Ensuring Balance WHO Guidelines Jim Cleary, MBBS FAChPM ! ! - - PowerPoint PPT Presentation

Ensuring Balance “WHO Guidelines”

Jim Cleary, MBBS FAChPM!

!

Associate Professor of Medicine (Medical Oncology)!

University of Wisconsin School of Medicine & Public Health!

Palliative Care Physician !

UW Hospital & Clinics!

Program Director, Non Communicable Diseases!

UW Global Health Institute!

Director, WHO Collaborating Center for Pain Policy and Palliative Care!

UW Carbone Cancer Center! Madison, Wisconsin!

!

Twitter: @jfclearywisc!

Email: jfcleary@wisc.edu! Blog: http://painpolicy.wordpress.com! Website: http://www.painpolicy.wisc.edu!

Establishes a Framework to:

• 1. Prevent abuse and

diversion, and

• 2. Ensure the

availability of drugs for medical purposes

“the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering… adequate provision must be made to ensure the availability of narcotic drugs for such purposes.” (Preamble,

• p. 13)!

UN Single Convention

Article 1, paragraph 2

For the purposes of this Convention a drug shall be regarded as “consumed” when it has been supplied to any person

• r enterprise for retail distribution,

medical use or scientific research; and “consumption” shall be construed accordingly.!

UN Single Convention Article 20, paragraph 1

The parties shall furnish to the Board… statistical returns on forms supplied by it in respect of the following matters: … (c) consumption of drugs.!

“The low levels of consumption of opioid analgesics for the treatment of pain in many countries, in particular in developing countries, continue to be a matter of serious concern to the Board.! The Board again urges all Governments concerned to…take steps to improve the availability of those narcotic drugs for medical purposes…” ! !(INCB 2007 Annual Report, p. 20)! INCB Concern!

Global Consumption of Morphine, 2010

**Austria’s consumption includes use of morphine for substitution therapy Sources: International Narcotics Control Board; World Health Organization population data By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2012

mg/capita 152 countries

Global Mean! 5.9912!

PPSG Collaboration with INCB

• INCB publishes consumption

statistics annually!

• Public INCB reports do not

include reported amounts that are less than 500 g!

• PPSG has a long-term

relationship with INCB !

• PPSG receives complete annual

raw data, including amounts less than 500 g, for the most recent year!

Uses of Consumption Statistics

• Identification of the opioids that are available

(i.e., manufacture or import authorization) in a country!

• An indicator of a country’s current and

historical ability to treat moderate to severe pain!

• A tool to evaluate the efforts to improve
• pioid availability (i.e., following removal of a

barrier.)!

Limitations of Consumption Statistics

• Some countries may not annually report or may report

incorrect statistics!

• Not able to distinguish between different clinical uses,

e.g., methadone to treat pain vs. addiction (dependence syndrome)!

• Not able to distinguish between types of pain being

treated, e.g., acute vs. chronic!

• Consumption for single drugs offers only a partial view
• f a country’s ability to manage pain!

10 20 30 40 50 60 70 80 90 100

High Income (48) Low- and Middle-Income (102)

Population Consumption of Morphine

Global Consumption of Morphine High-Income vs. Low - and Middle - Income Countries, 2008

Source: International Narcotics Control Board; United Nations Population Data, 2007; World Bank Income Classification, 2008. By: Pain & Policy Studies Group, University of Wisconsin /WHO Collaborating Center, 2010.

Percent total

17% 91% 83% 9%

Disparity in Consumption:

High vs. Low- and Middle-income countries (LMIC)

2010 Population

LMIC (16%) High Income (84%)

2010 Morphine Consumption (kg)!

High Income (90%)! LMIC (10%)!

