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Striving for equity in
the treatment of pain
Nandini Vallath
WHO CC for Training and Policy on Access to Pain Relief, India
Side Event - International Doctors for Healthier Drug Policies
Commission on Narcotics Drugs, UN, Vienna
Pain management requires Opioid
medications
WHO Model List of
Essential Medicines
Zech DF et al - Validation of World Health Organization
Guidelines for cancer pain relief: a 10-year prospective
study. Pain. 1995.63(1):65-76.
Opioids in Acute
& Chronic Pain
Cancer
Non-Cancer
120 countries with grossly inadequate
access and availability
HRW Survey
• 96% adults and 99% children who require opioids DO
NOT have access to it
Unbearable Pain ….Human Rights Watch report – 2010
Duthey B, Scholten W: J of Pain and Symptom management 2013
http://www.nacoonline.org/QuickLinks/HIVData
1/6th of world’s population
Inequity in the treatment of pain
Does drug policy have a role?
Inequity in the treatment of pain
• India a major producer
• Regulatory obstacles became
obvious in the 1990s
• Doctors  Taxation
department
Central Bureau of Narcotics
Ministry of Finance
National Competent Authority
18th -19th century
Opium as trade crop
• Need for monopoly
dictated the policy
language
19th -20th century
Opioids as drug for abuse
• Need to eradicate drug
abuse dictated the
policy language
Medical use
NOT within
policy
language
Poor stocking
Under-treatment
Fear
Poor demand
Prohibitory orientation of policies
impacted Knowledge, Attitudes,
Priorities and AVAILABILITY
Lack of Job
mandate for
NCA
for ensuring
availability
Complex
procurement,
procedures,
prescriptions
Doctors
No Training,
Experience in
using Opioids
Misconceptions
about opioid
benefits / risks
Threat of
Harsh
punishments
International Narcotics Control Board
Central Bureau of Narcotics
Ministry of Finance
Production
at Govt. Factories
Quotas to
Manufacturers
Opioid
Consumption
Mandate for
Regulations
Pain Relief Providers
Narcotics Control Bureau
Ministry of Home Affairs
Enforcement of drug laws
Distribution System
in India
1231-03-2016
Availability of essential
narcotics is NOT a
mandate at any of NCA
office!!
Post NDPS Act 1985, Morphine
consumption in india ↓ by 97% [716 Kg  18 Kgs]
Dr Nandini Vallath 13
J Cleary et al Annals of Oncology - Vol 24 (11) Dec 2013
Basis for National Drug Policies
• Ensure availability of drugs for medical and scientific
use
• “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
• Prevent against diversion and abuse
• “addiction to narcotic drugs constitutes a serious evil for the
individual and is fraught with social and economic danger
to mankind…” Preamble, p. 13
18th -19th century
Opium as trade crop
• Need for monopoly
dictated the policy
language
19th -20th century
Opioids as drug for abuse
• Need to eradicate drug
abuse dictated the
policy language
20th -21st century
Opioids as medicine
• Need to improve access
for medical use to
dictate policy language
Step1
Supportive Policy
Supportive
policies
Ensured and
SAFE access and
availability of
essential drugs
Poor access and
availability of
essential drugs
We are here..
Many other countries
What did it take for policy reform in India?
• Acknowledging Untreated pain as a major public health issue
• Awareness of the contribution of policy language to availability
• 25 years of efforts
• Support ……lots and lots of it
Teachers
Policy Analysis
Government
Civil Society Alliance
Litigation
Draft Proposal
of
National Program for Palliative
Care
for
12th plan (2012-17)
Directorate General of Health Services
Ministry of Health & Family Welfare
2014 Amendment of NDPS Act
Transformation of mindset of key policy makers - the notion that
ensuring opioid availability is an essential objective of the national
narcotic control policy
March 2016 - India
• The Revised Rules following the 2014 Act amendment not released
• Old barriers with New look
Unmet need for pain relief Continues
Study at Cancer Centres: Kolkata, Hyderabad, Ahmedabad, Cuttack
79.7% of the patients who came in with pain received inadequate or NO
pain management
30%
Authors: M R Rajagopal, Gayatri Palat, Joseph Amon, Diederik Lohman
Quality of Death Index
Wide availability of opioid analgesics-
was a constant element in countries
with high Indices
India
Ref: Economist Intelligence Report
Reoriented drug policy for all member-
states
What if all member states have
policies with appropriate
language ……??
