Snezana Bosnjak - Drug Availability

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Transcript Snezana Bosnjak - Drug Availability

“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
EURO Regional Morphine
consumption (2004)
(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. SR
100 mg supp
50 mg IV
100 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
• 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 / access to oral
morphine
• 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
Advocacy efforts
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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
1996
1998
2004
Pharmacotherapy
of cancer pain
Bosnjak, Beleslin,
Vuckovic-Dekic
(2007)
First textbook in
serbian
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)
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
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
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 costeffective)
Working with Government is
essential
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IPPF appointed as VP of the National Commission for PC
Commision formulated National Strategy for PC
recognizing
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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)
Drug
Dosage Form
Oral/Rectal
Tramadol
IR caps, drops
SR tbl
IR Suppositories
Methadone
IR drops
Morphine
IR: drops, solution
Parenteral
Transdermal
Vials for IV use
x
Not available
x
20 mg vial
x
Fentanyl TDS
Hydromorphone
25-100 ugr/h
SR tablets
x
x
Partners
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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.