Kathleen M. Foley, MDKathleen M. Foley, MDOSF SeminarOSF Seminar

ViennaViennaMarch 5-6, 2013March 5-6, 2013

A Global Policy Approach to A Global Policy Approach to Opioid Drug AvailabilityOpioid Drug Availability

OSF International Palliative OSF International Palliative Care InitiativeCare Initiative

Overarching goal:Overarching goal: To advance palliative care globallyTo advance palliative care globally IPCI works to integrate palliative care IPCI works to integrate palliative care

into national health plans, policies, into national health plans, policies, financing, legislation, delivery systems, financing, legislation, delivery systems, professional and public education and professional and public education and to ensure the availability of essential to ensure the availability of essential drugs for pain relief and symptom drugs for pain relief and symptom management. management.

Freedom From Cancer PainFreedom From Cancer Pain

““Nothing would have a greater impact than using the Nothing would have a greater impact than using the knowledge we have now to improve the care of knowledge we have now to improve the care of

the patient with cancer painthe patient with cancer pain””

Dr. Jan StjernswardDr. Jan Stjernsward

Chief, Cancer Unit, Chief, Cancer Unit, WHO,1986WHO,1986

World Health OrganizationWorld Health Organization

WHO MONOGRAPHSWHO MONOGRAPHS

2002 WHO Definition of 2002 WHO Definition of Palliative CarePalliative Care

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

EducationEducation

ImplementationImplementation

DrugAvailability

DrugAvailability

WHO Public Health ModelWHO Public Health ModelWHO Public Health ModelWHO Public Health Model

PolicyPolicyPolicyPolicy

Context

Context

O utcomes

O utcomes

Ukraine Ukraine 1.78 mg / 1.78 mg /

capitacapita≈ 81 kg≈ 81 kg

Ukraine Ukraine 1.78 mg / 1.78 mg /

capitacapita≈ 81 kg≈ 81 kg

WHO Public Health ModelWHO Public Health Model

The continuum of palliative The continuum of palliative carecare

DiagnosisDiagnosis DeathDeath

Therapies to modify diseaseTherapies to modify disease(curative, restorative intent)(curative, restorative intent)

Actively Actively DyingDying

BereavementBereavementCareCare

Life Life ClosureClosure

Therapies to relieve Therapies to relieve suffering, improve quality of suffering, improve quality of

lifelife

6m6m

Global Cancer Global Cancer Mortality Mortality

12.7 million patients diagnosed 12.7 million patients diagnosed each year with cancereach year with cancer

7.6 million who die from cancer7.6 million who die from cancer 29 million cancer survivors29 million cancer survivors

Global Cancer Mortality Global Cancer Mortality (millions/yr)(millions/yr)

Data Source: World BankData Source: World Bank

UNAIDS ReportUNAIDS Report

40 million living with HIV/AIDS40 million living with HIV/AIDS-28.5 million in sub-saharan Africa-28.5 million in sub-saharan Africa

14 million orphans worldwide14 million orphans worldwide-11 million in sub-saharan Africa-11 million in sub-saharan Africa

20 million have died since 198120 million have died since 1981

Pediatric Palliative Pediatric Palliative Care Care

Worldwide there are 7-9 million Worldwide there are 7-9 million children with life-limiting and children with life-limiting and life-threatening conditions life-threatening conditions requiring palliative carerequiring palliative care

80% live in resource-limited 80% live in resource-limited countriescountries

Estimated Estimated number of number of

casescases

Estimated Estimated number of number of

deathsdeaths1.45 million1.45 million

(range: 1.2–1.6 (range: 1.2–1.6 million)million)

8.8 million8.8 million

(range: 8.5–9.2 (range: 8.5–9.2 million)million)

650,000650,000

(460,000 – 870,000) (460,000 – 870,000)

All forms of TBAll forms of TB

Multidrug-Multidrug-resistant resistant TB (Prevalent)TB (Prevalent)

HIV-associated HIV-associated TBTB

1.1 million (13%)1.1 million (13%) (range: 1.0–1.2 (range: 1.0–1.2 million)million)

350,000350,000(range: 320,000–(range: 320,000–390,000)390,000)

The Global Burden of The Global Burden of TB 2010TB 2010

about 150,000about 150,000

Source: WHO Global Tuberculosis Control Report 2011. Source: WHO Global Tuberculosis Control Report 2011.

Palliative Care RoadmapPalliative Care Roadmap

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

Elements of Policy Work Elements of Policy Work

International documents with symbolic International documents with symbolic languagelanguage

International documents to guide policy International documents to guide policy development development

Passionate committed championsPassionate committed champions Financial support for technical expertiseFinancial support for technical expertise

Reasons for unavailability of opioidsReasons for unavailability of opioids

•Inadequate method for assessing needsInadequate method for assessing needs• Unduly strict drug regulations Unduly strict drug regulations • Burdensome administrative proceduresBurdensome administrative procedures• Exaggerated fears of addictionExaggerated fears of addiction• Fear of investigation, penaltiesFear of investigation, penalties• Lack of training in pain managementLack of training in pain management

PPSG 2007PPSG 2007 INCB, 2002INCB, 2002

Meeting the ChallengeMeeting the Challenge

Unquestioned need to relieve painUnquestioned need to relieve pain Solid scientific and medical basisSolid scientific and medical basis Clear Guidelines from UN Bodies Clear Guidelines from UN Bodies International Narcotic Control BoardInternational Narcotic Control Board World Health AssemblyWorld Health Assembly

-Economic, Social and Cultural Council-Economic, Social and Cultural Council

-UN Human Rights Rapporteurs for Health and Torture-UN Human Rights Rapporteurs for Health and Torture

