group
Madison October 2006
International Pain Policy Fellowship (IPPF) Univ of Wisconsin Pain & Policy Studies Group
Madison October 2006
• To improve the accessibility and availability of opioid analgesics in Serbia
• To work with government to remove regulatory barriers to legitimate opioid use
• To improve the accessibility and availability of opioid analgesics in Serbia
• To work with government to remove regulatory barriers to legitimate opioid use
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Action plan Action plan
• Lack of availability of oral morphine • No recognition that opioid analgesics are
absolutely necessary for the relief of pain & suffering.
• No recognition that it is government’s obligation to ensure adequate availability of opioid analgesics while preventing abuse and diversion
• Overly restrictive laws and regulations related to opioid use.
• Lack of availability of oral morphine • No recognition that opioid analgesics are
absolutely necessary for the relief of pain & suffering.
• No recognition that it is government’s obligation to ensure adequate availability of opioid analgesics while preventing abuse and diversion
• Overly restrictive laws and regulations related to opioid use.
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• Acute shortage of supply of SR morphine (2006): previous supplier of SR morphine stopped importing
• IR morphine never available • Low interest of pharmaceutical companies to
register oral morphine• Lack of recognition by HCP that oral morphine is
essential for successful management of chronic pain
• No recognition by Gvm`t of the need to take action to improve morphine availability
• Acute shortage of supply of SR morphine (2006): previous supplier of SR morphine stopped importing
• IR morphine never available • Low interest of pharmaceutical companies to
register oral morphine• Lack of recognition by HCP that oral morphine is
essential for successful management of chronic pain
• No recognition by Gvm`t of the need to take action to improve morphine availability
Lack of availability of / access to oral morphine
Lack of availability of / access to oral morphine
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Advocacy efforts Advocacy efforts
• Education at all levels • Request help from professional societies • Request that IORS import oral morphine• Request help from IORS Ombudsman• Media campaign (newspapers, radio,
television)• Request meeting with drug regulators • Raise interest on the part of pharmaceutical
companies to register oral morphine
• Education at all levels • Request help from professional societies • Request that IORS import oral morphine• Request help from IORS Ombudsman• Media campaign (newspapers, radio,
television)• Request meeting with drug regulators • Raise interest on the part of pharmaceutical
companies to register oral morphine
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Education of HCP: promotion of existing guidelines
Education of HCP: promotion of existing guidelines
19981996 2004
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First textbook in serbian
First textbook in serbian
Pharmacotherapy of cancer pain
Bosnjak, Beleslin, Vuckovic-Dekic
(2007)
Pharmacotherapy of cancer pain
Bosnjak, Beleslin, Vuckovic-Dekic
(2007)
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Patient/family education: IPPF Patient/family education: IPPF
• Education leaflet for patients: cancer pain management (IORS website)
• Articles (3) about cancer pain management (Serbian Society for the fight against cancer, the Society Journal “RAK”)
• Lectures (4) aimed at education of general public about cancer pain management /role of opioids (Academy of the Serbian Medical Association)
• Education leaflet for patients: cancer pain management (IORS website)
• Articles (3) about cancer pain management (Serbian Society for the fight against cancer, the Society Journal “RAK”)
• Lectures (4) aimed at education of general public about cancer pain management /role of opioids (Academy of the Serbian Medical Association)
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Wallpaper promoting pain relief as a human right
Wallpaper promoting pain relief as a human right
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Activities at the IORSActivities at the IORS
• Request that IORS import oral morphine as unregistered drug
• MoH’s agreed to instruct all health care institutions to import morphine
• IORS was the only institution that has imported SR and IR morphine
• Example of a good practice and the opportunity for HCP, patients and families to witness the efficacy and safety of morphine for the treatment of cancer pain
• Request that IORS import oral morphine as unregistered drug
• MoH’s agreed to instruct all health care institutions to import morphine
• IORS was the only institution that has imported SR and IR morphine
• Example of a good practice and the opportunity for HCP, patients and families to witness the efficacy and safety of morphine for the treatment of cancer pain
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Working with IORS Ombudsman Working with IORS Ombudsman
• Unavailability of opioid analgesics in general, and morphine in particular, is a violation of a patient’s right to the best available health care
• The fact that IORS is the only institution that has imported oral morphine, despite the MoH’s recommendation to all institutions is a violation of patients’ rights not to be discriminated against
• Information given to patients that it is their right to complain
• The Ombudsman from the IORS raised the issue of patients’ rights at a meeting organized by the MoH
• Unavailability of opioid analgesics in general, and morphine in particular, is a violation of a patient’s right to the best available health care
• The fact that IORS is the only institution that has imported oral morphine, despite the MoH’s recommendation to all institutions is a violation of patients’ rights not to be discriminated against
• Information given to patients that it is their right to complain
• The Ombudsman from the IORS raised the issue of patients’ rights at a meeting organized by the MoH
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Counter-Campaign: why morphine?Counter-Campaign: why morphine?
