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

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
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.
Goal is to inform Action Planning
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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
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
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
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From any part of the distribution system
– From within system: licensees, employees, patients
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From outside system: abusers/shoppers (fraud),
criminals (theft/robbery)
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Little data on types of unlawful activity
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
• ??
January 2011
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
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
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, mishandling
• Restrict prescribing authority
(INCB Survey quoted in UNODC, January 2011)
Communication is essential to achieving
balanced responses to diversion
DOMAIN
Pain
Diversion
HCPs
• Know about pain
control;
• Assess and treat
pain
• Comply with drug
control regulations
• Understand
diversion and avoid
contributing to it
DRUG CONTROLLERS
• Understand need for
pain control
• Ensure adequate drug
availability
• Manage control
system, monitor and
address diversion
• Avoid interfering in
pain control
Relevance to your country
Action Plan?
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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?
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Balanced drug control is necessary because…
Thanks to
the 2012 IPPF Fellows,
Government Representatives,
International Experts,
and Sponsors