1. Methods to Evaluate and Improve National Policy: Focus on 2011 WHO Guidelines and PPSG Global Policy Evaluation Aaron M. Gilson, MS, MSSW, PhD Research 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

2. 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 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.

3. World Health Organization (WHO): Ensuring Balance in National Policies on Controlled Substances (April 20, 2009) WHO Guidelines http://www.who.int/medicines/areas/quality_safety/GLs_Ens_Balance_NOCP_Col_EN_sanend.pdf8

4.  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 Guidelines Country 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.

5.  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 21 WHO Guidelines Country Assessment Checklist (67 items) World Health Organization. Ensuring balance in national policies on controlled substances: Guidance for availability and accessibility of controlled medicines. 2011.

6.  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” 21 WHO Guidelines Country Assessment Checklist (67 items) World Health Organization. Ensuring balance in national policies on controlled substances: Guidance for availability and accessibility of controlled medicines. 2011.

7.  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 21 WHO Guidelines Country Assessment Checklist (67 items)  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.

8.  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 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)  Other (Guideline 21)  Applying WHO Guidelines to medicines not controlled under international drug control conventions

9. 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.

10. 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 Single Convention on Narcotic Drugs of 1961

11. 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 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. 6. Withdrawal syndrome or analgesic tolerance are not confused with addiction

12. 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.

13. 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 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. 5. Length of prescription validity is restricted

14. 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.

15. 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

16. 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