1. Ensuring Availability and Preventing Diversion International Pain Policy Fellowship August 7, 2012 David E. Joranson University of Wisconsin Pain & Policy Studies Group Paul P. Carbone Comprehensive Cancer Center World Health Organization Collaborating Center www.painpolicy.wisc.edu

2. Definition of diversion “Diversion” is the transfer of a drug from a licit to an illicit channel of distribution or use. Pain & Policy Studies Group, 2007

3. Why does diversion occur? Pain & Policy Studies Group, 2007

4. Does drug control policy allow for drug availability? International drug control law: YES Treaty responsibilities of National governments: YES Recommendations of international organizations: YES National policies and procedures: ??

5. Obligation of National Governments to Ensure Availability of Opioids “...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. By: University of Wisconsin Pain & Policy Studies Group/WHO Collaborating Center, 2000

7. “Drugs don’t have legs…”

8. Opioid Analgesics Information International Narcotics Control Board Hospitals / Pharmacies / Hospice/ PC facilities PATIENTS National Competent Authority Importers / Manufacturers / Distributors Physicians / Pharmacists / Nurses

9. International Narcotics Control Board Confirm estimated requirements Ensure adequate international supply National Policy/Competent Authority Approve needed drugs Estimate requirements; use adequate method; consult with HCP Report consumption statistics Authorize import/manufacture/distribution of adequate amounts Importers, Manufacturers, Distributors Procure adequate amounts; distribute promptly; avoid shortages Hospitals, Pharmacies, Patient care programs (“Retail”) Obtain licenses; make pain relief a priority; support training Anticipate needs; procure adequate amounts; maintain stocks Physicians/Nurses Obtain training; assess and treat pain; Rx according to patient need Patients Report pain; take medication as directed How control system ensures access Pain & Policy Studies Group, 2008

10. International Narcotics Control Board Confirm estimated requirements; monitor import/export Arrange for secure cultivation and movement of material National Policy/Competent Authority (and other agencies) Import/manufacture only within confirmed estimate Rules for licensing, import/export, transit, security, reporting, forms, prescriptions, dispensing; inspection; require medical prescriptions Importers, Manufacturers, Distributors Adhere to rules for secure storage, records, reports Distribute only to authorized entities Hospitals, Pharmacies, Patient care programs (“retail level”) Maintain secure storage, inventory, records; report theft Dispense on medical prescription Physicians Avoid contributing to abuse; examine patients; Rx for medical purposes; Patients Safe storage; don’t share; dispose left-overs How control system prevents diversion Pain & Policy Studies Group, 2008

11. Methods of diversion at the national level Theft from the distribution system - Manufacturers, distributors, shipments, hospitals, pharmacies, patients/homes Dishonest health professionals Prescription fraud (Loss from accidental breakage, etc) - Not really diversion Pain & Policy Studies Group Pain & Policy Studies Group, 2007

12. Balancing drug control and availability responsibilities HEALTH CAREDRUG CONTROL Pain Know about pain control; Assess and treat pain Understand pain control Ensure adequate availability Diversion Comply with regulations Understand diversion and avoid contributing to it Manage control system, monitor for diversion Avoid interfering in pain control Pain & Policy Studies Group, 2007

13. When diversion does occur, use a balanced response If misuse or diversion of opioid analgesics should occur, the person who is the source of diversion should be identified quickly and addressed directly, without affecting drug availability or patient care. This is the work of law enforcement and regulators, with cooperation of health professionals Pain & Policy Studies Group, 2007

14. Unbalanced responses to diversion? Terminate availability of opioid Restrict prescribing for all physicians Switch to lesser controlled drug Why are these “unbalanced”?? Pain & Policy Studies Group Pain & Policy Studies Group, 2007

15. Take-away messages The Single Convention establishes an obligation to relieve pain and suffering Availability and access to opioids should increase Diversion and abuse should be prevented When diversion occurs, use a balanced approach The Single Convention drug control system is intended to ensure availability as well as to prevent diversion Medical use of opioids and drug control are compatible Pain & Policy Studies Group, 2007

16. Applications for Fellows (Action Plans) Inform policy recommendations Inform control and tracking measures/implementation Increase understanding and communication between healthcare and regulatory Inform educational efforts Other? Pain & Policy Studies Group, 2007

17. Thank you! Pain & Policy Studies Group University of Wisconsin-Madison