Download Methods to Evaluate and Improve National Policy: Focus on 2011

Methods to Evaluate and Improve National Policy:
Focus on 2011 WHO Guidelines and PPSG Global
Policy Evaluation
International Pain Policy Fellowship
Pain & Policy Studies Group
WHO Collaborating Center for Pain Policy & Palliative Care
University of Wisconsin Carbone Cancer Center
August 8, 2012
Aaron M. Gilson, MS, MSSW, PhD
Research Program Manager/Senior Scientist
Pain & Policy Studies Group
Conceptual Framework for WHO Guidelines
and PPSG Global Policy Evaluation
The Central Principle of Balance
The central principle of “balance” represents 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.
While misuse of controlled substances poses a risk to society, the system of
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.
World Health Organization. Ensuring balance in national policies on controlled substances:
Guidance for availability and accessibility of controlled medicines. 2011.
WHO Guidelines
World Health
Organization (WHO):
Ensuring Balance in
National Policies on
Controlled
Substances
(April 20, 2009)
21 WHO Guidelines
Country Assessment Checklist (67 items)
Objective: To be used by governments, health care
practitioners, and others to determine whether their national
drug control system has the legal, administrative, and policy
framework required to make medicines available for pain
relief and other purposes.
 Content of drug control legislation and policy
(Guidelines 1 & 2)

Recognize that controlled medicines are necessary for
medical and scientific purposes
 Governments should comply with international legal
obligation to ensure LACM for medical and scientific
purposes (including the relief of pain and suffering)
LACM = legitimate availability of controlled medicines
World Health Organization. Ensuring balance in national policies on controlled substances: Guidance for
availability and accessibility of controlled medicines. 2011.
21 WHO Guidelines
Country Assessment Checklist (67 items)
 Authorities and their role in the system
(Guidelines 3-6)




Designate a national Competent Authority to ensure LACM
Authorities who create policies should coordinate to
promote LACM and prevent abuse, dependence syndrome,
and diversion
Cooperation between government authorities and health
care professionals to ensure LACM and prevent abuse,
dependence syndrome, and diversion
Government agencies should avoid impeding LACM, and
there should be cooperation between health authorities and
law enforcement/other agencies
World Health Organization. Ensuring balance in national policies on controlled substances: Guidance for
availability and accessibility of controlled medicines. 2011.
21 WHO Guidelines
Country Assessment Checklist (67 items)
 Policy planning for availability and accessibility
(Guidelines 7-10)


National medicines policy plans include LACM
Policies should ensure that all patient populations
benefit from LACM
 institutional and home-care access


Examination of national policies to ensure LACM and
prevent abuse, dependence syndrome, & diversion
Clear and unambiguous terminology
 particularly “addiction”
World Health Organization. Ensuring balance in national policies on controlled substances: Guidance for
availability and accessibility of controlled medicines. 2011.
21 WHO Guidelines
Country Assessment Checklist (67 items)
 Health professionals (Guidelines 11-14)

Training and being allowed to treat pain
 Physicians, pharmacists, and nurses and all others who
prescribe, dispense, or administer


School curriculum
Educational initiatives when opioids become available for
the first time
 Estimates and statistics (Guidelines 15-17)


Realistic estimates of medical and scientific requirements
for controlled substances
Furnish annual estimates to the INCB
 Supplementary estimates

Submit quarterly and annual statistical reports to the INCB
World Health Organization. Ensuring balance in national policies on controlled substances: Guidance for
availability and accessibility of controlled medicines. 2011.
21 WHO Guidelines
Country Assessment Checklist (67 items)
 Procurement (Guidelines 18-20)



Procurement, manufacture, and distribution is
accomplished in a timely manner with good
geographical coverage to reduce supply shortages
Reduce the negative impact of control and safety
measures on affordability and availability
Awareness and use of existing WHO Model Guidelines
for the International Provision of Controlled Medicines
for Emergency Medical Care
 Simplified procedure for importing and exporting
http://apps.who.int/medicinedocs/pdf/who32e/who32e.pdf
 Other (Guideline 21)

