1. A Global Policy Approach to Opioid Drug Availability
Kathleen M. Foley, MD
OSF Seminar
Vienna
March 5-6, 2013

2. OSF International Palliative Care Initiative
Overarching goal:
To advance palliative care globally
IPCI works to integrate palliative care into national health plans, policies, financing, legislation, delivery systems, professional and public education and to ensure the availability of essential drugs for pain relief and symptom management.

4. Freedom From Cancer Pain
“Nothing would have a greater impact than using the knowledge we have now to improve the care of the patient with cancer pain”
Dr. Jan Stjernsward
Chief, Cancer Unit, WHO,1986

6. World Health Organization
WHO MONOGRAPHS
World Health Organization

7. 2002 WHO Definition of Palliative Care
"Palliative care is an approach which improves quality of life of patients and their families facing life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual"

8. WHO Public Health Model
Policy
O u t c o m e s
C o n t e x t
Drug Availability
Education
Implementation

9. Ukraine 1.78 mg / capita ≈ 81 kg

10. WHO Public Health Model

11. The continuum of palliative care
Life Closure
Therapies to modify disease (curative, restorative intent)
Actively Dying
Slide Note
This chart shows the integration of palliative care early in the disease process.
Examples:
Mitigate side effects of treatment.
Provide medications to treat other conditions that impact quality of lie—fatigue, dementia, neuropathy, depression.
Advance care planning.
Building a trusting relationship with patient, family, friends.
Death
Diagnosis 6m
Bereavement Care
Therapies to relieve suffering, improve quality of life

12. Global Cancer Mortality
12.7 million patients diagnosed each year with cancer
7.6 million who die from cancer
29 million cancer survivors

13. Global Cancer Mortality (millions/yr)
Data Source: World Bank

14. UNAIDS Report 40 million living with HIV/AIDS
-28.5 million in sub-saharan Africa
14 million orphans worldwide
-11 million in sub-saharan Africa
20 million have died since 1981

15. Pediatric Palliative Care
Worldwide there are 7-9 million children with life-limiting and life-threatening conditions requiring palliative care
80% live in resource-limited countries

20. Estimated number of cases Estimated number of deaths
The Global Burden of TB 2010
Estimated number of cases
Estimated number of deaths
8.8 million
(range: 8.5–9.2 million)
1.45 million
(range: 1.2–1.6 million)
All forms of TB
HIV-associated TB
1.1 million (13%)
(range: 1.0–1.2 million)
350,000
(range: 320,000–
390,000)
Multidrug-resistant
TB (Prevalent)
650,000
(460,000 – 870,000)
about 150,000
Source: WHO Global Tuberculosis Control Report 2011.

21. Palliative Care Roadmap
Identify National Champions
Complete a Country Needs Assessment
Hold a National Stakeholders Meeting
Create Various Government Task Forces
Development of a Palliative Care Concept

22. Elements of Policy Work
International documents with symbolic language
International documents to guide policy development
Passionate committed champions
Financial support for technical expertise

23. Reasons for unavailability of opioids
Inadequate method for assessing needs
Unduly strict drug regulations
Burdensome administrative procedures
Exaggerated fears of addiction
Fear of investigation, penalties
Lack of training in pain management
PPSG 2007
INCB, 2002

24. Meeting the Challenge Unquestioned need to relieve pain
Solid scientific and medical basis
Clear Guidelines from UN Bodies
International Narcotic Control Board
World Health Assembly
-Economic, Social and Cultural Council
-UN Human Rights Rapporteurs for Health and Torture
-Committee on Narcotic Drugs
Acceptance of pain relief and palliative as human rights issues

25. A sense of urgency from UN Organizations
International Narcotics Control Board
World Health Organization
World Health Assembly
UN Economic and Social Council
Commission on Narcotic Drugs
The critical importance of opioid analgesics has been repeatedly recognized by international bodies around the world.
In 2005, the WHA and ECOSOC both issued resolutions calling attn to importance of OA, and encouraging Gvts to address ntl barriers to improve pt access

28. WHO Criteria for Assessing Policy
Opioids absolutely necessary
Gov’t obligation to ensure availability
Designate Competent Authority
Estimate requirements; report statistics
Address fear of legal sanctions
Use correct terminology regarding addiction
Avoid restrictions that limit medical decisions
Avoid unduly strict prescription requirements
Cooperation to ensure availability

29. Main Parts to Achieving Balanced Policy WHO, 2000
WHO/ EDM/QSM/2000.4
ENGLISH ONLY
DISTRIBUTION: GENERAL 
Evaluate national drug control policy
Estimate annual requirements; report consumption statistics
3. Administer an effective distribution system to patients
NARCOTIC & PSYCHOTROPIC DRUGS
 ACHIEVING BALANCE IN NATIONAL OPIOIDS CONTROL POLICY 
GUIDELINES FOR ASSESSMENT
World Health Organization

31. Old and New Policy in Romania
35-year-old policies
No independent prescribing authority beyond 3-day period
Opioid analgesics limited by patient diagnosis (3)
Limit of 60 mg per day of morphine
10-day prescription possible, but with very complex authorization process (expires in 90 days).
Burdensome for physicians and patient family
New policies
Prescribing authority granted for 30-day period
(for physicians with specific specialties or who have received training)
Not limited by patient diagnosis
No limit of daily dose
Less burdensome for physicians and patient family
Rxing had been severely restricted; complicated forms / authorizations; dose and time limits; no flexibility; 3 diagnoses (inclurable cancer), no AIDS
Many pts die before obtaining morphine. Used WHO G. New law in Nov 2005, new regs in Progress driven by a MOH Commission
Every licensed doctor can prescribe; no max dose, 30 days per Rx; 4 self-copying Rxs; no special auth for pharmacies to stock
Implementation began March 2006, meeting with all stakeholders. CPC educating; 3000 docs and pharmacists in 2007

32. An introduction to ATOME
                                                 
The ATOME project aims to improve access to opioids across Europe. A consortium of academic institutions and public health organizations is working to help governments, particularly in Eastern Europe, identify and remove barriers that prevent people from accessing medicines that could improve end of life care, alleviate debilitating pain and treat heroin dependence.

33. ATOME 12 Target Countries
                                                                                    

35. International Pain Policy Fellowship Pain and Policy Study Group University of Wisconsin
Nigeria, Serbia, Panama, Uganda,
Argentina, Columbia Sierra Leone
Kenya, Moldova, Guatemala, Georgia,
Armenia, Nepal, Jamaica
India, Bangladesh, Sri lanka, Albania,
Kyrgyzstan, Ukraine

36. http://www. hrw. org/sites/default/files/reports/health1009webwcover

37. Ukraine’s Obligation to Ensure Evidence-Based Palliative Care
Uncontrolled Pain
Ukraine’s Obligation to Ensure Evidence-Based Palliative Care

38. 50 Milligrams is Not Enough
People with debilitating illnesses are left to die in excruciating pain as a result of restrictions on pain medicines. Health care workers must be allowed to provide patients with relief from severe pain
Vlad is suffering from incurable brain cancer. Despite his chronic pain, doctors in Ukraine are only allowed to prescribe 50 mg of pain medicine. In another country, doctors would typically prescribe more than 2,000 mg for a patient like Vlad.

39. Pain crippled me more than cancer…..

40. Seeing my patients’ suffering and not being able to help … killing me

41. Unlike to my illness, my pain could be treated

42. Pain relief lasts only for 4 hours. The rest of the day I live in hell