“Improving opioid availability through advocacy” Experience from Serbia Snežana Bošnjak International Pain Policy Fellow ( ) Institute for Oncology and Radiology of Serbia: National center for palliative care development Snežana Bošnjak International Pain Policy Fellow ( ) Institute for Oncology and Radiology of Serbia: National center for palliative care development

EURO Regional Morphine consumption (2004)

(Un)available opioids: 2006 DrugDosage Form Oral/RectalParenteralTransdermal Tramadol50 mg caps. 10 ml drops (100 mg / 1 ml) 100 mg tbl. SR 100 mg supp 50 mg IV 100 mg IV x MethadoneIR 10 ml drops (10 mg / 1 ml) Not availablex MorphineNOT AVAILABLE20 mg vialx Fentanyl TDS ugr/h

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

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.

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

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

Education of HCP: promotion of existing guidelines

First textbook in serbian Pharmacotherapy of cancer pain Bosnjak, Beleslin, Vuckovic-Dekic (2007)

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)

Wallpaper promoting pain relief as a human right

Activities 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

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

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)

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

Available opioids (2008) DrugDosage Form Oral/RectalParenteralTransdermal TramadolIR caps, drops SR tbl IR Suppositories Vials for IV usex MethadoneIR dropsNot availablex MorphineIR: drops, solution20 mg vialx Fentanyl TDS ugr/h HydromorphoneSR tabletsxx

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)

Conclusions 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.