• The consumption of morphine is declining all over the world (Not true! Check INCB)
• There are alternatives to morphine (oxycodon is more expensive!)
• Why spending money on morphine, when the drug is not “popular” any more (since the drug is on WHO and IAHPC essential medication list it is cost-effective)
• The consumption of morphine is declining all over the world (Not true! Check INCB)
• There are alternatives to morphine (oxycodon is more expensive!)
• Why spending money on morphine, when the drug is not “popular” any more (since the drug is on WHO and IAHPC essential medication list it is cost-effective)
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Working with Government is essential
Working with Government is essential
• IPPF appointed as VP of the National Commission for PC• Commision formulated National Strategy for PC
recognizing – opioids as absolutely necessary for pain relief/palliative care – the need for opioids control policy that balance concerns about
abuse and the need for medical use – MoH responsibility to make opioids available to patients – MoH willingness to examine drug control policies for potential
barriers • Commission proposed the national list of essential drugs
for Palliative Care • Commission accepted the document “National opioid
control policy in Serbia with proposal for change” written by IPPF with assistance from the PPSG
• IPPF appointed as VP of the National Commission for PC• Commision formulated National Strategy for PC
recognizing – opioids as absolutely necessary for pain relief/palliative care – the need for opioids control policy that balance concerns about
abuse and the need for medical use – MoH responsibility to make opioids available to patients – MoH willingness to examine drug control policies for potential
barriers • Commission proposed the national list of essential drugs
for Palliative Care • Commission accepted the document “National opioid
control policy in Serbia with proposal for change” written by IPPF with assistance from the PPSG
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Available opioids (2008)Available opioids (2008)
Drug Dosage Form
Oral/Rectal Parenteral Transdermal
Tramadol IR caps, drops SR tbl IR Suppositories
Vials for IV use x
Methadone IR drops Not available x
Morphine IR: drops, solution 20 mg vial x
Fentanyl TDS 25-100 ugr/h
Hydromorphone SR tablets x x
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Partners Partners
• Ministry of Health (MoH)• Medicines and Medical Devices Agency of Serbia • National Competent Authority for narcotics• Republic Institute of Health Insurance • Ministry of Internal Affairs• Institute for Oncology and Radiology of Serbia• Professional societies (IASP, ESMO, anestesiology, hematology,
pharmacotherapy) • NGOs: BELhospice, Serbian Society for the Fight Against
Cancer• Academy of the Serbian Medical Association• WHO and EU (ATOME project)• Pharmaceutical companies• Influential individuals who have had recent positive experiences
w/opioid use• Media (Vlajić Đorđe, BBC)
• Ministry of Health (MoH)• Medicines and Medical Devices Agency of Serbia • National Competent Authority for narcotics• Republic Institute of Health Insurance • Ministry of Internal Affairs• Institute for Oncology and Radiology of Serbia• Professional societies (IASP, ESMO, anestesiology, hematology,
pharmacotherapy) • NGOs: BELhospice, Serbian Society for the Fight Against
Cancer• Academy of the Serbian Medical Association• WHO and EU (ATOME project)• Pharmaceutical companies• Influential individuals who have had recent positive experiences
w/opioid use• Media (Vlajić Đorđe, BBC)
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ConclusionsConclusions
• Cancer patients in many countries suffer pain needlessly
• The challenge is to create national demand /pressure for changes
• Working with Gvm`t, experts and local partners • IPPF training program empowers Fellows with
necessary knowledge, methods and advocacy skills
• Significant progress towards overcoming barriers and improving the availability of opioids in Serbia.
• Cancer patients in many countries suffer pain needlessly
• The challenge is to create national demand /pressure for changes
• Working with Gvm`t, experts and local partners • IPPF training program empowers Fellows with
necessary knowledge, methods and advocacy skills
• Significant progress towards overcoming barriers and improving the availability of opioids in Serbia.