Ensuring Availability and Preventing Diversion International Pain Policy Fellowship August 7, 2012...
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Transcript of Ensuring Availability and Preventing Diversion International Pain Policy Fellowship August 7, 2012...
Ensuring Availability
and Preventing Diversion
International Pain Policy Fellowship
August 7, 2012
David E. JoransonUniversity of Wisconsin Pain & Policy Studies Group
Paul P. Carbone Comprehensive Cancer Center
World Health Organization Collaborating Center
www.painpolicy.wisc.edu
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
Why does diversion occur?
Pain & Policy Studies Group, 2007
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: ??
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
“Drugs don’t have legs…”
Op
ioid
An
alg
esi
cs
Info
rma
tion
International Narcotics Control Board
Hospitals / Pharmacies / Hospice/ PC facilities
PATIENTS
National Competent Authority
Importers / Manufacturers / Distributors
Physicians / Pharmacists / Nurses
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
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
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 GroupPain & Policy Studies Group, 2007
Balancing drug control and availability responsibilities
HEALTH CARE DRUG 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
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
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 GroupPain & Policy Studies Group, 2007
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
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
Thank you!
Pain & Policy Studies Group
University of Wisconsin-Madison