Methods to Evaluate and Improve National Policy: Focus on 2011 WHO Guidelines and PPSG Global Policy...

Methods to Evaluate and Improve National Policy: Focus on 2011 WHO Guidelines and PPSG Global

Policy Evaluation

Methods to Evaluate and Improve National Policy: Focus on 2011 WHO Guidelines and PPSG Global

Policy Evaluation

Aaron M. Gilson, MS, MSSW, PhDResearch Program Manager/Senior Scientist

Pain & Policy Studies Group

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

World Health Organization. Ensuring balance in national policies on controlled substances:Guidance for availability and accessibility of controlled medicines. 2011.

Conceptual Framework for WHO Guidelines and PPSG Global Policy Evaluation

Conceptual Framework for WHO Guidelines and PPSG Global Policy Evaluation

The Central Principle of BalanceThe 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 (WHO):

Ensuring Balance in National Policies on Controlled Substances(April 20, 2009)

WHO GuidelinesWHO Guidelines

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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)

21 WHO GuidelinesCountry Assessment Checklist (67 items)


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.

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.

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




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”




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


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 exportinghttp://apps.who.int/medicinedocs/pdf/who32e/who32e.pdf




Other (Guideline 21) Applying WHO Guidelines to medicines not controlled

under international drug control conventions

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

?Livestrong Funded Project

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.

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 EvaluationPositive Criteria related to the Single

Convention on Narcotic Drugs of 1961

PPSG Global Policy EvaluationPositive Criteria related to the Single

Convention on Narcotic Drugs of 1961

PPSG Global Policy EvaluationPositive Criteria related to theCentral 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



7. Other provisions that may enhance pain managementCategory 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


PPSG Global Policy EvaluationNegative 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 characteristicsCategory B: Mandated consultationCategory C: Undue prescription quantity or duration limitsCategory D: Undue prescription limitations


5. Length of prescription validity is restricted





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 languageCategory A: Issues related to health care professionalsCategory B: Issues related to patientsCategory C: Regulatory or policy issues

8. Policy language is ambiguousCategory A: Arbitrary standards for legitimate prescribingCategory B: Unclear intent leading to possible misinterpretationCategory C: Conflicting or inconsistent policies or provisions


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 engageProvincial, state, or local

Engage with government members to promote review of and improvements in current policy content framework of Balance International call



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

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