Ensured and SAFE
access and
availability of
essential drugs
Poor access and
availability of
essential drugs
?
Striving for equity in the treatment
of pain
•Yes, we should have supportive drug policy
•What more should we do to overcome the
inequity?
Perceptions far more
powerful …than substance
of the law
Process towards equity
• Changing the perception of the purpose of drug policy
• Culture and mandates of competent authorities
• Reflect the spirit of policy reform in the functioning units
• Interagency collaboration, Participatory, inclusive consultative
processes
Perception of Purpose at the Highest level
Illicit use medical use
In the 5 UN Drug reports
……Out of the total
256 times of
mentioning “opioids”
"opioids for medical use” is mentioned 9 times
HRW
Expression of Purpose at the Highest level
Perception Purpose at the NCA
Revenue, Finance, Police, Crime, Home,
Foreign affairs, Economic development,
Drug enforcement, internal affairs
DEPARTMENT OF HEALTH
Reorientation of Policy Mandate
The Convention to articulate specific
provisions to ensure availability
Reorient National Drug Policy
Identify negative language, themes Add
Specific strategies, action plans
National Competent Authority
Should have Opioid Availability as their job mandate
Process towards equity
• Changing the perception of purpose of drug policy
• Culture and mandates of competent authorities
• Reflect the spirit of policy reform in the functions
• Interagency collaboration, Participatory, inclusive consultative
processes
Review of Policy Tools
Intent, priorities, language of the National Drug Control Strategy
With Specific Provisions and plans towards balance
MODEL POLICY??
The Participatory and inclusive
consultative process
Process towards equity
• Changing the perception of purpose of drug policy
• Culture and mandates of competent authorities
• Reflect the spirit of policy reform in the functions of the competent
authorities
• Interagency cooperation and collaborative action
• Participatory Inclusive consultative processes
Resources
• WHO guidelines for Ensuring balance in national policies
• WHO, UNODC and UNAIDS Technical Guides
• WHO/INCB Guidance for estimates
• World Health Assembly Resolution on Palliative Care
• International Community as Regional consultative Bodies?
Strong Licit Drug Distribution System
Level 6. PATIENTS
Level 2: National Competent Authority
Level 3. Importer/Manufacturers/Distributors
Level 1: International Narcotics Control Board
Level 4. Hospitals/Pharmacies/Hospice/PC
programs
Level 5. Physicians/Pharmacists/Other
X
Supportive
policies
Interagency
collaboration
Participatory,
inclusive
consultative
processes
Enlightened
implementation,
monitoring
Ensured and SAFE
access and
availability of
essential drugs
Poor access and
availability of
essential drugs
Agencies of
the UN unite
Conventions
Clear
Purpose of
drug policy
Medical
Availability a Job
Mandate of NCA
Functioning
supply and
distribution
systems
Simple
procedures for
access
Knowledge in
SAFE medical
usage of
opioids
Penalties
proportionate
to offence
More and more of Justice …..less and less of Rules
International
Community
NCA
31-03-2016 47
UNGASS 2016
For Freedom from Pain
Thank You
aanandini@gmail.com

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Nandini vallathvienna final

  • 1. Striving for equity in the treatment of pain Nandini Vallath WHO CC for Training and Policy on Access to Pain Relief, India Side Event - International Doctors for Healthier Drug Policies Commission on Narcotics Drugs, UN, Vienna
  • 2. Pain management requires Opioid medications WHO Model List of Essential Medicines Zech DF et al - Validation of World Health Organization Guidelines for cancer pain relief: a 10-year prospective study. Pain. 1995.63(1):65-76.