Applying WHO Guidelines to medicines not controlled
under international drug control conventions
World Health Organization. Ensuring balance in national policies on controlled substances: Guidance for
availability and accessibility of controlled medicines. 2011.
PPSG Global Policy Evaluation
Objective: To be used to
determine if a country’s
legislation, regulations, and
administrative policies
promote adequate
availability of opioid
medicines for safe and
effective medical uses, and
do not create barriers to
their legitimate uses.
Livestrong Funded Project
Pain & Policy Studies
Group (PPSG):
Improving Global
Opioid Availability for
Medical Purposes: A
Guide to Evaluation
of National Laws
(in preparation)
PPSG Global Policy Evaluation
Positive Criteria related to the Single
Convention on Narcotic Drugs of 1961
1. Acknowledges the intent to carry out drug control
Conventions
2. Designates administrative responsibility to implement the
Conventions in the country (e.g., Competent Authority)
3. Acknowledges that it is the Government’s responsibility to
ensure adequate provision of narcotic drugs for medical
and scientific purposes
4. Recognizes that the medical use of controlled substances
are indispensable for the relief of pain and suffering,
including being necessary for the public health
Pain & Policy Studies Group. Improving Global Opioid Availability for Medical Purposes: A Guide to Evaluation of
National Laws. University of Wisconsin Carbone Cancer Center. In process.
PPSG Global Policy Evaluation
Positive Criteria related to the
Central Principle of Balance
1. Pain management is general healthcare practice
2. Medical use of opioids is recognized as legitimate
professional practice
3. Pain management is encouraged
4. Practitioners’ concerns about sanctions are addressed
5. Prescription amount is insufficient to determine legitimacy
of prescribing
6. Withdrawal syndrome or analgesic tolerance are not
confused with addiction
Pain & Policy Studies Group. Improving Global Opioid Availability for Medical Purposes: A Guide to Evaluation of
National Laws. University of Wisconsin Carbone Cancer Center. In process.
PPSG Global Policy Evaluation
Positive Criteria related to the
Central Principle of Balance
7. Other provisions that may enhance pain management
Category A: Issues related to health care professionals
 ability to perform professional responsibilities without having to
acquire an additional license
 authorizes healthcare workers with appropriate training to
prescribe controlled medicines
Category B: Issues related to patients
 allows equitable treatment, especially with specific at-risk patient
populations
Category C: Regulatory or policy issues
 requires health professional schools (e.g., medical, pharmacy,
and nursing schools) to provide curricula regarding the medical
use of controlled medicines, including pain management and the
use of opioids
Pain & Policy Studies Group. Improving Global Opioid Availability for Medical Purposes: A Guide to Evaluation of
National Laws. University of Wisconsin Carbone Cancer Center. In process.
PPSG Global Policy Evaluation
Negative Criteria related to the
Central Principle of Balance
1. Opioids are considered a treatment of last resort, regardless
of pain severity
2. Medical use of opioids is implied to be outside legitimate
professional practice
3. Withdrawal syndrome or analgesic tolerance are confused
with “addiction”
4. Medical decisions are restricted
Category A: Restrictions based on patient characteristics
Category B: Mandated consultation
Category C: Undue prescription quantity or duration limits
Category D: Undue prescription limitations
5. Length of prescription validity is restricted
Pain & Policy Studies Group. Improving Global Opioid Availability for Medical Purposes: A Guide to Evaluation of
National Laws. University of Wisconsin Carbone Cancer Center. In process.
PPSG Global Policy Evaluation
Negative Criteria related to the
Central Principle of Balance
6. Practitioners are subject to undue prescription requirements
 multiple-copy or counterfoil prescription forms
 patients receiving controlled medications be registered in or
reported to a national, state, or local database
7. Other restrictive language
Category A: Issues related to health care professionals
Category B: Issues related to patients
Category C: Regulatory or policy issues
8. Policy language is ambiguous
Category A: Arbitrary standards for legitimate prescribing
Category B: Unclear intent leading to possible misinterpretation
Category C: Conflicting or inconsistent policies or provisions
Pain & Policy Studies Group. Improving Global Opioid Availability for Medical Purposes: A Guide to Evaluation of
National Laws. University of Wisconsin Carbone Cancer Center. In process.
Action Steps:
Need for Policy Improvement
 Become familiar with international policy change tools
 language that promotes LACM
 potential barriers to LACM
 Become familiar with your country’s policy requirements
 “policy” includes laws (Acts), regulations, accords, decrees,
resolutions, and ministerial orders
 Formulate action plan to address policies in a balanced manner
 Type of policy dictates with whom to engage
Provincial, state, or local
 Engage with government members to promote review of and
improvements in current policy content
 framework of Balance
 International call
Action Steps:
Need for Policy Improvement
 Determine whether terminology relates to currently-accepted
standards (WHO “dependence syndrome”)
 Ensure that “addiction” does not characterize only the
development of withdrawal syndrome or tolerance
 Present findings at national/regional/global meetings
 Include description of process
 Offer assistance in developing new policy language
 Monitor for policy change, and periodic monitoring for future
change