“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

EURO Regional Morphine consumption (2004)

EURO Regional Morphine consumption (2004)

(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

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

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.

• 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

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

Education of HCP: promotion of existing guidelines

Education of HCP: promotion of existing guidelines

19981996 2004

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)

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)

Wallpaper promoting pain relief as a human right

Wallpaper promoting pain relief as a human right

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

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

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)

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

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

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)

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.