  • 3. Opioids in Acute & Chronic Pain Cancer Non-Cancer
  • 4. 120 countries with grossly inadequate access and availability HRW Survey
  • 5.
  • 6. • 96% adults and 99% children who require opioids DO NOT have access to it Unbearable Pain ….Human Rights Watch report – 2010 Duthey B, Scholten W: J of Pain and Symptom management 2013 http://www.nacoonline.org/QuickLinks/HIVData 1/6th of world’s population
  • 7. Inequity in the treatment of pain Does drug policy have a role?
  • 8. Inequity in the treatment of pain • India a major producer • Regulatory obstacles became obvious in the 1990s • Doctors  Taxation department
  • 9. Central Bureau of Narcotics Ministry of Finance National Competent Authority
  • 10. 18th -19th century Opium as trade crop • Need for monopoly dictated the policy language 19th -20th century Opioids as drug for abuse • Need to eradicate drug abuse dictated the policy language
  • 11. Medical use NOT within policy language Poor stocking Under-treatment Fear Poor demand Prohibitory orientation of policies impacted Knowledge, Attitudes, Priorities and AVAILABILITY Lack of Job mandate for NCA for ensuring availability Complex procurement, procedures, prescriptions Doctors No Training, Experience in using Opioids Misconceptions about opioid benefits / risks Threat of Harsh punishments
  • 12. International Narcotics Control Board Central Bureau of Narcotics Ministry of Finance Production at Govt. Factories Quotas to Manufacturers Opioid Consumption Mandate for Regulations Pain Relief Providers Narcotics Control Bureau Ministry of Home Affairs Enforcement of drug laws Distribution System in India 1231-03-2016 Availability of essential narcotics is NOT a mandate at any of NCA office!!
  • 13. Post NDPS Act 1985, Morphine consumption in india ↓ by 97% [716 Kg  18 Kgs] Dr Nandini Vallath 13
  • 14. J Cleary et al Annals of Oncology - Vol 24 (11) Dec 2013
  • 15. Basis for National Drug Policies • Ensure availability of drugs for medical and scientific use • “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 • Prevent against diversion and abuse • “addiction to narcotic drugs constitutes a serious evil for the individual and is fraught with social and economic danger to mankind…” Preamble, p. 13
  • 16. 18th -19th century Opium as trade crop • Need for monopoly dictated the policy language 19th -20th century Opioids as drug for abuse • Need to eradicate drug abuse dictated the policy language 20th -21st century Opioids as medicine • Need to improve access for medical use to dictate policy language
  • 18. Supportive policies Ensured and SAFE access and availability of essential drugs Poor access and availability of essential drugs We are here.. Many other countries
  • 19. What did it take for policy reform in India? • Acknowledging Untreated pain as a major public health issue • Awareness of the contribution of policy language to availability • 25 years of efforts • Support ……lots and lots of it
  • 23. Litigation Draft Proposal of National Program for Palliative Care for 12th plan (2012-17) Directorate General of Health Services Ministry of Health & Family Welfare
  • 24. 2014 Amendment of NDPS Act Transformation of mindset of key policy makers - the notion that ensuring opioid availability is an essential objective of the national narcotic control policy
  • 25.
  • 26. March 2016 - India • The Revised Rules following the 2014 Act amendment not released • Old barriers with New look
  • 27. Unmet need for pain relief Continues Study at Cancer Centres: Kolkata, Hyderabad, Ahmedabad, Cuttack 79.7% of the patients who came in with pain received inadequate or NO pain management 30% Authors: M R Rajagopal, Gayatri Palat, Joseph Amon, Diederik Lohman
  • 28. Quality of Death Index Wide availability of opioid analgesics- was a constant element in countries with high Indices India Ref: Economist Intelligence Report
  • 29. Reoriented drug policy for all member- states
  • 30. What if all member states have policies with appropriate language ……?? Ensured and SAFE access and availability of essential drugs Poor access and availability of essential drugs ?
