Transcript Case: increased use of oral morphine at home did not lead to

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
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…”
International Narcotics Control Board
Importers / Manufacturers / Distributors
Hospitals / Pharmacies / Hospice/ PC facilities
Physicians / Pharmacists / Nurses
PATIENTS
Information
Opioid Analgesics
National Competent Authority
How control system ensures access
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
Pain & Policy Studies Group, 2008
How control system prevents diversion
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
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 Group, 2007
Pain & Policy Studies Group
Balancing drug control
and availability responsibilities
Pain
Diversion
HEALTH CARE
• Know about pain
control;
• Assess and treat
pain
• Comply with
regulations
• Understand
diversion and avoid
contributing to it
Pain & Policy Studies Group, 2007
DRUG CONTROL
• Understand pain
control
• Ensure adequate
availability
• Manage control
system, monitor for
diversion
• Avoid interfering in
pain control
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 Group, 2007
Pain & Policy Studies Group
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