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, Wiscons in ! ! 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 or 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. !
INCB Concern ! “ 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) !
Global Consumption of Morphine, 2010 mg/capita Global Mean ! 5.9912 ! 152 countries ** 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
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 opioid 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 of a country’s ability to manage pain !
Global Consumption of Morphine High-Income vs. Low - and Middle - Income Countries, 2008 Population Consumption of Morphine Percent total 100 90 80 91% 70 83% 60 50 40 30 20 10 17% 9% 0 High Income (48) Low- and Middle-Income (102) 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.
Disparity in Consumption: High vs. Low- and Middle-income countries (LMIC) 2010 Population LMIC (16%) High Income (84%) LMIC (10%) ! High Income (90%) ! 2010 Morphine Consumption (kg) !
2012 PPSG International Pain Policy Fellowship (IPPF) Supported by – Open Society Institute IPCI: 2006- – US Cancer Pain Relief Committee: 2006- – Livestrong: » 2010-
WHO Regional Office for Southeast Asia (SEARO) 2010 Morphine Consumption SEARO mean, 0.1350 mg/capita Global mean, 5.9912 mg/capita mg/capita 1.5 Bhutan 3.9738 1.0 Sri Lanka 0.3872 Bangladesh India 0.5 0.0502 0.0913 0.0 Sources: International Narcotics Control Board; World Health Organization population data By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2012
WHO Regional Office for Europe (EURO) 2010 Morphine Consumption mg/capita EURO mean, 12.4285 mg/capita Global mean, 5.9912 mg/capita 60 **Austria 122.5037 50 40 30 Albania Ukraine Kyrgyzstan 0.9429 0.6418 0.1048 20 10 0 United Kingdom Austria Denmark Switzerland Iceland France Slovenia Norway Sweden Germany Belgium Netherlands Spain Malta Ireland Luxembourg Slovakia Bulgaria Poland Czech Republic Finland Israel Italy Estonia Croatia Lithuania Cyprus Latvia Andorra Republic of Moldova Georgia Albania Bosnia and Herzegovina Hungary Portugal Ukraine Russian Federation Belarus Serbia Armenia Greece Montenegro Kazakhstan Uzbekistan Kyrgyzstan Turkey Turkmenistan Azerbaijan Tajikistan **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
Morphine Equivalence (ME) statistic – a more complete picture PPSG developed a morphine equivalence ( ME ) statistic for each principal opioid 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 ! !
Global Consumption in Morphine Equivalence (ME) 1980-2010, mg/person 70 Fentanyl ME 60 Hydromorphone ME Methadone ME Morphine ME 50 Oxycodone ME Pethidine ME Total ME 40 30 20 10 0 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
2009 Opioid Consumption in Morphine Equivalence http://www.painpolicy.wisc.edu / !
Opioid Consumption Motion Chart http://www.painpolicy.wisc.edu/
Global Trend 1980 - 2008 ! 10000 9000 Morphine ME Total ME 8000 7000 6000 5000 4000 3000 2000 1000 0 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 Source: International Narcotics Control Board By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2010
Total ME: High Income vs. Low and Middle Income Countries ! 9000 8000 High Income LMICs Global Total 7000 6000 5000 4000 3000 2000 1000 0 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 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) mg/capita ! 25 20 Western Europe Eastern Europe 15 10 5 0 0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0 1 2 3 8 8 8 8 8 8 8 8 8 8 9 9 9 9 9 9 9 9 9 9 0 0 0 0 0 0 0 0 2 2 2 2
Opioid availability and cost: West Europe 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% 25-50% 50-75% 100% Cost Cost Cost cost
Opioid availability and cost: Eastern 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% 25-50% 50-75% 100% Cost Cost cost cost
29 !
30 !
31 !
“Balance” ! 32 !
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 International Narcotics Control Board. (1996). Report Lack of national policy, guidelines of the International Narcotics Control Board for 1995: Availability of Opiates for Medical Needs . New York, NY: United Nations. !
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