  • 31. Striving for equity in the treatment of pain •Yes, we should have supportive drug policy •What more should we do to overcome the inequity?
  • 32. Perceptions far more powerful …than substance of the law
  • 33. Process towards equity • Changing the perception of the purpose of drug policy • Culture and mandates of competent authorities • Reflect the spirit of policy reform in the functioning units • Interagency collaboration, Participatory, inclusive consultative processes
  • 34. Perception of Purpose at the Highest level Illicit use medical use In the 5 UN Drug reports ……Out of the total 256 times of mentioning “opioids” "opioids for medical use” is mentioned 9 times HRW
  • 35. Expression of Purpose at the Highest level
  • 36. Perception Purpose at the NCA Revenue, Finance, Police, Crime, Home, Foreign affairs, Economic development, Drug enforcement, internal affairs DEPARTMENT OF HEALTH
  • 37. Reorientation of Policy Mandate The Convention to articulate specific provisions to ensure availability Reorient National Drug Policy Identify negative language, themes Add Specific strategies, action plans National Competent Authority Should have Opioid Availability as their job mandate
  • 38. Process towards equity • Changing the perception of purpose of drug policy • Culture and mandates of competent authorities • Reflect the spirit of policy reform in the functions • Interagency collaboration, Participatory, inclusive consultative processes
  • 39. Review of Policy Tools Intent, priorities, language of the National Drug Control Strategy With Specific Provisions and plans towards balance
  • 40. MODEL POLICY?? The Participatory and inclusive consultative process
  • 41. Process towards equity • Changing the perception of purpose of drug policy • Culture and mandates of competent authorities • Reflect the spirit of policy reform in the functions of the competent authorities • Interagency cooperation and collaborative action • Participatory Inclusive consultative processes
  • 42. Resources • WHO guidelines for Ensuring balance in national policies • WHO, UNODC and UNAIDS Technical Guides • WHO/INCB Guidance for estimates • World Health Assembly Resolution on Palliative Care • International Community as Regional consultative Bodies?
  • 43. Strong Licit Drug Distribution System Level 6. PATIENTS Level 2: National Competent Authority Level 3. Importer/Manufacturers/Distributors Level 1: International Narcotics Control Board Level 4. Hospitals/Pharmacies/Hospice/PC programs Level 5. Physicians/Pharmacists/Other X
  • 45. Agencies of the UN unite Conventions Clear Purpose of drug policy Medical Availability a Job Mandate of NCA Functioning supply and distribution systems Simple procedures for access Knowledge in SAFE medical usage of opioids Penalties proportionate to offence
  • 46. More and more of Justice …..less and less of Rules International Community NCA
  • 47. 31-03-2016 47 UNGASS 2016 For Freedom from Pain Thank You aanandini@gmail.com

Editor's Notes

  1. 88% achieve Pain relief using WHO guidelines
  2. They combined INCB 2013 data with epidemiological factors that influence the regional medical need for opioid analgesics
  3. > 80 % global population live in countries that utilise 9.5% of world’s licit opium
  4. Focus of national regulations is prohibitory  Negative language
  5. “Medical Use” and the patient requiring these medicines left undefined within the policy Multiple licenses and agencies causing barriers for transportation from source to dispensary Inadequate knowledge - Concerns about addiction, negative attitudes, rreluctance to prescribe or stock Special authorization required to prescribe special forms to fill Discouraged by the extra administrative, record keeping requirements Anxiety of harsh punishments for even minor errors Misconceptions and opiophobia- professionals, public and POLICY MAKERS Poor availability of palliative care and pain management services
  6. Government opium and Alkaloid Works
  7. Of the many contributory factors – prescription related factors are mentioned here E.G India - Restrictions on the drug and quantity and duration that may be prescribed – e.g. Methadone may be prescribed for OST but not for pain management
  8. Opioids belong to the Schedule 1. Because of this, opioid production, consumption, and importation are strictly controlled
  9. Time changes perspectives Striving for improving access to pain relief
