Factors influencing the implementation of innovations

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Improving patient access to opioids through
consensus building with government
David E. Joranson Pain Policy Studies
Group World Health Organization Collaborating
Center www.medsch.wisc.edu/painpolicy
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Global Consumption of Morphine1972-2000
Kilograms
Source International Narcotics Control Board By
Pain Policy Studies Group/WHO Collaborating
Center, 2001 Top 10 countries Australia,
Canada, Denmark, Iceland, Ireland, New Zealand,
Norway, Sweden, the United Kingdom, and the
United States
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Global Per Capita Consumption of Morphine, 1999
mg/capita
GLOBAL MEAN 5.93 mg
Source International Narcotics Control Board
United Nations Demographic Yearbook, 1999 By
Pain Policy Studies Group, University of
Wisconsin/WHO Collaborating Center, 2002
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Morphine Consumption vs. Development Status, 1998
104 Countries
Source (1) International Narcotics Control
Board, (2) CIA population data, (3) Human
Development Index By University of Wisconsin
Pain Policy Studies Group/WHO Collaborating
Center, 1999
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Factors influencing diffusion of innovations

• Observable?
• Simple?
• Demonstrable?
• Relative advantage?
• Compatible?

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Factors influencing compatibility(i.e., the
barriers)

• Knowledge, attitudes
• Health care system policies, priorities,
  resources
• Policies governing opioids, professional practice

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Barriers perceived by government
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www.medsch.wisc.edu/painpolicy
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INCB Survey of National Governments

• Purpose To identify barriers to improving
  availability of opioids for relief of pain
• 48 national policies recognize medical
  necessity of narcotics/opioids
• 59 excessively strict narcotic laws and
  regulations
• 72 concern about drug abuse and addiction
• INCB, 1996

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Reasons for unavailability
(INCB, 2002)

• -Inadequate method, personnel to assess needs
• -Unduly restrictive regulations
• -Burdensome administrative procedures
• -Concerns about addiction, dependence
• -Physicians fear of investigation, penalties
• -Lack of medical training in pain relief

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Guidance to governmentsfor addressing barriers
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WHO/EDM/QSM/2000.4 ENGLISH ONLY DISTRIBUTION
GENERAL 
NARCOTIC PSYCHOTROPIC DRUGS  ACHIEVING BALANCE
IN NATIONAL OPIOIDS CONTROL POLICY    GUIDELINES
FOR ASSESSMENT
World Health Organization
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The goal is a balanced national policy

• National narcotics control system should ensure
  availability for medical use and patient care,
  while preventing diversion
• Efforts to prevent diversion must not interfere
  with availability of opioid analgesics to the
  patient

Source World Health Organization. Achieving
balance in national opioids control policy
Guidelines for Assessment. Geneva, Switzerland
WHO 2000.
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Achieving Balance in National Opioids Control
Policy Guidelines for Assessment (WHO, 2000)

- For governments and health professionals -
Explains need, rationale and imperative for
balanced national drug control policy - 16
criteria for evaluating national drug control
policy and administration - Simplified
Checklist www.medsch.wisc.edu/painpolicy
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Working Group on WHO Guidelines for Achieving
Balance in National Opioid Control Policy

• Mr. T. Yoshida WHO Geneva Sponsor
• Mr. D. Joranson WHOCC USA Chair
• Mr. R. Bhattacharji India
• Dr. C. Blengini Italy
• Dra. L. De Lima PAHO/Colombia
• Dr. P. Emafo Nigeria
• Ms. Gu Wei-ping China
• Dr. A. Nixon Saudi Arabia
• Ms. C. Selva INCB Secretariat- Vienna

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Achieving Balance in National Opioids Control
PolicyWHO, 2000

• 1. Estimate annual requirements
• 2. Administer an effective distribution system
  to the patient
• 3. Evaluate national narcotics control policy
• 4. Communication between government and health
  professionals

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Putting WHO Guidelines into action

• Chinese regulators and physicians (2000)
• Regulators from Asian countries (JICWELS 2001-02)
• WHO workshops with government teams
• 6 Andean countries (2000)
• 6 Central European Countries (2002)
• 5 African countries (2002)
• WHOCC project in India

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Population 273 million
Population 1.03 billion
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Consumption of Morphine in India
Kilograms
Source International Narcotics Control Board
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• As the domestic consumption of morphine has
  decreased to an extremely low level over the last
  few years, the Government of India should take
  effective measures to ensure its adequate
  availability for medical purposes.
• INCB, 1999

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What does low and declining use of morphine mean
for people in India?
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1994-1996 Morphine shortages

• Measures taken by doctors
• - Rationing of morphine
• Use less effective drugs codeine, buprenorphine
• Invasive procedures
• With these measures
• - only 10 received adequate pain relief

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The paradox

• India grows poppy to supply much of the worlds
  pain medications, yet a million Indians with
  cancer and pain have no access to morphine

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Why no oral morphine?

• - Fear of respiratory depression
• - Fear of addiction
• - Excessive licensing requirements
• - 1985 Narcotic Drugs Act

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• National opioid policy project
• Analysis of regulatory problem
• 1. Key informants, focus workshops (1992-94)

2. Review of national and state policies (1995)

• 3. Proposal to simplify national policy (1997)

4. Model state regulation (1997) 5. 11
Implementation workshops (1998- 2001)
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Present morphine licensing system in India
??
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WHOCC proposal to Government of India
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Workshops to adopt model rule
1998 2000
Kerala Andhra Pradesh
1999 Gujarat
Karnataka Madhya Pradesh
Maharashtra New Delhi
Orissa 2001
West Bengal Assam New Delhi
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KERALA 32 million
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Pain Palliative Care Society Link Centres
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Consumption of Morphine in India
Kilograms
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Project to evaluate morphine use, misuse and
diversion 1999-2000

• Study conducted in
• Pain and Palliative Care Clinic, Calicut,
  Kerala
• Supported by
• - PPSG/WHOCC, Madison-Wisconsin
• - United States Cancer Pain Relief Committee
• 4,057 patients treated
• 1723 received oral morphine (43)

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Pain Palliative Care ClinicCalicut, India

• 80 patients have cancer
• - 1/3 head and neck
• - 2/3 cervix, lung, breast, other
• 20 non cancer
• Peripheral vascular disease
• Neuralgias

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Results of 2 Year Evaluation

• Availability to patients ensured
• No shortages
• No evidence of misuse or diversion
• Increases in dose related to disease
• Lack of stock discrepancies
• No reports of loss or theft
• - No reports from law enforcement
• The Lancet 2001 358139-143

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But what ifmisuse or diversion of opioid
analgesics should take place, the sources of
diversion should be identified quickly and
directly, without affecting opioid availability
or patient care. The Lancet 2001 358139-143
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The Board notes with satisfaction that several
governments have taken steps to improve the
availability of narcotic drugs. For example, in
India, model regulations aimed at simplifying
access to morphine for use in palliative care
were developed by the Government, in cooperation
with WHO, in 1998 and have since been introduced
in several states in that country. INCB, 2001
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Take-home messages

• Government cooperation is essential
• Unduly restrictive regulatory requirements
  barriers can be changed
• Training of health professionals is essential
• Opioids can be made safely available
• Pain relief with limited resources is possible
• Patient access to pain relief is the bottom line

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Thank you!

• Univ of Wisconsin Pain Policy Studies Group
• WHO Collaborating Center for Policy and
  Communications
• www.medsch.wisc.edu/painpolicy