1. Preventing drug diversion: Principles and concepts International Pain Policy Fellowship August 7, 2012 David E. Joranson Distinguished Scientist, Founder University of Wisconsin Pain & Policy Studies Group

2. INCB to National Governments: Prevent diversion; Ensure adequate availability “...an efficient national drug control regime must involve not only a programme to prevent illicit trafficking and diversion, but also a programme to ensure the adequate availability of narcotic drugs for medical and scientific purposes” International Narcotics Control Board, 1995.

3. Goal is to inform Action Planning What is diversion? “Diagnosing” and “treating” diversion Single Convention measures What is balanced diversion control? What is unbalanced diversion control? Importance of communication between health professionals and regulators

4. Diversion is… Diversion is the transfer of a drug from a licit to an illicit channel of distribution or use. “Diversion” is used this way in the Single Convention. By definition, diversion is unlawful activity

5. Types, extent, methods and data vary Loss from accidental breakage is not diversion People divert drugs from distribution system for non medical use (to abuse or sell) Diverters –From any part of the distribution system –From within system: licensees, employees, patients –From outside system: abusers/shoppers (fraud), criminals (theft/robbery) –Little data on types of unlawful activity

6. Impacts of diversion Harm and tragedy: opioid-related abuse, overdose, death Publicity may exacerbate patient fears HCPs may be reluctant to prescribe Increased regulation of opioids ??

7. January 2011

8. Single Convention measures for safe distribution of controlled medicines Import & manufacture of supply within estimate –Only for medical and scientific purposes Licenses for manufacture, trade, distribution –“adequate qualifications for full and faithful execution” –Record-keeping requirements Reporting statistics, including consumption Medical prescription required for lawful possession -Official Rx forms optional

9. What is a balanced response to diversion? Identify persons who violate the law (diagnosis) Inspection, investigation Correction, penalty Correction (treatment) should address the problem, and not adversely affect needed patient access (do no harm) By law, diversion control is the work of government law enforcement and regulators, in cooperation with HCPs

10. Responses to diversion that are “unduly restrictive or burdensome” Limit the number of days’ supply per Rx Limit the dose that may be prescribed Require patients to have special permission or registration Strong penalties for record-keeping errors, mis- handling Restrict prescribing authority ( INCB Survey quoted in UNODC, January 2011)

11. Communication is essential to achieving balanced responses to diversion DOMAIN HCPsDRUG CONTROLLERS Pain Know about pain control; Assess and treat pain Understand need for pain control Ensure adequate drug availability Diversion Comply with drug control regulations Understand diversion and avoid contributing to it Manage control system, monitor and address diversion Avoid interfering in pain control

12. Relevance to your country Action Plan? Data on amount, sources of diversion? Single Convention measures fully implemented and enforced? INCB comment on national policy or implementation? Palliative care education include diversion? Communicate with your regulator? Messages? –Balanced drug control is necessary because…

13. Thanks to the 2012 IPPF Fellows, Government Representatives, International Experts, and Sponsors