-Committee on Narcotic Drugs -Committee on Narcotic Drugs Acceptance of pain relief and palliative as human rights Acceptance of pain relief and palliative as human rights

issuesissues

A sense of urgency from A sense of urgency from UN Organizations UN Organizations

International Narcotics Control Board International Narcotics Control Board

World Health OrganizationWorld Health Organization

World Health AssemblyWorld Health Assembly

UN Economic and Social CouncilUN Economic and Social Council

Commission on Narcotic Drugs Commission on Narcotic Drugs

WHO Criteria for Assessing PolicyWHO Criteria for Assessing Policy

Opioids absolutely necessaryOpioids absolutely necessary Gov’t obligation to ensure availabilityGov’t obligation to ensure availability Designate Competent AuthorityDesignate Competent Authority Estimate requirements; report statisticsEstimate requirements; report statistics Address fear of legal sanctionsAddress fear of legal sanctions Use correct terminology regarding addictionUse correct terminology regarding addiction Avoid restrictions that limit medical decisionsAvoid restrictions that limit medical decisions Avoid unduly strict prescription requirementsAvoid unduly strict prescription requirements Cooperation to ensure availabilityCooperation to ensure availability

WORLD HEALTH ORGANIZATION

WHO/ EDM/QSM/2000.4WHO/ EDM/QSM/2000.4

ENGLISH ONLYENGLISH ONLY

DISTRIBUTION: GENERAL DISTRIBUTION: GENERAL 

NARCOTIC & NARCOTIC & PSYCHOTROPIC DRUGSPSYCHOTROPIC DRUGS

  ACHIEVING ACHIEVING BALANCE IN BALANCE IN NATIONAL NATIONAL OPIOIDS OPIOIDS

CONTROL CONTROL POLICYPOLICY  

  

GUIDELINES FOR GUIDELINES FOR ASSESSMENTASSESSMENT

World Health World Health OrganizationOrganization

1.1. Evaluate national drug Evaluate national drug control policycontrol policy

2.2. Estimate annual Estimate annual requirements; report requirements; report consumption statisticsconsumption statistics

3. Administer an effective 3. Administer an effective distribution systedistribution system m to to patientspatients

Main Parts to Achieving Balanced PolicyMain Parts to Achieving Balanced PolicyWHO, 2000WHO, 2000

www.who.int/medicines/areas/quality_safety/www.who.int/medicines/areas/quality_safety/GLs_Ens_Balance_NOCPGLs_Ens_Balance_NOCP

Old and New Policy in RomaniaOld and New Policy in Romania

35-year-old policies35-year-old policies- No independent prescribing No independent prescribing

authority beyond 3-day periodauthority beyond 3-day period- Opioid analgesics limited by Opioid analgesics limited by

patient diagnosis (3)patient diagnosis (3)- Limit of 60 mg per day of Limit of 60 mg per day of

morphinemorphine- 10-day prescription possible, 10-day prescription possible,

but with very complex but with very complex authorization process (expires authorization process (expires in 90 days). in 90 days).

- Burdensome for physicians and Burdensome for physicians and patient familypatient family

New policiesNew policies- Prescribing authority granted for Prescribing authority granted for

30-day period30-day period

(for physicians with specific (for physicians with specific specialties or who have specialties or who have received training)received training)

- Not limited by patient diagnosisNot limited by patient diagnosis- No limit of daily doseNo limit of daily dose- Less burdensome for physicians Less burdensome for physicians

and patient familyand patient family

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.

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.

ATOME 12 Target Countries                                                                                      

ATOME 12 Target Countries                                                                                      

3434

International Pain Policy FellowshipInternational Pain Policy FellowshipPain and Policy Study GroupPain and Policy Study Group

University of WisconsinUniversity of Wisconsin

2006 2006 Nigeria, Serbia, Panama, Uganda, Nigeria, Serbia, Panama, Uganda,

Argentina, Columbia Sierra LeoneArgentina, Columbia Sierra Leone

2008 Kenya, Moldova, Guatemala, Georgia,2008 Kenya, Moldova, Guatemala, Georgia,

Armenia, Nepal, JamaicaArmenia, Nepal, Jamaica

2012 India, Bangladesh, Sri lanka, Albania,2012 India, Bangladesh, Sri lanka, Albania,

Kyrgyzstan, UkraineKyrgyzstan, Ukraine

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

http://www.hrw.org/reports/2011/05/12/uncontrolled-painhttp://www.hrw.org/reports/2011/05/12/uncontrolled-pain

Uncontrolled PainUncontrolled PainUkraine’s Obligation to Ensure Ukraine’s Obligation to Ensure Evidence-Based Palliative CareEvidence-Based Palliative Care

Vlad is suffering from incurable brain cancer. Despite his chronic 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. doctors in Ukraine are only allowed to prescribe 50 mg of pain medicine. In another country, doctors would typically prescribe more than 2,000 In another country, doctors would typically prescribe more than 2,000 mg for a patient like Vlad.mg for a patient like Vlad.

50 Milligrams is Not 50 Milligrams is Not EnoughEnough

People with People with debilitating debilitating illnesses are left to illnesses are left to die in excruciating die in excruciating pain as a result of pain as a result of restrictions on pain restrictions on pain medicines. Health medicines. Health care workers must care workers must be allowed to be allowed to provide patients provide patients with relief from with relief from severe painsevere pain

http://http://www.stoptortureinhealthcare.org/www.stoptortureinhealthcare.org/

Pain crippled me more than cancer…..Pain crippled me more than cancer…..

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

Unlike to my illness, my pain could be treatedUnlike to my illness, my pain could be treated

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