2012 PPSG International Pain Policy Fellowship (IPPF)

Supported by – Open Society Institute IPCI: 2006- – US Cancer Pain Relief Committee: 2006- – Livestrong: » 2010-

0.0 0.5 1.0 1.5

SEARO mean, 0.1350 mg/capita Global mean, 5.9912 mg/capita Bhutan 3.9738 Sri Lanka 0.3872 India 0.0913 Bangladesh 0.0502

Sources: International Narcotics Control Board; World Health Organization population data By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2012

mg/capita

WHO Regional Office for Southeast Asia (SEARO) 2010 Morphine Consumption

10 20 30 40 50 60

Austria United Kingdom Denmark Switzerland Iceland France Slovenia Norway Sweden Germany Belgium Netherlands Spain Malta Ireland Luxembourg Slovakia Bulgaria Poland Finland Czech Republic Israel Italy Estonia Croatia Lithuania Cyprus Latvia Andorra Georgia Republic of Moldova Albania Hungary Portugal Bosnia and Herzegovina Ukraine Belarus Russian Federation Serbia Armenia Greece Montenegro Kazakhstan Uzbekistan Kyrgyzstan Turkey Turkmenistan Azerbaijan Tajikistan

EURO mean, 12.4285 mg/capita Global mean, 5.9912 mg/capita **Austria 122.5037 Kyrgyzstan 0.1048 Ukraine 0.6418 Albania 0.9429

**Austria includes data for substitution therapy Sources: International Narcotics Control Board; World Health Organization population data By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2012

mg/capita

WHO Regional Office for Europe (EURO) 2010 Morphine Consumption

Morphine Equivalence (ME) statistic – a more complete picture

PPSG developed a morphine equivalence (ME) statistic for each principal

• pioid used to treat severe pain:!
• Fentanyl!
• Hydromorphone!
• Methadone!
• Morphine!
• Oxycodone!
• Pethidine!

! Allows for a comparison of the consumption of morphine to the equianalgesic consumption of other medications! ! Total ME statistic represents in one metric the aggregate consumption of these principal opioid analgesics used for severe pain! !

Data sources: Consumption data - International Narcotics Control Board; Population – United Nations World Population Prospects, 2010 Revision; ME conversion factors – WHOCC Centre for Drug Statistics Methodology

Global Consumption in Morphine Equivalence (ME)

1980-2010, mg/person

10 20 30 40 50 60 70 Fentanyl ME Hydromorphone ME Methadone ME Morphine ME Oxycodone ME Pethidine ME Total ME

2009 Opioid Consumption in Morphine Equivalence

http://www.painpolicy.wisc.edu/!

Opioid Consumption Motion Chart http://www.painpolicy.wisc.edu/

1000 2000 3000 4000 5000 6000 7000 8000 9000 10000 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Morphine ME Total ME

Global Trend 1980 - 2008!

Source: International Narcotics Control Board By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2010

1000 2000 3000 4000 5000 6000 7000 8000 9000 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 High Income LMICs Global Total

Total ME: High Income vs. Low and Middle Income Countries!

Source: International Narcotics Control Board By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2010

PPSG’s Country Profiles!

http://www.painpolicy.wisc.edu/internat/countryprofiles.htm!

PPSG’s Country Profiles!

Consumption of Morphine 1980 - 2003 East vs. West Europe (mg/capita/yr)

5 10 15 20 25

8 8 1 8 2 8 3 8 4 8 5 8 6 8 7 8 8 8 9 9 9 1 9 2 9 3 9 4 9 5 9 6 9 7 9 8 9 9 2 2 1 2 2 2 3

Western Europe Eastern Europe

mg/capita!

Codeine Propox HC/DHC BuprPO BuprTD MoIR MoCR MoInj OcIR OcCR

• Methad. FentTD

FentTM HmIR HmCR PethInj

Finland France Norway Austria Portugal Italy Denmark Israel Netherlands Cyprus Greece Germany Luxemburg Spain Switzerland UK Belgium Iceland Turkey Free <25% Cost 25-50% Cost 50-75% Cost 100% cost

Opioid availability and cost: West Europe

Codeine Propox HC/DHC BuprPO BuprTD MoIR MoCR MoInj OcIR OcCR

• Methad. FentTD FentTM HmIR

HmCR PethInj Czech R. Croatia Latvia Rumania Slovak R. Hungary Estonia Serbia Bulgaria Moldova Poland Russia Monten. Maced. Bosnia-H Lithuania Belarus Albania Georgia Ukraine Free <25% Cost 25-50% Cost 50-75% cost 100% cost

Opioid availability and cost: Eastern Europe!