  10. The experience from India of engaging with policy makers, judicial interventions and advocacy, awareness activity 25 years of relentless efforts
  11. Evolution of a diligent multi-sectorial civil-society alliance committed to reform Wonderful citizens of India
  12. Cancer Control Policy prioritized availability of opioids Awareness workshops – 1992-1994 Direct Supply – 10,000 tablets purchased by Min of Health for the Cancer centres Licensure difficulties with distribution Refusal to accept the consignment, misconceptions on opioids
  13. Dialogue between the Department of Revenue  Min of Health Transitions in job mandates unclear Implementation strategies not clearly defined There is an entrenched anti-drug culture Debate on Standard Operating procedures
  14. 2015 Index evaluates 80 countries using 20 quantitative and qualitative indicators across five categories: the palliative and healthcare environment, human resources, the affordability of care, the quality of care and the level of community engagement > 70 % countries had unsatisfactory QOL during terminal phase
  15. Some amongst the reds and orange do have policy language
  16. Law enforcement
  17. Perceptions and expressions at the highest level….
  18. The core UN pillars of human rights, development, peace and security Keeping Health central to the Drug Policies at the highest level and reflect the same at country levels INCB, UNODC, WHO, UNAIDS, UN Develoopment Program and other relevant entities in Geneva and New York and Vienna Interagency participatory action to strengthen the HEALTH component of drug policy policy reforms can go ahead, guided by evidence and human rights principles but unhindered by legal constraints coming from outdated drug control treaties Synchronous implementation of WHA 2014 resolution - Strengthening of palliative care within the Health Policy framework Synergise action plans with the framework of the Sustainable Development Goals
  19. Now that this high level discussion has acknowledged the negative impact of the international drug control system
  20. Did it identify availability of controlled substances for medical purposes as an objective? Did it include specific agencies and measures to ensure medical availability? Did it identify prevention of misuse / diversion of controlled medicines as an objective? Did it include specific measures to prevent such misuse or diversion? Is there evidence for Interagency cooperation
  21. Developing standards on the use of controlled medicines for HIV Prevention, Treatment and Care for Injecting Drug Users Guidelines for opioid substitution therapy
  22. Define the patient who needs a controlled medicine, Abuse - drug use inconsistent with or unrelated to acceptable medical practice Support for estimating medical need for controlled substances Training healthcare workers on appropriate use of opioids Eliminating excessive restrictions on prescribing and dispensing Click The main idea is that when the system’s functioning is optimal and responsibilities are administered efficiently, the DDS will allow for a smooth flow of controlled substances to meet demand, and efficient estimation of annual requirement Click while also minimizing the likelihood of diversion occurring. Errors in the licit system dealt distinctly from illicit system
  23. – drug availability when and where needed, education of professionals, awareness amongst public Health, Human welfare, Security, Revenue, Law, internal affairs
  24. Accessibility is the degree to which a medicine is obtainable for those who need it at the moment of need with the least possible regulatory, social or psychological barriers. Availability is the degree to which a medicine is present at distribution points in a defined area for the population living in that area at the moment of need.
  25. The core UN pillars of human rights, development, peace and security Keeping Health central to the Drug Policies at the highest level and reflect the same at country levels INCB, UNODC, WHO, UNAIDS, UN Develoopment Program and other relevant entities in Geneva and New York and Vienna Interagency participatory action to strengthen the HEALTH component of drug policy policy reforms can go ahead, guided by evidence and human rights principles but unhindered by legal constraints coming from outdated drug control treaties Synchronous implementation of WHA 2014 resolution - Strengthening of palliative care within the Health Policy framework Synergise action plans with the framework of the Sustainable Development Goals