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?


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


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


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


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


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


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?


Thank you!

Pain & Policy Studies Group

University of Wisconsin-Madison

ensuring availability and preventing diversion international pain policy fellowship august 7, 2012...

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