29!

30!

31!

32!

“Balance”!

Why is opioid use so low?

! 1995 Survey of government drug control authorities – 65 countries ! Impediments to opioid availability: Fear of addiction Lack of training Excessively restrictive laws and regulations Fear of legal consequences Insufficient amount of opioids Cost of opioids Inadequate health care resources Lack of national policy, guidelines

International Narcotics Control Board. (1996). Report

• f the International Narcotics Control Board for 1995:

Availability of Opiates for Medical Needs. New York, NY: United Nations.!

Why is opioid use so low?

! 2006 Survey of Health care workers, and hospice/PC staff in Asia, Africa and Latin America

Adams, V. (2007). Access to Pain Relief – an essential human right. Help the Hospices, Worldwide Palliative Care Alliance.!

Barriers to accessing oral morphine: ! Excessively strict national drug laws and regulations; ! Fear of addiction;! Poorly developed health care systems;! Lack of knowledge !

Barriers 1) Opioid Regulatory Policy! 2) Drug Distribution System! 3) Cost of Opioid Analgesics! 4) Knowledge & Attitudes!

" For governments and health professionals " Explains need, rationale and imperative " 16 criteria " Simplified Checklist " 22 Languages

Achieving Balance in National Opioids Control Policy: Guidelines for Assessment (2000)!

36!

" For governments and health professionals " Explains need, rationale and imperative " 16 criteria " Simplified Checklist " 22 Languages

Achieving Balance in National Opioids Control Policy: Guidelines for Assessment (2000)!

37!

38! http://www.who.int/medicines/areas/ quality_safety/guide_nocp_sanend/ en/! “ensuring balance opioids”!

The central principle of balance:

• a dual obligation of governments to establish a system of control

that ensures the adequate availability of controlled substances for medical and scientific purposes, while simultaneously preventing abuse, diversion and trafficking. Many controlled medicines are essential medicines and are absolutely necessary for the relief of pain, treatment of illness and the prevention of premature death. To ensure the rational use of these medicines, governments should both enable and empower healthcare professionals to prescribe, dispense and administer them according to the individual medical needs of patients, ensuring that a sufficient supply is available to meet those needs. While misuse of controlled substances poses a risk to society, the system

• f control is not intended to be a barrier to their availability for

medical and scientific purposes, nor interfere in their legitimate medical use for patient care.

• CND. Resolution 53/4: Promoting adequate availability of internationally controlled licit drugs

for medical and scientific purposes while preventing their diversion and abuse. 10th Plenary Meeting. 2010.

“Balance” is the Fundamental Principle!

National policy should establish a drug control system that prevents diversion and ensures adequate availability for medical use Drug control measures should not interfere with medical access to opioid

Guidelines

• 1. Content of drug control legislation & policy
• 2. Authorities and their role in the system
• 3. Policy planning for availability and accessibility
• 4. Healthcare Professionals.
• 5. Estimates and statistics.
• 6. Procurement
• 7. Other

Content of drug control legislation & policy

• 1. National drug control policies should recognize

that controlled medicines are absolutely necessary for medical and scientific purposes.

• 2. Governments should comply with their

international legal obligations to ensure adequate availability and accessibility of controlled medicines for all medical and scientific purposes through national legislation and drug control policies.

Authorities and their role in the system

• 3. Governments should designate a National

Authority for ensuring adequate availability and accessibility of controlled medicines in health care.

• 4. Governments should ensure that all authorities

involved in developing and implementing policies on controlled substances cooperate and meet as necessary for the promotion of their availability and accessibility for medical and scientific purposes as well as the prevention of abuse, dependence syndrome and diversion.

Authorities and their role in the system

• 5. Governments should ensure that there is a forum

where drug control authorities and public health authorities cooperate and meet as necessary with health professional organizations and other stakeholders for the promotion of the availability and accessibility of controlled medicines for medical and scientific purposes, as well as the prevention of abuse, dependence syndrome and diversion.

• 6. All government agencies, depending on their roles

and obligations, should ensure that in the fulfilment

• f their duties, they do not impede health policies

and access to legitimate treatment with controlled

• medicines. Health authorities should provide

relevant information on treatment principles to drug law enforcement and other relevant agencies.

Policy planning for availability and accessibility

7. Governments should include the availability and accessibility of controlled medicines for all relevant medical uses in their national pharmaceutical policy plans. They should also include the relevant controlled medicines and relevant services in specific national disease control programmes and other public health policies. 8. Governments should ensure that all population groups without discrimination equally benefit from their policies on the availability and accessibility of controlled medicines for rational medical use and the prevention of diversion, abuse, and dependence syndrome.

Policy planning for availability and accessibility

• 9. Governments should examine their drug

control legislation and policies for the presence

• f overly restrictive provisions that affect

delivery of appropriate medical care involving controlled medicines. They should also ensure that provisions aim at optimizing health

• utcomes and take corrective action as needed.

Decisions which are ordinarily medical in nature should be taken by health professionals.

• 10. Terminology in national drug control

legislation and policies should be clear and unambiguous in order not to confuse the use of controlled medicines for medical and scientific purposes with misuse.

Healthcare Professionals

• 11. Appropriately trained and qualified

physicians, and, if applicable, nurses and

• ther health professionals, at all levels of

health care should be allowed to prescribe and administer controlled medicines, based on their general professional license, current medical knowledge and good practice without any further license requirements.

• 12. Appropriately trained and qualified

pharmacists at all levels of health care should be allowed to dispense controlled medicines, based on their general professional license, current medical knowledge and good practice without any further license requirements.

Healthcare Professionals

13. Governments should promote that medical, pharmaceutical and nursing schools teach the knowledge and skills for the treatment of pain, substance use disorders in the context of medical use of controlled medicines, and other health conditions that need treatment with controlled medicines. 14. In countries where controlled medicines become available and accessible for the first time, governments should organize education initiatives for healthcare professionals to ensure their rational use.

Estimates and Statistics

• 15. Governments should develop a practical method to estimate

realistically the medical and scientific requirements for controlled substances, using all relevant information.

• 16. Governments should furnish to the INCB estimates and

assessments of the quantities of controlled substances required for legitimate medical and scientific purposes (estimates annually for narcotic drugs and certain precursors; assessments at least every three years for psychotropic substances). Governments should furnish supplementary estimates or modified assessments to the INCB if it appears that the availability of controlled substances for legitimate purposes will fall short because of initial underestimation of regular demand, emergencies or exceptional demand.

Estimates & Statistics

17. Governments are required to submit statistical reports to the INCB on narcotic drugs and psychotropic substances in accordance with the respective provisions of the international drug control conventions and relevant resolutions of the Economic and Social Council.

Procurement

18. Governments should ensure, in cooperation with companies and agencies managing distribution, that the procurement, manufacture, and distribution of controlled medicines are accomplished in a timely manner with good geographical coverage so that there are no shortages of supply, and that such medicines are always available when they are needed while maintaining adequate controls to prevent diversion, abuse, or dependence syndrome.

Procurement

19. Governments should minimize the negative impact of control and safety measures on the affordability and availability of controlled medicines. 20. Drug control authorities should be aware of the existence of the WHO model guidelines for the international provision of controlled medicines for emergency medical care, which provide a simplified procedure for importation and exportation of controlled medicines into a country where disaster disrupted the functioning of the drug control

• authorities. They should apply them when necessary.

Other

21. Governments that decide to bring medicines under national control that are not controlled under the international drug control conventions should apply these guidelines equally to those nationally controlled medicines.

Country Assessment Checklist

WHO Public Health Model __________________________

Drug ug Availa ilability bility Educ Education tion Polic

• licy

y

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